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.
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.
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.
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.
Active Pharmaceutical Ingredients (API)
Additives
Finished Products
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
Pharmaceutical Companies
Biopharmaceutical Companies
Contract Research Organizations
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
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.
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.
Active Pharmaceutical Ingredients (API)
Additives
Finished Products
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
Pharmaceutical Companies
Biopharmaceutical Companies
Contract Research Organizations
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
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.
Kindly, note that this only represents a partial list of companies, and the complete list has been provided in the report.