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 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.