Abstract
Summary
The clinical trials market is projected to reach USD 52.0 billion by 2026 from USD 38.7 billion in 2021, at a CAGR of 6.1% during the forecast period, owing to increasing number of clinical trials, rising prevalence of orphan & rare diseases and high cost of in-house drug development.
“By service type, the laboratory services segment accounted for the largest share of the clinical trials market”
Based on service type, the clinical trials market is segmented into protocol designing, site identification, patient recruitment, laboratory services, bioanalytical testing, analytical testing, clinical trial supply & logistic services, decentralized clinical services, clinical trial data management services, medical device testing services, and other services. Laboratory services is the leading segment of clinical trial services market, this can be attributed to the increasing preference of clinical research professionals to outsource such services.
“Asia Pacific: The fastest-growing region in the clinical trials market.”
The Asia Pacific market is projected to grow at the highest CAGR during the forecast period. The high growth rate in this region can be attributed to the fast-growing pharmaceutical industry in the region, favorable government policies, the increasing number of pharmaceutical companies establishing manufacturing facilities in the region, and the lower cost of clinical trials in the region.
“North America: The North America region accounted for the largest share of the clinical trials market”
North America accounted for the largest share of the clinical trials market. Rapid growth in the biosimilar and biologics markets and an increase in clinical trial activity are the major factors driving the market growth.
Breakdown of primaries
The study contains insights from various industry experts, ranging from component suppliers to Tier 1 companies and OEMs. The break-up of the primaries is as follows:
By Respondent– Supply Side- 40%, Demand Side- 60%
By Designation— Executives- 25%, CXOs & Directors--30%, Managers - 45%
By Region— North America - 40%, Europe - 25%, APAC – 20%, LATAM- 10%, MEA- 5%
The clinical trials market is dominated by a few globally established players such as including IQVIA (US), LabCorp (US), Charles River Laboratories (US), WuXi AppTec (China), Syneos Health (US), Parexel International (US), PPD (US), and ICON Plc (US). Other players operating in the market are Medpace Holdings (US), SGS (Switzerland), PSI CRO AG (US), Axcent Advanced Analytics (US), BIO Agile Therapeutics (US), Firma Clinical Research (US), Acculab Life Sciences (US), Azelix (US), CTserv (US), Pepgra (UK), and Dove Quality Solutions (US), Novotech Health Holding (Australia), Geneticist Inc. (US), Linical Americas (US), Frontage Holding Corporation (US), and Celerion (US).
Research Coverage:
The report segments the clinical trials market based on region (North America, Europe, Asia Pacific, Latin America and Middle East & Africa), Phase (Phase I, Phase II, Phase III, Phase IV), Service Type (Protocol Designing, Site Identification, Patient Recruitment, Laboratory Services, Bioanalytical Testing Services (Cell-based Assays, Virology Testing, Method Development, Optimization & Validation, Serology, Immunogenicity, & Neutralizing Antibodies, Biomarker Testing Services, PK/PD Testing Services, Other Bioanalytical Testing Services), Analytical Testing Services, Clinical Trial Supply & Logistic Services, Decentralized Clinical Services, Clinical Trial Data Management Services, Medical Device Testing Services, Other Clinical Trial Services), Therapy Area (Oncology, Infectious Diseases, Cardiology, Neurology, Women's Health, Genetic Diseases, Immunology, and Other Therapy Areas), Application (Vaccine, Cell & Gene Therapy, Small Molecules, Other Applications)
The report also provides a comprehensive review of market drivers, challenges, and opportunities in the clinical trials market.
Key Benefits of Buying the Report:
The report will help the leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall market and the sub-segments. This report will help stakeholders understand the competitive landscape and gain more insights to better position their businesses and plan suitable go-to-market strategies. The report also helps stakeholders understand the pulse of the clinical trials market and provides them information on key market drivers, challenges, and opportunities.
Table of Contents
1 INTRODUCTION 40
1.1 OBJECTIVES OF THE STUDY 40
1.2 MARKET DEFINITION 40
1.2.1 INCLUSIONS & EXCLUSIONS 40
1.3 MARKET SCOPE 41
1.3.1 YEARS CONSIDERED FOR THE STUDY 42
1.4 CURRENCY 42
1.5 LIMITATIONS 42
1.6 STAKEHOLDERS 43
1.7 SUMMARY OF CHANGES 43
2 RESEARCH METHODOLOGY 44
2.1 RESEARCH DATA 44
2.1.1 SECONDARY DATA 45
2.1.2 PRIMARY DATA 46
2.2 MARKET SIZE ESTIMATION 47
2.3 GROWTH RATE ASSUMPTIONS/GROWTH FORECAST 50
2.4 MARKET BREAKDOWN AND DATA TRIANGULATION 53
2.5 INSIGHTS FROM PRIMARIES 54
2.6 RESEARCH ASSUMPTIONS 54
2.6.1 COVID-19 SPECIFIC ASSUMPTIONS 55
2.7 RISK ANALYSIS 55
3 EXECUTIVE SUMMARY 56
4 PREMIUM INSIGHTS 60
4.1 CLINICAL TRIALS MARKET OVERVIEW 60
4.2 NORTH AMERICA: CLINICAL TRIALS MARKET SHARE, BY PHASE & COUNTRY (2020) 61
4.3 CLINICAL TRIALS MARKET, BY BIOANALYTICAL SERVICE TYPE
5 MARKET OVERVIEW 63
5.1 INTRODUCTION 63
5.2 MARKET DYNAMICS 63
5.2.1 DRIVERS 64
- 5.2.1.1 Increasing investment in pharmaceutical R&D 64
- 5.2.1.2 Increasing number of clinical trials 66
- 5.2.1.3 High cost of in-house drug development 66
- 5.2.1.4 Rising prevalence of orphan and rare diseases 67
5.2.2 OPPORTUNITIES 68
- 5.2.2.1 Growth in drugs and biologics market despite COVID-19 pandemic 68
- 5.2.2.2 Rising demand for specialized testing services among end users 69
- 5.2.2.3 Need for novel clinical trial designs for complex cell and gene therapies 70
5.2.3 CHALLENGES 70
- 5.2.3.1 Shortage of skilled professionals for clinical trials 70
- 5.2.3.2 Requirement of unique analytical testing approaches for innovative drug molecules 70
5.2.4 MARKET TRENDS 71
- 5.2.4.1 Adoption of artificial intelligence-based tools for drug discovery 71
- 5.2.4.2 Increasing outsourcing activities in emerging Asian economies 71
- 5.2.4.3 Integrated end-to-end R&D service solutions 73
5.3 RANGES/SCENARIOS 73
5.4 IMPACT OF COVID-19 ON CLINICAL TRIALS MARKET 74
5.5 PORTER’S FIVE FORCES ANALYSIS 75
5.5.1 THREAT OF NEW ENTRANTS 75
5.5.2 THREAT OF SUBSTITUTES 75
5.5.3 BARGAINING POWER OF BUYERS 75
5.5.4 BARGAINING POWER OF SUPPLIERS 76
5.5.5 DEGREE OF COMPETITION 76
5.6 TRENDS/DISRUPTIONS IMPACTING CUSTOMER’S BUSINESS 76
5.7 ECOSYSTEM ANALYSIS 77
5.8 REGULATORY ANALYSIS 79
6 CLINICAL TRIALS MARKET, BY PHASE 82
6.1 INTRODUCTION 83
6.2 CLINICAL TRIALS PLANNING AND DESIGNING SOLUTION 84
6.3 PHASE I 87
6.3.1 ROBUST PIPELINE OF PHARMACEUTICAL COMPANIES DRIVES THE GROWTH OF THIS SEGMENT 87
6.4 PHASE II 89
6.4.1 LONG DURATION OF PHASE II STUDIES PROVIDES GROWTH OPPORTUNITIES FOR CROS 89
6.5 PHASE III 92
6.5.1 RISING COSTS OF PHASE III TRIALS INCREASES THE DEMAND FOR COST-EFFECTIVE CLINICAL RESEARCH SERVICES 92
6.6 PHASE IV 94
6.6.1 RISING NUMBER OF CLINICAL RESEARCH ENTITIES PROVIDING POST-MARKETING SURVEILLANCE TO DRIVE THE SEGMENT GROWTH 94
7 CLINICAL TRIALS MARKET, BY SERVICE TYPE 97
7.1 INTRODUCTION 98
7.2 PROTOCOL DESIGNING 99
7.2.1 PROTOCOL DESIGNING SERVICES SERVE AS AN EFFECTIVE STRATEGY TO ENSURE RAPID & EFFECTIVE PLANNING FOR CLINICAL TRIAL STUDIES 99
7.3 SITE IDENTIFICATION 101
7.3.1 NEW DIGITAL TECHNOLOGIES THAT ENABLE DATA VARIABILITY ENHANCES SITE IDENTIFICATION SERVICE EFFICACY 101
7.4 PATIENT RECRUITMENT 103
7.4.1 GROWING REQUIREMENT TO WORK WITH A PATIENT-CENTRIC CLINICAL TRIAL COMPANY SUPPORTS THE GROWTH OF THIS SEGMENT 103
7.5 LABORATORY SERVICES 105
7.5.1 INCREASING IMPORTANCE OF LABORATORY SERVICES TO ENSURE REGULATORY COMPLIANCE PROPELS THE GROWTH OF THIS SEGMENT 105
7.5.2 ANALYTICAL TESTING SERVICES 107
- 7.5.2.1 Increasing demand for analytical testing for drug development to drive the growth of this segment 107
7.6 BIOANALYTICAL TESTING SERVICES 109
7.6.1 HIGH DEMAND FOR BIOANALYTICAL TESTING DUE TO THE GROWING USE OF MACROMOLECULES AND BIOSIMILARS TO DRIVE THE GROWTH OF THIS SEGMENT 109
7.6.2 CELL-BASED ASSAYS 111
- 7.6.2.1 Increasing number of service providers offering customized cell-based assay testing services to drive the growth of this segment 111
7.6.3 VIROLOGY TESTING 113
- 7.6.3.1 Higher uptake of in vitro virology assays in the development of antiviral pharmaceuticals to drive the growth of this segment 113
7.6.4 PK/PD (PHARMACOKINETICS/PHARMACODYNAMICS) TESTING SERVICES 115
- 7.6.4.1 Rising importance of studies to determine pharmacokinetic behavior of drug candidates to drive the growth of this segment 115
7.6.5 METHOD DEVELOPMENT, OPTIMIZATION, & VALIDATION 117
- 7.6.5.1 Increasing preference of biopharmaceutical companies to outsource method validation services for clinical trials to drive this segment 117
7.6.6 SEROLOGY, IMMUNOGENICITY, & NEUTRALIZING ANTIBODIES 119
- 7.6.6.1 High demand for immunogenicity and neutralizing antibody assays in biosimilar development to propel market growth 119
7.6.7 BIOMARKER TESTING SERVICES 121
- 7.6.7.1 Growing emphasis on biomarker testing to develop personalized medicines and companion diagnostics to augment segment growth 121
7.6.8 OTHER BIOANALYTICAL TESTING SERVICES 122
7.7 CLINICAL TRIAL DATA MANAGEMENT SERVICES 124
7.7.1 DATA MANAGEMENT SERVICES SEGMENT IS EXPECTED TO RECORD
7.8 CLINICAL TRIAL SUPPLY & LOGISTIC SERVICES 127
7.8.1 ADVANCED DATA ANALYTICS INCORPORATED IN CLINICAL TRIAL SUPPLY MANAGEMENT IS EXPECTED TO DRIVE THE GROWTH OF THIS SEGMENT 127
7.9 DECENTRALIZED CLINICAL TRIAL SERVICES 128
7.9.1 THE SARS-COV-2 OUTBREAK HAS SIGNIFICANTLY CATALYZED THE DEMAND FOR DECENTRALIZED CLINICAL TRIALS 128
7.10 MEDICAL DEVICE TESTING SERVICES 130
7.10.1 INCREASING R&D FOR THE DEVELOPMENT OF ADVANCED MEDICAL DEVICES TO DRIVE THE GROWTH OF THIS MARKET 130
7.11 OTHER CLINICAL TRIAL SERVICES 132
7.11.1 OTHER CLINICAL TRIAL SERVICES SEGMENT INCLUDES CONSULTING SERVICES, MEDICAL WRITING SERVICES, AND PHARMACOGENOMICS TESTING SERVICES 132
8 CLINICAL TRIALS MARKET, BY THERAPY AREA 135
8.1 INTRODUCTION 136
8.2 ONCOLOGY 136
8.2.1 RISING INCIDENCE OF CANCER TO DRIVE MARKET GROWTH 136
8.3 INFECTIOUS DISEASES 140
8.3.1 INFECTIOUS DISEASES SEGMENT TO REGISTER THE HIGHEST GROWTH RATE IN THE FORECAST PERIOD 140
8.4 NEUROLOGY 142
8.4.1 INCREASING INVESTMENTS IN R&D AND GRANTS FOR NEUROLOGICAL DISORDERS TO DRIVE MARKET GROWTH 142
8.5 IMMUNOLOGY 145
8.5.1 GROWING PIPELINE OF IMMUNOLOGICAL DRUGS HAS RESULTED IN INCREASING OUTSOURCING ACTIVITIES 145
8.6 CARDIOLOGY 147
8.6.1 HIGH MORTALITY RATES ARE DRIVING PHARMACEUTICAL COMPANIES TO DEVELOP NEW TREATMENT OPTIONS 147
8.7 GENETIC DISEASES 149
8.7.1 PROMISING DRUGS IN PIPELINE FOR RARE DISEASES TO SUPPORT MARKET GROWTH 149
8.8 WOMEN’S HEALTH 151
8.8.1 RISING PREVALENCE OF CHRONIC DISORDERS IN WOMEN TO DRIVE MARKET GROWTH 151
8.9 OTHER THERAPY AREAS 153
9 CLINICAL TRIALS MARKET, BY APPLICATION 156
9.1 INTRODUCTION 157
9.2 SMALL MOLECULE 157
9.2.1 INCREASING INVESTMENTS BY VIRTUAL AND SMALLER COMPANIES TO DRIVE SMALL MOLECULE DEVELOPMENT PROJECTS SUPPORTS
9.3 VACCINES 160
9.3.1 OUTBREAK OF THE COVID-19 PANDEMIC IS EXPECTED TO EMERGE AS A MARKET DISRUPTOR, IMPOSING LONG-TERM POSITIVE EFFECTS ON
9.4 CELL & GENE THERAPY 162
9.4.1 THE RISING TREND OF OUTSOURCING SERVICES AND THE ONGOING EFFORTS OF SERVICE PROVIDERS TO EXPAND THEIR RESPECTIVE OFFERINGS IS DRIVING THE CLINICAL DEVELOPMENT PIPELINE FOR CELL & GENE THERAPY 162
9.5 OTHER APPLICATIONS 166
9.5.1 INCREASE IN R&D FOR THE DEVELOPMENT OF HORMONES AND BLOOD COMPONENTS SUPPORTS MARKET GROWTH 166
10 CLINICAL TRIALS MARKET, BY REGION 168
10.1 INTRODUCTION 169
10.2 NORTH AMERICA 169
10.2.1 US 173
- 10.2.1.1 Robust clinical research activities to become a key factor supporting the US market growth 173
10.2.2 CANADA 176
- 10.2.2.1 Increasing number of clinical trials in Canada to support market growth 176
10.3 EUROPE 179
10.3.1 GERMANY 182
- 10.3.1.1 Government support and flexible labor laws have made Germany a favorable location for clinical trials 182
10.3.2 UK 185
- 10.3.2.1 Investments by pharmaceutical sponsors in the UK for drug discovery services to support market growth 185
10.3.3 FRANCE 188
- 10.3.3.1 High number of oncology clinical trials in France is expected to drive market growth in France 188
10.3.4 ITALY 191
- 10.3.4.1 Low drug approval times along with the growing number of clinical trials in Italy to drive market growth 191
10.3.5 SPAIN 194
- 10.3.5.1 Rising R&D expenditure to boost market growth for clinical trials
10.3.6 REST OF EUROPE (ROE) 198
10.4 ASIA PACIFIC (APAC) 201
10.4.1 CHINA 205
- 10.4.1.1 China dominates the clinical trials services market owing to a robust pharmaceutical industry and presence of prominent clinical trial service providers 205
10.4.2 JAPAN 208
- 10.4.2.1 Strong focus on R&D activities in Japan is expected to drive market growth 208
10.4.3 INDIA 211
- 10.4.3.1 Growing pharmaceutical industry in India to drive the market growth for clinical trails 211
10.4.4 REST OF ASIA PACIFIC 214
10.5 LATIN AMERICA 217
10.5.1 GROWING R&D EXPENDITURE IN THE PHARMACEUTICAL & BIOPHARMACEUTICAL SECTOR TO DRIVE THE MARKET
10.6 MIDDLE EAST & AFRICA 220
10.6.1 GROWING PHARMACEUTICAL INDUSTRY TO DRIVE THE MARKET GROWTH IN MIDDLE EAST & AFRICA 220
11 COMPETITIVE LANDSCAPE 224
11.1 INTRODUCTION 224
11.2 RIGHT-TO-WIN APPROACHES ADOPTED BY KEY PLAYERS 224
11.3 MARKET SHARE ANALYSIS 226
11.4 COMPANY EVALUATION QUADRANT 228
11.4.1 STARS 228
11.4.2 EMERGING LEADERS 228
11.4.3 PERVASIVE PLAYERS 228
11.4.4 PARTICIPANTS 228
11.5 COMPETITIVE BENCHMARKING 230
11.5.1 COMPANY SERVICE FOOTPRINT (20 COMPANIES) 230
11.5.2 COMPANY REGIONAL FOOTPRINT (20 COMPANIES) 231
11.6 COMPETITIVE SCENARIO AND TRENDS 232
11.6.1 SERVICES LAUNCHES 232
11.6.2 DEALS 233
11.6.3 OTHER DEVELOPMENTS 234
12 COMPANY PROFILES 235
12.1 KEY COMPANIES 235
12.1.1 IQVIA 235
12.1.2 LABCORP DRUG DEVELOPMENT (COVANCE) 240
12.1.3 SYNEOS HEALTH INC. 246
12.1.4 WUXI APPTEC 252
12.1.5 CHARLES RIVER LABORATORIES 259
12.1.6 PAREXEL INTERNATIONAL 265
12.1.7 PRA HEALTH SCIENCES 271
12.1.8 PPD INC 275
12.1.9 ICON PLC 281
12.1.10 MEDPACE HOLDINGS INC 287
12.1.11 ACM GLOBAL LABORATORIES 289
12.1.12 ADVANCED CLINICAL 291
12.1.13 SGS 293
12.1.14 FRONTAGE HOLDINGS CORPORATION 296
12.1.15 PSI CRO AG 300
12.1.16 BIO AGILE THERAPEUTICS 301
12.2 OTHER PLAYERS 303
12.2.1 AZELIX 303
12.2.2 CTSERV 304
12.2.3 PEPGRA 304
12.2.4 AXCENT ADVANCED ANALYTICS (A3) 305
12.2.5 DOVE QUALITY SOLUTIONS 306
12.2.6 FIRMA CLINICAL RESEARCH 306
12.2.7 CELERION 307
12.2.8 NOVOTECH HEALTH HOLDINGS 308
12.2.9 GENETICIST INC. 308
12.2.10 LINICAL AMERICAS 309
13 APPENDIX 310
13.1 DISCUSSION GUIDE 310
13.2 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 313
13.3 AVAILABLE CUSTOMIZATIONS 315
13.4 RELATED REPORT 316
13.5 AUTHOR DETAILS 317
2017 VS. 2019 208
2021 VS. 2026 (USD BILLION) 62