생물 RA(Regulatory Affairs) 아웃소싱 시장 규모, 점유율, 동향 분석 보고서 : 서비스별, 단계별, 모달리티별, 서비스단계별, 모달리티단계별, 서비스모달리티별, 지역별, 부문 예측(2025-2030년)

Biologics Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Service (Regulatory Consulting), By Phase, By Modality, Phase by Service, Phase by Modality, Modality by Service, By Region, And Segment Forecasts, 2025 - 2030

US $ 5,950 ￦ 8,212,000

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한글목차

생물 RA(Regulatory Affairs) 아웃소싱 시장의 성장과 동향 :

Grand View Research, Inc.의 최신 보고서에 따르면 세계 생물 RA(Regulatory Affairs) 아웃소싱 시장 규모는 2030년까지 36억 9,000만 달러에 달할 것으로 예상되며, 2025년부터 2030년까지의 CAGR은 9.06%를 나타낼 것으로 예측되고 있습니다.

바이오 의약품 기업의 세계화는 시장 전체 수요를 높이는 주요 성장 요인 중 하나입니다. 아시아태평양, 라틴아메리카, 중동 및 아프리카의 신흥 시장은 제품 개발 및 제조 비용이 낮고 세제 우대가 있으며 숙련 노동자가 비교적 저비용으로 입수 가능하며 규제도 정비되고 있습니다. 위의 요인으로 인해 이 지역 시장은 바이오 의약품 기업에게 아웃소싱과 사업 확대 측면에서 매력적인 전망이 되어 약사 서비스 수요를 자극하고 있습니다. 게다가 신흥국에 EMA 및/또는 FDA의 인가를 받은 시설이 존재함으로써, 그 나라에 대한 외국 투자가 증가하고, 법정 대리인이나 약사 컨설팅 서비스 등의 약사 서비스에 대한 수요가 높아질 것으로 예상됩니다.

신흥국에서 실시되는 임상시험의 수는 크게 증가하고 있습니다. 이는 미국 등 신흥경제국에 비해 비교적 저비용으로 숙련노동력, 첨단기술, 인프라시설을 이용할 수 있기 때문이며, 이들 지역에서는 임상시험신청 및 제품등록 등 약사서비스 수요가 자극될 것으로 예상됩니다. 신흥국은 세계의 임상시험 신청 총 건수의 30.0% 이상을 차지하고 있으며, 이 점유율은 향후 수년간 증가하여 시장 성장에 기여할 것으로 예상됩니다.

일부 바이오 의약품 기업은 핵심 역량에 집중하고 비 코어 기능을 아웃소싱하여 생산성과 업무 효율성을 높입니다. 이러한 기업은 국제 규제에 대응하는 몇 가지 과제에 직면하고 있으며, 그 대응에는 시간과 노력이 걸립니다. 이 때문에 새로운 분자를 실현 가능한 스케줄과 합리적인 비용으로 시장에 투입하기 위한 경쟁이 서비스 제공업체에 대한 수요를 끌어올릴 가능성이 높습니다. 게다가 사내에 역량이 없는 중소규모의 바이오의약품 기업의 대부분이 약업무의 아웃소싱에 기울고 있으며, 이는 업계의 진전에 긍정적인 영향을 미칠 것으로 추정됩니다.

바이오시밀러, 희귀의약품, 개별화 의약품, 적응 시험 설계 등 시장의 성장은 이러한 분야에서 약사 전문 업무 수요를 높일 것으로 예측됩니다. 여러 기업이 새로운 분야에 진출함에 따라 규제 경험이 있는 숙련된 서비스 제공업체에 대한 요구가 커지고 규제를 준수할 필요성이 발생하고 있습니다. 특히 신흥경제국에서는 정부의 지원으로 희소질병용 의약품 개발이 크게 증가하고 있습니다. 심렉트, 벡티빅스, 미르셀라, 키네렛 등의 생물학적 제제의 특허 해지는 바이오시밀러 수요와 개발을 증가시키고 있으며, 이 부문에서 약사 서비스 수요에 기여하고 있습니다.

생물 RA(Regulatory Affairs) 아웃소싱 시장 : 분석 개요

• 규제 문서의 집필·간행 부문이 2024년에 최대 시장 점유율을 차지했습니다. 이 부문이 높은 성장을 거둔 배경에는 정확하고 종합적인 문서화가 필요한 생물 제제의 복잡화, 철저한 제출을 요구하는 엄격한 국제 규제 요구 사항, 컴플라이언스를 보장하기위한 전문 지식의 필요성 등이 있습니다. 유전자 치료나 바이오시밀러와 같은 생물제제의 기술 혁신 속도가 빠르기 때문에 진화하는 규제에 대한 최신 지식이 필요해 시장 전체의 성장이 전망되고 있습니다.
• 2024년에는 임상 단계 부문이 가장 큰 점유율을 차지했습니다. 이 부문별로 수익이 높은 성장률은 지난 몇 년간의 시험 등록 건수 증가로 인한 것입니다.
• 단클론 항체(mAb) 부문은 2024년에 가장 큰 수익 점유율을 차지했습니다. 이 부문의 성장은 새로운 전달 방법과 치료 표적을 포함한 mAb 기술의 급속한 발전으로 인해 시장 전체의 성장 가능성으로 이어지는 최신의 정확한 규제 전략이 필요합니다.
• 아시아태평양의 생물 RA(Regulatory Affairs) 아웃소싱 시장은 2024년 40.94%의 최대 수익 점유율을 차지했으며 예측 기간 동안 가장 빠른 CAGR로 성장할 것으로 예상됩니다.

목차

제1장 분석 방법·범위

제2장 주요 요약

제3장 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 변동 요인·경향·범위

• 시장 연관 전망
  • 상위 시장 전망
  • 관련/부수 시장 전망
• 시장 역학
  • 시장 성장 촉진요인 분석
  • 시장 성장 억제요인 분석
• 기술진보
  • 기존·신규 기술과 추천 툴의 사용
  • 사내 툴과 널리 이용 가능한 툴의 차별화
  • 주요 기술의 기둥
  • 빅데이터와 분석
  • RTP, 텍스트 처리, 분석
  • 음성 및 비디오 분석
  • 사물인터넷(IoT)
  • AI도구
• 가격 모델 분석
• 시험 건수 분석(2024년)
  • 임상시험의 총수 : 지역별(2024년)
  • 임상시험의 총수 : 단계별(2024년)
  • 임상시험의 총수 : 연구 디자인별(2024년)
  • 임상시험의 총수 : 주된 치료 영역별(2024년)
• 시장 분석 도구
  • Porter's Five Forces 분석
  • PESTEL 분석
  • COVID-19의 영향 분석

제4장 생물 RA(Regulatory Affairs) 아웃소싱 시장의 추정과 동향 분석 : 서비스별

• 부문 대시보드
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 변동 분석
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 시장 규모와 동향 분석, 서비스별(2018-2030년)
  • 규제 컨설팅
  • 법적 대리
  • 규제 문서의 집필·간행
  • 제품 등록 및 임상시험 신청
  • 규제 당국에 제출
  • 규제 업무
  • 기타 서비스

제5장 생물 RA(Regulatory Affairs) 아웃소싱 시장의 추정과 동향 분석 : 단계별

• 부문 대시보드
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 변동 분석
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 시장 규모와 동향 분석, 위상별(2018-2030년)
  • 전임상
  • 임상

제6장 생물 RA(Regulatory Affairs) 아웃소싱 시장의 추정과 동향 분석 : 모달리티별

• 부문 대시보드
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 변동 분석
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 시장 규모와 동향 분석, 모달리티별(2018-2030년)
• 단클론항체(mAb)
• 재조합 단백질
• 백신
• 세포 및 유전자 치료
• 바이오시밀러
• 기타

제7장 생물 RA(Regulatory Affairs) 아웃소싱 시장의 추정과 동향 분석 : 서비스 단계별

• 부문 대시보드
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 변동 분석
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 시장 규모와 동향 분석, 서비스 단계별(2018-2030년)
  • 전임상
  • 임상

제8장 생물 RA(Regulatory Affairs) 아웃소싱 시장의 추정과 동향 분석 : 모달리티 단계별

• 부문 대시보드
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 변동 분석
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 시장 규모와 동향 분석, 모달리티별 단계별(2018-2030년)
  • 전임상
  • 임상

제9장 생물 RA(Regulatory Affairs) 아웃소싱 시장의 추정과 동향 분석 : 모달리티 서비스별

• 부문 대시보드
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 변동 분석
• 세계의 생물 RA(Regulatory Affairs) 아웃소싱 시장 : 시장 규모와 동향 분석, 모달리티 서비스별(2018-2030년)
  • 단클론항체(mAb)
  • 재조합 단백질
  • 백신
  • 세포 및 유전자 치료
  • 바이오시밀러
  • 기타

제10장 생물 RA(Regulatory Affairs) 아웃소싱 시장의 추정과 동향 분석 : 지역별

• 시장 대시보드 : 지역별
• 세계 시장 현황 : 지역별
• 시장 규모 예측과 동향 분석(2018-2030년)
• 북미
  • 미국
  • 캐나다
  • 멕시코
• 유럽
  • 영국
  • 독일
  • 프랑스
  • 이탈리아
  • 스페인
  • 덴마크
  • 스웨덴
  • 노르웨이
• 아시아태평양
  • 중국
  • 일본
  • 인도
  • 호주
  • 한국
  • 태국
• 라틴아메리카
  • 브라질
  • 아르헨티나
• 중동 및 아프리카
  • 남아프리카
  • 사우디아라비아
  • 아랍에미리트(UAE)
  • 쿠웨이트

제11장 경쟁 구도

• 시장 진출기업의 분류
  • 시장 리더
  • 신흥기업
• 경쟁 시장 점유율/평가 분석(2024)
• 기업 프로파일
  • Lonza AG
  • Wuxi Apptec Inc.
  • Thermo Fisher Scientific Inc.
  • Eurofins Scientific SE
  • Freyrsolutions
  • Catalent Inc.
  • Piramal Group
  • AGC Biologics
  • ICON Plc.

KTH

영문 목차

영문목차

Biologics Regulatory Affairs Outsourcing Market Growth & Trends:

The global biologics regulatory affairs outsourcing market size is expected to reach USD 3.69 billion by 2030, registering a CAGR of 9.06% from 2025 to 2030, according to a new report by Grand View Research, Inc. Globalization of biopharmaceutical companies is one of the major growth drivers boosting overall market demand. Emerging markets of Asia Pacific, Latin America, and MEA regions offer low product development & manufacturing costs, tax benefits, and availability of skilled labor at relatively low costs with supportive regulations. The abovementioned factors have made the regional markets attractive prospects in terms of outsourcing and expansion for biopharmaceutical companies, thereby stimulating the demand for regulatory services. Furthermore, the presence of EMA- and/or FDA-approved facilities in emerging economies is anticipated to increase foreign investments in the country and the demand for regulatory services, such as legal representation and regulatory consulting services.

A significant increase has been witnessed in the number of clinical trials conducted in emerging economies. This can be attributed to the availability of skilled labor, advanced technologies, and infrastructure facilities at relatively lower costs than developed economies such as the U.S., which is expected to stimulate the demand for regulatory services such as clinical trial applications & product registrations in these regions. Emerging economies contribute to more than 30.0% of total clinical trial applications submitted across the globe, and the share is expected to increase over the coming years, contributing to market growth.

Several biopharmaceutical companies are focusing on their core competencies and outsourcing noncore functions to increase their productivity & operational efficiency. These companies face several challenges with regard to complying with global regulations, which can be a lengthy and tedious process. Thus, the race to launch a novel molecule in the market in a feasible timeline and at a reasonable cost will likely propel the demand for service providers. Furthermore, many small- and medium-scale biopharma companies lacking in-house capabilities are inclined towards outsourcing regulatory affairs, which is estimated to positively influence the industry's progression.

Growth in markets for biosimilars, orphan drugs, personalized medicines, adaptive trial designs, and others is projected to boost the demand for regulatory specialization in these areas. As several companies expand into new avenues, the increasing need for skilled service providers with experience in regulations leads to the necessity to comply with regulations. Government support, especially in developed economies, has significantly increased the development of orphan drugs. 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 in this segment.

Biologics Regulatory Affairs Outsourcing Market Report Highlights:

• The regulatory writing & publishing segment held the largest market share in 2024. The high segment growth is owing to the increasing complexity of biologics requiring precise and comprehensive documentation, stringent global regulatory requirements demanding thorough submissions, and the need for specialized expertise to ensure compliance. The rapid pace of innovation in biologics, such as gene therapies and biosimilars, necessitates up-to-date knowledge of evolving regulations is anticipated overall market growth
• The clinical phase segment accounted for the largest share in 2024. The high segmental revenue growth can be attributed to the increasing number of clinical trial registrations over the past few years
• The monoclonal antibodies (mAbs) segment accounted for the largest revenue share in 2024. The segmental growth is owing to rapid advancements in mAb technology, including novel delivery methods and therapeutic targets, which require updated and precise regulatory strategies leading to overall market growth potential
• The Asia Pacific biologics regulatory affairs outsourcing market held the largest revenue share of 40.94% in 2024 and is expected to grow at the fastest CAGR over the forecast period.

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. Research Methodology
• 1.3. Information Procurement
  • 1.3.1. Purchased Database
  • 1.3.2. GVR's Internal Database
  • 1.3.3. Secondary Sources
  • 1.3.4. 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. Market Definitions
• 1.8. List of Secondary Sources
• 1.9. List of Abbreviations
• 1.10. Objectives
  • 1.10.1. Objective - 1:
  • 1.10.2. Objective - 2:
  • 1.10.3. Objective - 3:
  • 1.10.4. Objective - 4:

Chapter 2. Executive Summary

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

Chapter 3. Biologics Regulatory Affairs Outsourcing 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. Growing Number of Clinical Trials
    • 3.2.1.2. Increasing Adoption of the Personalized Medicine and Novel Therapeutics
    • 3.2.1.3. Rising R&D Investment in the Healthcare Industry
    • 3.2.1.4. Advancements in the Regulatory Affairs Market
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Compliance Issues While Outsourcing
    • 3.2.2.2. Managing Relationships
• 3.3. Technological Advancements
  • 3.3.1. Existing and Emerging Use of Technology and Preferred Tools
  • 3.3.2. Differentiating In-House Tools Vs Widely Available
  • 3.3.3. Key Technology Pillars
    • 3.3.3.1. Digital Transformation and Data Integrity
    • 3.3.3.2. Artificial Intelligence, Machine Learning/Automation
    • 3.3.3.3. Data Analysis and Predictive Modeling
    • 3.3.3.4. Automation of Routine Tasks
    • 3.3.3.5. Compliance Monitoring
    • 3.3.3.6. Discovery and Development
    • 3.3.3.7. Regulatory Guidelines Related to AI/ML
  • 3.3.4. Big Data and Analytics
  • 3.3.5. RTP, Text Processing and Analytics
  • 3.3.6. Speech and Video Analytics
  • 3.3.7. IoT (Internet Of Things)
  • 3.3.8. AI Tools
• 3.4. Pricing Model Analysis
• 3.5. Clinical Trials Volume Analysis, 2024
  • 3.5.1. Total Number of Clinical Trials, by Region (2024)
  • 3.5.2. Total Number of Clinical Trials, by Phase (2024)
  • 3.5.3. Total Number of Clinical Trials, by Study Design (2024)
  • 3.5.4. Total Number of Clinical Trials, by Key Therapeutic Area (2024)
• 3.6. Market Analysis Tools
  • 3.6.1. Porter's Five Forces Analysis
  • 3.6.2. PESTEL Analysis
  • 3.6.3. COVID-19 Impact Analysis

Chapter 4. Biologics Regulatory Affairs Outsourcing Market: Service Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 4.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
  • 4.3.1. Regulatory Consulting
    • 4.3.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 4.3.1.2. Strategy & Development Planning
      • 4.3.1.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 4.3.1.3. QA Consulting
      • 4.3.1.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 4.3.1.4. Agent Services
      • 4.3.1.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 4.3.1.5. Others
      • 4.3.1.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.2. Legal Representation
    • 4.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.3. Regulatory Writing & Publishing
    • 4.3.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.4. Product Registration & Clinical Trial Applications
    • 4.3.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.5. Regulatory Submissions
    • 4.3.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.6. Regulatory Operations
    • 4.3.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.3.7. Other Services
    • 4.3.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 5. Biologics Regulatory Affairs Outsourcing Market: Phase Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 5.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, by Phase, 2018 to 2030 (USD Million)
  • 5.3.1. Preclinical
    • 5.3.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.3.2. Clinical
    • 5.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 5.3.2.2. Phase I
      • 5.3.2.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 5.3.2.3. Phase II
      • 5.3.2.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 5.3.2.4. Phase III
      • 5.3.2.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 5.3.2.5. Phase IV
      • 5.3.2.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 6. Biologics Regulatory Affairs Outsourcing Market: Modality Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 6.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, by Modality, 2018 to 2030 (USD Million)
• 6.4. Monoclonal Antibodies (mAbs)
  • 6.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.5. Recombinant Proteins
  • 6.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.6. Vaccines
  • 6.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.7. Cell & Gene Therapies
  • 6.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.8. Biosimilars
  • 6.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.9. Others
  • 6.9.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 7. Biologics Regulatory Affairs Outsourcing Market: Phase by Service Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 7.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, Phase by Service, 2018 to 2030 (USD Million)
  • 7.3.1. Preclinical
    • 7.3.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.2. Regulatory Consulting
      • 7.3.1.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.3. Legal Representation
      • 7.3.1.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.4. Regulatory Writing & Publishing
      • 7.3.1.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.5. Product Registration & Clinical Trial Applications
      • 7.3.1.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.6. Regulatory Submissions
      • 7.3.1.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.7. Regulatory Operations
      • 7.3.1.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.1.8. Other Services
      • 7.3.1.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.3.2. Clinical
    • 7.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.2. Regulatory Consulting
      • 7.3.2.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.3. Legal Representation
      • 7.3.2.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.4. Regulatory Writing & Publishing
      • 7.3.2.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.5. Product Registration & Clinical Trial Applications
      • 7.3.2.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.6. Regulatory Submissions
      • 7.3.2.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.7. Regulatory Operations
      • 7.3.2.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 7.3.2.8. Other Services
      • 7.3.2.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 8. Biologics Regulatory Affairs Outsourcing Market: Phase by Modality Estimates & Trend Analysis

• 8.1. Segment Dashboard
• 8.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 8.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, Phase by Modality, 2018 to 2030 (USD Million)
  • 8.3.1. Preclinical
    • 8.3.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.2. Monoclonal Antibodies (mAbs)
      • 8.3.1.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.3. Recombinant Proteins
      • 8.3.1.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.4. Vaccines
      • 8.3.1.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.5. Cell & Gene Therapies
      • 8.3.1.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.6. Biosimilars
      • 8.3.1.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.1.7. Others
      • 8.3.1.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 8.3.2. Clinical
    • 8.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.2. Monoclonal Antibodies (mAbs)
      • 8.3.2.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.3. Recombinant Proteins
      • 8.3.2.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.4. Vaccines
      • 8.3.2.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.5. Cell & Gene Therapies
      • 8.3.2.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.6. Biosimilars
      • 8.3.2.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 8.3.2.7. Others
      • 8.3.2.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 9. Biologics Regulatory Affairs Outsourcing Market: Modality by Service Estimates & Trend Analysis

• 9.1. Segment Dashboard
• 9.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
• 9.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, Modality by Service, 2018 to 2030 (USD Million)
  • 9.3.1. Monoclonal Antibodies (mAbs)
    • 9.3.1.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.2. Regulatory Consulting
      • 9.3.1.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.3. Legal Representation
      • 9.3.1.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.4. Regulatory Writing & Publishing
      • 9.3.1.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.5. Product Registration & Clinical Trial Applications
      • 9.3.1.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.6. Regulatory Submissions
      • 9.3.1.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.7. Regulatory Operations
      • 9.3.1.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.1.8. Other Services
      • 9.3.1.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 9.3.2. Recombinant Proteins
    • 9.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.2. Regulatory Consulting
      • 9.3.2.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.3. Legal Representation
      • 9.3.2.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.4. Regulatory Writing & Publishing
      • 9.3.2.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.5. Product Registration & Clinical Trial Applications
      • 9.3.2.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.6. Regulatory Submissions
      • 9.3.2.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.7. Regulatory Operations
      • 9.3.2.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.2.8. Other Services
      • 9.3.2.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 9.3.3. Vaccines
    • 9.3.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.2. Regulatory Consulting
      • 9.3.3.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.3. Legal Representation
      • 9.3.3.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.4. Regulatory Writing & Publishing
      • 9.3.3.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.5. Product Registration & Clinical Trial Applications
      • 9.3.3.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.6. Regulatory Submissions
      • 9.3.3.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.7. Regulatory Operations
      • 9.3.3.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.3.8. Other Services
      • 9.3.3.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 9.3.4. Cell & Gene Therapies
    • 9.3.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.2. Regulatory Consulting
      • 9.3.4.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.3. Legal Representation
      • 9.3.4.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.4. Regulatory Writing & Publishing
      • 9.3.4.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.5. Product Registration & Clinical Trial Applications
      • 9.3.4.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.6. Regulatory Submissions
      • 9.3.4.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.7. Regulatory Operations
      • 9.3.4.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.4.8. Other Services
      • 9.3.4.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 9.3.5. Biosimilars
    • 9.3.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.2. Regulatory Consulting
      • 9.3.5.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.3. Legal Representation
      • 9.3.5.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.4. Regulatory Writing & Publishing
      • 9.3.5.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.5. Product Registration & Clinical Trial Applications
      • 9.3.5.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.6. Regulatory Submissions
      • 9.3.5.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.7. Regulatory Operations
      • 9.3.5.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.5.8. Other Services
      • 9.3.5.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 9.3.6. Others
    • 9.3.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.2. Regulatory Consulting
      • 9.3.6.2.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.3. Legal Representation
      • 9.3.6.3.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.4. Regulatory Writing & Publishing
      • 9.3.6.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.5. Product Registration & Clinical Trial Applications
      • 9.3.6.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.6. Regulatory Submissions
      • 9.3.6.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.7. Regulatory Operations
      • 9.3.6.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
    • 9.3.6.8. Other Services
      • 9.3.6.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 10. Biologics Regulatory Affairs Outsourcing 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. 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. 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. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.5. Europe
  • 10.5.1. 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. 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. 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. 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. 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. 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. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.8. Sweden
    • 10.5.8.1. Key Country Dynamics
    • 10.5.8.2. Competitive Scenario
    • 10.5.8.3. Regulatory Framework
    • 10.5.8.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.5.9. Norway
    • 10.5.9.1. Key Country Dynamics
    • 10.5.9.2. Competitive Scenario
    • 10.5.9.3. Regulatory Framework
    • 10.5.9.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.6. Asia Pacific
  • 10.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.2. China
    • 10.6.2.1. Key Country Dynamics
    • 10.6.2.2. Competitive Scenario
    • 10.6.2.3. Regulatory Framework
    • 10.6.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.3. Japan
    • 10.6.3.1. Key Country Dynamics
    • 10.6.3.2. Competitive Scenario
    • 10.6.3.3. Regulatory Framework
    • 10.6.3.4. 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. 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. 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. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.6.7. Thailand
    • 10.6.7.1. Key Country Dynamics
    • 10.6.7.2. Competitive Scenario
    • 10.6.7.3. Regulatory Framework
    • 10.6.7.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.7. Latin America
  • 10.7.1. 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. 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. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 10.8. MEA
  • 10.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.2. South Africa
    • 10.8.2.1. Key Country Dynamics
    • 10.8.2.2. Competitive Scenario
    • 10.8.2.3. Regulatory Framework
    • 10.8.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.3. Saudi Arabia
    • 10.8.3.1. Key Country Dynamics
    • 10.8.3.2. Competitive Scenario
    • 10.8.3.3. Regulatory Framework
    • 10.8.3.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.4. UAE
    • 10.8.4.1. Key Country Dynamics
    • 10.8.4.2. Competitive Scenario
    • 10.8.4.3. Regulatory Framework
    • 10.8.4.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 10.8.5. Kuwait
    • 10.8.5.1. Key Country Dynamics
    • 10.8.5.2. Competitive Scenario
    • 10.8.5.3. Regulatory Framework
    • 10.8.5.4. 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 share/Assessment Analysis, 2024
• 11.3. Company Profiles
  • 11.3.1. Lonza AG
    • 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. Wuxi Apptec 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. Thermo Fisher Scientific Inc.
    • 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. Eurofins Scientific SE
    • 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. Freyrsolutions
    • 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. Catalent Inc.
    • 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. Piramal Group
    • 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. AGC Biologics
    • 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. ICON Plc.

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