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医薬品パイプラインの再評価:将来の意思決定を形成する新興市場、生物製剤およびオーファンドラッグ

Re-evaluating Pharmaceutical Pipelines - Emerging Markets, Biologics and Orphan Drugs to Shape Future Decision Making

発行 GBI Research 商品コード 244539
出版日 ページ情報 英文 120 Pages
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医薬品パイプラインの再評価:将来の意思決定を形成する新興市場、生物製剤およびオーファンドラッグ Re-evaluating Pharmaceutical Pipelines - Emerging Markets, Biologics and Orphan Drugs to Shape Future Decision Making
出版日: 2012年06月12日 ページ情報: 英文 120 Pages
概要

当レポートでは、医薬品パイプラインの再評価に影響する主な課題、および内的・外的課題の双方に対処するための戦略について分析し、リスクを抑えた製品開発の新しいアプローチ、R&D動向、R&Dの主な課題と機会、主なM&A活動と提携、および競合情勢と大手製薬企業による成長戦略の分析などを提供しており、概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

  • 市況
  • 新興市場
  • 医療制度改革
  • M&Aおよび提携
  • 新しいビジネスモデルの採用
  • 科学と技術の進歩

第3章 R&D動向

  • イントロダクション
  • 製品ポートフォリオの最大化
  • 結論

第4章 R&Dの課題と機会

  • イントロダクション
  • 地域的差異
  • 治療による違い
  • ジェネリック医薬品とバイオシミラー
  • OTC医薬品
  • ビジネスの多様性
  • 結論

第5章 買収、合併および提携:パイプラインの補給

  • 買収
  • 戦略的合併
  • 協力・提携
  • 結論

第6章 企業分析

  • Johnson & Johnson
  • Merck & Co.
  • Pfizer
  • Roche Group
  • Novartis

第7章 市場展望

  • 再評価

第8章 付録

図表

目次

Summary

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.

Executive Summary

'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.

Re-evaluating Pharmaceutical Pipelines - Emerging Markets, Biologics and Orphan Drugs to Shape Future Decision Making

This report examines the key issues influencing the re-evaluation of pharmaceutical pipelines, and the strategies the industry has adopted to address both internal and external challenges. It provides an overview of the factors impacting the pharmaceuticals industry and discusses trends in pharma productivity, the impact of drug attrition rates on different drug therapies and business models adopted to reduce failure rates in Phase III development and maximize their product portfolios to ensure future growth and shareholder value. The report provides an overview of different strategies available to companies to acquire, partner or license products as they re-evaluate their pipelines and includes company profiles and detailed analysis of their pipelines, M&A and partnering activity, and pharma R&D growth strategies. Finally, it raises questions regarding the future outlook of the market and the ways in which pharma needs to re-evaluate its product pipelines to secure future growth.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Table of Contents

1 Table of Contents 6

  • 1.1 List of Tables 8
  • 1.2 List of Figures 9

2 Introduction 11

  • 2.1 Market Conditions 11
  • 2.2 Emerging Markets 12
    • 2.2.1 Brazil 12
    • 2.2.2 Russia 12
    • 2.2.3 India 12
    • 2.2.4 China 13
  • 2.3 Healthcare Reform 14
    • 2.3.1 The US 14
    • 2.3.2 European Austerity 15
  • 2.4 M&A and Partnerships 16
    • 2.4.1 M&A Activity 16
    • 2.4.2 Partnership Activity 18
    • 2.4.3 Trends in 2011 20
  • 2.5 Adopting New Business Models 22
    • 2.5.1 Open Innovation Business Models 23
  • 2.6 Advances in Science and Technology 24
    • 2.6.1 Preclinical 24
    • 2.6.2 Clinical 25

3 R&D Trends 27

  • 3.1 Introduction 27
    • 3.1.1 Drug Attrition vs. Therapy 28
    • 3.1.2 Drug Attrition vs. Business Strategy 31
    • 3.1.3 Strategies to Reduce Failure Rates in Phase III 33
    • 3.1.4 Other Strategies to Reduce Drug Attrition 35
  • 3.2 Maximizing Product Portfolios 36
    • 3.2.1 New Uses for Existing Therapeutic Classes 37
  • 3.3 Conclusions 40

4 R&D Challenges and Opportunities 41

  • 4.1 Introduction 41
  • 4.2 Geographical Diversification 42
  • 4.3 Therapeutic Diversification 45
    • 4.3.1 Biologics 45
    • 4.3.2 Vaccines 47
    • 4.3.3 Orphan Drugs 51
  • 4.4 Generics and Biosimilars 58
  • 4.5 OTC Medicines 60
  • 4.6 Business Diversification 62
    • 4.6.1 Animal Health 62
    • 4.6.2 Consumer Healthcare 62
    • 4.6.3 Diagnostics 62
    • 4.6.4 Ophthalmic 62
    • 4.6.5 Medical Devices 62
  • 4.7 Conclusions 63

5 Mergers, Acquistions and Partnerships - Refuelling Pipelines 64

  • 5.1 Mergers 64
  • 5.2 Strategic Acquisitions 65
    • 5.2.1 Acquisitions through Equity Stakes 65
    • 5.2.2 Strategic Acquisitions in the New Market Segments 65
    • 5.2.3 Strategic Acquisitions in the Therapeutic Areas 67
  • 5.3 Collaborations and Partnerships 67
    • 5.3.1 Collaborations 68
    • 5.3.2 Licensing Deals 70
    • 5.3.3 Public-Private Partnerships 71
    • 5.3.4 Cooperative Research and Development Agreements 73
    • 5.3.5 Joint Ventures 74
    • 5.3.6 Risk Sharing Models 75
  • 5.4 Conclusion 75

6 Company Anaylsis 76

  • 6.1 Johnson & Johnson 77
    • 6.1.1 Pharmaceuticals 78
    • 6.1.2 Pharma R&D Growth Strategies 82
    • 6.1.3 Divestments 83
    • 6.1.4 Summary 83
  • 6.2 Merck & Co. 84
    • 6.2.1 Pharmaceuticals 85
    • 6.2.2 Strategic Acquisitions and Partnerships 88
    • 6.2.3 Pharma R&D Growth Strategies 89
    • 6.2.4 Summary 91
  • 6.3 Pfizer 92
    • 6.3.1 Biopharmaceuticals 94
    • 6.3.2 Strategic Acquisitions and Partnerships 97
    • 6.3.3 Pharma R&D Growth Strategies 98
    • 6.3.4 Summary 100
  • 6.4 Roche Group 100
    • 6.4.1 Pharmaceuticals 102
    • 6.4.2 Pharma R&D Growth Strategies 103
    • 6.4.3 Personalized Healthcare 106
    • 6.4.4 Summary 107
  • 6.5 Novartis 108
    • 6.5.1 Pharmaceuticals 109
    • 6.5.2 Pharma R&D Strategy 112
    • 6.5.3 Alcon Division 113
    • 6.5.4 Summary 113

7 Market Outlook 114

  • 7.1 Re-evaluation 114
    • 7.1.1 Investing for the Future 114
    • 7.1.2 Conflicts in the Business Model 115
    • 7.1.3 Cost-Effectiveness of Drugs 115

8 Appendix 116

  • 8.1 Market Definition 116
  • 8.2 Abbreviations 116
  • 8.3 Sources 117
  • 8.4 Methodology 119
    • 8.4.1 Primary Research 119
    • 8.4.2 Secondary Research 120
  • 8.5 Contacts Us 120
  • 8.6 Disclaimer 120

List of Tables

  • Table 1: Re-evaluating Pharmaceutical Pipelines, Pharma Deals in India 13
  • Table 2: Re-evaluating Pharmaceutical Pipelines, Healthcare Spending, International Comparison (% of GDP) 14
  • Table 3: Re-evaluating Pharmaceutical Pipelines, Probability of Success Based on Therapy 29
  • Table 4: Re-evaluating Pharmaceutical Pipelines, Target-unbiased Molecular Property Differences 34
  • Table 5: Re-evaluating Pharmaceutical Pipelines, Repurposed Drugs 39
  • Table 6: Re-evaluating Pharmaceutical Pipelines, Recent Foreign Investment in BRIC 43
  • Table 7: Re-evaluating Pharmaceutical Pipelines, Leading Biologics, 2010 45
  • Table 8: Re-evaluating Pharmaceutical Pipelines, Pharma Acquisitions in Vaccines, 2006-2011 48
  • Table 9: Re-evaluating Pharmaceutical Pipelines, Pharma Alliances in Vaccines, 2006-2011 48
  • Table 10: Re-evaluating Pharmaceutical Pipelines, Strategic M&A and Licensing Activity in the Orphan Drug Arena 56
  • Table 11: Re-evaluating Pharmaceutical Pipelines, Drugs Losing Patent, 2011-2013 58
  • Table 12: Re-evaluating Pharmaceutical Pipelines, Mega Mergers, 2000-2011 64
  • Table 13: Re-evaluating Pharmaceutical Pipelines, Recent Strategic Acquisitions, 2008-2011 66
  • Table 14: Re-evaluating Pharmaceutical Pipelines, Recent Collaborations, 2008-2011 68
  • Table 15: Re-evaluating Pharmaceutical Pipelines, Recent Licensing Deals, 2008-2011 70
  • Table 16: Re-evaluating Pharmaceutical Pipelines, Recent Public-Private Partnerships 72
  • Table 17: Re-evaluating Pharmaceutical Pipelines, Recent CRADAs, 2011 73
  • Table 18: Re-evaluating Pharmaceutical Pipelines, Recent Joint Ventures, 2009-2011 74
  • Table 19: Re-evaluating Pharmaceutical Pipelines, J&J Top 10 Drugs, 2010 78
  • Table 20: Re-evaluating Pharmaceutical Pipelines, New Product Launches and NDA/sNDA and BLA Files 79
  • Table 21: Re-evaluating Pharmaceutical Pipelines, Strategic Partnerships, Collaboration and Licensing Deals 81
  • Table 22: Re-evaluating Pharmaceutical Pipelines, Merck's Top 10 Drugs, 2010 86
  • Table 23: Re-evaluating Pharmaceutical Pipelines, New Product Launches and NDA Drug Files, 2011 87
  • Table 24: Re-evaluating Pharmaceutical Pipelines, Strategic Partnerships, Collaboration and Licensing Deals, 2011 88
  • Table 25: Re-evaluating Pharmaceutical Pipelines, Pfizer's Top 10 Drugs, 2010 94
  • Table 26: Re-evaluating Pharmaceutical Pipelines, New Product Launches and NDA/sNDA and BLA Files 95
  • Table 27: Re-evaluating Pharmaceutical Pipelines, Strategic Partnerships, Collaboration and Licensing Deals 97
  • Table 28: Re-evaluating Pharmaceutical Pipelines, Roche's Top 10 Drugs, 2010 102
  • Table 29: Re-evaluating Pharmaceutical Pipelines, Novartis Top 10 Drugs, 2010 110

List of Figures

  • Figure 1: Re-evaluating Pharmaceutical Pipelines, M&A Deals by Value, 2008-2011 16
  • Figure 2: Re-evaluating Pharmaceutical Pipelines, M&A Deals by Market Segment, 2008-2011 17
  • Figure 3: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Value, 2008-2011 18
  • Figure 4: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Market Segment, 2008-2011 19
  • Figure 5: Re-evaluating Pharmaceutical Pipelines, M&A versus Partnering Activity, 2011 20
  • Figure 6: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Stage, 2011 21
  • Figure 7: Re-evaluating Pharmaceutical Pipelines, Partnering Activity by Therapy, 2011 21
  • Figure 8: Re-evaluating Pharmaceutical Pipelines, Open Innovation Business Model for Drug Development 22
  • Figure 9: Re-evaluating Pharmaceutical Pipelines, Application of Biomarkers in Drug Development 24
  • Figure 10: Re-evaluating Pharmaceutical Pipelines, Types of Biomarkers 25
  • Figure 11: Re-evaluating Pharmaceutical Pipelines, Learn and Confirm R&D Model 26
  • Figure 12: Re-evaluating Pharmaceutical Pipelines, FDA Approval Rates and R&D Expenditure, 2004-2010 27
  • Figure 13: Re-evaluating Pharmaceutical Pipelines, Probability of Success Based on Developmental Stage, 2005-2009 28
  • Figure 14: Re-evaluating Pharmaceutical Pipelines, Probability of Success Based on Therapy, 1991-2000 28
  • Figure 15: Re-evaluating Pharmaceutical Pipelines, Switch in Pipeline Focus,(%), 1990-1999 and 2000-2007 30
  • Figure 16: Re-evaluating Pharmaceutical Pipelines, FDA Approvals, 2006-2007 31
  • Figure 17: Re-evaluating Pharmaceutical Pipelines, Phase III Drug Failures, 2006-2007 32
  • Figure 18: Re-evaluating Pharmaceutical Pipelines, Reasons for Drug Failure in Late-stage Development, 1991 and 2000 33
  • Figure 19: Re-evaluating Pharmaceutical Pipelines, Maximizing Product Portfolio 36
  • Figure 20: Re-evaluating Pharmaceutical Pipelines, Drug Categories for Repurposing 37
  • Figure 21: Re-evaluating Pharmaceutical Pipelines, Maximizing Product Portfolio 38
  • Figure 22: Re-evaluating Pharmaceutical Pipelines, R&D Challenges and Opportunities 41
  • Figure 23: Re-evaluating Pharmaceutical Pipelines, Geographical Diversification 42
  • Figure 24: Re-evaluating Pharmaceutical Pipelines, FDA Drug Approvals, 2000-2010 46
  • Figure 25: Re-evaluating Pharmaceutical Pipelines, Pharmaceutical and Biological Revenues, $bn, 2010-2015 47
  • Figure 26: Re-evaluating Pharmaceutical Pipelines, Top Five Selling Vaccines, $m, 2009 50
  • Figure 27: Re-evaluating Pharmaceutical Pipelines, Exponential Growth of Drugs with Orphan Drug Designations in the US, 1985-2010 52
  • Figure 28: Re-evaluating Pharmaceutical Pipelines, FDA Orphan Diseases with the most Orphan Drug Approvals, 2010 53
  • Figure 29: Re-evaluating Pharmaceutical Pipelines, FDA Orphan Diseases with the Most Orphan Drug Designations 54
  • Figure 30: Re-evaluating Pharmaceutical Pipelines, Marketing approval of orphan medicines and COMP opinion on orphan designation by therapeutic area,%, 2000-2010 55
  • Figure 31: Re-evaluating Pharmaceutical Pipelines, FDA Orphan Drug Designations and Approvals for Large Pharma Companies, 1983-2011 57
  • Figure 32: Re-evaluating Pharmaceutical Pipelines, Top 10 Global Players in the Generics Market, $bn, 2008 59
  • Figure 33: Re-evaluating Pharmaceutical Pipelines, Geographical Sales Split of the OTC Market,(%), 2010 60
  • Figure 34: Re-evaluating Pharmaceutical Pipelines, Rx-to-OTC Product Switches by Company, 2000-2011 61
  • Figure 35: Re-evaluating Pharmaceutical Pipelines, Schematic Summarizing Business Model of Leading Companies 76
  • Figure 36: Re-evaluating Pharmaceutical Pipelines, Johnson & Johnson Global Revenues, $bn & %, 2010 77
  • Figure 37: Re-evaluating Pharmaceutical Pipelines, Johnson & Johnson, Revenue by Geography, $bn & %, 2010 78
  • Figure 38: Re-evaluating Pharmaceutical Pipelines, Johnson & Johnson New Product Revenues, $bn, 2010 80
  • Figure 39: Re-evaluating Pharmaceutical Pipelines, J&J's Pharma Growth Strategies 82
  • Figure 40: Re-evaluating Pharmaceutical Pipelines, J&J's New Product Launches Driving Future Growth 83
  • Figure 41: Re-evaluating Pharmaceutical Pipelines, Merck's Global Revenues, $bn, 2010 84
  • Figure 42: Re-evaluating Pharmaceutical Pipelines, Merck's Pharmaceutical Revenues, $bn, 2010 85
  • Figure 43: Re-evaluating Pharmaceutical Pipelines, Merck's Pharma Growth Strategies 89
  • Figure 44: Re-evaluating Pharmaceutical Pipelines, Merck's Late-Stage Product Pipeline, 2011 91
  • Figure 45: Re-evaluating Pharmaceutical Pipelines, Pfizer Global Revenues, $bn, 2010 92
  • Figure 46: Re-evaluating Pharmaceutical Pipelines, Pfizer Revenue by Geography, $bn, 2010 93
  • Figure 47: Re-evaluating Pharmaceutical Pipelines, Pfizer Biopharmaceutical Revenues, $bn, 2010 94
  • Figure 48: Re-evaluating Pharmaceutical Pipelines, Pfizer Product Pipeline, 2011 99
  • Figure 49: Re-evaluating Pharmaceutical Pipelines, Roche's Global Revenues, $bn, 2010 100
  • Figure 50: Re-evaluating Pharmaceutical Pipelines, Roche, Regional Revenues, $bn, 2010 101
  • Figure 51: Re-evaluating Pharmaceutical Pipelines, Roche Group, FDA Approvals for NMEs and Line Extensions 103
  • Figure 52: Re-evaluating Pharmaceutical Pipelines, Roche's Late-stage Pharma Pipeline, 2011 104
  • Figure 53: Re-evaluating Pharmaceutical Pipelines, Roche Group, Pipeline Products, 2011 105
  • Figure 54: Re-evaluating Pharmaceutical Pipelines, Roche's PHC Strategy 106
  • Figure 55: Re-evaluating Pharmaceutical Pipelines, Novartis Global Revenues, $bn, 2010 108
  • Figure 56: Re-evaluating Pharmaceutical Pipelines, Novartis Regional Revenues, $bn, 2010 108
  • Figure 57: Re-evaluating Pharmaceutical Pipelines, Novartis Pharmaceutical Revenues, $bn, 2010 109
  • Figure 58: Re-evaluating Pharmaceutical Pipelines, Novartis Planned Product Filings, 2001-2015 111
  • Figure 59: Re-evaluating Pharmaceutical Pipelines, Novartis 2011 Strategic Priorities 112
  • Figure 60: Re-evaluating Pharmaceutical Pipelines, Novartis New Alcon Division 113
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