세계의 규제 업무 아웃소싱 시장 : 산업 규모, 점유율, 동향, 기회, 예측, 서비스별, 카테고리별, 기업 규모별, 적응증별, 제품 단계별, 최종 용도별, 지역별, 경쟁별(2020-2030년)
Regulatory Affairs Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service, By Category, By Company Size, By Indication, By Product Stage, By End Use, By Region and Competition, 2020-2030F
상품코드:1732819
리서치사:TechSci Research
발행일:2025년 05월
페이지 정보:영문 180 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
세계의 규제 업무 아웃소싱 시장 규모는 2024년에 68억 4,000만 달러로 평가되었고, 2030년에는 119억 4,000만 달러에 이를것으로 예측되며, CAGR 9.73%로 성장할 것으로 전망됩니다.
시장 확대는 주로 R&D 노력의 증가와 임상시험 신청 및 제품 등록 건수의 증가에 의해 주도됩니다. 또한 의약품 비용 통제를 목표로 하는 규제 조치로 인해 생명과학 기업이 규제 기능을 아웃소싱하도록 장려하는 경제적 압박이 발생하고 있습니다. 코로나19 팬데믹으로 인해 긴급한 백신 개발로 인해 간소화된 규제 프로세스의 중요성이 강조되면서 이러한 추세는 더욱 가속화되었습니다. 글로벌화가 계속되면서 해외 시장에 진출하는 기업은 복잡한 규제 표준에 직면하게 되었고, 이에 따라 규정 준수를 효율적으로 수행하기 위해 외부 전문 지식에 대한 의존도가 높아지고 있습니다. 이러한 수요는 운영 비용이 낮고 규제 환경이 점점 더 매력적인 신흥 시장에서 특히 강세를 보이고 있습니다.
시장 개요
예측 기간
2026-2030년
시장 규모(2024년)
68억 4,000만 달러
시장 규모(2030년)
119억 4,000만 달러
CAGR(2025-2030년)
9.73%
급성장 부문
법정 대리
최대 시장
아시아태평양
시장 성장 촉진요인
바이오 의약품 및 의료 기기 기업의 세계화
주요 시장 과제
데이터 보안 및 개인정보 보호에 대한 우려
주요 시장 동향
규제 프로세스의 기술 발전
목차
제1장 개요
제2장 조사 방법
제3장 주요 요약
제4장 고객의 목소리
제5장 세계의 규제 업무 아웃소싱 시장 전망
시장 규모와 예측
금액별
시장 점유율 및 예측
서비스별(규제 컨설팅, 법정 대리, 규제 작성 및 출판, 제품 등록 및 임상시험 신청, 규제 제출, 규제 업무, 기타 서비스)
카테고리별(의약품, 의료 기기)
기업 규모별(중소 기업, 중견 기업, 대규모 기업)
적응증별(종양학, 신경학, 심장학, 면역학, 기타 적응증)
제품 단계별(전임상, 임상, 시판 전 승인)
용도별(의료 기기, 제약, 생명공학)
지역별(북미, 유럽, 아시아태평양, 남미, 중동 및 아프리카)
기업별(2024년)
시장 맵
서비스별
카테고리별
기업 규모별
적응증별
제품 단계별
최종 용도별
제6장 북미의 규제 업무 아웃소싱 시장 전망
시장 규모와 예측
시장 점유율 및 예측
북미 : 국가별 분석
미국
캐나다
멕시코
제7장 유럽의 규제 업무 아웃소싱 시장 전망
시장 규모와 예측
시장 점유율과 예측
유럽 : 국가별 분석
프랑스
독일
영국
이탈리아
스페인
제8장 아시아태평양의 규제 업무 아웃소싱 시장 전망
시장 규모와 예측
시장 점유율 및 예측
아시아태평양 : 국가별 분석
중국
인도
일본
한국
호주
제9장 남미의 규제 업무 아웃소싱 시장 전망
시장 규모와 예측
시장 점유율 및 예측
남미 : 국가별 분석
브라질
아르헨티나
콜롬비아
제10장 중동 및 아프리카의 규제 업무 아웃소싱 시장 전망
시장 규모와 예측
시장 점유율 및 예측
중동 및 아프리카 : 국가별 분석
남아프리카
사우디아라비아
아랍에미리트(UAE)
제11장 시장 역학
성장 촉진요인
과제
제12장 시장 동향 및 발전
최근 동향
합병 및 인수
제품 출시
제13장 세계의 규제 업무 아웃소싱 시장 : SWOT 분석
제14장 Porter's Five Forces 분석
업계 내 경쟁
신규 진입의 가능성
공급자의 힘
고객의 힘
대체품의 위협
제15장 경쟁 구도
Accell Clinical Research, LLC.
Genpact Ltd.
CRITERIUM, INC.
Promedica International.
WuXi AppTec Co Ltd.
Medpace Inc.
Charles River Laboratories Inc.
ICON plc.
Covance, Inc.
Parexel International Corporation.
제16장 전략적 제안
제17장 기업 소개와 면책사항
HBR
영문 목차
영문목차
The Global Regulatory Affairs Outsourcing Market was valued at USD 6.84 billion in 2024 and is anticipated to reach USD 11.94 billion by 2030, growing at a CAGR of 9.73%. Market expansion is primarily driven by increased R&D efforts and a rising number of clinical trial applications and product registrations. Additionally, regulatory measures aimed at controlling drug costs are generating economic pressures that encourage life sciences companies to outsource regulatory functions. The COVID-19 pandemic further accelerated this trend, as the urgent development of vaccines underscored the importance of streamlined regulatory processes. As globalization continues, companies entering international markets face a complex web of regulatory standards, prompting greater reliance on external expertise to navigate compliance efficiently. This demand is especially strong in emerging markets where operational costs are lower and regulatory environments are increasingly attractive for expansion.
Market Overview
Forecast Period
2026-2030
Market Size 2024
USD 6.84 Billion
Market Size 2030
USD 11.94 Billion
CAGR 2025-2030
9.73%
Fastest Growing Segment
Legal Representation
Largest Market
Asia Pacific
Key Market Drivers
Globalization of Biopharmaceutical and Medical Device Companies
The expansion of biopharmaceutical and medical device companies into international markets is a major driver behind the growth of regulatory affairs outsourcing. Each new market introduces unique compliance requirements, demanding specialized regulatory knowledge. Outsourcing helps companies manage these challenges efficiently and cost-effectively. Emerging regions such as Asia Pacific, Latin America, and the Middle East & Africa are particularly appealing due to lower development costs, skilled labor availability, and favorable regulatory climates. For instance, infrastructure investments like B. Braun's five new facilities in Malaysia and Flex Ltd.'s site in India reflect the trend of companies expanding regionally while leveraging outsourced regulatory expertise to ensure compliance.
Key Market Challenges
Data Security and Privacy Concerns
Security and privacy of sensitive regulatory information are critical challenges in this market. As outsourcing increases, so does the risk of data breaches and cyberattacks. The growing use of digital platforms-such as electronic Common Technical Document (eCTD) submissions and digital IND safety reporting-amplifies vulnerabilities. Additionally, mergers and acquisitions within the healthcare sector can expose organizations to greater cybersecurity threats due to the volume and sensitivity of exchanged data, posing a significant risk to business continuity and regulatory compliance.
Key Market Trends
Technological Advancements in Regulatory Processes
Technological progress is reshaping regulatory affairs outsourcing, introducing tools that enhance transparency, speed, and collaboration. Regulatory Information Management Systems (RIMS) are streamlining submission tracking and compliance monitoring. Cloud-based platforms enable real-time interaction between clients and service providers, improving operational efficiency. Furthermore, artificial intelligence (AI) and machine learning are being used to automate administrative tasks like data entry and document processing, allowing regulatory professionals to focus on strategic functions. These technologies are optimizing regulatory workflows, making it easier for companies to meet global compliance standards swiftly and accurately.
Key Market Players
Accell Clinical Research, LLC.
Genpact Ltd.
CRITERIUM, INC.
Promedica International.
WuXi AppTec Co Ltd.
Medpace Inc.
Charles River Laboratories Inc.
ICON plc.
Covance, Inc.
Parexel International Corporation.
Report Scope:
In this report, Global Regulatory Affairs Outsourcing market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Regulatory Affairs Outsourcing Market, By Service:
Regulatory Affairs Outsourcing Market, By Category:
Pharmaceutical
Medical Device
Regulatory Affairs Outsourcing Market, By Company Size:
Small Companies
Medium Companies
Large Companies
Regulatory Affairs Outsourcing Market, By Indication:
Oncology
Neurology
Cardiology
Immunology
Other Indications
Regulatory Affairs Outsourcing Market, By Product Stage:
Preclinical
Clinical
Premarket Approval
Regulatory Affairs Outsourcing Market, By End Use:
Medical Device Companies
Pharmaceutical Companies
Biotechnology Companies
Regulatory Affairs Outsourcing Market, By Region:
North America
United States
Canada
Mexico
Europe
France
Germany
United Kingdom
Italy
Spain
Asia Pacific
China
India
Japan
South Korea
Australia
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 Regulatory Affairs Outsourcing Market.
Available Customizations:
Global Regulatory Affairs 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 Regulatory Affairs Outsourcing Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
5.2.2. By Category (Pharmaceutical, Medical Device)
5.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
5.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
5.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
5.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
5.2.7. By Region (North America, Europe, Asia Pacific, South America, Middle East & Africa)
5.2.8. By Company (2024)
5.3. Market Map
5.3.1 By Service
5.3.2 By Category
5.3.3 By Company Size
5.3.4 By Indication
5.3.5 By Product Stage
5.3.6 By End Use
6. North America Regulatory Affairs Outsourcing Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
6.2.2. By Category (Pharmaceutical, Medical Device)
6.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
6.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
6.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
6.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
6.2.7. By Country
6.3. North America: Country Analysis
6.3.1. United States Regulatory Affairs 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 Service
6.3.1.2.2. By Category
6.3.1.2.3. By Company Size
6.3.1.2.4. By Indication
6.3.1.2.5. By Product Stage
6.3.1.2.6. By End Use
6.3.2. Canada Regulatory Affairs 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 Service
6.3.2.2.2. By Category
6.3.2.2.3. By Company Size
6.3.2.2.4. By Indication
6.3.2.2.5. By Product Stage
6.3.2.2.6. By End Use
6.3.3. Mexico Regulatory Affairs 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 Service
6.3.3.2.2. By Category
6.3.3.2.3. By Company Size
6.3.3.2.4. By Indication
6.3.3.2.5. By Product Stage
6.3.3.2.6. By End Use
7. Europe Regulatory Affairs Outsourcing Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
7.2.2. By Category (Pharmaceutical, Medical Device)
7.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
7.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
7.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
7.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
7.2.7. By Country
7.3. Europe: Country Analysis
7.3.1. France Regulatory Affairs 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 Service
7.3.1.2.2. By Category
7.3.1.2.3. By Company Size
7.3.1.2.4. By Indication
7.3.1.2.5. By Product Stage
7.3.1.2.6. By End Use
7.3.2. Germany Regulatory Affairs 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 Service
7.3.2.2.2. By Category
7.3.2.2.3. By Company Size
7.3.2.2.4. By Indication
7.3.2.2.5. By Product Stage
7.3.2.2.6. By End Use
7.3.3. United Kingdom Regulatory Affairs 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 Service
7.3.3.2.2. By Category
7.3.3.2.3. By Company Size
7.3.3.2.4. By Indication
7.3.3.2.5. By Product Stage
7.3.3.2.6. By End Use
7.3.4. Italy Regulatory Affairs 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 Service
7.3.4.2.2. By Category
7.3.4.2.3. By Company Size
7.3.4.2.4. By Indication
7.3.4.2.5. By Product Stage
7.3.4.2.6. By End Use
7.3.5. Spain Regulatory Affairs 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 Service
7.3.5.2.2. By Category
7.3.5.2.3. By Company Size
7.3.5.2.4. By Indication
7.3.5.2.5. By Product Stage
7.3.5.2.6. By End Use
8. Asia-Pacific Regulatory Affairs Outsourcing Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
8.2.2. By Category (Pharmaceutical, Medical Device)
8.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
8.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
8.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
8.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
8.2.7. By Country
8.3. Asia-Pacific: Country Analysis
8.3.1. China Regulatory Affairs 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 Service
8.3.1.2.2. By Category
8.3.1.2.3. By Company Size
8.3.1.2.4. By Indication
8.3.1.2.5. By Product Stage
8.3.1.2.6. By End Use
8.3.2. India Regulatory Affairs 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 Service
8.3.2.2.2. By Category
8.3.2.2.3. By Company Size
8.3.2.2.4. By Indication
8.3.2.2.5. By Product Stage
8.3.2.2.6. By End Use
8.3.3. Japan Regulatory Affairs 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 Service
8.3.3.2.2. By Category
8.3.3.2.3. By Company Size
8.3.3.2.4. By Indication
8.3.3.2.5. By Product Stage
8.3.3.2.6. By End Use
8.3.4. South Korea Regulatory Affairs 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 Service
8.3.4.2.2. By Category
8.3.4.2.3. By Company Size
8.3.4.2.4. By Indication
8.3.4.2.5. By Product Stage
8.3.4.2.6. By End Use
8.3.5. Australia Regulatory Affairs 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 Service
8.3.5.2.2. By Category
8.3.5.2.3. By Company Size
8.3.5.2.4. By Indication
8.3.5.2.5. By Product Stage
8.3.5.2.6. By End Use
9. South America Regulatory Affairs Outsourcing Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
9.2.2. By Category (Pharmaceutical, Medical Device)
9.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
9.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
9.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
9.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
9.2.7. By Country
9.3. South America: Country Analysis
9.3.1. Brazil Regulatory Affairs 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 Service
9.3.1.2.2. By Category
9.3.1.2.3. By Company Size
9.3.1.2.4. By Indication
9.3.1.2.5. By Product Stage
9.3.1.2.6. By End Use
9.3.2. Argentina Regulatory Affairs 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 Service
9.3.2.2.2. By Category
9.3.2.2.3. By Company Size
9.3.2.2.4. By Indication
9.3.2.2.5. By Product Stage
9.3.2.2.6. By End Use
9.3.3. Colombia Regulatory Affairs 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 Service
9.3.3.2.2. By Category
9.3.3.2.3. By Company Size
9.3.3.2.4. By Indication
9.3.3.2.5. By Product Stage
9.3.3.2.6. By End Use
10. Middle East and Africa Regulatory Affairs Outsourcing Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
10.2.2. By Category (Pharmaceutical, Medical Device)
10.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
10.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
10.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
10.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
10.2.7. By Country
10.3. MEA: Country Analysis
10.3.1. South Africa Regulatory Affairs 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 Service
10.3.1.2.2. By Category
10.3.1.2.3. By Company Size
10.3.1.2.4. By Indication
10.3.1.2.5. By Product Stage
10.3.1.2.6. By End Use
10.3.2. Saudi Arabia Regulatory Affairs 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 Service
10.3.2.2.2. By Category
10.3.2.2.3. By Company Size
10.3.2.2.4. By Indication
10.3.2.2.5. By Product Stage
10.3.2.2.6. By End Use
10.3.3. UAE Regulatory Affairs 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 Service
10.3.3.2.2. By Category
10.3.3.2.3. By Company Size
10.3.3.2.4. By Indication
10.3.3.2.5. By Product Stage
10.3.3.2.6. By End Use
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Recent Development
12.2. Mergers & Acquisitions
12.3. Product Launches
13. Global Regulatory Affairs Outsourcing Market: SWOT Analysis
