Biomarker Research

Report
Worldwide Trends
2014

What is a Biomarker?
Worldwide Trends
2014

What is a Biomarker?
A biological marker, better
known as a biomarker, is
a characteristic that is
objectively measured and
evaluated as an indicator of
normal biological
processes, pathogenic
processes or
pharmacological responses
to a therapeutic
intervention.

Source: Drug Discovery World

http://www.ddw-online.com/personalised-medicine/p145613-biomarkers-make-their-mark-on-current-research-and-drug-development-trendssummer-10.html

History of Biomarkers
Worldwide Trends
2014

History of Biomarkers
Term biomarker first coined in the 1980s.
Biomarkers were developed as a response to understand the
relationship between environmental factors and disease.
Association or causation?

Increase in the use of the term biomarker is a recent one (the

last fifty years).
Use of the term and the characteristic continues to grow
today.
Source: The Environment and Disease: Association or Causation?
http://www.totalscientific.com/biomarkerblog/?p=55

Biomarker Uses and

Applications
Worldwide Trends
2014

Biomarker Uses and Applications

Biomarkers include tools and
technologies that can aid in
understanding the

Prediction
Cause
Diagnosis
Progression
Regression and
Outcome

of various diseases

Source: The Journal of the American Society for Experimental NeuroTherapeutics

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/

Biomarker Uses and Applications

Variety of Biomarkers
Each body system has a specific
biomarker (i.e.-cardiovascular,
respiratory, lymphatic).
Each biomarker is relatively easy to
measure.
Each biomarker forms a piece of routine
medical examinations. (i.e.- weight and
Source: News Medical
BMI measurements to predict
obesity)
http://www.news-medical.net/health/Biomarker-What-is-a-Biomarker.aspx

Biomarker Uses and Applications

Biomarkers can be:

Specific cells
Molecules
Genes
Gene products
Enzymes
Hormones
Complex organ functions
General characteristic changes in
biological structures

Source: http://en.wikipedia.org/wiki/Biomarker_(medicine)

Biomarker Uses and Applications

Ideal Biomarkers:
Safe and easy to measure
Create as little discomfort for patient (i.e.
blood sample, not invasive biopsy)

Cost efficient to follow up

Rapid return of results for early initiation
of treatment and monitoring effectiveness
Modifiable with treatment
Consistent across gender and ethnic
groups
Highly reproducible among various clinical
laboratories.
Source: Coriell Institute for Medical Research
http://www.coriell.org/research-services/biomarkers/characteristics-of-the-ideal-biomarker
and
News Medical
http://www.news-medical.net/health/Biomarker-What-is-a-Biomarker.aspx

Biomarker uses and applications

Biomarker identification and validation
Applied to a wide variety of therapeutic areas
including:
Neurological disease
Metabolic disorders
Immune dysregulation

Most predominant field of application lies in

Source: Drug Discovery World
oncology.
http://www.ddw-online.com/personalised-medicine/p145613-biomarkers-make-their-mark-on-current-research-and-drug-development-trendssummer10.html

Types of Biomarkers
Worldwide Trends
2014

Types of Biomarkers
Though many Biomarkers exist, there are two
major categories of Biomarkers:
Biomarkers of exposure
Biomarkers of disease

Source: The Journal of the American Society for Experimental NeuroTherapeutics

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/

Types of Biomarkers

Biomarkers of exposure
Used in risk prediction
Used in screening
Used in diagnostic tests
All tests are well established, allowing for a
distinct advantage:
improves sensitivity and specificity of the
measurement of the exposures or risk factors.
Source: The Journal of the American Society for Experimental NeuroTherapeutics
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/

Types of Biomarkers

Biomarkers of disease
Used for screening or diagnosis that represent
surrogate manifestations of the disease.
Distinct Advantage:
Biomarkers depicting prodromal signs enable
earlier diagnosis or allow for the outcome of
interest to be determined a more primitive stage of
disease.

Biomarkers of disease are used as an indicator

of a biological factor that represents either a
subclinical manifestation, stage of the disorder,
or a surrogate manifestation of the disease.
Source: The Journal of the American Society for Experimental NeuroTherapeutics
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/
e:

Biomarkers and Prostate

Cancer Detection
Worldwide Trends
2014

Biomarkers and Prostate Cancer Detection

Goal of Biomarkers in Prostate Cancer
Detection:
Avoiding over-diagnosis in patients with
indolent (causing little or no pain) prostate
tumors.
When patients with indolent diseases receive
aggressive treatments, negative effects result:
Negative side effects occur
Reduction in a patients quality of life
Little to no benefit to the patient.
Source: Prostate Cancer- A Biomarker Perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745/

Biomarkers and Prostate Cancer Detection

One of the current clinical priorities is to develop
prognostic biomarkers to identify those with
indolent prostate diseases at low risk of
progressing
Allows patients to better benefit from active
surveillance or watchful waiting, thus avoiding:
unnecessary treatment (allowing for no unnecessary
adverse effects)
unnecessary financial burden
Source: Prostate Cancer- A Biomarker Perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745

Biomarkers and Prostate Cancer Detection

Types of biomarkers in prostate cancer
prognosis:
therapeutic response
drug development

Biomarkers can be used to predict:

the expected course of a prostate disease (prognosis)
help clinicians with making decisions about likelihood to
respond to a given drug (predictive)
what dose might be most effective for severity and stage of
disease (pharmacodynamics).
Source: Prostate Cancer- A Biomarker Perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745

Biomarkers and Prostate Cancer

Detection
Red color denotes
types of biomarker
Blue color denotes the
biomarker-based
decision making
Green color indicates
the exemplary actions
or events
PSA=prostate-specific
antigen
DRE=digital rectal
examination
TRUS= transrectal
ultrasound
PD= biomarker,
pharmacodynamic
biomarker.
Source: Prostate Cancer- A Biomarker Perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745

Biomarkers and Prostate Cancer Detection

The previous graph shows the specificity of drug
development for prostate cancer in respect to the
actual treatment necessary for the cancer.

Biomarkers allow for proper treatment of the

cancer, dismissing over-diagnosis.

Biomarkers and Prostate Cancer

Detection

Black boxes denote

conceptual
breakthroughs
Blue boxes denote
biomarker advances
Green boxes denote
therapeutic and
technological outlook.
PAP= prostatic acid
phosphatase
PSA= prostatespecific antigen
FDA= US Food and
Drug Administration
CTC= circulating
tumor cells
NGS= nextgeneration
sequencing
miRNA= microRNA.

Source: Prostate Cancer- A Biomarker Perspective

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745

Biomarkers and Prostate Cancer Detection

The previous timeline depicts the advances of prostate
cancer detection and diagnosis.

It is clear that biomarkers are leading to technologically

therapeutic advances, allowing for the proper prevention
and treatment of prostate cancer as the years progress.
Personalized cancer prevention will ensue as
technological advancements in biomarkers continues.

Key Players in Biomarker

Industry
Worldwide Trends
2014

Key Players
Discovery and development of biomarkers is
very costly and extremely time consuming.
However. application of biomarkers in drug
discovery and development reduces overall cost of
the entire drug development process
Therefore, demand for novel biomarkers is expected
to increase in the next five years

Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm

Key Players
Due to the immense cost
and time commitment of
the development of
biomarkers, many
companies are combining
forces to ensure that
biomarkers are created in
the most cost efficient of
manners as a main
market strategy.
Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm

Key Players
Companies such as:

Thermo Fisher Scientific, Inc. (U.S.)

QIAGEN N.V. (Netherlands)
Hologic, Inc. (U.S.)
Roche Diagnostics Limited (Switzerland)
Johnson & Johnson (U.S.)
Siemens Healthcare (Germany)
Abbott Laboratories, Inc. (U.S.) and
Bio-Rad Laboratories, Inc. (U.S.)

are all actively adopting strategies of partnerships and

collaborations, to ensure their growth in the biomarkers
market.
Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm
and
PR News Wire
http://www.prnewswire.com/news-releases/biomarkers-market---discovery-technologies--validation-services-applications--diseases---global-trends--forecasts-2013---2018-244202091.html

Other Key Players

Abcodia Ltd
Affymetrix Inc
Agilent Technologies Inc
Amgen Inc
Astrazeneca Plc
Augurex Life Sciences Corp
Aushon Biosystems Inc
BGI
Bayer Ag
Beckman Coulter Inc
Biocrates Life Sciences AG
Biomarkers Strategies
Biosystems International
Bristol-Myers Squibb
Caprion Proteomics Inc
Crescendo Bioscience
Eisai Co Ltd
Epiontis GMBH
Epistem Holdings PLC

Eurogentec SA
Evotec AG
Glaxosmithkline PLC
Ipsen
Merck & Co
Micromedic Technologies Ltd
Myriad Genetics Inc
Nextgen Sciences Inc
Novartis International AG
Ocimum Biosolutions Ltd
Pacific Biomarkers Inc
Pfizer Inc
Pronota NV
Proteome Sciences Plc
Quintiles Transnational Corporation
Sanofi-Aventis
Trans-Hit Biomarkers Inc
Vermillion Inc

Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm

Market Growth
Worldwide Trends
2014

Market Growth
Factors increasing usage of biomarkers:
rising demand for personalized medicine
companion diagnostics

Global biomarkers market is expected to grow at

a CAGR (Compounded Annual Growth Rate) of
18.5% from 2013 to 2018
Expected CAGR of $40.8 billion by 2018.
Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm

Other Factors Increasing Market Growth

Omics technology such as:

Proteomics
Genomics
Transcriptomics
Metabolomics

serve as the largest segment of the global

biomarkers discovery technology market
Advancement in discovery technologies such as genome
sequencing is the prime factor contributing to the
growth of this market.
Source: PR Web
http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm

Future of Biomarkers
Worldwide Trends
2014

Future of Biomarkers
The future appears bright for the
development of biomarkers as
personalized solutions for cancer
prevention and treatment
increase in medicine
Global upward trends in respect
to utilization of biomarkers are
promising as biomarkers
continue to serve as central hub
in cancer detection, treatment,
and prevention.

Future of Biomarkers
The next breakthroughs in therapeutics and
biomarkers?
Only can occur with in-depth understanding of
fundamental disease mechanisms
I.E. prostate cancer initiation and progression, response
to therapy, and mechanisms of action of anticancer
agents.

Such disease orientation will require a greater

collaboration between industry, academia, regulatory
agencies, and patients (revert to the idea of cost and
resource efficiency).

Source: Prostate Cancer- A biomarker perspective

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745/

Future of Biomarkers
The integrative, interdisciplinary systems biology
approach, along with omics technologies, offers
potential in next-generation biomarkers.
The decades approaching will allow for proper
identification, qualification, and application of
novel biomarkers.
Biomarkers will remain a focal point of patient
care and the drug discovery paradigm for not only
prostate cancer, but all disease.
Source: Prostate Cancer- A biomarker perspective
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745