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Webinar Presentation 100909
Webinar Presentation 100909
drug development
Addressing key challenges in predictability, solubility, toxicity,
stability and intellectual property
© GlobalData
Table of Contents
• Unmet Needs
– Understanding unmet needs
© GlobalData 3
Table of Contents
• Unmet Needs
– Understanding unmet needs
© GlobalData 4
Understanding Unmet Needs in Drug Solubilization
Market – Why is Drug Solubilization a Problem?
• Poor solubility has become a major challenge in drug delivery as
Active Ingredients in 90%1 of the active ingredients are proved to be having low aqueous
Issue development are solubility issues and this proportion is still growing
poorly soluble • This implies that drug solubilization techniques could potentially
impact up to 90% of R&D
Failure of drugs to • Nearly 75% of preclinical stage drugs do NOT move to phase I
Effect on
move from preclinical • Around 39%3 of these failures are attributed to poor drug-like
Pipeline to phase I properties of the drugs (implying low solubility)
© GlobalData 5
Table of Contents
• Unmet Needs
– Understanding unmet needs
© GlobalData 6
Impact on R&D Revenues due to Poor Drug like
Properties
Drugs in
Why do they fail?
Preclinical Stage
Others
10%
Poor Drug Like Property Group could be helped by advanced drug solubilization
techniques $8.2B
© GlobalData 7
Calculating Unproductive R&D Costs due to
Poor Drug-like Properties
Preclinical
Development
Number of products in preclinical phase 2007 3,9004
© GlobalData 8
Quantifying Unmet Need for Missed
Revenue Opportunity
Of 775 (39% failing due to poor drug-like properties) new compounds enter
Assumptions phase I from preclinical stage in 1996
If at least, 18-30 compounds are approved and enters the market in 2006
If new drug solubilization technology becomes the new benchmark for all the R&D
products, then above number would be much higher (at least 2X)
© GlobalData 9
Table of Contents
• Unmet Needs
– Understanding unmet needs
© GlobalData 10
Impact on R&D Costs due to Better
Solubilization – Forecasts
R&D Revenue Loss due to Poor Drug like Properties, 2007-15
20
10 .7 % 16.7
18 CAGR
16 15.1
13.7
Revenues $ billion 14 12.4
Entry point for Drug 12 11.2
solubilization techniques 10.1
10 9.1
will fall in this group 8.2
8
6
4
2
0
2007 2008 2009 2010 2011 2012 2013 2014
In 2007, there is a loss of $8.2 billion approximately due to poor drug like properties
in the R&D and will rise to $18.5 billion by 2015, with a compound annual growth
rate of 10.7% (if better solubilization techniques are not used)
© GlobalData 11
Impact on Added Revenues due to Better
Solubilization – Forecasts
Revenue Generated by Addressing Poor Drug like Properties, 2007-15
100
90
80 Better Drug solubilization
%
R 31 techniques will add extra
CAG
Revenues $ billion
70 revenues to the
60 pharma/biotech market
67.5
50 59.6
40 51.6
39.3
30 28.2
Cost savings is relatively minor
20 18.1
5.1
10.5 component of value added
10 1.6 16.7 18.5
10.1 11.2 12.4 13.7 15.1 by Nanotechnology
8.2 9.1
0
2007 2008 2009 2010 2011 2012 2013 2014 2015
In 2007, nearly $9.8 billion potential value could have been created if better
solubilization techniques were employed.
This value could increase to $86.0 billion by 2015, with a growth rate of 31%
© GlobalData 12
Table of Contents
• Unmet Needs
– Understanding unmet needs
© GlobalData 13
Impact of Nanotechnology on Product Lifecycle
Management
Impact in Development
Impact in Discover Phase Life Cycle Management
Phase
© GlobalData 14
Trends for Nanotechnology Acceptance in
Pharma/Biotech – Market Size of Nanotechnology
Sales within Pharma/Biotech Industry
Nanotechnology enabled DDS Market Potential Forecast 2007-15
300
250
Revenues $ billion
50
0
2007 2008 2009 2010 2011 2012 2013 2014 2015
In 2007, the market forDDS
Nano-enabled Nanotechnology enabled DDS
Other DDS Total is
DDSapproximately $3.4 billion.
If Nanotechnology is completely adopted, the market is expected to be $216 billion
by 2015, with a compound annual growth rate of 68.4%
© GlobalData 15
Table of Contents
• Unmet Needs
– Understanding unmet needs
© GlobalData 16
Technology Adoption Framework
High unmet need exists and creates a As a result clients look for potential
Significant bottle neck which
significant challenge to drug solutions that might solve the
impacts the key business metrics
development bottleneck
Technology Exists
Client Awareness Evaluation of Technology Trial – Unmet Need
to Fulfill Unmet Complete Adoption
of Technology Technology Proof of Concept Fulfillment
Need
Nanotechnology Awareness of Only 30 products Even though, Nanotechnology Nanotechnology is
enabled drug Nanotechnology in have been Nanotechnology has not been very efficient in
solubilizers has pharma/biotech developed using has demonstrated adopted addressing the
better safety R&D is low. Full Nanotechnology, its effectiveness in completely in solubility issues
profile and market potential of implying low pharma/biotech pharma/biotech and thereby
enhances the Nanotechnology evaluation rate, industry, it has not industry due to the bioavailability
bioavailability of a will be captured which needs to been exploited huge investments needs of the
drug only by increasing increase for the completely due to involved in the pharma/biotech
the awareness of technology to inadequate testing initial stages and industry and will
this technology become a gold- methodologies low awareness be a huge success
standard to levels by overcoming the
address solubility hurdles for
issues complete adoption
© GlobalData 17
Typical Technology Adoption Curve
Nanotechnology is in
early stages of
adoption in
pharma/biotech
industry
1 2 3 4 5
© GlobalData 18
Market Drivers for Nanotechnology
• Innovative technologies such as NeoWater, NanoCrystal and NanoEdge for enhancing drug
Innovations in drug
solubilization
solubilization • New approaches such as tissue targeting and permeation enhancement are being explored in
technology tandem with the nano-sizing concept
• High demand for innumerable formulation-related performance issues such as poor solubility,
High demand due to
toxicity, poor bioavailability, lack of dose proportionality, safety issues with use of co-solvents,
unmet needs and slow onset of action
sr evi r D
• Pharma/biotech companies with number of potential treatments that remain unexplored due to
Adopting effective and
poor solubility issues adding to the unproductive spent, are exploring the newer ways to generate
superior technologies ROI
Extending product and • Nanotechnology-enabled drug delivery systems help in extending the product and patent
patent lifecycles lifecycles by creating novel reformulations of existing or discontinued compounds
© GlobalData 19
Barriers and Challenges for Nanotechnology
Huge investments in
• ‘Known Devil is better than Unknown God’ seems to be the rule followed by pharma/biotech
the initial stages to
industry. Uncertainty of ROI on new technology investments is inhibiting the companies from
evaluate the new adopting Nano-enabled technologies
technologies
Industry Awareness • As is seen from Technology adoption curve, awareness is relatively low amongst industry
regarding role of stakeholders with regards to potential of nanotechnology applications in Pharma/Biotech R&D. If
nanotechnology in the awareness does not increase, it could have a potential impact on growth of nanotechnology
sr oti bi hnI
Environmentalists • Nanotechnology has drawn severe criticism from health advocacy groups, environmentalists and
perceptions other non-government organizations due to hypothetical safety concerns
© GlobalData 20
Trends Indicating Growth of Nanotechnology
Market
• Nanotechnology patent filings are increasing across the globe and there by protecting the
Shift in patent patterns with the Intellectual Property (IP) due to the favorable changes by the regulatory authorities by creating a
separate registration category for the Nanotechnology inventions for example, Class 977 in the US
entry of Nanotechnology
by U.S. Patent and Trademark Office (USPTO)
• Nanotechnology companies have become very popular in addressing the key unmet needs across
all the industry segments
Increasing M&A activities in
• In Pharma/Biotech industry, companies are looking for potential mergers and acquisitions with
Nanomarkets Nano companies to handle pressure and overcome the issues such as generics entering the
market, low productivity
• Government programs to fund Nanotechnology R&D has increased significantly in the US, the UK,
Increased government funding for Russia, Japan, China, Germany and many nations in Europe and Asia
• In the last five years, more than $40 billion in government funds have been invested into
Nano projects Nanotechnology research worldwide and in 2009 alone it is estimated to be approximately $10
billion
• Nanotechnology applications are being used across all the sectors such as pharma/biotech,
Cross industry applications of electronics & IT, machinery & engineering, consumer goods and equipment, agriculture and food,
instruments etc.,
Nanotechnology • In healthcare, drug delivery technologies, Nano-structured medical devices etc
• In electronics and IT, manufacturing advanced memory chips and electronic displays
© GlobalData 21
Bibliography
1. Kathrin Nollenberger, Andreas Gryczke, Takayuki Morita, Tatsuya Ishii, ‘Using Polymers to Enhance Solubility of Poorly Soluble
Drugs’, April 2009,
http://pharmtech.findpharma.com/pharmtech/Ingredients/Using-Polymers-to-Enhance-Solubility-of-Poorly-Sol/ArticleStandard/Article/detail/59045
2. Kathrin Nollenberger, Andreas Gryczke, Takayuki Morita, Tatsuya Ishii, ‘Using Polymers to Enhance Solubility of Poorly Soluble
Drugs’, April 2009,
http://pharmtech.findpharma.com/pharmtech/Ingredients/Using-Polymers-to-Enhance-Solubility-of-Poorly-Sol/ArticleStandard/Article/detail/59045
3. Elizabeth B. Vadas, ‘Selection of the Best Candidate for Development’,
http://www.bioscienceworld.ca/SelectionoftheBestCandidateforDevelopment
4. ‘Drug development by world status’, http://www.pharmaprojects.com/contentimg/0407/Graph-2pr.gif
5. ‘Integrated Research and Development Center’, June 2006,
http://www.mpsidc.org/mp07/state-profile/Short-project-profiles/R_D_Center.pdf
© GlobalData 22
DO-COOP TECHNOLOGIES LTD.
PBR Webinar
September 10th , 2009
Webinar Agenda
•Neowater®
•Actual Cases
•Business Model
•Contact Us
An existing Technology available today which addresses the unmet
needs raised by Dr. Ajay is Neowater®
Technology/business process
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