Abstract
Summary
The Healthcare analytical testing services Market is projected to reach USD 12.6 billion by 2029 from USD 7.4 billion in 2024, at a CAGR of 11.2% during the forecast period. The growth of the healthcare analytical testing services market is fueled by increasing demand across industries for quality assurance and regulatory compliance. Challenges in developing precise analytical techniques provide opportunities for service providers, while government initiatives encourage investment and innovation. These factors drive market expansion globally, alongside trends such as outsourcing due to pricing concerns and the development of innovative medicines. Expansion into new locations also boosts demand for specific tests, further driving the need for healthcare analytical testing services.
“Biohealthcare analytical testing services segment accounted for a substantial share of the healthcare analytical testing services market, by type in 2023.”
The Biohealthcare analytical testing services segment is expected to account for the largest share of 37.1% of the global Healthcare analytical testing services Market in 2023. It is projected to grow at the highest CAGR of 10.7% during the forecast period. The healthcare analytical testing services market is segmented by type into various categories, including bioanalytical testing, physical characterization, method development and validation, stability testing, batch-release testing, raw material testing, microbial testing, genomic services, and environmental monitoring services. In 2023, the biohealthcare analytical testing services segment stood out as the largest, primarily due to its comprehensive offerings tailored to different drug types like vaccines, small molecules, and biologics. This extensive range of services meets the diverse requirements of pharmaceutical and biopharmaceutical companies, thereby driving the segment's substantial market share.
“The cell-based assays segment accounted for the largest share in the healthcare analytical testing services market”
Based on bioanalytical service types type, the market encompasses cell-based assays, virology testing, biomarker testing, immunogenicity and neutralizing antibody testing, pharmacokinetic testing, and other biohealthcare analytical testing services. In 2023, the cell-based assays segment emerged as the market leader. This dominance is attributed to the growing preference for cell-based assays in high-throughput screening, as they offer pertinent in vivo biological insights compared to biochemical assays. This advantage accelerates the drug discovery process, thus contributing to the segment's prominence.
“North America to witness the substantial growth rate during the forecast period.”
North America commands the largest share in the healthcare analytical testing services market, outstripping other regions such as Europe, Asia Pacific, Latin America, and the Middle East & Africa. This dominance is primarily fueled by the burgeoning number of biopharmaceutical and pharmaceutical companies based in the United States. Moreover, the US market benefits from the strong foothold of well-established players, which further propels the market's growth trajectory. The region's advanced infrastructure, supportive regulatory environment, and emphasis on research and development also contribute significantly to its leadership position in the global healthcare analytical testing services market.
The break-down of primary participants is as mentioned below:
• By Company Type - Tier 1: 45%, Tier 2: 30%, and Tier 3: 25%
• By Designation - C-level: 42%, Director-level: 31%, and Others: 27%
• By Region - North America: 32%, Europe: 32%, Asia Pacific: 26%, ROW-10%
Key Players in the Healthcare analytical testing services Market
The prominent players in the global healthcare analytical testing services market include Eurofins Scientific (Luxembourg), Laboratory Corporation of America Holdings (US), SGS S.A. (Switzerland), Medpace Holdings, Inc. (US), LGC Limited (Cinven) (UK), Parexel International Corporation (US), Celerion (US). Pharmaron (China), BioAgilytix Labs (US), Charles River Laboratories (US), WuXi AppTec Co. Ltd. (China), Element Materials Technology (UK), Thermo Fisher Scientific, Inc. (US), Pace Analytical Services LLC (US), Intertek Group plc (UK), IQVIA Inc. (US), Merck KGaA (Germany), Source BioScience (UK), Almac Group (UK), ICON Plc (Ireland), Frontage Laboratories, Inc. (US), STERIS Plc (US), Sartorius AG (Germany), ALS Life Science (US), and Syneos Health, INC (US).
Research Coverage:
The report analyzes the Healthcare analytical testing services Market and aims to estimate the market size and future growth potential of various market segments, based on type, end user, and region. The report also provides a competitive analysis of the key players operating in this market, along with their company profiles, product offerings, recent developments, and key market strategies.
Reasons to Buy the Report
This report will enrich established firms as well as new entrants/smaller firms to gauge the pulse of the market, which, in turn, would help them garner a greater share of the market. Firms purchasing the report could use one or a combination of the below-mentioned strategies to strengthen their positions in the market.
This report provides insights on:
Analysis of Market Dynamics (Stringent regulatory landscape, growing focus on analytical testing of bilogics and biomilars, rising investments in pharma and biopharma R & D), restraints (Increasing Preassure on market players due to rising cost and market competition), opportunities (Adoption of new technologies, supporting government initiatives), and challenges (increasing need for improvement of sentsitivity of bioanalytical methods)
Services/Innovations: Detailed insights on upcoming technologies, research & development activities, and new service launches in the Healthcare analytical testing services market.
Market Development: Comprehensive information on the lucrative emerging markets, component, demographics , end-user, and region.
Market Diversification: Exhaustive information about the product portfolios, growing geographies, recent developments, and investments in the healthcare analytical testing services market
Competitive Assessment: In-depth assessment of market shares, growth strategies, product offerings, and capabilities of the leading players in the healthcare analytical testing services market like Eurofins Scientific (Luxembourg), Laboratory Corporation of America Holdings (US), SGS S.A. (Switzerland), Charles River Laboratories (US), WuXi AppTec Co. Ltd. (China), Element Materials Technology (UK) among others.
Table of Contents
1 INTRODUCTION 50
1.1 STUDY OBJECTIVES 50
1.2 MARKET DEFINITION 50
1.2.1 INCLUSIONS & EXCLUSIONS 51
1.2.2 MARKET SEGMENTATION 52
1.2.3 REGIONS COVERED 53
1.2.4 YEARS CONSIDERED 53
1.3 CURRENCY CONSIDERED 54
1.4 LIMITATIONS 54
1.4.1 METHODOLOGY-RELATED LIMITATIONS 54
1.4.2 SCOPE-RELATED LIMITATIONS 54
1.5 STAKEHOLDERS 54
1.6 SUMMARY OF CHANGES 55
2 RESEARCH METHODOLOGY 56
2.1 RESEARCH DATA 56
2.2 RESEARCH METHODOLOGY DESIGN 56
2.2.1 SECONDARY RESEARCH 57
- 2.2.1.1 Key data from secondary sources 58
2.2.2 PRIMARY DATA 58
- 2.2.2.1 Key data from primary sources 60
- 2.2.2.2 Insights from primary experts 60
2.3 MARKET SIZE ESTIMATION METHODOLOGY 62
2.4 DATA TRIANGULATION PROCEDURE 67
2.5 MARKET SHARE ESTIMATION 68
2.6 STUDY ASSUMPTIONS 68
2.7 RISK ASSESSMENT 68
2.8 RECESSION IMPACT ANALYSIS 69
3 EXECUTIVE SUMMARY 70
4 PREMIUM INSIGHTS 75
4.1 HEALTHCARE ANALYTICAL TESTING SERVICES MARKET OVERVIEW 75
4.2 EUROPE: HEALTHCARE ANALYTICAL TESTING SERVICES MARKET, BY TYPE AND COUNTRY (2023) 76
4.3 HEALTHCARE ANALYTICAL TESTING SERVICES MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES 77
4.4 REGIONAL MIX: HEALTHCARE ANALYTICAL TESTING SERVICES MARKET (2022-2029) 78
4.5 HEALTHCARE ANALYTICAL TESTING SERVICES MARKET: DEVELOPED VS. EMERGING ECONOMIES (2024 VS. 2029) 79
5 MARKET OVERVIEW 80
5.1 INTRODUCTION 80
5.2 MARKET DYNAMICS 80
5.2.1 DRIVERS 81
- 5.2.1.1 Stringent regulatory guidelines 81
- 5.2.1.2 Growing focus on analytical testing of biologics & biosimilars 82
- 5.2.1.3 Increasing outsourcing of analytical testing by pharmaceutical & medical device companies 82
- 5.2.1.4 Increasing number of clinical trials 83
- 5.2.1.5 Growing R&D expenditure in pharmaceutical & biopharmaceutical industry 84
- 5.2.1.6 Rising acceptance of quality-by-design approach in pharmaceutical research & manufacturing 85
5.2.2 RESTRAINTS 86
- 5.2.2.1 Increasing pressure on market players due to rising costs and market competition 86
5.2.3 OPPORTUNITIES 87
- 5.2.3.1 Adoption of new techniques and technologies 87
- 5.2.3.2 Growing focus on emerging economies 87
5.2.4 CHALLENGES 88
- 5.2.4.1 Shortage of skilled professionals 88
- 5.2.4.2 Specific requirements for innovative formulations and medical devices 89
- 5.2.4.3 Need to improve sensitivity of bioanalytical methods 89
5.3 ECOSYSTEM ANALYSIS 90
5.4 VALUE CHAIN ANALYSIS 91
5.5 CASE STUDY ANALYSIS 92
5.5.1 UNLOCKING BIOPHARMACEUTICAL DEVELOPMENT POTENTIAL THROUGH OUTSOURCING ANALYTICAL TESTING 92
5.5.2 REVOLUTIONIZING PHARMACEUTICAL TESTING: A CASE STUDY IN ANALYTICAL TESTING EVOLUTION 92
5.6 PORTER’S FIVE FORCES ANALYSIS 92
5.6.1 THREAT OF NEW ENTRANTS 93
5.6.2 BARGAINING POWER OF SUPPLIERS 93
5.6.3 INTENSITY OF COMPETITIVE RIVALRY 94
5.6.4 BARGAINING POWER OF BUYERS 94
5.6.5 THREAT OF SUBSTITUTES 94
5.7 REGULATORY LANDSCAPE 95
5.7.1 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 95
5.7.2 REGULATORY ANALYSIS 96
5.7.3 NORTH AMERICA 98
5.7.4 EUROPE 99
5.7.5 ASIA PACIFIC 100
5.8 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES 100
5.9 KEY CONFERENCES & EVENTS, 2024-2025 101
5.10 INVESTMENT AND FUNDING SCENARIO 102
5.11 KEY STAKEHOLDERS & BUYING CRITERIA 103
5.11.1 KEY STAKEHOLDERS IN BUYING PROCESS 103
5.11.2 BUYING CRITERIA 104
6 HEALTHCARE ANALYTICAL TESTING SERVICES MARKET, BY TYPE 106
6.1 INTRODUCTION 107
6.2 BIOANALYTICAL TESTING 107
6.2.1 PHARMACOKINETIC & TOXICOKINETIC TESTING 109
- 6.2.1.1 Increasing number of clinical trials for drug development to propel growth 109
6.2.2 IMMUNOGENICITY & NEUTRALIZING ANTIBODY TESTING 110
- 6.2.2.1 Increasing requirement for drug safety approvals to support market growth 110
6.2.3 BIOMARKER TESTING 111
- 6.2.3.1 Rising need for specialized drug development to drive market 111
6.2.4 BIOASSAY TESTING 112
- 6.2.4.1 Growing adoption of high-content screening for cytotoxicity testing to fuel growth 112
6.2.5 OTHER BIOANALYTICAL TESTING SERVICES 113
6.3 PHYSICAL CHARACTERIZATION 114
6.3.1 LASER PARTICLE SIZE ANALYSIS 116
- 6.3.1.1 Growing importance of particle size analysis in manufacturing pharmaceutical dosage forms to drive market 116
6.3.2 THERMAL ANALYSIS 117
- 6.3.2.1 Advancements in thermal analysis techniques to support growth 117
6.3.3 OPTICAL CHARACTERIZATION 117
- 6.3.3.1 Growing complexity of biological structures to contribute to growth 117
6.3.4 SURFACE AREA ANALYSIS 118
- 6.3.4.1 Growing need for surface analysis to streamline drug development processes to fuel growth 118
6.3.5 OTHER PHYSICAL CHARACTERIZATION SERVICES 119
6.4 METHOD DEVELOPMENT & VALIDATION 120
6.4.1 EXTRACTABLES/LEACHABLES METHOD DEVELOPMENT & VALIDATION 122
- 6.4.1.1 Growing development of parenterally administered drugs and biologic products to drive market 122
6.4.2 PROCESS IMPURITY METHOD DEVELOPMENT & VALIDATION 123
- 6.4.2.1 Rising emphasis on impurity testing to boost market 123
6.4.3 STABILITY-INDICATING METHOD VALIDATION 124
- 6.4.3.1 Need to ensure safety and efficacy of therapeutic drugs to spur growth 124
6.4.4 CLEANING VALIDATION & METHOD DEVELOPMENT 124
- 6.4.4.1 Growing needs to evaluate cleaning practices and ensure complete decontamination to fuel growth 124
6.4.5 ANALYTICAL STANDARD CHARACTERIZATION 125
- 6.4.5.1 Growing importance of analytical standard characterization in drug development to support market 125
6.4.6 TECHNICAL CONSULTING 126
- 6.4.6.1 Need for regulatory approvals for drug development to drive market 126
6.4.7 OTHER METHOD DEVELOPMENT & VALIDATION SERVICES 127
6.5 RAW MATERIAL TESTING 128
6.5.1 COMPLETE COMPENDIAL TESTING 129
- 6.5.1.1 Need to determine efficacy and safety of therapeutic products to drive growth 129
6.5.2 CONTAINER TESTING 130
- 6.5.2.1 Need to optimize sealing and evaluate temperature impact to fuel growth 130
6.5.3 HEAVY METAL TESTING 131
- 6.5.3.1 Implementation of various techniques and technologies for heavy metal testing to aid growth 131
6.5.4 WATER CONTENT ANALYSIS 132
- 6.5.4.1 Need to check for water content in pharmaceutical products to support growth 132
6.5.5 OTHER RAW MATERIAL TESTING SERVICES 133
6.6 BATCH-RELEASE TESTING SERVICES 134
6.6.1 DISSOLUTION TESTING 135
- 6.6.1.1 Wide usage of dissolution testing in formulation development and manufacturing to drive growth 135
6.6.2 ELEMENTAL IMPURITY TESTING 136
- 6.6.2.1 Need to minimize cost of in-house analysis and labor to fuel growth 136
6.6.3 DISINTEGRATION TESTING 137
- 6.6.3.1 Need to ensure batch-to-batch consistency of pharmaceutical dosage forms to promote growth 137
6.6.4 HARDNESS TESTING 139
- 6.6.4.1 Need to assess manufacturability and compactness of pharmaceutical formulations to ensure growth 139
6.6.5 FRIABILITY TESTING 140
- 6.6.5.1 Need to measure resistance of tablets and granules to abrasion or fracture to support market 140
6.6.6 OTHER BATCH-RELEASE TESTING SERVICES 140
6.7 STABILITY TESTING 141
6.7.1 DRUG SUBSTANCE STABILITY TESTING 142
- 6.7.1.1 Regulatory requirements for drug approval to drive market 142
6.7.2 FORMULATION EVALUATION STABILITY TESTING 143
- 6.7.2.1 Need to analyze and predict shelf life of products to drive demand 143
6.7.3 ACCELERATED STABILITY TESTING 144
- 6.7.3.1 Growing use of accelerated stability testing to determine shelf life of pharmaceutical products to fuel growth 144
6.7.4 PHOTOSTABILITY TESTING 145
- 6.7.4.1 Need for robust photostability testing process to ensure product quality and safety to drive adoption 145
6.7.5 FORCED DEGRADATION TESTING 146
- 6.7.5.1 Regulatory requirements and need for comprehensive stability testing in pharmaceutical industry to boost market 146
6.7.6 OTHER STABILITY TESTING SERVICES 147
6.8 MICROBIAL TESTING 148
6.8.1 MICROBIAL LIMIT TESTING 149
- 6.8.1.1 Need to determine whether products comply with compendial specifications for microbial quality to boost adoption 149
6.8.2 VIROLOGY TESTING 150
- 6.8.2.1 Increasing outbreaks of viral diseases to drive market 150
6.8.3 STERILITY TESTING 151
- 6.8.3.1 Rising development of parenteral preparations and immunological products to drive market 151
6.8.4 ENDOTOXIN TESTING 152
- 6.8.4.1 Need to standardize procedures and follow regulatory guidelines to support demand 152
6.8.5 PRESERVATIVE EFFICACY TESTING 153
- 6.8.5.1 Need to ensure product safety for product approval to support growth 153
6.8.6 OTHER MICROBIAL TESTING SERVICES 154
6.9 GENOMIC TESTING SERVICES 155
6.9.1 NEED TO GAIN INSIGHTS INTO DISEASE MECHANISMS AND TREATMENT RESPONSES TO BOOST MARKET 155
6.10 OTHER ANALYTICAL TESTING SERVICES 156
7 HEALTHCARE ANALYTICAL TESTING SERVICES MARKET, BY END USER 157
7.1 INTRODUCTION 158
7.2 PHARMACEUTICAL COMPANIES 158
7.2.1 INCREASED OUTSOURCING OF R&D ACTIVITIES TO DRIVE MARKET GROWTH 158
7.3 BIOPHARMACEUTICAL COMPANIES 160
7.3.1 GROWING INVESTMENTS IN BIOPHARMACEUTICAL COMPANIES TO BOOST MARKET GROWTH 160
7.4 MEDICAL DEVICE COMPANIES 161
7.4.1 STRICT APPROVAL NORMS FOR MEDICAL DEVICES TO SUPPORT GROWTH 161
7.5 HOSPITALS & CLINICS 162
7.5.1 GROWING PREVALENCE OF CHRONIC DISEASES TO FAVOR MARKET GROWTH 162
7.6 FORENSIC LABS 163
7.6.1 GROWING USE OF ANALYTICAL TESTING IN FORENSIC LABS TO BOOST MARKET GROWTH 163
7.7 COSMETIC & NUTRACEUTICAL COMPANIES 164
7.7.1 STRINGENT GUIDELINES FOR QUALITY CONTROL TO DRIVE MARKET 164
8 HEALTHCARE ANALYTICAL TESTING MARKET, BY REGION 166
8.1 INTRODUCTION 167
8.2 NORTH AMERICA 168
8.2.1 NORTH AMERICA: RECESSION IMPACT 168
8.2.2 US 175
- 8.2.2.1 High number of pre-registration drugs in pipeline to drive market 175
8.2.3 CANADA 180
- 8.2.3.1 Presence of well-established CROs to support market growth 180
8.3 EUROPE 185
8.3.1 EUROPE: RECESSION IMPACT 185
8.3.2 GERMANY 191
- 8.3.2.1 Government support and flexible labor laws make Germany favorable location for clinical trials 191
8.3.3 FRANCE 196
- 8.3.3.1 Favorable government regulations to drive market 196
8.3.4 UK 201
- 8.3.4.1 Investments by pharmaceutical sponsors for drug discovery services to support growth 201
8.3.5 ITALY 205
- 8.3.5.1 Low drug approval time to support market growth 205
8.3.6 SWITZERLAND 210
- 8.3.6.1 Large and growing pharma production volume to drive demand for analytical testing services 210
8.3.7 SPAIN 214
- 8.3.7.1 Rising R&D expenditure to boost growth 214
8.3.8 REST OF EUROPE 219
8.4 ASIA PACIFIC 224
8.4.1 ASIA PACIFIC: RECESSION IMPACT 224
8.4.2 CHINA 231
- 8.4.2.1 Low manufacturing cost of medicines to drive demand 231
8.4.3 JAPAN 235
- 8.4.3.1 Rising geriatric population to support market growth 235
8.4.4 INDIA 240
- 8.4.4.1 Increasing number of clinical trials to drive market 240
8.4.5 AUSTRALIA 245
- 8.4.5.1 Large number of research institutes make Australia favorable location for drug discovery 245
8.4.6 SOUTH KOREA 249
- 8.4.6.1 Growth in clinical trial activities to propel market 249
8.4.7 REST OF ASIA PACIFIC 254
8.5 LATIN AMERICA 259
8.5.1 LATIN AMERICA: RECESSION IMPACT 259
8.5.2 BRAZIL 265
- 8.5.2.1 Rising adoption of emerging medical technologies to drive market 265
8.5.3 MEXICO 270
- 8.5.3.1 Government initiatives and robust supply to drive market 270
8.5.4 REST OF LATIN AMERICA 275
8.6 MIDDLE EAST & AFRICA 279
8.6.1 MIDDLE EAST & AFRICA: RECESSION IMPACT 280
8.6.2 GCC 285
- 8.6.2.1 Supportive government initiatives to aid market growth 285
8.6.3 REST OF MIDDLE EAST & AFRICA 290
9 COMPETITIVE LANDSCAPE 295
9.1 INTRODUCTION 295
9.2 RIGHT-TO-WIN APPROACHES ADOPTED BY KEY PLAYERS 296
9.3 REVENUE SHARE ANALYSIS 297
9.4 MARKET SHARE ANALYSIS 298
9.5 COMPANY EVALUATION MATRIX: KEY PLAYERS 299
9.5.1 STARS 300
9.5.2 PERVASIVE PLAYERS 300
9.5.3 EMERGING LEADERS 300
9.5.4 PARTICIPANTS 300
9.5.5 COMPANY FOOTPRINT 302
- 9.5.5.1 Overall footprint 302
- 9.5.5.2 Service footprint 303
- 9.5.5.3 End-user footprint 304
- 9.5.5.4 Regional footprint 305
9.6 COMPANY EVALUATION MATRIX: START-UPS/SMES 306
9.6.1 PROGRESSIVE COMPANIES 306
9.6.2 DYNAMIC COMPANIES 306
9.6.3 RESPONSIVE COMPANIES 306
9.6.4 STARTING BLOCKS 306
9.6.5 COMPETITIVE BENCHMARKING 308
9.7 VALUATION AND FINANCIAL METRICS OF HEALTHCARE ANALYTICAL TESTING SERVICE VENDORS 310
9.8 BRAND/PRODUCT COMPARATIVE ANALYSIS 311
9.8.1 EUROFINS SCIENTIFIC 312
9.8.2 WUXI APPTEC 312
9.8.3 CHARLES RIVER LABORATORIES 312
9.8.4 SGS S.A 312
9.8.5 LABORATORY CORPORATION OF AMERICA HOLDINGS 313
9.9 COMPETITIVE SCENARIO 313
9.9.1 SERVICE LAUNCHES 313
9.9.2 DEALS 314
10 COMPANY PROFILES 318
10.1 KEY PLAYERS 318
10.1.1 EUROFINS SCIENTIFIC 318
10.1.2 LABORATORY CORPORATION OF AMERICA HOLDINGS 323
10.1.3 WUXI APPTEC 327
10.1.4 CHARLES RIVER LABORATORIES 332
10.1.5 SGS S.A 338
10.1.6 THERMO FISHER SCIENTIFIC INC 344
10.1.7 MEDPACE, INC 348
10.1.8 SARTORIUS AG 350
10.1.9 INTERTEK GROUP PLC 353
10.1.10 MERCK KGAA 358
10.1.11 SOURCE BIOSCIENCE 363
10.1.12 ICON PLC 366
10.1.13 ALS 369
10.1.14 FRONTAGE LABORATORIES, INC 372
10.1.15 STERIS 377
10.1.16 IQVIA INC 380
10.1.17 ELEMENT MATERIALS TECHNOLOGY 383
10.1.18 PACE ANALYTICAL SERVICES 386
10.1.19 ALMAC GROUP 391
10.1.20 PHARMARON 393
10.2 OTHER PLAYERS 395
10.2.1 SYNEOS HEALTH 395
10.2.2 PAREXEL INTERNATIONAL (MA) CORPORATION 396
10.2.3 LGC LIMITED 397
10.2.4 CELERION 398
10.2.5 BIOAGILYTIX 399
11 APPENDIX 400
11.1 DISCUSSION GUIDE 400
11.2 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 405
11.3 CUSTOMIZATION OPTIONS 407
11.4 RELATED REPORTS 407
11.5 AUTHOR DETAILS 408