Critical Analysis of Strategic Adoption of Biologic Medication in Pharmaceutical Industry Case Study of LEO Pharma

A Case Study of Leo Pharma
Surname, Initials: Ghaith Albasha, GA

Cohort 17
CRITICAL ANALYSIS OF STRATEGIC ADOPTION OF BIOLOGIC MEDICATIONS IN
THE PHARMACEUTICAL INDUSTRY: A CASE STUDY OF LEO PHARMA
MBA
Date of submission: 1st of August
Ethic code: 2020D0315
CARDIFF METROPOLITIAN UNIVERSITY

Declaration and Statement

This work is being submitted in partial fulfilment of the requirements for the degree of
MBA .and has not previously been accepted in substance for any degree and is not being
concurrently submitted in candidature for any degree.
Signed:
Date: 18th of March 2021
STATEMENT 1
This dissertation is the result of my own work and investigations, except where otherwise stated.
Where correction services have been used, the extent and nature of the correction is clearly
marked in a footnote(s).
Other sources are acknowledged by footnotes giving explicit references. A bibliography is

appended.
Signed:
STATEMENT 2
I hereby give consent for my dissertation, if accepted, to be available for photocopying and for
inter-library loan, for deposit in Cardiff Metropolitan University’s e-Repository, and that the title
and summary may be available to outside organizations.
Signed:

Supervisor’s Statement
Supervisor Declaration Form
Student Name: Ghaith Albasha
Supervisor’s Name: Stephen Bibby
I acknowledge that the above-named student has regularly attended the planned meetings and
actively engaged in the dissertation supervision process. They have provided regular timely draft
chapters of the dissertation and followed given guidance.
Signed ..........Stephen Bibby....................................
Date .............29/07/21.................................
Acknowledgment
I would like to express my deep gratitude to my supervisor Dr. Stephen Bibby who
expertly guided me through my thesis step by step, Dr. Stephen always showed
enthusiasm and excitement to mark my work and provide me with insightful feedbacks.
Our meetings were always full of fruitful discussions and kept me constantly engaged
with my research.
My appreciation extends to my colleagues, Mohamed Helmi’s mentoring and

encouraging have been especially valuable, his insights on the biologic market and
knowledge helped me a lot to finalize the thesis. Thanks also to Ahmed Safwat for his
enthusiasm in helping me with all the information and details about the biologic market, I
learned a lot from our discussions and I’m looking forward for more discussions.
continuous support, advices, positive vibes, sense of humor they all provided me with
genuine support and kindness and helped me to sustain a positive atmosphere.
Above ground, I’m indebted to my family, the backbone that always supported me,
without them I wouldn’t have reached this level of success, my parents, showing love
and care, I acknowledge my father, Fadhil who is my champion and my inspiring leader,
the teacher and the friend, who guided me and taught me everything in life, he’s a great
father first and great businessman second.
My special thanks to all my friends who helped me and supported me either with
company or with great times, on top Ali Jassim, who encouraged me to continue
working my MBA, who helped me when I needed help, he’s been a great friend.
Lastly, I offer my regards and benefits to everyone who have been of aid and support to
me to finish this thesis.
Abstract
The discovery, growth, and manufacture of drug molecules are concepts that influence
the pharmaceutical industry’s operations and sustainability. However, time and financial
constraints, data collection issues, reduced enjoyment from participation, inadequate
research training, absence of local supportive infrastructure, increasing contract
complexity, changing sophistication of regulations, lack of trust, unequipped research
environment, poor prioritization, and shortage of specialists are critical factors that are
challenging the advancement of the sector. In this regard, the purpose of this study was
to critically analyze the strategic adoption of biological drug in the pharmaceutical
industry through the prism of LEO Pharma. The researcher gathered information and
knowledge on strategic approaches used by the pharmaceutical industry to embrace
biologic medications as a core treatment approach besides enhancing understanding on
the rationale for adopting biologically based drugs and drawing conclusion and
recommendations on biological medications as a core treatment approach. This study
evaluated the strategic approaches of adopting biologics medications at LEO Pharma
as core treatment plans in an exploratory research with an inductive approach. The
researcher conducted qualitative and semi-structured interviews with two subject matter
experts selected through convenience sampling. The findings illustrated that LEO
Pharma has not effectively adopted of biologics as a core treatment approach, despite
expecting biologics to become the leading revenue source by 2030. The firm has limited
number of commercialized and underdevelopment biologics notwithstanding extensive
investment. LEO Pharma is unable to commercialize its developed innovations and
generate positive return on investment. The firm needs to embrace biologics medication
strategically by introducing techno-financial and care services for funding development
and commercialization of medical innovations. The enhancement of innovation,
motivation, strategic choice, cost, and economics will enhance financial performance,
competitiveness, and business continuity of the firm. Thus, strategic embracement of
biologics will aid long-term strategic planning, product development, communication,
and partnership for successful manufacturing and commercializing of biologics
medications.
Contents
Declaration and Statement.........................................................................................................i
STATEMENT 1......................................................................................................................... i
STATEMENT 2......................................................................................................................... i
Supervisor’s Statement............................................................................................................. ii
Supervisor Declaration Form....................................................................................................ii
Acknowledgment...................................................................................................................... iii
Abstract..................................................................................................................................... iv
Contents..................................................................................................................................... v
Introduction................................................................................................................................ 1
Background.............................................................................................................................. 1
Rationale................................................................................................................................. 2
Research Questions................................................................................................................3
Aims and Objectives................................................................................................................3
Methodology............................................................................................................................ 4
Scope...................................................................................................................................... 5
Limitations................................................................................................................................ 6
Outline..................................................................................................................................... 6
Literature Review....................................................................................................................... 8
Introduction.............................................................................................................................. 8
Biologic Medication..................................................................................................................8
Rationale for Strategic Adoption of New Biologically Based Drugs..........................................9
Strategy............................................................................................................................... 9
Innovation.......................................................................................................................... 10
Operational Effectiveness..................................................................................................11
External Factors promoting adoption.................................................................................11
Strategic Adoption of Biologic Medications............................................................................12
The Need for Strategic Position.........................................................................................12
Operational effectiveness...................................................................................................12
Innovation.......................................................................................................................... 12
Marketing New Drugs/Products..........................................................................................13
Outcomes of Strategic Adoption............................................................................................16
Costs of Developing New Products....................................................................................16
Economics of Biologics......................................................................................................17
Legal frameworks............................................................................................................... 18
The Impetus for Change and Change Process......................................................................19
Strategic Choice................................................................................................................. 20
Conclusion............................................................................................................................. 21
Methodology............................................................................................................................ 23
Introduction............................................................................................................................ 23
Research Philosophy............................................................................................................. 23
Research Approach............................................................................................................... 23
Case Study............................................................................................................................ 24
Qualitative Research.............................................................................................................. 25
Data Collection...................................................................................................................... 26
Interviews........................................................................................................................... 26
Sampling............................................................................................................................ 27
Data Analysis......................................................................................................................... 27
Validity and Reliability............................................................................................................ 27
Ethical Considerations........................................................................................................... 28
Results and Discussion.......................................................................................................... 29
Introduction............................................................................................................................ 29
Rationale for the Adoption of New Biologically Based Drugs.................................................29
Performance Measurements..............................................................................................29
The Impetus for Biologics at Leo Pharma..........................................................................29
Cost of Biologics Medication..............................................................................................30
Operational Effectiveness..................................................................................................30
Future of Biologics Medication...........................................................................................31
Documented Strategic Choice...........................................................................................31
Resource Prioritization.......................................................................................................32
LEO Pharma Biologics Performance..................................................................................32
Discussion............................................................................................................................. 32
Cost and Economics.......................................................................................................... 32
Strategic Choice................................................................................................................. 32
Marketing........................................................................................................................... 33
Innovation.......................................................................................................................... 34
Summary............................................................................................................................... 34
Conclusion and Recommendations.......................................................................................36
Recommendations................................................................................................................. 38
References............................................................................................................................... 39
Appendix.................................................................................................................................. 45
Interview Script 1................................................................................................................... 45
Interview Script 2................................................................................................................... 52
Introduction
Background
The adoption of new or unique medication in the health sector requires enhanced
cooperation between different stakeholders (Morley and Cashell 2017). Each group of
stakeholders provide or support crucial tool for fostering trials, deployment, or adoption
of proposed medication or diagnosis. However, the participation is not guaranteed due
to time and financial constraints, data collection issues, reduced enjoyment from
participation, inadequate research training, absence of local supportive infrastructure,
increasing contract complexity, changing sophistication of regulations, lack of trust,
unequipped research environment, poor prioritization, and shortage of specialists (Badr,
2018; English et al., 2010). The challenges constrain development and adoption of new
medication and diagnosis techniques and approaches. In this regard, the strategic
adoption of new medicines is facing significant limitations due to the absence of
enhanced cooperation among all stakeholders.
The discovery, growth, and manufacture of drug molecules are concepts factors that
influence operations and sustainability of the pharmaceutical industry. Until now, the
role of the industry was to execute research (discovery of new drug molecules) and
legal enforcement through nearly independent players (meeting the guidelines by
various regulatory authorities in terms of safety and performance of therapeutic drugs).
However, the research and development of new molecule are a very complex process
where a research center need several scientists from different knowledge backgrounds
and experiences to create a new molecule. In this regard, drug discovery and research
takes around 10 - 15 years and the average cost for introducing it to the market is
between $314 million and $2.8 billion (Wouters et al., 2020). The complexity and costs
cannot be entrusted on a single organization, meaning that cooperation is paramount in
modern research and development.
Big disruptions have altered the pharmaceutical industry's position with emergence of
new technology and decline of conventional medicines. Salman et al. (2020) indicate
that weak and unstructured research and development apparatus are critical factors
sidelining the pharmaceutical industry in the enhancement of medical care. Teramae et
al. (2020) argue that the conventional model of pharmaceutical business is increasingly
becoming obsolete and encouraging individual firms to adopt strategic transactions that
will increase the number of approved drugs and treatment models. Additionally, the
patent cliffs and the expiry of blockbuster drug patents, often require improvements to
the business models of the pharmaceutical industry, which have helped many small
generic drug firms to compete with pharmaceutical giants by entering the market with
cost-effective copies of expensive blockbuster drugs. However, the reduced income
among pharmaceutical giants are discouraging investment in research and
development. The industry is becoming increasingly dependent on established practices
and care rather than development of new medical techniques and tools.
This study focuses on analyzing the strategic adoption of biological medication in the
pharmaceutical industry based on the findings and predictions of the Transparency
Market Research (TMR). The expected global biologic market expansion between 2016
and 2024 is around 10.9%, which present significant investment and revenue
generation opportunities. The TMR research explains that the total market revenue
could jump to 479.7$ Billion in 2024 from 231.2$ Billion achieved in 2017.[CITATION
Tra16 \l 1033]. The guaranteed growth of biological medication necessitates assessing
strategic adoption of the innovation in the pharmaceutical industry. In this regard, the
sector needs enhanced preparedness to manufacture, prepare, market, distribute, and
dispense biological medication.
Rationale
The treatment of immune-related diseases is not limited to biologics. However, biologic
medicines are gradually revolutionizing medical research by providing new approaches
of treating or managing immune-related diseases that have been challenging
conventional medications. For instance, biologics have revolutionized to a certain
degree cancer care and provided patients with hope for treatment using emerging
choices. National Cancer Institute (2019) notes that cancer patients can choose
different immunotherapy approaches, including immune system modulators, treatment
vaccines, monoclonal antibodies, t-cell transfer therapy, and immune checkpoint
inhibitors. Meanwhile, use of immunotherapy and oncolytic virus therapy to treat cancer
reduce side effects and generates long-lasting efficacy (Phan, 2014; Schirrmacher,
2019). Therefore, enhancing popularity of biologic medications, chiefly for cancer

patients, is highly critical to societal health and welfare.
Pharmaceutical businesses with annual revenue not exceeding $3 billion are
experiencing significant market challenges due to globalization and digitization. As a
result, they need new business models that will integrate emerging technologies and
express high level of flexibility to effectively respond to the rapidly changing market.
Historically, the explosion of the dotcom bubble in the computing industry forced IBM
(International Business Machines) to switch to service model. Thus, the pharmaceutical
firms need to embrace emerging medical technologies and innovation to revitalize their
competitiveness and relevance in the market. However, embracing strategic adoption in
their business models is relatively challenging, time consuming, and expensive,
meaning enhanced knowledge of the concept is essential before its endorsement.
This paper examines business and related issues, which impact on the current business
model for pharmaceuticals. The study also examined accepted new creative
technologies and their detrimental effect on sales growth. In this regard, the researcher
identified several measures and recommendations for fixing the problem by modifying
the pharmaceutical environment. The researcher further analyzed the success of firms
seeking to change their corporate models through several techniques, mostly fusions
and acquisitions. Early outcomes are particularly relevant, as it is impossible to foresee
or plan if businesses cannot make a substantial improvement to their corporate process
or structure, so investors and shareholders praise or threaten companies by meeting
their pre-fusion or reorganization commitments.
Research Questions
 Can LEO pharma strategically embrace biological medication into its treatment
strategies?
Aims and Objectives
The aim of the research is to critically evaluate the rationale for the adoption of new
biologically based drugs in the pharmaceutical industry using the case study of LEO
Pharma. In this regard, this study’s objectives are
1. Gathering analytical information and knowledge on approaches used by the

pharmaceutical industry to strategically embrace biologic medications as a
core treatment approach,
2. Evaluate and test data for inspiring change in the field of pharmaceuticals,
and
3. Draw conclusions and recommendations on effects of strategically adopting
biological medications as a core treatment approach in the pharmaceutical
industry.
Methodology
This study utilized inductive approach with qualitative data collected from different
sources, including journals, peer-reviewed articles, books, corporate websites, and
other articles available online. The researcher utilized the resources build a solid base
for further analysis and responding to the research questions. The research formulated
two semi-structured interviews with managers from LEO Pharma organization to collect
primary data regarding the adoption of biologic medication. The case study involved
LEO Pharma A/S, a leading global pharmaceutical organization specialized in
dermatology based in Denmark. LEO Pharma was founded in 1908 and operates in
more than 100 countries. The pharmaceutical firm has more than one hundred years of
experience as a pharmaceutical business, dedicated to discovering and creating new
medicines for patients.
 Market goods worldwide in more than 100 countries.
 6,000 devoted colleagues in 61 countries are employed.
In the meantime, LEO Pharma is intended as the leading medical dermatology company
with a wider range of treatments, including oral, biological, and topical treatments, and
investing in rare skin disease therapies. The organization also needs 125 million people
to attain safe skin, which amounted to 76 million in 2018. Such growth is ambitious, but
it has the benefit of not needing to achieve these objectives and of giving shareholders
rich returns[CITATION LEO \l 1033]. In this context, the case study involved techniques
for collecting primary qualitative data and justifying the researcher’s decisions data
gathering and analysis.
Scope
The enhanced competition in modern business environment is encouraging enterprises
to embrace new strategies. The primary goal is to enhance competitiveness and
business continuity. In this regard, Chesbrough 2003 developed the innovation of
biologic medication in different industries to recognize its future sustainability. Although
some aspects of open innovation are in use in different ways in the pharmaceutical
industry, recent discussion primarily concerning the pharmaceutical industry illustrated
an ongoing research to develop a pharmaceutical open innovation theoretical structure.
The pharmacy business is a component of diversified industry containing numerous
actors in different stages who practice open innovation. In this regard, this study
focuses on strategic adoption of biologic medication in the pharmaceutical industry is a
critical tool for promoting sustainability and competitiveness of individual businesses.
The pharmaceutical industry has been using non-biologic medications, which are
becoming ineffective for treating and managing chronic conditions. Although the
established treatment approaches are relatively cheap and readily available, they are
proving ineffective with mutation of pathogens. As a result, numerous people around the
world do not get satisfactory treatment or management of their medical condition. In this
regard, Salman et al. (2020) indicate that weak and unstructured research and
development apparatus are critical factors sidelining the pharmaceutical industry in the
enhancement of medical care. The industry need to embrace new and innovative
treatment approaches away from conventional medications to guarantee growth and
business continuity of individual firms.
The study focuses on analyzing how pharmaceutical companies are implementing or
choosing their biological medication using a case study. The researcher conducted two
semi- structured interviews with higher manager in LEO pharma to determine the
methods and rationale of LEO Pharma decision on biologic medications in their
products portfolio (Chesbrough, 2003). The assessment focused on the factors that
promote strategic adoption of the medical innovation as a reliable alternative for treating
common and chronic ailment. In this regard, the researcher evaluated the role of
strategic adoption on corporate performance and established medication supply chain.
The goal was to understand the role of biological medications on growth, sustainability,
productivity, and business continuity of pharmaceutical companies. The assessment

also identifies the challenges, risks, and weaknesses of adopting biologic medications
as crucial sources of growth.
Limitations
This research involved a case study that focused on LEO Pharma. The approach
allowed in-depth analysis of a single firm, which is not an effective representation of the
entire pharmaceutical industry. In this context, the generalization of the findings is
relatively misleading because the sector involves millions of individual businesses of
varying sizes and operating from distinct consumer segments and geographic location.
The researcher utilized two semi-structured interviews involving two managers,
meaning that the study did not consider views of all critical stakeholders, including
suppliers, investors, customers, executive management, and clerical workers. In case
the interviewees lacked adequate knowledge on the study area or possessed personal
biases, the study might have suffered from constrained reliability and validity.
Meanwhile, the research significantly relied on secondary sources, which lack
guarantee for quality or established methods for assessing validity.
Outline
Chapter 1 discusses foundation of the study by evaluating the background, presenting
the research questions, aims, and objectives, summarizing methodologies, and
describing the scope. The section also presents limitations that constrained the findings
and practicality of the inferences. Chapter 2 evaluates previous literature on how some
businesses have already responded to strategic adoption by seeking ways to improve
their business operations, such as finding ways to acquire or get investors that do not
currently have an asset in their portfolio. Chapter 3 is devoted to methodology, whereby
the researcher described the methods and techniques for collected primary data from
the field. The offer justifications for choices and decisions employed in data gathering
besides concluding the section with an ethical consideration. Chapter 4 comprises the
results obtained from primary study conducted in Chapter 3 and literature review in
Chapter 2. The researcher formulated a discussion that links the findings from primary
research with existing knowledge base. The final section named chapter 5 is devoted to
the conclusion and policy recommendations. The researcher summarizes the findings
on the entire study before using the identified conclusion to formulate policy and
managerial recommendations.
Literature Review
Introduction
In this chapter, we are carrying out a detailed analysis of current research information to
provide the appropriate basis for our discussions. Biological medicines are the most
sophisticated treatments available that are used to cure multiple illnesses and disorders.
Meanwhile, alternatives, such as usable organics have revolutionized cancer care,
deferred or reversed immune deficiencies, improved people's lives, and gave hope to
many patients who did not have effective drug choices for their disease previously. Leo
Pharma notes that about 125 million people worldwide have immune-mediated
psoriasis, a chronic and inflammatory condition. In particular, patients with plaque
psoriasis, which is the most prevalent form, face an elevated risk of contracting other
disorders like heart disease and metabolic syndrome. There is a high degree of loss of
fulfillment. LEO Pharma highlights need to extend an effective dermatology pipelines
into new treatments and indications. In this regard, strategic adoption of biologic
medications is highly essential in fostering efficient and reliable health care.
Consequently, this chapter evaluates the existing knowledge base on strategic adoption
and biologic medication to formulate a strong foundation for the subsequent primary
research.
Biologic Medication
Biological drugs vary in ways that influence their therapeutic utility, management,
processing, and costs from traditional medicines. Traditional medicines have been
made via chemical synthesis conventional medicines are made. The method requires
an artificial process with beneficial chemical reactions to obtain more than one
medicinal substance. Chemical substance handling requires a sequence of reactions of
one or more molecules that transform when subjected to certain conditions. Yuan et al.
(2016) indicate that firms that maintains traditional business model relies on reaction of
different reagents and chemical compounds to develop desired treatment products.
Therefore, traditional industries refer to the final products as reaction outcomes.
However, biological and traditional drugs are both made and put on the market in the
health sector. For instance, LEO Pharma employs Fucidin is a conventional antibiotic
cream with fusidic acid for destroying harmful bacteria on the skin of the human body
upon application. The medication cannot however be offered to people with fusidic acid
allergy (LEO Pharma 2020). Furthermore, repeated cream use can establish a
resistance to antibiotics in patients. The substance is different from new generation
medicines because they are produced by chemical engineering.
Rationale for Strategic Adoption of New Biologically Based Drugs
Strategy
Strategic management is an old term, it was first appeared in 1950s according to Seth
and Thomas (1994), Strategic management is crucial step in every organization to
increase their profit and improve their competitiveness. The strategic adoption is a
concept from strategic management on why or what are the factors that an organization
decides to select or choose when investing in a particular product or field ( JAOUA,
2014). According to Karanja and Wario (2015), the term describes the strategic choices
refer to the activities in organizations that focus on understanding of principles guiding
future strategy and evaluation and selection of strategic options. The strategic adoption
highlights why some pharmaceutical organization adopt strategic management in
certain products or field while others fail to consider the concept. The pharmaceutical
industry is a large and competitive industry that requires continuous growth, meaning
individual organizations need innovative strategic adoption to thrive in the market
(JAOUA, 2014). Thus, the concept is crucial in the pharmaceutical segment for fostering
competitiveness and sustainability by identifying profitable investment opportunities and
suitable business decisions.
Brown et al. (2019) indicates that high need for cognition, low confidence, and negative
feedback significantly foster strategic adoption. This research conducted in a school
environment concluded that factors that affect strategy change are numerous,
depending on the characteristics of firm or customers. Anyieni and Areri (2016)
assessed strategic adoption in secondary schools in Kenya as tool for directing
transformation of plans to action by prioritizing fiscal requirements, conveying corporate
strategy, and formulating competitive edge. The researchers found that democratic style
of management with clear top-down communication influenced strategic adoption.
Therefore, learning institution tend to embrace strategic adoption due to constrains on
their operation environment besides the characteristics of critical stakeholders, including

staff members and learners.
Strategic adoption requires effective selection and implementation of plans. Wandera
(2014) notes that poor choices result to massive losses while effective selection with
poor oversight generates undesired results. The assessment of financial institutions in
Eldoret Kenya revealed that organizational structure, adoption of business level
strategies, industry competition and corporate culture influence strategic orientation
(Wandera, 2014). In this context, Karanja and Wario (2015) indicate that the most
critical factors that influence strategic adoption in nongovernmental organizations
include technological advances, increased diversification, economic growth, culture,
leadership, pressure from donors, and organization structure. Meanwhile, strategic
adoption is a multifaceted concept obtaining influence from business scope or level of
interaction with operational environment. Resource endowment is also a critical
influencer due to its role in the accomplishment of established goals and objectives.
Consequently, Karanja and Wario (2015) highlight external environment, culture, vision
and mission, availability of resources, organization structure, and leadership as the
factors promoting or challenging strategic adoption in corporate settings. The concept
depends on business environment, characteristics, and resources.
Innovation
Companies tend to adopt superior innovation and replace inferior solutions. The relative
advantage that forces firm to embrace new technology include economic feasibility,
convenience factor, or status aspect. Nonetheless, the factor cannot guarantee fast
diffusion, meaning that firms tend to evaluate compatibility. In this regard, innovation
must be consistent with established organizational culture, beliefs, values, and norms.
Moreover, technology adopters require innovation to deliver expected function with
enhanced ease of use. Technologies with low level of complexity appeal to numerous
customers, resulting in competitive edge in the market. In this regard, modern
customers require trialability to convince them that a given innovation will satisfy their
requirement. The degree of observability influences strategic adoption by encouraging
organizations to value or favor highly observable innovations.
The nature of innovation, technology, or concept under consideration by a business

determine factors influencing strategic adoption. For instance, Jaoua et al. (2013)
assessed adoption of strategic management and found that organizational structure has
insignificant role, skills of the entrepreneur has partial correlation, and the nature of the
environment has a central role. Mosleh and Elayan (2012) indicate that perceived
usefulness and available infrastructure are the main components that steer strategic
adoption in modern organizations. Additionally, Nyangara et al. (2015) identified firm
characteristic, including size, ownership structure, scale of operation, and scope of
operation as crucial influencers.
Operational Effectiveness
Kyntheum is a biologic medication for treating severe psoriasis. A physician administers
living cells to human bodies, which mimic or change processes (Psoriasis Association,
2018). Kyntheum is popular in the treatment of plaque psoriasis characterized by red
scale patches among adults who require systemic treatment administered as oral
medicines or injectable (European Medicines Agency, 2017). Additionally,
approximately 1% of patients treated with oral kyntheum experience pain in the mouth
and throat. However, popularity of the medication is rising around the world due to its
effectiveness compared conventional medical, which offer management rather than
treatment.
The continued and enhanced use of kyntheum in an example of the expanding
popularity of biologic medication. The medication reflects conventional concepts found
in traditional medicines, including mode of action and symptoms. In this regard, the
pharmaceutical industry requires enhanced planning to embrace biologic medication. As
a result, the sector will have adequate strategies and measures for formulating ethical
consumption besides effectively controlling side effects and contraindication. The
institution of strategic adoption of biologic medication improves compliance with
established legislations and regulations. Meanwhile, many regulatory policies in the
United States for improving pharmaceutical market competition extend beyond
biosimilars to include biological reference products, to mean individual firms require
enhanced understanding of the implications of existing policies and laws on their
businesses after adopting biologic medication.
External Factors promoting adoption

The external issues steering strategic adopting were challenges emanating from
enhanced liberalization, globalization, and technological change, while personal factors
dependent on personality traits. In this context, strategic adoption involves a set of
influencing factors with partial or critical correlation.
Strategic Adoption of Biologic Medications
The Need for Strategic Position
The cost of biologics is relatively high and gradually increasing. Dabrowska (2019)
reports that, in the United States, the annual cost of administering drugs, such as
eculizumab and elosulfase alfa, exceeds $250,000 per patient, while the spending on
biologics increased by 12.5% in 2017 from 2016 to $120.1 billion. However, coordinated
government efforts and market factors significantly influence the pricing of biologics and
biosimilar. For instance, European countries with price regulation interventions and a
competitive market forced AbbVie to reduce the price of monoclonal antibody Humira by
80% in October 2018 (Dabrowska, 2019). Therefore, manufacturing, marketing, and
distribution of biologics and biosimilars require individual firms to embrace strategic
adoption practices.
Operational effectiveness
Biologics and biosimilar require special handling in manufacturing, distribution, and
administration. Dabrowska (2019) notes that the medications constitute specialty drugs
due to special handling required to contamination by unwanted substances and
microbes. In this regard, the expensive drugs are dispensed by pharmacies with
specialized facilities and personnel.
Innovation
Biotechnology represents a critical breakthrough that significantly contributes to
pharmaceutical innovation by enhancing patient care, mechanisms of action, and
combined therapy. Rybka, Roijakkers, Lundan, and Vanhaverbeke (2015) indicate that
the focal concept of pharmaceutical innovation is advanced therapeutic, meaning that a
new drug that improves patient care compared to existing options obtains a priority
rating, leading to faster clearance for marketing and ﬁrst-cycle approval rates. In this
regard, new drugs that advance available therapy are not innovation imperative,
meaning marketing clearance is not highly prioritized. Rybka et al. (2015) indicate that
biologics in the United States represented high innovation between 1998 and 2006,
resulting in accelerated clearance by Food and Drug Administration. Meanwhile, small
microenterprises are the majority stakeholders in the biotechnological sector due to their
enhanced innovation, but most fail due to inadequate financing. Therefore, increased
approval of biologics requires a high level of innovation and massive capital investment,
which demand strategic adoption.
The classical diffusion theory outlines the factor that influences dissemination of
innovation in the healthcare sector. Thomas and McCarty (2004) acknowledge that
strategic adoption allows individual firms to consider communication methods,
characteristics of stakeholders, organizational structures, nature of the technology, and
cost in distributing clinical innovations. In this regard, biologics should articulate relative
advantages over existing technologies, promise new and effective therapies, and
possess compatibility with current drug treatment practices (Thomas & McCarty, 2004).
Moreover, disseminating information on social systems and professional networks
through advertising, social media, and mainstream media is essential for creating
awareness. Thomas and McCarty (2004) argue that success information should foster
favorable reimbursement, competitive marketplace, organizational slack, system
openness, and academic network. In this context, strategic adoption guarantees a
collection and interaction of critical resources required for high-efficiency levels. Thus,
the concept provides enhanced planning required success development and
commercialization of biologics.
Marketing New Drugs/Products
The development and marketing of biologics and biosimilar are expensive ventures.
Rybka et al. (2015) indicate that the ventures require state-of-the-art technologies and
specialized laboratories operated by skilled professionals who perform risky and costly
experiments. Moreover, revenue generation from biotechnological invention requires
transforming a registered patent to a marketed drug, which involves extensive success,
development, and growth limitations. In this context, Rybka et al. (2015) report that
biotechnological companies need strategic adoption of biologics to ensure they do not
exclusively focus on research excellence without engaging in the accumulation of
strategic, operational, and commercial capabilities for successfully launching the

products in the market.
The penetration of biologics in the healthcare sector is relatively limited. Sengupta
(2018) notes that the main barriers to adoption in standard treatment practices include
available drugs treating a limited number of disease, high cost of development, and the
need for developed health systems to supervise treatment. However, strategic adoption
has enabled some firm to reap a substantial return on investment. Sengupta (2018)
indicates that pharmaceutical firms focus on distributing biologics in high-income
countries. For instance, approximately 19% of rheumatoid arthritis patients in Europe
used biologics in 2010, while more than 3.1 million patients in the United States were
using the seven top-selling biologics in 2014. In this context, Sengupta (2018) notes that
the United States market account for a 32.4% growth of spending on biologics and more
than half of revenues generated by the sale of biologics. The top 2015 selling drugs in
the country in 2016 were biologics, suggesting that strategic adoption of biologics in the
pharmaceutical industry focuses on distributing them in high potential markets.
In addition, the go-to-market skills involved in marketing biologics require expertise
obtained through an extensive investment of time, capital, and human resources. In an
attempt to foster strategic adoption, small firms with limited resources embrace strategic
alliances that provide complementary skills with draining scarce resources away from
research and innovation (Rybka et al., 2015). Therefore, strategic planning and
adoption of biologic therapy in the pharmaceutical industry are essential for growth,
profit generation, value creation, and business continuity.
The substitution of established therapies is relatively slow and complex due to a lack of
adequate knowledge on the new drugs. Garjón, Azparren, Vergara, Azaola, and
Loayssa (2012) indicate that new drugs have unknown side effects, disproportionate
price to the alleged benefits, and occasionally lack improvements in effectiveness. In
this regard, pharmaceutical firms developing biologics require practical innovations with
an enhanced clinical investigation to foster optimal treatments. Garjón et al. (2012) note
that a high degree of therapeutic innovation enhances cost, convenience, safety,
efficiency, and evidence. The deployment of strategic adoption promotes therapeutic
innovation, personal perceptions about effectiveness, increased range of indications,
and information on relative efficacy and safety (Garjón et al., 2012). In this regard,
biosimilar and biologics should provide alternative therapy, enhanced management and
treatment efficiency, and improved reliability compared to traditional medicines.
Consequently, strategic adoption promotes cautious adoption of innovative drugs while
restraining premature abandonment of established therapies and adopting non-
innovative biologics.
The US is the largest prescription sector by far. Companies understand the need in
other regions and states that are capable of being important drivers of development in
the very distant future to start supplying more infrastructure and services. China and
India are quickly recalled countries, but countries such as Brazil, Russia, and even
Poland are seen as markets in regions where patients with certain diseases still have
serious needs. According to Patrick Aiyes, senior immunology analyst at GlobalData,
the major trends shaping immunology and consequently the pharmaceutical industry
include continued increase in the sales of immunology drugs, significant breakthrough in
research surrounding diseases that did not have established therapies, and enhanced
prevalence of biosimilars (GlobalData, 2020). Meanwhile, the global biosimilar market
will expand with a composite annual growth rate (CAGR) of 23% from 2019 to 2027. In
this regard, numerous business and revenue facing individual firms in the
pharmaceutical industry highlights the need to embrace biologic medication to foster
growth, revenue maximization, and business continuity. The innovation requires
businesses and stakeholders to evaluate the market to ensure the expensive venture
generates return on investment with short payback.
The leading multinational pharmaceutical companies are responsible for enhanced
marketing of biological drugs despite enhanced discoveries by specialized biotech
companies. Sengupta (2018) notes that traditional pharmaceutical companies have
entered the biological drug market in recent years by acquiring small biotech
companies. For instance, Pfizer has merged with Wyeth, Merck with Schering Plough,
and Roche with Genentech. As a result, biologics contributed to 22% of the Big Pharma
companies’ sales in 2013, which will expand to 32% by 2023. In this regard, Table 1
presents the leading multinational pharmaceutical companies that are increasingly
benefiting from the strategic adoption of biologics. However, Sengupta (2018) indicates
that introducing new biologics is slowing down due to high patented and developed
products in the 1990s that saturated available approved indications. With strategic
adoption, firms are focusing on the development and marketing of biosimilar in new
consumer segments. Therefore, strategic adoption introduces new dynamics in the
biotechnology industry through enhanced business models, marketing approaches, and
product development cycles.
Table 1. The top 2015 selling drugs in the United States and their revenue share.
Outcomes of Strategic Adoption

Costs of Developing New Products
The extensive costs involved in the development and commercialization of biologics are
forcing firms to engage in strategic alliances. Rybka et al. (2015), in the analysis of the
American biotechnology industry, found that firms have partnerships for conducting joint
research or exchanging technological knowledge and alliances focused on joint-
commercialization activities. In this regard, small firms without alliances have low
outputs illustrated by launched products compared to the investment in research and
development. In this regard, firms have a substantive number of commercialization
alliances for formulating joint ventures, licensing agreements, research and
development alliances, and technology-transfer agreements (Rybka et al., 2015).
Hence, strategic adoption of biologics foster cost and risk sharing besides encouraging
enhanced learning potential in all stages of new drug development, resulting in
improved efficiency and effectiveness. Furthermore, strategic alliances are highly
reliable compared to general partnerships that pull resources rather than strategic
competencies geared to survival and growth.
Economics of Biologics
Biologic medications are somewhat similar to other conventional medicines that are
already licensed. The area with the highest number of licensed bio-like medicines is
Europe, with 55 bio-like medicinal products for 15 biologic medications. The importance
of genetically and biologically related medicinal products is growing due to enhanced
demand for cheap health care solutions. Despite some regulatory obstacles to the
biologically comparable market, the demand for cheaper alternatives to biologics
continues to grow. Rees (2020) notes that the raising demands for oncology will
escalate biosimilar market value to $21.1 billion by 2027. Meanwhile, Darrow (2020)
posits that the need for mAbs used in cancer therapies will spur the market growth. In
this regard, biologic medications, such as kyntheum, are becoming increasingly popular
in the market but feature inhibitive costs.
Since they first appeared in the 1980s, there has been a lot of speculation about the
emergence and use of biologics. The medications are critical sources of tangible
advantages to people with chronic or long-term diseases, such as rheumatoid arthritis,
by providing hope for treatment or effective management. Biologics outperform the
development of small-molecule drugs, one of the fastest-growing types of a medicinal
compounds. According to Hirst, biologics are increasingly changing patient
management and interaction because physicians are abandoning conventional
treatment modalities and embracing innovations (Kuhlman and Hreczuk-Hirst, 2018).
As a result, researchers plan to cover a fifth of the entire prescription industry in
biologics by 2020.
Although Europe has seen a smooth transition to bio-similars in general, the US has a
range of issues that have hindered their acceptance (Darrow, 2020). However, FDA
research indicates that, in terms of this market's slow development in the US, this drug
class will, after entering the market, make substantial savings and an enticing
alternative for combating biological substances. The perceived benefits are contributing
to the elimination of administrative hurdles. From March 2020 the Federal Food, Drug,
and Cosmetic Act (FD&C Act) licensed use and application of biological products for
medical and cosmetic purposes across the United States upon successful testing and
approval by relevant bodies.
Legal frameworks
Some countries around the world are encouraging the development and growth of the
biotechnology industry through policy and legal framework. For instance, Kalotra (2014)
notes that India utilized the Patents Act in 1970 and economic liberalization in the 1990s
to steer the growth of the local industry at the expense of multinational companies. As a
result, the local companies capitalized on their expertise in reverse-engineering new
processes used to manufacture drugs at low costs. Currently, the firms are using their
massive revenues to engage in drug discovery, novel product development, and
pharma services (Kalotra, 2014). In this regard, policy and legal frameworks encourage
strategic adoption of biologics through development and marketing biosimilar. Kalotra
(2014) indicates that the loss or expiry of patents encourages Indian firms to sell
biosimilar in the United States, United Kingdom, Australia, Brazil, and Europe.
Therefore, the need to foster strategic adoption of biologics in the pharmaceutical
industry encourages alignment and amendment of policy and legal frameworks.
The need for strategic adoption of biologics is encouraging government and stakeholder
to forge enhanced cooperation. For instance, the United Kingdom launched Accelerated
Access Review in 2014 to improve assessment and adoption of innovative medicines
and medical technology, while the Biologics Price Competition and Innovation Act
abbreviates licensure for biosimilar biologics and biosimilar (Dabrowska, 2019;
Wooding, Cochrane, Taylor, Kamenetzky, Sousa, & Parks, 2015). In this regard, health
innovation systems involve inevitable tensions in adopting new medicines and medical
technologies because patients want early access to potentially life-saving medical
innovations, while manufacturers want favorable regulatory and environmental
conditions that guarantee commercial return besides intensive clinical trials (Wooding et
al., 2015). Meanwhile, medical innovations are unique and need to be considered
independently to guarantee public safety and comprehensive testing before approval.
The formulation of strategic adoption of biologics enables stakeholders to consider the

safety, effectiveness, and cost-effectiveness of the innovation by ensuring that
development and adoption processes are not linear. Therefore, the concept encourages
process improvement, risk sharing, process linkage, and market failure.
The Impetus for Change and Change Process
The pharmaceutical sector is transforming how it operates and how it produces drugs.
High financing for research and development is constantly invested by major
pharmaceutical companies (Festa et al. 2018). The sector faces a high degree of failure
in the exploration process. Management structures and development models used by
organizations that deal with the progression of drug treatments in biological products
are some of the obstacles (Cassidy & Kreitner 2014). The industry lacks effective
practices for adopting and managing innovation and technology. TMR (2019) notes that
pharmaceutical firms are avoiding biologic medication because of enhanced demand for
planning, investment, and personnel expertise. In this context, management issues
facing individual businesses are stimulating need for strategic adoption to enhance
market performance and profit optimization.
The formulation of strategic adoption or management of process is increasingly
becoming popular with digitization and automation of business operations. The new
phenomenon requires individual firms to plan and organize resources before formulating
and implementing new decisions. Meanwhile, in an attempt to consistently introduce
new technologies to the market to retain its position in the industry, the strategic theory
was developed to feed a sci-based innovation for production process (Chesbrough,
H.W., 2003). With the contextual shifts, this conventional paradigm, known as closed
creativity, cannot be assumed. Indeed, a company that adheres to this approach must
have a wide array of technology and information fields.
Technology is one of the critical impetus for change and change processes. TMR
(2019) reports that biologic medications are promising solution for the currently unmet
medical needs. The innovation is becoming increasingly popular in the health sector
and requiring pharmaceutical firms to enhance their investment. For instance, the
compounded annual growth rates for biologics exceeds 10% while approximately 50%
of new molecular entities approved by FDA in 2016 were biologics besides constituting
the 10 best-selling prescription drugs in 2016 (TMR, 2019). TMR (2020) notes that
business need to enhance their efficacy in hybridoma-based technology used to
develop monoclonal antibodies (mAbs) for treating diabetes, cancer, and autoimmune
diseases. Consequently, the pharmaceutical firms need to focus on investing in new
technologies to meet the increasing demand for biologics in the consumer segments.
Several businesses in the pharmaceutical industry have poor profits, with some of them
unable to contain high cost of research and development (R&D). TMR (2019) notes that
new drug requires an average of $1 billion investment over a period of nine years. For
instance, 10 pharmaceutical giants in the past five years have investment more than
$1.5 billion in R&D. Consequently, most drugs are not fully perfected in such a way that
they will succeed for the intended purpose. Darrow et al. (2020) indicate that the
bureaucratic approval process of the Food and Drug Administration (FDA) coupled with
established confirmation rate limitations exclude some medical products from
debasement in the consumer segments. Therefore, pharmaceutical firms consider cost
as the motivation factor to optimize their constantly changing industry output by
establishing a new method and business maturity model.
Historically, companies pursued market distinction by cultivating key competencies
internally and defending them from leaks to preserve their competitor dominance.
Throughout 40 years, the concept of the strategic theory is steadily penetrating the
realm of international relations and political studies through work by classical strategic
theorists Thomas Schelling and Colin Gray, and is being used and recognized as an
instrument of understanding decision-making. Harry Yarger made one of the best claims
of usefulness in strategic theory: 'Strategic theory opens the mind to all opportunities
and powers at stake, allowing us to take into account the costs and risks of our actions
and weighing up the effects of those of our adversaries and allies.’ Thus, enhance
review and assessment of strategic theories made the concept popular in the industries
due to enhanced competitiveness and sustainability of individual firms.
Strategic Choice
The strategic theory is a critical tool for enhancing the comprehension of decision
making. In this regard, it is responsible for generating insights into possibilities and
forces, which prompt decision-makers to consider the costs and risks of their action
while weighing the consequences of their rivals, partners, and stakeholders (Yarger,
2006). According to Smith (2011), the strategic theory focuses in linking the end with
means, whereby organizations utilize the available resources to accomplish established
objectives. The deployment of the philosophy translates to the description of the
available choices to an organization to determine the most suitable decisions, which will
generate optimum returns. The subsequent decision-making process entails evaluation
of motivation and values besides the strategic environment. Consequently,
pharmaceutical firms intending to embrace biologics employ strategic theory to ensure
available resources, including assets, capital base, and alliance, are adequate and
suited for developing and commercializing the innovation. The theory improves
knowing, weighing, and selecting appropriate for solving particular problems (Wisdom,
Chor, Hoagwood, & Horwitz, 2013). Additionally, the philosophy encourages individual
organizations to evaluate their motivation and operational environment and determine
their readiness to embrace biologics and biosimilar.
The strategic theory focuses on balancing the welfare and interests of all stakeholders.
Garrido (2018) indicates that executives ignore many stakeholders’ interests, such as
long-term investors, employees, and clients, to pursue short-term financial interests
responsible for quick incentive and bonuses. In this regard, paying executive
management based on short-term performance discourages strategic planning.
Strategic theory emphasizes long-term planning through strategic adoption of innovation
and informed decision making. Thus, the philosophy is crucial for biologic adoption in
the pharmaceutical industry to enhance long-term returns and benefits. The formulation
of research, development of innovations, and commercialization of products require an
extensive investment of resources, which will take time to deploy and optimize. Garrido
(2018) notes that the strategic theory encourages the employment of executive
management ability to make solid future decisions for maintaining business continuity
and sustainability. In this context, the theory is responsible for minimizing the cost of
inaccurate decisions besides maximizing future value by integrating strategic wisdom
and a practical approach in developing and commercializing biologics.
Conclusion
Biologic medications are here to stay claim the essential aspect to minimize the
increasing costs of healthcare, particularly with the growing cost of healthcare and
insurance. In this climate, major pharmaceutical firms need to be innovative to shift the
typical medicine to biologic medication to change or excel in transforming their business
model. They may be offered opportunities to improve their pharmaceutical life cycling
method to provide patients with an added benefit from developed compounds, to work
with biotech firms, and to explore additional indications and uses for their products
(Garrido, 2018).
Biological medicines are the most sophisticated treatments available that are used to
cure multiple illnesses and disorders. However, biologics are not highly popular in the
healthcare sector due to cost, convenience, safety, and efficiency issues. Thus, firms
need to strategically embrace biologics to enhance return on investment. Individual
firms subsequently consider economic feasibility, convenience, and status aspects that
align with organizational culture, beliefs, values, and norms. Strategic adoption also
fosters special handling required to prevent contamination biologics by unwanted
substances and microbes through dispensing by pharmacies with specialized facilities
and personnel. The employment of strategic theory allows strategic adoption of
biologics by ensuring executive management focus on long-term decisions rather than
short-term gains. Consequently, numerous business and revenue challenges facing
individual firms in the pharmaceutical industry highlights the need for strategic adoption
of biologic medication to foster growth, revenue maximization, and business continuity.
The innovation requires coordination research, development, and commercialization
strategies to ensure the expensive venture generates a return on investment with short
payback.
Methodology
Introduction
The design of research focuses on generating a practical approach for instituting
accurate data gathering and analysis. Consequently, research methodology provides
strategies and techniques that the researcher uses to collect data to identify gaps in the
existing knowledge base and resolve research questions. Smith (2000) considers the
methodology one of the significant and central parts of the research process due to its
significant role in enhancing the accomplishment of a study’s purpose. Jackson et al.
(2007) indicate that methodologies influence the research process by identifying
practical problems for assessment, framing the problem for exploration, developing
techniques for generating relevant data, and linking the problem with data collected,
analysis methods, and inferences drawn. Meanwhile, this section evaluates the
methods and techniques used to collect and analyze primary data. Additionally, the
researcher presents the rationale and justification of utilizing specific methods and
embracing certain research process decisions.
Research Philosophy
The research philosophy describes a set of beliefs, which constitute the foundation for
research. According to Saunders et al. (2019), the research concept describes a system
of beliefs and assumptions that influence knowledge development. A researcher
embraces axiological, epistemological, or ontological assumptions consciously or
unconsciously about realities encountered in the research process, human knowledge,
and the extent personal values influence the research process. Saunders et al. (2019)
indicate that an adequate formulation of a research philosophy provides a reliable
understanding of research questions, methods, and findings interpretation. The
researcher in this study embraced a positivism philosophy, which assumes that the
future is predictable and controllable based on present and past knowledge
(Melnikovas, 2018). The study intends to influence the pharmaceutical industry’s future
by assessing the impact and effectiveness of biologic medication’s strategic adoption.
Research Approach
Researchers need specific approaches for formulating, testing, or evaluating theories.
Saunders et al. (2016) provided three distinct approaches, including deductive,
inductive, and abductive. The researcher in this study employed inductive reasoning,
which fosters theory building by starting with specific observation before formulating a
general rule (Crossley and Jansen, 2021 Melnikovas, 2018). Sahay (2016) notes that
the approach leads to a qualitative method or methods. Meanwhile, the present
research involved an inductive approach using qualitative data, which comprises
descriptive and exploratory data analysis for generating accurate findings and extracting
appropriate inference. Soiferman (2010) posits that qualitative researchers gather
information from individuals to identify themes that allow inductive development of
theories. In this context, the researcher embraced inductive approach to foster
execution of a qualitative study for evaluating strategic adoption of biologic medications
in the pharmaceutical industry. Meanwhile, qualitative study are generally exploratory
and inductive (Soiferman, 2010). In this context, inductive approach was the most
suitable due to its ability to support collection of qualitative data, identification of themes,
and description of strategic adoption of biologic medications.
Case Study
A case study is one of the research strategies that details how a researcher utilizes the
aims to conduct a coherent study. Crossley and Jansen (2021) consider a case study a
detailed and in-depth evaluation of a specific subject, which can be a person, institution,
event, issue, or group of people. The strategy’s primary goal is to develop an in-depth
understanding of issues affecting a subject in real-life settings but the context of the
study. For instance, the researcher in this study evaluates the strategic adoption of
biologics medication in the pharmaceutical industry through LEO Pharma’s prism, which
constitutes the case study. The researcher identified a single case study of LEO
Pharma for conducting the research and believes it was enough for developing a better
understanding of the entire phenomenon. The case study technique focused on
individual factors in the pharmaceutical industry, and the complete study evaluated LEO
Pharma only. The selected company represents the strategic adoption of bio medication
in the pharmaceutical industry.
The pharmaceutical industry is one of the world’s biggest industries by innovation that
generates significant changes in operations and business models. Innovation is
considered the major success factor for any company, and it is one of the keys to
discriminating a company from its competitors. Meanwhile, the current research focuses
on biologic medication innovation in the pharmaceutical industry by evaluating Leo
Pharmaceutical Company’s case study or simple LEO Pharma. The case study
considered the company’s issues relevant to the study problem, including challenges
associated with the innovation, success factor, and aligning innovation with the
corporate strategy. The researcher assumed that the LEO Pharma assessment would
significantly impact the pharmaceutical industry and related companies that can use the
findings to influence market factors. The case study inspires pharmaceutical firms to
evaluate new rules and laws on drugs to enhance biologic medications’ strategic
adoption.
Qualitative Research
Qualitative research involves methods, such as observation, conversational analysis,
questionnaires, interviews, and focus groups, which can collect textual data. Al Zefeiti
and Mohamad (2015) indicate that the underlying research methods collect views,
attitudes, and perceptions of respondents, meaning that qualitative research relies on
interpreting their life experiences. Meanwhile, the topic, objectives, and research
questions formulated in this study encourage the researcher to embrace qualitative
research methods to assess the research problem. Palmer and Bolderston (2006)
indicate that the design helped the researcher to understand people within their
sociocultural contexts. Qualitative research provided a straightforward, disciplined,
systematic approach for formulating the most appropriate results (Mohajan, 2018).
Thus, the qualitative research and relevant case study methodology provided
instruments for investigating intricate phenomena within their context.
Effective deployment of qualitative research makes it a critical tool in the pharmaceutical
industry research due to its ability to support theory development, program assessment,
and interference formulation. Meanwhile, the principal purpose of qualitative research in
this study is to guide the core components for designing and implementing a case
study-related research method. The present research focuses on designing case study-
related methodology to mean qualitative methods constituted the foundation for data
collection.
The case study strategy incorporated in the qualitative research helped the researcher
identify the causes and why the Leo Company adopted the biological medication
strategies (Howells, 2002). The strategy supported the gathering of primary and
secondary data using the qualitative method. In this regard, the researcher collected
secondary from journals, reports, ebooks, peer-reviewed articles, and corporate
websites using desk review. The research also conducted one-to-one interviews via an
online platform (Zoom, Teams) with two LEO Pharma managers. The qualitative
methods involved in the case study guaranteed that the researcher was gathering
accurate data.
Data Collection
The data collection focused on a primary data source of subject matter expert’s (SME’s)
knowledge and experience; gained from working with the case study organization (LEO
Pharma). The need for explanation, enhanced understanding, and exploration of
research subjects' opinions and experiences ensured interviewing was the most suitable
data collection technique in this study (Mathers, Fox, and Hunn, 2000). Moreover,
SMEs were highly knowledgeable on biologic medication for valid and reliable in-depth
interview but limited in number for other data collection methods, such as questionnaire.
The researcher articulated the interviews using an online platform due the COVID-19
pandemic that requires social distancing and minimal or no physical between
individuals. The first SME works as a biological business lead in UAE and KSA, while
the second one is an interim lead in UAE and KSA. The SMEs were selected based on
the following criteria.
- Have the necessary knowledge and experience in the research subject.
- Responsible for a country distribution of the company products.
- More than 10+ years of experience in the company.
- Effective communication skills to answer the question efficiently.
Interviews
The data was collected by conducting online interviews using (zoom, teams) with LEO
Pharma’s managers. The researcher interviewed high-level managers based on their
knowledge and experiences in biologics medication. Each semi-structured interview
session lasted approximately half an hour. The interviewer asked all the prefabricated
questions and supplementary questions to clarify issues. In this regard, the researcher
collected quantitative and qualitative on the number of medications, time to distribute,
opinions from the SME’s knowledge and experience, and other information presented in
the Appendix. Meanwhile, Appendix (Interview Script 1 and Interview Script 2) presents
the questions and transcribed answers from each subject matter expert.
Sampling
The researcher relied on convenience sampling to identify the respondents to
participate in the interviews. The non-probabilistic technique allowed collection of data
from individuals who met criteria outlined in Data Collection. The researcher used SMEs
in this study because they were easily accessible and the technique was affordable and
simple to administer (Etikan, Musa, and Alkassim, 2016). The researcher contacted
higher officials at LEO Pharma to ensure the organization will avail some managers for
online interviews. In this regard, the researcher selected two managers out of five
presented by the company for interviews. The respondents head departments, meaning
they have an extensive understanding of the pharmaceutical industry and strategic
management. Meanwhile, the sampling technique used to identify the interviewees did
not consider gender, race, nation, and culture during selection but focused
knowledgeability of the topic and ease of access of the respondents.
Data Analysis
The researcher analyzed the collected data from the interview with the SME’s by
summarizing the typical results in thematic analysis. The process involved identification
of prevalent issues and key points and grouping them into categories, which were
combined into themes. In this regard, the initial process transcribed the interviews to
obtain qualitative data that can support analysis. The researcher codified the data to
ease categorization and grouping that were common and suggested themes. The
following activity involved theme development, where the researcher used titles to
identify or group related information. The next chapter presents the themes identified
from the transcribed interviews with SMEs.
Validity and Reliability
Reliability means that the same responses can be produced more than one time using
the same instruments. According to Taherdoost (2016), reliability focuses on a
phenomenon’s ability to generate stable and consistent results, meaning the study and
its findings should be repeatable. Other researchers should produce the same
outcomes in simple terms, using the same research methods in similar circumstances if
they are correlated with high levels of dependability. Edwin (2019) notes that
measurements should be repeatable across different people on different occasions,
under varying conditions, with alternative instruments. According to Wilson (2010),
reliability, in most cases, tends to relate to subjectivity. Nonetheless, the use of a single
respondent as the data source raises reliability issues because the researcher does not
have precautions against the subjectivity effect.
Research validity can be defined as complying with the criteria of the scientific research
method to produce research results. Heale and Twycross (2015) indicate that the
research concept describes the extent of accuracy involved in assessing a quantitative
study variable. For all forms of research, Oliver (2010) believes that validity is a
mandatory condition. Cohen et al. (2007) specify various forms of study validity as the
validity of the material, validity of criteria, validity of constructs, internal validity, external
validity, simultaneity validity, and face validity. Creswell (2013) explains that detailed
knowledge-gathering involves various sources of information, where a case study
concentrates on one or more cases over time. Thus, using a case study enhanced the
validity of the outcome due to an in-depth assessment of the study phenomenon.
Ethical Considerations
The researcher followed established codes and ethics for researching with human
subjects. The University approved the study under Ethic code: 2020D0315. Moreover,
the research obtained permission from LEO Pharma authority to draw participants from
its employees. Meanwhile, the secrecy and the ethical code of research help develop a
trustworthy relationship with the respondents (Tohidi, 2012). The researcher, before the
interviews, guaranteed to the participants that private and confidential information will
not be disclosed to third parties.
Results and Discussion

Introduction
In this chapter, the researcher outlines the prevalent themes obtained from semi-
structured interviews with SMEs. The findings explain the reasons why LEO Pharma
has strategic adoption of biologics medication. The researcher also correlates the
findings with the literature review to formulate reliable and practical inferences through a
discussion.
Rationale for the Adoption of New Biologically Based Drugs
Performance Measurements
There are various ways of measuring the performance strategy, which is relevant to
biological medications. However, the pharmaceutical industry prefers to utilize
quantitative scales, which are highly effective in visualization. The researcher found out
from the interview that LEO Pharma measures performance through sales and profit
and uptake of the market along with IMS (in-market sales) data. Moreover, the firm
regularly conducts market research that provides consumer feedback and perception on
products and services. The strategy enables the firm to evaluate its performance using
consumer metrics. Meanwhile, the interviews revealed that the pharma assesses its
international strategy after every five years to determine its suitability to drive growth
and competitiveness. For instance, LEO Pharma is currently planning for 2025/2030. In
this context, the firm determines the previous plan’s achievement and identifies aspects
requiring improvement or adjustment. Additionally, the firm refines pricing practices
during planning to optimize profitability and customer value.
The Impetus for Biologics at Leo Pharma
LEO Pharma has been in the pharmaceutical market for more than 100 years, and
according to observation, most of its products are exciting and continually updated. The
company retains the motivation to introduce more advanced treatments over time. The
interviews implied that the classical or traditional medication and treatment modes are
increasingly becoming old and outdated.
The company understands the need to meet prevailing demand and customer
expectations. Thus, impetus for biologics emerges from the need to provide efficient
services and high-quality products to patients as the factors generate long-term benefit
by enabling the firm to stay at the top of patients’ satisfaction level. The company also
derives motivation from customer needs because patients with certain severe conditions
must use new and modern treatment methods, such as biological medication, which
require continued research and innovation to develop and produce. For instance, LEO
Pharma is increasingly focused on the potentials of dermatology by 2030. The medical
field is more biological than conventional, meaning that new technology is now the
significant contributor globally because the current medications do not fulfill patient
requirements translating to the need for new alternatives that can meet customer
expectations. Thus, the need to enhance the company’s competitiveness and
sustainability in the market motivates the company to focus on customer satisfaction.
Cost of Biologics Medication
The SMEs indicated that more than 90% of LEO Pharma’s turnover is generated from
traditional or typical medications. Meanwhile, conventional medication’s strong
performance provides the company with adequate capital outlay to research, develop,
and launch new drugs and medication. For instance, the firm ventured into biologics
medications almost four years ago, incurring significant investment costs. In this regard,
the established portfolio is powering the mega launch of these biologic medications.
However, the interviewees revealed that probably by 2030, the company expects a
mega shift of revenue turnover in the future. Biologics medications should become the
primary source of revenue due to their enhanced demand and popularity in the market.
Meanwhile, one of the interviewees noted that Humira from Abbvie was launched at the
cost of $4 billion, and it is currently generating more than 10B$ in revenue. Dabrowska
(2019) notes that Humira was selling at 20% of its market value in Europe to get a
breakthrough. Thus, the current performance of biologics medications characterizes a
massive investment with minimal returns. The SMEs noted that Leo Pharma is unlikely
to generate significant revenue from production of Adtrazla, a molecule for treating
eczema, until 2025 due to limited popularity in the market and price in the market.
Operational Effectiveness
The supply chain management of LEO Pharma involves several issues that influence its
reliability and efficiency. For instance, internal issues such as tools and technologies
influence the firm’s ability to engage in R&D and develop new solutions and molecules.
Moreover, the pharma needs to be ready to promote biologic with new and advanced
strategies because they are unique from conventional medication. Meanwhile,
manufacturing has a vital role because biologics are complex and costly than traditional
medication. The interviewees noted that producing biologics medication tends to
demand more than one manufacturer complete a batch. For instance, a typical biologics
production may involve one manufacturer for producing the syringes, one for filling the
syringes, and another one more for packing. As for delivery, it requires a more complex
procedure due to their reliance on a cold chain with specific temperatures ranging
between 2 and 8 degrees. Supply chain management also involves external issues,
such as reliance on consumers and healthcare providers. LEO Pharma needs to
evaluate whether the patients/consumers and health care providers will perceive LEO
biologics as suitable alternatives or not. According to Rees (2020), the raising demands
for oncology will escalate biosimilar market value to $21.1 billion by 2027. In this
context, the rise of biosimilar, which are cheaper than biologics will stimulate them as
suitable alternatives for conventional medicine.
Future of Biologics Medication
Biologics reduce infection and avoid disease growth, but they are expensive to develop
and produce. In this context, the interviewees noted that the increased embracement of
biologics in the market would attract more producers and large-scale production,
making the costs decrease, enabling them to become readily available to all patients.
Additionally, many manufacturers and brands of biologics will provide the consumer with
a choice to select the preferred firm or brand of interest.
Documented Strategic Choice
LEO Pharma’s process to adopt a biological medication is linked with the business
development aspects of market development. The approach enables the firm to adopt
different strategies for delivering goods and services of interest. From this perspective,
when there is a need for a new product, LEO pharma decides based on the consumers’
feedback and commercial aspects, then start the adaptation process by deciding if the
medication will be developed by LEO pharma R&D or by inquiring it from a third-party
organization based on the cost and time.
Resource Prioritization
The resources prioritization at LEO Pharma utilizes the following criteria.
 The time a product is needed in the market;
 The time required to develop and launch a product to the market;
 The turnover in terms of monetary value;
 The number of patients using biologics medications, and
 Product description and expected revenue.
LEO Pharma Biologics Performance
LEO Pharma’s current financial returns are mainly generated from traditional or typical
medications. However, in the next ten years, LEO Pharma expects that the most
significant income will be generated from biologics medications because they are likely
to increase patient satisfaction. The firm is currently developing and investing in
biologics medication, meaning revenue generated is either too low or negative.
Discussion
Cost and Economics
Pharmaceuticals companies implement and adopt R&D for biological medication based
on several quantitative or qualitative factors. For instance, the quantitative figures
describe the expected profits and market expansion. The literature review revealed that
the global market could reach $479.7 billion by 2024 from $231.2 billion attained in 2017
(TMR, 2016). Thus, LEO Pharma needs to follow the market developments and invest
in innovative medications to share a fraction of the growing revenue from biologics’
global sales. Meanwhile, qualitative factors are based on consumer feedback and
chronic health conditions. For instance, patients increasingly suffer when utilizing
traditional medication to mean that their needs are not met (Teramae et al., 2020).
Therefore, LEO Pharma requires enhanced consideration of qualitative and quantitative
factors when deciding on R&D in biologics medications.
Strategic Choice
LEO pharma chose biologics medications as the new product portfolio because of the
perceived benefits to the consumers. Thus, the company can enhance its performance
by integrating new product development within the established strategy by studying the
current market and analyzing the results of the customers’ feedbacks. From this
perspective, LEO Pharma depends on R&D, assessment of customer needs, and brand
extension when developing new products. However, the factors require formulation of
strategic adoption responsible for restraining financial constraints, data collection
issues, reduced enjoyment from participation, inadequate research training, absence of
local supportive infrastructure, increasing contract complexity, changing sophistication
of regulations, lack of trust, unequipped research environment, poor prioritization, and
shortage of specialists (Badr, 2018; English et al., 2010) The concept guarantees
significant market success due to an enhanced understanding of customer and
industrial dynamics.
The significant advancement in biotechnology and inclusion of biologics biomimetic
professional training to clinicians in the present days are contributing factors that
enhance the strategic adoption of biological medication in the pharmaceutical industry.
Brown et al. (2019) indicate that a high need for cognition, low confidence, and negative
feedback significantly foster strategic adoption. Additionally, Karanja and Wario (2015)
indicate that factors influencing the strategic adoption in nongovernmental organizations
include technological advances, increased diversification, economic growth, culture,
leadership, pressure from donors, and organization structure. In this context, enhanced
training improves the confidence level of stakeholders while advancement of research in
biologics effectively constrains negative feedback.
Marketing
The interviewees reported that LEO Pharma regularly conducts market surveys, which
aid strategic planning. The approach promotes the strategic adoption of biologics
medications by promoting high cognition of factors that influence customer behaviors
besides promoting confidence in the company’s long-term decisions. Biotechnological
companies need strategic adoption of biologics to ensure they do not solely focus on
research excellence without engaging on the accumulation of a set of strategic,
operational, and commercial capabilities for successfully launching the products in the
market (Rybka et al., 2015). Thus, the respondents reported LEO Pharma had to
change its business model by including new strategies for adding biologics medication.
The failure to develop new model will result in poor choices with massive losses or
effective selection with poor oversight that is likely to generate undesired results
(Wandera, 2014). Therefore, the company has to institute a foundation that will enhance
success in the adoption, development, and sales of biologics through strategic adoption
responsible for fostering cost and risk sharing besides encouraging enhanced learning
potential (Rybka et al., 2015; Mosleh and Elayan, 2012; Sengupta, 2018). In this regard,
the interviewees stated that the company is attaining motivation from customer needs
because patients with certain severe conditions must use new and modern treatment
methods, such as biological medication (Thomas & McCarty, 2004). The conditions
require enhanced research and innovation to develop and produce new or distinct
therapies. Thus, strategic adoption is responsible for steering Leo Pharma growth and
expansion through manufacture and commercialization of biologics.
Innovation
As observed, inventive biotechnological organizations have been enjoying significant
achievements since the inventions of bio drugs. For instance, Sengupta (2018) notes
that traditional pharmaceutical companies have entered biological drug market in the
recent years through acquisitions of small biotech companies. In this regard, big
pharmaceutical companies are using innovative ways to enter the new consumer
segments by conducting R&D in manufacturing, customer service, supporting activities,
and marketing abilities (Kalotra, 2014; Sengupta, 2018). The development of
understanding within the dynamic of strategic adoption of drugs and medications
presents significant biomedicine opportunities. Thus, research is essential because
firms that maintain traditional business models rely on the reaction of different reagents
and chemical compounds to develop desired treatment products (Yuan et al., 2016).
However, biologics involve the manipulation of living cells to mimic or change processes
in the human body. The new and advanced treatment model entails significant cultural,
financial, environmental, and ethical considerations. The interviewees revealed that
biologics require complex procedures due to their reliance on a cold chain, consumers’
and healthcare providers’ perception, and expensive tools and technology. Therefore,
strategic adoption’s purpose is to provide cost-benefit analysis besides optimizing
expected benefits.
Summary
This research’s significant findings suggest that LEO Pharma has adopted new
biomedicine trends, which are not generating profits due to the high cost of developing
and launching them and limited popularity among patients. According to Festa et al.
(2018), major pharmaceutical companies are dominating R&D due to the significant
capital required to achieve breakthroughs and success in a sector with a high degree of
failure in the exploration process. Meanwhile, limited advances in biologics are
discouraging LEO Pharma from promoting the new medications with new zeal, resulting
in enhanced reliance on the traditional model of medicine for revenue generation
(Rybka et al., 2015). Moreover, the supply chain required improved care to ensure
timely delivery. Therefore, the company need to consider strategic theory and lead to
the perception of biologics medication a long-term investment, which will become a
significant revenue source by 2030.
Conclusion and Recommendations

To gather analytical information and knowledge on approaches used by the
pharmaceutical industry to strategically embrace biologic medications as a core
treatment approach.
The pharmaceutical industry’s operations and sustainability require enhanced focus on
innovation to stimulate business continuity, new product development to steer growth,
and discovery to enhance relevance amid dynamic consumer segments. In this context,
R&D in the development and commercialization of biologic medication is highly
essential for the sectors for articulating growth, competitiveness, and sustainability.
However, the process is complex, expensive, and time-consuming, meaning that the
pharmaceutical industry requires enhanced alliances, collaborations, organization, and
financing model to capitalize on the emerging treatment regimen involving biologic
medication.
Nonetheless, the conventional pharmaceutical business model is increasingly becoming
obsolete and encouraging individual firms to adopt strategic transactions that will
enhance their sustainability and competitiveness in the market. The SMEs noted that
conventional medicine are becoming increasingly ineffective for treating chronic
conditions. In this regard, Darrow (2020) notes that mAbs used in cancer therapies is
highly effective compared to traditional medication. Moreover, immunotherapy and
oncolytic virus therapy for cancer treatment are effective for reducing side effects and
enhancing efficacy (Phan, 2014; Schirrmacher, 2019). Thus, the strategic adoption of
biologic medications is one of the transactions aimed at enhancing customer
satisfaction, introducing new treatment models, increasing revenue channels for
pharmaceutical firms, and enhancing individual businesses’ competitiveness.
The present research on the strategic adoption of biological medications in the
pharmaceutical industry assessed LEO Pharma, a Danish-based organization, as a
single case study. The findings indicate that the firm has adopted biologic medication to
treat and manage complex chronic diseases. The main achievement of the company in
biologic medicine entails the development of dermatological medicine. LEO Pharma is
currently planning for 2025/2030, whereby the company focus on its biologic medicine
as a critical source of revenue by 2028 rather than in the short-term. Subsequently, LEO
Pharma does not have established biologics’ commercialization strategies due to limited
market popularity. The SMEs noted that the company continue to rely on traditional
medicines for revenue generation despite success development and production of
biologics. In this regard, the firm is not effectively deploying strategic theory in decision
making, resulting in enhanced focus on short-term goals. The dissertation found this to
be the case because the firm lacks inadequate research training, absence of local
supportive infrastructure, increasing contract complexity, unequipped research
environment, poor prioritization, and shortage of specialists (Badr, 2018; English et al.,
2010). LEO Pharma increasingly focused on responding to technological advances,
enhanced diversification, economic growth, and pressure from rival firms (Karanja &
Wario, 2015).
To evaluate and test data for inspiring change in the field of pharmaceuticals.
The successful commercialization of biologics requires a partnership between LEO
Pharma and other industry stakeholders, including healthcare providers and patients,
which are not currently established. According to Rybka et al. (2015), partnerships for
conducting joint research or exchanging technological knowledge enhance
commercialization and marketing of innovation. Consequently, LEO Pharma’s
investment in biologics medication as a long-term project, which should generate
returns on investment by 2030, when the treatment model will become popular by
attracting numerous manufacturers and extending the consumer segment is unrealistic.
The company is unlikely to achieve the objective without effective partnership and
alliance. According to the SMEs, LEO Pharma lacks established commercialization
strategies despite massive investment in the development of biologics.
Meanwhile, this study motivates pharmaceutical firms to strategically embrace different
innovations that will enhance their market position and profitability. According to Mosleh
and Elayan (2012), firms need to embrace innovation to establish and sustain perceived
usefulness and available infrastructure responsible for steering strategic. In this regard,
pharmaceutical innovation is essential for advancing therapeutic, leading to
development of new drugs for improving (Rybka et al., 2015). Subsequently, this study
found that the innovation induce significant changes and disruptions in the growth and
manufacturing of drugs, leading to new trends and roles of pharmaceutical firms. For
instance, individual companies require new and unique approaches for differentiating,
diversifying, and increasing their business networks to achieve assured growth and
sustainability in the industry. Therefore, the pharmaceutical industry must embrace
medical innovations’ strategic adoption to maximize their profit and raise medical care
choices’ efficiency. Biologics innovation are responsible for creating lifeline for
pharmaceutical industry by enhancing patient management and interaction (Kuhlman
and Hreczuk-Hirst, 2018). Innovation articulates relative advantages over existing
technologies by providing new and effective therapies (Thomas & McCarty, 2004).
Draw conclusions and recommendations on effects of strategically adopting biological
medications as a core treatment approach in the pharmaceutical industry.
The pharmaceutical industry is experiencing a significant decline in development
activities. The changes in consumer segments, which enhance alternative medicine
preference, are responsible for the sector’s decline. Salman et al. (2020) consider weak
and unstructured R&D apparatus as critical elements for enhancing decline of the
pharmaceutical industry. Meanwhile, Teramae et al. (2020) attribute the decline to
obsolete business models in the sector. Subsequently, biologics medication, alongside
the introduction of diagnostic centers with genetic testing and drug reaction at the
clinical level, provides new hope to the pharmaceutical industry. The approach creates
opportunities in creating and selling new medicines or researching the interaction of
conventional drugs and biologics medication. Thus, the sector needs to massively
invest in biologics medication to reinvent business models and regain market relevance.
Nonetheless, the activities and processes are relatively expensive and beyond the
capital outlays of most pharmaceutical firms. In this regard, individuals firms need to
embrace biologics medication’s strategic adoption, which will introduce techno-financial
and care service for funding development and commercialization of medical
innovations.
Recommendations
LEO Pharma needs to focus on altering its supply chain and making partnerships with
local distributors to market its new product. Although the company is following
environmentally friendly packaging and testing, it does not effectively communicate its
achievement and plans to the consumer segments. As a result, biologics medication is
not generating a significant fraction of the entire revenue despite massive investment.
The company needs to extensively market its innovations in biologics medications
during the new treatment model’s developmental stages. The strategy will improve
consumer perception and shorten the payback period. Meanwhile, LEO Pharma’s
current biological medications result from business deals with other pharmaceutical
organizations, meaning the firm needs to enhance its R&D investments to maximize
returns from the venture. Additionally, intensifying research will enable LEO Pharma to
become a market leader in manufacturing and commercializing biological molecules for
treating specific diseases.
11,305 Words Excluding appendix and references.

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11 Word Total.
Appendix
Interview Script 1
Question Answer
1- Name Ahmed Safwat
2- Company LEO Pharma
3- Current position? Biologic Business Lead
UAE/Saudi Arabia
4- Department? Biologic Marketing & Sales
5- How many biological medications do Two
leo pharma have? Atralza ( Atopic dermatitis )
Kyntheum (Psorias)
6- How many non-biological medications 8

do leo pharma have?
7- What is the current strategy of LEO
pharma?
8- How do you measure your strategy That’s a good question there are
performance? Related to biological Quantitative and qualitative ways
medications. of measurement, quantitative way
by the sales and profit and by
market uptake and IMS data ,
qualitative is by market
surveillance , consumer feedback.
9- What are the key factors that made LEO Pharma have been around
LEO pharma include the biological for more than 100 years , and
medication in their products portfolio? most of its products are topical
Based on what you are choosing products and by time more
biological medications? advanced treatment are coming
out , so the classical or traditional
treatment becomes outdated , Leo
pharma found there is a need and
demand because it is more
effective to the patient and gives
long term clearance and on top of
that patient satisfaction instead of
using classical medications once
or twice a day you can use
biologic medication once weekly or
reaches up to once every two or
three month. That’s why leo
pharma has to provide the best
products in class medication or
become first in its class medication
10-What is LEO pharma current More of 90% of LEO Pharma turn
performance of normal medications vs over comes from the traditional or
biological medications? In sales? normal medications and reason for
that is LEO Pharma recently
launched the Biologic (4 years
ago) and the current established
(traditional) Portfolio is fueling the
launching of these biologic
medication. However, in the future
after 10 years by 2030 expecting
to total shift of our turnover and we
start having our most income from

the biologic medications.
Mr.safwat continues giving an
example of another product from
different company saying that
Humira from Abbvie was
generating initially 4B $ and now
Humira is generating over 10B $
11-What are the internal and external First thing is to be considered is
issues related to medication supply the lead time for the productions,
chain? Also, related to biological for example the syringes are
medication? Internal (strength and manufactured in one site and then
weakness) external (legal, economic, shifted to another site to be filled
social) and then shifted to third site to be
packed and sent to the market. so
the process of biologic medication
production is more complex and
difficult when compare it to the
traditional. So when you are
forecasting for your region market
or for your patients and clients you
need to calculate the production
time and the shipping time; for
biologic we usually use air
shipping for faster delivery or
shorter shipping time, however
you have to follow the guidelines
of shipping for example some
products needs to be in cold chain
shipping from 2-8 degree some
needs to stay at zero degree etc.
12-What are the benefits of biological
medications?
13-Why has LEO pharma adopted
strategies related to biological
medication?
14-What is the normal time to distribute a
normal medication vs biological
medication? From research to the
market. (are there challenges in time)
15-What is the challenges of biological
medication in supply chain?
16-Is there a documented process or plan The R&D in global of LEO
for adoption of biological medication? Pharma, they get feedback from
the market, from the commercial
from the market insight that there
is a need in this field for example
hand contact eczema and they
start researching or developing
specific molecule that they may
find certain efficacy in that specific
disease then they start
researching what are the best way
to develop that molecule and what.
Is the best type of administration is
it orally, topically subcutaneous etc
17-What are the risks of biological The key point in any product, is
medication in supply chain and the patient access, or market
consumers and market? access, you need a robust plan,
there is no sense in putting a
product in the market but not
accessible, for example, product in
the market priced at 1000$ and
patient can afford only 600 $ so
means the patient cannot afford it,
so you need to find ways,

insurance, aid programs to help
making it accessible to patient
18-Based on what do you prioritize From dr. ahmed pov is that there
resources on products? is two points first the time to
market, how long this product will
need to be launched to market,
second point the turnover in terms
of money value or number of
patient using the biologic
medications. For example there
country A and Country B, Country
A turnover is 1 m $, country B
turnover is 4m$ so you definitely
put your resources and prioritize
country B. or product going to be
launched next year and a product
going to be launched in three
years times, so definitely you
going to put your resources on the
one launching next year
19-What are LEO pharma resources that Functions wise, Regulatory ,
they use to adopt biological market access, sales, scientific
medication? affairs and supply chains ,
commercial and marketing
20-What is the position of LEO pharma in
terms of financial returns and patient
satisfaction?
21-In respect of LEO pharma Country standard of launching
management system policies and medication, definitely, if we talking
procedures, do you think it is aligned about regulatory authority then you
with the national standards of have to have an NA certificate
launching a new medication? which you need for product

registration , you need also to
follow the pricing guidelines, for
pricing in Europe and US, assess
the price of the product, for
example sees the cost and then
leo or pharma company says that
they believe it can be sold for this
price, and provide this price to
FDA in US or EMA in Europe or
NHS in UK and then FDA or EMA
has to approve it or reject and
there will be some kind of
negotiation regarding the pricing,
however in Saudi and UAE its
different, the Pricing in Saudi
there is something called the “form
30” form 30 is basically a list of 30
country all over the world, so when
you provide your product and you
suggest your price, they will check
the same price in all the 30
countries and then they will come
back and either approve the price
or they say we will take the second
highest in the 30 country list, and
this is not negotiable, either agree
on the price or you have the right
to appeal, same thing in UAE
however the list is “Form 18”
which is 18 country, including
Saudi, but UAE puts in

consideration is the medication
first of its class , how many
competitors.
Interview Script 2
Ethic code: 2020D0315
Question Answer
1- Name Mohamed Helmi
2- Company LEO Pharma
3- Current position? UAE Country Lead & Saudi Arabia
Interim
4- Department? Sales
5- How many biological medications do Two
leo pharma have? Atralza ( Atopic dermatitis )
Kyntheum (Psoriasis)
6- How many non-biological medications 9

do leo pharma have?
7- What is the current strategy of LEO LEO pharma is world leader in
pharma? dermatology, especially for the
topical creams ( Traditional
medications ), the recent strategy
for leo pharma is to be the medical
leader in dermatology in the
biologics, the strategy is focusing
on the niche market of only
Dermatology field. Leo pharma
strategy is 10 years and business
goals differs every 5 years
however the leo vision and
missions and aim remains the
same which is becoming the
leader in medical dermatology
partner
8- How do you measure your strategy Global leo pharma strategy is
performance? Related to biological measured every 5 years, so for
medications. example what leo pharma is doing
right now is preparing for 2025 and
2030 strategy, the major things

happens every 5 years, and if
there was emerging need then leo
pharma has to adapt to the new
strategy like what happened in
2020.
9- What are the key factors that made This is based on the analysis on
LEO pharma include the biological what is the future of dermatology
medication in their products portfolio? field by 2030 treatment and the
Based on what you are choosing market is heading towards the
biological medications? biologic more than the traditional,
also the global is now much
effected with the new technologies
and what is offered to the patient,
the current one right now is not
filling the needs for the patient,
therefore there was a need to
provide a better solutions to the
patients which was the biologics.
10-What is LEO pharma current More of 90% of LEO Pharma turn
performance of normal medications vs over comes from the traditional or
biological medications? In sales? normal medications and reason for
that is LEO Pharma recently
launched the Biologic (4 years
ago) and the current established
(traditional) Portfolio is fueling the
launching of these biologic
medication. However, in the future
after 10 years by 2030 expecting
to total shift of our turnover and we
start having our most income from
the biologic medications.
Mr.safwat continues giving an

example of another product from
different company saying that
Humira from Abbvie was
generating initially 4B $ and now
Humira is generating over 10B $
11-What are the internal and external The internal one: is the
issues related to medication supply technology, does the R&D have
chain? Also, related to biological the tools and capabilities and
medication? Internal (strength and ready to have the new solutions,
weakness) external (legal, economic, second one is the organization : is
social) the organization which is
promoting conventional medication
(traditional) is ready to promote
the biologics or not, and also the
manufacturing does the
manufacturing facilities allow to
produce the new biologic molecule
or not.
The external: will the patient and

HCP (healthcare partner) perceive
you as a partner in biologics or
not, and the needs, does the
biologic meet the needs of the
patients and can the patient
receive the biologic and the
reimbursement system are harder
than the convential cheaper
molecule (topical)
12-Do you think biologic medication will These products reduce

replace traditional medication and inflammation and suppress

why? disease progression, however they
come pricey or costly, however, to
answer your question yes, as we
are progressing, and a lot of other
biologics are coming into the
market the biologic prices will go
down in the future and it will be
easily accessible to patient and
also now there is the biosimilar
which is also providing an option
to patient to choose from which
company to buy.
13-Why has LEO pharma adopted
strategies related to biological
medication?
14-What is the normal time to distribute a The time frame of R&D for both
normal medication vs biological the biologic and normal (traditional
medication? From research to the medication) is the same 10-15
market. (are there challenges in time) years to pass the clinical trials and
to be approved by the FDA EMA
and NHS, to be able to launch it.
In terms of distribution after
manufacturing biologics are more
complicated process, because
some of them require cold chain,
and the manufacturing process
itself is more complicated, so the
lead time to manufacture the
biologic takes more time and the
process its more complicated
15-What is the challenges pf biological
medication in supply chain?

16-Is there a documented process or plan Kyntheum and Adtralza, were not
for adoption of biological medication? crafted in LEO pharma R&D, both
biologic medications were
business development
opportunities made with other
pharma companies to be specific
Astrazeneca and astrazeneca
acquired Kyntheum from Amgen.
There was opportunity that
molecules that showing positive at
the early stages of clinical trials or
phase 1 and phase 2 of pre clinical
trials on rheumatoid arthritis it is
expected to have nature of
disease in psoriasis and molecules
that show positive impacts on
asthma at the early stages of
clinical or pre-clinical trials, most
likely have an impact on eczema,
so leo pharma have taken the
opportunities and have invested
on the indication of psoriasis and
eczema.
17-What are the risks of biological
medication in supply chain and
consumers and market?
18-Based on what do you prioritize All Resources goes on the pre-
resources on products? launch product in this case
(Kyntheum) biologic medication
and not expecting a revenue
meanwhile your established
(traditional) portfolio put minimum

to no resources and expect a big
revenue as we can say the cash
cow. It follows the same
management style of any other
product, established and
traditional product generate
revenue to be used on the
innovative products
19-What are LEO pharma resources that
they use to adopt biological
medication?
20-What is the position of LEO pharma in The financial returns still coming.
terms of financial returns and patient From the established traditional
satisfaction? medication, the biologic didn’t
generate and not expected to
generate now, but it is expected to
generate revenue by 2025 to be
50% of leo pharma returns from
biologic and by 2030, it is
expected to be 80% of leo pharma
returns from biologic. In sense of
patient satisfaction, the official
launch is one only (Kyntheum) and
it comes number 20 compared to
other biologics for same indication
and you have to understand the
opportunity still not the biggest in
biologic market, however
Kyntheum is taking a good market
share in Europe. However leo
strategy to launch the Adtrazla
which will be the second molecule

to treat eczema other than
Dupixant from Sanofi and later on
LEO plans on releasing the first of
its class in dermatology oncology
molecule. So the patient
satisfaction will become higher as
we are meeting the unmet needs
of patients
21-In respect of LEO pharma Yes All the time, and even leo is
management system policies and expanding to market where leo
procedures, do you think it is aligned was not point of strength. So
with the national standards of initially Leo used to seek
launching a new medication? approvals from EMA, later on it
was nice to have US FDA
approval. And now leo pharma the
submission for EMA and FDA are
done at the same time, so you can
see there is a big investment of
LEO pharma on regulatory

Critical Analysis of Strategic Adoption of Biologic Medication in Pharmaceutical Industry Case Study of LEO Pharma

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A Case Study of Leo Pharma

Surname, Initials: Ghaith Albasha, GA

CARDIFF METROPOLITIAN UNIVERSITY

Declaration and Statement

Date: 18th of March 2021

Other sources are acknowledged by footnotes giving explicit references. A bibliography is

Date: 18th of March 2021

Date: 18th of March 2021

Supervisor Declaration Form

Student Name: Ghaith Albasha

Supervisor’s Name: Stephen Bibby

Signed ..........Stephen Bibby....................................

My appreciation extends to my colleagues, Mohamed Helmi’s mentoring and

2019). Therefore, enhancing popularity of biologic medications, chiefly for cancer

1. Gathering analytical information and knowledge on approaches used by the

productivity, and business continuity of pharmaceutical companies. The assessment

their operation environment besides the characteristics of critical stakeholders, including

The nature of innovation, technology, or concept under consideration by a business

External Factors promoting adoption

strategic, operational, and commercial capabilities for successfully launching the

Outcomes of Strategic Adoption

The formulation of strategic adoption of biologics enables stakeholders to consider the

Results and Discussion

Conclusion and Recommendations

11,305 Words Excluding appendix and references.

12. European Medicines Agency, 2017. Kyntheum.

International Academic Journal of Human Resource and Business

6- How many non-biological medications 8

start having our most income from

so you need to find ways,

launching a new medication? which you need for product

Saudi, but UAE puts in

6- How many non-biological medications 9

2030 strategy, the major things

Mr.safwat continues giving an

The external: will the patient and

12-Do you think biologic medication will These products reduce

replace traditional medication and inflammation and suppress

medication in supply chain?

(traditional) portfolio put minimum

which will be the second molecule

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