The Clinical Trials Business

  • January 2011
  • -
  • BCC Research

New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period.  Clinical trial spending in 2010 is an estimated $25 billion and is expected to reach $28.5 billion by 2014. 
In 2010, the number of clinical trials in the U.S. is 25,992. This number is expected to increase at a 5.7% compound annual growth rate (CAGR) to reach 32,318 in 2014.
Pharmaceutical and biotechnology companies devote a greater percentage of their budgets to R&D than does any other U.S. industry.  In 2009, the pharmaceutical industry invested 34.8% of sales in domestic R&D. In 2014, this percentage is projected to increase to 48.8, a 7% compound annual growth rate (CAGR).

STUDY GOALS AND OBJECTIVES

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 2014.

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.

REASONS FOR DOING THE STUDY

The mapping of the human genome has opened new possibilities for the development of new medications to treat disease. Genomics, the emerging field of study resulting from the Human Genome Project, is coupling with bioengineering technology and biotechnology, producing accelerated development of new and novel treatments.

At the same time, existing biochemical techniques are advancing to enhance the process of biotechnological research. X-ray crystallography and combinatorial chemistry are two examples of increased modernization. As discovery technologies more quickly determine greater numbers of targets, greater numbers of compounds will be reaching the clinical trial phase of development sooner.

The clinical trial is that segment of research in the drug development process that tests a product or device to determine such factors as safety, efficacy, and adverse reactions in a human population. This report will focus on the following:

Research and development of drugs and biologics and new applications for old drugs and devices
Major product pipelines in development for the top biotechnology and pharmaceutical companies
The impact of new technologies on the costs and processes of clinical trials. 

This report also addresses current and future trends in clinical trial research, how new focuses are driven by epidemiological trends, treatment of rare diseases, and the threat of bioterrorism.

INTENDED AUDIENCE

This report provides a thorough background of the clinical trial process. It is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investor consultants, and anyone interested in the clinical trials business and its future.

METHODOLOGY

Both primary and secondary research methodologies were used in preparing this study. 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

Jon Evans has been involved in business development and research for the medical industry since 1984. Mr. Evans’ career includes 4 years as a diagnostic systems sales representative and over 15 years in market research and strategy analysis with Fortune 500 clients. He has developed expertise in assessing the unique business development challenges facing firms in the medical industry and designing strategies to optimize market performance. Mr. Evans received a BS in biology from Rutgers University in 1983, and an MBA in business analysis from San Francisco State University in 1989.

SCOPE OF REPORT

The report provides an overview of clinical development phases, the regulatory issues involved, and the factors influencing clinical trial costs. An overview is provided of new technologies that will be affecting the clinical trial process in the near future. Major product pipelines are provided by physiological system and company.

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

Chapter- 1: INTRODUCTION -- Complimentary

STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
INTENDED AUDIENCE 2
METHODOLOGY 2
ANALYST CREDENTIALS 2
SCOPE OF REPORT 2
INFORMATION SOURCES 3
RELATED BCC REPORTS 3
BCC ONLINE SERVICES 3
DISCLAIMER 4

Chapter-2: SUMMARY

SUMMARY 5
SUMMARY TABLE   U.S. FORECAST OF SPONSORED CLINICAL TRIALS MARKET, THROUGH 2014 6
SUMMARY FIGURE   U.S. FORECAST OF SPONSORED CLINICAL TRIALS MARKET, 2009-2014 ($ BILLIONS) 7

Chapter-3: OVERVIEW

TYPES OF CLINICAL TRIALS 8
CLINICAL TRIAL PHASES 8
WHO SPONSORS CLINICAL TRIALS? 8
TABLE 1 U.S. FORECAST OF SPONSORED CLINICAL TRIALS, THROUGH 2014 9
FIGURE 1 U.S. SPONSORED CLINICAL TRIALS MARKET, 2009-2014 ($ BILLIONS) 9
FIGURE 2 DRUG DEVELOPMENT TIME LINE 10
TABLE 2 PHASES OF THE CLINICAL TRIAL 10
PHASE I 11
PHASE II 11
PHASE III 12
PHASE IV/POST-MARKETING TRIALS 12
FACTORS AFFECTING STUDY SIZE 12
PHYSICIAN AND PATIENT RECRUITMENT 13
U.S. GOVERNMENT REGULATIONS 14
PHARMACEUTICALS AND BIOLOGICS 14
TABLE 3 U.S. LAWS AFFECTING DRUG APPROVAL TIMES 14
Additional U.S. Laws Affecting Clinical Trials 14
Health Insurance Portability and Accountability Act of 1996 (HIPAA) 14
Best Pharmaceuticals for Children Act (BPCA), 2002 15
TABLE 4 TOTAL APPROVED ACTIVE MOIETIES WITH NO MARKETING PROTECTION FOR WHICH FDA HAS ISSUED A WRITTEN REQUEST 16
FOOD AND DRUG ADMINISTRATION (FDA) 16
Background 16
Center for Biologics Evaluation and Research (CBER) 17
CBER and Bioterrorism 18
Center for Drug Evaluation and Research (CDER) 18
CDER and Bioterrorism 18
Critical Path Initiative (CPI) 19
MEDICAL DEVICES 19
Center for Devices and Radiologic Health (CDRH) 19
Articles Subject to Medical Device Amendments 19
Classification of Devices (General Section 513) 20
• Class I—General Controls 20
• Class II—Special Controls 20
• Class III 21
Expedited Review 21
FIGURE 3 NEW DRUG DEVELOPMENT 21
TABLE 5 CDER APPROVAL TIMES FOR PRIORITY AND STANDARD NDAS AND BLAS, CALENDAR YEARS, 1993 2008 22
Expedited Development and Review 22
TABLE 6 FIRST CYCLE APPROVAL RATE FOR OVERALL STUDY COHORT BY YEAR, 2002-2007 23
Subpart E 23
Accelerated Approval (Subpart H) 24
Priority Review 24
Fast Track 24
TABLE 7 NUMBER AND TOTAL APPROVAL TIME (IN MONTHS) OF APPROVED NDAS AND BLAS, BY FISCAL YEAR OF SUBMISSION AND BY REVIEW PROCEDURE 25
Pediatrics 25
U.S. LITIGATION AND CLINICAL TRIALS 25
TABLE 8 INSURANCE COMPANIES OFFERING CLINICAL TRIAL LIABILITY INSURANCE 26
INVESTIGATIONAL REVIEW BOARD (IRB) 26
EUROPEAN REGULATIONS 27
JAPANESE REGULATIONS 28
GLOBAL REGULATORY STANDARDS 28
INTERNATIONAL CONFERENCE OF HARMONIZATION (ICH) 28
International Conference of Harmonization … (Continued) 29

Chapter-4: CLINICAL TRIAL COST AND FUNDING

MANAGING CLINICAL TRIALS 30
CONTRACT RESEARCH ORGANIZATIONS (CROS) 31
CLINICAL TRIAL RESEARCH THERAPEUTIC AREAS 31
FIGURE 4 PHRMA MEMBER RandD FUNDING BY THERAPEUTIC CATEGORY, 2010 (% SHARE) 32
TABLE 9 BEST-SELLING PHARMACEUTICAL DRUGS WORLDWIDE, 2009 ($ BILLIONS) 33
TRENDS IN CLINICAL TRIALS 33
ELECTRONIC DATA CAPTURE (EDC) 33
CLINICAL TRIAL COSTS 34
FACTORS INFLUENCING CLINICAL TRIAL COSTS 34
Factors Increasing Clinical Trial Costs 34
Factors Increasing Clinical … (Continued) 35
Factors Decreasing Clinical Trial Costs 36
RECENT AND FUTURE TRENDS IN CLINICAL TRIAL PROCESSES 36
RESEARCH AND DEVELOPMENT BUDGETS 36
TABLE 10   INVESTMENT IN RandD AS A PERCENT OF SALES, PHARMACEUTICAL INDUSTRY, THROUGH 2014 (%) 37
TABLE 11 INVESTMENT IN RandD AS A PERCENT OF SALES, PHARMACEUTICAL INDUSTRY, THROUGH 2014, PHRMA MEMBERS, (%) 37
FUNDING CLINICAL TRIALS 38
TABLE 12   TOTAL RandD SPENDING BY SOURCE, THROUGH 2014 ($ BILLIONS) 39
TABLE 13   ESTIMATES OF NIH RESEARCH FUNDING FOR TOP 50 CONDITIONS AND DISEASE CATEGORIES, RESEARCH/DISEASE AREAS, THROUGH 2010 ($ MILLIONS/ROUNDED) 40
BIOTECH/PHARMACEUTICAL COMPANIES 41
TABLE 14 U.S. MARKET FORECAST OF REGISTERED CLINICAL TRIALS SPONSORED BY INDUSTRY BY PHASE, THROUGH 2014 (RECRUITING SUBJECTS) 42
NATIONAL INSTITUTES OF HEALTH AND OTHER FEDERAL AGENCIES OF THE FEDERAL GOVERNMENT 42
TABLE 15   U.S. MARKET FORECAST OF REGISTERED CLINICAL TRIALS SPONSORED BY FEDERAL GOVERNMENT BY PHASE, THROUGH 2014 (RECRUITING SUBJECTS) 43
PRIVATE ORGANIZATIONS, UNIVERSITIES, AND SPECIALTY GROUPS 43
TABLE 16 U.S. MARKET FORECAST OF REGISTERED CLINICAL TRIALS SPONSORED BY UNIVERSITIES OR OTHER ORGANIZATIONS BY PHASE, THROUGH 2014 (RECRUITING SUBJECTS) 44
TABLE 17 TOP 25 FOUNDATIONS AWARDING U.S.-FOCUSED GRANTS FOR GLOBAL HEALTH, RANKED BY NUMBER OF GRANTS AND DOLLAR AMOUNT, 2008 44
Private Organizations, Universities… (Continued) 45

Chapter-5: CLINICAL TRIAL PIPELINES AND TECHNOLOGY TRENDS

DRUGS BY SYSTEM 46
CARDIOVASCULAR 46
PhRMA Facts 46
PhRMA Facts (Continued) 47
TABLE 18 SELECTED CARDIOVASCULAR THERAPEUTICS IN DEVELOPMENT, 2010 48
CANCER 49
PhRMA Facts 49
PhRMA Facts (Continued) 50
TABLE 19 SELECTED ANTICANCER CRUGS IN DEVELOPMENT, 2010 51
CENTRAL NERVOUS SYSTEM 51
PhRMA Facts 52
TABLE 20 SELECTED CENTRAL NERVOUS SYSTEM THERAPEUTICS IN DEVELOPMENT, 2010 53
INFECTION 54
INFLAMMATION 54
RESPIRATORY 55
TABLE 21 CDER PRIORITY DRUG AND BIOLOGIC APPROVALS: CALENDAR YEAR 2009 55
TABLE 21 (CONTINUED) 56
DEVICES 56
BIOMEMS 56
STENTS 56
IMPLANTS 57
TABLE 22 MEDICAL DEVICES CLEARED OR APPROVED BY FDA IN 2010 57
TABLE 22 (CONTINUED) 58
TABLE 23 TOP MEDICAL DEVICE COMPANIES, IN TERMS OF 2009 REVENUES ($ MILLIONS) 58
BIOTECHNOLOGY VERSUS PHARMACEUTICAL 59
BIOLOGICS 60
TABLE 24 SELECTED BIOLOGICS IN DEVELOPMENT, 2010 60
TABLE 25 BIOTECHNOLOGY CANDIDATES IN DEVELOPMENT BY MODALITY, 2008 61
TABLE 26 BIOTECHNOLOGY CANDIDATES IN DEVELOPMENT BY INDICATION, 2008 62
TECHNOLOGIES 62
TABLE 27 NUMBER OF CLINICAL TRIALS USING NEW TECHNOLOGIES, THROUGH 2014 63
TABLE 28 NEW TECHNOLOGIES AND PROJECTED EFFECT ON CLINICAL TRIALS 64
ANTISENSE 64
APOPTOSIS 65
BIOCHIPS/MICROARRAYS 65
BIOINFORMATICS 65
BIOPROCESSORS 65
CELLS AND CELL SIGNALING 66
CELL THERAPY (I.E., STEM CELLS, TISSUE REPAIR) 66
CHEMICAL GENOMICS 67
CYTOMICS 67
ELECTRONIC DATA CAPTURE AND E-SUBMISSION 67
GENE THERAPY 67
GENOMICS 67
NOVEL DRUG DELIVERY SYSTEMS 68
PROTEOMICS 68
Four-part Definition of Proteomics 68
THERANOSTICS 69
TRANSGENICS 69
NANOTECHNOLOGY 69
NATURAL SOURCES 69
BIOMARKERS CONSORTIUM 69
NIH Public-Private Partnerships Policy Statement 69
FACTORS INFLUENCING DRUG DEVELOPMENT 70
FIGURE 5 FACTORS INFLUENCING DRUG DEVELOPMENT 71
EPIDEMIOLOGICAL TRENDS 71
LEGISLATION 71
NEW TECHNOLOGIES 72
BIOTERRORISM 72

Chapter-6: CONTRACT RESEARCH ORGANIZATIONS AND GLOBALIZATION

CONTRACT RESEARCH ORGANIZATIONS AND GLOBALIZATION 73
CONTRACT RESEARCH ORGANIZATIONS … (CONTINUED) 74
ASSOCIATION OF CLINICAL RESEARCH ORGANIZATIONS FACTS 75
ASSOCIATION OF CLINICAL RESEARCH … (CONTINUED) 76
TABLE 29 TOP TEN CROS BY REVENUES, 2009 77
GLOBALIZATION 77
TABLE 30 CLINICAL TRIALS WITH OPEN ENROLLMENT BY REGION, JULY 2010 78
OUTSOURCING CLINICAL TRIALS TO FOREIGN COUNTRIES 78
TABLE 31 CLINICAL TRIALS RECRUITING SUBJECTS IN TARGETED COUNTRIES, JULY 2010 78
TABLE 31 (CONTINUED) 79
TABLE 32 AVERAGE COST PER PATIENT FOR TRIALS IN THE U.S., CANADA, AND WESTERN EUROPE FOR ALL THERAPEUTIC AREAS, THROUGH 2014 ($) 80
Advantages 80
Costs 80
TABLE 33 AVERAGE COST PER PATIENT FOR TRIALS IN REDUCED COST COUNTRIES, THROUGH 2014 ($) 81
Efficiency 81
Disadvantages 81
Sociopolitical Issues 82
BRAZIL 82
Patent Protection 82
Pharmaceutical and Clinical Trial Registration 82
Clinical Trials 82
TABLE 34 BRAZILIAN DOMESTIC PHARMACEUTICAL COMPANIES 83
CHINA 83
Patent Protection 83
Pharmaceutical and Clinical Trial Registration 83
Clinical Trials 83
Leading Chinese Pharmaceutical Companies 84
Beijing Double-Crane Pharmaceutical (DCPC) 84
Northeast General Pharmaceutical 84
Sanjiu Medical and Pharmaceutical Co., Ltd. 84
C and O Pharmaceutical Technology Holdings Ltd. 84
Shijiazhuang Pharma Group 84
Wuxi Pharmatech 84
Harbin Pharmaceutical Group Co. 85
INDIA 85
Advantages 85
Disadvantages 85
Key Points for Doing Clinical Studies in India 86
TABLE 35 INDIAN DOMESTIC PHARMACEUTICAL PRODUCERS 86
TABLE 36 INDIA’S DOMESTIC PHARMACEUTICAL MARKET (12 MONTHS ENDED JANUARY 2009) 87
TABLE 37 TOP FIVE BIOTECHNOLOGY COMPANIES IN INDIA 87
ROMANIA 87
Patent Protection 88
RUSSIA 88
Patent Protection 88
TABLE 38 LEADING RUSSIAN PHARMACEUTICAL COMPANIES 88

Chapter-7: BIOTECHNOLOGY COMPANIES

ACTELION PHARMACEUTICALS, LTD 89
TABLE 39 CLINICAL PIPELINE AS OF 12/31/2009 89
ALEXION PHARMACEUTICALS, INC. 90
TABLE 40 CLINICAL PIPELINE AS OF 12/31/2009 90
ALLERGAN, INC. 91
TABLE 41 CLINICAL PIPELINE AS OF 12/31/2009 91
TABLE 41 (CONTINUED) 92
ALSERES PHARMACEUTICALS, INC. 92
TABLE 42 CLINICAL PIPELINE AS OF 12/31/2009 92
AMGEN 93
TABLE 43 CLINICAL PIPELINE AS OF 12/31/2009 93
TABLE 43 (CONTINUED) 94
ARQULE 95
TABLE 44 CLINICAL PIPELINE AS OF 12/31/2009 95
ARRAY BIOPHARMA 96
TABLE 45 CLINICAL PIPELINE AS OF 12/31/2009 96
AVANIR PHARMACEUTICALS 97
TABLE 46 CLINICAL PIPELINE AS OF 12/31/2009 97
BAXTER BIOSCIENCE 98
TABLE 47 SAMPLE OF BAXTER’S CLINICAL TRIALS IN PROGRESS, AUGUST 2010 98
TABLE 47 (CONTINUED) 99
TABLE 47 (CONTINUED) 100
BIOCON 100
TABLE 48 CLINICAL PIPELINE AS OF 12/31/2009 101
BIOGEN IDEC 101
TABLE 49 CLINICAL PIPELINE AS OF 12/31/2009 101
TABLE 49 (CONTINUED) 102
CELGENE CORP 102
TABLE 50 CLINICAL PIPELINE AS OF 12/31/2009 103
CELL THRAPEUTICS 103
TABLE 51 CLINICAL PIPELINE AS OF 12/31/2009 104
CELLDEX THERAPEUTICS 104
TABLE 52 CLINICAL PIPELINE AS OF 12/31/2009 105
CEPHALON, INC. 105
TABLE 53 CLINICAL PIPELINE AS OF 12/31/2009 106
CSL BEHRING (CSL, LTD) 106
TABLE 54 CLINICAL PIPELINE AS OF 12/31/2009 107
CYTOKINETICS 107
TABLE 55 CLINICAL PIPELINE AS OF 12/31/2009 108
DENDREON 108
TABLE 56 CLINICAL PIPELINE AS OF 12/31/2009 109
DYNAVAX TECHNOLOGIES 110
TABLE 57 CLINICAL PIPELINE AS OF 12/31/2009 110
ELAN 110
TABLE 58 CLINICAL PIPELINE AS OF 12/31/2009 111
ENZON PHARMACEUTICALS 111
TABLE 59 CLINICAL PIPELINE AS OF 12/31/2009 112
EPICEPT CORPORATION 112
TABLE 60 CLINICAL PIPELINE AS OF 12/31/2009 113
GENENTECH 113
TABLE 61 CLINICAL PIPELINE AS OF 12/31/2009 114
TABLE 61 (CONTINUED) 115
GENZYME 116
TABLE 62 CLINICAL PIPELINE AS OF 12/31/2009 117
GILEAD 117
TABLE 63 CLINICAL PIPELINE AS OF 12/31/2009 118
GTC BIOTHERAPEUTICS, INC. 119
TABLE 64 CLINICAL PIPELINE AS OF 12/31/2009 119
GTX 120
TABLE 65 CLINICAL PIPELINE AS OF 12/31/2009 120
HUMAN GENOME SCIENCES 120
TABLE 66 CLINICAL PIPELINE AS OF 12/31/2009 121
IDERA PHARMACEUTICALS, INC. 121
TABLE 67 CLINICAL PIPELINE AS OF 12/31/2009 122
IMMUNOGEN, INC. 122
TABLE 68 CLINICAL PIPELINE AS OF 12/31/2009 123
IMMUNOMEDICS, INC. 123
TABLE 69 CLINICAL PIPELINE AS OF 12/31/2009 124
LORUS THERAPEUTICS INC. 124
TABLE 70 CLINICAL PIPELINE AS OF 12/31/2009 124
MAXYGEN 125
TABLE 71 CLINICAL PIPELINE AS OF 12/31/2009 125
MYRIAD PHARMACEUTICALS, INC. 125
TABLE 72 CLINICAL PIPELINE AS OF 12/31/2009 126
NOVO NORDISK A/S 126
TABLE 73 CLINICAL PIPELINE AS OF 12/31/2009 127
NPS PHARMACEUTICALS, INC. 127
TABLE 74 CLINICAL PIPELINE AS OF 12/31/2009 128
REPLIGEN CORPORATION 128
TABLE 75 CLINICAL PIPELINE AS OF 12/31/2009 129
SANGAMO BIOSCIENCES, INC. 129
TABLE 76 CLINICAL PIPELINE AS OF 12/31/2009 129
SEATTLE GENETICS, INC. 130
TABLE 77 CLINICAL PIPELINE AS OF 12/31/2009 130
TALECRIS BIOTHERAPEUTICS, INC. 131
TABLE 78 CLINICAL PIPELINE AS OF 12/31/2009 131
UCB SA 132
TABLE 79 CLINICAL PIPELINE AS OF 12/31/2009 132
URIGEN PHARMACEUTICALS, INC. 133
TABLE 80 CLINICAL PIPELINE AS OF 12/31/2009 133
VERTEX PHARMACEUTICALS INCORPORATED 133
TABLE 81 CLINICAL PIPELINE AS OF 12/31/2009 134
VICAL, INCORPORATED 134
TABLE 82 CLINICAL PIPELINE AS OF 12/31/2009 135
XOMA, LTD. 135
TABLE 83 CLINICAL PIPELINE AS OF 12/31/2009 136

Chapter-8: PHARMACEUTICAL COMPANIES



ABBOTT LABORATORIES 137
TABLE 84 CLINICAL PIPELINE HIGHLIGHTS AS OF 8/2010 137
ASTRAZENECA PLC 138
TABLE 85 CLINICAL PIPELINE AS OF 12/31/2009 138
TABLE 85 (CONTINUED) 139
TABLE 85 (CONTINUED) 140
TABLE 85 (CONTINUED) 141
BAYER SCHERING PHARMA AG 141
TABLE 86 PHASE II/III CLINICAL PIPELINE AS OF 12/31/2009 142
TABLE 86 (CONTINUED) 143
BOEHRINGER INGELHEIM GMBH 143
TABLE 87 CLINICAL PIPELINE AS OF 12/31/2009 144
BRISTOL-MYERS SQUIBB COMPANY 144
TABLE 88 CLINICAL PIPELINE, SELECTED PHASE I/II CANDIDATES AS OF 12/31/2009 145
TABLE 88 (CONTINUED) 146
TABLE 89 INVESTIGATIONAL CANDIDATES IN PHASE III CLINICAL TRIALS 146
ELI LILLY AND COMPANY 147
TABLE 90 CLINICAL PIPELINE HIGHLIGHTS AS OF 8/2010 147
GLAXOSMITHKLINE PLC 148
TABLE 91 CLINICAL PIPELINE AS OF 12/31/2009 148
TABLE 91 (CONTINUED) 149
TABLE 91 (CONTINUED) 150
TABLE 91 (CONTINUED) 151
TABLE 91 (CONTINUED) 152
JOHNSON and JOHNSON 152
TABLE 92 SELECTED PHASE III CLINICAL PIPELINE AS OF 12/31/2009 153
MERCK and CO., INC. 154
TABLE 93 CLINICAL PIPELINE AS OF 12/31/2009 154
TABLE 93 (CONTINUED) 155
MERCK SERONO 155
TABLE 94 CLINICAL PIPELINE AS OF 12/31/2009 156
NOVARTIS AG 156
TABLE 95 CLINICAL PIPELINE AS OF 12/31/2009 157
TABLE 95 (CONTINUED) 158
TABLE 95 (CONTINUED) 159
TABLE 95 (CONTINUED) 160
TABLE 95 (CONTINUED) 161
PFIZER, INC. 161
TABLE 96 CLINICAL PIPELINE AS OF 12/31/2009 162
TABLE 96 (CONTINUED) 163
TABLE 96 (CONTINUED) 164
TABLE 96 (CONTINUED) 165
ROCHE 165
TABLE 97 CLINICAL PIPELINE AS OF 12/31/2009 166
TABLE 97 (CONTINUED) 167
TABLE 97 (CONTINUED) 168
SANOFI-AVENTIS 168
TABLE 98 CLINICAL PIPELINE AS OF 12/31/2009 169
TABLE 98 (CONTINUED) 170
TAKEDA PHARMACEUTICAL COMPANY LIMITED 171
TABLE 99 CLINICAL PIPELINE AS OF 12/31/2009 172
TABLE 99 (CONTINUED) 173
TABLE 99 (CONTINUED) 174
TABLE 99 (CONTINUED) 175

Chapter-9: MEDICAL EQUIPMENT AND DEVICES

TABLE 100 MEDICAL EQUIPMENT AND DEVICE COMPANIES IN THE U.S. WITH ANNUAL REVENUES EXCEEDING $1 BILLION 176
TABLE 100 (CONTINUED) 177
TABLE 100 (CONTINUED) 178
TABLE 100 (CONTINUED) 179

Chapter-10: CLINICAL RESEARCH ORGANIZATIONS

TOP 10 CROS 180
TABLE 101 TOP 10 CROS BY REVENUE (ACCOUNTED FOR MORE THAN 50% OF TOTAL INDUSTRY REVENUE IN 2008/2009) 180
SECONDARY CROS (ALPHABETICAL ORDER) 180
TABLE 102   SECONDARY CROS (ALPHABETICAL ORDER) 180
TABLE 102 (CONTINUED) 181
NICHE CRO SPECIALIZED BY REGION OR THERAPEUTIC FOCUS (ALPHABETICAL ORDER) 181
TABLE 103   NICHE CRO SPECIALIZED BY REGION OR THERAPEUTIC FOCUS (ALPHABETICAL ORDER) 181
TABLE 103 (CONTINUED) 182

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