RA(Regulatory Affairs) 시장 : 시장 규모, 점유율, 동향 분석 보고서 - 서비스별, 카테고리별, 제품 유형별, 기업 규모별, 제품 스테이지별, 적응증별, 최종 용도별, 지역별, 부문 동향(2025-2030년)

Regulatory Affairs Market Size, Share & Trends Analysis Report By Services (Regulatory Consulting, Legal Representation), By Categories, By Type, By Company Size, By Product Stage, By Indication, By End Use, By Region, And Segment Forecasts, 2025 - 2030

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한글목차

RA(Regulatory Affairs) 시장의 성장 및 동향

Grand View Research, Inc.의 최신 보고서에 따르면 세계의 RA(Regulatory Affairs) 시장 규모는 2025-2030년 CAGR 8.80%로 확대될 전망이며, 2030년에는 271억 8,000만 달러에 이를 전망입니다.

이 시장의 성장에 기여할 것으로 예상되는 요인으로는 사업 활동이나 지역에 따라 변화하는 규제 요건, 규제 당국에 의한 승인의 신속화에 수반하는 임상 검사나 의약품 승인 증가, 규제 당국용 소프트웨어의 기술 진보 등을 들 수 있습니다. 또한, 개별화 의약품의 진화, 기업이 핵심적인 사업 활동에 집중할 필요성의 증대, 경제적 및 시장 경쟁적 압력 등도 시장의 성장에 기여하고 있는 요인입니다.

COVID-19 감염과 싸우는 데 필요한 백신과 의료 제품을 신속하게 개발하기 위해 제약 회사와 규제 당국이 손을 잡았습니다. 규제당국은 임상검사 중인 환자와 인력의 안전을 확보하고 데이터 무결성과 적정한 실험실 업무가 유지될 수 있도록 수많은 예방 조치를 강구하고 있습니다. 바이오시밀러, 희귀병용의약품, 개별화의약품, 동반진단약, 적응검사 디자인 등의 시장 성장은 이러한 부문에서 규제당국의 전문성에 대한 수요를 끌어올릴 것으로 예측됩니다. 기업이 새로운 부문에 진출함에 따라 규제를 준수할 필요성이 높아지고, 약사 업무의 전문 지식을 가진 전문 서비스 프로바이더에 대한 수요가 높아지고 있습니다. 심렉트, 벡티빅스, 밀세라, 키네레트 등 생물제제의 특허가 만료되면서 바이오시밀러 수요와 개발이 증가하고 있어 약사서비스 수요에 기여하고 있습니다.

맞춤형 의료 시장에서 주도권을 잡기 위해 여러 기업이 제휴 및 신제품 개척에 적극적으로 노력하고 있으며, 약사 업무 지원이 필요하다는 것을 보여줍니다. 예를 들어 2020년 5월 Regeneron Pharmaceuticals, Inc.는 맞춤형 의료 및 인간 유전학의 진보를 설계하기 위해 Colorado Center for Personalized Medicine과 제휴했습니다.

RA(Regulatory Affairs) 시장 보고서 하이라이트

• 2024년에는 아웃소싱 부문이 59.05%의 점유율을 차지해 시장을 독점했습니다. 이 부문의 성장은 주로 제약기업이나 의료기기 기업이 사내에 없는 전문적인 전문지식이나 리소스를 이용할 수 있는 아웃소싱에 주력하게 되었기 때문입니다.
• 레귤러 트리 라이팅 및 퍼블리싱 부문은 2024년 시장에서 큰 점유율을 차지하고 있습니다. 이 부문의 성장은 여러 제약 및 바이오의약품 기업이 비용을 절감하고 전략적 프로젝트를 우선시하며, 직원 교육 시간을 단축하고, 전체적인 효율성을 향상시키며, 더 높은 유연성을 제공하는 데 기인합니다.
• 2024년 RA(Regulatory Affairs) 시장은 의약품 부문이 지배적이었습니다. 이 부문의 성장은 다양한 규제와 프로세스에 관련된 각 단계에서의 관련 규제당국에 대한 신청 및 문서작성에 기인하고 있습니다.
• 2024년에는 암 영역이 시장을 독점했습니다. 이 부문의 성장은 효과적이고 안전한 치료 옵션을 필요로 하는 암 유병률의 증가에 의한 것입니다.
• 임상 연구가 2024년 시장을 독점했습니다. 만성 질환의 유병률 증가와 새로운 질환의 출현이 더해져, 보다 좋은 치료 옵션에 수요가 높아지고, 환자의 증대하는 요구에 대응하기 위해서 세계적으로 실시되는 임상 검사의 수가 한층 더 증가합니다.
• 2024년 시장 규모는 중견 기업 규모 부문이 지배적이었습니다. 이 시장의 성장은 주로 비상장 기업을 중심으로 하는 중견기업의 위상이 크기 때문입니다.
• 2024년 시장 규모는 제약기업이 압도적이었습니다. 이 부문의 성장은 승인 의약품 수의 증가와 맞물려 연구개발 활동이 활발해지고 있는 것에 기인한다.
• 아시아태평양의 RA(Regulatory Affairs) 시장은 세계 시장을 석권해 2024년에는 38.03%의 점유율을 차지했습니다.

목차

제1장 조사 방법 및 범위

제2장 주요 요약

제3장 RA(Regulatory Affairs) 시장의 변수, 동향 및 범위

• 시장 계통의 전망
  • 모 시장 전망
  • 관련 및 보조적인 시장 전망
• 시장 역학
  • 시장 성장 촉진요인 분석
  • 시장 성장 억제요인 분석
• 산업 시장 분석 도구
  • 산업 분석-Porter's Five Forces 분석
  • PESTEL 분석
  • COVID-19의 영향 분석

제4장 RA(Regulatory Affairs) 시장 : 서비스별 추정 및 동향 분석

• 부문 대시보드
• 세계의 RA(Regulatory Affairs) 시장 : 서비스별 변동 분석
• 세계의 RA(Regulatory Affairs) 시장 : 서비스별 규모 및 동향 분석(2018-2030년)
• 규제 컨설팅
• 법적 대리
• 규제 문서의 집필 및 출판
• 제품 등록 및 임상 검사 신청
• 기타

제5장 RA(Regulatory Affairs) 시장 : 카테고리별 추정 및 동향 분석

• 부문 대시보드
• 세계의 RA(Regulatory Affairs) 시장 : 카테고리별 변동 분석
• 세계의 RA(Regulatory Affairs) 시장 : 카테고리별 규모 및 동향 분석(2018-2030년)
• 약
  • 이노베이터
  • 제네릭 의약품
• 생물제제
  • 생명공학
  • ATMP
• 바이오시밀러
• 의료기기
  • 진단
  • 치료

제6장 RA(Regulatory Affairs) 시장 : 적응증별 추정 및 동향 분석

• 부문 대시보드
• 세계의 RA(Regulatory Affairs) 시장 : 적응증별 변동 분석
• 세계의 RA(Regulatory Affairs) 시장 : 적응증별 규모 및 동향 분석(2018-2030년)
• 종양학
• 신경학
• 심장병학
• 면역학
• 기타

제7장 RA(Regulatory Affairs) 시장 : 제품 스테이지별 추정 및 동향 분석

• 부문 대시보드
• 세계의 RA(Regulatory Affairs) 시장 : 제품 스테이지별 변동 분석
• 세계의 RA(Regulatory Affairs) 시장 : 제품 스테이지별 규모 및 동향 분석(2018-2030년)
• 전임상
• 임상 연구
• 시판전 승인(PMA)

제8장 RA(Regulatory Affairs) 시장 : 유형별 추정 및 동향 분석

• 부문 대시보드
• 세계의 RA(Regulatory Affairs) 시장 : 유형별 변동 분석
• 세계의 RA(Regulatory Affairs) 시장 : 유형별 규모 및 동향 분석(2018-2030년)
• 사내
• 아웃소싱

제9장 RA(Regulatory Affairs) 시장 : 기업 규모별 추정 및 동향 분석

• 부문 대시보드
• 세계의 RA(Regulatory Affairs) 시장 : 기업 규모별 변동 분석
• 세계의 RA(Regulatory Affairs) 시장 : 기업 규모별 규모 및 동향 분석(2018-2030년)
• 소
• 중
• 대

제10장 RA(Regulatory Affairs) 시장 : 최종 용도별 추정 및 동향 분석

• 부문 대시보드
• 세계의 RA(Regulatory Affairs) 시장 : 최종 용도별 변동 분석
• 세계의 RA(Regulatory Affairs) 시장 : 최종 용도별 규모 및 동향 분석(2018-2030년)
• 의료기기 기업
• 제약회사
• 바이오테크놀러지 기업

제11장 RA(Regulatory Affairs) 시장 : 지역별 추정 및 동향 분석

• 지역별 시장 점유율 분석(2024년, 2030년)
• 지역별 시장 대시보드
• 시장 규모와 예측 및 동향 분석(2018-2030년)
• 북미
  • 미국
  • 캐나다
  • 멕시코
• 유럽
  • 영국
  • 독일
  • 프랑스
  • 이탈리아
  • 스페인
  • 덴마크
  • 노르웨이
  • 네덜란드
  • 스위스
  • 스웨덴
• 아시아태평양
  • 일본
  • 중국
  • 인도
  • 호주
  • 한국
  • 태국
  • 인도네시아
  • 말레이시아
  • 싱가포르
  • 대만
• 라틴아메리카
  • 브라질
  • 아르헨티나
  • 콜롬비아
  • 칠레
• 중동 및 아프리카
  • 남아프리카
  • 사우디아라비아
  • 아랍에미리트(UAE)
  • 이집트
  • 이스라엘
  • 쿠웨이트

제12장 경쟁 구도

• 경쟁의 분류
  • 마켓 리더
  • 신흥 진출기업
• 기업의 시장 점유율 및 평가 분석(2024년)
• 기업 프로파일
  • Accell Clinical Research, LLC
  • Genpact
  • Criterium, Inc.
  • ICON plc
  • iuvo BioScience, LLC.
  • WuXi AppTec
  • Medpace
  • Charles River Laboratories
  • Laboratory Corporation of America Holdings
  • Parexel International(MA) Corporation
  • Freyr
  • PHARMALEX GMBH
  • SSI Strategy LLC
  • Pharmexon
  • Qvigilance
  • BlueReg
  • Cambridge Regulatory Services
  • VCLS

AJY

영문 목차

영문목차

Regulatory Affairs Market Growth & Trends:

The global regulatory affairs market size is expected to reach USD 27.18 billion by 2030, expanding at a CAGR of 8.80% from 2025 to 2030, according to a new report by Grand View Research, Inc. The factors expected to contribute to the growth of this market include changing regulatory requirements based on business activities and geographies, an increase in clinical trials & drug approvals along with accelerated regulatory approval, and technological advancement in regulatory software. Also, the evolution of personalized medicines, the increasing need for companies to focus on core business activities, and economic and competitive pressures are other factors that are contributing to the growth of the market.

The pharmaceutical and regulatory agencies joined forces to rapidly develop vaccines and medical products required to fight against the COVID-19 infection. The regulatory authorities take numerous precautions to ensure patient and personnel safety during a clinical trial, as well as data integrity and good laboratory practices are maintained. Growth in markets for biosimilars, orphan drugs, personalized medicines, companion diagnostics, and adaptive trial designs is projected to boost the demand for regulatory specialization in these areas. As companies venture into newer fields, the growing need to comply with regulations is boosting the demand for specialized service providers with expertise in regulatory affairs. Patent expiration of biologics, such as Simulect, Vectibix, Mircera, and Kineret, is increasing the demand and development of biosimilars, thereby contributing to the demand for regulatory services.

Several companies are actively involved in collaborations and new product development to gain leadership in the personalized medicine market, indicating a need for supportive regulatory affairs. For instance, in May 2020, Regeneron Pharmaceuticals, Inc. collaborated with Colorado Center for Personalized Medicine to design advancements in personalized medicine and human genetics.

Regulatory Affairs Market Report Highlights:

• The outsourcing segment dominated the market with a share of 59.05% in 2024. The growth of the segment is mainly due to the growing focus of the pharmaceutical and medical device companies to outsource their activities as it allows access to specialized expertise and resources that they may not have in-house.
• The regulatory writing & publishing segment held a significant share of the market in 2024. The growth of the segment is attributed to several pharmaceutical or biopharmaceutical companies reducing costs, prioritizing strategic projects, reducing staff training time, and improving overall efficiency, as well as providing greater flexibility.
• The drugs segment dominated the regulatory affairs market in 2024. The growth of the segment can be attributed to various regulations and related regulatory submissions/documentation at each of the steps involved in the process.
• The oncology segment dominated the market in 2024. The growth of the segment is due to the increasing prevalence of cancer, which requires effective and safe treatment options.
• Clinical studies dominated the market in 2024. The increasing prevalence of chronic diseases coupled with the emergence of new diseases will increase the demand for better treatment options, further growing the number of clinical trials conducted globally to meet the growing needs of the patients.
• The medium company size segment dominated the market in 2024. The growth of the market is mainly due to the strong presence of several mid-sized established firms, mainly which are privately held.
• The pharmaceutical companies segment dominated the market in 2024. The growth of the segment is due to growing research and development activities coupled with an increase in the number of approved pharmaceutical products.
• The regulatory affairs market in Asia Pacific dominated the global industry and accounted for a 38.03% share in 2024.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
  • 1.1.1. Regional Scope
  • 1.1.2. Estimates and Forecast Timeline
• 1.2. Market Definitions
• 1.3. Research Methodology
  • 1.3.1. Information Procurement
  • 1.3.2. Purchased Database
  • 1.3.3. GVR's Internal Database
  • 1.3.4. Secondary Sources
  • 1.3.5. Primary Research
• 1.4. Information or Data Analysis
  • 1.4.1. Information Analysis
  • 1.4.2. Market Formulation & Data Visualization
  • 1.4.3. Data Validation & Publishing
• 1.5. Model Details
  • 1.5.1. Commodity Flow Analysis (Model 1)
  • 1.5.2. Top Down Market Estimation (Model 2)
  • 1.5.3. Value-Chain-Based Sizing & Forecasting (Model 3)
  • 1.5.4. Multivariate Analysis (Model 4)
• 1.6. List of Secondary Sources
• 1.7. List of Abbreviations
• 1.8. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Insights Landscape

Chapter 3. Regulatory Affairs Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent market outlook
  • 3.1.2. Related/ancillary market outlook.
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Changing regulatory landscape
    • 3.2.1.2. Entry of companies into the global market
    • 3.2.1.3. Life science companies focusing on their core competencies
    • 3.2.1.4. Economic and competitive pressures
    • 3.2.1.5. Demand for the faster approval process for breakthrough drugs and devices
    • 3.2.1.6. Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Risk Associated with Data Security
    • 3.2.2.2. Monitoring Issues and Lack of Standardization
• 3.3. Industry Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

Chapter 4. Regulatory Affairs Market: Services Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Regulatory Affairs Market Services Movement Analysis
• 4.3. Global Regulatory Affairs Market Size & Trend Analysis, by Services, 2018 to 2030 (USD Million)
• 4.4. Regulatory Consulting
  • 4.4.1. Regulatory consulting market estimates and forecasts, 2018 - 2030 (USD Million)
• 4.5. Legal Representation
  • 4.5.1. Legal representation market estimates and forecasts, 2018 - 2030 (USD Million)
• 4.6. Regulatory Writing & Publishing
  • 4.6.1. Regulatory writing & publishing market estimates and forecasts, 2018 - 2030 (USD Million)
    • 4.6.1.1. Writing
      • 4.6.1.1.1. Writing market estimates and forecasts, 2018 - 2030 (USD Million)
    • 4.6.1.2. Publishing
      • 4.6.1.2.1. Publishing market estimates and forecasts, 2018 - 2030 (USD Million)
• 4.7. Product Registration & Clinical Trial Applications
  • 4.7.1. Product registration & clinical trial applications market estimates and forecasts, 2018 - 2030 (USD Million)
• 4.8. Other Services
  • 4.8.1. Other services market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 5. Regulatory Affairs Market: Category Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Regulatory Affairs Market Category Movement Analysis
• 5.3. Global Regulatory Affairs Market Size & Trend Analysis, by Category, 2018 to 2030 (USD Million)
• 5.4. Drugs
  • 5.4.1. Drugs market estimates and forecasts, 2018 - 2030 (USD Million)
  • 5.4.2. Innovator
    • 5.4.2.1. Innovator market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.4.2.2. Preclinical
      • 5.4.2.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.4.2.3. Clinical
      • 5.4.2.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.4.2.4. Pre-Market Approval (PMA)
      • 5.4.2.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • 5.4.3. Generics
    • 5.4.3.1. Generics market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.4.3.2. Preclinical
      • 5.4.3.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.4.3.3. Clinical
      • 5.4.3.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.4.3.4. Pre-Market Approval (PMA)
      • 5.4.3.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
• 5.5. Biologics
  • 5.5.1. Biologics market estimates and forecasts, 2018 - 2030 (USD Million)
  • 5.5.2. Biotech
    • 5.5.2.1. Biotech market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.5.2.2. Preclinical
      • 5.5.2.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.5.2.3. Clinical
      • 5.5.2.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.5.2.4. Pre-Market Approval (PMA)
      • 5.5.2.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • 5.5.3. ATMP
    • 5.5.3.1. ATMP market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.5.3.2. Preclinical
      • 5.5.3.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.5.3.3. Clinical
      • 5.5.3.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.5.3.4. Pre-Market Approval (PMA)
      • 5.5.3.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
• 5.6. Biosimilars
  • 5.6.1. Biosimilars market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.6.1.1. Preclinical
      • 5.6.1.1.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.6.1.2. Clinical
      • 5.6.1.2.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.6.1.3. Pre-Market Approval (PMA)
      • 5.6.1.3.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
• 5.7. Medical Devices
  • 5.7.1. Medical devices market estimates and forecasts, 2018 - 2030 (USD Million)
  • 5.7.2. Diagnostics
    • 5.7.2.1. Diagnostics market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.7.2.2. Preclinical
      • 5.7.2.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.7.2.3. Clinical
      • 5.7.2.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.7.2.4. Pre-Market Approval (PMA)
      • 5.7.2.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • 5.7.3. Therapeutics
    • 5.7.3.1. Therapeutics market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.7.3.2. Preclinical
      • 5.7.3.2.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.7.3.3. Clinical
      • 5.7.3.3.1. Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
    • 5.7.3.4. Pre-Market Approval (PMA)
      • 5.7.3.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 6. Regulatory Affairs Market: Indication Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Regulatory Affairs Market Indication Movement Analysis
• 6.3. Global Regulatory Affairs Market Size & Trend Analysis, by Indication, 2018 to 2030 (USD Million)
• 6.4. Oncology
  • 6.4.1. Oncology market estimates and forecasts, 2018 - 2030 (USD Million)
• 6.5. Neurology
  • 6.5.1. Neurology market estimates and forecasts, 2018 - 2030 (USD Million)
• 6.6. Cardiology
  • 6.6.1. Cardiology market estimates and forecasts, 2018 - 2030 (USD Million)
• 6.7. Immunology
  • 6.7.1. Immunology market estimates and forecasts, 2018 - 2030 (USD Million)
• 6.8. Others
  • 6.8.1.1. Others market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 7. Regulatory Affairs Market: Product Stage Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. Global Regulatory Affairs Market Product Stage Movement Analysis
• 7.3. Global Regulatory Affairs Market Size & Trend Analysis, by Product Stage, 2018 to 2030 (USD Million)
• 7.4. Preclinical
  • 7.4.1. Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
• 7.5. Clinical studies
  • 7.5.1. Clinical studies market estimates and forecasts, 2018 - 2030 (USD Million)
• 7.6. Pre-Market Approval (PMA)
  • 7.6.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 8. Regulatory Affairs Market: Type Estimates & Trend Analysis

• 8.1. Segment Dashboard
• 8.2. Global Regulatory Affairs Market Type Movement Analysis
• 8.3. Global Regulatory Affairs Market Size & Trend Analysis, by Type, 2018 to 2030 (USD Million)
• 8.4. In-house
  • 8.4.1. In-house market estimates and forecasts, 2018 - 2030 (USD Million)
• 8.5. Outsourced
  • 8.5.1. Outsourced market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 9. Regulatory Affairs Market: Company Size Estimates & Trend Analysis

• 9.1. Segment Dashboard
• 9.2. Global Regulatory Affairs Market Company Size Movement Analysis
• 9.3. Global Regulatory Affairs Market Size & Trend Analysis, by Company Size, 2018 to 2030 (USD Million)
• 9.4. Small
  • 9.4.1. Small market estimates and forecasts, 2018 - 2030 (USD Million)
• 9.5. Medium
  • 9.5.1. Medium market estimates and forecasts, 2018 - 2030 (USD Million)
• 9.6. Large
  • 9.6.1. Large market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 10. Regulatory Affairs Market: End-use Estimates & Trend Analysis

• 10.1. Segment Dashboard
• 10.2. Global Regulatory Affairs Market End-use Movement Analysis
• 10.3. Global Regulatory Affairs Market Size & Trend Analysis, by End-use, 2018 to 2030 (USD Million)
• 10.4. Medical Device Companies
  • 10.4.1. Medical device companies market estimates and forecasts, 2018 - 2030 (USD Million)
• 10.5. Pharmaceutical Companies
  • 10.5.1. Pharmaceutical companies market estimates and forecasts, 2018 - 2030 (USD Million)
• 10.6. Biotechnology Companies
  • 10.6.1. Biotechnology companies market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 11. Regulatory Affairs Market: Regional Estimates & Trend Analysis

• 11.1. Regional Market Share Analysis, 2024 & 2030
• 11.2. Regional Market Dashboard
• 11.3. Market Size & Forecasts Trend Analysis, 2018 to 2030 (USD Million)
• 11.4. North America
  • 11.4.1. North America Market Estimates and Forecasts 2018 to 2030, (USD Million)
  • 11.4.2. U.S.
    • 11.4.2.1. Key country dynamics
    • 11.4.2.2. Competitive scenario
    • 11.4.2.3. Regulatory scenario
    • 11.4.2.4. U.S. market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.4.3. Canada
    • 11.4.3.1. Key country dynamics
    • 11.4.3.2. Competitive scenario
    • 11.4.3.3. Regulatory scenario
    • 11.4.3.4. Canada market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.4.4. Mexico
    • 11.4.4.1. Key country dynamics
    • 11.4.4.2. Competitive scenario
    • 11.4.4.3. Regulatory scenario
    • 11.4.4.4. Mexico market estimates and forecasts, 2018 - 2030 (USD Million)
• 11.5. Europe
  • 11.5.1. Europe Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 11.5.2. UK
    • 11.5.2.1. Key country dynamics
    • 11.5.2.2. Competitive scenario
    • 11.5.2.3. Regulatory scenario
    • 11.5.2.4. UK market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.5.3. Germany
    • 11.5.3.1. Key country dynamics
    • 11.5.3.2. Competitive scenario
    • 11.5.3.3. Regulatory scenario
    • 11.5.3.4. Germany market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.5.4. France
    • 11.5.4.1. Key country dynamics
    • 11.5.4.2. Competitive scenario
    • 11.5.4.3. Regulatory scenario
    • 11.5.4.4. France market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.5.5. Italy
    • 11.5.5.1. Key country dynamics
    • 11.5.5.2. Competitive scenario
    • 11.5.5.3. Regulatory scenario
    • 11.5.5.4. Italy market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.5.6. Spain
    • 11.5.6.1. Key country dynamics
    • 11.5.6.2. Competitive scenario
    • 11.5.6.3. Regulatory scenario
    • 11.5.6.4. Spain market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.5.7. Denmark
    • 11.5.7.1. Key country dynamics
    • 11.5.7.2. Competitive scenario
    • 11.5.7.3. Regulatory scenario
    • 11.5.7.4. Denmark market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.5.8. Norway
    • 11.5.8.1. Key country dynamics
    • 11.5.8.2. Competitive scenario
    • 11.5.8.3. Regulatory scenario
    • 11.5.8.4. Norway market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.5.9. Netherlands
    • 11.5.9.1. Key country dynamics
    • 11.5.9.2. Competitive scenario
    • 11.5.9.3. Regulatory scenario
    • 11.5.9.4. Netherlands market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.5.10. Switzerland
    • 11.5.10.1. Key country dynamics
    • 11.5.10.2. Competitive scenario
    • 11.5.10.3. Regulatory scenario
    • 11.5.10.4. Switzerland market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.5.11. Sweden
    • 11.5.11.1. Key country dynamics
    • 11.5.11.2. Competitive scenario
    • 11.5.11.3. Regulatory scenario
    • 11.5.11.4. Sweden market estimates and forecasts, 2018 - 2030 (USD Million)
• 11.6. Asia Pacific
  • 11.6.1. Asia Pacific Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 11.6.2. Japan
    • 11.6.2.1. Key country dynamics
    • 11.6.2.2. Competitive scenario
    • 11.6.2.3. Regulatory scenario
    • 11.6.2.4. Japan market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.6.3. China
    • 11.6.3.1. Key country dynamics
    • 11.6.3.2. Competitive scenario
    • 11.6.3.3. Regulatory scenario
    • 11.6.3.4. China market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.6.4. India
    • 11.6.4.1. Key country dynamics
    • 11.6.4.2. Competitive scenario
    • 11.6.4.3. Regulatory scenario
    • 11.6.4.4. India market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.6.5. Australia
    • 11.6.5.1. Key country dynamics
    • 11.6.5.2. Competitive scenario
    • 11.6.5.3. Regulatory scenario
    • 11.6.5.4. Australia market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.6.6. South Korea
    • 11.6.6.1. Key country dynamics
    • 11.6.6.2. Competitive scenario
    • 11.6.6.3. Regulatory scenario
    • 11.6.6.4. South Korea market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.6.7. Thailand
    • 11.6.7.1. Key country dynamics
    • 11.6.7.2. Competitive scenario
    • 11.6.7.3. Regulatory scenario
    • 11.6.7.4. Thailand market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.6.8. Indonesia
    • 11.6.8.1. Key country dynamics
    • 11.6.8.2. Competitive scenario
    • 11.6.8.3. Regulatory scenario
    • 11.6.8.4. Indonesia market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.6.9. Malaysia
    • 11.6.9.1. Key country dynamics
    • 11.6.9.2. Competitive scenario
    • 11.6.9.3. Regulatory scenario
    • 11.6.9.4. Malaysia market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.6.10. Singapore
    • 11.6.10.1. Key country dynamics
    • 11.6.10.2. Competitive scenario
    • 11.6.10.3. Regulatory scenario
    • 11.6.10.4. Singapore market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.6.11. Taiwan
    • 11.6.11.1. Key country dynamics
    • 11.6.11.2. Competitive scenario
    • 11.6.11.3. Regulatory scenario
    • 11.6.11.4. Taiwan market estimates and forecasts, 2018 - 2030 (USD Million)
• 11.7. Latin America
  • 11.7.1. Latin America Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 11.7.2. Brazil
    • 11.7.2.1. Key country dynamics
    • 11.7.2.2. Competitive scenario
    • 11.7.2.3. Regulatory scenario
    • 11.7.2.4. Brazil market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.7.3. Argentina
    • 11.7.3.1. Key country dynamics
    • 11.7.3.2. Competitive scenario
    • 11.7.3.3. Regulatory scenario
    • 11.7.3.4. Argentina market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.7.4. Colombia
    • 11.7.4.1. Key country dynamics
    • 11.7.4.2. Competitive scenario
    • 11.7.4.3. Regulatory scenario
    • 11.7.4.4. Colombia market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.7.5. Chile
    • 11.7.5.1. Key country dynamics
    • 11.7.5.2. Competitive scenario
    • 11.7.5.3. Regulatory scenario
    • 11.7.5.4. Chile market estimates and forecasts, 2018 - 2030 (USD Million)
• 11.8. MEA
  • 11.8.1. MEA Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 11.8.2. South Africa
    • 11.8.2.1. Key country dynamics
    • 11.8.2.2. Competitive scenario
    • 11.8.2.3. Regulatory scenario
    • 11.8.2.4. South Africa market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.8.3. Saudi Arabia
    • 11.8.3.1. Key country dynamics
    • 11.8.3.2. Competitive scenario
    • 11.8.3.3. Regulatory scenario
    • 11.8.3.4. Saudi Arabia market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.8.4. UAE
    • 11.8.4.1. Key country dynamics
    • 11.8.4.2. Competitive scenario
    • 11.8.4.3. Regulatory scenario
    • 11.8.4.4. UAE market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.8.5. Egypt
    • 11.8.5.1. Key country dynamics
    • 11.8.5.2. Competitive scenario
    • 11.8.5.3. Regulatory scenario
    • 11.8.5.4. Egypt market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.8.6. Israel
    • 11.8.6.1. Key country dynamics
    • 11.8.6.2. Competitive scenario
    • 11.8.6.3. Regulatory scenario
    • 11.8.6.4. Israel market estimates and forecasts, 2018 - 2030 (USD Million)
  • 11.8.7. Kuwait
    • 11.8.7.1. Key country dynamics
    • 11.8.7.2. Competitive scenario
    • 11.8.7.3. Regulatory scenario
    • 11.8.7.4. Israel market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 12. Competitive Landscape

• 12.1. Competition Categorization
  • 12.1.1. Market Leaders
  • 12.1.2. Emerging Players
• 12.2. Company Market Share/Assessment Analysis, 2024
• 12.3. Company Profiles
  • 12.3.1. Accell Clinical Research, LLC
    • 12.3.1.1. Company overview
    • 12.3.1.2. Financial performance
    • 12.3.1.3. Service benchmarking
    • 12.3.1.4. Strategic initiatives
  • 12.3.2. Genpact
    • 12.3.2.1. Company overview
    • 12.3.2.2. Financial performance
    • 12.3.2.3. Service benchmarking
    • 12.3.2.4. Strategic initiatives
  • 12.3.3. Criterium, Inc.
    • 12.3.3.1. Company overview
    • 12.3.3.2. Financial performance
    • 12.3.3.3. Service benchmarking
    • 12.3.3.4. Strategic initiatives
  • 12.3.4. ICON plc
    • 12.3.4.1. Company overview
    • 12.3.4.2. Financial performance
    • 12.3.4.3. Service benchmarking
    • 12.3.4.4. Strategic initiatives
  • 12.3.5. iuvo BioScience, LLC.
    • 12.3.5.1. Company overview
    • 12.3.5.2. Financial performance
    • 12.3.5.3. Service benchmarking
    • 12.3.5.4. Strategic initiatives
  • 12.3.6. WuXi AppTec
    • 12.3.6.1. Company overview
    • 12.3.6.2. Financial performance
    • 12.3.6.3. Service benchmarking
    • 12.3.6.4. Strategic initiatives
  • 12.3.7. Medpace
    • 12.3.7.1. Company overview
    • 12.3.7.2. Financial performance
    • 12.3.7.3. Service benchmarking
    • 12.3.7.4. Strategic initiatives
  • 12.3.8. Charles River Laboratories
    • 12.3.8.1. Company overview
    • 12.3.8.2. Financial performance
    • 12.3.8.3. Service benchmarking
    • 12.3.8.4. Strategic initiatives
  • 12.3.9. Laboratory Corporation of America Holdings
    • 12.3.9.1. Company overview
    • 12.3.9.2. Financial performance
    • 12.3.9.3. Service benchmarking
    • 12.3.9.4. Strategic initiatives
  • 12.3.10. Parexel International (MA) Corporation
    • 12.3.10.1. Company overview
    • 12.3.10.2. Financial performance
    • 12.3.10.3. Service benchmarking
    • 12.3.10.4. Strategic initiatives
  • 12.3.11. Freyr
    • 12.3.11.1. Company overview
    • 12.3.11.2. Financial performance
    • 12.3.11.3. Service benchmarking
    • 12.3.11.4. Strategic initiatives
  • 12.3.12. PHARMALEX GMBH
    • 12.3.12.1. Company overview
    • 12.3.12.2. Financial performance
    • 12.3.12.3. Service benchmarking
    • 12.3.12.4. Strategic initiatives
  • 12.3.13. SSI Strategy LLC
    • 12.3.13.1. Company overview
    • 12.3.13.2. Financial performance
    • 12.3.13.3. Service benchmarking
    • 12.3.13.4. Strategic initiatives
  • 12.3.14. Pharmexon
    • 12.3.14.1. Company overview
    • 12.3.14.2. Financial performance
    • 12.3.14.3. Service benchmarking
    • 12.3.14.4. Strategic initiatives
  • 12.3.15. Qvigilance
    • 12.3.15.1. Company overview
    • 12.3.15.2. Financial performance
    • 12.3.15.3. Service benchmarking
    • 12.3.15.4. Strategic initiatives
  • 12.3.16. BlueReg
    • 12.3.16.1. Company overview
    • 12.3.16.2. Financial performance
    • 12.3.16.3. Service benchmarking
    • 12.3.16.4. Strategic initiatives
  • 12.3.17. Cambridge Regulatory Services
    • 12.3.17.1. Company overview
    • 12.3.17.2. Financial performance
    • 12.3.17.3. Service benchmarking
    • 12.3.17.4. Strategic initiatives
  • 12.3.18. VCLS
    • 12.3.18.1. Company overview
    • 12.3.18.2. Financial performance
    • 12.3.18.3. Service benchmarking
    • 12.3.18.4. Strategic initiatives

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