세계의 규제업무 아웃소싱 시장(2025-2035년) : 산업 분석, 시장 규모, 점유율, 성장, 동향, 예측
Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2025-2035
상품코드:1769904
리서치사:Transparency Market Research
발행일:2025년 05월
페이지 정보:영문 221 Pages
라이선스 & 가격 (부가세 별도)
한글목차
규제업무 아웃소싱 시장 - 분석 범위
TMR의 조사 보고서 '세계의 규제업무 아웃소싱 시장'은 2025년부터 2035년까지의 예측 기간 동안 시장 지표에 관한 귀중한 인사이트를 얻기 위해 과거뿐만 아니라 현재의 성장 동향과 기회에 대해서도 조사했습니다. 2025년을 기준연도, 2035년을 예측연도로 하여 2019년부터 2035년까지 세계의 규제업무 아웃소싱 시장의 수익과 예측을 제공합니다.
이 보고서는 광범위한 조사를 거쳐 작성되었으며, 1차 조사에서 분석가는 KOL(Key Opinion Leader), 업계 리더, 의사결정자와의 인터뷰를 실시했습니다.
시장 개황
시장 규모(2024년)
74억 달러
시장 규모(2035년)
223억 달러
CAGR
10.6%
본 보고서에서는 세계의 규제업무 아웃소싱 시장 경쟁 구도에 대해 분석했습니다.
목차
제1장 서론
제2장 전제조건과 분석방법
제3장 주요 요약 : 세계 시장
제4장 시장 개요
소개
개요
시장 역학
세계의 규제업무 아웃소싱 시장 분석과 예측(2020-2035년)
제5장 주요 인사이트
현재의 동향의 개요
Porter's Five Forces 분석
PESTEL 분석
주요 지역/국가의 규제 시나리오
주요 기업/규제 당국에 의한 서비스 개시/승인
기업 합병 및 인수(M&A) 시나리오 : 규제업무 아웃소싱 시장
경쟁이 제공하는 서비스의 벤치마크
규제업무 아웃소싱 서비스에 대한 투자 동향
신규 시장 참가자를 위한 시장 개척 전략
제6장 세계 시장의 분석과 예측 : 서비스 유형별
소개 및 정의
주요 분석결과/진전
시장 예측(금액 기준) : 서비스 유형별(2020-2035년)
규제 컨설팅 및 법적 대리
제품 등록 및 임상시험 신청
규제문서의 작성 및 간행
규제당국 제출
규제업무
기타
시장의 매력 : 서비스 유형별
제7장 세계 시장 분석 및 예측 : 제품개발 단계별
소개 및 정의
주요 분석결과/진전
시장 예측(금액 기준) : 제품개발 단계별(2020-2035년)
전임상
임상
PMA(시판 후 승인)
시장의 매력 : 제품개발 단계별
제8장 세계 시장 분석과 예측 : 기업 규모별
소개 및 정의
주요 분석결과/진전
시장 예측(금액 기준) : 기업 규모별(2020-2035년)
중소기업
대기업
시장의 매력 : 기업 규모별
제9장 세계 시장의 분석과 예측 : 치료영역별
소개 및 정의
주요 분석결과/진전
시장 예측(금액 기준) : 치료영역별(2020-2035년)
종양학
신경학
심장병학
면역학
피부과
기타
시장의 매력 : 치료영역별
제10장 세계 시장 분석 및 예측 : 최종사용자별
소개 및 정의
주요 분석결과/진전
시장 예측(금액 기준) : 최종사용자별(2020-2035년)
의료기기 기업
바이오의약품 및 제약회사
기타
시장의 매력 : 최종사용자별
제11장 세계 시장 분석 및 예측 : 지역별
주요 분석결과
시장 예측(금액 기준) : 지역별
북미
유럽
아시아태평양
라틴아메리카
중동 및 아프리카
시장의 매력 : 지역별
제12장 북미 시장의 분석과 예측
미국
캐나다
제13장 유럽 시장의 분석과 예측
독일
영국
프랑스
이탈리아
스페인
스위스
네덜란드
기타 유럽
제14장 아시아태평양시장의 분석과 예측
중국
일본
인도
호주 및 뉴질랜드
한국
기타 아시아태평양
제15장 라틴아메리카 시장의 분석과 예측
브라질
멕시코
아르헨티나
기타 라틴아메리카
제16장 중동 및 아프리카 시장의 분석과 예측
GCC 국가
남아프리카
기타 중동 및 아프리카
제17장 경쟁 구도
시장 기업 및 경쟁 매트릭스(기업의 계층별 및 규모별)
시장 점유율 분석 : 기업별(2024년)
기업 프로파일
Accell Clinical Research, LLC
Genpact
CRITERIUM, INC
Promedica International
WuXi AppTec
Medpace
Charles River Laboratories
ICON plc
Parexel International Corporation
Freyr
PHARMALEX GMBH
Labcorp Drug Development
Other Prominent Players
CSM
영문 목차
영문목차
Regulatory Affairs Outsourcing Market - Scope of Report
TMR's report on the global regulatory affairs outsourcing market studies the past as well as the current growth trends and opportunities to gain valuable insights of the indicators of the market during the forecast period from 2025 to 2035. The report provides revenue of the global regulatory affairs outsourcing market for the period 2019-2035, considering 2025 as the base year and 2035 as the forecast year. The report also provides the compound annual growth rate (CAGR %) of the global regulatory affairs outsourcing market from 2025 to 2035.
The report has been prepared after an extensive research. Primary research involved bulk of the research efforts, wherein analysts carried out interviews with key opinion leaders, industry leaders, and opinion makers. Secondary research involved referring to key players' product literature, annual reports, press releases, and relevant documents to understand the regulatory affairs outsourcing market.
Market Snapshot
Market Value in 2024
US$ 7.4 Bn
Market Value in 2035
US$ 22.3 Bn
CAGR
10.6%
Secondary research also included Internet sources, statistical data from government agencies, websites, and trade associations. Analysts employed a combination of top-down and bottom-up approaches to study various attributes of the global regulatory affairs outsourcing market.
The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments included in the scope of the study. Moreover, the report throws light on the changing competitive dynamics in the global regulatory affairs outsourcing market. These serve as valuable tools for existing market players as well as for entities interested in participating in the global regulatory affairs outsourcing market.
The report delves into the competitive landscape of the global regulatory affairs outsourcing market. Key players operating in the global regulatory affairs outsourcing market have been identified and each one of these has been profiled in terms of various attributes. Company overview, financial standings, recent developments, and SWOT are the attributes of players in the global regulatory affairs outsourcing market profiled in this report.
Key Questions Answered in Global regulatory affairs outsourcing Market Report:
What is the sales/revenue generated by regulatory affairs outsourcing across all regions during the forecast period?
What are the opportunities in the global regulatory affairs outsourcing market?
What are the major drivers, restraints, opportunities, and threats in the market?
Which regional market is set to expand at the fastest CAGR during the forecast period?
Which segment is expected to generate the highest revenue globally in 2035?
Which segment is projected to expand at the highest CAGR during the forecast period?
What are the market positions of different companies operating in the global market?
Regulatory Affairs Outsourcing Market - Research Objectives and Research Approach
The comprehensive report on the global regulatory affairs outsourcing market begins with an overview, followed by the scope and objectives of the study. The report provides detailed explanation of the objectives behind this study and key vendors and distributors operating in the market and regulatory scenario for approval of products.
For reading comprehensibility, the report has been compiled in a chapter-wise layout, with each section divided into smaller ones. The report comprises an exhaustive collection of graphs and tables that are appropriately interspersed. Pictorial representation of actual and projected values of key segments is visually appealing to readers. This also allows comparison of the market shares of key segments in the past and at the end of the forecast period.
The report analyzes the global regulatory affairs outsourcing market in terms of product, end-user, and region. Key segments under each criterion have been studied at length, and the market share for each of these at the end of 2035 has been provided. Such valuable insights enable market stakeholders in making informed business decisions for investment in the global regulatory affairs outsourcing market.
Table of Contents
1. Preface
1.1. Market Definition and Scope
1.2. Market Segmentation
1.3. Key Research Objectives
1.4. Research Highlights
2. Assumptions and Research Methodology
3. Executive Summary : Global Regulatory Affairs Outsourcing Market
4. Market Overview
4.1. Introduction
4.1.1. Segment Definition
4.2. Overview
4.3. Market Dynamics
4.3.1. Drivers
4.3.2. Restraints
4.3.3. Opportunities
4.4. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, 2020 to 2035
4.4.1. Market Revenue Projections (US$ Mn)
5. Key Insights
5.1. Overview on Current Trends
5.2. PORTER's Five Forces Analysis
5.3. PESTEL Analysis
5.4. Regulatory Scenario across Key Regions/Country
5.5. Service Launches/Approvals by the Major Players/Regulatory Authority
5.6. Mergers and Acquisition Scenario for Regulatory Affairs Outsourcing Market
5.7. Benchmarking of the Services Offered by the Competitors
5.8. Investment Trends in Regulatory Affairs Outsourcing Services
5.9. Go-to-Market Strategy for New Market Entrants
6. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Service Type
6.1. Introduction & Definition
6.2. Key Findings / Developments
6.3. Market Value Forecast By Service Type, 2020 to 2035
6.3.1. Regulatory Consulting and Legal Representation
6.3.2. Product Registration and Clinical Trial Applications
6.3.3. Regulatory Writing and Publishing
6.3.4. Regulatory Submission
6.3.5. Regulatory Operations
6.3.6. Others
6.4. Market Attractiveness By Service Type
7. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Product Development Stage
7.1. Introduction & Definition
7.2. Key Findings / Developments
7.3. Market Value Forecast By Product Development Stage, 2020 to 2035
7.3.1. Preclinical
7.3.2. Clinical
7.3.3. PMA (Post Market Authorization)
7.4. Market Attractiveness By Product Development Stage
8. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Enterprise Size
8.1. Introduction & Definition
8.2. Key Findings / Developments
8.3. Market Value Forecast By Enterprise Size, 2020 to 2035
8.3.1. Small/Medium Enterprises
8.3.2. Large Enterprises
8.4. Market Attractiveness By Enterprise Size
9. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Therapeutic Area
9.1. Introduction & Definition
9.2. Key Findings / Developments
9.3. Market Value Forecast By Therapeutic Area, 2020 to 2035
9.3.1. Oncology
9.3.2. Neurology
9.3.3. Cardiology
9.3.4. Immunology
9.3.5. Dermatology
9.3.6. Others
9.4. Market Attractiveness By Therapeutic Area
10. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By End-user
10.1. Introduction & Definition
10.2. Key Findings / Developments
10.3. Market Value Forecast By End-user, 2020 to 2035
10.3.1. Medical Device Companies
10.3.2. Biopharma & Pharmaceutical Companies
10.3.3. Others
10.4. Market Attractiveness By End-user
11. Global Regulatory Affairs Outsourcing Market Analysis and Forecasts, By Region
11.1. Key Findings
11.2. Market Value Forecast By Region
11.2.1. North America
11.2.2. Europe
11.2.3. Asia Pacific
11.2.4. Latin America
11.2.5. Middle East & Africa
11.3. Market Attractiveness By Region
12. North America Regulatory Affairs Outsourcing Market Analysis and Forecast
12.1. Introduction
12.1.1. Key Findings
12.2. Market Value Forecast By Service Type, 2020 to 2035
12.2.1. Regulatory Consulting and Legal Representation
12.2.2. Product Registration and Clinical Trial Applications
12.2.3. Regulatory Writing and Publishing
12.2.4. Regulatory Submission
12.2.5. Regulatory Operations
12.2.6. Others
12.3. Market Value Forecast By Product Development Stage, 2020 to 2035
12.3.1. Preclinical
12.3.2. Clinical
12.3.3. PMA (Post Market Authorization)
12.4. Market Value Forecast By Enterprise Size, 2020 to 2035
12.4.1. Small/Medium Enterprises
12.4.2. Large Enterprises
12.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
12.5.1. Oncology
12.5.2. Neurology
12.5.3. Cardiology
12.5.4. Immunology
12.5.5. Dermatology
12.5.6. Others
12.6. Market Value Forecast By End-user, 2020 to 2035
12.6.1. Medical Device Companies
12.6.2. Biopharma & Pharmaceutical Companies
12.6.3. Others
12.7. Market Value Forecast By Country, 2020 to 2035
12.7.1. U.S.
12.7.2. Canada
12.8. Market Attractiveness Analysis
12.8.1. By Service Type
12.8.2. By Product Development Stage
12.8.3. By Enterprise Size
12.8.4. By Therapeutic Area
12.8.5. By End-user
12.8.6. By Country
13. Europe Regulatory Affairs Outsourcing Market Analysis and Forecast
13.1. Introduction
13.1.1. Key Findings
13.2. Market Value Forecast By Service Type, 2020 to 2035
13.2.1. Regulatory Consulting and Legal Representation
13.2.2. Product Registration and Clinical Trial Applications
13.2.3. Regulatory Writing and Publishing
13.2.4. Regulatory Submission
13.2.5. Regulatory Operations
13.2.6. Others
13.3. Market Value Forecast By Product Development Stage, 2020 to 2035
13.3.1. Preclinical
13.3.2. Clinical
13.3.3. PMA (Post Market Authorization)
13.4. Market Value Forecast By Enterprise Size, 2020 to 2035
13.4.1. Small/Medium Enterprises
13.4.2. Large Enterprises
13.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
13.5.1. Oncology
13.5.2. Neurology
13.5.3. Cardiology
13.5.4. Immunology
13.5.5. Dermatology
13.5.6. Others
13.6. Market Value Forecast By End-user, 2020 to 2035
13.6.1. Medical Device Companies
13.6.2. Biopharma & Pharmaceutical Companies
13.6.3. Others
13.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
13.7.1. Germany
13.7.2. UK
13.7.3. France
13.7.4. Italy
13.7.5. Spain
13.7.6. Switzerland
13.7.7. The Netherlands
13.7.8. Rest of Europe
13.8. Market Attractiveness Analysis
13.8.1. By Service Type
13.8.2. By Product Development Stage
13.8.3. By Enterprise Size
13.8.4. By Therapeutic Area
13.8.5. By End-user
13.8.6. By Country/Sub-region
14. Asia Pacific Regulatory Affairs Outsourcing Market Analysis and Forecast
14.1. Introduction
14.1.1. Key Findings
14.2. Market Value Forecast By Service Type, 2020 to 2035
14.2.1. Regulatory Consulting and Legal Representation
14.2.2. Product Registration and Clinical Trial Applications
14.2.3. Regulatory Writing and Publishing
14.2.4. Regulatory Submission
14.2.5. Regulatory Operations
14.2.6. Others
14.3. Market Value Forecast By Product Development Stage, 2020 to 2035
14.3.1. Preclinical
14.3.2. Clinical
14.3.3. PMA (Post Market Authorization)
14.4. Market Value Forecast By Enterprise Size, 2020 to 2035
14.4.1. Small/Medium Enterprises
14.4.2. Large Enterprises
14.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
14.5.1. Oncology
14.5.2. Neurology
14.5.3. Cardiology
14.5.4. Immunology
14.5.5. Dermatology
14.5.6. Others
14.6. Market Value Forecast By End-user, 2020 to 2035
14.6.1. Medical Device Companies
14.6.2. Biopharma & Pharmaceutical Companies
14.6.3. Others
14.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
14.7.1. China
14.7.2. Japan
14.7.3. India
14.7.4. Australia & New Zealand
14.7.5. South Korea
14.7.6. Rest of Asia Pacific
14.8. Market Attractiveness Analysis
14.8.1. By Service Type
14.8.2. By Product Development Stage
14.8.3. By Enterprise Size
14.8.4. By Therapeutic Area
14.8.5. By End-user
14.8.6. By Country/Sub-region
15. Latin America Regulatory Affairs Outsourcing Market Analysis and Forecast
15.1. Introduction
15.1.1. Key Findings
15.2. Market Value Forecast By Service Type, 2020 to 2035
15.2.1. Regulatory Consulting and Legal Representation
15.2.2. Product Registration and Clinical Trial Applications
15.2.3. Regulatory Writing and Publishing
15.2.4. Regulatory Submission
15.2.5. Regulatory Operations
15.2.6. Others
15.3. Market Value Forecast By Product Development Stage, 2020 to 2035
15.3.1. Preclinical
15.3.2. Clinical
15.3.3. PMA (Post Market Authorization)
15.4. Market Value Forecast By Enterprise Size, 2020 to 2035
15.4.1. Small/Medium Enterprises
15.4.2. Large Enterprises
15.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
15.5.1. Oncology
15.5.2. Neurology
15.5.3. Cardiology
15.5.4. Immunology
15.5.5. Dermatology
15.5.6. Others
15.6. Market Value Forecast By End-user, 2020 to 2035
15.6.1. Medical Device Companies
15.6.2. Biopharma & Pharmaceutical Companies
15.6.3. Others
15.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
15.7.1. Brazil
15.7.2. Mexico
15.7.3. Argentina
15.7.4. Rest of Latin America
15.8. Market Attractiveness Analysis
15.8.1. By Service Type
15.8.2. By Product Development Stage
15.8.3. By Enterprise Size
15.8.4. By Therapeutic Area
15.8.5. By End-user
15.8.6. By Country/Sub-region
16. Middle East & Africa Regulatory Affairs Outsourcing Market Analysis and Forecast
16.1. Introduction
16.1.1. Key Findings
16.2. Market Value Forecast By Service Type, 2020 to 2035
16.2.1. Regulatory Consulting and Legal Representation
16.2.2. Product Registration and Clinical Trial Applications
16.2.3. Regulatory Writing and Publishing
16.2.4. Regulatory Submission
16.2.5. Regulatory Operations
16.2.6. Others
16.3. Market Value Forecast By Product Development Stage, 2020 to 2035
16.3.1. Preclinical
16.3.2. Clinical
16.3.3. PMA (Post Market Authorization)
16.4. Market Value Forecast By Enterprise Size, 2020 to 2035
16.4.1. Small/Medium Enterprises
16.4.2. Large Enterprises
16.5. Market Value Forecast By Therapeutic Area, 2020 to 2035
16.5.1. Oncology
16.5.2. Neurology
16.5.3. Cardiology
16.5.4. Immunology
16.5.5. Dermatology
16.5.6. Others
16.6. Market Value Forecast By End-user, 2020 to 2035
16.6.1. Medical Device Companies
16.6.2. Biopharma & Pharmaceutical Companies
16.6.3. Others
16.7. Market Value Forecast By Country/Sub-region, 2020 to 2035
16.7.1. GCC Countries
16.7.2. South Africa
16.7.3. Rest of Middle East & Africa
16.8. Market Attractiveness Analysis
16.8.1. By Service Type
16.8.2. By Product Development Stage
16.8.3. By Enterprise Size
16.8.4. By Therapeutic Area
16.8.5. By End-user
16.8.6. By Country/Sub-region
17. Competition Landscape
17.1. Market Player - Competition Matrix (By Tier and Size of companies)
