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Re-evaluating Pharmaceutical Pipelines - Emerging Markets, Biologics and Orphan Drugs to Shape Future Decision Making
GBI Research, June 2012, Pages: 120
GBI Research, a leading business intelligence provider, has released its latest research, “Re-evaluating Pharmaceutical Pipelines - Emerging Markets, Biologics and Orphan Drugs to Shape Future Decision Making”, which examines the key issues influencing the re-evaluation of pharmaceutical pipelines due to changes in the economic environment, the emergence of new markets, M&A and partnering activity, and recent advances in science and technology. It discusses the strategies the industry has adopted to address both internal and external challenges through open innovation, strategic acquisitions, partnerships and licensing deals.
GBI Research’s analysis highlights the trends in pharma productivity, the impact of drug attrition rates on different drug therapies, and the routes taken by companies to improve R&D efficiencies and maximize their product lifecycle management to ensure future growth and shareholder value.
It has been estimated that more than half of the products currently in late stage clinical development in pharmaceutical companies were originally derived from external sources. However, as the pool of innovative biotech and start-up companies contracts due to lack of venture capitalist funding, where will Pharma turn next? Find out more about the ways in which pharma is re-evaluating its product pipelines to invest in the future.
Scope
- Data and analysis regarding novel approaches to de-risk product development and address the shift in the geographical and therapeutic demands due to pharmerging markets and the changes in healthcare reform.
- Market analysis of R&D trends, identifying key areas of drug attrition and the strategies to reduce drug attrition and optimize product lifecycle management, including the expansion into OTC medicines, generics and biosimilars.
- Key challenges and opportunities that have had a significant impact on the market regarding geographical and therapeutic diversification of leading pharmaceutical companies.
- Key M&A activities and partnerships refueling company pipelines, including strategic acquisitions, collaborations, licensing deals, PPPs, CRADA s, JVs and risk sharing models.
- The competitive landscape and pharma R&D growth strategies adopted by leading pharmaceutical companies, including Johnson & Johnson, Merck & Co., Pfizer, Roche Group and Novartis.
Reasons to buy
- Identify the key market opportunities and align R&D portfolios to maximize growth
- Develop business strategies to optimize strategic acquisitions, collaborations and partnerships and licensing deals
- Devise a more tailored R&D approach to address specific geographical and therapeutic demands
- Develop key strategic initiatives by understanding the key factors impacting pharma R&D and preventing late stage product failures
- Re-evaluate and reassess investment decisions and explore ways in which to diversify and de-risk product development.
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Market Conditions
2.2 Emerging Markets
2.2.1 Brazil
2.2.2 Russia
2.2.3 India
2.2.4 China
2.3 Healthcare Reform
2.3.1 The US
2.3.2 European Austerity
2.4 M&A and Partnerships
2.4.1 M&A Activity
2.4.2 Partnership Activity
2.4.3 Trends in 2011
2.5 Adopting New Business Models
2.5.1 Open Innovation Business Models
2.6 Advances in Science and Technology
2.6.1 Preclinical
2.6.2 Clinical
3 R&D Trends
3.1 Introduction
3.1.1 Drug Attrition vs. Therapy
3.1.2 Drug Attrition vs. Business Strategy
3.1.3 Strategies to Reduce Failure Rates in Phase III
3.1.4 Other Strategies to Reduce Drug Attrition
3.2 Maximizing Product Portfolios
3.2.1 New Uses for Existing Therapeutic Classes
3.3 Conclusions
4 R&D Challenges and Opportunities
4.1 Introduction
4.2 Geographical Diversification
4.3 Therapeutic Diversification
4.3.1 Biologics
4.3.2 Vaccines
4.3.3 Orphan Drugs
4.4 Generics and Biosimilars
4.5 OTC Medicines
4.6 Business Diversification
4.6.1 Animal Health
4.6.2 Consumer Healthcare
4.6.3 Diagnostics
4.6.4 Ophthalmic
4.6.5 Medical Devices
4.7 Conclusions
5 Mergers, Acquistions and Partnerships - Refuelling Pipelines
5.1 Mergers
5.2 Strategic Acquisitions
5.2.1 Acquisitions through Equity Stakes
5.2.2 Strategic Acquisitions in the New Market Segments
5.2.3 Strategic Acquisitions in the Therapeutic Areas
5.3 Collaborations and Partnerships
5.3.1 Collaborations
5.3.2 Licensing Deals
5.3.3 Public-Private Partnerships
5.3.4 Cooperative Research and Development Agreements
5.3.5 Joint Ventures
5.3.6 Risk Sharing Models
5.4 Conclusion
6 Company Anaylsis
6.1 Johnson & Johnson
6.1.1 Pharmaceuticals
6.1.2 Pharma R&D Growth Strategies
6.1.3 Divestments
6.1.4 Summary
6.2 Merck & Co.
6.2.1 Pharmaceuticals
6.2.2 Strategic Acquisitions and Partnerships
6.2.3 Pharma R&D Growth Strategies
6.2.4 Summary
6.3 Pfizer
6.3.1 Biopharmaceuticals
6.3.2 Strategic Acquisitions and Partnerships
6.3.3 Pharma R&D Growth Strategies
6.3.4 Summary
6.4 Roche Group
6.4.1 Pharmaceuticals
6.4.2 Pharma R&D Growth Strategies
6.4.3 Personalized Healthcare
6.4.4 Summary
6.5 Novartis
6.5.1 Pharmaceuticals
6.5.2 Pharma R&D Strategy
6.5.3 Alcon Division
6.5.4 Summary
7 Market Outlook
7.1 Re-evaluation
7.1.1 Investing for the Future
7.1.2 Conflicts in the Business Model
7.1.3 Cost-Effectiveness of Drugs
8 Appendix
8.1 Market Definition
8.2 Abbreviations
8.3 Sources
8.4 Methodology
8.4.1 Primary Research
8.4.2 Secondary Research
8.5 Contacts Us
8.6 Disclaimer
1.1 List of Tables
Table 1: Re-evaluating Pharmaceutical Pipelines, Pharma Deals in India
Table 2: Re-evaluating Pharmaceutical Pipelines, Healthcare Spending, International Comparison (% of GDP)
Table 3: Re-evaluating Pharmaceutical Pipelines, Probability of Success Based on Therapy
Table 4: Re-evaluating Pharmaceutical Pipelines, Target-unbiased Molecular Property Differences
Table 5: Re-evaluating Pharmaceutical Pipelines, Repurposed Drugs
Table 6: Re-evaluating Pharmaceutical Pipelines, Recent Foreign Investment in BRIC
Table 7: Re-evaluating Pharmaceutical Pipelines, Leading Biologics, 2010
Table 8: Re-evaluating Pharmaceutical Pipelines, Pharma Acquisitions in Vaccines, 2006-2011
Table 9: Re-evaluating Pharmaceutical Pipelines, Pharma Alliances in Vaccines, 2006-2011
Table 10: Re-evaluating Pharmaceutical Pipelines, Strategic M&A and Licensing Activity in the Orphan Drug Arena
Table 11: Re-evaluating Pharmaceutical Pipelines, Drugs Losing Patent, 2011-2013
Table 12: Re-evaluating Pharmaceutical Pipelines, Mega Mergers, 2000-2011
Table 13: Re-evaluating Pharmaceutical Pipelines, Recent Strategic Acquisitions, 2008-2011
Table 14: Re-evaluating Pharmaceutical Pipelines, Recent Collaborations, 2008-2011
Table 15: Re-evaluating Pharmaceutical Pipelines, Recent Licensing Deals, 2008-2011
Table 16: Re-evaluating Pharmaceutical Pipelines, Recent Public-Private Partnerships
Table 17: Re-evaluating Pharmaceutical Pipelines, Recent CRADAs, 2011
Table 18: Re-evaluating Pharmaceutical Pipelines, Recent Joint Ventures, 2009-2011
Table 19: Re-evaluating Pharmaceutical Pipelines, J&J Top 10 Drugs, 2010
Table 20: Re-evaluating Pharmaceutical Pipelines, New Product Launches and NDA/sNDA and BLA Files
Table 21: Re-evaluating Pharmaceutical Pipelines, Strategic Partnerships, Collaboration and Licensing Deals
Table 22: Re-evaluating Pharmaceutical Pipelines, Merck’s Top 10 Drugs, 2010
Table 23: Re-evaluating Pharmaceutical Pipelines, New Product Launches and NDA Drug Files, 2011
Table 24: Re-evaluating Pharmaceutical Pipelines, Strategic Partnerships, Collaboration and Licensing Deals, 2011
Table 25: Re-evaluating Pharmaceutical Pipelines, Pfizer’s Top 10 Drugs, 2010
Table 26: Re-evaluating Pharmaceutical Pipelines, New Product Launches and NDA/sNDA and BLA Files
Table 27: Re-evaluating Pharmaceutical Pipelines, Strategic Partnerships, Collaboration and Licensing Deals
Table 28: Re-evaluating Pharmaceutical Pipelines, Roche’s Top 10 Drugs, 2010
Table 29: Re-evaluating Pharmaceutical Pipelines, Novartis Top 10 Drugs, 2010
1.2 List of Figures
Figure 1: Re-evaluating Pharmaceutical Pipelines, M&A Deals by Value, 2008-2011
Figure 2: Re-evaluating Pharmaceutical Pipelines, M&A Deals by Market Segment, 2008-2011
Figure 3: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Value, 2008-2011
Figure 4: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Market Segment, 2008-2011
Figure 5: Re-evaluating Pharmaceutical Pipelines, M&A versus Partnering Activity, 2011
Figure 6: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Stage, 2011
Figure 7: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Therapy, 2011
Figure 8: Re-evaluating Pharmaceutical Pipelines, Open Innovation Business Model for Drug Development
Figure 9: Re-evaluating Pharmaceutical Pipelines, Application of Biomarkers in Drug Development
Figure 10: Re-evaluating Pharmaceutical Pipelines, Types of Biomarkers
Figure 11: Re-evaluating Pharmaceutical Pipelines, Learn and Confirm R&D Model
Figure 12: Re-evaluating Pharmaceutical Pipelines, FDA Approval Rates and R&D Expenditure, 2004-2010
Figure 13: Re-evaluating Pharmaceutical Pipelines, Probability of Success Based on Developmental Stage, 2005-2009
Figure 14: Re-evaluating Pharmaceutical Pipelines, Probability of Success Based on Therapy, 1991-2000
Figure 15: Re-evaluating Pharmaceutical Pipelines, Switch in Pipeline Focus,(%), 1990-1999 and 2000-2007
Figure 16: Re-evaluating Pharmaceutical Pipelines, FDA Approvals, 2006-2007
Figure 17: Re-evaluating Pharmaceutical Pipelines, Phase III Drug Failures, 2006-2007
Figure 18: Re-evaluating Pharmaceutical Pipelines, Reasons for Drug Failure in Late-stage Development, 1991 and 2000
Figure 19: Re-evaluating Pharmaceutical Pipelines, Maximizing Product Portfolio
Figure 20: Re-evaluating Pharmaceutical Pipelines, Drug Categories for Repurposing
Figure 21: Re-evaluating Pharmaceutical Pipelines, Maximizing Product Portfolio
Figure 22: Re-evaluating Pharmaceutical Pipelines, R&D Challenges and Opportunities
Figure 23: Re-evaluating Pharmaceutical Pipelines, Geographical Diversification
Figure 24: Re-evaluating Pharmaceutical Pipelines, FDA Drug Approvals, 2000-2010
Figure 25: Re-evaluating Pharmaceutical Pipelines, Pharmaceutical and Biological Revenues, $bn, 2010-2015
Figure 26: Re-evaluating Pharmaceutical Pipelines, Top Five Selling Vaccines, $m, 2009
Figure 27: Re-evaluating Pharmaceutical Pipelines, Exponential Growth of Drugs with Orphan Drug Designations in the US, 1985-2010
Figure 28: Re-evaluating Pharmaceutical Pipelines, FDA Orphan Diseases with the most Orphan Drug Approvals, 2010
Figure 29: Re-evaluating Pharmaceutical Pipelines, FDA Orphan Diseases with the Most Orphan Drug Designations
Figure 30: Re-evaluating Pharmaceutical Pipelines, Marketing approval of orphan medicines and COMP opinion on orphan designation by therapeutic area,%, 2000-2010
Figure 31: Re-evaluating Pharmaceutical Pipelines, FDA Orphan Drug Designations and Approvals for Large Pharma Companies, 1983-2011
Figure 32: Re-evaluating Pharmaceutical Pipelines, Top 10 Global Players in the Generics Market, $bn, 2008
Figure 33: Re-evaluating Pharmaceutical Pipelines, Geographical Sales Split of the OTC Market,(%), 2010
Figure 34: Re-evaluating Pharmaceutical Pipelines, Rx-to-OTC Product Switches by Company, 2000-2011
Figure 35: Re-evaluating Pharmaceutical Pipelines, Schematic Summarizing Business Model of Leading Companies
Figure 36: Re-evaluating Pharmaceutical Pipelines, Johnson & Johnson Global Revenues, $bn & %, 2010
Figure 37: Re-evaluating Pharmaceutical Pipelines, Johnson & Johnson, Revenue by Geography, $bn & %, 2010
Figure 38: Re-evaluating Pharmaceutical Pipelines, Johnson & Johnson New Product Revenues, $bn, 2010
Figure 39: Re-evaluating Pharmaceutical Pipelines, J&J’s Pharma Growth Strategies
Figure 40: Re-evaluating Pharmaceutical Pipelines, J&J’s New Product Launches Driving Future Growth
Figure 41: Re-evaluating Pharmaceutical Pipelines, Merck’s Global Revenues, $bn, 2010
Figure 42: Re-evaluating Pharmaceutical Pipelines, Merck’s Pharmaceutical Revenues, $bn, 2010
Figure 43: Re-evaluating Pharmaceutical Pipelines, Merck’s Pharma Growth Strategies
Figure 44: Re-evaluating Pharmaceutical Pipelines, Merck’s Late-Stage Product Pipeline, 2011
Figure 45: Re-evaluating Pharmaceutical Pipelines, Pfizer Global Revenues, $bn, 2010
Figure 46: Re-evaluating Pharmaceutical Pipelines, Pfizer Revenue by Geography, $bn, 2010
Figure 47: Re-evaluating Pharmaceutical Pipelines, Pfizer Biopharmaceutical Revenues, $bn, 2010
Figure 48: Re-evaluating Pharmaceutical Pipelines, Pfizer Product Pipeline, 2011
Figure 49: Re-evaluating Pharmaceutical Pipelines, Roche’s Global Revenues, $bn, 2010
Figure 50: Re-evaluating Pharmaceutical Pipelines, Roche, Regional Revenues, $bn, 2010
Figure 51: Re-evaluating Pharmaceutical Pipelines, Roche Group, FDA Approvals for NMEs and Line Extensions
Figure 52: Re-evaluating Pharmaceutical Pipelines, Roche’s Late-stage Pharma Pipeline, 2011
Figure 53: Re-evaluating Pharmaceutical Pipelines, Roche Group, Pipeline Products, 2011
Figure 54: Re-evaluating Pharmaceutical Pipelines, Roche’s PHC Strategy
Figure 55: Re-evaluating Pharmaceutical Pipelines, Novartis Global Revenues, $bn, 2010
Figure 56: Re-evaluating Pharmaceutical Pipelines, Novartis Regional Revenues, $bn, 2010
Figure 57: Re-evaluating Pharmaceutical Pipelines, Novartis Pharmaceutical Revenues, $bn, 2010
Figure 58: Re-evaluating Pharmaceutical Pipelines, Novartis Planned Product Filings, 2001-2015
Figure 59: Re-evaluating Pharmaceutical Pipelines, Novartis 2011 Strategic Priorities
Figure 60: Re-evaluating Pharmaceutical Pipelines, Novartis New Alcon Division
Co-operation Will be Key’ to Success of Future Pharma Pipelines, says Report
Co-operation will be key to the development of pharmaceuticals in coming years in order to avoid further struggles caused by isolated paths of discovery within the biotech industry, according to a new report by pharmaceutical experts GBI Research.
The new report* discusses how industry leaders have blamed the lack of improvements in pharma productivity on the industry’s closed innovation systems, which rely primarily on utilizing in-house expertise to address the challenges faced by product research and development (R&D). However, during the last decade, the pharmaceutical sector has begun to embrace an open innovation R&D model, establishing cooperative alliances, partnerships and joint ventures with R&D specialists to make use of diverse expertise and technologies in order to help develop proactive solutions and expand their potential markets.
In 2008, Czerepak and Ryser investigated the sources of drugs approved by the FDA as well as those failing in Phase III during the period January 2006 to December 2007, from small, medium and large pharmaceutical companies. Of the 103 FDA approvals, 46% were from biotech, 16% from pharma-biotech relationships, and 39% from pharmaceutical companies. Interestingly, only 30% of products were new chemical entities/novel drugs, while 30% were line extensions and 40% were “me-toos”. According to the investigation, more than 50% of novel drug approvals were originally generated by the biotech industry, and 95% of the phase III failures were products originating from biotech companies.
The pharmaceutical industry was therefore proven to have a much better success rate than biotech companies in getting drugs approved in the US during this investigation. However, 40% of all pharmaceutical companies' approved products were sourced from the biotech industry, either through collaborations or acquisitions.
Since 2000, most major pharmaceutical companies have undergone a major re-evaluation of their product pipelines, refining their therapeutic focus, expanding the contribution of biologics, repositioning products in emerging markets, managing their product lines through the migration of some prescription products to over-the-counter (OTC) drugs, and promoting the launch of branded generics and biosimilars.
Over the next ten years, the pharmaceutical industry will seek new ways to improve patient access to cost-effective, innovative medicines. Companies have adopted diverse tactics in order to refine their pipelines.
Companies have begun including the redirection of their R&D budgets and investments into new scientific hubs in China and India, strategically shifting funds out of research and into product development. Meanwhile, leading academic institutions have been actively patenting their research discoveries in reaction to knocks on their door from big pharma looking for alternative routes for innovation. These developments are expected to promote future growth and shareholder value alongside internal improvement on R&D efficiency.
- Johnson & Johnson
- Merck & Co.
- Pfizer
- Roche Group
- Novartis
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