화학, 제조, 관리 서비스 아웃소싱 시장 규모, 점유율, 동향 분석 보고서 : 유형별, 서비스별, 최종 용도별, 지역별, 부문 예측(2025-2030년)

Chemistry, Manufacturing And Control Services Outsourcing Market Growth & Trends:

The global chemistry, manufacturing and control services outsourcing market size is anticipated to reach USD 15.16 billion by 2030, according to a new report by Grand View Research, Inc. The market is projected to grow at a CAGR of 6.94% from 2025 to 2030. Stringent regulatory requirements, increasing R&D investments, and growing need for cost-efficient manufacturing solutions are key factor driving market growth potential. Moreover, complexity of drug development, technological advancements in biologics and personalized medicine, and biopharmaceutical companies focusing on core competencies are another key factors positively impacting the market growth.

The incorporation of state-of-the-art technologies such as automation, artificial intelligence, continuous manufacturing, and digital analytics serves to enhance precision, reduce costs, and accelerate production capabilities. For instance, AI and machine learning applications in quality control and predictive maintenance are expected to reduce operational costs by 20-30%. AI and machine learning algorithms offers predictive analytics for process optimization, quality control, and troubleshooting, reducing time and cost in drug development. Automation in manufacturing processes, including robotics and continuous manufacturing, improves production efficiency, minimizes human error, and enhance product quality. In addition, advancements in digitalization, such as electronic lab notebooks (ELNs) and laboratory information management systems (LIMS), streamline data management and regulatory compliance, assisting seamless information flow and traceability. These advancements enable CMC service providers to offer e nhanced quality and heightened reliability services compliant to complex demands of modern biopharmaceuticals including biologics and personalized medicines. The integration of advanced solutions is expected to further propel the market growth and competitiveness of the market.

Stringent regulatory scenario in several economies is anticipated to boost the global CMC services outsourcing market. Regulatory agencies, such as the U.S. FDA, the EU EMA, and several other national regulatory authorities enforce strict standards to ensure the safety, efficacy, and quality of pharmaceuticals and biologics. These stringent regulations require thorough documentation, comprehensive testing, and robust quality control throughout the drug development and manufacturing process. Pharmaceutical and biotechnology companies often encounter difficulties in keeping abreast of the evolving regulatory landscape and the associated compliance costs resulting in outsourcing of CMC services to specialized service providers. Moreover, market participants offer critical support in areas such as regulatory submissions, stability studies, analytical method validation, GMP compliance and several others, thereby propelling the industry growth potential.

Chemistry, Manufacturing And Control Services Outsourcing Market Report Highlights:

• Based on type, the finished drug formulation segment led market with the largest revenue share of 43.77% in 2024.High revenue share is attributed to increasing demand for specialized expertise in formulation development, stringent regulatory requirements for finished drug products, the growing complexity of drug formulations, and the need for cost-effective manufacturing solutions
• Based on service, the analytical testing segment is expected to grow at the fastest CAGR during the forecast period. Growing adoption of biologics and advanced therapeutics along with stringent regulatory guidelines requiring comprehensive analytical testing throughout drug development cycles are anticipated to boost segmental demand in the global market.
• Based on end use, the pharmaceutical segment led the market with the largest revenue share of 40.56% in 2024. Several pharmaceutical companies outsourcing CMC services to focus on R&D activities such as drug discovery and clinical development, and cost affordability. Moreover, surge in outsourcing trends, evolving regulatory landscape and demand for specialized expertise among pharmaceutical companies are driving the segment growth potential
• North America dominated the market with the largest revenue share of 47.3% in 2024. Several factors such as stringent regulatory requirements, technological advancements, significant R&D investment, and increasing demand for specialized services are key factors accelerating the regional market growth. In addition, strong presence of leading pharmaceutical and biotechnology companies and growing focus on development of advanced therapies further propels market expansion

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. Chemistry, Manufacturing, and Control (CMC) Services 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. Evolving Regulatory Landscape
    • 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. Technological Advancement in the Medical Equipment
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Regulatory Challenges
    • 3.2.2.2. Managing Relationships
• 3.3. Technological Advancements
• 3.4. Pricing Model Analysis
• 3.5. Market Analysis Tools
  • 3.5.1. Porter's Five Forces Analysis
  • 3.5.2. PESTEL Analysis

Chapter 4. Chemistry, Manufacturing, and Control (CMC) Services Outsourcing Market: Type Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Chemistry, Manufacturing, and Control (CMC) Services Outsourcing Market Movement Analysis
• 4.3. Global Chemistry, Manufacturing, and Control (CMC) Services Outsourcing Market Size & Trend Analysis, by Type, 2018 to 2030 (USD Million)
• 4.4. API
  • 4.4.1. API Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.4.2. Small Molecule
    • 4.4.2.1. Small Molecule Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.4.3. Large Molecule
    • 4.4.3.1. Large Molecule Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 4.5. Finished Drug Formulation
  • 4.5.1. Finished Drug Formulation Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.5.2. Solid Dosage Forms
    • 4.5.2.1. Solid Dosage Forms Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.5.3. Liquid Dosage Forms
    • 4.5.3.1. Liquid Dosage Forms Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.5.4. Semi-solid Dosage Forms
    • 4.5.4.1. Semi-solid Dosage Forms Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 4.5.5. Others
    • 4.5.5.1. Others Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 4.6. Others
  • 4.6.1. Others Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 5. Chemistry, Manufacturing, and Control (CMC) Services Outsourcing Market: Service Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Chemistry, Manufacturing, and Control (CMC) Services Outsourcing Market Movement Analysis
• 5.3. Global Chemistry, Manufacturing, and Control (CMC) Services Outsourcing Market Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
• 5.4. Manufacturing Services
  • 5.4.1. Manufacturing Services Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.4.2. Clinical Manufacturing
    • 5.4.2.1. Clinical Manufacturing Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.4.3. Drug Product Development and Manufacturing
    • 5.4.3.1. Drug Product Development and Manufacturing Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.4.4. Fill Finish Manufacturing
    • 5.4.4.1. Fill Finish Manufacturing Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.4.5. Others
    • 5.4.5.1. Others Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 5.5. Regulatory Services
  • 5.5.1. Regulatory Services Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.5.2. Regulatory Consulting
    • 5.5.2.1. Regulatory Consulting Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.5.3. Regulatory Submissions
    • 5.5.3.1. Regulatory Submissions Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.5.4. Compliance Audits
    • 5.5.4.1. Compliance Audits Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.5.5. Others
    • 5.5.5.1. Others Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 5.6. Analytical Testing
  • 5.6.1. Analytical Testing Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.6.2. Stability Testing
    • 5.6.2.1. Stability Testing Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.6.3. Method Development and Validation
    • 5.6.3.1. Method Development and Validation Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.6.4. Quality Control (QC) Testing
    • 5.6.4.1. Quality Control (QC) Testing Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.6.5. Bioanalytical Testing
    • 5.6.5.1. Bioanalytical Testing Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 5.6.6. Others
    • 5.6.6.1. Others Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 5.7. Others
  • 5.7.1. Others Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 6. Chemistry, Manufacturing, and Control (CMC) Services Outsourcing Market: End-Use Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Chemistry, Manufacturing, and Control (CMC) Services Outsourcing Market Movement Analysis
• 6.3. Global Chemistry, Manufacturing, and Control (CMC) Services Outsourcing Market Size & Trend Analysis, by End-Use, 2018 to 2030 (USD Million)
• 6.4. Pharmaceutical Companies
  • 6.4.1. Pharmaceutical Companies Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.5. Medical Device Companies
  • 6.5.1. Medical Device Companies Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.6. Biotechnological Companies
  • 6.6.1. Biotechnological Companies Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 6.7. Others
  • 6.7.1. Others Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 7. Chemistry, Manufacturing, and Control (CMC) Services Outsourcing Market: Regional Estimates & Trend Analysis by Type, Service & End-Use

• 7.1. Regional Market Dashboard
• 7.2. Global Regional Market Snapshot
• 7.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
• 7.4. North America
  • 7.4.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Competitive Scenario
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Competitive Scenario
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Competitive Scenario
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 7.5. Europe
  • 7.5.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Competitive Scenario
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Competitive Scenario
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Competitive Scenario
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Competitive Scenario
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Competitive Scenario
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Competitive Scenario
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Competitive Scenario
    • 7.5.8.3. Regulatory Framework
    • 7.5.8.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Competitive Scenario
    • 7.5.9.3. Regulatory Framework
    • 7.5.9.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.6.2. China
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Competitive Scenario
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.6.3. Japan
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Competitive Scenario
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Competitive Scenario
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.6.5. Australia
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Competitive Scenario
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.6.6. South Korea
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Competitive Scenario
    • 7.6.6.3. Regulatory Framework
    • 7.6.6.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.6.7. Thailand
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Competitive Scenario
    • 7.6.7.3. Regulatory Framework
    • 7.6.7.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 7.7. Latin America
  • 7.7.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Competitive Scenario
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Competitive Scenario
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
• 7.8. MEA
  • 7.8.1. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Competitive Scenario
    • 7.8.2.3. Regulatory Framework
    • 7.8.2.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Competitive Scenario
    • 7.8.3.3. Regulatory Framework
    • 7.8.3.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Competitive Scenario
    • 7.8.4.3. Regulatory Framework
    • 7.8.4.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Competitive Scenario
    • 7.8.5.3. Regulatory Framework
    • 7.8.5.4. Market Estimates and Forecasts, 2018 to 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Market Participant Categorization
  • 8.1.1. Market Leaders
  • 8.1.2. Emerging Players
• 8.2. Service Heat Map Analysis (a comparative analysis of the players together)
• 8.3. Company Profiles
  • 8.3.1. ICON plc
    • 8.3.1.1. Company Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Service Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. Catalent, Inc.
    • 8.3.2.1. Company Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Service Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. Thermo Fisher Scientific Inc.
    • 8.3.3.1. Company Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Service Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. Recipharm AB
    • 8.3.4.1. Company Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Service Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. WuXi AppTec
    • 8.3.5.1. Company Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Service Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. Jubilant Life Sciences
    • 8.3.6.1. Company Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Service Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. Samsung Biologics
    • 8.3.7.1. Company Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Service Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. Boehringer Ingelheim BioXcellence
    • 8.3.8.1. Company Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Service Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. Evonik Industries AG
    • 8.3.9.1. Company Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Service Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. Allucent
    • 8.3.10.1. Company Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Service Benchmarking
    • 8.3.10.4. Strategic Initiatives
  • 8.3.11. Ardena Holding NV
    • 8.3.11.1. Company Overview
    • 8.3.11.2. Financial Performance
    • 8.3.11.3. Service Benchmarking
    • 8.3.11.4. Strategic Initiatives
  • 8.3.12. Argonaut Manufacturing Services Inc
    • 8.3.12.1. Company Overview
    • 8.3.12.2. Financial Performance
    • 8.3.12.3. Service Benchmarking
    • 8.3.12.4. Strategic Initiatives
  • 8.3.13. Siegfried Holding AG
    • 8.3.13.1. Company Overview
    • 8.3.13.2. Financial Performance
    • 8.3.13.3. Service Benchmarking
    • 8.3.13.4. Strategic Initiatives
  • 8.3.14. Bachem
    • 8.3.14.1. Company Overview
    • 8.3.14.2. Financial Performance
    • 8.3.14.3. Service Benchmarking
    • 8.3.14.4. Strategic Initiatives
  • 8.3.15. AbbVie Inc
    • 8.3.15.1. Company Overview
    • 8.3.15.2. Financial Performance
    • 8.3.15.3. Service Benchmarking
    • 8.3.15.4. Strategic Initiatives
  • 8.3.16. Ajinomoto Bio-Pharma
    • 8.3.16.1. Company Overview
    • 8.3.16.2. Financial Performance
    • 8.3.16.3. Service Benchmarking
    • 8.3.16.4. Strategic Initiatives
  • 8.3.17. CordenPharma
    • 8.3.17.1. Company Overview
    • 8.3.17.2. Financial Performance
    • 8.3.17.3. Service Benchmarking
    • 8.3.17.4. Strategic Initiatives