Introduction
Pharma faces a number of key resistors to growth including the impending 2011 patent cliff which is set to erode $78 billion in global branded sales from drugs facing patent expiry over the 201014 period (plus $32 billion from continued erosion of already expired brands). Price cuts, reimbursement restrictions and growing regulatory pressure are further set to limit sales growth going forward.
Scope
* Overview of the key drivers and resistors facing Pharma, Biotech and generics players out to 2014
* Analysis of recent regulatory changes in the US, EU and emerging markets and their impact on pricing and reimbursement, drug development and marketing
* Examination of key global and country-specific issues facing both biosimilars and generics players
* Assessment of the impact of the global economic downturn on the Pharma and Biotech sectors and their respective counter strategies
Highlights
Annual sales growth of pharmaceuticals in the emerging markets is already double-digit, providing a key opportunity for Pharma. Revenue streams in these markets can be derived from launching branded off-patent drugs, branded generics, and local brands owned or licensed by the acquiring pharma company.
Pharma is moving away from the "me-too" and increasingly genericized primary care market towards more high value biologic therapies in secondary care as well as more niche markets; markets with little or no existing competition, and which despite their smaller size (in terms of patient numbers) are still commercially attractive.
To maintain profitability in the face of slowing sales to 2014, pharma companies have implemented a number of cost-cutting measures (in addition to strategic repositioning and diversification strategies) in order to boost profitability going forward.
Reasons to Purchase
* Examine the combined prescription drug sales forecasts for the top 50 Pharma out to 2014 by molecule type, product source, geography and therapy area
* Identify the key factors impacting Pharma’s R&D productivity as well as the solutions companies are implementing to strengthen their R&D efforts
* Assess key drivers behind Pharma’s M&A activity and its role in boosting profits by opening up new access to new markets as well as cutting costs
ABOUT DATAMONITOR HEALTHCARE 2
About the Healthcare Strategic Analysis Team 2
1. About this report 3
Data sourcing – the PharmaVitae Explorer database 3
Chapter structure 4
Glossary 5
Related reports 5
Upcoming related reports 5
2. Executive Summary 6
Key drivers and resistors facing Pharma 6
Resistors for Pharma 7
Drivers for Pharma 14
Neutral for Pharma 23
Key drivers and resistors facing generics and biosimilars companies 26
Key drivers and resistors facing Biotech 28
3. Healthcare Systems and Regulations 32
Expansion of healthcare provision top of the agenda of many countries 32
US health reform set to change the country’s healthcare landscape 36
The FDA is set on restoring its reputation 62
Drug prices suffer in Japan 69
Five major EU markets – cost-containment pressures mount 72
EU legislation focused on streamlining regulatory processes 80
New healthcare initiatives in the emerging markets are tackling growing costs 83
Brazil’s ANVISA may hamper the domestics growth of multinational pharma companies 85
Russia enhances regulations to boost growth of the domestic pharma industry 87
India tackles growing healthcare expenditure by tightening price controls and increasing access to generic drugs 90
China’s healthcare reforms will expand the domestic market but may create challenges for foreign companies 92
4. Generics and Biosimilars 95
The generics market 96
The biosimilars market 117
5. Recession and Recovery 131
Appendix
Pharmaceutical Key Trends 2010 DMHC2599 Published 03/2010
© Datamonitor. This report is a licensed product and is not to be photocopied Page 7
Largely insulated from the recession Pharma’s key threat is the patent cliff 131
Biotech emerges from its funding crisis 138
6. Prescription Drug Market Outlook 146
Definitions – launch, core, expiry 146
Drivers and resistors for sales growth of the top 50 pharma companies out to 2014 146
7. Research and Development 164
Pharma continues to battle with R&D issues 164
Pharma’s R&D cost-cutting exercise is only a short-term solution 168
Pharma’s late-stage deal activity set to increase to help offset the patent cliff 170
Pharma’s level of early-stage R&D collaboration intensifies 171
Outsourcing set to rise following initial cost-cutting exercises implemented during the economic downturn 173
Pharma sharpens its focus on secondary care indications through high value biologic therapies as the patent cliff looms 175
Personalized medicine and stem cell technology are key strategies in the commercialization of niche indications 183
Pharma embraces low cost late-stage lifecycle management strategies 187
8. Mergers and Acquisitions 192
M&A will remain a central strategy for Pharma 192
M&A deals to increase scale and cut costs 196
M&A deals to target high growth therapeutic markets 199
M&A deals to target high growth geographic markets 201
M&A deals to increase pharma focus or diversify into other healthcare markets 205
9. Bibliography 212
Executive Summary 212
Healthcare Systems and Regulations 212
Generics and Biosimilars 223
Recession and Rrecovery 232
Prescription Drug Market Outlook 235
Research and Development 235
Mergers and Acquisitions 241
APPENDIX 244
Exchange rates 244
US healthcare reform model 245
About Datamonitor 253
Appendix
Pharmaceutical Key Trends 2010 DMHC2599 Published 03/2010
© Datamonitor. This report is a licensed product and is not to be photocopied Page 8
Datamonitor consulting 254
Disclaimer 256
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