바이오 분석 검사 서비스 시장 평가 : 검사 유형별, 분자별, 용도별, 최종사용자별, 지역별 기회 및 예측(2018-2032년)

Global bioanalytical testing services market is projected to witness a CAGR of 10.69% during the forecast period 2025-2032, growing from USD 4.04 billion in 2024 to USD 9.10 billion in 2032. Growing R&D expenditure, rise in clinical trials, and demand for biologics and biosimilars augment the market's growth for bioanalytical testing services. This drives the demand for specialty testing services and enhances the trend of outsourcing; therefore, it improves technological advancement, which can collectively generate a strong market growth environment in the following years.

The rising cases of chronic diseases like diabetes, cancer, and cardiovascular disorders fuel the requirement for bioanalytical testing services. As per WHO, non-communicable diseases account for 74% of all global deaths annually. This increased burden demands a requirement for advanced drug development and precision medicine, wherein bioanalytical testing would be of immense importance. Such services provide proper and accurate therapeutic efficacy and safety assessment, thereby contributing to innovation in pharmaceuticals and regulatory compliance that satisfies increased healthcare demands around the globe.

Furthermore, CROs are expanding their global reach by opening state-of-the-art bioanalytical labs and strategic partnerships. These activities enhance the services offered, streamline drug development processes, and ensure that these services comply with regional regulations. This focused expansion unlocks new growth opportunities as the demand for localized and specialized bioanalytical testing increases. In August 2024, BioAgilytix Labs, LLC, recently opened the expanded 360biolabs laboratory in Melbourne, Australia. This cutting-edge facility provides a broad range of bioanalytical services such as LC-MS/MS, molecular testing, biomarker analysis, flow cytometry, large molecule PK and immunogenicity, virology, and central lab services, all performed in a quality-assured environment. This expansion supports global pharmaceutical and biotech clients, driving significant growth opportunities in the market.

Increasing R&D Expenditure Boosts Market Demand

Increasing R&D spending is also propelling the demand for bioanalytical testing in the market. As pharmaceutical companies invest more in R&D, clinical trials and drug development are rising, demanding more comprehensive bioanalytical testing services. Furthermore, pharmaceuticals' improvement and acceleration of R&D manufacturing units to enhance efficiency and make drug development more streamlined involves implementing advanced technologies and automation, for which specialized bioanalytical testing is required to ensure quality and safety. This concern about biologics and biosimilars also leads to more compatibility studies, stability testing, and protein analysis, further driving the bioanalytical testing market. In November 2024, AstraZeneca PLC made a USD 3.5 billion investment to accelerate R&D and manufacturing in the U.S. This expansion includes a new R&D center in Massachusetts and a next-gen biologics facility in Maryland. These improvements boost the development of leading-edge therapies and drive considerable growth opportunities in the market. With higher R&D investment comes greater demand for all-inclusive bioanalytical services for new pharmaceutical development and approval.

Rising Number of Clinical Trials Support Market Expansion

The rise in clinical trials has greatly propelled the growth of the bioanalytical testing services market. The volume of biological samples is increasing, and the complexity of the trials involving biologics and personalized medicines require advanced bioanalytical methods because of their tailored treatment approaches and complex molecular structures. Therefore, the demand for bioanalytical testing increases. Moreover, outsourcing bioanalytical testing, which focuses on biopharmaceuticals, including gene therapies and biosimilars, strengthens the market by improving efficiency and boosting investment in advanced technologies by pharmaceutical companies. Additionally, various collaborations ensure comprehensive clinical trial services in several companies to ease all drug development processes. All these collaborations positively influence the market through data accuracy, regulation compliance, and acceleration of new pharmaceutical approvals for its growth. In March 2024, EPNextS, Inc. and Frontage Laboratories, Inc. collaborated to improve early-phase clinical trials in Japan. This collaboration is meant to overcome the delay in drug availability due to strict regulations and complicated procedures. Combining their expertise, they are trying to streamline drug development and enhance market growth opportunities through improved access to innovative therapies.

Pharmaceuticals and Biopharmaceutical Companies Account for Significant Share of the Market

The pharmaceutical and biopharmaceutical firms are the most prominent end-users in this market for bioanalytical testing services, focusing on developing drugs and, hence, for severe stringent regulations. Such companies rely on bioanalytical testing for early-phase development, pharmacokinetics, and clinical laboratory testing. This has been one of the significant growth drivers for outsourcing such activities for cost savings and high-end expertise. Demand for personalized medicine and biologics is continuously growing and will continue to drive this trend. This trend further followed the increasing demand for personalized medicine and biologics.

Many biopharma and biotechnology companies have extended their partnership with CROs for bioanalytical services, which has accelerated biological drug development. This recent surge in outsourcing reflects the strategic shift to streamline operations and meets the rising demand for innovative therapies. For instance, in May 2024, BioAgilytix Labs, LLC, and BBI Solutions OEM Limited partnered to streamline bioanalytical testing. This partnership aligns reagent development with assay creation, making testing easier for pharma and biopharma sponsors. This streamlined approach accelerates the market entry of innovative therapies.

North America Holds Major Market Share

North America dominates the bioanalytical testing services market because of innovation and strong infrastructure. The region has well-established and developed facilities. In particular, the United States has many pharmaceutical and biotechnology companies, which creates a high demand for bioanalytical testing services. Also, strict FDA regulations in the region ensure that pharmaceutical companies maintain high-quality testing standards, which demand bioanalytical testing services. Thus, major companies are expanding their testing service portfolios to meet the increasing demand. In August 2024, SGS Societe Generale de Surveillance SA launched its new bioanalytical testing services in North America with the help of Agilex Biolabs Pty Ltd. This expansion provides more extensive, high-quality testing solutions and enhances market growth through comprehensive support for clinical trials and drug development.

Moreover, the growing need for advanced testing methods, such as immunoassays and electrophoresis, will further drive the market growth in the region. The region's strength is further emphasized due to its significant R&D investment and focus on new and innovative biopharmaceutical drug development, which enables it to set the pace of excellence in bioanalytical testing.

Future Market Scenario (2025-2032F)

The bioanalytical testing services market is anticipated to grow with the rise of R&D expenditure, biopharmaceutical industry expansion, technological advancements, severe regulatory compliance, and outsourcing trends that increase demand during the forecast period.

Strategic collaborations between pharmaceutical companies and CROs will expand the scope of high-end bioanalytical testing solutions to address varied pharmaceutical and biopharma requirements and present new growth opportunities. For example, in October 2024, Synexa Life Sciences BV enhanced its bio-analysis capabilities by acquiring Alderley Analytical Ltd. The acquisition strengthens Synexa's growth strategy and enhances its biomarker and bioanalytical assay capability, including DNA, RNA, protein, cell, and tissue analysis.

Additionally, key players are expanding their services to invest more in the advancements that support market expansion. In September 2024, Laboratory Corporation of America Holdings expanded its molecular bioanalytical laboratory in Indiana. The expansion enhanced LabCorp's global capacity to deliver advanced therapies more quickly to patients. Expanding bioanalytical capabilities supports biopharmaceutical companies, which drives future market growth and accelerates the availability of life-saving treatments.

Key Players Landscape and Outlook

Market players aim to grow by expanding services and adopting new technologies. They enter into strategic partnerships, mergers, and acquisitions to improve their offerings and benefit from the technology available to enhance their global market position.

In October 2024, Eurofins Scientific SE acquired clinical diagnostics operations for the German company SYNLAB International GmbH in Spain. The deal increases the company's commitment to delivering the best testing services worldwide. Eurofins Scientific SE considers itself the trusted, sophisticated partner of private and public sectors involved in health services, private hospitals, and insurance companies, ensuring excellent testing facilities.

In January 2024, Frontage Laboratories, Inc. expanded its European footprint by acquiring the Bioanalytical and Drug Metabolism & Pharmacokinetics businesses of Accelera S.r.l (part of an NMS Group S.p.A). The acquisition is one of the most significant steps forward for the company from its base in Italy, focusing on providing the best quality and cutting-edge services to clients.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Bioanalytical 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 Test Type
    • 4.2.1.1. Pharmacokinetic Testing
    • 4.2.1.2. Pharmacodynamic Testing
    • 4.2.1.3. Biomarker Testing
    • 4.2.1.4. Virology Testing
    • 4.2.1.5. Serology testing
    • 4.2.1.6. Cell-based Assays
    • 4.2.1.7. Other Test Types
  • 4.2.2. By Molecule
    • 4.2.2.1. Small Molecule
    • 4.2.2.2. Large Molecule
  • 4.2.3. By Application
    • 4.2.3.1. Oncology
    • 4.2.3.2. Neurology
    • 4.2.3.3. Cardiology
    • 4.2.3.4. Infectious Diseases
    • 4.2.3.5. Others
  • 4.2.4. By End-user
    • 4.2.4.1. Pharmaceutical and Biotechnology Companies
    • 4.2.4.2. Contract Research Organizations (CROs)
    • 4.2.4.3. Research & Academic Institutes
    • 4.2.4.4. Others
  • 4.2.5. By Region
    • 4.2.5.1. North America
    • 4.2.5.2. Europe
    • 4.2.5.3. Asia-Pacific
    • 4.2.5.4. South America
    • 4.2.5.5. Middle East and Africa
  • 4.2.6. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 4.3. Market Map Analysis, 2024
  • 4.3.1. By Test Type
  • 4.3.2. By Molecule
  • 4.3.3. By Application
  • 4.3.4. By End-user
  • 4.3.5. By Region

5. North America Bioanalytical 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 Test Type
    • 5.2.1.1. Pharmacokinetic Testing
    • 5.2.1.2. Pharmacodynamic Testing
    • 5.2.1.3. Biomarker Testing
    • 5.2.1.4. Virology Testing
    • 5.2.1.5. Serology testing
    • 5.2.1.6. Cell-based Assays
    • 5.2.1.7. Other Test Types
  • 5.2.2. By Molecule
    • 5.2.2.1. Small Molecule
    • 5.2.2.2. Large Molecule
  • 5.2.3. By Application
    • 5.2.3.1. Oncology
    • 5.2.3.2. Neurology
    • 5.2.3.3. Cardiology
    • 5.2.3.4. Infectious Diseases
    • 5.2.3.5. Others
  • 5.2.4. By End-user
    • 5.2.4.1. Pharmaceutical and Biotechnology Companies
    • 5.2.4.2. Contract Research Organizations (CROs)
    • 5.2.4.3. Research & Academic Institutes
    • 5.2.4.4. Others
  • 5.2.5. By Country Share
    • 5.2.5.1. United States
    • 5.2.5.2. Canada
    • 5.2.5.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States Bioanalytical 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 Test Type
        • 5.3.1.2.1.1. Pharmacokinetic Testing
        • 5.3.1.2.1.2. Pharmacodynamic Testing
        • 5.3.1.2.1.3. Biomarker Testing
        • 5.3.1.2.1.4. Virology Testing
        • 5.3.1.2.1.5. Serology testing
        • 5.3.1.2.1.6. Cell-based Assays
        • 5.3.1.2.1.7. Other Test Types
      • 5.3.1.2.2. By Molecule
        • 5.3.1.2.2.1. Small Molecule
        • 5.3.1.2.2.2. Large Molecule
      • 5.3.1.2.3. By Application
        • 5.3.1.2.3.1. Oncology
        • 5.3.1.2.3.2. Neurology
        • 5.3.1.2.3.3. Cardiology
        • 5.3.1.2.3.4. Infectious Diseases
        • 5.3.1.2.3.5. Others
      • 5.3.1.2.4. By End-user
        • 5.3.1.2.4.1. Pharmaceutical and Biotechnology Companies
        • 5.3.1.2.4.2. Contract Research Organizations (CROs)
        • 5.3.1.2.4.3. Research & Academic Institutes
        • 5.3.1.2.4.4. Others
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Bioanalytical 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. Poland

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

• 8.1. Brazil
• 8.2. Argentina

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

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

10. Demand Supply Analysis

11. Import and Export Analysis

12. Value Chain Analysis

13. Porter's Five Forces Analysis

14. PESTLE Analysis

15. Pricing Analysis

16. Market Dynamics

• 16.1. Market Drivers
• 16.2. Market Challenges

17. Market Trends and Developments

18. Regulatory Framework and Innovation

• 18.1. Clinical Trials
• 18.2. Regulatory Approvals

19. Patent Landscape

20. Case Studies

21. Competitive Landscape

• 21.1. Competition Matrix of Top 5 Market Leaders
• 21.2. SWOT Analysis for Top 5 Players
• 21.3. Key Players Landscape for Top 10 Market Players
  • 21.3.1. WuXi AppTec Co., Ltd.
    • 21.3.1.1. Company Details
    • 21.3.1.2. Key Management Personnel
    • 21.3.1.3. Products and Services
    • 21.3.1.4. Financials (As Reported)
    • 21.3.1.5. Key Market Focus and Geographical Presence
    • 21.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 21.3.2. Eurofins Scientific SE
  • 21.3.3. Charles River Laboratories International, Inc.
  • 21.3.4. ICON Plc
  • 21.3.5. Thermo Fisher Scientific Inc.
  • 21.3.6. Laboratory Corporation of America Holdings
  • 21.3.7. SGS Societe Generale de Surveillance SA
  • 21.3.8. Intertek Group plc
  • 21.3.9. Frontage Laboratories, Inc.
  • 21.3.10. BioAgilytix Labs, LLC

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

22. Strategic Recommendations

23. About Us and Disclaimer