Home About Us FAQ Policies Contact Site Map
 
 
QUICK SEARCH
   Advanced Search
 
 
 
   
 
Stay updated on your favorite report topics! We are adding hundreds of new reports daily. Receive email alerts when those reports affect you!

Stay on top of your industry.
  
 

The Clinical Trials Business
Product Type: Market Research Report Publication Date: Aug 31, 2006
 
Download a sample from "The Infoshop", another service of Global Information.

SUMMARY

INTRODUCTION

This report is designed to provide readers with a comprehensive understanding of the clinical trials process and its role in the research and development of new medicines in the U.S. It will provide an overview of clinical trials, including phases of clinical trials, U.S. government regulations, international regulations, costs of clinical trials, technologies, contract research organizations (CROs), and other factors. This report will forecast trends and clinical trial costs through 2011.

Generally, clinical trials are performed on drugs that have undergone a long test period. What are some of the factors that are and will bring drugs/devices as far as the clinical trial? What percentage of new chemical entities/proposals makes it to clinical trial? Who benefits from clinical trials, medically and financially? These areas will be reviewed and analyzed in this report.

SCOPE OF STUDY

This report contains:

  • An overview of clinical development phases, the regulatory issues involved and the factors influencing clinical trial costs
  • An in-depth analysis of the U.S. market for clinical trials that reviews historical data, market trends, and forecasts through 2011
  • Highlights for new and upcoming technologies and developments that could have an impact on the clinical trials business
  • Profiles of the major players in the business.

METHODOLOGY

Information contained in this report includes data obtained from government agencies, corporate publications, industry trade publications and various news sources. Interviews were conducted with leaders from trade associations, universities, the Food and Drug Administration (FDA) and professional agencies. Further information was obtained through an extensive literature search. Forecasts were based on 10K filings, specific factors that could impact clinical trials, and conversations with industry insiders.

ANALYST CREDENTIALS

Kecia Brown holds a Masters of Public Health degree with a concentration in epidemiology and biostatistics. She has participated in medical research and in public health projects at universities and public health agencies. Ms. Brown also has worked in the biotechnology industry and the pharmaceutical industry as a medical writer.

INFORMATION SOURCES

Information contained in this report includes data obtained from government agencies, corporate publications, industry trade publications and various news sources. Interviews were conducted with leaders from trade associations, universities, the Food and Drug Administration (FDA) and professional agencies. Further information was obtained through an extensive literature search and conference attendance. Forecasts were based on 10K filings, specific factors that could impact clinical trials, and conversations with industry insiders.

TABLE OF CONTENTS

  • 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

Publisher: Business Communications Co., Inc.

Format Price Order
PDF by E-mail (Single User License) US $4850.00
Hard Copy US $4850.00
PDF by E-mail (Site License) US $5950.00
PDF by E-Mail (Corporate Use License) US $8500.00
All orders are processed by "www.the-infoshop.com". www.the-infoshop.com is another Global Information web site. This transfer is entirely safe.
Copyright© 2008 GII - All Rights Reserved.