의약품 분석 시험 아웃소싱 시장 : 유형별, 서비스별, 최종사용자별, 지역별(2025-2033년)

The global pharmaceutical analytical testing outsourcing market size reached USD 9.0 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 15.9 Billion by 2033, exhibiting a growth rate (CAGR) of 6.49% during 2025-2033. The market is driven by the growing focus on new drug delivery systems, such as liposomes, nanoparticles, and microspheres, increasing prevalence of chronic diseases like cancer, diabetes, and cardiovascular disease, and rising emphasis on drug development.

Pharmaceutical analytical testing outsourcing is a testing activity used in the pharmaceutical industry to minimize in-house production costs by outsourcing parts of the work to a third party. As an extension of contract research organizations, pharmaceutical analytical testing outsourcing services have begun replacing a significant portion of in-house analytical development and testing. As part of the development process for drugs and therapies, pharmaceutical testing plays a vital role from the beginning through the commercialization of the product. It entails determining the structures of chemicals, purifying a mixture of substances, and synthesizing and characterizing active medicinal ingredients (APIs). Formulation development and early-phase manufacturing are usually involved in this initiative to speed up compound activities.

Pharmaceutical Analytical Testing Outsourcing Market Trends:

The market is majorly driven by the increasing adoption of outsourcing practices in pharmaceutical companies, contract research organizations, and biotech companies. This can be attributed to the escalating demand for analytical information on the end-to-end process of drug development by various regulatory agencies. Additionally, continual technological advancements with an enhanced focus on shortening the product lifecycle have resulted in the rapid development of new products, which is providing an impetus to the market. The rising need for product safety and quality, changing regulations for in vivo and in vitro tests, and an augmented emphasis on customized care is also impacting the market positively. The development of combination products, biosimilar, and other innovative medicines leading to the introduction of specific types of tests and specialty product manufacturing are further fueling the market. Some of the other factors contributing to the market include numerous innovations in the pharmaceutical industry, the pricing benefits of outsourcing, extensive research and development (R&D) conducted to develop sustainable drugs, favorable initiatives by the governments of several countries, and the growing number of clinical trial registrations.

Key Market Segmentation:

Breakup by Type:

Active Pharmaceutical Ingredients (API)

Additives

Finished Products

Breakup by Service:

Bioanalytical Testing

Clinical

Non-Clinical

Method Development and Validation

Extractable and Leachable

Impurity Method

Technical Consulting

Others

Stability Testing

Drug Substance

Stability Indicating Method Validation

Accelerated Stability Testing

Photostability Testing

Others

Others

Breakup by End User:

Pharmaceutical Companies

Biopharmaceutical Companies

Contract Research Organizations

Breakup by Region:

North America

United States

Canada

Asia-Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Latin America

Brazil

Mexico

Others

Middle East and Africa

Competitive Landscape:

The competitive landscape of the industry has also been examined along with the profiles of the key players being Ajinomoto Bio-Pharma Services (Ajinomoto Co. Inc.), Alcami Corporation Inc., Boston Analytical Inc., Catalent Inc., Charles River Laboratories International Inc., Eurofins Scientific SE, Intertek Group plc, Laboratory Corporation of America Holdings, Pace Analytical Services LLC, SGS S.A., Thermo Fisher Scientific Inc., West Pharmaceutical Services Inc. and WuXi AppTec Inc. Kindly, note that this only represents a partial list of companies, and the complete list has been provided in the report.

The global pharmaceutical analytical testing outsourcing market size reached USD 9.0 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 15.9 Billion by 2033, exhibiting a growth rate (CAGR) of 6.49% during 2025-2033. The market is driven by the growing focus on new drug delivery systems, such as liposomes, nanoparticles, and microspheres, increasing prevalence of chronic diseases like cancer, diabetes, and cardiovascular disease, and rising emphasis on drug development.

Pharmaceutical analytical testing outsourcing is a testing activity used in the pharmaceutical industry to minimize in-house production costs by outsourcing parts of the work to a third party. As an extension of contract research organizations, pharmaceutical analytical testing outsourcing services have begun replacing a significant portion of in-house analytical development and testing. As part of the development process for drugs and therapies, pharmaceutical testing plays a vital role from the beginning through the commercialization of the product. It entails determining the structures of chemicals, purifying a mixture of substances, and synthesizing and characterizing active medicinal ingredients (APIs). Formulation development and early-phase manufacturing are usually involved in this initiative to speed up compound activities.

Pharmaceutical Analytical Testing Outsourcing Market Trends:

The market is majorly driven by the increasing adoption of outsourcing practices in pharmaceutical companies, contract research organizations, and biotech companies. This can be attributed to the escalating demand for analytical information on the end-to-end process of drug development by various regulatory agencies. Additionally, continual technological advancements with an enhanced focus on shortening the product lifecycle have resulted in the rapid development of new products, which is providing an impetus to the market. The rising need for product safety and quality, changing regulations for in vivo and in vitro tests, and an augmented emphasis on customized care is also impacting the market positively. The development of combination products, biosimilar, and other innovative medicines leading to the introduction of specific types of tests and specialty product manufacturing are further fueling the market. Some of the other factors contributing to the market include numerous innovations in the pharmaceutical industry, the pricing benefits of outsourcing, extensive research and development (R&D) conducted to develop sustainable drugs, favorable initiatives by the governments of several countries, and the growing number of clinical trial registrations.

Key Market Segmentation:

Breakup by Type:

Active Pharmaceutical Ingredients (API)

Additives

Finished Products

Breakup by Service:

Bioanalytical Testing

Clinical

Non-Clinical

Method Development and Validation

Extractable and Leachable

Impurity Method

Technical Consulting

Others

Stability Testing

Drug Substance

Stability Indicating Method Validation

Accelerated Stability Testing

Photostability Testing

Others

Others

Breakup by End User:

Pharmaceutical Companies

Biopharmaceutical Companies

Contract Research Organizations

Breakup by Region:

North America

United States

Canada

Asia-Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Latin America

Brazil

Mexico

Others

Middle East and Africa

Competitive Landscape:

The competitive landscape of the industry has also been examined along with the profiles of the key players being Ajinomoto Bio-Pharma Services (Ajinomoto Co. Inc.), Alcami Corporation Inc., Boston Analytical Inc., Catalent Inc., Charles River Laboratories International Inc., Eurofins Scientific SE, Intertek Group plc, Laboratory Corporation of America Holdings, Pace Analytical Services LLC, SGS S.A., Thermo Fisher Scientific Inc., West Pharmaceutical Services Inc. and WuXi AppTec Inc. Kindly, note that this only represents a partial list of companies, and the complete list has been provided in the report.

Key Questions Answered in This Report:

• How has the global pharmaceutical analytical testing outsourcing market performed so far and how will it perform in the coming years?
• What has been the impact of COVID-19 on the global pharmaceutical analytical testing outsourcing market?
• What are the key regional markets?
• What is the breakup of the market based on the type?
• What is the breakup of the market based on the service?
• What is the breakup of the market based on the end user?
• What are the various stages in the value chain of the industry?
• What are the key driving factors and challenges in the industry?
• What is the structure of the global pharmaceutical analytical testing outsourcing market and who are the key players?
• What is the degree of competition in the industry?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Pharmaceutical Analytical Testing Outsourcing Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID-19
• 5.4 Market Forecast

6 Market Breakup by Type

• 6.1 Active Pharmaceutical Ingredients (API)
  • 6.1.1 Market Trends
  • 6.1.2 Market Forecast
• 6.2 Additives
  • 6.2.1 Market Trends
  • 6.2.2 Market Forecast
• 6.3 Finished Products
  • 6.3.1 Market Trends
  • 6.3.2 Market Forecast

7 Market Breakup by Service

• 7.1 Bioanalytical Testing
  • 7.1.1 Market Trends
  • 7.1.2 Key Players
    • 7.1.2.1 Clinical
    • 7.1.2.2 Non-Clinical
  • 7.1.3 Market Forecast
• 7.2 Method Development and Validation
  • 7.2.1 Market Trends
  • 7.2.2 Key Players
    • 7.2.2.1 Extractable and Leachable
    • 7.2.2.2 Impurity Method
    • 7.2.2.3 Technical Consulting
    • 7.2.2.4 Others
  • 7.2.3 Market Forecast
• 7.3 Stability Testing
  • 7.3.1 Market Trends
  • 7.3.2 Key Players
    • 7.3.2.1 Drug Substance
    • 7.3.2.2 Stability Indicating Method Validation
    • 7.3.2.3 Accelerated Stability Testing
    • 7.3.2.4 Photostability Testing
    • 7.3.2.5 Others
  • 7.3.3 Market Forecast
• 7.4 Others
  • 7.4.1 Market Trends
  • 7.4.2 Market Forecast

8 Market Breakup by End User

• 8.1 Pharmaceutical Companies
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Biopharmaceutical Companies
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast
• 8.3 Contract Research Organizations
  • 8.3.1 Market Trends
  • 8.3.2 Market Forecast

9 Market Breakup by Region

• 9.1 North America
  • 9.1.1 United States
    • 9.1.1.1 Market Trends
    • 9.1.1.2 Market Forecast
  • 9.1.2 Canada
    • 9.1.2.1 Market Trends
    • 9.1.2.2 Market Forecast
• 9.2 Asia-Pacific
  • 9.2.1 China
    • 9.2.1.1 Market Trends
    • 9.2.1.2 Market Forecast
  • 9.2.2 Japan
    • 9.2.2.1 Market Trends
    • 9.2.2.2 Market Forecast
  • 9.2.3 India
    • 9.2.3.1 Market Trends
    • 9.2.3.2 Market Forecast
  • 9.2.4 South Korea
    • 9.2.4.1 Market Trends
    • 9.2.4.2 Market Forecast
  • 9.2.5 Australia
    • 9.2.5.1 Market Trends
    • 9.2.5.2 Market Forecast
  • 9.2.6 Indonesia
    • 9.2.6.1 Market Trends
    • 9.2.6.2 Market Forecast
  • 9.2.7 Others
    • 9.2.7.1 Market Trends
    • 9.2.7.2 Market Forecast
• 9.3 Europe
  • 9.3.1 Germany
    • 9.3.1.1 Market Trends
    • 9.3.1.2 Market Forecast
  • 9.3.2 France
    • 9.3.2.1 Market Trends
    • 9.3.2.2 Market Forecast
  • 9.3.3 United Kingdom
    • 9.3.3.1 Market Trends
    • 9.3.3.2 Market Forecast
  • 9.3.4 Italy
    • 9.3.4.1 Market Trends
    • 9.3.4.2 Market Forecast
  • 9.3.5 Spain
    • 9.3.5.1 Market Trends
    • 9.3.5.2 Market Forecast
  • 9.3.6 Russia
    • 9.3.6.1 Market Trends
    • 9.3.6.2 Market Forecast
  • 9.3.7 Others
    • 9.3.7.1 Market Trends
    • 9.3.7.2 Market Forecast
• 9.4 Latin America
  • 9.4.1 Brazil
    • 9.4.1.1 Market Trends
    • 9.4.1.2 Market Forecast
  • 9.4.2 Mexico
    • 9.4.2.1 Market Trends
    • 9.4.2.2 Market Forecast
  • 9.4.3 Others
    • 9.4.3.1 Market Trends
    • 9.4.3.2 Market Forecast
• 9.5 Middle East and Africa
  • 9.5.1 Market Trends
  • 9.5.2 Market Breakup by Country
  • 9.5.3 Market Forecast

10 SWOT Analysis

• 10.1 Overview
• 10.2 Strengths
• 10.3 Weaknesses
• 10.4 Opportunities
• 10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis

• 12.1 Overview
• 12.2 Bargaining Power of Buyers
• 12.3 Bargaining Power of Suppliers
• 12.4 Degree of Competition
• 12.5 Threat of New Entrants
• 12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape

• 14.1 Market Structure
• 14.2 Key Players
• 14.3 Profiles of Key Players
  • 14.3.1 Ajinomoto Bio-Pharma Services (Ajinomoto Co. Inc.)
    • 14.3.1.1 Company Overview
    • 14.3.1.2 Product Portfolio
  • 14.3.2 Alcami Corporation Inc.
    • 14.3.2.1 Company Overview
    • 14.3.2.2 Product Portfolio
  • 14.3.3 Boston Analytical Inc.
    • 14.3.3.1 Company Overview
    • 14.3.3.2 Product Portfolio
  • 14.3.4 Catalent Inc.
    • 14.3.4.1 Company Overview
    • 14.3.4.2 Product Portfolio
    • 14.3.4.3 Financials
    • 14.3.4.4 SWOT Analysis
  • 14.3.5 Charles River Laboratories International Inc.
    • 14.3.5.1 Company Overview
    • 14.3.5.2 Product Portfolio
    • 14.3.5.3 Financials
    • 14.3.5.4 SWOT Analysis
  • 14.3.6 Eurofins Scientific SE
    • 14.3.6.1 Company Overview
    • 14.3.6.2 Product Portfolio
    • 14.3.6.3 Financials
    • 14.3.6.4 SWOT Analysis
  • 14.3.7 Intertek Group plc
    • 14.3.7.1 Company Overview
    • 14.3.7.2 Product Portfolio
    • 14.3.7.3 Financials
    • 14.3.7.4 SWOT Analysis
  • 14.3.8 Laboratory Corporation of America Holdings
    • 14.3.8.1 Company Overview
    • 14.3.8.2 Product Portfolio
    • 14.3.8.3 Financials
    • 14.3.8.4 SWOT Analysis
  • 14.3.9 Pace Analytical Services LLC
    • 14.3.9.1 Company Overview
    • 14.3.9.2 Product Portfolio
  • 14.3.10 SGS S.A.
    • 14.3.10.1 Company Overview
    • 14.3.10.2 Product Portfolio
    • 14.3.10.3 Financials
  • 14.3.11 Thermo Fisher Scientific Inc.
    • 14.3.11.1 Company Overview
    • 14.3.11.2 Product Portfolio
    • 14.3.11.3 Financials
    • 14.3.11.4 SWOT Analysis
  • 14.3.12 West Pharmaceutical Services Inc.
    • 14.3.12.1 Company Overview
    • 14.3.12.2 Product Portfolio
    • 14.3.12.3 Financials
    • 14.3.12.4 SWOT Analysis
  • 14.3.13 WuXi AppTec Inc.
    • 14.3.13.1 Company Overview
    • 14.3.13.2 Product Portfolio
    • 14.3.13.3 Financials

Kindly, note that this only represents a partial list of companies, and the complete list has been provided in the report.