www.datamonitor.com
Datamonitor America
245 Fifth Avenue
4th Floor
New York, NY 10016
USA
t: +1 212 686 7400
f: +1 646 365...
About Datamonitor
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or tran...
About Datamonitor
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or tran...
Executive Summary
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 4
This report is a licensed ...
Table of contents
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 5
This report is a licensed ...
Table of contents
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 6
This report is a licensed ...
Table of contents
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 7
This report is a licensed ...
Table of contents
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 8
This report is a licensed ...
Table of contents
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 9
This report is a licensed ...
Table of contents
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 10
This report is a licensed...
Table of contents
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 11
This report is a licensed...
Table of contents
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 12
This report is a licensed...
Table of contents
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 13
This report is a licensed...
Table of contents
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 14
This report is a licensed...
Table of contents
Future Pharmaceutical Industry Trends DMHC2497
© Datamonitor (03/2009) Page 15
This report is a licensed...
Upcoming SlideShare
Loading in …5
×

Future Pharma Trends - Long-term opportunities tempered by short-term challenges

4,820 views
4,719 views

Published on

An overview of the key trends shaping the pharmaceutical industry today, and those that are set to play a central role in the future, as companies transition towards a new business model: Pharma 2.0.

Provides key strategies and trends shaping the future of the pharmaceutical industry. Examines the impact of the Obama administration on US healthcare, and the implications for Pharma. Assesses the implications of the current economic and financial situation on healthcare. Analyzes key growth drivers and resistors set to shape Pharma\'s future.

Contact me at sosur@datamonitor.com to learn more!

0 Comments
2 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
4,820
On SlideShare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
52
Comments
0
Likes
2
Embeds 0
No embeds

No notes for slide

Future Pharma Trends - Long-term opportunities tempered by short-term challenges

  1. 1. www.datamonitor.com Datamonitor America 245 Fifth Avenue 4th Floor New York, NY 10016 USA t: +1 212 686 7400 f: +1 646 365 3362 e: usinfo@datamonitor.com Datamonitor Europe Charles House 108-110 Finchley Road London NW3 5JJ United Kingdom t: +44 20 7675 7000 f: +44 20 7675 7500 e: eurinfo@datamonitor.com Datamonitor Asia Pacific Level 46 / 2 Park Street Sydney NSW 2000 Australia t: +61 2 8705 6900 f: +61 2 8705 6901 e: apinfo@datamonitor.com Datamonitor Japan Da Vinci Ginza East 7th Floor 5-14-5 Ginza Chuo-ku Tokyo 104-0061 Japan t: +81 3 5148 7670 f: +81 3 4496 4316 e: jpinfo@datamonitor.com Future Pharmaceutical Industry Trends Long-term opportunities tempered by short-term challenges In recent years, Pharma has begun to adapt its business model in response to growing industry constraints and the decline of the primary-care focused blockbuster therapy. This process of change has recently been disrupted by unprecedented challenges caused by the global economic downturn, and by President Obama’s planned overhaul of the US healthcare system. To continue on its journey towards Pharma 2.0, Pharma needs to balance the more pressing short-term issues against the longer-term trends shaping the industry. Reference Code: DMHC2497 Publication Date: 03/2009
  2. 2. About Datamonitor All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, Datamonitor plc. The facts of this report are believed to be correct at the time of publication but cannot be guaranteed. Please note that the findings, conclusions and recommendations that Datamonitor delivers will be based on information gathered in good faith from both primary and secondary sources, whose accuracy we are not always in a position to guarantee. As such Datamonitor can accept no liability whatever for actions taken based on any information that may subsequently prove to be incorrect. Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 2 This report is a licensed product and is not to be photocopied ABOUT DATAMONITOR Datamonitor plc is a premium business information company specializing in industry analysis. We help our clients, 5,000 of the world’s leading companies, to address complex strategic issues. Through our proprietary databases and wealth of expertise, we provide clients with unbiased expert analysis and in-depth forecasts for six industry sectors: Automotive, Consumer Markets, Energy, Financial Services, Healthcare, Technology. Datamonitor maintains its headquarters in London and has regional offices in New York, Frankfurt and Hong Kong. ABOUT DATAMONITOR HEALTHCARE Datamonitor Healthcare provides a total business solution to the pharmaceutical and healthcare industries. Its services reflect its expertise in therapeutic, strategic and eHealth market analysis and competitive intelligence. Nick Bennett, Director of Research and Analysis, +44 (0)20 7551 9200, nbennett@datamonitor.com
  3. 3. About Datamonitor All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, Datamonitor plc. The facts of this report are believed to be correct at the time of publication but cannot be guaranteed. Please note that the findings, conclusions and recommendations that Datamonitor delivers will be based on information gathered in good faith from both primary and secondary sources, whose accuracy we are not always in a position to guarantee. As such Datamonitor can accept no liability whatever for actions taken based on any information that may subsequently prove to be incorrect. Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 3 This report is a licensed product and is not to be photocopied TEAM INFORMATION AND CONTACT DETAILS Datamonitor’s Strategic Analysis team led by Alistair Sinclair includes both analysts and senior analysts. In addition to prior experience in bioinformatics, pharmaceutical consulting and medical market research, the team’s educational backgrounds span a variety of science and business based degrees (BSc, MSc and PhD) from universities in the UK and abroad. The team focuses upon providing in-depth strategic insight through syndicated reports in the following five key areas: • Healthcare Systems and Markets – analysis of strategic issues ranging from emerging markets to the changing pricing and reimbursement environments in the major pharmaceutical markets and their impact on the industry as a whole; • Research and Development (R&D) – coverage of topics including strategies aimed at improving R&D productivity and the impact of emerging technologies; • Corporate Strategy – providing understanding behind corporate development strategies such as mergers and acquisitions and licensing/alliance networks, plus major trends impacting business models; • Sales and Marketing – examining issues affecting sales and marketing, from strategies to improve sales force effectiveness to the impact of new media; • Lifecycle Management – offering insight into the opportunities presented by reformulations or OTC switching, in addition to providing up to date coverage of the rapidly evolving generic and biosimilars markets. For inquiries about the content of this report, please contact Alistair Sinclair asinclair@datamonitor.com
  4. 4. Executive Summary Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 4 This report is a licensed product and is not to be photocopied CHAPTER 1 EXECUTIVE SUMMARY Scope of the report Future Pharmaceutical Industry Trends – Long-term opportunities tempered by short- term challenges provides an overview of key trends shaping the pharmaceutical industry today and those that are set to play a central role in the future as companies transition towards a new business model: Pharma 2.0. The report has been structured into the following chapters: • Chapter 1 presents an overview of the reports findings • Chapter 2 provides key strategies and trends that will shape the future of the pharmaceutical industry • Chapter 3 examines the impact of President Obama’s administration on US healthcare and its implications for Pharma • Chapter 4 explores the evolving global generic and biosimilar landscape • Chapter 5 assesses the impact of the current economic and financial situation on healthcare • Chapter 6 investigates key growth drivers and resistors set to shape the industry’s future • Chapter 7 lays out regulatory issues and their impact on the global healthcare market • Chapter 8 contains a comprehensive bibliography
  5. 5. Table of contents Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 5 This report is a licensed product and is not to be photocopied TABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 4 Scope of the report 4 Key findings 5 CHAPTER 2 STRATEGIC & FUTURE TRENDS AFFECTING PHARMA 24 Strategic and future trends in the branded pharmaceutical market 24 Corporate trends and strategies 25 Return of the mega-merger… but for how long? 25 Pharma set to capitalize on biotech funding crisis through M&A 25 Academic collaborations – a longer-term solution to R&D innovation 26 Biotech consolidation – an option for cash-strapped companies to remain independent of Big Pharma 26 Contract research organization market evolution – M&A, consolidation and R&D investment 27 Focus on cash and credit management to boost profit growth 27 Portfolio expansion or specialization – both strategies have their merit 28 Emerging markets set to play pivotal role in future Pharma success 29 Vaccines, over-the-counter products, and generics provide market access to emerging markets 30 Pharma will continue to seek cost-efficiencies in emerging markets 30 Sales and marketing trends and strategies 31 New sales models will become tailored to product portfolio 31
  6. 6. Table of contents Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 6 This report is a licensed product and is not to be photocopied Marketing teams will become more involved clinical development decisions 31 Collaborative payer relationships are vital to secure optimal drug pricing... 32 …and improve healthcare strategy and patient compliance 32 The shift from drug promotion to information provision will continue 32 Pharma to enter into closer and earlier collaboration with regulators 32 Scenario-based pricing expected for US Pharma 33 R&D trends and strategies 34 Niche indications offer Pharma better opportunities for market access 34 Reformulations no longer an approval certainty – more creative lifecycle management strategies needed 34 Widening the ‘R&D bottleneck’ will shorten R&D time and increase productivity 35 Biomarker analysis set to grow simultaneously with targeting of niche markets 35 Employment of proactive pharmacovigilance strategies could limit future costs 35 Big Pharma collaboration on R&D processes should enhance drug discovery 36 Reduction in Pharma’s reliance on traditional R&D strategies leads to further cost savings 37 Pharma in-house R&D will evolve through satellite start-ups 38 Pharma’s use of contract research organizations set to grow 38 Pharma will increase focus on specialty markets 39 Personalized drugs to become an important part of future drug portfolios 40 Drug-diagnostic test combinations will become more common 40 External trends and resultant company strategies 41 President Obama’s overhaul of US healthcare will define Pharma strategies 41 Regulatory pressures become more restrictive, but solutions are available 42
  7. 7. Table of contents Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 7 This report is a licensed product and is not to be photocopied Manufacturers will be more proactive in securing drug supply-chain 43 Pharma must adapt to divergent distribution channels in Europe 43 Closer co-operation with regulators on drug safety is anticipated 43 Strategic and future trends in the generic pharmaceutical market 45 Corporate trends and strategies 45 Consolidation in the generics sector to accelerate 45 Larger generics or branded pharma companies set to be biosimilars winners 46 Greater convergence between branded and generic companies expected 46 Acquisition of small biotech companies by innovators will increase 47 Increase in acquisitions and alliances between Big Pharma and Japanese generics companies 47 R&D trends and strategies 47 Would-be biosimilar manufacturers should concentrate on more complex second- generation products 47 Sales and marketing trends and strategies 48 Generics companies in the US must build ties with retailers 48 Patient information databases to become important tools for generics growth 48 Branded biologic companies must lower prices following biosimilar incursion 48 Biosimilars manufacturers will court physicians to drive near-term uptake 48 External trends and resultant company strategies 49 Reverse payments in decline in the US 49 Risk Evaluation Management Strategy will act to delay generic entry 49 Generics companies must fight to secure global trade routes 49 Companies operating in Germany must lower price and survive on lower margins 50
  8. 8. Table of contents Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 8 This report is a licensed product and is not to be photocopied Germany set to become the biosimilar testing ground 50 CHAPTER 3 PRESIDENT OBAMA’S REFORMS 51 President Obama – time for change! 51 Current issues with US healthcare 52 The financial crisis has impacted private insurance coverage 53 Growing strain on public insurance schemes 54 Baby boomers hit 65 driving up Medicare healthcare costs 54 High drug, medical device and administrative costs stretch budgets 54 Increased prevalence of chronic diseases 54 President Obama sets out to provide quality, affordable and portable healthcare insurance to all US citizens 55 Provision of healthcare for all uninsured US children 55 Coverage cannot be denied based on pre-existing conditions 56 Implement universal healthcare through establishing a national healthcare plan 56 Minimizing the ‘donut hole’ 57 Medicare reform 58 Establishment of a national health insurance exchange scheme 58 Pressure on large employers who choose not to contribute to their employees healthcare insurance costs 59 Obama’s healthcare reform ambitions – how realistic are they? 59 Good news for Pharma 60 Patient power achieves greater choice for seniors 61 Continuing support for R&D tax credits 61
  9. 9. Table of contents Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 9 This report is a licensed product and is not to be photocopied Stem cell research – a quick win for Obama 62 Obama’s support for disease prevention and personalized medicine is good news for Pharma 62 Bad news for Pharma 63 Establishment of a comparative effectiveness board 64 Bad time for Pharma, but good times ahead for generic companies as a pro- generic senator takes power 65 President Obama promises biosimilars pathway 66 The uncertain news for Pharma 67 Re-importation will not happen until FDA reforms are in place to ensure safety 67 Pharma must pre-empt direct pricing negotiations by going to the federal government with a compromise 68 CHAPTER 4 GENERICS & BIOSIMILARS 69 The need for cost-containment will drive generic and biosimilar uptake 69 Generics growth begins to slow 70 Global march towards a commodity generics market gathers pace 70 High-volume, low-value market of US and UK beginning to contract 70 Retailers grow in power, forcing down margins 71 Germany on the road to a commodity generics market 72 Increasing scrutiny of innovator-generic company deals 73 Reverse payments in US remain a contentious issue 73 European Pharma sector enquiry uncovers generic delay tactics 75 Promotion of generics uptake gains momentum 76 Getting the basics right in less mature generics markets 77
  10. 10. Table of contents Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 10 This report is a licensed product and is not to be photocopied Novel strategies to increase generic uptake in mature markets 78 Biosimilars uptake set to grow 80 First biosimilars in Europe have yet to make a splash 80 Pre-filled Omnitrope cartridges boost sales for Sandoz 80 Epoetin uptake picking up in Germany 81 Biosimilar filgrastim looks to be a crowded market 82 Lessons from the EU 83 The hospital retail divide will impact biosimilar uptake 83 Physicians pivotal to biosimilars uptake 84 Branded pharma taking the biosimilar leap 84 The US outlook 85 Interchangeability a distant but alluring prospect 86 Market exclusivity for branded and biosimilar drugs is a contentious issue 87 The US biosimilars pathway will be informed by lessons learned from Hatch- Waxman 88 CHAPTER 5 FINANCE & THE ECONOMY 89 The global economic downturn is set to exacerbate Pharma’s problems 89 Greater focus on Pharma spending 90 The Biotech financing crisis – no sign improvement for Biotech 91 The number of biotechs struggling for cash continues to grow 91 Still no biotech IPOs 92 Investors demand their cash back 92 Slump in licensing deals but rise in M&A 93
  11. 11. Table of contents Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 11 This report is a licensed product and is not to be photocopied Growing uninsured population – patients even less able to cover the costs of healthcare including pharmaceuticals 94 Pharma may struggle to justify the costs of expensive prescription drugs 96 CHAPTER 6 STRATEGIC GROWTH DRIVERS & RESISTORS 98 Unprecedented industry pressures will affect future growth potential 98 Key drivers 101 Emerging markets set to drive future growth for Pharma 101 Global pharmaceutical market growth will be driven by emerging market sales 102 Big Pharma embraces the emerging markets 103 Vaccines drive emerging market growth 105 Off-shoring to emerging markets begins to take hold 106 From blockbusters to personalized medicine 108 Key drivers and resistors to personalized medicine 108 Personalized medicines are a growing industry 110 State, industry and academia collaborations drive personalized medicines 112 Diagnostics take center stage as personalized medicines become a reality 112 Niche markets offer growth potential for Pharma 113 Key advantages of targeting secondary care, niche markets 114 Hospital branded pharmaceutical sales outgrow the retail branded pharmaceutical market 115 Key drivers of the secondary care, niche markets 117 Key resistors 118 Growing regulatory pressures are set to restrict Pharma 118
  12. 12. Table of contents Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 12 This report is a licensed product and is not to be photocopied Regulatory pressures affecting Pharma 119 Pharma’s responses to growing regulatory pressure 121 Pharma needs to reassess its R&D strategies 122 Factors impacting Pharma’s innovation and R&D process 124 The Biotech financing crisis provides Pharma an opportunity to access innovative research through M&A 126 Regulatory pricing pressures and limited payer healthcare spend impact Pharma sales 128 CHAPTER 7 REGULATORY PRESSURES & CHANGES 129 Heightening regulatory pressure restricts Pharma’s options 129 Drug safety regulations set to intensify 130 Drug safety takes center stage 130 Digoxin, Chantix and heparin drive up adverse events reports 131 FDA looks to introduce toll-free number to report adverse events 132 Manufacturers in breach of Good Manufacturing Practice 133 FDA’s failing oversight 134 EU-US collaboration for foreign facility inspections 135 Use of certified independent third parties to assess compliance 135 Establishment of foreign outposts 135 Pilot program to secure foreign imports 136 FDA – expansion will be a challenge without industry funding 137 Funding the FDA’s expansion is vital to the implementation of President Obama’s reforms 138 Tighter regulations for Pharma marketers in 2009 138
  13. 13. Table of contents Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 13 This report is a licensed product and is not to be photocopied Until a new FDA commissioner is appointed reforms will stall 139 FDAAA is up and running forcing Pharma to adjust its internal processes to comply 140 Developing a REMS adds between 3 and 9 months to the FDA approval process 141 REMS slow down generic approvals 142 Companies to submit all bioequivalence studies in ANDA applications 142 EU approvals to become faster and more tailored to specialty products 143 US direct to consumer advertising is waning as EU relaxes rules 143 FDA’s direct to consumer oversight is lacking 144 Drug advertisements falling foul of the FDA 144 Vytorin advertising campaign run despite poor study outcome 145 Failure to disclose payment to ‘celebrity’ posing as doctor in Lipitor ads 145 Bayer to launch a corrective ad campaign for Yaz 145 Pharma moving away from direct-to-consumer advertising 146 A shift in balance between promotion and patient education 148 Industry looking to pre-empt direct to consumer regulatory changes 149 EU direct to consumer communication guidelines partially relaxed 150 Security and supply dominate drug distribution 151 Contrasting distribution trends in Germany and the UK 152 UK drug distribution system in flux 152 Competition in Germany’s drug distribution sector set to grow 153 Securing the drug supply chain 154 Goods in transit subject to seizure in EU 154 Track and trace could get federal in the US 156
  14. 14. Table of contents Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 14 This report is a licensed product and is not to be photocopied Drug tracking gains traction in the EU 157 Pound’s depreciation turns UK into parallel exporter 158 Evolving pricing and reimbursement set to restrict pharma further 159 US – President Obama’s cost-cutting strategies will drive down drug prices 159 Japans NHI drug pricing system reforms will balance innovation with cost- containment 160 Germanys healthcare reforms will create difficult market conditions for branded Pharma 162 Germany’s planned implementation of IQWiG reforms will increase scrutiny on branded drugs 162 German statutory healthcare funds are gaining considerable negotiating power and autonomy 162 UK – introduction of the PPRS is not all bad news for Pharma 163 Flexible pricing agreements introduced to reward innovation 164 NICE – patient access schemes and the government’s action plan set to boost access to new drugs 164 France, Italy and Spain – continue to implement cost cutting strategies through greater generic use 166 Evolution of a payer centric sales and marketing model 167 Sales force cuts will intensify in 2009 167 Pharma discloses physician fees to enhance public perception 169 Internet-based approaches in reaching key stakeholders will intensify 170 CHAPTER 8 BIBLIOGRAPHY 171 Publications and online articles 171 Datamonitor resources 194
  15. 15. Table of contents Future Pharmaceutical Industry Trends DMHC2497 © Datamonitor (03/2009) Page 15 This report is a licensed product and is not to be photocopied Conference Literature 195 APPENDIX 196

×