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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

  • 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

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

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
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