바이오의약품 CMO 및 CRO 시장 : 공급업체, 서비스 유형, 제품 유형, 사업 규모, 치료 용도별 - 세계 예측(2025-2030년)

The Biopharmaceutical CMO & CRO Market was valued at USD 81.32 billion in 2023, expected to reach USD 95.65 billion in 2024, and is projected to grow at a CAGR of 18.10%, to USD 260.65 billion by 2030.

The biopharmaceutical Contract Manufacturing Organization (CMO) and Contract Research Organization (CRO) markets have become essential in the drug development and manufacturing continuum, propelling pharmaceutical innovations while mitigating costs and capacity constraints. CMOs provide manufacturing services that range from pre-clinical development to commercial production, while CROs offer research services to aid clients in accelerating the development of new drugs through specialized knowledge and analytical tools. This symbiotic relationship is increasingly necessary as pharmaceutical companies strive to expedite time-to-market amidst stringent regulatory environments. The application scope includes biologics, biosimilars, small molecules, and personalized medicine, with end-use industries spanning therapeutics to vaccines. Key growth influencers include the rising prevalence of chronic diseases, advancements in biologics and biosimilars, governmental incentives, and the outsourcing trend by pharmaceutical companies eager to retain market competitiveness while lowering operational risks and costs. The latest opportunities lie in the surge of biotechnology startups seeking partnerships with CMOs/CROs for niche skill sets and capabilities, and the growing demand for clinical trials across emerging markets. Nevertheless, the market grapples with challenges such as complex regulatory landscapes, intellectual property concerns, and quality assurance issues, which often constrain seamless growth and scalability. Additionally, the market is impacted by high competition and the need for skilled labor, which complicate the operational landscapes. Innovation and research opportunities abound in areas like process optimization using artificial intelligence and machine learning, enhancing data-driven decision-making in drug development and manufacturing processes, and increasing efficiency through continuous manufacturing. Companies can benefit from investing in robust Quality by Design (QbD) frameworks and data analytics to enhance compliance and accelerate timelines. The market is characterized by rapid technological advancements, competitive collaboration, and regulatory scrutiny, making business agility and adaptability crucial for sustained growth.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Biopharmaceutical CMO & CRO Market

The Biopharmaceutical CMO & CRO Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Rising need for outsourced service in pharmaceutical and biotechnology sector
  • Potential demand for macromolecular therapeutics
  • Ongoing research and development activities in biopharmaceutical sector
• Market Restraints
  • Issues pertinent to fewer outsource suppliers and less competition
• Market Opportunities
  • Penetration of advanced technology in the biotechnology field
  • Emergence of Cell and Gene Therapies for Targeted Treatment
• Market Challenges
  • Concern associated with accountability and quality control of CMO and CRO

Porter's Five Forces: A Strategic Tool for Navigating the Biopharmaceutical CMO & CRO Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Biopharmaceutical CMO & CRO Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Biopharmaceutical CMO & CRO Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Biopharmaceutical CMO & CRO Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Biopharmaceutical CMO & CRO Market

A detailed market share analysis in the Biopharmaceutical CMO & CRO Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Biopharmaceutical CMO & CRO Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Biopharmaceutical CMO & CRO Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the Biopharmaceutical CMO & CRO Market

A strategic analysis of the Biopharmaceutical CMO & CRO Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the Biopharmaceutical CMO & CRO Market, highlighting leading vendors and their innovative profiles. These include AbbVie, Inc., arexel International Corporation, Baxter International Inc., Boehringer Ingelheim Biopharmaceuticals GmbH, Boehringer Ingelheim GmbH, Catalent, Inc., Charles River Laboratories International, Inc., Eurofins Scientific Limited, FUJIFILM Diosynth Biotechnologies U.S.A., Inc., ICON Plc, KBI Biopharma, Inc., KEMWELL BIOPHARMA PRIVATE LIMITED, Laboratory Corporation of America Holdings, Lonza Group AG, NANOGEN PHARMACEUTICAL BIOTECHNOLOGY JSC, Patheon Inc., Rentschler Biopharma SE, and Sterling Pharma Solutions.

Market Segmentation & Coverage

This research report categorizes the Biopharmaceutical CMO & CRO Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Source, market is studied across Mammalian and Non-Mammalian.
• Based on Service Type, market is studied across Contract Manufacturing and Contract Research.
• Based on Product, market is studied across Biologics and Biosimilars.
• Based on Scale of Operation, market is studied across Clinical and Commercial.
• Based on Therapeutic Applications, market is studied across Cardiovascular Diseases, Infectious Disease, Neurology, Oncology, Ophthalmology, and Respiratory Disorder.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Rising need for outsourced service in pharmaceutical and biotechnology sector
    • 5.1.1.2. Potential demand for macromolecular therapeutics
    • 5.1.1.3. Ongoing research and development activities in biopharmaceutical sector
  • 5.1.2. Restraints
    • 5.1.2.1. Issues pertinent to fewer outsource suppliers and less competition
  • 5.1.3. Opportunities
    • 5.1.3.1. Penetration of advanced technology in the biotechnology field
    • 5.1.3.2. Emergence of Cell and Gene Therapies for Targeted Treatment
  • 5.1.4. Challenges
    • 5.1.4.1. Concern associated with accountability and quality control of CMO and CRO
• 5.2. Market Segmentation Analysis
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Biopharmaceutical CMO & CRO Market, by Source

• 6.1. Introduction
• 6.2. Mammalian
• 6.3. Non-Mammalian

7. Biopharmaceutical CMO & CRO Market, by Service Type

• 7.1. Introduction
• 7.2. Contract Manufacturing
• 7.3. Contract Research

8. Biopharmaceutical CMO & CRO Market, by Product

• 8.1. Introduction
• 8.2. Biologics
• 8.3. Biosimilars

9. Biopharmaceutical CMO & CRO Market, by Scale of Operation

• 9.1. Introduction
• 9.2. Clinical
• 9.3. Commercial

10. Biopharmaceutical CMO & CRO Market, by Therapeutic Applications

• 10.1. Introduction
• 10.2. Cardiovascular Diseases
• 10.3. Infectious Disease
• 10.4. Neurology
• 10.5. Oncology
• 10.6. Ophthalmology
• 10.7. Respiratory Disorder

11. Americas Biopharmaceutical CMO & CRO Market

• 11.1. Introduction
• 11.2. Argentina
• 11.3. Brazil
• 11.4. Canada
• 11.5. Mexico
• 11.6. United States

12. Asia-Pacific Biopharmaceutical CMO & CRO Market

• 12.1. Introduction
• 12.2. Australia
• 12.3. China
• 12.4. India
• 12.5. Indonesia
• 12.6. Japan
• 12.7. Malaysia
• 12.8. Philippines
• 12.9. Singapore
• 12.10. South Korea
• 12.11. Taiwan
• 12.12. Thailand
• 12.13. Vietnam

13. Europe, Middle East & Africa Biopharmaceutical CMO & CRO Market

• 13.1. Introduction
• 13.2. Denmark
• 13.3. Egypt
• 13.4. Finland
• 13.5. France
• 13.6. Germany
• 13.7. Israel
• 13.8. Italy
• 13.9. Netherlands
• 13.10. Nigeria
• 13.11. Norway
• 13.12. Poland
• 13.13. Qatar
• 13.14. Russia
• 13.15. Saudi Arabia
• 13.16. South Africa
• 13.17. Spain
• 13.18. Sweden
• 13.19. Switzerland
• 13.20. Turkey
• 13.21. United Arab Emirates
• 13.22. United Kingdom

14. Competitive Landscape

• 14.1. Market Share Analysis, 2023
• 14.2. FPNV Positioning Matrix, 2023
• 14.3. Competitive Scenario Analysis
• 14.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. AbbVie, Inc.
• 2. arexel International Corporation
• 3. Baxter International Inc.
• 4. Boehringer Ingelheim Biopharmaceuticals GmbH
• 5. Boehringer Ingelheim GmbH
• 6. Catalent, Inc.
• 7. Charles River Laboratories International, Inc.
• 8. Eurofins Scientific Limited
• 9. FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
• 10. ICON Plc
• 11. KBI Biopharma, Inc.
• 12. KEMWELL BIOPHARMA PRIVATE LIMITED
• 13. Laboratory Corporation of America Holdings
• 14. Lonza Group AG
• 15. NANOGEN PHARMACEUTICAL BIOTECHNOLOGY JSC
• 16. Patheon Inc.
• 17. Rentschler Biopharma SE
• 18. Sterling Pharma Solutions