의약품 RA(Regulatory Affairs) 시장 규모, 점유율, 동향 분석 보고서 : 서비스 제공업체별, 서비스별, 카테고리별, 적응증별, 개발 단계별, 기업 규모별, 지역별, 부문별 예측(2025-2030년)

Pharmaceutical Regulatory Affairs Market Size, Share & Trends Analysis Report By Service Provider (In-house, Outsourcing), By Service, By Category, By Indication, By Development Stage, By Company Size, By Region, And Segment Forecasts, 2025 - 2030

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한글목차

의약품 RA(Regulatory Affairs) 시장 성장과 동향

그랜드 뷰 리서치(Grand View Research, Inc.)의 최신 보고서에 따르면, 세계 의약품 RA(Regulatory Affairs) 시장 규모는 2030년까지 143억 4,000만 달러에 달할 것으로 예상되며, 2025-2030년 연평균 7.17%의 CAGR을 기록할 것으로 예상됩니다. 시장 성장을 이끄는 주요 요인은 규제 환경의 변화와 맞춤형 의료, 바이오시밀러, 희귀질환 치료제 등 신흥 부문의 성장이며, FDA의 의약품 승인 절차에 큰 변화가 일어나고 있습니다. 최근 21세기 치료법안이 통과되어 특정 유형의 의약품에 대한 FDA의 승인 절차가 가속화될 것으로 예상됩니다.

FDA는 4가지 프로그램(Accelerated Approval, Priority Review, Fast Track, Breakthrough Therapy)을 통해 중증 및 생명을 위협하는 질병에 대한 의약품의 심사를 신속히 진행하고 있습니다. 이 프로그램을 통해 의약품은 규제 당국의 승인을 더 빨리 받을 수 있습니다. 또한, 영국에서는 획기적인 신약에 대한 환자 접근을 가속화하기 위한 정부 주도 이니셔티브인 Accelerated Access Collaborative가 시작되어 영국에서 새로운 치료제의 가용성과 접근성을 향상시킬 것으로 기대됩니다. 이러한 승인 프로세스의 변화는 기술 혁신을 촉진하고, 최근 세계 승인 프로세스의 변화에 정통한 제약 서비스 제공업체에 대한 수요를 증가시킬 것으로 예상됩니다.

바이오시밀러, 희귀의약품, 맞춤형 의약품, 동반진단, 적응증 설계 및 기타 제품 시장의 성장에 따라 이들 분야의 약사법 전문성에 대한 수요가 증가할 것으로 예상됩니다. 기업들이 다양한 산업으로 진출하고 규제 준수에 대한 부담이 증가함에 따라 약사 업무에 대한 전문성을 갖춘 전문 서비스 제공업체에 대한 수요가 증가하고 있습니다. 특히 신흥 경제국에서는 정부의 재정적 지원으로 희귀질환 치료제 개발이 크게 가속화되고 있습니다.

시장 개척을 위해 여러 기업이 제휴, 인수, 신제품 개발에 힘쓰고 있습니다. 예를 들어, 프레이어는 2022년 10월 한국의 정형외과용 임플란트 제조회사와 제휴하여 계약에 따라 규제 기기 등록 및 법적 대리 서비스를 제공했습니다. 또한, 2022년 1월 Parexel International Corporation은 Regulatory & Access Consulting Organization을 설립했습니다. 이 조직은 임상시험의 초기 단계부터 약사 지원을 제공하기 위해 설립되었습니다.

의약품 RA(Regulatory Affairs) 시장 보고서 하이라이트

• 부문별로는 제약 부문이 2024년 55.36% 이상의 매출 점유율을 차지하며 가장 큰 비중을 차지했습니다. 인구 증가, 도시화, 양질의 의료 서비스에 대한 국내 수요 증가로 인해 혁신적인 의약품을 개발 및 제조하는 제약 기업에 큰 잠재력을 창출하고 있습니다.
• 카테고리별로는 말라리아, HIV/AIDS, 비감염성 질환과 같은 질병의 확산으로 인해 생물학적 제제 부문이 예측 기간 동안 가장 빠른 CAGR 9.07%를 기록할 것으로 예상됩니다.
• 적응증별로는 암 분야가 2024년 시장을 주도했습니니다. 제약사 및 바이오 제약사의 강력한 면역학 파이프라인은 이 부문의 성장을 더욱 촉진할 것으로 예상됩니다.
• 2024년 시장 점유율은 암 분야가 32.98%로 가장 큰 비중을 차지했습니다. 이는 암 발병률이 높고, 안전하고 효과적인 치료 옵션에 대한 수요가 증가하고 있기 때문으로 분석됩니다.
• 개발 단계별로는 임상 연구 부문이 2024년 가장 큰 시장 점유율을 차지했습니다. 이는 임상시험 등록 건수가 증가함에 따라 이 부문의 성장을 촉진할 것으로 예상됩니다.
• 전임상 검사 부문은 예측 기간 동안 CAGR 8.40%로 가장 빠른 속도로 성장할 것으로 예상됩니다. 암, CVD, 신경질환 등 기존 질환의 유병률 증가가 시장 성장을 촉진하는 요인으로 작용할 것으로 보입니다.
• 서비스 제공업체별로는 제약 아웃소싱 부문이 2024년 59.07%로 가장 큰 시장 점유율을 차지했으며, 예측 기간 동안 8.76%의 가장 빠른 CAGR을 기록할 것으로 예상됩니다. 이러한 서비스의 인기가 높아지는 배경에는 아웃소싱을 통해 의료 기업이 비용을 절감할 수 있다는 점이 시장 성장의 주요 요인으로 작용하고 있습니다.

목차

제1장 조사 방법과 범위

제2장 주요 요약

제3장 의약품 RA(Regulatory Affairs) 시장 변수, 동향, 범위

• 시장 계통 전망
  • 상부 시장 전망
  • 보조 시장 전망
• 시장 역학
  • 시장 성장 촉진요인 분석
  • 시장 성장 억제요인 분석
• 서비스 격차 분석
  • 시장 기회
  • 시장 과제 분석
• 임상 검사량 분석, 2024년
  • 지역별 임상 검사 총수(2024년)
  • 임상 검사 총수(상별)(2024년)
  • 임상 검사 총수(연구 디자인별)(2024년)
  • 주요 치료 분야별 임상 검사 총수(2024년)
• 시장 분석 툴
  • Porter's Five Forces 분석
  • PESTEL 분석
  • COVID-19의 영향 분석
• 의약품 RA(Regulatory Affairs) 서비스에 관한 베스트 프랙티스와 사례 연구

제4장 의약품 RA(Regulatory Affairs) 시장 : 서비스 프로바이더별, 추정·동향 분석

• 부문 대시보드
• 세계의 의약품 RA(Regulatory Affairs) 시장 변동 분석
• 세계의 의약품 RA(Regulatory Affairs) 시장 규모와 동향 분석, 서비스 프로바이더, 2018-2030년
• 사내
• 아웃소싱

제5장 의약품 RA(Regulatory Affairs) 시장 : 서비스별, 추정·동향 분석

• 부문 대시보드
• 세계의 의약품 RA(Regulatory Affairs) 시장 변동 분석
• 세계의 의약품 RA(Regulatory Affairs) 시장 규모와 동향 분석, 서비스, 2018-2030년
• 규제 컨설팅
• 법적 대리
• 규제 문서 집필과 출판
  • 기입
  • 출판
• 제품 등록과 임상 검사 신청
• 기타

제6장 의약품 RA(Regulatory Affairs) 시장 : 카테고리별, 추정·동향 분석

• 부문 대시보드
• 세계의 의약품 RA(Regulatory Affairs) 시장 변동 분석
• 세계의 의약품 RA(Regulatory Affairs) 시장 규모와 동향 분석, 카테고리, 2018-2030년
• 약제
  • 이노베이터
  • 제네릭
• 생물학적 제제
  • 바이오테크놀러지
  • ATMP
  • 바이오시밀러

제7장 의약품 RA(Regulatory Affairs) 시장 : 적응증별, 추정·동향 분석

• 부문 대시보드
• 세계의 의약품 RA(Regulatory Affairs) 시장 변동 분석
• 세계의 의약품 RA(Regulatory Affairs) 시장 규모와 동향 분석, 적응증, 2018-2030년
• 종양학
• 신경학
• 심장병학
• 면역학
• 기타

제8장 의약품 RA(Regulatory Affairs) 시장 : 개발 단계별, 추정·동향 분석

• 부문 대시보드
• 세계의 의약품 RA(Regulatory Affairs) 시장 변동 분석
• 세계의 의약품 RA(Regulatory Affairs) 시장 규모와 동향 분석, 개발 단계, 2018-2030년
• 전임상
• 임상 연구
• 시판 후 승인(PMA)

제9장 의약품 RA(Regulatory Affairs) 시장 : 기업 규모별, 추정·동향 분석

• 부문 대시보드
• 세계의 의약품 RA(Regulatory Affairs) 시장 변동 분석
• 세계의 의약품 RA(Regulatory Affairs) 시장 규모와 동향 분석, 기업 규모, 2018-2030년
• 소
• 중
• 대

제10장 의약품 RA(Regulatory Affairs) 시장 : 지역별, 추정·동향 분석

• 지역별 시장 대시보드
• 세계 지역 시장 현황
• 시장 규모, 예측 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
  • 인도네시아
  • 말레이시아
  • 싱가포르
  • 태국
  • 대만
• 라틴아메리카
  • 브라질
  • 아르헨티나
  • 콜롬비아
  • 칠레
• 중동
  • 사우디아라비아
  • 아랍에미리트
  • 쿠웨이트
  • 이집트
  • 이스라엘
• 아프리카
  • 남아프리카공화국
  • 보츠와나
  • 나미비아
  • 짐바브웨
  • 잠비아
  • 탄자니아
  • 르완다
  • 가나
  • 나이지리아
  • 우간다
  • 모리셔스
  • 케냐

제11장 경쟁 구도

• 시장 진출 기업 분류
  • 시장 리더
  • 신흥 진출 기업
• 경쟁 시장 평가 분석(2024년)
• 기업 개요
  • Freyr
  • IQVIA Inc.
  • ICON plc.
  • WuXi AppTec(WAI)
  • Charles River Laboratories International, Inc.
  • Labcorp Drug Development
  • Parexel International Corporation
  • Pharmalex GmbH
  • Pharmexon
  • Genpact

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영문 목차

영문목차

Pharmaceutical Regulatory Affairs Market Growth & Trends:

The global pharmaceutical regulatory affairs market size is expected to reach USD 14.34 billion by 2030, registering a CAGR of 7.17% from 2025 to 2030, according to a new report by Grand View Research, Inc. The key factors driving the market growth are the changing regulatory landscape and growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs. There have been significant changes to the FDA's drug approval processes. Recently, the 21st Century Cures bill was passed, which is expected to speed up the approval process of the FDA for certain types of drugs.

The FDA has launched four programs-Accelerated Approval, Priority Review, Fast Track, and Breakthrough Therapy-to expedite drug reviews for serious and life-threatening diseases. The medicines under these programs are approved faster by regulatory agencies. In addition, in the UK, the launch of The Accelerated Access Collaborative, a government initiative to fast-track patient access to potential breakthrough medicines, is anticipated to boost the availability and accessibility of novel therapies in the country. These changes in approval processes are expected to drive innovation and increase the demand for regulatory service providers who are well-acquainted with recent changes in approval processes globally.

The demand for regulatory specialization in these fields is anticipated to increase with the growth of the markets for biosimilar, orphan medications, personalized medicines, companion diagnostics, adaptive trial designs, and other products. Demand for specialized service providers with expertise in regulatory affairs is increasing as companies expand into different industries and face a growing burden of regulatory compliance. Government financing has considerably accelerated the development of orphan medications, particularly in industrialized economies.

Several companies are involved in collaborations, acquisitions, and new product development to gain a position in the market. For instance, in October 2022, Freyr partnered with an orthopedic implant manufacturing company in Korea, and as per the agreement, provided it with regulatory device registration and legal representation services. Moreover, in January 2022, Parexel International Corporation formed a Regulatory & Access Consulting Organization. This organization was established to provide regulatory support to clinical studies from the early stages.

Pharmaceutical Regulatory Affairs Market Report Highlights:

• In terms of category, the drug segment held the largest revenue share of over 55.36% in 2024. The growing population, increasing urbanization, and rising demand for quality healthcare in the country have created a significant potential for pharmaceutical companies that develop and manufacture innovative drugs
• Based on category, the biologics segment is anticipated to register the fastest CAGR of 9.07% over the forecast period owing to the prevalence of diseases such as malaria, HIV/AIDS, and non-communicable diseases
• In terms of indication, the oncology segment dominated the market in 2024. The robust immunology pipeline of pharmaceutical and biopharmaceutical companies is anticipated to further boost segment growth
• The oncology segment dominated the market in 2024 with the largest revenue share of 32.98%. This can be attributed to the high prevalence of cancer, which is boosting the need for safe and effective treatment options
• In terms of development stage, the clinical studies segment held the largest market share in 2024. This can be attributed to the increasing number of clinical trial registrations, which is expected to drive the segment growth
• The preclinical segment is projected to grow at the fastest CAGR of 8.40% during the forecast period. Increasing prevalence of existing diseases such as cancer, CVDs, & neurological diseases are factors driving the market growth
• In terms of service providers, the outsourced regulatory affairs segment held the largest market share in 2024 at 59.07% and is anticipated to witness the fastest CAGR of 8.76% over the forecast period. The increasing popularity of these services can be attributed to the fact that outsourcing enables healthcare companies to reduce costs, which is a major contributing factor to market growth

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. Data Analysis Models
• 1.5. Market Formulation & Validation
  • 1.5.1. Region Wise Market: Base Estimates
  • 1.5.2. Global Market: CAGR Calculation
• 1.6. Model Details
  • 1.6.1. Commodity Flow Analysis (Model 1)
  • 1.6.2. Value-Chain-Based Sizing & Forecasting (Model 2)
  • 1.6.3. QFD Model Sizing & Forecasting (Model 3)
  • 1.6.4. Bottom-Up Approach (Model 4)
• 1.7. List of Secondary Sources
• 1.8. List of Abbreviations
• 1.9. Objectives

Chapter 2. Executive Summary

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

Chapter 3. Pharmaceutical Regulatory Affairs Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Changing Regulatory Landscape
    • 3.2.1.2. Life Sciences Companies Focusing on Their Core Competencies
    • 3.2.1.3. Economic and Competitive Pressures
    • 3.2.1.4. Demand for the Faster Approval Process for Breakthrough Drugs and Devices
    • 3.2.1.5. Entry of Companies into the Global Market
    • 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. Service Gap Analysis
  • 3.3.1. Market Opportunities
    • 3.3.1.1. Service Upgrade
    • 3.3.1.2. Technological Advancements
    • 3.3.1.3. Latest Trends
  • 3.3.2. Market Challenges Analysis
    • 3.3.2.1. Analysis Pertaining to Existing Gaps & Shortcomings in the Regulatory Services
    • 3.3.2.2. Bottlenecks Faced by Companies Seeking Regulatory Approvals or Maintaining Compliance
• 3.4. Clinical Trials Volume Analysis, 2024
  • 3.4.1. Total Number of Clinical Trials, by Region (2024)
  • 3.4.2. Total Number of Clinical Trials, by Phase (2024)
  • 3.4.3. Total Number of Clinical Trials, by Study Design (2024)
  • 3.4.4. Total Number of Clinical Trials, by Key Therapeutic Area (2024)
• 3.5. Market Analysis Tools
  • 3.5.1. Porter's Five Forces Analysis
  • 3.5.2. PESTEL Analysis
  • 3.5.3. COVID-19 Impact Analysis
• 3.6. Best Practices and Case Study Pertaining to Regulatory Affairs Services

Chapter 4. Pharmaceutical Regulatory Affairs Market: Service Provider Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Pharmaceutical Regulatory Affairs Market Movement Analysis
• 4.3. Global Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, by Service Provider, 2018 to 2030 (USD Million)
• 4.4. In-house
  • 4.4.1. In-house Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 4.5. Outsourcing
  • 4.5.1. Outsourcing Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 5. Pharmaceutical Regulatory Affairs Market: Service Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Pharmaceutical Regulatory Affairs Market Movement Analysis
• 5.3. Global Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
• 5.4. Regulatory Consulting
  • 5.4.1. Regulatory Consulting Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 5.5. Legal Representation
  • 5.5.1. Legal Representation Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 5.6. Regulatory Writing & Publishing
  • 5.6.1. Regulatory Writing & Publishing Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.6.2. Writing
    • 5.6.2.1. Writing Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.6.3. Publishing
    • 5.6.3.1. Publishing Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 5.7. Product Registration & Clinical Trial Applications
  • 5.7.1. Product Registration & Clinical Trial Applications Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 5.8. Other Services
  • 5.8.1. Other Services Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 6. Pharmaceutical Regulatory Affairs Market: Category Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Pharmaceutical Regulatory Affairs Market Movement Analysis
• 6.3. Global Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, by Category, 2018 to 2030 (USD Million)
• 6.4. Drugs
  • 6.4.1. Drugs Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 6.4.2. Innovator
    • 6.4.2.1. Innovator Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.4.2.2. Preclinical
      • 6.4.2.2.1. Preclinical Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.4.2.3. Clinical
      • 6.4.2.3.1. Clinical Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.4.2.4. Post Market Approval (PMA)
      • 6.4.2.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 6.4.3. Generics
    • 6.4.3.1. Generics Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.4.3.2. Preclinical
      • 6.4.3.2.1. Preclinical Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.4.3.3. Clinical
      • 6.4.3.3.1. Clinical Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.4.3.4. Post Market Approval (PMA)
      • 6.4.3.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.5. Biologics
  • 6.5.1. Biologics Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 6.5.2. Biotech
    • 6.5.2.1. Biotech Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.5.2.2. Preclinical
      • 6.5.2.2.1. Preclinical Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.5.2.3. Clinical
      • 6.5.2.3.1. Clinical Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.5.2.4. Post Market Approval (PMA)
      • 6.5.2.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 6.5.3. ATMP
    • 6.5.3.1. ATMP Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.5.3.2. Preclinical
      • 6.5.3.2.1. Preclinical Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.5.3.3. Clinical
      • 6.5.3.3.1. Clinical Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.5.3.4. Post Market Approval (PMA)
      • 6.5.3.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 6.5.4. Biosimilars
    • 6.5.4.1. Biosimilars Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.5.4.2. Preclinical
      • 6.5.4.2.1. Preclinical Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.5.4.3. Clinical
      • 6.5.4.3.1. Clinical Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 6.5.4.4. Post Market Approval (PMA)
      • 6.5.4.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 7. Pharmaceutical Regulatory Affairs Market: Indication Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. Global Pharmaceutical Regulatory Affairs Market Movement Analysis
• 7.3. Global Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, Indication, 2018 to 2030 (USD Million)
• 7.4. Oncology
  • 7.4.1. Oncology Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 7.5. Neurology
  • 7.5.1. Neurology Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 7.6. Cardiology
  • 7.6.1. Cardiology Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 7.7. Immunology
  • 7.7.1. Immunology Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 7.8. Others
  • 7.8.1. Others Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 8. Pharmaceutical Regulatory Affairs Market: Development Stage Estimates & Trend Analysis

• 8.1. Segment Dashboard
• 8.2. Global Pharmaceutical Regulatory Affairs Market Movement Analysis
• 8.3. Global Pharmaceutical Regulatory Affairs Market Size & Trend Analysis, Development Stage, 2018 to 2030 (USD Million)
• 8.4. Preclinical
  • 8.4.1. Preclinical Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 8.5. Clinical studies
  • 8.5.1. Clinical Studies Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 8.6. Post Market Approval (PMA)
  • 8.6.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2018 to 2030 (USD Million)

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

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

Chapter 10. Pharmaceutical Regulatory Affairs Market: Regional Estimates & Trend Analysis

• 10.1. Regional Market Dashboard
• 10.2. Global Regional Market Snapshot
• 10.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
• 10.4. North America
  • 10.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.4.2. U.S.
    • 10.4.2.1. Key Country Dynamics
    • 10.4.2.2. Competitive Scenario
    • 10.4.2.3. Regulatory Framework
    • 10.4.2.4. U.S. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.4.3. Canada
    • 10.4.3.1. Key Country Dynamics
    • 10.4.3.2. Competitive Scenario
    • 10.4.3.3. Regulatory Framework
    • 10.4.3.4. Canada Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.4.4. Mexico
    • 10.4.4.1. Key Country Dynamics
    • 10.4.4.2. Competitive Scenario
    • 10.4.4.3. Regulatory Framework
    • 10.4.4.4. Mexico Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.5. Europe
  • 10.5.1. Europe Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.2. UK
    • 10.5.2.1. Key Country Dynamics
    • 10.5.2.2. Competitive Scenario
    • 10.5.2.3. Regulatory Framework
    • 10.5.2.4. UK Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.3. Germany
    • 10.5.3.1. Key Country Dynamics
    • 10.5.3.2. Competitive Scenario
    • 10.5.3.3. Regulatory Framework
    • 10.5.3.4. Germany Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.4. France
    • 10.5.4.1. Key Country Dynamics
    • 10.5.4.2. Competitive Scenario
    • 10.5.4.3. Regulatory Framework
    • 10.5.4.4. France Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.5. Italy
    • 10.5.5.1. Key Country Dynamics
    • 10.5.5.2. Competitive Scenario
    • 10.5.5.3. Regulatory Framework
    • 10.5.5.4. Italy Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.6. Spain
    • 10.5.6.1. Key Country Dynamics
    • 10.5.6.2. Competitive Scenario
    • 10.5.6.3. Regulatory Framework
    • 10.5.6.4. Spain Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.7. Denmark
    • 10.5.7.1. Key Country Dynamics
    • 10.5.7.2. Competitive Scenario
    • 10.5.7.3. Regulatory Framework
    • 10.5.7.4. Denmark Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.8. Norway
    • 10.5.8.1. Key Country Dynamics
    • 10.5.8.2. Competitive Scenario
    • 10.5.8.3. Regulatory Framework
    • 10.5.8.4. Norway Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.9. The Netherlands
    • 10.5.9.1. Key Country Dynamics
    • 10.5.9.2. Competitive Scenario
    • 10.5.9.3. Regulatory Framework
    • 10.5.9.4. The Netherlands Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.10. Switzerland
    • 10.5.10.1. Key Country Dynamics
    • 10.5.10.2. Competitive Scenario
    • 10.5.10.3. Regulatory Framework
    • 10.5.10.4. Switzerland Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.11. Sweden
    • 10.5.11.1. Key Country Dynamics
    • 10.5.11.2. Competitive Scenario
    • 10.5.11.3. Regulatory Framework
    • 10.5.11.4. Sweden Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.6. Asia Pacific
  • 10.6.1. Asia Pacific Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.2. Japan
    • 10.6.2.1. Key Country Dynamics
    • 10.6.2.2. Competitive Scenario
    • 10.6.2.3. Regulatory Framework
    • 10.6.2.4. Japan Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.3. China
    • 10.6.3.1. Key Country Dynamics
    • 10.6.3.2. Competitive Scenario
    • 10.6.3.3. Regulatory Framework
    • 10.6.3.4. China Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.4. India
    • 10.6.4.1. Key Country Dynamics
    • 10.6.4.2. Competitive Scenario
    • 10.6.4.3. Regulatory Framework
    • 10.6.4.4. India Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.5. Australia
    • 10.6.5.1. Key Country Dynamics
    • 10.6.5.2. Competitive Scenario
    • 10.6.5.3. Regulatory Framework
    • 10.6.5.4. Australia Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.6. South Korea
    • 10.6.6.1. Key Country Dynamics
    • 10.6.6.2. Competitive Scenario
    • 10.6.6.3. Regulatory Framework
    • 10.6.6.4. South Korea Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.7. Indonesia
    • 10.6.7.1. Key Country Dynamics
    • 10.6.7.2. Competitive Scenario
    • 10.6.7.3. Regulatory Framework
    • 10.6.7.4. Indonesia Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.8. Malaysia
    • 10.6.8.1. Key Country Dynamics
    • 10.6.8.2. Competitive Scenario
    • 10.6.8.3. Regulatory Framework
    • 10.6.8.4. Malaysia Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.9. Singapore
    • 10.6.9.1. Key Country Dynamics
    • 10.6.9.2. Competitive Scenario
    • 10.6.9.3. Regulatory Framework
    • 10.6.9.4. Singapore Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.10. Thailand
    • 10.6.10.1. Key Country Dynamics
    • 10.6.10.2. Competitive Scenario
    • 10.6.10.3. Regulatory Framework
    • 10.6.10.4. Thailand Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.11. Taiwan
    • 10.6.11.1. Key Country Dynamics
    • 10.6.11.2. Competitive Scenario
    • 10.6.11.3. Regulatory Framework
    • 10.6.11.4. Taiwan Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.7. Latin America
  • 10.7.1. Latin America Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.7.2. Brazil
    • 10.7.2.1. Key Country Dynamics
    • 10.7.2.2. Competitive Scenario
    • 10.7.2.3. Regulatory Framework
    • 10.7.2.4. Brazil Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.7.3. Argentina
    • 10.7.3.1. Key Country Dynamics
    • 10.7.3.2. Competitive Scenario
    • 10.7.3.3. Regulatory Framework
    • 10.7.3.4. Argentina Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.7.4. Colombia
    • 10.7.4.1. Key Country Dynamics
    • 10.7.4.2. Competitive Scenario
    • 10.7.4.3. Regulatory Framework
    • 10.7.4.4. Colombia Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.7.5. Chile
    • 10.7.5.1. Key Country Dynamics
    • 10.7.5.2. Competitive Scenario
    • 10.7.5.3. Regulatory Framework
    • 10.7.5.4. Chile Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.8. Middle East
  • 10.8.1. Middle East Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.2. Saudi Arabia
    • 10.8.2.1. Key Country Dynamics
    • 10.8.2.2. Competitive Scenario
    • 10.8.2.3. Regulatory Framework
    • 10.8.2.4. Saudi Arabia Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.3. UAE
    • 10.8.3.1. Key Country Dynamics
    • 10.8.3.2. Competitive Scenario
    • 10.8.3.3. Regulatory Framework
    • 10.8.3.4. UAE Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.4. Kuwait
    • 10.8.4.1. Key Country Dynamics
    • 10.8.4.2. Competitive Scenario
    • 10.8.4.3. Regulatory Framework
    • 10.8.4.4. Kuwait Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.5. Egypt
    • 10.8.5.1. Key Country Dynamics
    • 10.8.5.2. Competitive Scenario
    • 10.8.5.3. Regulatory Framework
    • 10.8.5.4. Egypt Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.6. Israel
    • 10.8.6.1. Key Country Dynamics
    • 10.8.6.2. Competitive Scenario
    • 10.8.6.3. Regulatory Framework
    • 10.8.6.4. Israel Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.9. Africa
  • 10.9.1. Africa Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.2. South Africa
    • 10.9.2.1. Key Country Dynamics
    • 10.9.2.2. Competitive Scenario
    • 10.9.2.3. Regulatory Framework
    • 10.9.2.4. South Africa Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.3. Botswana
    • 10.9.3.1. Key Country Dynamics
    • 10.9.3.2. Competitive Scenario
    • 10.9.3.3. Regulatory Framework
    • 10.9.3.4. Botswana Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.4. Namibia
    • 10.9.4.1. Key Country Dynamics
    • 10.9.4.2. Competitive Scenario
    • 10.9.4.3. Regulatory Framework
    • 10.9.4.4. Namibia Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.5. Zimbabwe
    • 10.9.5.1. Key Country Dynamics
    • 10.9.5.2. Competitive Scenario
    • 10.9.5.3. Regulatory Framework
    • 10.9.5.4. Zimbabwe Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.6. Zambia
    • 10.9.6.1. Key Country Dynamics
    • 10.9.6.2. Competitive Scenario
    • 10.9.6.3. Regulatory Framework
    • 10.9.6.4. Zambia Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.7. Tanzania
    • 10.9.7.1. Key Country Dynamics
    • 10.9.7.2. Competitive Scenario
    • 10.9.7.3. Regulatory Framework
    • 10.9.7.4. Tanzania Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.8. Rwanda
    • 10.9.8.1. Key Country Dynamics
    • 10.9.8.2. Competitive Scenario
    • 10.9.8.3. Regulatory Framework
    • 10.9.8.4. Rwanda Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.9. Ghana
    • 10.9.9.1. Key Country Dynamics
    • 10.9.9.2. Competitive Scenario
    • 10.9.9.3. Regulatory Framework
    • 10.9.9.4. Ghana Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.10. Nigeria
    • 10.9.10.1. Key Country Dynamics
    • 10.9.10.2. Competitive Scenario
    • 10.9.10.3. Regulatory Framework
    • 10.9.10.4. Nigeria Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.11. Uganda
    • 10.9.11.1. Key Country Dynamics
    • 10.9.11.2. Competitive Scenario
    • 10.9.11.3. Regulatory Framework
    • 10.9.11.4. Uganda Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.12. Mauritius
    • 10.9.12.1. Key Country Dynamics
    • 10.9.12.2. Competitive Scenario
    • 10.9.12.3. Regulatory Framework
    • 10.9.12.4. Mauritius Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.9.13. Kenya
    • 10.9.13.1. Key Country Dynamics
    • 10.9.13.2. Competitive Scenario
    • 10.9.13.3. Regulatory Framework
    • 10.9.13.4. Kenya Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 11. Competitive Landscape

• 11.1. Market Participant Categorization
  • 11.1.1. Market Leaders
  • 11.1.2. Emerging Players
• 11.2. Competitive Market Assessment Analysis (2024)
• 11.3. Company Profiles
  • 11.3.1. Freyr
    • 11.3.1.1. Company Overview
    • 11.3.1.2. Financial Performance
    • 11.3.1.3. Service Benchmarking
    • 11.3.1.4. Strategic Initiatives
  • 11.3.2. IQVIA Inc.
    • 11.3.2.1. Company Overview
    • 11.3.2.2. Financial Performance
    • 11.3.2.3. Service Benchmarking
    • 11.3.2.4. Strategic Initiatives
  • 11.3.3. ICON plc.
    • 11.3.3.1. Company Overview
    • 11.3.3.2. Financial Performance
    • 11.3.3.3. Service Benchmarking
    • 11.3.3.4. Strategic Initiatives
  • 11.3.4. WuXi AppTec (WAI)
    • 11.3.4.1. Company Overview
    • 11.3.4.2. Financial Performance
    • 11.3.4.3. Service Benchmarking
    • 11.3.4.4. Strategic Initiatives
  • 11.3.5. Charles River Laboratories International, Inc.
    • 11.3.5.1. Company Overview
    • 11.3.5.2. Financial Performance
    • 11.3.5.3. Service Benchmarking
    • 11.3.5.4. Strategic Initiatives
  • 11.3.6. Labcorp Drug Development
    • 11.3.6.1. Company Overview
    • 11.3.6.2. Financial Performance
    • 11.3.6.3. Service Benchmarking
    • 11.3.6.4. Strategic Initiatives
  • 11.3.7. Parexel International Corporation
    • 11.3.7.1. Company Overview
    • 11.3.7.2. Financial Performance
    • 11.3.7.3. Service Benchmarking
    • 11.3.7.4. Strategic Initiatives
  • 11.3.8. Pharmalex GmbH
    • 11.3.8.1. Company Overview
    • 11.3.8.2. Financial Performance
    • 11.3.8.3. Service Benchmarking
    • 11.3.8.4. Strategic Initiatives
  • 11.3.9. Pharmexon
    • 11.3.9.1. Company Overview
    • 11.3.9.2. Financial Performance
    • 11.3.9.3. Service Benchmarking
    • 11.3.9.4. Strategic Initiatives
  • 11.3.10. Genpact
    • 11.3.10.1. Company Overview
    • 11.3.10.2. Financial Performance
    • 11.3.10.3. Service Benchmarking
    • 11.3.10.4. Strategic Initiatives

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