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世界の医薬品製造、研究開発、パッケージング受託市場:受託研究開発に焦点を当てて

Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging - Focus on Contract Research

発行 BCC Research 商品コード 279427
出版日 ページ情報 英文 155 Pages
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世界の医薬品製造、研究開発、パッケージング受託市場:受託研究開発に焦点を当てて Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging - Focus on Contract Research
出版日: 2013年08月30日 ページ情報: 英文 155 Pages
概要

当レポートでは、世界の医薬品製造、研究開発、パッケージング受託市場の概要と現在および将来の見通し、アウトソーシングに対する市場のニーズ、法規制環境、技術的課題、および競合動向と主要企業のプロファイルなどをまとめ、概略下記の構成で取り上げております。

第1章 イントロダクション

第2章 サマリー

第3章 概要

  • 定義
    • アウトソーシング
    • 製造受託
    • 製造受託会社
    • コアコンペテンシー
    • ベンダー
    • 研究開発受託機関(CRO)
  • アウトソーシングする理由
    • 運転費用の削減と管理
    • コアコンペテンシーへの注力
    • 世界クラスの能力へのアクセス
    • パートナー企業とのリスクシェア
  • アウトソーシングの歴史
  • 製造受託
  • 研究開発受託
  • パッケージング受託
    • パッケージング受託会社のための倫理基準

第4章 法規制の側面

  • 警告文
  • 法的認可

第5章 新たな開発

  • LONZA
  • BRISTOL-MYERS SQUIBB
  • ABBOTT
  • ALBANY MOLECULAR RESEARCH INC. (AMRI)
  • EVOTEC AG
  • HOSPIRA
  • COVIDIEN
  • DR. REDDY'S LABORATORIES
  • その他

第6章 世界市場

  • 種類別市場
  • 地域別市場
  • 治療用途別市場
    • 心血管薬剤
    • 腫瘍科
    • 抗生物質
    • 鎮痛剤
    • 抗ウイルス
    • 生殖用薬剤
    • 炎症・免疫
    • 神経科学
    • ワクチン
    • その他

第7章 研究開発受託市場

  • 分野別市場
  • 地域別市場
  • 治療用途別市場
    • 心臓外科
    • 腫瘍科
    • 炎症・免疫
    • 神経科学
    • ワクチン
    • その他
  • 業界構造
    • 市場リーダー
    • 市場シェア

第8章 特許分析

第9章 現在の市場環境

  • アウトソーシング市場に影響を及ぼす要因
    • コスト削減
    • 厳しい法規制
    • 特許の失効
    • 研究開発成功率の減少
    • バイオシミラー需要の増加
  • 医薬品アウトソーシング動向

第10章 企業プロファイル

第11章 付録:略語

図表

目次
Product Code: PHM156A

REPORT HIGHLIGHTS

The global market for pharmaceutical and biopharmaceutical contract manufacturing, research and packaging was $219.9 billion in 2012. This market is estimated to reach $242.2 billion in 2013 and $374.8 billion by 2018, a five-year compound annual growth rate (CAGR) of 9.1%.

This report provides:

  • An overview of the global market for contract pharmaceutical manufacturing, research, and packaging, with emphasis on the current and future outlook of the market and a comprehensive analysis of the overall pharmaceutical and biotechnology outsourcing industry.
  • Analyses of global market trends, with data from 2011 and 2012, estimates for 2013, and projections of compound annual growth rates (CAGRs) through 2018.
  • Examination of the effects on market growth of state-of-the-art packaging facilities as well as expensive research facilities and the capabilities of research organizations.
  • Coverage of the market's need for outsourcing, the regulatory environment, and technological issues, including the latest trends and developments.
  • Comprehensive company profiles of major players.

STUDY OBJECTIVE

BCC Research's objective in conducting this study is to provide an overview of the current and future global pharmaceutical contract manufacturing, research and packaging markets. The study provides a global as well as a regionally specific market overview. The key objective is to present a comprehensive analysis of the current and future direction of contract manufacturing, research and packaging as an important tool for a company's growth and financial stability and as a way to overcome various trade barriers. It also addresses the role of these organizations in reducing costs, meeting strict regulatory requirements globally, dealing with the effects of patent expiries on market share and in competing in a highly competitive and tough business environment.

A detailed analysis of the industry structure of contract manufacturing, contract research and contract packaging has been conducted. Revenues are broken down by type of industry. Sales figures are estimated for the five-year period from 2013 through 2018.

Applications and various formulations for which contract manufacturing, research and packaging are widely used are also discussed separately in the report. The report also takes into account various new developments and regulatory aspects in this industry. The report also covers significant patents in each category.

REASONS FOR DOING THIS STUDY

Comprehensive research in the fields of contract manufacturing, contract research and contract packaging has revealed their benefits in various industries. Contract manufacturing, research and packaging are advantageous to both parties to the contract as it provides the manufacturing company with financial stability for the duration of the contract and the hiring company the benefit of cost savings, time saved in operating and managing a production facility and research. Many industries have now begun to explore the advantages of contracting their research, production and packaging, leading to a steady market for these services.

Cost control, R&D spend, new technologies, increasing competition and patent expiries resulting in markets for generics are moving this industry in a new direction. New advancements, product launches and changing technologies will drive the growth of the market in the foreseeable future. This study looks at most of the systems affected by these factors.

Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strength and weaknesses of each type of technology in light of the new technologies, growing competition and changing market needs.

SCOPE OF THE STUDY

The scope of this study encompasses contract manufacturers, contract research and contract packaging in the pharmaceutical and biotechnology markets. BCC analyzes each market and its applications, regulatory environment, technology, market projections and market shares. Technological issues include the latest trends and developments. The emerging markets for contract manufacturing research and packaging include countries such as India, China, Japan, Korea, Taiwan, Canada, Africa, Australia and New Zealand.

ABOUT THE AUTHOR

A team of professionals in the biotechnology industry carried out this study. The project manager is Shalini S. Dewan, who holds a master's degree in pharmaceutical chemistry and has more than 14 years of industry experience. Among the research topics she has covered are studies on compounds of potential pharmaceutical interest such as ibuprofen and 2-naphthyl acetic acid. Shalini was awarded a Gold Medal by the Prime Minister of India for her work and has worked with top companies in India and the U.S.

The lead consultant for this project was Dr. Kapil A. Setia, who holds a doctoral degree in the life sciences. She has a number of research publications to her credit, including her thesis, which was given an award of excellence.

Table of Contents

CHAPTER 1 - INTRODUCTION

  • STUDY OBJECTIVES
  • REASONS FOR DOING THIS STUDY
  • CONTRIBUTIONS OF THE STUDY AND INTENDED AUDIENCE
  • SCOPE OF THE STUDY
  • METHODOLOGY
  • INFORMATION SOURCES
  • ABOUT THE AUTHOR
  • RELATED BCC RESEARCH REPORTS
  • BCC ONLINE SERVICES
  • DISCLAIMER

CHAPTER 2 - SUMMARY

  • SUMMARY TABLE: GLOBAL MARKET FOR PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT MANUFACTURING, RESEARCH AND PACKAGING, THROUGH 2018 ($ BILLIONS)
  • SUMMARY FIGURE: GLOBAL MARKET FOR PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT MANUFACTURING, RESEARCH AND PACKAGING, 2011-2018 ($ BILLIONS)

CHAPTER 3 - OVERVIEW

  • DEFINITIONS
    • OUTSOURCING
    • CONTRACT MANUFACTURING
    • CONTRACT MANUFACTURER
    • CORE COMPETENCIES
    • VENDOR
    • CONTRACT RESEARCH ORGANIZATION (CRO)
  • REASONS FOR OUTSOURCING
    • REDUCE AND CONTROL OPERATING COSTS
    • IMPROVE FOCUS ON CORE COMPETENCIES
    • GAIN ACCESS TO WORLD-CLASS CAPABILITIES
    • SHARE RISKS WITH A PARTNER COMPANY
  • HISTORY OF OUTSOURCING
    • TABLE 1: KEY DEVELOPMENTS IN THE HISTORY OF OUTSOURCING
  • CONTRACT MANUFACTURING
    • TYPES OF CONTRACT MANUFACTURERS
      • Supply Manufacturers
      • Toll Manufacturers
        • Types of Toll Manufacturers
          • Vendors of Excess Capacity
          • Providers of Niche Services
          • Academic Institutions
    • SPECIFIC REASONS FOR OUTSOURCING
    • STRATEGIES FOR SUCCESSFUL OUTSOURCING
    • ADVANTAGES AND DISADVANTAGES OF CONTRACT MANUFACTURING
      • TABLE 2: KEY ADVANTAGES OF CONTRACT MANUFACTURING
      • TABLE 3: KEY DISADVANTAGES OF CONTRACT MANUFACTURING
    • SELECTING A CONTRACT MANUFACTURER
      • TABLE 4: KEY FACTORS IN SELECTING A CONTRACT MANUFACTURER
    • IMPORTANT FACTORS IN WORKING WITH A CONTRACT MANUFACTURER
      • Product Quality
      • Cost Competitiveness
      • Delivery Schedule
      • Client-CMO Relationship
    • CONTRACT RESEARCH
      • RESPONSIBILITIES OF CONTRACT RESEARCH ORGANIZATIONS
      • CRO-SPONSOR RELATIONSHIP: KEY TO SUCCESS
      • SERVICES OFFERED BY CONTRACT RESEARCH ORGANIZATIONS
        • TABLE 5: SERVICES OFFERED BY CONTRACT RESEARCH ORGANIZATIONS
      • SELECTION CRITERIA
        • TABLE 6: KEY FACTORS IN SELECTING A CONTRACT RESEARCH ORGANIZATION
      • RESEARCH PROVIDED BY CONTRACT RESEARCH ORGANIZATIONS
        • TABLE 7: TYPES OF SERVICES PROVIDED BY CONTRACT RESEARCH ORGANIZATIONS
  • CONTRACT PACKAGING
    • NEED FOR CONTRACT PACKAGERS
      • TABLE 8: REASONS COMPANIES HIRE CONTRACT PACKAGERS
    • ETHICAL STANDARDS FOR CONTRACT PACKAGERS

CHAPTER 4 - REGULATORY ASPECTS

  • WARNING LETTERS
    • TABLE 9: WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT MANUFACTURERS, 2012
    • TABLE 10: WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT MANUFACTURERS, 2011
    • TABLE 11: WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT MANUFACTURERS, 2010
  • REGULATORY APPROVALS
    • TABLE 12: REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT MANUFACTURER ACTIVITIES AND FACILITIES, JAN. AND FEB. 2013
    • TABLE 13: REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT MANUFACTURER ACTIVITIES AND FACILITIES, 2012
    • TABLE 14: REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT MANUFACTURER ACTIVITIES AND FACILITIES, 2011
    • TABLE 15: REGULATORY APPROVALS OF CONTRACT MANUFACTURER ACTIVITIES AND FACILITIES, 2010

CHAPTER 5 - NEW DEVELOPMENTS

  • LONZA
  • BRISTOL-MYERS SQUIBB
  • ABBOTT
  • ALBANY MOLECULAR RESEARCH INC. (AMRI)
  • EVOTEC AG
  • HOSPIRA
  • COVIDIEN
  • DR. REDDY'S LABORATORIES
  • OTHER

CHAPTER 6 - GLOBAL MARKETS FOR CONTRACT MANUFACTURING, RESEARCH AND PACKAGING

  • MARKETS BY TYPE
    • CONTRACT MANUFACTURE OF VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS
      • Market Overview
      • Market Revenue
        • TABLE 16: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS, THROUGH 2018 ($ BILLIONS)
        • FIGURE 1: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS, 2011-2018 ($ BILLIONS)
      • Market Shares
        • TABLE 17: MARKET SHARES OF CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS, 2012 (%)
        • FIGURE 2: MARKET SHARES OF CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS, 2012 (%)
    • MARKET FOR CONTRACT MANUFACTURING OF OTC DRUGS AND NUTRITIONALS
      • Market Overview
      • Market Revenues
        • TABLE 18: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF OTC DRUGS AND NUTRITIONAL PRODUCTS BY FORMULATION, THROUGH 2018 ($ BILLIONS)
        • FIGURE 3: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF OTC DRUGS AND NUTRITIONAL PRODUCTS BY FORMULATION, 2011-2018 ($ BILLIONS)
      • Market Share
        • TABLE 19: MARKET SHARES OF CONTRACT MANUFACTURING OF OTC DRUGS AND NUTRITIONAL PRODUCTS BY FORMULATION, 2012 (%)
        • FIGURE 4: MARKET SHARES OF CONTRACT MANUFACTURING OF OTC DRUGS AND NUTRITIONAL PRODUCTS BY FORMULATION, 2012 (%)
    • MARKET FOR VARIOUS DOSAGE FORMS, BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND OTC DRUGS/NUTRITIONALS
      • Market Revenue
        • TABLE 20: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND OTC DRUGS/NUTRITIONAL PRODUCTS, THROUGH 2018 ($ BILLIONS)
        • FIGURE 5: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND OTC DRUGS/NUTRITIONAL PRODUCTS, 2011-2018 ($ BILLIONS)
      • Market Share
        • TABLE 21: MARKET SHARES OF CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND OTC DRUGS/NUTRITIONAL PRODUCTS, 2012 (%)
        • FIGURE 6: MARKET SHARES OF CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND OTC DRUGS/NUTRITIONAL PRODUCTS, 2012 (%)
    • CONTRACT RESEARCH MARKET
      • Market Overview
      • Market Revenue
        • TABLE 22: GLOBAL MARKET FOR CONTRACT RESEARCH BY SEGMENT, THROUGH 2018 ($ BILLIONS)
        • FIGURE 7: GLOBAL MARKET FOR CONTRACT RESEARCH BY SEGMENT, 2011-2018 ($ BILLIONS)
      • Market Shares
        • TABLE 23: CONTRACT RESEARCH MARKET SHARES BY SEGMENT, 2012 (%)
        • FIGURE 8: CONTRACT RESEARCH MARKET SHARES BY SEGMENT, 2012 (%)
    • CONTRACT PACKAGING MARKET
      • Market Overview
      • Market Revenue
        • TABLE 24: GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, THROUGH 2018 ($ BILLIONS)
        • FIGURE 9: GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, 2011-2018 ($ BILLIONS)
      • Market Share
        • TABLE 25: MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%)
        • FIGURE 10: MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%)
  • MARKET BY REGION
    • MARKET FOR CONTRACT MANUFACTURE OF VARIOUS DOSAGE FORMS, BULK DRUGS AND ACTIVE PHARMACEUTICAL INGREDIENTS
      • Market Overview
      • Market Revenue
        • TABLE 26: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS BY REGION, THROUGH 2018 ($ BILLIONS)
        • FIGURE 11: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS BY REGION, 2011-2018 ($ BILLIONS)
      • Market Share
        • TABLE 27: REGIONAL MARKETS SHARES OF CONTRACT MANUFACTURING OF VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, 2012 (%)
        • FIGURE 12: REGIONAL MARKETS SHARES OF CONTRACT MANUFACTURING OF VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, 2012 (%)
    • MARKET FOR CONTRACT MANUFACTURING, RESEARCH AND PACKAGING
      • Market Overview
      • Market Revenue
        • TABLE 28: GLOBAL MARKET FOR CONTRACT MANUFACTURING, RESEARCH AND PACKAGING BY REGION, THROUGH 2018 ($ BILLIONS)
        • FIGURE 13: GLOBAL MARKET FOR CONTRACT MANUFACTURING, RESEARCH AND PACKAGING BY REGION, 2011-2018 ($ BILLIONS)
      • Market Share
        • TABLE 29: REGIONAL MARKET SHARES OF CONTRACT MANUFACTURING, RESEARCH AND PACKAGING, 2012 (%)
        • FIGURE 14: REGIONAL MARKET SHARES OF CONTRACT MANUFACTURING, RESEARCH AND PACKAGING, 2012 (%)
  • MARKET BY THERAPEUTIC USE
    • CARDIOVASCULAR DRUGS
    • ONCOLOGY
    • ANTIBIOTICS
    • ANALGESICS
    • ANTIVIRALS
    • REPRODUCTIVE DRUG PRODUCTS
    • INFLAMMATION AND IMMUNOLOGY
    • NEUROSCIENCE
    • VACCINES
    • OTHERS
    • MARKET REVENUE
      • TABLE 30: GLOBAL MARKET FOR CONTRACT MANUFACTURING AND RESEARCH OF DRUGS BY THERAPEUTIC AREA, THROUGH 2018 ($ MILLIONS)
      • FIGURE 15: GLOBAL MARKET FOR CONTRACT MANUFACTURING AND RESEARCH OF DRUGS BY THERAPEUTIC AREA, 2011-2018 ($ MILLIONS)
    • MARKET SHARES
      • TABLE 31: CONTRACT MANUFACTURING AND RESEARCH MARKET SHARES BY THERAPEUTIC AREA, 2012 (%)
      • FIGURE 16: CONTRACT MANUFACTURING AND RESEARCH MARKET SHARES BY THERAPEUTIC AREA, 2012 (%)

CHAPTER 7 - CONTRACT RESEARCH MARKET

  • MARKET BY DISCIPLINE
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 32: GLOBAL MARKET FOR CONTRACT RESEARCH BY DISCIPLINE, THROUGH 2018 ($ BILLIONS)
      • FIGURE 17: GLOBAL MARKET FOR CONTRACT RESEARCH BY DISCIPLINE, 2011-2018 ($ BILLIONS)
    • MARKET SHARES
      • TABLE 33: MARKET SHARES OF CONTRACT RESEARCH BY DISCIPLINE, 2012 (%)
      • FIGURE 18: MARKET SHARES OF CONTRACT RESEARCH BY DISCIPLINE, 2012 (%)
  • MARKET BY REGION
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 34: GLOBAL MARKET FOR CONTRACT RESEARCH BY REGION, THROUGH 2018 ($ BILLIONS)
      • FIGURE 19: GLOBAL MARKET FOR CONTRACT RESEARCH BY REGION, 2011-2018 ($ BILLIONS)
    • MARKET SHARES
      • TABLE 35: CONTRACT RESEARCH MARKET SHARES BY REGION, 2012 (%)
      • FIGURE 20: CONTRACT RESEARCH MARKET SHARES BY REGION, 2012 (%)
      • Contract Clinical Research Market by Region
        • TABLE 36: GLOBAL MARKET FOR CONTRACT CLINICAL RESEARCH BY REGION, THROUGH 2018 ($ MILLIONS)
        • FIGURE 21: GLOBAL MARKET FOR CONTRACT CLINICAL RESEARCH BY REGION, 2011-2018 ($ MILLIONS)
      • Contract Drug Discovery Market by Region
        • TABLE 37: GLOBAL MARKET FOR CONTRACT DRUG DISCOVERY BY REGION, THROUGH 2018 ($ MILLIONS)
        • FIGURE 22: GLOBAL MARKET FOR CONTRACT DRUG DISCOVERY BY REGION, 2011-2018 ($ MILLIONS)
      • Contract Analytical Research Market by Region
        • TABLE 38: GLOBAL MARKET FOR CONTRACT ANALYTICAL RESEARCH BY REGION, THROUGH 2018 ($ MILLIONS)
        • FIGURE 23: GLOBAL MARKET FOR CONTRACT ANALYTICAL RESEARCH BY REGION, 2011-2018 ($ MILLIONS)
      • Other Contract Research Activities Market by Region
        • TABLE 39: GLOBAL MARKET FOR OTHER CONTRACT RESEARCH SERVICES BY REGION, THROUGH 2018 ($ MILLIONS)
        • FIGURE 24: GLOBAL MARKET FOR OTHER CONTRACT RESEARCH SERVICES BY REGION, 2011-2018 ($ MILLIONS)
  • MARKET BY THERAPEUTIC AREA
    • CARDIOLOGY
    • ONCOLOGY
    • INFLAMMATION AND IMMUNOLOGY
    • NEUROSCIENCE
    • VACCINES
    • OTHERS
    • MARKET REVENUE
      • TABLE 40: GLOBAL MARKET FOR CONTRACT RESEARCH BY THERAPEUTIC AREA, THROUGH 2018 ($ MILLIONS)
      • FIGURE 25: GLOBAL MARKET FOR CONTRACT RESEARCH BY THERAPEUTIC AREA, 2011-2018 ($ MILLIONS)
    • MARKET SHARE
      • TABLE 41: MARKET SHARES OF CONTRACT RESEARCH BY THERAPEUTIC AREA, 2012 (%)
      • FIGURE 26: MARKET SHARES OF CONTRACT RESEARCH BY THERAPEUTIC AREA, 2012 (%)
  • INDUSTRY STRUCTURE
    • MARKET LEADERS
      • TABLE 42: SERVICES PROVIDED BY RESEARCH FIRMS
    • MARKET SHARES
      • TABLE 43: MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2012 (%)
      • FIGURE 27: MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2012 (%)

CHAPTER 8 - PATENT ANALYSIS

  • PATENTS BY YEAR
    • TABLE 44: SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010-FEB. 2013 (NO.)
    • FIGURE 28: SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010-FEB. 2013 (NO.)
  • PATENTS BY EMPHASIS
    • TABLE 45: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.)
    • FIGURE 29: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.)
  • PATENTS BY COMPANY
    • TABLE 46: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES, 2010-FEB. 2013 (NO.)
  • PATENTS BY THE PATENT HOLDER'S COUNTRY
    • TABLE 47: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY THE PATENT HOLDER'S COUNTRY, 2010-FEB. 2013 (NO.)
    • FIGURE 30: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010-FEB. 2013 (NO.)
    • TABLE 48: SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010-FEB. 2013 (%)
    • FIGURE 31: SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010-FEB. 2013 (%)
  • PATENTS BY PATENT HOLDER TYPE
    • TABLE 49: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.)
    • FIGURE 32: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.)

CHAPTER 9 - CURRENT MARKET ENVIRONMENT

  • FACTORS AFFECTING THE OUTSOURCING MARKET
    • COST SAVINGS
    • STRINGENT REGULATIONS
    • PATENT EXPIRIES
    • DECREASING RESEARCH AND DEVELOPMENT SUCCESS RATES
    • INCREASING DEMAND FOR BIOSIMILARS
  • PHARMACEUTICAL OUTSOURCING TRENDS

CHAPTER 10 - COMPANY PROFILES

  • 3M CO.
  • AAI PHARMA INC.
  • ABBOTT LABORATORIES
  • AEROGEN LTD.
  • ALBANY MOLECULAR RESEARCH INC. (AMRI)
  • ALKERMES PLC
  • ALTHEA TECHNOLOGIES
  • AMCOR
  • AMERISOURCEBERGEN CORP.
  • AMPAC FINE CHEMICALS
  • A.P. PHARMA INC.
  • APTIV SOLUTIONS
  • APTUIT INC.
  • ARADIGM CORP.
  • BASF SE
  • BAXTER HEALTHCARE
  • BCM/BOOTS MANUFACTURING
  • BOEHRINGER INGELHEIM
  • CAMBREX CORP.
  • CANGENE BIOPHARMA INC.
  • CATALENT PHARMA SOLUTIONS
  • CEDARBURG HAUSER PHARMACEUTICALS INC.
  • CENEXI
  • CHARLES RIVER LABORATORIES
  • CHEMBRIDGE CORP.
  • CONFAB LABORATORIES
  • COVANCE INC.
  • COVIDIEN
  • CONTRACT PHARMACEUTICALS LTD.
  • CORDENPHARMA SWITZERLAND LLC
  • DECODE GENETICS
  • DISHMAN PHARMACEUTICALS AND CHEMICALS LTD.
  • DOW PHARMACEUTICAL SCIENCES
  • DPT LABORATORIES INC.
  • DR. REDDY'S LABORATORIES
  • DSM PHARMACEUTICAL PRODUCTS
  • FUJIFILM DIOSYNTH BIOTECHNOLOGY
  • ELAN DRUG TECHNOLOGIES
  • EVOTEC AG
  • GIRINDUS AG
  • GLAXOSMITHKLINE
  • GRIFOLS INTERNATIONAL SA
  • HOSPIRA
  • HAUPT PHARMA AG
  • HOVIONE SA
  • ICON PLC
  • INC RESEARCH LLC
  • JUBILANT LIFESCIENCES
  • KENDLE INTERNATIONAL INC.
  • KP PHARMACEUTICAL TECHNOLOGIES INC.
  • LIGAND PHARMACEUTICALS INC.
  • LONZA GROUP
  • LYNE LABORATORIES
  • MEADWESTVACO CORP.
  • MIKART INC.
  • NEXTPHARMA TECHNOLOGIES
  • NORWICH PHARMACEUTICALS
  • NOVAVAX INC.
  • PAREXEL INTERNATIONAL CORP.
  • PATHEON INC.
  • PERRIGO CO.
  • PFIZER CENTRESOURCE
  • PIRAMAL HEALTHCARE LTD.
  • PPD
  • PRA INTERNATIONAL
  • QUINTILES
  • RANBAXY LABORATORIES LTD.
  • RECIPHARM AB
  • REGIS TECHNOLOGIES INC.
  • SCHOTT PHARMACEUTICAL PACKAGING
  • SKYEPHARMA PLC
  • TAKEDA PHARMACEUTICALS
  • THEOREM CLINICAL RESEARCH
  • VETTER PHARMA INTERNATIONAL GMBH
  • WOCKHARDT LTD.
  • WUXI APP TEC
  • XCELLEREX LLC
  • ZACH SYSTEM SPA

CHAPTER 11 - APPENDIX: ACRONYMS

LIST OF TABLES SUMMARY

  • TABLE GLOBAL MARKET FOR PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT MANUFACTURING, RESEARCH AND PACKAGING, THROUGH 2018 ($ BILLIONS)
    • TABLE 1: KEY DEVELOPMENTS IN THE HISTORY OF OUTSOURCING
    • TABLE 2: KEY ADVANTAGES OF CONTRACT MANUFACTURING
    • TABLE 3: KEY DISADVANTAGES OF CONTRACT MANUFACTURING
    • TABLE 4: KEY FACTORS IN SELECTING A CONTRACT MANUFACTURER
    • TABLE 5: SERVICES OFFERED BY CONTRACT RESEARCH ORGANIZATIONS
    • TABLE 6: KEY FACTORS IN SELECTING A CONTRACT RESEARCH ORGANIZATION
    • TABLE 7: TYPES OF SERVICES PROVIDED BY CONTRACT RESEARCH ORGANIZATIONS
    • TABLE 8: REASONS COMPANIES HIRE CONTRACT PACKAGERS
    • TABLE 9: WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT MANUFACTURERS, 2012
    • TABLE 10: WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT MANUFACTURERS, 2011
    • TABLE 11: WARNING LETTERS ISSUED TO PHARMACEUTICAL CONTRACT MANUFACTURERS, 2010
    • TABLE 12: REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT MANUFACTURER ACTIVITIES AND FACILITIES, JAN. AND FEB. 2013
    • TABLE 13: REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT MANUFACTURER ACTIVITIES AND FACILITIES, 2012
    • TABLE 14: REGULATORY APPROVALS OF PHARMACEUTICAL CONTRACT MANUFACTURER ACTIVITIES AND FACILITIES, 2011
    • TABLE 15: REGULATORY APPROVALS OF CONTRACT MANUFACTURER ACTIVITIES AND FACILITIES, 2010
    • TABLE 16: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS, THROUGH 2018 ($ BILLIONS)
    • TABLE 17: MARKET SHARES OF CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS, 2012 (%)
    • TABLE 18: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF OTC DRUGS AND NUTRITIONAL PRODUCTS BY FORMULATION, THROUGH 2018 ($ BILLIONS)
    • TABLE 19: MARKET SHARES OF CONTRACT MANUFACTURING OF OTC DRUGS AND NUTRITIONAL PRODUCTS BY FORMULATION, 2012 (%)
    • TABLE 20: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND OTC DRUGS/NUTRITIONAL PRODUCTS, THROUGH 2018 ($ BILLIONS)
    • TABLE 21: MARKET SHARES OF CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND OTC DRUGS/NUTRITIONAL PRODUCTS, 2012 (%)
    • TABLE 22: GLOBAL MARKET FOR CONTRACT RESEARCH BY SEGMENT, THROUGH 2018 ($ BILLIONS)
    • TABLE 23: CONTRACT RESEARCH MARKET SHARES BY SEGMENT, 2012 (%)
    • TABLE 24: GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, THROUGH 2018 ($ BILLIONS)
    • TABLE 25: MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%)
    • TABLE 26: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS BY REGION, THROUGH 2018 ($ BILLIONS)
    • TABLE 27: REGIONAL MARKETS SHARES OF CONTRACT MANUFACTURING OF VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, 2012 (%)
    • TABLE 28: GLOBAL MARKET FOR CONTRACT MANUFACTURING, RESEARCH AND PACKAGING BY REGION, THROUGH 2018 ($ BILLIONS)
    • TABLE 29: REGIONAL MARKET SHARES OF CONTRACT MANUFACTURING, RESEARCH AND PACKAGING, 2012 (%)
    • TABLE 30: GLOBAL MARKET FOR CONTRACT MANUFACTURING AND RESEARCH OF DRUGS BY THERAPEUTIC AREA, THROUGH 2018 ($ MILLIONS)
    • TABLE 31: CONTRACT MANUFACTURING AND RESEARCH MARKET SHARES BY THERAPEUTIC AREA, 2012 (%)
    • TABLE 32: GLOBAL MARKET FOR CONTRACT RESEARCH BY DISCIPLINE, THROUGH 2018 ($ BILLIONS)
    • TABLE 33: MARKET SHARES OF CONTRACT RESEARCH BY DISCIPLINE, 2012 (%)
    • TABLE 34: GLOBAL MARKET FOR CONTRACT RESEARCH BY REGION, THROUGH 2018 ($ BILLIONS)
    • TABLE 35: CONTRACT RESEARCH MARKET SHARES BY REGION, 2012 (%)
    • TABLE 36: GLOBAL MARKET FOR CONTRACT CLINICAL RESEARCH BY REGION, THROUGH 2018 ($ MILLIONS)
    • TABLE 37: GLOBAL MARKET FOR CONTRACT DRUG DISCOVERY BY REGION, THROUGH 2018 ($ MILLIONS)
    • TABLE 38: GLOBAL MARKET FOR CONTRACT ANALYTICAL RESEARCH BY REGION, THROUGH 2018 ($ MILLIONS)
    • TABLE 39: GLOBAL MARKET FOR OTHER CONTRACT RESEARCH SERVICES BY REGION, THROUGH 2018 ($ MILLIONS)
    • TABLE 40: GLOBAL MARKET FOR CONTRACT RESEARCH BY THERAPEUTIC AREA, THROUGH 2018 ($ MILLIONS)
    • TABLE 41: MARKET SHARES OF CONTRACT RESEARCH BY THERAPEUTIC AREA, 2012 (%)
    • TABLE 42: SERVICES PROVIDED BY RESEARCH FIRMS
    • TABLE 43: MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2012 (%)
    • TABLE 44: SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010--FEB. 2013 (NO.)
    • TABLE 45: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.)
    • TABLE 46: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES, 2010--FEB. 2013 (NO.)
    • TABLE 47: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY THE PATENT HOLDER'S COUNTRY, 2010--FEB. 2013 (NO.)
    • TABLE 48: SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010--FEB. 2013 (%)
    • TABLE 49: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.)

LIST OF FIGURES SUMMARY

  • FIGURE GLOBAL MARKET FOR PHARMACEUTICAL AND BIOPHARMACEUTICAL CONTRACT MANUFACTURING, RESEARCH AND PACKAGING, 2011-2018 ($ BILLIONS)
    • FIGURE 1: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS, 2011-2018 ($ BILLIONS)
    • FIGURE 2: MARKET SHARES OF CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS AND VARIOUS DOSAGE FORMS, 2012 (%)
    • FIGURE 3: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF OTC DRUGS AND NUTRITIONAL PRODUCTS BY FORMULATION, 2011-2018 ($ BILLIONS)
    • FIGURE 4: MARKET SHARES OF CONTRACT MANUFACTURING OF OTC DRUGS AND NUTRITIONAL PRODUCTS BY FORMULATION, 2012 (%)
    • FIGURE 5: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND OTC DRUGS/NUTRITIONAL PRODUCTS, 2011-2018 ($ BILLIONS)
    • FIGURE 6: MARKET SHARES OF CONTRACT MANUFACTURING OF BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, VARIOUS DOSAGE FORMS AND OTC DRUGS/NUTRITIONAL PRODUCTS, 2012 (%)
    • FIGURE 7: GLOBAL MARKET FOR CONTRACT RESEARCH BY SEGMENT, 2011-2018 ($ BILLIONS)
    • FIGURE 8: CONTRACT RESEARCH MARKET SHARES BY SEGMENT, 2012 (%)
    • FIGURE 9: GLOBAL MARKET FOR CONTRACT PACKAGING BY TYPE, 2011-2018 ($ BILLIONS)
    • FIGURE 10: MARKET SHARES OF CONTRACT PACKAGING BY TYPE, 2012 (%)
    • FIGURE 11: GLOBAL MARKET FOR CONTRACT MANUFACTURING OF VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS BY REGION, 2011-2018 ($ BILLIONS)
    • FIGURE 12: REGIONAL MARKETS SHARES OF CONTRACT MANUFACTURING OF VARIOUS DOSAGE FORMS AND BULK DRUGS/ACTIVE PHARMACEUTICAL INGREDIENTS, 2012 (%)
    • FIGURE 13: GLOBAL MARKET FOR CONTRACT MANUFACTURING, RESEARCH AND PACKAGING BY REGION, 2011-2018 ($ BILLIONS)
    • FIGURE 14: REGIONAL MARKET SHARES OF CONTRACT MANUFACTURING, RESEARCH AND PACKAGING, 2012 (%)
    • FIGURE 15: GLOBAL MARKET FOR CONTRACT MANUFACTURING AND RESEARCH OF DRUGS BY THERAPEUTIC AREA, 2011-2018 ($ MILLIONS)
    • FIGURE 16: CONTRACT MANUFACTURING AND RESEARCH MARKET SHARES BY THERAPEUTIC AREA, 2012 (%)
    • FIGURE 17: GLOBAL MARKET FOR CONTRACT RESEARCH BY DISCIPLINE, 2011-2018 ($ BILLIONS)
    • FIGURE 18: MARKET SHARES OF CONTRACT RESEARCH BY DISCIPLINE, 2012 (%)
    • FIGURE 19: GLOBAL MARKET FOR CONTRACT RESEARCH BY REGION, 2011-2018 ($ BILLIONS)
    • FIGURE 20: CONTRACT RESEARCH MARKET SHARES BY REGION, 2012 (%)
    • FIGURE 21: GLOBAL MARKET FOR CONTRACT CLINICAL RESEARCH BY REGION, 2011-2018 ($ MILLIONS)
    • FIGURE 22: GLOBAL MARKET FOR CONTRACT DRUG DISCOVERY BY REGION, 2011-2018 ($ MILLIONS)
    • FIGURE 23: GLOBAL MARKET FOR CONTRACT ANALYTICAL RESEARCH BY REGION, 2011-2018 ($ MILLIONS)
    • FIGURE 24: GLOBAL MARKET FOR OTHER CONTRACT RESEARCH SERVICES BY REGION, 2011-2018 ($ MILLIONS)
    • FIGURE 25: GLOBAL MARKET FOR CONTRACT RESEARCH BY THERAPEUTIC AREA, 2011-2018 ($ MILLIONS)
    • FIGURE 26: MARKET SHARES OF CONTRACT RESEARCH BY THERAPEUTIC AREA, 2012 (%)
    • FIGURE 27: MARKET SHARES OF CONTRACT RESEARCH COMPANIES, 2012 (%)
    • FIGURE 28: SIGNIFICANT U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY YEAR, 2010-FEB. 2013 (NO.)
    • FIGURE 29: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY EMPHASIS, 2010-FEB. 2013 (NO.)
    • FIGURE 30: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010-FEB. 2013 (NO.)
    • FIGURE 31: SHARES OF U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY PATENT HOLDER'S COUNTRY, 2010-FEB. 2013 (%)
    • FIGURE 32: U.S. PATENTS GRANTED TO CONTRACT MANUFACTURING, RESEARCH AND PACKAGING COMPANIES BY TYPE OF PATENT HOLDER, 2010-FEB. 2013 (NO.)
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