세계의 헬스케어 분석 시험 서비스 시장 : 서비스 유형별, 샘플 유형별, 최종사용자별, 지역별, 기회 및 예측(2018-2032년)

Global healthcare analytical testing services market is projected to witness a CAGR of 10.17% during the forecast period 2025-2032, growing from USD 8.37 billion in 2024 to USD 18.16 billion in 2032. The market's growth can be attributed to the increasing number of clinical trials, rising emphasis on biosimilars, and increasing manufacturing outsourcing by pharmaceutical companies. Meanwhile, the market's demand is also increasing due to the growing requirement for innovative and novel therapeutic solutions, including gene therapies. According to the American Society of Gene and Cell Therapy, 32 gene therapies and 28 RNA therapies have been approved as of April 2024. Thus, bolstering the requirement for analytical testing services as they play a crucial role in characterizing gene therapy products, including assessing their potency, purity, and stability. Thus, ensuring their compliance with stringent regulatory standards and accelerating the approval processes.

Healthcare analytical testing services ensure the safety and efficacy of medical and pharmaceutical products and are an essential aspect of the drug development and manufacturing processes. Rising regulatory stringency, increasing outsourcing of research and development and manufacturing activities by leading pharmaceutical companies, and the rising requirement for consistent quality assurance and control for healthcare and pharmaceutical products are further driving the growth of the market.

Increasing Pharmaceutical Outsourcing Boosts Market Demand

Pharmaceutical and biopharmaceutical companies are increasingly seeking contract research organizations (CROs) to comply with regulatory requirements and minimize internal costs. This increased reliance can also be attributed to the rapid expansion of pharmaceutical industries across the globe. According to India Brand Equity Foundation (IBEF), India has the highest number of United States Food and Drug Administration (US FDA) compliant pharmaceutical plants outside the United States and over 2000 World Health Organization- Good Manufacturing Practices (WHO-GMP) approved facilities.

Additionally, regulatory bodies such as the US FDA are tightening their quality assurance frameworks, necessitating greater testing accuracy and documentation, thus encouraging pharmaceutical companies to partner with external laboratories that provide advanced analytical testing services. The increasing requirement of complex biologics, biosimilars, and personalized therapies is creating additional demand for sophisticated testing protocols that ensure patient safety and product consistency. Thus, outsourcing provides a strategic and economic alternative to pharmaceutical companies that are working on remaining compliant and competitive in the rapidly evolving pharmaceutical industry.

Rising Requirement for Biologics and Biosimilars Supports Market Expansion

Biologics, including monoclonal antibodies, cell and gene therapies, and recombinant proteins, require rigorous analytical characterization as they are sensitive to environmental conditions due to their complex structure. Analytical testing of these products includes structural elucidation, potency assays, impurity profiling, and stability assessment. The rising prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes are also propelling the requirement for biologics. The American Cancer Society estimates that approximately 2,041,910 new cancer cases will be reported in the United States in 2025. This increase is thus creating the demand for constant quality assurance. Regulatory agencies are mandating extensive analytical data to provide approval to biologic and biosimilar products, resulting in the increased demand for specialized testing services that include chromatography, mass spectrometry, immunoassays, and cell-based assays.

Bioanalytical Testing Services Account for Significant Share of the Market

The growth of the segment can be attributed to its role in the evaluation of pharmacokinetics, pharmacodynamics, and bioequivalence studies during clinical trials. These testing services are essential for determining the absorption, distribution, metabolism, and excretion (ADME) profile of drugs, particularly for novel biosimilars, biologics, and specialty medications. Additionally, rising clinical trial volumes across phases I to IV, especially in oncology, and immunotherapy, are further increasing the demand for bioanalytical testing services. CROs and pharmaceutical companies are heavily investing in automation technologies and high-throughput platforms to meet this rising demand while ensuring regulatory compliance. Additionally, increasing acquisitions of various analytical service providers is also supporting the segment's growth. For instance, in December 2023, Sterling Accuris Wellness Private Limited acquired Vaibhav Analytical Services, an NABL-accredited laboratory that adheres to international standards and serves clients across India. The acquisition aligns with Sterling Accuris Diagnostics' commitment to advance healthcare through innovation and excellence in diagnostics and analytical testing services and allows the company to meet the growing demand for comprehensive testing solutions.

North America Holds Major Market Share

The market's growth in North America can be attributed to the strong presence of leading healthcare and pharmaceutical companies, rising requirement for high-end pharmaceuticals and medical devices to combat the growing threat of various diseases and disorders, and increasing need for regulated drug development processes to meet the safety standards. The growing number of ongoing clinical trials in the region are also positively influencing the market's growth. The demand for complete analytical testing services for biosimilars, vaccine development, and novel drug formulations has also increased in the region. Additionally, the leading service providers in the country are investing in expanding their analytical testing services. For instance, in March 2024, LGM Pharma LLC invested over USD 2 million in standalone analytical testing services (ATS) and expanded these services by 50% while adding suppository manufacturing capabilities to its contract development and manufacturing organization (CDMO) portfolio, at their facility in Texas, United States. The new suppository manufacturing capabilities address the growing demand for specialized drug delivery methods, particularly for geriatric, pediatric, and women's health needs. Such investments further supports the expansion of the market in North America.

Future Market Scenario (2025 - 2032F)

The market is expected to witness significant growth in the coming years as the demand for complex drug development, personalized medicine, and regulatory compliance increases. Increased investments in healthcare infrastructure by developing countries is expected to provide lucrative growth opportunities for the market. Meanwhile, Advances in automation, AI-integrated platforms, and high-throughput screening, among others, are aiding in improving the accuracy and efficiency of methodologies used in healthcare analytical testing.

The advent of cloud computing and big data analytics are expected to facilitate transformative changes in data management for healthcare analytical testing by allowing real-time analysis. Meanwhile, strategic mergers and acquisitions among contract research organizations (CROs), the entry of new players, and the expansion of service portfolios by various services providers are also expected to positively influence the market's expansion.

Key Players Landscape and Outlook

The key players of the market are focusing on strategic alliances and partnerships as they foster innovation, expand service portfolios, and enhance the ability of companies to meet regulatory requirements. By pooling resources and expertise, companies are also able to develop more precise and efficient analytical testing methods, which are crucial for ensuring the safety and efficacy of medical devices and pharmaceuticals.

For instance, in March 2024, Charles River Laboratories International, Inc. partnered with Wheeler Bio to combine their antibody discovery services with Wheeler's portable CMC platform to accelerate therapeutic discoveries. The strategic agreement offers a comprehensive solution that connects preclinical development, clinical manufacturing, and release testing processes. By incorporating CMC development early in the discovery phase, companies developing therapeutic solutions can leverage phase-appropriate manufacturing and analytics.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Healthcare Analytical Testing Services Market Outlook, 2018-2032F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Service Type
    • 4.2.1.1. Bioanalytical Testing Services
      • 4.2.1.1.1. Pharmacokinetics (PK)
      • 4.2.1.1.2. Pharmacodynamics (PD)
      • 4.2.1.1.3. Bioavailability (BA)
      • 4.2.1.1.4. Bioequivalence (BE)
      • 4.2.1.1.5. Bioassays
      • 4.2.1.1.6. Others
    • 4.2.1.2. Physical Characterization
      • 4.2.1.2.1. Particle Size Analysis
      • 4.2.1.2.2. Thermal Analysis
      • 4.2.1.2.3. Surface Area Analysis
      • 4.2.1.2.4. Others
    • 4.2.1.3. Stability Testing
    • 4.2.1.4. Raw Material Testing
    • 4.2.1.5. Microbial Testing
      • 4.2.1.5.1. Bioburden Testing
      • 4.2.1.5.2. Sterility Testing
      • 4.2.1.5.3. Endotoxin Testing
      • 4.2.1.5.4. Microbial Identification
      • 4.2.1.5.5. Others
    • 4.2.1.6. Environmental Monitoring
    • 4.2.1.7. Method Development and Validation
    • 4.2.1.8. Other Services
  • 4.2.2. By Sample Type
    • 4.2.2.1. Raw Material
    • 4.2.2.2. Finished Products
      • 4.2.2.2.1. Monoclonal Antibodies
      • 4.2.2.2.2. Vaccines
      • 4.2.2.2.3. Cell and Gene Therapy Products
  • 4.2.3. By End-user
    • 4.2.3.1. Pharmaceutical and Biotechnology Companies
    • 4.2.3.2. Medical Device Manufacturers
    • 4.2.3.3. Contract Research Organizations (CROs)
    • 4.2.3.4. Academic and Research Institutes
    • 4.2.3.5. Others
  • 4.2.4. By Region
    • 4.2.4.1. North America
    • 4.2.4.2. Europe
    • 4.2.4.3. Asia-Pacific
    • 4.2.4.4. South America
    • 4.2.4.5. Middle East and Africa
  • 4.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 4.3. Market Map Analysis, 2024
  • 4.3.1. By Service Type
  • 4.3.2. By Sample Type
  • 4.3.3. By End-user
  • 4.3.4. By Region

5. North America Healthcare Analytical Testing Services Market Outlook, 2018-2032F

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Service Type
    • 5.2.1.1. Bioanalytical Testing Services
      • 5.2.1.1.1. Pharmacokinetics (PK)
      • 5.2.1.1.2. Pharmacodynamics (PD)
      • 5.2.1.1.3. Bioavailability (BA)
      • 5.2.1.1.4. Bioequivalence (BE)
      • 5.2.1.1.5. Bioassays
      • 5.2.1.1.6. Others
    • 5.2.1.2. Physical Characterization
      • 5.2.1.2.1. Particle Size Analysis
      • 5.2.1.2.2. Thermal Analysis
      • 5.2.1.2.3. Surface Area Analysis
      • 5.2.1.2.4. Others
    • 5.2.1.3. Stability Testing
    • 5.2.1.4. Raw Material Testing
    • 5.2.1.5. Microbial Testing
      • 5.2.1.5.1. Bioburden Testing
      • 5.2.1.5.2. Sterility Testing
      • 5.2.1.5.3. Endotoxin Testing
      • 5.2.1.5.4. Microbial Identification
      • 5.2.1.5.5. Others
    • 5.2.1.6. Environmental Monitoring
    • 5.2.1.7. Method Development and Validation
    • 5.2.1.8. Other Services
  • 5.2.2. By Sample Type
    • 5.2.2.1. Raw Material
    • 5.2.2.2. Finished Products
      • 5.2.2.2.1. Monoclonal Antibodies
      • 5.2.2.2.2. Vaccines
      • 5.2.2.2.3. Cell and Gene Therapy Products
  • 5.2.3. By End-user
    • 5.2.3.1. Pharmaceutical and Biotechnology Companies
    • 5.2.3.2. Medical Device Manufacturers
    • 5.2.3.3. Contract Research Organizations (CROs)
    • 5.2.3.4. Academic and Research Institutes
    • 5.2.3.5. Others
  • 5.2.4. By Country Share
    • 5.2.4.1. United States
    • 5.2.4.2. Canada
    • 5.2.4.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States Healthcare Analytical Testing Services Market Outlook, 2018-2032F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Service Type
        • 5.3.1.2.1.1. Bioanalytical Testing Services
        • 5.3.1.2.1.1.1. Pharmacokinetics (PK)
        • 5.3.1.2.1.1.2. Pharmacodynamics (PD)
        • 5.3.1.2.1.1.3. Bioavailability (BA)
        • 5.3.1.2.1.1.4. Bioequivalence (BE)
        • 5.3.1.2.1.1.5. Bioassays
        • 5.3.1.2.1.1.6. Others
        • 5.3.1.2.1.2. Physical Characterization
        • 5.3.1.2.1.2.1. Particle Size Analysis
        • 5.3.1.2.1.2.2. Thermal Analysis
        • 5.3.1.2.1.2.3. Surface Area Analysis
        • 5.3.1.2.1.2.4. Others
        • 5.3.1.2.1.3. Stability Testing
        • 5.3.1.2.1.4. Raw Material Testing
        • 5.3.1.2.1.5. Microbial Testing
        • 5.3.1.2.1.5.1. Bioburden Testing
        • 5.3.1.2.1.5.2. Sterility Testing
        • 5.3.1.2.1.5.3. Endotoxin Testing
        • 5.3.1.2.1.5.4. Microbial Identification
        • 5.3.1.2.1.5.5. Others
        • 5.3.1.2.1.6. Environmental Monitoring
        • 5.3.1.2.1.7. Method Development and Validation
        • 5.3.1.2.1.8. Other Services
      • 5.3.1.2.2. By Sample Type
        • 5.3.1.2.2.1. Raw Material
        • 5.3.1.2.2.2. Finished Products
        • 5.3.1.2.2.2.1. Monoclonal Antibodies
        • 5.3.1.2.2.2.2. Vaccines
        • 5.3.1.2.2.2.3. Cell and Gene Therapy Products
      • 5.3.1.2.3. By End-user
        • 5.3.1.2.3.1. Pharmaceutical and Biotechnology Companies
        • 5.3.1.2.3.2. Medical Device Manufacturers
        • 5.3.1.2.3.3. Contract Research Organizations (CROs)
        • 5.3.1.2.3.4. Academic and Research Institutes
        • 5.3.1.2.3.5. Others
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Healthcare Analytical Testing Services Market Outlook, 2018-2032F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Turkey
• 6.9. Poland

7. Asia-Pacific Healthcare Analytical Testing Services Market Outlook, 2018-2032F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America Healthcare Analytical Testing Services Market Outlook, 2018-2032F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa Healthcare Analytical Testing Services Market Outlook, 2018-2032F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa

10. Demand Supply Analysis

11. Porter's Five Forces Analysis

12. PESTLE Analysis

13. Pricing Analysis

14. Market Dynamics

• 14.1. Market Drivers
• 14.2. Market Challenges

15. Market Trends and Developments

16. Case Studies

17. Competitive Landscape

• 17.1. Competition Matrix of Top 5 Market Leaders
• 17.2. SWOT Analysis for Top 5 Players
• 17.3. Key Players Landscape for Top 10 Market Players
  • 17.3.1. Thermo Fisher Scientific, Inc.
    • 17.3.1.1. Company Details
    • 17.3.1.2. Key Management Personnel
    • 17.3.1.3. Products and Services
    • 17.3.1.4. Financials (As Reported)
    • 17.3.1.5. Key Market Focus and Geographical Presence
    • 17.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 17.3.2. Charles River Laboratories International, Inc.
  • 17.3.3. Eurofins Scientific SE
  • 17.3.4. Labcorp Holdings Inc.
  • 17.3.5. ICON plc
  • 17.3.6. WuXi AppTec Co., Ltd.
  • 17.3.7. Medpace Holdings, Inc.
  • 17.3.8. Intertek Group plc
  • 17.3.9. SGS SA
  • 17.3.10. Toxikon, Inc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

18. Strategic Recommendations

19. About Us and Disclaimer