Healthcare Medical Devices Biotechnology

Pharmaceutical Analytical Testing Outsourcing Market Report Cover

Pharmaceutical Analytical Testing Outsourcing Market

Pharmaceutical Analytical Testing Outsourcing Market Report Cover

Pharmaceutical Analytical Testing Outsourcing Market Size, Share, Growth & Industry Analysis, By Product Type (Small Molecule Drugs, Biologics, Medical Devices), By Service Type (Bioanalytical Testing, Method Development & Validation, Stability Testing, Raw Material Testing, Others), By End User, and Regional Analysis, 2024-2031

Author : Versha V.


Pages : 170

Base Year : 2023

Release : February 2025

Report ID: KR1351


TABLE OF CONTENT

1 INTRODUCTION OF THE GLOBAL PHARMACEUTICAL ANALYTICAL TESTING OUTSOURCING MARKET 
1.1 Market Definition
1.2 Market Segmentation
1.3 Research Timelines
1.4 Limitations
1.5 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY
3.1 Data Collection
3.1.1 Secondary Sources
3.1.2 Primary Sources
3.1.3 Research Flow
3.2 Subject Matter Expert Advice
3.3 Quality Check
3.4 Final Review
3.5 Bottom-up Approach
3.6 Top-down Approach

4 GLOBAL PHARMACEUTICAL ANALYTICAL TESTING OUTSOURCING MARKET OUTLOOK
4.1 Market Evolution
4.2 Overview
4.3 Market Dynamics
4.3.1 Drivers
4.3.2 Restraints
4.3.3 Opportunities
4.3.4 Challenges
4.4 Pricing Analysis
4.5 Porter’s Five Forces Analysis
4.6 Value Chain Analysis
4.7 Macroeconomic Analysis

5 IMPACT OF REGULATORY FRAMEWORKS

6 GLOBAL PHARMACEUTICAL ANALYTICAL TESTING OUTSOURCING MARKET, BY PRODUCT TYPE
6.1 Overview
6.2 Small Molecule Drugs
6.3 Biologics
6.3.1 Vaccines
6.3.2 Monoclonal Antibodies
6.3.3 Gene & Cell Therapies
6.4 Medical Devices

7 GLOBAL PHARMACEUTICAL ANALYTICAL TESTING OUTSOURCING MARKET, BY SERVICE TYPE
7.1 Overview
7.2 Bioanalytical Testing
7.2.1 Clinical Bioanalysis
7.2.1.1 Pharmacokinetics (PK) & Pharmacodynamics (PD) Studies
7.2.1.2 Bioavailability (BA) & Bioequivalence (BE) Studies
7.2.1.3 Biomarker Analysis
7.2.1.4 Immunogenicity Testing
7.2.1.5 Cell-Based Assays
7.2.1.6 Large & Small Molecule Bioanalysis
7.2.2 Non-Clinical Bioanalysis
7.2.2.1 Toxicokinetics
7.2.2.2 ADME (Absorption, Distribution, Metabolism, and Excretion) Studies
7.2.2.3 Drug-Drug Interaction Studies
7.3 Method Development & Validation
7.3.1 Assay Development & Optimization
7.3.2 Validation of Analytical Methods (ICH Q2(R1) Compliance)
7.3.3 Process-related Impurity Analysis
7.3.4 Forced Degradation Studies
7.4 Stability Testing
7.4.1 Long-term Stability Testing
7.4.2 Accelerated Stability Testing
7.4.3 Photostability Testing
7.4.4 Forced Degradation Studies
7.4.5 Temperature & Humidity Studies
7.5 Raw Material Testing
7.5.1 Identification & Purity Testing
7.5.2 Heavy Metal & Elemental Impurity Testing
7.5.3 Residual Solvent Analysis
7.5.4 Particle Size Analysis
7.5.5 Polymorphism Analysis
7.6 Microbial Testing
7.6.1 Sterility Testing
7.6.2 Endotoxin & Pyrogen Testing
7.6.3 Microbial Limits Testing
7.6.4 Bioburden Testing
7.6.5 Environmental Microbial Monitoring
7.7 Environmental Monitoring
7.7.1 Air & Surface Monitoring in Manufacturing Facilities
7.7.2 Water Quality Testing (USP, EP, JP Compliance)
7.7.3 Particulate Contamination Testing
7.8 Other Analytical Testing Services
7.8.1 Extractables & Leachables Testing
7.8.2 Elemental Impurity Analysis
7.8.3 Batch Release Testing
7.8.4 Residual DNA & Host Cell Protein Testing

8 GLOBAL PHARMACEUTICAL ANALYTICAL TESTING OUTSOURCING MARKET, BY END USER
8.1 Overview
8.2 Pharmaceutical & Biotechnology Companies
8.3 Contract Research Organizations (CROs)
8.4 Academic & Research Institutions
8.5 Other End Users

9 GLOBAL PHARMACEUTICAL ANALYTICAL TESTING OUTSOURCING MARKET, BY GEOGRAPHY
9.1 Overview

10 NORTH AMERICA 
10.1 U.S.
10.2 Canada
10.3 Mexico

11 EUROPE 
11.1 France
11.2 UK
11.3 Spain
11.4 Germany
11.5 Italy
11.6 Russia
11.7 Rest of Europe

12 ASIA PACIFIC 
12.1 China
12.2 Japan
12.3 India
12.4 Australia
12.5 ASEAN
12.6 South Korea
12.7 Rest of Asia Pacific

13 MIDDLE EAST & AFRICA 
13.1 Turkey
13.2 UAE
13.3 Saudi Arabia
13.4 South Africa
13.5 Rest of Middle East & Africa

14 SOUTH AMERICA 
14.1 Brazil
14.2 Argentina
14.3 Rest of South America

15  GLOBAL PHARMACEUTICAL ANALYTICAL TESTING OUTSOURCING MARKET COMPETITIVE LANDSCAPE
15.1 Overview
15.2 Key Developments
15.3 Key Strategic Developments
15.4 Company Market Ranking
15.5 Regional Footprint
15.6 Industry Footprint

16 COMPANY PROFILES
16.1 Charles River Laboratories
16.2 Eurofins Scientific
16.3 Intertek Group plc
16.4 SGS Société Générale de Surveillance SA
16.5 Pace
16.6 WuXi AppTec Co., Ltd.
16.7 Labcorp
16.8 West Pharmaceutical Services, Inc.
16.9 ICON plc
16.10 Thermo Fisher Scientific Inc.
16.11 Cambrex Corporation
16.12  Novo Holdings A/S
16.13 AptarGroup, Inc.
16.14 Pharmaron
16.15 Dr. Reddy’s Laboratories Ltd.

LIST OF TABLES

TABLE 1 Global Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 2 Global Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 3 Global Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 4 Global Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Geography, 2021 – 2031 (USD Million)
TABLE 5 North America Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Country, 2021 – 2031 (USD Million)
TABLE 6 North America Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 7 North America Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 8 North America Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 9 U.S. Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 10 U.S. Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 11 U.S. Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 12 Canada Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 13 Canada Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 14 Canada Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 15 Mexico Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 16 Mexico Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 17 Mexico Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 18 Europe Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Country, 2021 – 2031 (USD Million)
TABLE 19 Europe Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 20 Europe Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 21 Europe Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 22 Germany Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 23 Germany Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 24 Germany Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 25 France Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 26 France Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 27 France Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 28 UK Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 29 UK Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 30 UK Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 31 Spain Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 32 Spain Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 33 Spain Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 34 Italy Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 35 Italy Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 36 Italy Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 37 Russia Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 38 Russia Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 39 Russia Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 40 Rest of Europe Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 41 Rest of Europe Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 42 Rest of Europe Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 43 Asia Pacific Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Country, 2021 – 2031 (USD Million)
TABLE 44 Asia Pacific Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 45 Asia Pacific Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 46 Asia Pacific Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 47 China Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 48 China Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 49 China Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 50 Japan Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 51 Japan Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 52 Japan Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 53 India Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 54 India Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 55 India Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 56 South Korea Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 57 South Korea Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 58 South Korea Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 59 Rest of Asia Pacific Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 60 Rest of Asia Pacific Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 61 Rest of Asia Pacific Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 62 Middle East & Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Country, 2021 – 2031 (USD Million)
TABLE 63 Middle East & Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 64 Middle East & Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 65 Middle East & Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 66 GCC Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 67 GCC Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 68 GCC Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 69 North Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 70 North Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 71 North Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 72 South Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 73 South Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 74 South Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 75 Rest of Middle East & Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 76 Rest of Middle East & Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 77 Rest of Middle East & Africa Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 78 Latin America Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Country, 2021 – 2031 (USD Million)
TABLE 79 Latin America Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 80 Latin America Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 81 Latin America Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 82 Brazil Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 83 Brazil Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 84 Brazil Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 85 Argentina Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 86 Argentina Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 87 Argentina Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 88 Rest of Latin America Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Product Type, 2021 – 2031 (USD Million)
TABLE 89 Rest of Latin America Pharmaceutical Analytical Testing Outsourcing Market Revenue, By Service Type, 2021 – 2031 (USD Million)
TABLE 90 Rest of Latin America Pharmaceutical Analytical Testing Outsourcing Market Revenue, By End User, 2021 – 2031 (USD Million)
TABLE 91 Company Market Ranking
TABLE 92 Regional Footprint
TABLE 93 Product Benchmarking
TABLE 94 Recent Developments
TABLE 95 Winning Imperatives

LIST OF FIGURES

FIG. 1 Market Segmentation
FIG. 2 Research Timeline
FIG. 3 Global Pharmaceutical Analytical Testing Outsourcing Market 2021-2031 (USD Million)
FIG. 4 Global Pharmaceutical Analytical Testing Outsourcing Market Geographical Analysis (CAGR %)
FIG. 5 Global Pharmaceutical Analytical Testing Outsourcing Absolute Market Opportunity (USD Million)
FIG. 6 Global Pharmaceutical Analytical Testing Outsourcing Market Attractiveness (USD Million)
FIG. 7 Global Pharmaceutical Analytical Testing Outsourcing Market, By Product Type, 2021-2031 (USD Million)
FIG. 8 Global Pharmaceutical Analytical Testing Outsourcing Market, By Service Type, 2021-2031 (USD Million)
FIG. 9 Global Pharmaceutical Analytical Testing Outsourcing Market, By End User, 2021-2031 (USD Million)
FIG. 10 Research Methodology
FIG. 11 Research Process
FIG. 12 Bottom-up Approach
FIG. 13 Top-bottom Approach
FIG. 14 Market Dynamics Overview
FIG. 15 Porter's Five Forces Analysis
FIG. 16 Value Chain Analysis
FIG. 17 Macroeconomic Analysis
FIG. 18 Global Pharmaceutical Analytical Testing Outsourcing Market Revenue Share, By Product Type, 2021 and 2031 (%)
FIG. 19 Global Pharmaceutical Analytical Testing Outsourcing Market Revenue Share, By Service Type, 2021 and 2031 (%)
FIG. 20 Global Pharmaceutical Analytical Testing Outsourcing Market Revenue Share, By End User, 2021 and 2031 (%)
FIG. 21 Global Pharmaceutical Analytical Testing Outsourcing Market Revenue Share, By Geographic Regions, 2021 and 2031 (%)
FIG. 22 Market Size and Projections, 2021 - 2031 (USD Million)
FIG. 23 North America Pharmaceutical Analytical Testing Outsourcing Market Overview Share, By Countries, 2021 – 2031 (%)
FIG. 24 Market Size and Projections, 2021 - 2031 (USD Million)
FIG. 25 Europe Pharmaceutical Analytical Testing Outsourcing Market Overview Share, By Countries, 2021 – 2031 (%)
FIG. 26 Market Size and Projections, 2021 - 2031 (USD Million)
FIG. 27 Asia Pacific Pharmaceutical Analytical Testing Outsourcing Market Overview Share, By Countries, 2021 – 2031 (%)
FIG. 28 Market Size and Projections, 2021 - 2031 (USD Million)
FIG. 29 Middle East & Africa Pharmaceutical Analytical Testing Outsourcing Market Overview Share, By Countries, 2021 – 2031 (%)
FIG. 30 Market Size and Projections, 2021 - 2031 (USD Million)
FIG. 31 Latin America Pharmaceutical Analytical Testing Outsourcing Market Overview Share, By Countries, 2021 – 2031 (%)
FIG. 32 Key Strategic Development
FIG. 33 Key Facts
FIG. 34 Financial Overview
FIG. 35 SWOT Analysis

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