市場調査レポート

医薬品開発のアウトソーシング:CRO・治験ラボ・EDC市場

Outsourcing in Drug Development: The Contract CRO, Clinical Trial Lab and EDC Market

発行 Kalorama Information 商品コード 225424
出版日 ページ情報 英文 235 Pages
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医薬品開発のアウトソーシング:CRO・治験ラボ・EDC市場 Outsourcing in Drug Development: The Contract CRO, Clinical Trial Lab and EDC Market
出版日: 2012年01月01日 ページ情報: 英文 235 Pages

当商品の販売は、2016年05月03日を持ちまして終了しました。

概要

新薬は開発から販売までに13億ドルを超える投資と時には15年におよぶ時間を要します。このため大手医薬品事業者は薬剤開発の各種段階のアウトソーシングを行っています。

当レポートでは、医薬品開発におけるアウトソーシングの動向について調査分析し、医薬品開発および治験のプロセスと手続き、関連法規制、各フェーズごとの医薬品開発状況の統計データ、医薬品開発受託市場の市場規模実績・予測、医薬品開発への投資額の推移と予測、治験の運用における動向、医薬品開発委託の成長推進因子の分析、主要企業のプロファイルなどをまとめ、概略下記の構成でお届けいたします。

第1章 エグゼクティブサマリー

  • 医薬品開発プロセス
  • 臨床研究に関する政府の規制
  • アクティブな第1・2・3相試験
  • 第4相研究:承認後
  • 治験のための採用
  • 治験の複雑さとコストの増大
  • 世界の治験
  • 医薬品開発受託産業
  • 医薬品開発受託業者へのR&Dアウトソーシング
  • 医薬品開発受託市場
  • 医薬品開発受託産業の成長への影響因子

第2章 イントロダクション

  • 臨床研究に関する法規制
  • CBER(Center for Biological Evaluation and Review)
  • CDER(Center for Drug Evaluation and Research)
  • 治験審査委員会(IRB:Institutional Review Board)
  • 臨床試験実施申請資料(INDA:Investigational New Drug Application)
  • 治験:開発ステージ別
  • 新薬の承認申請
  • 新規分子化合物と承認期間
  • 迅速承認
  • FDAのPDUFA ACTと安全性基準
  • リサーチ&レビュープロセスの向上のための政府のイニシアチブ
  • FDAのクリティカルパスレポート
  • 探索的IND試験(Exploratory IND Studies):CGMP遵守のアプローチ
  • IND:第1相でのCGMP遵守のアプローチ
  • バイオテクノロジー産業:FDAのクリティカルパスを支持
  • 医薬品開発のグローバル化動向
  • 世界の治験

第3章 治験の運用

  • 治験の実行
  • 政府のスポンサーによる治験
  • 治験実施受託機関
  • 医薬品開発業務受託機関(CRO:Contract Research Organization)
  • マネージドサイトネットワーク
  • 治験の主要エレメント
  • プロトコル
  • 資格基準
  • エンドポイント
  • 無作為化
  • 層別化
  • 盲検化
  • データ収集・管理ツール
  • 統計的解釈
  • 第IV相試験
  • 承認後調査
  • センチネルイニシアチブ
  • 治験のための採用
  • 治験の人員採用プロモーション
  • インターネット対応の採用
  • 治験への参加への影響因子
  • 治験の複雑さの増大
  • インフォームドコンセントのプロセス
  • 人口動態と治験
  • 治験における民族と性別
  • 電子データ管理(EDM)
  • EDCのメリット
  • EDC規格の必要性、など

第4章 動向

  • 医薬品開発コスト
  • 医薬品開発のアウトソーシング
  • CROの略歴
  • 臨床研究のアウトソーシングにおける焦点の移行:第II-III相から第IIIb/IV相へ
  • CRO戦略を推進する主要因子
  • コスト削減戦略としてのアウトソーシング
  • パイプラインにおけるNCE数の増加
  • 規制要件の複雑さの増大
  • 委託試験の競合事業者
  • ビジネス機会としての治験、など

第5章 市場

  • R&D支出額の増加
  • 主な医薬品開発事業者
  • 開発中の臨床研究製品
  • 臨床研究の支出における変化
  • 第I相試験への支出額の減少
  • 安全性の課題:第IIIb/IV相試験への支出額の増加に影響
  • 医薬品開発受託市場
  • 医薬品開発受託の競合企業
  • 医薬品開発受託産業の成長への影響因子、など

第6章 企業プロファイル

付録:企業ディレクトリー

図表

目次
Product Code: KLI6687130

Abstract

The cost and time of developing and bringing a drug to market is over $1.3 billion and often takes as long as 15 years, if not longer. Because of this, major pharmaceutical marketers continue to outsource stages of development, and over the years Kalorama Information has observed this process. In past editions of our outsourcing market studies, we found that outsourcing moved from "should" to "must." for manufacturers. This trend has only continued in the past two years.

Contract Research Organizations (CROs) and other entities can expect growing demand for their services. The demand for new drugs remains unabated, but the cost and need to bring those drugs to market is ever-increasing and intensifying. A key cost driver is the large number of failures during the expensive clinical trial phases. Driven by pressures to reduce costs, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry.

Kalorama Information's Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market is the third edition of this study of the drivers for outsourcing drug development, the companies involved in this market and the opportunity for revenues.

As part of its comprehensive coverage of this market, this report contains:

  • A Detailed Introduction to the Clinical Trial Process
  • Statistics of Drugs in Development by Phase
  • Market Size and Forecasts for Outsourcing In Drug Development by Academic Medical Center (AMC), Contract Research Organizations and Others.
  • Main Drivers for Outsourcing in Drug Development
  • How CROs are Meeting the Challenge of Patient Recruitment
  • Discussion of Industry and Regulatory Trends Protocols Funded in FY2009 by Percent and Gender
  • Global R&D Expenditures Outsourced by Percent 2003-2010
  • Selected Pharmaceutical Company Acquisitions, 2009-2011
  • Top Ten Therapeutic Categories in R&D
  • Selected Acquisitions of Leading CROs
  • Increasing role of EDCs
  • Globalization Trends in Drug Development and Breakout of Clinical Trials by Region
  • Directory of Companies
  • Market Share of Major CROs 2011
  • Profiles of CROs, Contract Laboratories, Clinical Trial Labs and EDC Solution Companies

As part of Kalorama Information's research process, information for this report is gathered from sources including trade press, company reports and government databases. Kalorama Information's analyst also interviewed dozens of experts in the industry to discover new trends and confirm assumptions.

As part of the report's coverage , the following CROs, clinical trial laboratories, EDC companies and site management networks are profiled:

  • Charles River Laboratories International, Inc.
  • Covance, Inc.
  • Encorium, Inc.
  • Icon, PLC
  • Parexel International Corporation
  • Medical Marketing Services
  • Pharmaceutical Product Development, Inc
  • INC Research
  • InVentiv Health
  • Pra International
  • Quintiles Transnational Corporation
  • Radiant Development
  • Theorem Clinical Research
  • Bioanalytical Research Corporation
  • Calvert Laboratories, Inc
  • Crl Medinet
  • Kronos Sicence Laboratories
  • LabCorp
  • MedTox Scientific Inc.
  • Pacific Biomarkers, Inc.
  • PRL Central Laboratory Services
  • Quest Diagnostics
  • TGA Sciences, Inc.
  • DaVita Clinical Research
  • SMO-USA, Inc.
  • CCBR-Synarc, Inc.
  • Advanced Clinical Software
  • eResearch Technology, Inc.
  • Interactive Clinical Technologies, Inc.
  • Medidata Solutions Worldwide
  • Perceptive Informatics, Inc.
  • EDC Solutions
  • Pharsight Corporation
  • Phase Forward, Inc.

All Kalorama reports advertise the single user price, which limits access to one user. We also feature department and global pricing for reports that will be utilized by more than one user at your company. Please ask your sales representative or select the correct license on our website.

Additional Information

Drug development has become increasingly global as sponsors seek to accelerate patient recruitment by gaining access large treatment-naive patient populations, broaden access to trained investigators, and reduce clinical trial costs. Today clinical research is being conducted in Eastern Europe, Asia and Latin America, as well as other geographic regions. However, the United States remains the world's largest clinical research market.

ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. The clinicaltrials.gov information resource was initiated as a result of the Food and Drug Administration Modernization Act of November 1997. The legislation requires the Department of Health and Human Services, through the NIH, to establish a registry of clinical trials for both federally and privately funded trials of experimental treatments for serious or life-threatening diseases or conditions

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

  • The Drug Development Process
  • Government Regulation of Clinical Research
  • Active Phase I, II & III Clinical Trials
  • Phase IV Studies: Post Approval
  • Recruiting for Clinical Trials
  • The Complexity and Costs Of Clinical Trials Are Increasing
  • Clinical Trials Worldwide
  • The Contract Drug Development Industry
  • R&D Outsourced to Contract Drug Development
  • Contract Drug Development Market
  • Trends Affecting Growth of Contract Drug Development Industry
    • Globalization of Drug Development
    • Rapid Technological Change Increasing Data
    • Biotechnology Industry Growth
    • Increased Regulatory Scrutiny
    • Need for Fast, Efficient, and Cost-Effective Drug Development
    • Drug Development Process

CHAPTER TWO: INTRODUCTION

  • Government Regulation of Clinical Research
  • Center for Biological Evaluation and Review
  • Center for Drug Evaluation and Research
  • Investigational Review Board
    • Preclinical Research
    • In Vitro and In Vivo Testing Process
  • Investigational New Drug Application
  • Clinical Trials
    • Preclinical Phase
    • Phase I
    • Phase IIa
    • Phase IIb
    • Phase III
    • Phase III
    • Phase IIIa
    • Phase IIIb
    • Phase IV: Post Approval
  • New Drug Applications
  • New Molecular Entities and Approval Times
  • Accelerated Approval
  • Has FDA's PDUFA ACT Weakened Safety Standards?
  • Government Initiatives to Improve Research and the Review Process
  • FDA's Critical Path Report
  • Exploratory IND Studies - An Approach to Complying with CGMP
  • INDs - Approaches to Complying with CGMP During Phase 1
  • Biotechnology Industry Endorses FDA's Critical Path
  • Globalization Trends in Drug Development
  • Clinical Trials Worldwide
    • China is Ranked First
    • India's Growing Market
    • Russia Dominates Eastern Europe

CHAPTER THREE: CLINICAL TRIAL OPERATIONS

  • Conducting Clinical Trails
  • Government Sponsored Clinical Trials
  • Organizations Contracted to Conduct Clinical Trials
  • Contract Research Organizations (CROs)
  • Managed Site Networks
  • Major Elements of Clinical Trials
  • Protocol
  • Eligibility Criteria
  • Endpoints
  • Randomization
  • Stratification
  • Blinding
  • Data Collection and Management Tools
  • Statistical Interpretation
  • Data Collection and Management Tools
  • Statistical Interpretation
  • Phase IV Studies
  • Post Approval Studies
  • Sentinel Initiative
  • Recruiting for clinical Trials
  • Clinical Trials Recruitment Promotion
  • Internet-Enabled Recruitment
  • Recruiting Principal Investigators
  • Physician as Principal Investigator
  • Recruiting Patients
  • Use of Homecare Services
  • Patient Recruitment Outside the U.S.
  • Delays in Patient Recruiting Increases Project Costs
  • Factors Influencing Participation in Clinical Trials
  • Increasing Complexity of Clinical Trials
  • Informed Consent Process
  • Demographics and Clinical Trials
  • Ethnicity and Gender in Clinical Trials
  • Electronic Data Management
  • Traditional Paper-based Case Report Forms
  • Advantages of EDC
  • Current Assessment of EDC Adoption
  • Need for an EDC Standard
  • FDA Releases Guidance for Using Computerized Systems for Clinical investigations
  • Electronic Patient Diaries

CHAPTER FOUR: TRENDS

  • Drug Development Costs
  • Outsourcing Drug Development
  • A Brief History of Contract Research Outsourcing
  • Focus Shifts in Outsourced Clinical Research Operations from Phase II-III to Phase I to IIIb/IV
  • Major Factors Driving Contract Research Outsourcing Strategy
  • Outsourcing as a Cost Reduction Strategy
  • Number of New Chemical Entities (NCEs) in Pipeline Increasing
  • Growing Complexity of Regulatory Requirements
  • Outsourcing to Gain Rapid Access to Patient Recruiting
  • Contract Research Competitors
    • Academic Medical Centers (AMCs)
      • Competing Factors
    • Contract Research Organizations (CROs)
      • CRO Contracts
      • Competing Factors
    • Managed Site Networks
      • Competing Factors
    • Clinical Trial Laboratories
      • Competing Factors
  • Clinical Trials as a Business Opportunity
    • Community Physicians
    • Electronic Technology Solutions
    • Internet Patient/Investigator Recruiting
    • Clinical Trials Packaging
      • Effective Packaging Promotes Patient Compliance

CHAPTER FIVE: MARKETS

  • R&D Spending Increasing
  • Leading Pharmaceutical Developers
  • Clinical Research Products in Development
  • Shift in Spending for Clinical Research
  • Spending for Phase I Trials Slows from Highs in 2004
  • Safety Issues Drive Phase IIIb/IV Trial Spending
  • Contract Drug Research Market
  • Contract Research Competitors
    • CROs Market Share
      • CROs Broaden Services through Acquisitions
      • CROs Expanding Laboratory Services
    • AMC Market Share
      • AMCs Reassess Role in Industry-funded Clinical Research
      • Academic Clinical Reseach Organizations Expanding
    • Niche Competitors' Market Share
    • Clinical Trial Laboratory Services
    • EDC Services Gaining Market Share
    • Managed Site Networks
  • Trends Affecting Growth in Contract Drug Development Industry
    • Globalization of Drug Development
    • Rapid Technological Change Increasing Data
    • Biotechnology Industry Growth
    • Increased Regulatory Scrutiny
    • Need for Fast, Efficient, and Cost-Effective Drug Development

CHAPTER SIX: COMPANY PROFILES

  • Charles River Laboratories International, Inc.
  • Covance, Inc.
  • Encorium Group, Inc.
  • Icon, Plc
  • Kendle International, Inc.
  • MDS Pharma Services
  • Omnicare Clinical Research
  • Paraxel International Corporation
  • Pharmanet Development Inc.
  • Pharmaceutical Product Development, Inc.
  • PRA Internation, Inc.
  • Radiant Development
  • Bioanalytical Research Corporation
  • Calvert Laboratories, Inc.
  • CRL Medinet, Inc.
  • Kronos Science Laboratories, Inc.
  • Lab Corp
  • Medtox Scientific Inc.
  • Pacific Biometric, Inc.
  • PRL Central Laboratory Services
  • Quest Diagnostics, inc.
  • TGA Sciences, Inc.
  • CNS Clinical Trials
  • DaVita Clinical Research
  • SMO-USA, Inc.
  • Synarc, Inc.
  • Advanced Clinical Software
  • eTrials Worldwide, Inc.
  • Interactive Clinical Technologies, Inc.
  • Medidata Solutions Worldwide
  • Perceptive Informatiocs
  • Pharsight Corporation

APPENDIX: COMPANY DIRECTORY

Table of Exhibits

CHAPTER ONE: EXECUTIVE SUMMARY

  • Exhibit 1-1: The U.S. Drug Discovery, Development, and Approval Process
  • Exhibit 1-2: Number of Active Clinical Drug Development Programs
  • (May 11, 2007)
  • Exhibit 1-3: Total Average Number of Active Clinical Drug
  • Development Programs, 2001-2007
  • Exhibit 1-4: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006
  • Exhibit 1-5: Worldwide Clinical Trial Sites, by Region and Percent, (as of 7/12/2008)
  • Exhibit 1-6: Portion of Global R&D Expenditures
  • Outsourced: 2003-2008 by percent
  • Exhibit 1-7: Contract Drug Development Market Share, Percent by Competitor Type (AMC, CRO's Others), 2007
  • Exhibit 1-8: Contract Research Market, 2002-2012

CHAPTER TWO: INTRODUCTION

  • Exhibit 2-1: Investigational New Drug Submissions, 1992-2006
  • Investigational New Drug Submissions, 1986-2008
  • Exhibit 2-3: Number of Clinical Trials Initiated Annually for U.S. Submissions
  • Exhibit 2-4: Median Total Approval Time for Standard NDAs,1993-2006
  • Exhibit 2-5: Median Total Approval Time for Priority NDAs,1993-2004
  • Exhibit 2-6: Median Total Approval Time for Standard NMEs, 1995-2004
  • Exhibit 2-7: Median Total Approval time for Priority NMEs, 1995-2004
  • Exhibit 2-8: U.S. NMEs 2006 Approvals: Review Times by Drug
  • Exhibit 2-10: Median Approval times for Safety vs All Drugs, By Decade
  • Exhibit 2-11: Number and Location of Clinical Trial Sites Worldwide, as of 7/12/2008
  • Exhibit 2-12: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008

CHAPTER THREE:CLINICAL TRIAL OPERATIONS

  • Exhibit 3-1: Key Clinical Trial Enrollment Statistics for: NMEs Approved in 2000-2006
  • Exhibit 3-2: Number of Active Clinical Drug Development Programs (May 11, 2007)
  • Exhibit 3-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007
  • Exhibit 3-4: Summary Of Postmarketing Study Commitments (Numbers as of September 30, 2007)
  • Exhibit 3-5: Benefits and Risks of Participating in Clinical Trials
  • Exhibit 3-6: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006
  • Exhibit 3-7: Aggregate Enrollment Data for All Extramural and Intramural Research Protocols Funded in FY2005 and Reported in FY2006, by Percent and Gender

CHAPTER FOUR: TRENDS

  • Exhibit 4-1: New Paradigm for R&D
  • Exhibit 4-2: Improvements in the Drug Development Process
  • Reduce Development Costs
  • Exhibit 4-3: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent
  • Exhibit 4-4: Percentage of Industry-Sponsored Clinical Trials Awarded to Academic Medical Centers Versus Private Sector Companies: 1991, 1996,2001 and 2006

CHAPTER FIVE: MARKETS

  • Exhibit 5-1: Global Drug Development Spending, 2002-2012
  • Exhibit 5-2: Global Drug Development Spending, 2002-2012
  • Exhibit 5-3: R&D Expenditures of Leading Pharmaceutical Developers, 2006 vs. 2005
  • Exhibit 5-4: Number of Companies with Active Product Development Projects, 1997-2006
  • Exhibit 5-5: Total Average Number of Active Phase I-III Clinical Trials Worldwide, 2001-2007
  • Exhibit 5-6: Top Ten Therapeutic Categories in R&D
  • Worldwide, March 2007
  • Exhibit 5-7: A Comparison of Spending Rates in Phase I and
  • Phase II/III Trials, 2004-2008
  • Exhibit 5-8: Clinical Trials Phase IIIb/IV Market
  • 2004-2008 (in U.S. billions)
  • Exhibit 5-9: Global R&D Spending and Portion Outsourced to Contract Research, 2002-2012 (in US Billions)
  • Exhibit 5-10: Contract Drug Development Market, 2002-2012 (Outsourced to CROs, Others)
  • Exhibit 5-11 Contract Drug Development Market Share, Percent by Competitor Type (AMCs, CROs, Others), 2007
  • Exhibit 5-12: Contract Research Market (CRO, AMC, Other)
  • Exhibit 5-13: CRO Market Share, 2007
  • Exhibit 5-14: Selected Acquisitions of Leading CROs, 2006 to present
  • Exhibit 5-15: Market Share of Niche Participants in Contract Drug Development, 2007 (MSN, EDC, nonCRO Labs)
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