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시장보고서
상품코드
1635909
의약품 분석 시험 아웃소싱 시장 : 유형별, 서비스별, 최종사용자별, 지역별(2025-2033년)Pharmaceutical Analytical Testing Outsourcing Market by Type (Active Pharmaceutical Ingredients, Additives, Finished Products), Service, End User, and Region 2025-2033 |
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의약품 분석 시험 아웃소싱 시장 세계 시장 규모는 2024년 90억 달러에 달했습니다. 향후 IMARC Group은 이 시장이 2033년까지 159억 달러에 달할 것으로 예상하며, 2025-2033년 연평균 성장률(CAGR)은 6.49%에 달할 것으로 전망하고 있습니다. 이 시장을 견인하는 것은 리포솜, 나노입자, 마이크로스피어 등 새로운 약물전달 시스템에 대한 관심 증가, 암, 당뇨병, 심혈관질환 등 만성질환의 유병률 증가, 의약품 개발에 대한 관심 증가 등입니다.
의약품 분석 시험 아웃소싱은 제약 업계에서 업무의 일부를 제3자에게 위탁하여 사내 생산 비용을 최소화하기 위해 활용되는 시험 활동입니다. 의약품 분석 시험 아웃소싱 서비스는 연구개발 업무 위탁기관의 연장선상에서 사내 분석 개발 및 시험의 상당 부분을 대체하기 시작했습니다. 의약품 및 치료제 개발 과정의 일환으로 의약품 시험은 제품 초기 단계부터 상품화까지 중요한 역할을 합니다. 화학제품의 구조를 결정하고, 혼합물을 정제하고, 활성 성분(API)을 합성하고, 특성을 밝혀야 합니다. 제제 개발 및 초기 단계의 제조는 일반적으로 화합물의 활동을 가속화하기 위해 이러한 노력에 관여합니다.
의약품 분석 시험 아웃소싱 시장 동향:
시장은 제약사, 의약품 개발 위탁기관, 바이오테크놀러지 기업의 아웃소싱 도입 확대가 주요 요인으로 작용하고 있습니다. 이러한 배경에는 의약품 개발의 엔드투엔드 프로세스에 대한 분석 정보에 대한 규제 당국의 요구가 증가하고 있는 것이 주요 요인으로 작용하고 있습니다. 또한, 제품 수명주기 단축에 초점을 맞춘 지속적인 기술 발전으로 인해 신제품 개발이 빠르게 진행되고 있으며, 이는 시장 성장에 박차를 가하고 있습니다. 제품 안전 및 품질에 대한 요구 증가, in vivo 및 in vitro 시험에 대한 규제 변화, 맞춤형 의료에 대한 중요성 증가도 시장에 긍정적인 영향을 미치고 있습니다. 복합제, 바이오시밀러 및 기타 혁신적인 의약품의 개발은 특정 유형의 검사 및 특수 제품 제조의 도입으로 이어져 시장을 더욱 활성화시키고 있습니다. 그 외에도 제약 산업의 수많은 혁신, 아웃소싱을 통한 가격 이점, 지속가능한 의약품 개발을 위해 수행되는 광범위한 연구 개발(R&D), 각국 정부의 우호적 인 노력, 임상시험 등록 건수 증가 등이 시장에 기여하고 있습니다.
본 보고서에서 다루는 주요 질문
- 세계 의약품 분석 시험 아웃소싱 시장은 지금까지 어떻게 변화해 왔으며, 앞으로 어떻게 변화할 것인가?
- COVID-19가 세계 의약품 분석 시험 아웃소싱 시장에 미치는 영향은?
- 주요 지역 시장이란?
- 유형별 시장 분석은?
- 서비스별 시장 현황은?
- 최종사용자별 시장 분석은 어떻게 되는가?
- 산업 가치사슬의 다양한 단계는 무엇인가?
- 업계의 주요 촉진요인과 과제는 무엇인가?
- 세계 의약품 분석 시험 아웃소싱 시장의 구조와 주요 업체는?
- 업계 경쟁은 어느 정도인가?
목차
제1장 서문
제2장 조사 범위와 조사 방법
- 조사 목적
- 이해관계자
- 데이터 소스
- 1차 정보
- 2차 정보
- 시장 추정
- 상향식 접근
- 하향식 접근
- 조사 방법
제3장 주요 요약
제4장 소개
- 개요
- 주요 업계 동향
제5장 세계의 의약품 분석 시험 아웃소싱 시장
- 시장 개요
- 시장 실적
- COVID-19의 영향
- 시장 예측
제6장 시장 내역 : 유형별
- 원료의약품(API)
- 시장 동향
- 시장 예측
- 첨가물
- 시장 동향
- 시장 예측
- 완성품
- 시장 동향
- 시장 예측
제7장 시장 내역 : 서비스별
- 생체 분석 시험
- 시장 동향
- 주요 기업
- 임상
- 비임상
- 시장 예측
- 방법 개발과 검증
- 시장 동향
- 주요 기업
- 추출 가능·침출 가능
- 불순물 방법
- 기술 컨설팅
- 기타
- 시장 예측
- 안정성 시험
- 시장 동향
- 주요 기업
- 약물 성분
- 안정성 지시법 검증
- 가속 안정성 시험
- 광안정성 시험
- 기타
- 시장 예측
- 기타
- 시장 동향
- 시장 예측
제8장 시장 내역 : 최종사용자별
- 제약 기업
- 시장 동향
- 시장 예측
- 바이오의약품 기업
- 시장 동향
- 시장 예측
- CRO
- 시장 동향
- 시장 예측
제9장 시장 내역 : 지역별
- 북미
- 미국
- 캐나다
- 아시아태평양
- 중국
- 일본
- 인도
- 한국
- 호주
- 인도네시아
- 기타
- 유럽
- 독일
- 프랑스
- 영국
- 이탈리아
- 스페인
- 러시아
- 기타
- 라틴아메리카
- 브라질
- 멕시코
- 기타
- 중동 및 아프리카
제10장 SWOT 분석
- 개요
- 강점
- 약점
- 기회
- 위협
제11장 밸류체인 분석
제12장 Porter's Five Forces 분석
- 개요
- 구매자의 교섭력
- 공급 기업의 교섭력
- 경쟁 정도
- 신규 참여업체의 위협
- 대체품의 위협
제13장 가격 분석
제14장 경쟁 구도
- 시장 구조
- 주요 기업
- 주요 기업 개요
- 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.
- WuXi AppTec Inc.
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
- 9.1.1 United States
- 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
- 9.2.1 China
- 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
- 9.3.1 Germany
- 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
- 9.4.1 Brazil
- 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
- 14.3.1 Ajinomoto Bio-Pharma Services (Ajinomoto Co. Inc.)
Kindly, note that this only represents a partial list of companies, and the complete list has been provided in the report.
