Clinical Trials Business; The

Content

• Introduction
  • Study Goals And Objectives
  • Reasons For Doing The Study
  • Contribution Of The Study And For Whom
  • Methodology
  • Analyst Credentials
  • Scope And Format
  • Information Sources
  • Related BCC Reports
  • BCC Online Services
  • Disclaimer
• Summary
  • Summary Table 1: U.S. Forecast Of Sponsored Clinical Trials Market, Through 2011
  • Summary Figure: U.S. Sponsored Clinical Trials Market, 2003-2011 ($ Billions)
  • Summary Table 2: U.S. Market Forecast Of Clinical Trial Funding Sources, Through 2011 ($ Billions)
• Clinical Trials Overview
  • Types Of Clinical Trials
  • Clinical Trial Phases
  • Who Sponsors Clinical Trials?
  • Phase I
  • Phase Ii
  • Phase Iii
  • Phase Iv/Post-Marketing Trials
  • Factors Affecting Study Size
  • Physician And Patient Recruitment
  • U.S. Government Regulations
    • Pharmaceuticals And Biologics
      • Additional U.S. Laws Affecting Clinical Trials
      • Health Insurance Portability And Accountability Act Of 1996 (HIPAA)
      • Best Pharmaceuticals For Children Act (BPCA), 2002
    • Food And Drug Administration (FDA)
      • Background
      • Center For Biologics Evaluation And Research (CBER)
      • Cber And Bioterrorism
      • Center For Drug Evaluation And Research (CDER)
      • Cder And Bioterrorism
      • Critical Path Initiative (CPI)
    • Medical Devices
      • Center For Devices And Radiologic Health (CDRH)
      • Articles Subject To Medical Device Amendments
      • Classification Of Devices (General Section 513)
      • Class I - General Controls
      • Class Ii - Special Controls
      • Class Iii
      • Expedited Review
      • Expedited Development And Review
      • Subpart E
      • Accelerated Approval (Subpart H)
      • Priority Review
      • Fast Track
      • Pediatrics
    • U.S. Litigation And Clinical Trials
    • Investigational Review Board (IRB)
  • European Regulations
    • European Agency For The Evaluation Of Medicinal Products (EMEA)
      • History
      • Quick Facts About The Emea Are As Follows
      • Approval Procedures
  • The Regulation Of Drug Development In Japan
  • International Conference Of Harmonization (ICH)
• Industry
  • Who Funds Clinical Trials?
    • Biotech/ Pharmaceutical Companies
    • National Institutes Of Health And Other Federal Agencies Of The Federal Government
    • Private Organizations, Universities And Specialty Groups
    • Who Conducts Clinical Trials?
      • Contract Research Organizations (CROS)
  • Biotechnology Vs. Pharmaceutical
  • Clinical Trial Research Therapeutic Areas
    • Trends In Clinical Trials
      • Electronic Data Capture (EDC)
    • Technologies
      • Antisense
      • Apoptosis
      • Biochips/ Microarrays
      • Bioinformatics
      • Bioprocessors
      • Cells And Cell Signaling
      • Cell Therapy (I.E., Stem Cells, Tissue Repair)
      • Chemical Genomics
      • Cytomics
      • Electronic Data Capture And E-Submission
      • Gene Therapy
      • Genomics
      • Novel Drug Delivery Systems
      • Proteomics
      • Theranostics
      • Transgenics
      • Nanotechnology
      • Natural Sources
    • Factors Influencing Drug Development
      • Epidemiological Trends
      • Legislation
      • New Technologies
      • Bioterrorism
  • Clinical Trial Costs
    • Factors Inlfluencing Clinical Trial Costs
      • Factors Increasing Clinical Trial Costs
      • Factors Increasing Clinical Trial Costs
      • Factors Decreasing Clinical Trial Costs
    • Recent And Future Trends In Clinical Trial Processes
    • Research And Development Budgets
  • Product Pipeline
    • Biologics
    • Outsourcing And Contract Research Organizations
    • Globalization
      • Time-To-Market Pressures
      • Technology Changes Will Increase Demand For Cro Services
      • Negative Pressures On The Cro Industry
    • Drugs By System
      • Cardiovascular
      • Central Nervous System
      • Gastrointestinal Disease
      • Infection
      • Inflammation
      • Cancer
      • Cancer Vaccines
      • Orthopedics
      • Respiratory
      • Devices
      • Biomems
      • Stents
      • Implants
• U.S. Patent Analysis
  • Introduction
  • General Trends
  • Trends In Select Therapeutic Areas
    • Conclusions Of Analysis
• Clinical Trial Markets
  • Contract Research Organizations (CROS)
    • Issues Driving The Cro Business
      • Financial
      • Organization
      • Efficiency
  • Outsourcing Clinical Trials To Foreign Countries
    • Advantages
      • Efficiency
    • Disadvantages
      • Sociopolitical Issues
    • Brazil
      • Patent Protection
      • Pharmaceutical And Clinical Trial Registration
      • Clinical Trials
    • China
      • Patent Protection
      • Pharmaceutical And Clinical Trial Registration
      • Clinical Trials
      • Leading Chinese Pharmaceutical Companies
    • India
      • Advantages
      • Disadvantages
      • Key Points For Doing Clinical Studies In India
    • Romania
      • Patent Protection
    • Russia
      • Patent Protection
  • Mergers And Acquisitions
• Company Profiles
  • Biotechnology Companies
    • Acambis
    • Amgen
    • Array Biopharma
    • Arqule, Inc.
    • Avanir
    • Biogen Idec Inc.
    • Boston Life Sciences, Inc.
    • Celgene
    • Cell Therapeutics, Inc. (CTI)
    • Cephalon Inc.
    • Chiron
    • Corgentech
    • Corixa Corp.
    • Curagen Corp.
    • Cytokinetics, Inc.
    • Dendreon Corp.
    • Dynavax Technologies
    • Elan Corporation, Plc
    • Enzon Pharmaceuticals, Inc.
    • Exact Sciences Corp.
    • Genentech
    • Genzyme
    • Gilead Sciences, Inc
    • Gtc Biotherapeutics, Inc.
    • Gtx Inc.
    • Human Genome Sciences Inc.
    • Idera Pharmaceuticals (Hybridon, Inc.)
    • Icos Corp.
    • Immunogen, Inc.
    • Imclone Systems Inc.
    • Immunogen, Inc.
    • Immune Response Corp.
    • La Jolla Pharmaceutical Co.
    • Lorus Therapeutics, Inc.
    • Maxim Pharmaceuticals/Epicept Corp.
    • Maxygen, Inc.
    • Medimmune
    • Millennium Pharmaceuticals, Inc.
    • Mgi Pharma, Inc.
    • Myriad Genetics, Inc.
    • Nps Pharmaceuticals, Inc.
    • Praecis Pharmaceuticals, Inc.
    • Repligen
    • Sangamo Biosciences, Inc.
    • Seattle Genetics, Inc.
    • Serono
    • Trimeris, Inc.
    • Valentis, Inc.
    • Vertex
    • Vical Inc.
    • Xechem International Inc.
    • Xoma
    • Pharmaceutical Companies
    • Abbott Laboratories
    • Advancis Pharmaceutical Corp.
    • Allergan, Inc.
    • Astrazeneca
    • Baxter International, Inc.
    • Bradley Pharmaceuticals, Inc.
    • Bristol-Myers Squibb
    • Cortex Pharmaceuticals
    • Dusa Pharmaceuticals, Inc.
    • Endo Pharmaceuticals
    • Eli Lilly
    • Glaxosmithkline
    • Hi-Tech Pharmacal, Inc.
    • Idenix Pharmaceuticals, Inc.
    • Inotek Pharmaceuticals
    • Johnson & Johnson
    • Merck
    • Novartis
    • Noven Pharmaceuticals, Inc.
    • Pfizer
    • Pharmion Corp,
    • Sepracor
    • Schering-Plough
    • Vion Pharmaceuticals, Inc.
    • Watson Pharmaceuticals, Inc.
    • Medical Device Companies
    • Agilent Technologies Life Sciences
    • Applied Biosystems Group
    • Bio-Logic
    • Bruker Biosciences Corp.
    • Calypte Biomedical Corp.
    • Ep Medsystems, Inc.
    • Genetronics Biomedical Corp.
    • Guidant Corp. (Now Part Of Boston Scientific)
    • Harvard Bioscience
    • Medex, Inc.
    • Medtronics
    • Nanogen
    • Qmed, Inc.
    • Quidel Corp.
    • Stryker
    • Ventana Medical Systems, Inc.
  • Contract Research Organization (CRO) Profiles
    • Aai
    • Advanced Biomedical Research, Inc.
    • Asian Clinical Trials
    • Aster Cephac
    • Biotechnology Research Institute
    • California Clinical Trials
    • Cato Research Ltd.
    • Cerb
    • Chiltern International
    • Clinical Trial Services (Now Part Of The Almac Group)
    • Clinphone
    • Clintrials Research, Inc.
    • Covance, Inc.
    • Epidemiology Resources, Inc.
    • Eresearch Technology
    • Factory-Cro Bv
    • Health Decisions, Inc.
    • Icon Clinical Research, Ltd
    • Ife Europe Gmbh
    • Kendle International, Inc.
    • Lab Preclinical Research International
    • Ncgs And Associates, Inc.
    • Nutratec, Llc
    • Omnicare Clinical Research
    • Oxford Research International Corp.
    • Paragon Biomedical, Inc.
    • Parexel International Corp.
    • Ppd, Inc. (Pharmaceutical Product Development)
    • Pra International
    • Pharsight Corp.
    • Quintiles
    • Research Triangle Institute
    • Scian Services Inc.
    • Sfbc International
    • Simbec Research Ltd.
• Appendix
  • Glossary Of Terms
  • Summary Table 1:
• U.S. Forecast Of Sponsored Clinical Trials Market, Through 2011
  • Summary Table 2:
• U.S. Market Forecast Of Clinical Trial Funding Sources, Through 2011 ($ Billions)
  • Table 1 Phases Of The Clinical Trial
  • Table 2 U.S. Laws Affecting Drug Approval Times
  • Table 3 Active Moieties For Which The Fda Has Requested Studies
  • Table 4 Original Pma Submissions
  • Table 5 New Drug Applications (Nda & Bla) And Average Approval Times, 2003-2005
  • Table 6 Indications Given Priority Review By Segment Of Fda
  • Table 7 New Drug Application Approvals
  • Table 8 Insurance Companies Offering Clinical Trial Liability Insurance
  • Table 9 Emea Member Countries And Representatives
  • Table 10 U.S. Market Forecast For Direct Spending Clinical Trials By Organization Type, Through 2011 ($ Billions)
  • Table 11 U.S. Clinical Trials By Organization Type And Phase, 2005 (Number Of Clinical Trials Recruiting Subjects)
  • Table 12 U.S. Market Forecast Of Registered Clinical Trials Sponsored By Industry By Phase, Through 2011 (UNITS)
  • Table 13 U.S. Market Forecast For R&d Spending By Pharma Member Companies And Major U.S. Biopharmaceutical Companies, Through 2011 ($ Billions)
  • Table 14 U.S. Market Forecast For Registered Clinical Trials Sponsored By The Federal Government, Through 2011
  • Table 15 U.S. Market Forecast For Numbers Of Registered Clinical Trials Sponsored By Universities Or Other Organizations, Through 2011 (UNITS)
  • Table 16 U.S. Market Forecast Of Phrma Member R&d Funding By Therapeutic Category*, Through 2011 ($ Billion)
  • Table 17 Best-Selling Pharmaceutical Drugs Worldwide, 2005 ($ Billion)
  • Table 18 Best-Selling Pharmaceutical Drugs In The United States, 2005 ($ Billion)
  • Table 19 Fastest Selling Pharmaceutical Drugs In The United States, 2005 ($ Million)
  • Table 20 Number Of Clinical Research Trials By Area, Through 2011
  • Table 21 Number Of Clinical Trials Using New Technologies, Through 2011
  • Table 22 New Technologies And Projected Effect On Clinical Trials
  • Table 23 Selected Biotechnology Companies, R&d Costs, Clinical Trial Costs, And Percentage Of R&d Spent On Clinical Trials, 2005 ($Millions)
  • Table 24 Projected Costs For Selected U.S.-Based Biotechnology Companies, 2006 And 2011 ($ Million)
  • Table 25 Selected Pharmaceutical Companies, R&d Costs, Clinical Trial Costs, And Percentage Of R&d To Net Sales, 2005 ($ Billion)
  • Table 26 Projected Costs For Selected U.S. Based Pharmaceutical Companies, 2006 ($ Billion)
  • Table 27 Selected Biologics
  • Table 28 Selected Cardiovascular Therapeutics In Development, 2005
  • Table 29 Average Cost Of Clinical Development For Cardiovascular Drugs Per Trial In The U.S. By Phase, Through 2011 ($ Million)
  • Table 30 Average Cost Of Clinical Development For Central Nervous System Drugs Per Trial In The U.S. By Phase, Through 2011 ($Millions)
  • Table 31 Selected Central Nervous System Therapeutics In Development, 2005-2006
  • Table 32 Selected Gastrointestinal Therapeutics In Development, 2005-2006
  • Table 33 Selected Anti-Infectives In Development, 2005
  • Table 34 U.S. Forecast For The Average Cost Of Clinical Development Of Anti-Infective Drugs Per Trial By Phase, Through 2011 ($ Million)
  • Table 35 Selected Anti-Inflammatory Therapeutics In Development, 2005
  • Table 36 Phase Iii And Iv Anti-Cancer Pipeline
  • Table 37 Phase Iii And Iv Musculoskeletal Therapeutics Pipeline
  • Table 38 Selected Respiratory/Pulmonary Therapeutics In Development, 2005
  • Table 39 Recent Major Device Approvals
  • Table 40 Number Of Listed Clinical Trials With A Treatment Arm Actively Recruiting Subjects Located In Targeted Outsourcing Countries, February 2006
  • Table 41 Average Cost Per Patient For Trials In The U.S., Canada, And Western Europe For All Therapeutic Areas, Through 2011 ($)
  • Table 42 Average Cost Per Patient For Trials In Reduced Cost Countries, Through 2011*
  • Table 43 Brazilian Domestic Pharmaceutical Companies
  • Table 44 Indian Domestic Pharmaceutical Producers
  • Table 45 Top Five Biotechnology Companies In India
  • Table 46 Leading Russian Pharmaceutical Companies
  • Table 47 Mergers And Acquisitions
  • Table 48 Revenues And R&d Expenditures For Selected Biotechnology Companies, With Percent Change, 2004 And 2005 ($ Millions)
  • Table 49 Acambis Product Pipeline
  • Table 50 Amgen Product Pipeline
  • Table 51 Array Biopharma Product Pipeline
  • Table 52 Arqule Product Pipeline
  • Table 53 Avanir Product Pipeline
  • Table 54 Biogen Product Pipeline
  • Table 55 Boston Life Sciences Product Pipeline
  • Table 56 Celgene Product Pipeline
  • Table 57 Cti Product Pipeline
  • Table 58 Cephalon Product Pipeline
  • Table 59 Chiron Product Pipeline
  • Table 60 Corgentech Product Pipeline
  • Table 61 Corixa Product Pipeline
  • Table 62 Curagen Product Pipeline
  • Table 63 Cytokinetics Product Pipeline
  • Table 64 Dendreon Product Pipeline
  • Table 65 Dynavax Technologies' Product Pipeline
  • Table 66 Elan Product Pipeline
  • Table 67 Enzon Product Pipeline
  • Table 68 Genentech Product Pipeline
  • Table 69 Genzyme Product Pipeline
  • Table 70 Gilead Sciences Product Pipeline
  • Table 71 Gtc Biotherapeutics Product Pipeline
  • Table 72 Gtx Product Pipeline
  • Table 73 Human Genome Systems Product Pipeline
  • Table 74 Idera Product Pipeline
  • Table 75 Icos Product Pipeline
  • Table 76 Immunogen Product Pipeline
  • Table 77 Imclone Systems Product Pipeline
  • Table 78 Immunogen Product Pipeline
  • Table 79 Immune Response Product Pipeline
  • Table 80 Lorus Product Pipeline
  • Table 81 Maxim Product Pipeline
  • Table 82 Maxygen Product Pipeline
  • Table 83 Medimmune Product Pipeline
  • Table 84 Millenium Product Pipeline
  • Table 85 Mgi Pharma Product Pipeline
  • Table 86 Myriad Product Pipeline
  • Table 87 Nps Pharmaceuticals Product Pipeline
  • Table 88 Praecis Product Pipeline
  • Table 89 Repligen Product Pipeline
  • Table 90 Sangamo Biosciences Product Pipeline
  • Table 91 Seattle Genetics Product Pipeline
  • Table 92 Serono Product Pipeline
  • Table 93 Valentis Product Pipeline
  • Table 94 Vertex Product Pipeline
  • Table 95 Vical Product Pipeline
  • Table 96 Xoma Product Pipeline
  • Table 97 Revenues And R&d Expenditures For Selected Pharmaceutical Companies, With Percent Change, 2004 And 2005 ($Billions)
  • Table 98 Abbott Product Pipeline
  • Table 99 Advancis Pharmaceuticals Product Pipeline
  • Table 100 Allergan Product Pipeline
  • Table 101 Astrazeneca Product Pipeline
  • Table 102 Bristol-Myers Squibb Product Pipeline
  • Table 103 Cortex Pharmaceuticals Product Pipeline
  • Table 104 Dusa Product Pipeline
  • Table 105 Endo Pharmaceuticals Product Pipeline
  • Table 106 Eli Lilly Product Pipeline
  • Table 107 Glaxosmithkline Product Pipeline
  • Table 108 Idenix Product Pipeline
  • Table 109 Inotek Product Pipeline
  • Table 110 Johnson & Johnson Product Pipeline
  • Table 111 Merck Product Pipeline
  • Table 112 Noven Product Pipeline
  • Table 113 Pharmion Product Pipeline
  • Table 114 Sepracor Product Pipeline
  • Table 115 Schering-Plough Product Pipeline
  • Table 116 Vion Pharmaceuticals Product Pipeline
  • Table 117 Top Medical Device Manufacturer Sales, 2004 ($ Billion)
  • Table 118 Selected Cro Companies Revenue, 2005 ($ Million)
• List Of Figures
  • Summary Figure:
• U.S. Sponsored Clinical Trials Market, 2003-2011 ($ Billions)
  • Figure 1 Drug Development Timeline
  • Figure 2 New Drug Development
  • Figure 3 Major Funding Sources For Clinical Trials, 2005-2011 ($Millions)
  • Figure 4 Number Of Clinical Trials By Major Sponsors, 2005 (Number Of Clinical Trials)
  • Figure 5 U.S. Market Forecast Of Clinical Trials Sponsored By Industry, 2005-2011 (UNITS)
  • Figure 6 Clinical Trials Sponsored By The Federal Government By Phase, 2005-2011 (Numbers Recruiting Subjects)
  • Figure 7 Numbers Of Clinical Trials Sponsored By Universities Or Other Organizations, 2005-2011 (Number Of Clinical Trials)
  • Figure 8 Phrma Member R&d Funding By Therapeutic Category, 2006 (Percent Share)
  • Figure 9 Phrma Member R&d Funding By Therapeutic Category, 2011 (Percent Share)
  • Figure 10 Factors Influencing Drug Development
  • Figure 11 New Molecular Entity (NME) Applications, 1995-2004
  • Figure 12 Notable Patents In Four Major Therapeutic Areas, 2005 (%)
  • Figure 13 Numbers Of Clinical Trials Listed With The Nih With A Treatment Arm In Specific Countries, 2006