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시장보고서
상품코드
1672676
세계의 약사 규제 업무 아웃소싱 시장 : 서비스 유형별, 최종사용자별, 스테이지별, 치료 영역별, 지역별Regulatory Affairs Outsourcing Market, By Service Type, By End User, By Stage, By Therapeutic Area, By Geography |
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※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.
세계의 약사 규제 업무 아웃소싱 시장 규모는 2025년에는 93억 3,000만 달러, 2032년에는 192억 6,000만 달러에 이르고, 2025-2032년 CAGR 10.9%로 성장할 것으로 예측됩니다.
| 보고서 범위 | 보고서 상세 | ||
|---|---|---|---|
| 기준연도 | 2024년 | 2025년 시장 규모 | 93억 3,000만 달러 |
| 실적 데이터 | 2020-2024년 | 예측 기간 | 2025-2032년 |
| 예측 기간(2025-2032년) CAGR : | 10.90% | 2032년 가치 예측 | 192억 6,000만 달러 |
그림. 약사 규제 업무 아웃소싱 시장 점유율(%), 2025년, 지역별
세계의 약사 규제 업무 아웃소싱 시장 성장을 가속하고 있는 것은 규제 프레임워크 복잡화입니다.규제 요건은 지역에 의해서 어려워지고 있어 컴플라이언스에 필요한 전문 지식과 리소스가 필요하고 있습니다. 또한 의약품 개발 프로세스는 첨단에 규제되게 되어, 임상 개발로부터 승인에 이르는 다양한 단계에서 컴플라이언스 면밀한 감시와 관리가 필요하게 되어 있습니다.이 때문에 의료기기 제조업체를 포함한 제약 기업이나 바이오테크놀러지 기업은 약사 규제 업무를 아웃소싱 하기 위해서, 전문 지식을 가지는 제삼자 서비스 제공업체를 이용하게 되어 있습니다.약사 규제 업무 아웃소싱은 기업이 프로세스를 합리화해, 비용을 삭감해, 핵심 역량에 리소스를 집중시키는데 도움이 됩니다.
시장 역학 :
세계의 약사 규제 업무 아웃소싱 시장 성장은 제약 기업 및 바이오테크놀러지 기업 연구개발비 증가, 엄격한 규제 환경, 비용 압력등의 요인에 의해 초래됩니다.그러나, 데이터 프라이버시와 보안에 관한 우려나 품질관리 문제가 시장 성장 방해가 될 가능성이 있습니다.신흥 시장은 아웃소싱이나 임상시험 활동이 아시아태평양이나 라틴아메리카 저비용 목적지에 시프트 하고 있기 때문에 큰 비즈니스 기회를 제공할 가능성이 있습니다. 또한 약사 규제 서비스 제공업체가 채택하는 M&A나 제휴 전략 증가에 의해 그 능력과 세계인 사업 전개가 확대해, 새로운 성장 기회가 초래될 가능성이 있습니다.
본 조사 주요 특징
- 본 보고서에서는 세계의 약사 규제 업무 아웃소싱 시장을 상세하게 분석하고 2024년을 기준연도으로 한 예측 기간(2025년-2032년) 시장 규모와 CAGR%를 게재했습니다.
- 또한 다양한 부문에 걸치는 잠재적인 매출 기회를 분명히 해, 이 시장의 매력적인 투자 제안 매트릭스에 대해 해설했습니다.
- 또한 시장 성장 촉진요인, 억제요인, 기회, 신제품 출시나 승인, 시장 동향, 지역별 전망, 주요 기업이 채택하는 경쟁 전략 등에 관한 중요 인사이트도 제공합니다.
- 본 보고서에서는 기업 하이라이트, 제품 포트폴리오, 주요 하이라이트, 재무 실적, 전략등의 파라미터에 근거하고, 세계의 약사 규제 업무 아웃소싱 시장 주요 기업 개요를 게재했습니다.
- 본 보고서로부터 통찰에 의해 마케팅 담당자나 기업 경영진은 향후 제품 발매, 유형 업그레이드, 시장 확대, 마케팅 전술에 관해서, 정보에 근거한 의사결정을 실시할 수 있습니다.
- 약사 규제 업무 아웃소싱 세계 시장 보고서는 투자자, 공급업체, 제품 제조업체, 유통업체, 신규 진출기업, 재무 애널리스트 등, 이 업계 다양한 이해관계자를 대상으로 하고 있습니다.
- 이해관계자는 세계의 약사 규제 업무 아웃소싱 시장 분석에 사용되는 다양한 전략 매트릭스를 통해서 의사결정이 용이하게 됩니다.
제1장 조사 목적과 전제조건
- 조사 목적
- 전제조건
- 약어
제2장 시장 전망
- 보고서 설명
- 시장 정의와 범위
- 주요 요약
- Coherent Opportunity Map(COM)
제3장 시장 역학, 규제, 동향 분석
- 시장 역학
- 성장 촉진요인
- 성장 억제요인
- 기회
- 영향 분석
- 시장 동향
- 주요 발전
- 규제 시나리오
- 인수와 제휴 시나리오
- 자금조달과 투자
- PEST 분석
- Porter의 Five Forces 분석
제4장 세계의 약사 규제 업무 아웃소싱 시장 : COVID-19 팬데믹의 영향
- 전체적인 영향
- 정부 이니셔티브
- 시장에 대한 COVID-19의 영향
제5장 세계의 약사 규제 업무 아웃소싱 시장 : 서비스 유형별(2020년-2032년)
- 규제 컨설팅 및 법적 대리
- 제품 등록 및 임상시험 신청
- 규제 문서 작성 및 출판
- 규제기관 제출
- 규제 업무
- 기타
제6장 세계의 약사 규제 업무 아웃소싱 시장 : 최종사용자별(2020년-2032년)
- 의료기기 기업
- 제약 기업
- 바이오테크놀러지 기업
제7장 세계의 약사 규제 업무 아웃소싱 시장 : 스테이지별(2020년-2032년)
- 전임상
- 임상
- PMA(시판 후 승인)
제8장 세계의 약사 규제 업무 아웃소싱 시장 : 치료 영역별(2020년-2032년)
- 종양학
- 신경학
- 심장병학
- 면역학
- 기타
제9장 세계의 약사 규제 업무 아웃소싱 시장 : 지역별(2020년-2032년)
- 북미
- 라틴아메리카
- 유럽
- 아시아태평양
- 중동
- 아프리카
제10장 경쟁 구도
- 기업 개요
- Accell Clinical Research, LLC
- Genpact
- CRITERIUM, INC.
- PRA Health Sciences
- Promedica International
- WuXiAppTec
- Medpace
- PPD Inc.
- Charles River Laboratories
- ICON plc
- Covance
- Parexel International Corporation
- Freyr
- Navitas Clinical Research, Inc.
- Medelis, Inc.
- Sciformix
- Tech Tammina
- Acorn Regulatory Consultancy Services Ltd.
- BIOMAPAS
- REGULATORY PROFESSIONALS
- CompareNetworks, Inc.
제11장 애널리스트 추천 사항
- Wheel of Fortune
- 애널리스트의 견해
- Coherent Opportunity Map(COM)
제12장 참고 문헌과 조사 방법
- 참고 문헌
- 조사 방법
Global Regulatory Affairs Outsourcing Market is estimated to be valued at USD 9.33 Bn in 2025 and is expected to reach USD 19.26 Bn by 2032, growing at a compound annual growth rate (CAGR) of 10.9% from 2025 to 2032.
| Report Coverage | Report Details | ||
|---|---|---|---|
| Base Year: | 2024 | Market Size in 2025: | USD 9.33 Bn |
| Historical Data for: | 2020 To 2024 | Forecast Period: | 2025 To 2032 |
| Forecast Period 2025 to 2032 CAGR: | 10.90% | 2032 Value Projection: | USD 19.26 Bn |
Figure. Regulatory Affairs Outsourcing Market Share (%), By Region 2025
Global regulatory affairs outsourcing market growth is driven by increasing complexity of regulatory frameworks. Regulatory requirements have become more stringent across regions necessitating specialized expertise and resources for compliance. Furthermore, drug development process has become highly regulated requiring close monitoring and management of compliance at various stages from clinical development to approvals. This has prompted pharmaceutical and biotech companies including medical device manufacturers to rely on third-party service providers with domain expertise to outsource regulatory functions. Regulatory outsourcing helps firms streamline processes, reduce costs, and focus resources on core competencies.
Market Dynamics:
Global regulatory affairs outsourcing market growth is driven by factors such as increasing R&D expenditure of pharmaceutical and biotechnology firms, stringent regulatory environment, and cost pressures. However, data privacy & security concerns and quality control issues can hamper the market growth. Emerging markets can offer significant opportunities due to outsourcing and clinical trial activities shifting to low-cost destinations in Asia Pacific and Latin America. Increased mergers and acquisitions and partnership strategies adopted by regulatory service providers can also expand their capabilities and global footprint, thus, offering new growth opportunities.
Key Features of the Study:
- This report provides in-depth analysis of the global regulatory affairs outsourcing market, and provides market size (USD Billion) and compound annual growth rate (CAGR%) for the forecast period (2025-2032), considering 2024 as the base year
- It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
- This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
- It profiles key players in the global regulatory affairs outsourcing market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies
- Key companies covered as a part of this study include Prophecy, PAREXEL, Clinitec, ICON, Accell, and Covance
- Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
- Global regulatory affairs outsourcing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
- Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global regulatory affairs outsourcing market
Detailed Segmentation-
- By Service Type
- Regulatory Consulting and Legal Representation
- Product Registration and Clinical Trial Applications
- Regulatory Writing and Publishing
- Regulatory Submission
- Regulatory Operations
- Others
- By End User
- Medical Device Companies
- Pharmaceutical Companies
- Biotechnology Companies
- By Stage
- Preclinical
- Clinical
- PMA (Post Market Authorization)
- By Therapeutic Area
- Oncology
- Neurology
- Cardiology
- Immunology
- Others
- By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East
- Africa
- Company Profiles:
- Accell Clinical Research, LLC
- Genpact
- CRITERIUM, INC.
- PRA Health Sciences
- Promedica International
- WuXiAppTec
- Medpace
- PPD Inc.
- Charles River Laboratories
- ICON plc
- Covance
- Parexel International Corporation
- Freyr
- Navitas Clinical Research, Inc.
- Medelis, Inc.
- Sciformix
- Tech Tammina
- Acorn Regulatory Consultancy Services Ltd.
- BIOMAPAS
- REGULATORY PROFESSIONALS
- CompareNetworks, Inc.
Table of Contents (TOC)
1. Research Objectives and Assumptions
- Research Objectives
- Assumptions
- Abbreviations
2. Market Purview
- Report Description
- Market Definition and Scope
- Executive Summary
- Market Snapshot, By Service Type
- Market Snapshot, By End User
- Market Snapshot, By Stage
- Market Snapshot, By Therapeutic Area
- Market Snapshot, By Region
- Coherent Opportunity Map (COM)
3. Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Drivers
- Restraints
- Opportunities
- Impact Analysis
- Market Trends
- Key Developments
- Regulatory Scenario
- Acquisitions and Partnerships Scenario
- Funding and Investments
- PEST Analysis
- Porter's Analysis
4. Global Regulatory Affairs Outsourcing Market - Impact of Coronavirus (COVID-19) Pandemic
- Overall Impact
- Government Initiatives
- COVID-19 Impact on the Market
5. Global Regulatory Affairs Outsourcing Market, By Service Type, 2020 - 2032, (USD Bn)
- Overview
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2020 - 2032
- Segment Trends
- Regulatory Consulting and Legal Representation
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Product Registration and Clinical Trial Applications
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Regulatory Writing and Publishing
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Regulatory Submission
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Regulatory Operations
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Others
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
6. Global Regulatory Affairs Outsourcing Market, By End User, 2020 - 2032, (USD Bn)
- Overview
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2020 - 2032
- Segment Trends
- Medical Device Companies
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Pharmaceutical Companies
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Biotechnology Companies
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
7. Global Regulatory Affairs Outsourcing Market, By Stage, 2020 - 2032, (USD Bn)
- Overview
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2020 - 2032
- Segment Trends
- Preclinical
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Clinical
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- PMA (Post Market Authorization)
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
8. Global Regulatory Affairs Outsourcing Market, By Therapeutic Area, 2020 - 2032, (USD Bn)
- Overview
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2020 - 2032
- Segment Trends
- Oncology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Neurology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Cardiology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Immunology
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
- Others
- Overview
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
9. Global Regulatory Affairs Outsourcing Market, By Region, 2020 - 2032, (USD Bn)
- Introduction
- Market Share Analysis, By Region, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, For Region, 2020-2032
- Regional Trends
- North America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2020 - 2032, (USD Bn)
- U.S.
- Canada
- Latin America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2020 - 2032, (USD Bn)
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- Europe
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area. 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2020 - 2032, (USD Bn)
- U.K.
- Germany
- Italy
- France
- Spain
- Russia
- Rest of Europe
- Asia Pacific
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2020 - 2032, (USD Bn)
- China
- India
- Japan
- ASEAN
- Australia
- South Korea
- Rest of Asia Pacific
- Middle East
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2020 - 2032, (USD Bn)
- GCC Countries
- Israel
- Rest of Middle East
- Africa
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Stage, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2020 - 2032, (USD Bn)
- Market Size and Forecast, and Y-o-Y Growth, By Country/Sub-region, 2020 - 2032, (USD Bn)
- North Africa
- Central Africa
- South Africa
10. Competitive Landscape
- Company Profiles
- Accell Clinical Research, LLC
- Company Highlights
- Service Type Portfolio
- Key Highlights
- Financial Performance
- Market Strategies
- Genpact
- CRITERIUM, INC.
- PRA Health Sciences
- Promedica International
- WuXiAppTec
- Medpace
- PPD Inc.
- Charles River Laboratories
- ICON plc
- Covance
- Parexel International Corporation
- Freyr
- Navitas Clinical Research, Inc.
- Medelis, Inc.
- Sciformix
- Tech Tammina
- Acorn Regulatory Consultancy Services Ltd.
- BIOMAPAS
- REGULATORY PROFESSIONALS
- CompareNetworks, Inc.
- Accell Clinical Research, LLC
11. Analyst Recommendations
- Wheel of Fortune
- Analyst View
- Coherent Opportunity Map
12. References and Research Methodology
- References
- Research Methodology
- About us and Sales Contact
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