임상시험 아웃소싱 시장 - 세계 산업 규모, 점유율, 동향, 기회, 예측 : 임상시험 단계별, 치료 분야별, 최종사용자별, 지역별 및 경쟁 상황(2021-2031년)
Clinical Trial Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Clinical Trial Phase, By Therapeutic Area, By End User, By Region & Competition, 2021-2031F
상품코드:1914704
리서치사:TechSci Research
발행일:2026년 01월
페이지 정보:영문 182 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
세계의 임상시험 아웃소싱 시장은 2025년 515억 3,000만 달러에서 2031년까지 771억 2,000만 달러로 확대되고, CAGR 6.95%를 기록할 것으로 예측됩니다.
임상시험 아웃소싱은 프로토콜 설계, 데이터 관리, 사이트 모니터링 등의 연구 업무를 외부 업체에 위탁하여 고정비 절감과 업무의 유연성 향상을 도모하는 것입니다. 이 시장은 주로 복잡한 치료법에 대한 전문 지식을 필요로 하는 동시에 세계화된 연구 물류를 관리하는 제약 개발 회사가 주도하고 있습니다. 임상연구기관협회(ACRO)에 따르면, 2024년 회원사들은 전 세계 약 170만 명의 환자를 대상으로 한 8,854건의 연구에 참여하거나 수행한 것으로 나타났습니다.
시장 개요
예측 기간
2027-2031년
시장 규모 : 2025년
515억 3,000만 달러
시장 규모 : 2031년
771억 2,000만 달러
CAGR : 2026-2031년
6.95%
가장 빠르게 성장하는 부문
종양학
최대 시장
북미
이러한 지속적인 확장에도 불구하고, 다양한 지역에서 일관된 품질 관리를 유지하는 것은 시장 성장의 큰 장벽이 되고 있습니다. 스폰서가 다양한 환자 등록을 보장하기 위해 여러 국가로 임상시험을 확장함에 따라, 서로 다른 규제 프레임워크와 데이터 무결성 기준을 엄격하게 준수해야 하고, 이는 승인까지의 기간을 연장시킬 수 있는 큰 운영상의 복잡성을 야기합니다.
시장 촉진요인
제약 R&D 및 의약품 개발 관련 비용의 상승은 재무적 리스크를 억제하고 파이프라인의 지속가능성을 유지하기 위한 전략적 전환으로 아웃소싱으로의 전환을 촉진하고 있습니다. 신약 개발 프로세스가 자본 집약적으로 변함에 따라, 스폰서 기업들은 임상 업무를 외부 업체에 위탁하여 고정 인프라 비용을 관리 가능한 변동 비용으로 효과적으로 전환하고 있습니다. 2024년 8월에 발표된 '2024년 PhRMA 연례 회원 조사'에 따르면, 회원사들은 2023년에 총 1,035억 달러를 연구개발에 투자했으며, 이러한 막대한 재정적 부담이 CRO(위탁연구기관)로의 전환을 촉진하고 있다는 것을 알 수 있습니다. 이 모델을 통해 개발사들은 현대 치료제 개발의 고위험 환경을 극복하고 자원 배분을 최적화할 수 있습니다.
동시에 중소 바이오텍 기업의 임상시험 활동이 증가하면서 아웃소싱 환경이 크게 변화하고 있습니다. 이러한 소규모 기업들은 내부 인프라가 부족한 경우가 많기 때문에 복잡한 업무와 규제 대응을 포괄적으로 대행해주는 서비스 제공업체에 크게 의존하고 있습니다. 2024년 1월 발표된 J.P. Morgan의 '2024 바이오의약품 라이선싱 벤처 연례 보고서'에 따르면, 2023년 바이오의약품 벤처 투자액은 231억 달러에 달해 외부 지원을 필요로 하는 연구 파이프라인의 강화를 뒷받침하고 있습니다. 이러한 자본 유입은 전 세계 연구를 관리할 수 있는 전문 벤더에 대한 수요를 직접적으로 견인하고 있으며, Icon Plc가 2024년 2023년 전체 매출 81억 2,000만 달러의 매출을 기록한 것이 그 증거입니다.
시장의 과제
다양한 지역에서 일관된 품질 관리와 엄격한 규제 준수를 보장하는 것은 전 세계 임상시험 아웃소싱 시장에서 심각한 병목현상이 되고 있습니다. 스폰서들은 다양한 환자층에 접근하기 위해 전 세계적으로 임상시험을 확대하고 있지만, 현지 시설의 역량에 차이가 있어 운영 환경이 파편화되어 있습니다. 이러한 파편화로 인해 아웃소싱 업체는 데이터의 무결성을 유지하기 위해 시정 조치 및 추가 모니터링에 많은 투자를 해야 하며, 이는 아웃소싱 모델을 추진하는 속도와 비용 효율성을 직접적으로 떨어뜨립니다. 지역 간 격차로 인해 벤더가 통일된 컴플라이언스를 확보하지 못하면, 승인까지 걸리는 시간이 길어지고 시장의 확장성이 제한됩니다.
이러한 운영상의 불안정성은 사이트 레벨의 리소스 제약으로 인해 더욱 악화되어 복잡한 프로토콜의 실행을 방해하고 있습니다. 임상연구사이트협회(SCRS)의 2024년 사이트 환경 조사에 따르면, 60% 이상의 사이트 전문가가 심각한 인력 부족에 직면해 있습니다. 자격을 갖춘 인력의 부족은 다양한 규제 프레임워크에 대응하기 위해 필요한 엄격한 모니터링과 데이터 관리를 직접적으로 저해합니다. 그 결과, 자원이 부족한 지역에서의 규제 준수에 대한 물류 요구가 세계 진출의 이점을 능가하여 시장은 성장 모멘텀을 유지하기 위해 고군분투하고 있습니다.
시장 동향
머신러닝(ML)과 인공지능(AI)의 통합은 업무 효율성과 예측 분석의 향상을 통해 임상시험 수행을 근본적으로 변화시키고 있습니다. 이러한 추세는 이론적 개념에서 위험 평가 및 환자 식별에 대한 실제 적용으로 발전하여, 스폰서가 방대한 데이터세트를 분석하여 프로토콜을 정확하게 최적화할 수 있게 해줍니다. 이러한 알고리즘을 활용하면 아웃소싱 업체는 사이트 성능 문제를 예측하고, 세계 연구의 복잡성 증가에 대응하기 위한 개발 타임라인을 크게 단축할 수 있습니다. Tufts Center for Drug Development Research(CSDD)의 조사에 따르면, 2025년 6월에 발간된 Applied Clinical Trials 저널 기사 "AI 활용 솔루션의 영향에 대한 새로운 발견"에서 지적한 바와 같이, 스폰서 기업 및 CRO의 35.2%가 임상시험 수행과 관련된 AI/ML 활동을 부분적으로 또는 완전히 도입한 것으로 나타났습니다. AI/ML 활동을 부분적으로 또는 완전히 도입한 것으로 나타났습니다.
동시에 하이브리드 및 분산형 임상시험(DCT) 모델의 확산은 물리적 사이트에 대한 의존도를 낮추면서 시장 구조를 변화시키고 있습니다. 이 모델은 환자에게 직접 물류와 원격 모니터링을 통해 다양한 피험자 등록과 환자 유지라는 중요한 요구를 충족시킵니다. 업계가 이러한 하이브리드 워크플로우를 확대함에 따라, 스폰서 기업들은 파일럿 프로그램에서 전사적 디지털 전략으로 전환하고 있으며, 벤더들은 기존 환경 밖에서 원활한 데이터 수집을 보장하는 통합 플랫폼을 제공해야 합니다. 이러한 디지털 의존도의 증가는 Medable의 2025년 1월 보도자료 "Medable, 포트폴리오 수준 eCOA 도입으로 수익 80% 증가"에도 반영되어 있으며, 스폰서들이 확장 가능한 포트폴리오 수준의 디지털 임상시험 투자로 전환함에 따라 2024년 수익이 80% 증가한 것으로 기록되어 있습니다.
The Global Clinical Trial Outsourcing Market is projected to expand from USD 51.53 Billion in 2025 to USD 77.12 Billion by 2031, registering a compound annual growth rate (CAGR) of 6.95%. Clinical trial outsourcing entails delegating research tasks, including protocol design, data management, and site monitoring, to external vendors to lower fixed costs and improve operational flexibility. This market is primarily fueled by pharmaceutical developers needing specialized expertise for complex therapies while managing the logistics of globalized studies. According to the Association of Clinical Research Organizations (ACRO), member companies participated in or conducted 8,854 studies involving roughly 1.7 million patients globally in 2024.
Market Overview
Forecast Period
2027-2031
Market Size 2025
USD 51.53 Billion
Market Size 2031
USD 77.12 Billion
CAGR 2026-2031
6.95%
Fastest Growing Segment
Oncology
Largest Market
North America
Despite this ongoing expansion, upholding consistent quality control across various geographic regions stands as a major obstacle to market growth. As sponsors increasingly spread trials across multiple countries to secure diverse patient enrollment, the necessity of strictly adhering to distinct regulatory frameworks and data integrity standards introduces significant operational complexity that can prolong approval timelines.
Market Driver
Rising costs associated with pharmaceutical R&D and drug development are compelling a strategic shift toward outsourcing to limit financial risks and sustain pipeline viability. As the drug discovery process becomes more capital-intensive, sponsors are delegating clinical operations to external vendors, effectively converting fixed infrastructure costs into manageable variable expenses. According to the '2024 PhRMA Annual Membership Survey' released by PhRMA in August 2024, member companies collectively invested $103.5 billion in R&D during 2023, a figure that highlights the substantial financial burden driving the transition to contract research organizations. This model enables developers to optimize resource allocation while navigating the high-stakes landscape of modern therapeutic development.
Concurrently, the increase in clinical trial activities by small and mid-sized biotech firms is significantly reshaping the outsourcing environment. These smaller entities, often lacking internal infrastructure, depend heavily on full-service providers to handle complex operational and regulatory tasks. J.P. Morgan's '2024 Annual Biopharma Licensing and Venture Report' from January 2024 indicates that biopharma venture investment hit $23.1 billion in 2023, supporting a strong pipeline of studies requiring external assistance. This capital influx directly drives demand for specialized vendors capable of managing global studies, as evidenced by Icon Plc recording full-year 2023 revenue of $8.12 billion in 2024.
Market Challenge
The difficulty of ensuring consistent quality control and strict regulatory adherence across diverse geographic regions serves as a critical bottleneck for the Global Clinical Trial Outsourcing Market. Although sponsors broaden trials globally to access diverse patient pools, variations in local site capabilities lead to a fragmented operational landscape. This fragmentation compels outsourcing vendors to invest heavily in remediation and additional oversight to maintain data integrity, which directly diminishes the speed and cost-efficiency that drive the outsourcing model. When vendors cannot ensure uniform compliance due to regional disparities, approval timelines extend, and market scalability is restricted.
This operational instability is further aggravated by resource constraints at the site level, which hinder the execution of complex protocols. The Society for Clinical Research Sites (SCRS) reported in its 2024 Site Landscape Survey that over 60% of site professionals face significant staffing shortages. This scarcity of qualified personnel directly impedes the rigorous monitoring and data management necessary to navigate varying regulatory frameworks. Consequently, the market struggles to maintain growth momentum as the logistical demands of ensuring regulatory compliance in under-resourced regions outweigh the advantages of global reach.
Market Trends
The integration of Machine Learning (ML) and Artificial Intelligence (AI) is fundamentally transforming clinical trial execution by improving operational efficiency and predictive analytics. This trend has advanced from theoretical concepts to practical application in risk assessment and patient identification, enabling sponsors to analyze massive datasets for accurate protocol optimization. By utilizing these algorithms, outsourcing vendors can forecast site performance issues and significantly shorten development timelines to address the rising complexity of global studies. As noted in the article 'New Insights On the Impact of AI-Enabled Solutions' by Applied Clinical Trials in June 2025, a survey by the Tufts Center for the Study of Drug Development (CSDD) revealed that 35.2% of sponsor companies and CROs have partially or fully adopted AI/ML activities related to clinical trial execution.
Simultaneously, the widespread acceptance of Hybrid and Decentralized Clinical Trial (DCT) models is reshaping the market by reducing reliance on physical sites. This model meets critical needs for diverse enrollment and patient retention through direct-to-patient logistics and remote monitoring. As the industry scales these hybrid workflows, sponsors are shifting from pilot programs to enterprise-wide digital strategies, requiring vendors to offer integrated platforms that ensure seamless data capture outside traditional settings. This increase in digital reliance is reflected in Medable's January 2025 press release, 'Medable Reports 80% Revenue Growth from Portfolio-Level eCOA Adoption', which recorded an 80% revenue increase for 2024 driven by sponsors moving toward scalable, portfolio-level digital trial investments.
Key Market Players
ICON plc
PAREXEL International Corp.
Thermo Fisher Scientific, Inc
Sygnature Discovery Limited
WuXi AppTec Co., Ltd.
Laboratory Corporation of America Holdings
Jubilant Biosys Limited
Charles River Laboratories International, Inc
Albany Molecular Research, Inc
Syneos Health Inc
Report Scope
In this report, the Global Clinical Trial Outsourcing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Clinical Trial Outsourcing Market, By Clinical Trial Phase
Phase 0
Phase 1
Phase 2
Phase 3
Phase 4
Clinical Trial Outsourcing Market, By Therapeutic Area
Oncology
Hematology
Central Nervous System
Cardiovascular/Metabolic
Respiratory
Infectious Diseases
Immunology
Rare Diseases
Medical Devices
Others
Clinical Trial Outsourcing Market, By End User
Biotechnology & Pharmaceutical Companies
Medical Device Companies
Academic & Research Institutions
Clinical Trial Outsourcing Market, By Region
North America
United States
Canada
Mexico
Europe
France
United Kingdom
Italy
Germany
Spain
Asia Pacific
China
India
Japan
Australia
South Korea
South America
Brazil
Argentina
Colombia
Middle East & Africa
South Africa
Saudi Arabia
UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Clinical Trial Outsourcing Market.
Available Customizations:
Global Clinical Trial Outsourcing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
Detailed analysis and profiling of additional market players (up to five).
Table of Contents
1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Clinical Trial Outsourcing Market Outlook
5.2.2. By Therapeutic Area (Oncology, Hematology, Central Nervous System, Cardiovascular/Metabolic, Respiratory, Infectious Diseases, Immunology, Rare Diseases, Medical Devices, Others)
5.2.3. By End User (Biotechnology & Pharmaceutical Companies, Medical Device Companies, Academic & Research Institutions)
5.2.4. By Region
5.2.5. By Company (2025)
5.3. Market Map
6. North America Clinical Trial Outsourcing Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Clinical Trial Phase
6.2.2. By Therapeutic Area
6.2.3. By End User
6.2.4. By Country
6.3. North America: Country Analysis
6.3.1. United States Clinical Trial Outsourcing Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Clinical Trial Phase
6.3.1.2.2. By Therapeutic Area
6.3.1.2.3. By End User
6.3.2. Canada Clinical Trial Outsourcing Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Clinical Trial Phase
6.3.2.2.2. By Therapeutic Area
6.3.2.2.3. By End User
6.3.3. Mexico Clinical Trial Outsourcing Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Clinical Trial Phase
6.3.3.2.2. By Therapeutic Area
6.3.3.2.3. By End User
7. Europe Clinical Trial Outsourcing Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Clinical Trial Phase
7.2.2. By Therapeutic Area
7.2.3. By End User
7.2.4. By Country
7.3. Europe: Country Analysis
7.3.1. Germany Clinical Trial Outsourcing Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Clinical Trial Phase
7.3.1.2.2. By Therapeutic Area
7.3.1.2.3. By End User
7.3.2. France Clinical Trial Outsourcing Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Clinical Trial Phase
7.3.2.2.2. By Therapeutic Area
7.3.2.2.3. By End User
7.3.3. United Kingdom Clinical Trial Outsourcing Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Clinical Trial Phase
7.3.3.2.2. By Therapeutic Area
7.3.3.2.3. By End User
7.3.4. Italy Clinical Trial Outsourcing Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Clinical Trial Phase
7.3.4.2.2. By Therapeutic Area
7.3.4.2.3. By End User
7.3.5. Spain Clinical Trial Outsourcing Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Clinical Trial Phase
7.3.5.2.2. By Therapeutic Area
7.3.5.2.3. By End User
8. Asia Pacific Clinical Trial Outsourcing Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Clinical Trial Phase
8.2.2. By Therapeutic Area
8.2.3. By End User
8.2.4. By Country
8.3. Asia Pacific: Country Analysis
8.3.1. China Clinical Trial Outsourcing Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Clinical Trial Phase
8.3.1.2.2. By Therapeutic Area
8.3.1.2.3. By End User
8.3.2. India Clinical Trial Outsourcing Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Clinical Trial Phase
8.3.2.2.2. By Therapeutic Area
8.3.2.2.3. By End User
8.3.3. Japan Clinical Trial Outsourcing Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Clinical Trial Phase
8.3.3.2.2. By Therapeutic Area
8.3.3.2.3. By End User
8.3.4. South Korea Clinical Trial Outsourcing Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Clinical Trial Phase
8.3.4.2.2. By Therapeutic Area
8.3.4.2.3. By End User
8.3.5. Australia Clinical Trial Outsourcing Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Clinical Trial Phase
8.3.5.2.2. By Therapeutic Area
8.3.5.2.3. By End User
9. Middle East & Africa Clinical Trial Outsourcing Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Clinical Trial Phase
9.2.2. By Therapeutic Area
9.2.3. By End User
9.2.4. By Country
9.3. Middle East & Africa: Country Analysis
9.3.1. Saudi Arabia Clinical Trial Outsourcing Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Clinical Trial Phase
9.3.1.2.2. By Therapeutic Area
9.3.1.2.3. By End User
9.3.2. UAE Clinical Trial Outsourcing Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Clinical Trial Phase
9.3.2.2.2. By Therapeutic Area
9.3.2.2.3. By End User
9.3.3. South Africa Clinical Trial Outsourcing Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Clinical Trial Phase
9.3.3.2.2. By Therapeutic Area
9.3.3.2.3. By End User
10. South America Clinical Trial Outsourcing Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Clinical Trial Phase
10.2.2. By Therapeutic Area
10.2.3. By End User
10.2.4. By Country
10.3. South America: Country Analysis
10.3.1. Brazil Clinical Trial Outsourcing Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Clinical Trial Phase
10.3.1.2.2. By Therapeutic Area
10.3.1.2.3. By End User
10.3.2. Colombia Clinical Trial Outsourcing Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Clinical Trial Phase
10.3.2.2.2. By Therapeutic Area
10.3.2.2.3. By End User
10.3.3. Argentina Clinical Trial Outsourcing Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Clinical Trial Phase
10.3.3.2.2. By Therapeutic Area
10.3.3.2.3. By End User
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Merger & Acquisition (If Any)
12.2. Product Launches (If Any)
12.3. Recent Developments
13. Global Clinical Trial Outsourcing Market: SWOT Analysis
14. Porter's Five Forces Analysis
14.1. Competition in the Industry
14.2. Potential of New Entrants
14.3. Power of Suppliers
14.4. Power of Customers
14.5. Threat of Substitute Products
15. Competitive Landscape
15.1. ICON plc
15.1.1. Business Overview
15.1.2. Products & Services
15.1.3. Recent Developments
15.1.4. Key Personnel
15.1.5. SWOT Analysis
15.2. PAREXEL International Corp.
15.3. Thermo Fisher Scientific, Inc
15.4. Sygnature Discovery Limited
15.5. WuXi AppTec Co., Ltd.
15.6. Laboratory Corporation of America Holdings
15.7. Jubilant Biosys Limited
15.8. Charles River Laboratories International, Inc
