CRO용 의약품 분석 시험 서비스 시장 규모, 점유율, 동향 분석 리포트 : 서비스별, 최종 사용별, 지역별, 부문 예측(2025-2030년)

Market Size & Trends:

The global pharmaceutical analytical testing services in CRO market size was estimated at USD 7.52 billion in 2024 and is projected to grow at a CAGR of 8.61% from 2025 to 2030. This growth is primarily attributed to factors such as the growing prevalence of chronic diseases, demand for outsourcing analytical testing services, investments in pharmaceutical R&D, and a shift toward cost-efficient drug development processes across the globe.

In addition, pharmaceuticals are increasingly outsourced to CROs to utilize specialized expertise, minimize their capital investment in the infrastructure, and streamline the timelines for the drug approval process and regulatory requirements. These tests are essential throughout development, from raw materials analysis and method validation to stability studies and impurity profiling.

As CROs offer advanced analytical technologies such as mass spectrometry, NGS, Raman spectroscopy, and automation/AI for rapid and accurate testing are expected to enhance the demand for pharmaceutical analytical testing services in CROs for developing personalized and precision medicine.

Moreover, factors such as an increasing pipeline of biologics, biosimilars, advanced therapies, and rising stringent quality control to enhance pharmaceutical products' safety, efficacy, and consistency are contributing to market growth. Besides, the expanding adoption of automation, artificial intelligence, and digital data management systems like Laboratory Information Management Systems (LIMS) in CROs is anticipated to boost the efficiency and reliability of analytical testing processes. This led pharmaceutical companies to expand their partnerships with CROs for cost-saving strategies and strategic collaborations that boost innovation, reduce risk, and improve time-to-market.

Furthermore, stringent regulatory frameworks worldwide are another major driver for the pharmaceutical analytical testing services in CRO market. Regulatory authorities such as the U.S. FDA, EMA, PMDA, and WHO require comprehensive analytical validation, method development, and stability testing to enhance drug safety, efficacy, and quality. These regulations are becoming increasingly stringent, particularly for complex biologics, biosimilars, and advanced therapies, mandating in-depth characterization and impurity profiling. The implementation of ICH guidelines (Q2, Q3, Q6) and GMP/GLP standards has intensified the demand for compliant analytical methodologies. Frequent audits and regulatory inspections further influence pharmaceutical companies to engage with specialized CROs possessing global regulatory knowledge, validated infrastructure, and quality management systems, allowing risk mitigation, faster approvals, and sustained market access across geographies.

Further, the adoption of Quality by Design (QbD) principles, which emphasize a systematic approach to product development, highlights the importance of early-stage analytical characterization. Under the QbD framework, pharmaceutical companies must define Critical Quality Attributes (CQAs) and ensure that variations in raw materials or manufacturing processes do not compromise product performance. The FDA's Process Analytical Technology (PAT) initiative promotes real-time monitoring of manufacturing parameters to maintain product consistency. This regulatory push, combined with the industry's transition toward more sophisticated drug formulations, is expanding the role of CROs in pharmaceutical analytical testing. Such aforementioned factors are expected to drive the overall market demand in the near future.

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 2018 to 2030. 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, 2018 - 2030)
• 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, 2018 - 2030)
• Pharmaceutical Companies
• Biopharmaceutical Companies
• Others
• Regional Outlook (Revenue, USD Million, 2018 - 2030)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Sweden
  • Denmark
  • Norway
  • Poland
  • Switzerland
  • Austria
  • Czech Republic
  • Croatia
  • Slovenia
  • Greece
• Asia Pacific
  • Japan
  • China
  • India
  • Thailand
  • South Korea
  • Australia
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Argentina
  • UAE
  • Kuwait

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Market Definitions
• 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. Parent Market 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
• 3.3. Pricing Model Analysis
• 3.4. Technology Landscape
• 3.5. Market Analysis Tools
  • 3.5.1. Porter's Five Force Analysis
  • 3.5.2. PESTEL by SWOT Analysis
  • 3.5.3. COVID-19 Impact 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, 2018 - 2030 (USD Million)
• 4.4. Bioanalytical Testing
  • 4.4.1. Bioanalytical Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.2. Clinical
    • 4.4.2.1. Clinical Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.3. Non-Clinical
    • 4.4.3.1. Non-Clinical Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Method Development & Validation
  • 4.5.1. Method Development & Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.2. Extractable & Leachable
    • 4.5.2.1. Extractable & Leachable Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.3. Impurity Method
    • 4.5.3.1. Impurity Method Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.4. Technical Consulting
    • 4.5.4.1. Technical Consulting Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5.5. Others
    • 4.5.5.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.6. Stability Testing
  • 4.6.1. Stability Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.2. Drug Substance
    • 4.6.2.1. Drug Substance Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.3. Stability Indicating Method Validation
    • 4.6.3.1. Stability Indicating Method Validation Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.4. Accelerated Stability Testing
    • 4.6.4.1. Accelerated Stability Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.5. Photostability Testing
    • 4.6.5.1. Photostability Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6.6. Others
    • 4.6.6.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.7. Others
  • 4.7.1. Others Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (USD Million)
• 5.4. Pharmaceutical Companies
  • 5.4.1. Pharmaceutical Companies Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.5. Biopharmaceutical Companies
  • 5.5.1. Biopharmaceutical Companies Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.6. Others
  • 5.6.1. Others Market Estimates and Forecasts, 2018 - 2030 (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, 2024 & 2030
• 6.3. North America
  • 6.3.1. North America Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (USD Million)
• 6.4. Europe
  • 6.4.1. Europe Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (USD Million)
  • 6.4.7. Sweden
    • 6.4.7.1. Key Country Dynamics
    • 6.4.7.2. Competitive Scenario
    • 6.4.7.3. Regulatory Framework
    • 6.4.7.4. Sweden Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.8. Denmark
    • 6.4.8.1. Key Country Dynamics
    • 6.4.8.2. Competitive Scenario
    • 6.4.8.3. Regulatory Framework
    • 6.4.8.4. Denmark Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (USD Million)
• 6.5. Asia Pacific
  • 6.5.1. Asia Pacific Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (USD Million)
  • 6.5.5. Thailand
    • 6.5.5.1. Key Country Dynamics
    • 6.5.5.2. Competitive Scenario
    • 6.5.5.3. Regulatory Framework
    • 6.5.5.4. Thailand Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.6. South Korea
    • 6.5.6.1. Key Country Dynamics
    • 6.5.6.2. Competitive Scenario
    • 6.5.6.3. Regulatory Framework
    • 6.5.6.4. South Korea Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.7. Australia
    • 6.5.7.1. Key Country Dynamics
    • 6.5.7.2. Competitive Scenario
    • 6.5.7.3. Regulatory Framework
    • 6.5.7.4. Australia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.6. Latin America
  • 6.6.1. Latin America Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (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, 2018 - 2030 (USD Million)
• 6.7. MEA
  • 6.7.1. MEA Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (USD Million)
  • 6.7.3. Saudi Arabia
    • 6.7.3.1. Key Country Dynamics
    • 6.7.3.2. Competitive Scenario
    • 6.7.3.3. Regulatory Framework
    • 6.7.3.4. Saudi Arabia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.7.4. UAE
    • 6.7.4.1. Key Country Dynamics
    • 6.7.4.2. Competitive Scenario
    • 6.7.4.3. Regulatory Framework
    • 6.7.4.4. UAE Market Estimates and Forecasts, 2018 - 2030 (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, 2018 - 2030 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Market Participant Categorization
• 7.2. Company Market Share/Assessment Analysis, 2024
• 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