臨床實驗業務 是由出版商BCC Research在2011年01月所出版的。
這份英文市場調查報告書包含186 Pages 價格從美金4850起跳。
美國製藥公司及生技企業之研發預算比率較其他產業高,2009年國內研發佔銷售之34.8%,預計2014年止將會增加至48.8%。
本報告為,概論美國臨床實驗業務,並匯整臨床實驗成本及資金到位、臨床試驗受託機構(CRO)趨勢、市場參與企業簡介等,以下列之摘要形式闡述。
第1章 簡介
第2章 摘要
第3章 概要
- 臨床實驗種類
- 臨床實驗階段
- 臨床實驗贊助商
- 醫療藥品及生物製劑
- 醫療儀器
- 美國訴訟及臨床實驗,其他
第4章 臨床實驗成本及資金到位
- 臨床實驗管理
- CRO
- 臨床實驗研究治療領域
- 臨床實驗趨勢
- 臨床實驗流程趨勢,其他
第5章 臨床實驗產品線及技術趨勢
- 心血管
- 癌症
- 中樞神經系統
- 傳染病
- 炎症
- 呼吸系統,其他
第6章 CRO及全球化
第7章 生技企業
第8章 製藥公司
第9章 醫療儀器
第10章 臨床研究機構
Abstract
Highlights
- 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).
INTRODUCTION
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 4
- 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 3
- 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 22
- 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 16
- MANAGING CLINICAL TRIALS 30
- CONTRACT RESEARCH ORGANIZATIONS (CROS) 31
- CLINICAL TRIAL RESEARCH THERAPEUTIC AREAS 31
- FIGURE 4 PHRMA MEMBER R&D 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 R&D AS A PERCENT OF SALES, PHARMACEUTICAL
INDUSTRY, THROUGH 2014 (%) 37
- TABLE 11 INVESTMENT IN R&D AS A PERCENT OF SALES, PHARMACEUTICAL INDUSTRY,
THROUGH 2014, PHRMA MEMBERS, (%) 37
- FUNDING CLINICAL TRIALS 38
- TABLE 12 TOTAL R&D 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 27
- 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 16
- 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 & 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 48
- 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 39
- 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 & JOHNSON 152
- TABLE 92 SELECTED PHASE III CLINICAL PIPELINE AS OF 12/31/2009 153
- MERCK & 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 4
- 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 7
- 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
- TABLE 103 (CONTINUED) 183
- TABLE 103 (CONTINUED) 184
- TABLE 103 (CONTINUED) 185
- TABLE 103 (CONTINUED) 186
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