Report: The Clinical Trials Business TOC

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?
  - Figure 1 DRUG DEVELOPMENT TIMELINE
  - Table 1 PHASES OF THE CLINICAL TRIAL
- 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
- Table 2 U.S. LAWS AFFECTING DRUG APPROVAL TIMES
  - ADDITIONAL U.S. LAWS AFFECTING CLINICAL TRIALS
    - HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA)
    - BEST PHARMACEUTICALS FOR CHILDREN ACT (BPCA), 2002
- Table 3 ACTIVE MOIETIES FOR WHICH THE FDA HAS REQUESTED STUDIES
  - 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
- Table 4 ORIGINAL PMA SUBMISSIONS
  - EXPEDITED REVIEW
- Figure 2 NEW DRUG DEVELOPMENT
- Table 5 NEW DRUG APPLICATIONS (NDA & BLA) AND AVERAGE APPROVAL TIMES, 2003-2005
  - EXPEDITED DEVELOPMENT AND REVIEW
- Table 6 INDICATIONS GIVEN PRIORITY REVIEW BY SEGMENT OF FDA
  - SUBPART E
  - ACCELERATED APPROVAL (SUBPART H)
  - PRIORITY REVIEW
  - FAST TRACK
- Table 7 NEW DRUG APPLICATION APPROVALS
  - PEDIATRICS
  - U.S. LITIGATION AND CLINICAL TRIALS
- Table 8 INSURANCE COMPANIES OFFERING CLINICAL TRIAL LIABILITY INSURANCE
  - INVESTIGATIONAL REVIEW BOARD (IRB)
- EUROPEAN REGULATIONS
  - EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS (EMEA)
    - HISTORY
      - QUICK FACTS ABOUT THE EMEA ARE AS FOLLOWS
- Table 9 EMEA MEMBER COUNTRIES AND REPRESENTATIVES
  - APPROVAL PROCEDURES
    - THE REGULATION OF DRUG DEVELOPMENT IN JAPAN
    - INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH)
  - INTERNATIONAL CONFERENCE OF ...(CONTINUED)
INDUSTRY
- WHO FUNDS CLINICAL TRIALS?
- Table 10 U.S. MARKET FORECAST FOR DIRECT SPENDING CLINICAL TRIALS BY ORGANIZATION TYPE, THROUGH 2011 ($ BILLIONS)
- Figure 3 MAJOR FUNDING SOURCES FOR CLINICAL TRIALS, 2005-2011 ($MILLIONS)
- Table 11 U.S. CLINICAL TRIALS BY ORGANIZATION TYPE AND PHASE, 2005 (NUMBER OF CLINICAL TRIALS RECRUITING SUBJECTS)
- Figure 4 NUMBER OF CLINICAL TRIALS BY MAJOR SPONSORS, 2005 (NUMBER OF CLINICAL TRIALS)
  - BIOTECH/ PHARMACEUTICAL COMPANIES
- Table 12 U.S. MARKET FORECAST OF REGISTERED CLINICAL TRIALS SPONSORED BY INDUSTRY BY PHASE, THROUGH 2011 (UNITS)
- Figure 5 U.S. MARKET FORECAST OF CLINICAL TRIALS SPONSORED BY INDUSTRY, 2005-2011 (UNITS)
- Table 13 U.S. MARKET FORECAST FOR R&D SPENDING BY PHARMA MEMBER COMPANIES AND MAJOR U.S. BIOPHARMACEUTICAL COMPANIES, THROUGH 2011 ($ BILLIONS)
  - NATIONAL INSTITUTES OF HEALTH AND OTHER FEDERAL AGENCIES OF THE FEDERAL GOVERNMENT
- Table 14 U.S. MARKET FORECAST FOR REGISTERED CLINICAL TRIALS SPONSORED BY THE FEDERAL GOVERNMENT, THROUGH 2011
- Figure 6 CLINICAL TRIALS SPONSORED BY THE FEDERAL GOVERNMENT BY PHASE, 2005-2011 (NUMBERS RECRUITING SUBJECTS)
  - PRIVATE ORGANIZATIONS, UNIVERSITIES AND SPECIALTY GROUPS
- Table 15 U.S. MARKET FORECAST FOR NUMBERS OF REGISTERED CLINICAL TRIALS SPONSORED BY UNIVERSITIES OR OTHER ORGANIZATIONS, THROUGH 2011 (UNITS)
- Figure 7 NUMBERS OF CLINICAL TRIALS SPONSORED BY UNIVERSITIES OR OTHER ORGANIZATIONS, 2005-2011 (NUMBER OF CLINICAL TRIALS)
  - WHO CONDUCTS CLINICAL TRIALS?
    - CONTRACT RESEARCH ORGANIZATIONS (CROS)
  - BIOTECHNOLOGY VS. PHARMACEUTICAL
  - CLINICAL TRIAL RESEARCH THERAPEUTIC AREAS
- Table 16 U.S. MARKET FORECAST OF PHRMA MEMBER R&D FUNDING BY THERAPEUTIC CATEGORY*, THROUGH 2011 ($ BILLION)
- Figure 8 PHRMA MEMBER R&D FUNDING BY THERAPEUTIC CATEGORY, 2006 (PERCENT SHARE)
- Figure 8 (CONTINUED)
- Figure 9 PHRMA MEMBER R&D FUNDING BY THERAPEUTIC CATEGORY, 2011 (PERCENT SHARE)
- Figure 9 (CONTINUED)
- 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)
  - TRENDS IN CLINICAL TRIALS
    - ELECTRONIC DATA CAPTURE (EDC)
- Table 20 NUMBER OF CLINICAL RESEARCH TRIALS BY AREA, THROUGH 2011
  - TECHNOLOGIES
- Table 21 NUMBER OF CLINICAL TRIALS USING NEW TECHNOLOGIES, THROUGH 2011
- Table 22 NEW TECHNOLOGIES AND PROJECTED EFFECT ON CLINICAL TRIALS
  - 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
- Figure 10 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 ... (CONTINUED)
    - FACTORS INCREASING CLINICAL TRIAL COSTS
    - FACTORS DECREASING CLINICAL TRIAL COSTS
  - RECENT AND FUTURE TRENDS IN CLINICAL TRIAL PROCESSES
  - RESEARCH AND DEVELOPMENT BUDGETS
- Table 23 SELECTED BIOTECHNOLOGY COMPANIES, R&D COSTS, CLINICAL TRIAL COSTS, AND PERCENTAGE OF R&D SPENT ON CLINICAL TRIALS, 2005 ($MILLIONS)
  - RESEARCH AND DEVELOPMENT ... (CONTINUED)
- Table 24 PROJECTED COSTS FOR SELECTED U.S.-BASED BIOTECHNOLOGY COMPANIES, 2006 AND 2011 ($ 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)
  - PRODUCT PIPELINE
    - BIOLOGICS
- Table 27 SELECTED 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
- 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)
  - CENTRAL NERVOUS SYSTEM
- Table 30 AVERAGE COST OF CLINICAL DEVELOPMENT FOR CENTRAL NERVOUS SYSTEM DRUGS PER TRIAL IN THE U.S. BY PHASE, THROUGH 2011 ($MILLIONS)
- Table 31 SELECTED CENTRAL NERVOUS SYSTEM THERAPEUTICS IN DEVELOPMENT, 2005-2006
  - GASTROINTESTINAL DISEASE
- Table 32 SELECTED GASTROINTESTINAL THERAPEUTICS IN DEVELOPMENT, 2005-2006
  - INFECTION
- Table 33 SELECTED ANTI-INFECTIVES IN DEVELOPMENT, 2005
- Table 34 U.S. FORECAST FOR THE AVERAGE COST OF CLINICAL DEVELOPMENT OF ANTI-INFECTIVE DRUGS PER TRIAL BY PHASE, THROUGH 2011 ($ MILLION)
  - INFLAMMATION
- Table 35 SELECTED ANTI-INFLAMMATORY THERAPEUTICS IN DEVELOPMENT, 2005
  - CANCER
    - CANCER VACCINES
- Table 36 PHASE III AND IV ANTI-CANCER PIPELINE
  - ORTHOPEDICS
- Table 37 PHASE III AND IV MUSCULOSKELETAL THERAPEUTICS PIPELINE
  - RESPIRATORY
- Table 38 SELECTED RESPIRATORY/PULMONARY THERAPEUTICS IN DEVELOPMENT, 2005
  - DEVICES
    - BIOMEMS
    - STENTS
    - IMPLANTS
- Table 39 RECENT MAJOR DEVICE APPROVALS
U.S. PATENT ANALYSIS
- INTRODUCTION
- GENERAL TRENDS
  - Figure 11 NEW MOLECULAR ENTITY (NME) APPLICATIONS, 1995-2004
- TRENDS IN SELECT THERAPEUTIC AREAS
  - Figure 12 NOTABLE PATENTS IN FOUR MAJOR THERAPEUTIC AREAS, 2005 (%)
- CONCLUSIONS OF ANALYSIS
CLINICAL TRIAL MARKETS
- CONTRACT RESEARCH ORGANIZATIONS (CROS)
  - ISSUES DRIVING THE CRO BUSINESS
    - FINANCIAL
    - ORGANIZATION
    - EFFICIENCY
  - OUTSOURCING CLINICAL TRIALS TO FOREIGN COUNTRIES
- Table 40 NUMBER OF LISTED CLINICAL TRIALS WITH A TREATMENT ARM ACTIVELY RECRUITING SUBJECTS LOCATED IN TARGETED OUTSOURCING COUNTRIES, FEBRUARY 2006
- Table 40 (CONTINUED)
- Figure 13 NUMBERS OF CLINICAL TRIALS LISTED WITH THE NIH WITH A TREATMENT ARM IN SPECIFIC COUNTRIES, 2006
- Table 41 AVERAGE COST PER PATIENT FOR TRIALS IN THE U.S., CANADA, AND WESTERN EUROPE FOR ALL THERAPEUTIC AREAS, THROUGH 2011 ($)
  - ADVANTAGES
- Table 42 AVERAGE COST PER PATIENT FOR TRIALS IN REDUCED COST COUNTRIES, THROUGH 2011*
  - EFFICIENCY
    - DISADVANTAGES
  - SOCIOPOLITICAL ISSUES
    - BRAZIL
  - PATENT PROTECTION
  - PHARMACEUTICAL AND CLINICAL TRIAL REGISTRATION
  - CLINICAL TRIALS
- Table 43 BRAZILIAN DOMESTIC PHARMACEUTICAL COMPANIES
  - CHINA
    - PATENT PROTECTION
    - PHARMACEUTICAL AND CLINICAL TRIAL REGISTRATION
    - CLINICAL TRIALS
    - LEADING CHINESE PHARMACEUTICAL COMPANIES
  - INDIA
    - ADVANTAGES
    - DISADVANTAGES
      - KEY POINTS FOR DOING CLINICAL STUDIES IN INDIA
- Table 44 INDIAN DOMESTIC PHARMACEUTICAL PRODUCERS
- Table 45 TOP FIVE BIOTECHNOLOGY COMPANIES IN INDIA
  - ROMANIA
    - PATENT PROTECTION
  - RUSSIA
    - PATENT PROTECTION
- Table 46 LEADING RUSSIAN PHARMACEUTICAL COMPANIES
  - MERGERS AND ACQUISITIONS
- Table 47 MERGERS AND ACQUISITIONS
  - COMPANY PROFILES
  - BIOTECHNOLOGY COMPANIES
- Table 48 REVENUES AND R&D EXPENDITURES FOR SELECTED BIOTECHNOLOGY COMPANIES, WITH PERCENT CHANGE, 2004 AND 2005 ($ MILLIONS)
  - ACAMBIS
- Table 49 ACAMBIS PRODUCT PIPELINE
  - AMGEN
- Table 50 AMGEN PRODUCT PIPELINE
  - ARRAY BIOPHARMA
- Table 51 ARRAY BIOPHARMA PRODUCT PIPELINE
  - ARQULE, INC.
- Table 52 ARQULE PRODUCT PIPELINE
  - AVANIR
- Table 53 AVANIR PRODUCT PIPELINE
  - BIOGEN IDEC INC.
- Table 54 BIOGEN PRODUCT PIPELINE
- Table 54 (CONTINUED)
  - BOSTON LIFE SCIENCES, INC.
- Table 55 BOSTON LIFE SCIENCES PRODUCT PIPELINE
  - CELGENE
- Table 56 CELGENE PRODUCT PIPELINE
- Table 56 (CONTINUED)
  - CELL THERAPEUTICS, INC. (CTI)
- Table 57 CTI PRODUCT PIPELINE
  - CEPHALON INC.
- Table 58 CEPHALON PRODUCT PIPELINE
  - CHIRON
- Table 59 CHIRON PRODUCT PIPELINE
  - CORGENTECH
- Table 60 CORGENTECH PRODUCT PIPELINE
  - CORIXA CORP.
- Table 61 CORIXA PRODUCT PIPELINE
  - CURAGEN CORP.
- Table 62 CURAGEN PRODUCT PIPELINE
  - CYTOKINETICS, INC.
- Table 63 CYTOKINETICS PRODUCT PIPELINE
  - DENDREON CORP.
- Table 64 DENDREON PRODUCT PIPELINE
  - DYNAVAX TECHNOLOGIES
- Table 65 DYNAVAX TECHNOLOGIES' PRODUCT PIPELINE
  - ELAN CORPORATION, PLC
- Table 66 ELAN PRODUCT PIPELINE
  - ENZON PHARMACEUTICALS, INC.
- Table 67 ENZON PRODUCT PIPELINE
  - EXACT SCIENCES CORP.
  - GENENTECH
- Table 68 GENENTECH PRODUCT PIPELINE
  - GENZYME
- Table 69 GENZYME PRODUCT PIPELINE
- Table 69 (CONTINUED)
  - GILEAD SCIENCES, INC
- Table 70 GILEAD SCIENCES PRODUCT PIPELINE
  - GTC BIOTHERAPEUTICS, INC.
- Table 71 GTC BIOTHERAPEUTICS PRODUCT PIPELINE
  - GTX INC.
- Table 72 GTX PRODUCT PIPELINE
  - HUMAN GENOME SCIENCES INC.
- Table 73 HUMAN GENOME SYSTEMS PRODUCT PIPELINE
  - IDERA PHARMACEUTICALS (HYBRIDON, INC.)
- Table 74 IDERA PRODUCT PIPELINE
  - ICOS CORP.
- Table 75 ICOS PRODUCT PIPELINE
  - IMMUNOGEN, INC.
- Table 76 IMMUNOGEN PRODUCT PIPELINE
  - IMCLONE SYSTEMS INC.
- Table 77 IMCLONE SYSTEMS PRODUCT PIPELINE
  - IMMUNOGEN, INC.
- Table 78 IMMUNOGEN PRODUCT PIPELINE
  - IMMUNE RESPONSE CORP.
- Table 79 IMMUNE RESPONSE PRODUCT PIPELINE
  - LA JOLLA PHARMACEUTICAL CO.
  - LORUS THERAPEUTICS, INC.
- Table 80 LORUS PRODUCT PIPELINE
  - MAXIM PHARMACEUTICALS/EPICEPT CORP.
- Table 81 MAXIM PRODUCT PIPELINE
  - MAXYGEN, INC.
- Table 82 MAXYGEN PRODUCT PIPELINE
  - MEDIMMUNE
- Table 83 MEDIMMUNE PRODUCT PIPELINE
  - MILLENNIUM PHARMACEUTICALS, INC.
- Table 84 MILLENIUM PRODUCT PIPELINE
- Table 84 (CONTINUED)
  - MGI PHARMA, INC.
- Table 85 MGI PHARMA PRODUCT PIPELINE
  - MYRIAD GENETICS, INC.
- Table 86 MYRIAD PRODUCT PIPELINE
  - NPS PHARMACEUTICALS, INC.
- Table 87 NPS PHARMACEUTICALS PRODUCT PIPELINE
  - PRAECIS PHARMACEUTICALS, INC.
- Table 88 PRAECIS PRODUCT PIPELINE
  - REPLIGEN
- Table 89 REPLIGEN PRODUCT PIPELINE
  - SANGAMO BIOSCIENCES, INC.
- Table 90 SANGAMO BIOSCIENCES PRODUCT PIPELINE
  - SEATTLE GENETICS, INC.
- Table 91 SEATTLE GENETICS PRODUCT PIPELINE
  - SERONO
- Table 92 SERONO PRODUCT PIPELINE
  - TRIMERIS, INC.
  - VALENTIS, INC.
- Table 93 VALENTIS PRODUCT PIPELINE
  - VERTEX
- Table 94 VERTEX PRODUCT PIPELINE
  - VICAL INC.
- Table 95 VICAL PRODUCT PIPELINE
  - XECHEM INTERNATIONAL INC.
  - XOMA
- Table 96 XOMA PRODUCT PIPELINE
  - PHARMACEUTICAL COMPANIES
- Table 97 REVENUES AND R&D EXPENDITURES FOR SELECTED PHARMACEUTICAL COMPANIES, WITH PERCENT CHANGE, 2004 AND 2005 ($BILLIONS)
  - ABBOTT LABORATORIES
- Table 98 ABBOTT PRODUCT PIPELINE
  - ADVANCIS PHARMACEUTICAL CORP.
- Table 99 ADVANCIS PHARMACEUTICALS PRODUCT PIPELINE
  - ALLERGAN, INC.
- Table 100 ALLERGAN PRODUCT PIPELINE
  - ASTRAZENECA
- Table 101 ASTRAZENECA PRODUCT PIPELINE
- Table 101 (CONTINUED)
- Table 101 (CONTINUED)
  - BAXTER INTERNATIONAL, INC.
  - BRADLEY PHARMACEUTICALS, INC.
  - BRISTOL-MYERS SQUIBB
- Table 102 BRISTOL-MYERS SQUIBB PRODUCT PIPELINE
  - CORTEX PHARMACEUTICALS
- Table 103 CORTEX PHARMACEUTICALS PRODUCT PIPELINE
  - DUSA PHARMACEUTICALS, INC.
- Table 104 DUSA PRODUCT PIPELINE
  - ENDO PHARMACEUTICALS
- Table 105 ENDO PHARMACEUTICALS PRODUCT PIPELINE
  - ELI LILLY
- Table 106 ELI LILLY PRODUCT PIPELINE
  - GLAXOSMITHKLINE
- Table 107 GLAXOSMITHKLINE PRODUCT PIPELINE
- Table 107 (CONTINUED)
- Table 107 (CONTINUED)
- Table 107 (CONTINUED)
  - HI-TECH PHARMACAL, INC.
  - IDENIX PHARMACEUTICALS, INC.
- Table 108 IDENIX PRODUCT PIPELINE
  - INOTEK PHARMACEUTICALS
- Table 109 INOTEK PRODUCT PIPELINE
  - JOHNSON & JOHNSON
- Table 110 JOHNSON & JOHNSON PRODUCT PIPELINE
  - MERCK
- Table 111 MERCK PRODUCT PIPELINE
- Table 111 (CONTINUED)
  - NOVARTIS
  - NOVEN PHARMACEUTICALS, INC.
- Table 112 NOVEN PRODUCT PIPELINE
  - PFIZER
  - PHARMION CORP,
- Table 113 PHARMION PRODUCT PIPELINE
  - SEPRACOR
- Table 114 SEPRACOR PRODUCT PIPELINE
  - SCHERING-PLOUGH
- Table 115 SCHERING-PLOUGH PRODUCT PIPELINE
  - VION PHARMACEUTICALS, INC.
- Table 116 VION PHARMACEUTICALS PRODUCT PIPELINE
  - WATSON PHARMACEUTICALS, INC.
  - MEDICAL DEVICE COMPANIES
- Table 117 TOP MEDICAL DEVICE MANUFACTURER SALES, 2004 ($ BILLION)
  - 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
- Table 118 SELECTED CRO COMPANIES REVENUE, 2005 ($ MILLION)
  - 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
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
  - GLOSSARY OF TERMS (CONTINUED)
LIST OF TABLES
- 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

The Clinical Trials Business

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