CRO용 의약품 분석 시험 서비스 시장 규모, 점유율, 동향 분석 보고서 : 서비스별, 최종 용도별, 지역별 및 부문 예측(2026-2033년)

Pharmaceutical Analytical Testing Services In CRO Market Summary

The global pharmaceutical analytical testing services in CRO market size was valued at USD 8.0 billion in 2025 and is projected to grow from USD 8.7 billion in 2026 to USD 15.9 billion by 2033, at a CAGR of 9.1% from 2026 to 2033. North America dominated the market, accounting for the largest share of 37.2% in 2025.

The pharmaceutical analytical testing services in CRO industry is anticipated to grow over the forecast period owing to increasing outsourcing of analytical testing by pharmaceutical and biotechnology companies, stringent global regulatory requirements for product quality and safety, rising development of biologics, biosimilars, and advanced therapies, growing pharmaceutical research and development activities, and expanding demand for specialized analytical capabilities across the drug development lifecycle. The market growth is further supported by the need to reduce development timelines, optimize operational costs, and access advanced analytical technologies without major capital investment. The increasing complexity of pharmaceutical formulations and regulatory expectations continues to drive the outsourcing of analytical testing services to specialized CROs.

The increasing outsourcing of pharmaceutical analytical testing remains one of the primary growth drivers for the market. The growing complexity of drug development, coupled with strict regulatory requirements for analytical method validation, stability testing, impurity profiling, and bioanalytical assessments, has encouraged pharmaceutical companies to partner with specialized CROs that offer advanced laboratory infrastructure and regulatory expertise. The outsourcing model enables companies to reduce operational costs, improve resource utilization, and accelerate product development timelines while maintaining regulatory compliance. For instance, in May 2025, SGS announced ISO 17025 accreditation for its pharmaceutical laboratory in Mississauga, Canada, enabling the facility to provide extractables and leachables testing services for pharmaceutical, biopharmaceutical, and medical device manufacturers across North America, thereby expanding analytical testing capacity to address increasing client demand.

The increasing development of biologics, biosimilars, cell and gene therapies, and other complex drug modalities is another significant factor supporting market growth. These products require sophisticated analytical characterization, bioanalytical testing, stability assessment, and regulatory documentation throughout development and commercialization, creating sustained demand for specialized CRO services. The growing number of clinical development programs involving complex biologics has further increased the need for advanced analytical technologies and scientific expertise. For instance, in June 2025, Svar Life Science and Lablytica Life Science entered a strategic partnership to expand regulated bioanalytical services with advanced LC-MS-MS capabilities for pharmacokinetic, pharmacodynamic, biomarker quantification, and therapeutic drug monitoring studies across drug discovery and clinical development programs.

The market growth is moderated by high investment requirements for advanced analytical laboratories, evolving regulatory expectations, and the limited availability of highly skilled analytical scientists with expertise in complex testing methodologies. The increasing pipeline of biologics and advanced therapies, continued outsourcing by emerging biotechnology companies, and ongoing investments in analytical laboratory expansion and regulatory consulting services are expected to create significant growth opportunities for pharmaceutical analytical testing service providers. The combination of increasing pharmaceutical outsourcing, expanding biologics development, stringent quality requirements, and continuous investments in analytical capabilities is expected to support the sustained market growth over the forecast period.

Global Pharmaceutical Analytical Testing Services In CRO Market Report Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global pharmaceutical analytical testing services in CRO market report based on service, end-use, and region:

• Service Outlook (Revenue, USD Million, 2021 - 2033)
• Bioanalytical Testing
  • Clinical
  • Non-Clinical
• Method Development & Validation
  • Extractable & Leachable
  • Impurity Method
  • Technical Consulting
  • Others
• Stability Testing
  • Drug Substance
  • Stability Indicating Method Validation
  • Accelerated Stability Testing
  • Photostability Testing
  • Others
• Others
• End-use Outlook (Revenue, USD Million, 2021 - 2033)
• Pharmaceutical Companies
• Biopharmaceutical Companies
• Others
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
  • Poland
  • Switzerland
  • Austria
  • Czech Republic
  • Croatia
  • Slovenia
  • Greece
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • Thailand
  • South Korea
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • UAE
  • Saudi Arabia
  • Kuwait
  • Qatar
  • Oman

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Service
  • 1.2.2. End Use
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased Database
  • 1.4.2. GVR's Internal Database
  • 1.4.3. Secondary Sources
  • 1.4.4. Primary Research
• 1.5. Information Or Data Analysis
  • 1.5.1. Data Analysis Models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity Flow Analysis
  • 1.7.2. Top-Down Analysis
  • 1.7.3. Bottom-Up Approach
  • 1.7.4. Multivariate Analysis
• 1.8. List Of Secondary Sources
• 1.9. List Of Abbreviations
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. Pharmaceutical Analytical Testing Services in CRO Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
  • 3.2.3. Market Opportunity Analysis
  • 3.2.4. Market Challenge Analysis
• 3.3. Technology Landscape
• 3.4. Pricing Model Analysis
• 3.5. Tariff Impact Analysis
• 3.6. Market Analysis Tools
  • 3.6.1. Porter's Five Force Analysis
  • 3.6.2. PESTEL by SWOT Analysis

Chapter 4. Pharmaceutical Analytical Testing Services in CRO Market: Service Estimates & Trend Analysis

• 4.1. Pharmaceutical Analytical Testing Services in CRO Market, By Service: Segment Dashboard
• 4.2. Pharmaceutical Analytical Testing Services in CRO Market, By Service: Movement Analysis
• 4.3. Pharmaceutical Analytical Testing Services in CRO Market Estimates & Forecasts, By Service, 2021 - 2033 (USD Million)
• 4.4. Bioanalytical Testing
  • 4.4.1. Bioanalytical Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.2. Clinical
    • 4.4.2.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.3. Non-Clinical
    • 4.4.3.1. Non-Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Method Development & Validation
  • 4.5.1. Method Development & Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.2. Extractable & Leachable
    • 4.5.2.1. Extractable & Leachable Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.3. Impurity Method
    • 4.5.3.1. Impurity Method Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.4. Technical Consulting
    • 4.5.4.1. Technical Consulting Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.5. Others
    • 4.5.5.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Stability Testing
  • 4.6.1. Stability Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.2. Drug Substance
    • 4.6.2.1. Drug Substance Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.3. Stability Indicating Method Validation
    • 4.6.3.1. Stability Indicating Method Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.4. Accelerated Stability Testing
    • 4.6.4.1. Accelerated Stability Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.5. Photostability Testing
    • 4.6.5.1. Photostability Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.6. Others
    • 4.6.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.7. Others
  • 4.7.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. Pharmaceutical Analytical Testing Services in CRO Market: End Use Estimates & Trend Analysis

• 5.1. Pharmaceutical Analytical Testing Services in CRO Market, By End Use: Segment Dashboard
• 5.2. Pharmaceutical Analytical Testing Services in CRO Market, By End Use: Movement Analysis
• 5.3. Pharmaceutical Analytical Testing Services in CRO Market Estimates & Forecasts, By End Use, 2021 - 2033 (USD Million)
• 5.4. Pharmaceutical Companies
  • 5.4.1. Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Biopharmaceutical Companies
  • 5.5.1. Biopharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Others
  • 5.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Pharmaceutical Analytical Testing Services in CRO Market: Regional Estimates & Trend Analysis

• 6.1. Regional Market Dashboard
• 6.2. Regional Market Share Analysis, 2025 & 2033
• 6.3. North America
  • 6.3.1. North America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.3.2. U.S
    • 6.3.2.1. Key Country Dynamics
    • 6.3.2.2. Competitive Scenario
    • 6.3.2.3. Regulatory Framework
    • 6.3.2.4. U.S. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.3.3. Canada
    • 6.3.3.1. Key Country Dynamics
    • 6.3.3.2. Competitive Scenario
    • 6.3.3.3. Regulatory Framework
    • 6.3.3.4. Canada Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.3.4. Mexico
    • 6.3.4.1. Key Country Dynamics
    • 6.3.4.2. Competitive Scenario
    • 6.3.4.3. Regulatory Framework
    • 6.3.4.4. Mexico Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.4. Europe
  • 6.4.1. Europe Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.2. UK
    • 6.4.2.1. Key Country Dynamics
    • 6.4.2.2. Competitive Scenario
    • 6.4.2.3. Regulatory Framework
    • 6.4.2.4. UK Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.3. Germany
    • 6.4.3.1. Key Country Dynamics
    • 6.4.3.2. Competitive Scenario
    • 6.4.3.3. Regulatory Framework
    • 6.4.3.4. Germany Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.4. France
    • 6.4.4.1. Key Country Dynamics
    • 6.4.4.2. Competitive Scenario
    • 6.4.4.3. Regulatory Framework
    • 6.4.4.4. France Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.5. Italy
    • 6.4.5.1. Key Country Dynamics
    • 6.4.5.2. Competitive Scenario
    • 6.4.5.3. Regulatory Framework
    • 6.4.5.4. Italy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.6. Spain
    • 6.4.6.1. Key Country Dynamics
    • 6.4.6.2. Competitive Scenario
    • 6.4.6.3. Regulatory Framework
    • 6.4.6.4. Spain Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.7. Denmark
    • 6.4.7.1. Key Country Dynamics
    • 6.4.7.2. Competitive Scenario
    • 6.4.7.3. Regulatory Framework
    • 6.4.7.4. Denmark Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.8. Sweden
    • 6.4.8.1. Key Country Dynamics
    • 6.4.8.2. Competitive Scenario
    • 6.4.8.3. Regulatory Framework
    • 6.4.8.4. Sweden Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.9. Norway
    • 6.4.9.1. Key Country Dynamics
    • 6.4.9.2. Competitive Scenario
    • 6.4.9.3. Regulatory Framework
    • 6.4.9.4. Norway Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.10. Poland
    • 6.4.10.1. Key Country Dynamics
    • 6.4.10.2. Competitive Scenario
    • 6.4.10.3. Regulatory Framework
    • 6.4.10.4. Poland Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.11. Switzerland
    • 6.4.11.1. Key Country Dynamics
    • 6.4.11.2. Competitive Scenario
    • 6.4.11.3. Regulatory Framework
    • 6.4.11.4. Switzerland Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.12. Austria
    • 6.4.12.1. Key Country Dynamics
    • 6.4.12.2. Competitive Scenario
    • 6.4.12.3. Regulatory Framework
    • 6.4.12.4. Austria Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.13. Czech Republic
    • 6.4.13.1. Key Country Dynamics
    • 6.4.13.2. Competitive Scenario
    • 6.4.13.3. Regulatory Framework
    • 6.4.13.4. Czech Republic Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.14. Croatia
    • 6.4.14.1. Key Country Dynamics
    • 6.4.14.2. Competitive Scenario
    • 6.4.14.3. Regulatory Framework
    • 6.4.14.4. Croatia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.15. Slovenia
    • 6.4.15.1. Key Country Dynamics
    • 6.4.15.2. Competitive Scenario
    • 6.4.15.3. Regulatory Framework
    • 6.4.15.4. Slovenia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.16. Greece
    • 6.4.16.1. Key Country Dynamics
    • 6.4.16.2. Competitive Scenario
    • 6.4.16.3. Regulatory Framework
    • 6.4.16.4. Greece Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Asia Pacific
  • 6.5.1. Asia Pacific Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.2. Japan
    • 6.5.2.1. Key Country Dynamics
    • 6.5.2.2. Competitive Scenario
    • 6.5.2.3. Regulatory Framework
    • 6.5.2.4. Japan Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.3. China
    • 6.5.3.1. Key Country Dynamics
    • 6.5.3.2. Competitive Scenario
    • 6.5.3.3. Regulatory Framework
    • 6.5.3.4. China Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.4. India
    • 6.5.4.1. Key Country Dynamics
    • 6.5.4.2. Competitive Scenario
    • 6.5.4.3. Regulatory Framework
    • 6.5.4.4. India Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.5. Australia
    • 6.5.5.1. Key Country Dynamics
    • 6.5.5.2. Competitive Scenario
    • 6.5.5.3. Regulatory Framework
    • 6.5.5.4. Australia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.6. Thailand
    • 6.5.6.1. Key Country Dynamics
    • 6.5.6.2. Competitive Scenario
    • 6.5.6.3. Regulatory Framework
    • 6.5.6.4. Thailand Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.7. South Korea
    • 6.5.7.1. Key Country Dynamics
    • 6.5.7.2. Competitive Scenario
    • 6.5.7.3. Regulatory Framework
    • 6.5.7.4. South Korea Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Latin America
  • 6.6.1. Latin America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6.2. Brazil
    • 6.6.2.1. Key Country Dynamics
    • 6.6.2.2. Competitive Scenario
    • 6.6.2.3. Regulatory Framework
    • 6.6.2.4. Brazil Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6.3. Argentina
    • 6.6.3.1. Key Country Dynamics
    • 6.6.3.2. Competitive Scenario
    • 6.6.3.3. Regulatory Framework
    • 6.6.3.4. Argentina Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.7. MEA
  • 6.7.1. MEA Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.7.2. South Africa
    • 6.7.2.1. Key Country Dynamics
    • 6.7.2.2. Competitive Scenario
    • 6.7.2.3. Regulatory Framework
    • 6.7.2.4. South Africa Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.7.3. UAE
    • 6.7.3.1. Key Country Dynamics
    • 6.7.3.2. Competitive Scenario
    • 6.7.3.3. Regulatory Framework
    • 6.7.3.4. UAE Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.7.4. Saudi Arabia
    • 6.7.4.1. Key Country Dynamics
    • 6.7.4.2. Competitive Scenario
    • 6.7.4.3. Regulatory Framework
    • 6.7.4.4. Saudi Arabia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.7.5. Kuwait
    • 6.7.5.1. Key Country Dynamics
    • 6.7.5.2. Competitive Scenario
    • 6.7.5.3. Regulatory Framework
    • 6.7.5.4. Kuwait Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.7.6. Qatar
    • 6.7.6.1. Key Country Dynamics
    • 6.7.6.2. Competitive Scenario
    • 6.7.6.3. Regulatory Framework
    • 6.7.6.4. Qatar Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.7.7. Oman
    • 6.7.7.1. Key Country Dynamics
    • 6.7.7.2. Competitive Scenario
    • 6.7.7.3. Regulatory Framework
    • 6.7.7.4. Oman Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Key Participant Categorization
  • 7.1.1. Market Leaders
  • 7.1.2. Emerging Players
• 7.2. Market Share/Assessment Analysis, 2025 (Heat Map Analysis)
• 7.3. Company Profiles
  • 7.3.1. SGS Societe Generale de Surveillance SA
    • 7.3.1.1. Company Overview
    • 7.3.1.2. Financial Performance
    • 7.3.1.3. Service Benchmarking
    • 7.3.1.4. Strategic Initiatives
  • 7.3.2. Worldwide Clinical Trials
    • 7.3.2.1. Company Overview
    • 7.3.2.2. Financial Performance
    • 7.3.2.3. Service Benchmarking
    • 7.3.2.4. Strategic Initiatives
  • 7.3.3. Sofpromed
    • 7.3.3.1. Company Overview
    • 7.3.3.2. Financial Performance
    • 7.3.3.3. Service Benchmarking
    • 7.3.3.4. Strategic Initiatives
  • 7.3.4. ClinChoice
    • 7.3.4.1. Company Overview
    • 7.3.4.2. Financial Performance
    • 7.3.4.3. Service Benchmarking
    • 7.3.4.4. Strategic Initiatives
  • 7.3.5. Evotec
    • 7.3.5.1. Company Overview
    • 7.3.5.2. Financial Performance
    • 7.3.5.3. Service Benchmarking
    • 7.3.5.4. Strategic Initiatives
  • 7.3.6. Eurofins Scientific
    • 7.3.6.1. Company Overview
    • 7.3.6.2. Financial Performance
    • 7.3.6.3. Service Benchmarking
    • 7.3.6.4. Strategic Initiatives
  • 7.3.7. KYMOS Group
    • 7.3.7.1. Company Overview
    • 7.3.7.2. Financial Performance
    • 7.3.7.3. Service Benchmarking
    • 7.3.7.4. Strategic Initiatives
  • 7.3.8. ViviaBiotech S.L.
    • 7.3.8.1. Company Overview
    • 7.3.8.2. Financial Performance
    • 7.3.8.3. Service Benchmarking
    • 7.3.8.4. Strategic Initiatives
  • 7.3.9. GalChimia
    • 7.3.9.1. Company Overview
    • 7.3.9.2. Financial Performance
    • 7.3.9.3. Service Benchmarking
    • 7.3.9.4. Strategic Initiatives
  • 7.3.10. TCI Laboratories
    • 7.3.10.1. Company Overview
    • 7.3.10.2. Financial Performance
    • 7.3.10.3. Service Benchmarking
    • 7.3.10.4. Strategic Initiatives
  • 7.3.11. Cotecna (NEOTRON SpA,)
    • 7.3.11.1. Company Overview
    • 7.3.11.2. Financial Performance
    • 7.3.11.3. Service Benchmarking
    • 7.3.11.4. Strategic Initiatives
  • 7.3.12. Tentamus
    • 7.3.12.1. Company Overview
    • 7.3.12.2. Financial Performance
    • 7.3.12.3. Service Benchmarking
    • 7.3.12.4. Strategic Initiatives
  • 7.3.13. Enzymlogic
    • 7.3.13.1. Company Overview
    • 7.3.13.2. Financial Performance
    • 7.3.13.3. Service Benchmarking
    • 7.3.13.4. Strategic Initiatives
  • 7.3.14. Pharmbiotest
    • 7.3.14.1. Company Overview
    • 7.3.14.2. Financial Performance
    • 7.3.14.3. Service Benchmarking
    • 7.3.14.4. Strategic Initiatives
  • 7.3.15. UNIFARM - Research Centre
    • 7.3.15.1. Company Overview
    • 7.3.15.2. Financial Performance
    • 7.3.15.3. Service Benchmarking
    • 7.3.15.4. Strategic Initiatives
  • 7.3.16. ANAPHARM EUROPE, S.L.U
    • 7.3.16.1. Company Overview
    • 7.3.16.2. Financial Performance
    • 7.3.16.3. Service Benchmarking
    • 7.3.16.4. Strategic Initiatives