생물학적 제제 아웃소싱 시장 : 제품 유형, 용도, 공급원, 서비스 유형, 최종사용자, 치료 분야별 - 세계 예측(2025-2030년)

The Biologics Outsourcing Market was valued at USD 20.56 billion in 2023, expected to reach USD 22.87 billion in 2024, and is projected to grow at a CAGR of 12.18%, to USD 45.98 billion by 2030.

Biologics outsourcing involves externalizing the production and development processes of biologic drugs to specialized third-party service providers. The scope includes activities such as cell line development, process development, analytical characterization, formulation, and production. This necessity arises from the complex nature of biologic drugs, which include proteins, antibodies, and gene therapies, demanding specialized expertise and facilities. Applications span across pharmaceuticals and biotechnology companies aiming to expedite product development, reduce capital expenditure on in-house facilities, and focus resources on core competencies. The end-use scope extends to therapeutic areas including oncology, autoimmune diseases, and rare genetic disorders. Key growth factors influencing the biologics outsourcing market include the increasing prevalence of chronic diseases, advancements in biotechnology, and growing investment in biologic drug development. Emerging markets offer potential opportunities, driven by lower operational costs and expanding healthcare infrastructures. Recommendations for capturing these opportunities include forming strategic alliances with local service providers and engaging in technology transfers. However, challenges persist, such as stringent regulatory requirements, concerns over intellectual property security, and variability in quality standards. These factors can hinder market expansion, particularly across regions with less mature regulatory frameworks. Despite these challenges, innovation in areas such as single-use technologies, automation, and advanced analytics holds significant promise for enhancing efficiency and scalability in biologics production. Companies could focus on the development of cost-effective bioprocessing technologies and personalized medicine to maintain competitive advantage. Furthermore, digital transformation, including the integration of artificial intelligence and machine learning in biologic R&D and manufacturing, can lead to significant breakthroughs. The market is characterized by a dynamic and competitive landscape, with a trend towards consolidation, as larger contract development and manufacturing organizations (CDMOs) acquire niche service providers to expand capabilities and geographical reach, thereby strengthening their market position.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Biologics Outsourcing Market

The Biologics Outsourcing 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
  • Stringent regulatory requirements and the need for compliance expertise in biologics production
  • Cost-efficiency and time reduction benefits driving outsourcing of biologics manufacturing
  • Expansion of biologics pipelines by pharmaceutical companies necessitating external manufacturing support
  • Adoption of single-use technologies and continuous bioprocessing by outsourcing firms
• Market Restraints
  • Limited availability of skilled workforce for specialized biologics manufacturing and process development
  • Variability in biological product quality during outsourcing leading to potential risks and liabilities
• Market Opportunities
  • Partnership opportunities with smaller biotechnology firms seeking affordable biologics manufacturing solutions
  • Growing need for specialized biologics development services in niche therapeutic areas
  • Rising collaboration between pharmaceutical companies and contract research organizations for biologics development
• Market Challenges
  • Managing supply chain disruptions and logistics challenges in the biologics outsourcing market
  • Ensuring cost efficiency while maintaining high quality standards in biologics outsourcing services

Porter's Five Forces: A Strategic Tool for Navigating the Biologics Outsourcing Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Biologics Outsourcing 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 Biologics Outsourcing Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Biologics Outsourcing 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 Biologics Outsourcing Market

A detailed market share analysis in the Biologics Outsourcing 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 Biologics Outsourcing Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Biologics Outsourcing 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 Biologics Outsourcing Market

A strategic analysis of the Biologics Outsourcing 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 Biologics Outsourcing Market, highlighting leading vendors and their innovative profiles. These include AbbVie Inc., Amgen Inc., Biocon Limited, Boehringer Ingelheim GmbH, Catalent, Inc., Charles River Laboratories International, Inc., Covance Inc., Eli Lilly and Company, Fujifilm Diosynth Biotechnologies, Genentech, Inc., Icon plc, Lonza Group AG, Merck KGaA, Novartis AG, Parexel International Corporation, Pfizer Inc., Samsung Biologics Co., Ltd., Sandoz International GmbH, Thermo Fisher Scientific Inc., and WuXi AppTec Co., Ltd..

Market Segmentation & Coverage

This research report categorizes the Biologics Outsourcing Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Product Type, market is studied across Antisense, RNAi, And Molecular Therapy, Monoclonal Antibodies, Other Biologics, Recombinant Proteins, and Vaccines.
• Based on Application, market is studied across Cardiovascular Diseases, Immunology, Infectious Diseases, Neurology, Oncology, and Other Applications. The Immunology is further studied across Allergic Disorders and Autoimmune Diseases. The Infectious Diseases is further studied across Bacterial Infections and Viral Infections. The Oncology is further studied across Cancer Biomarker Studies and Personalized Cancer Treatments.
• Based on Source, market is studied across Mammalian and Non-Mammalian. The Non-Mammalian is further studied across Bacteria, Insect Cells, Plant Cells, and Yeast.
• Based on Service Type, market is studied across Analytical And Quality Control, Clinical Trials, Fill And Finish Operations, Process Development, and Regulatory Services.
• Based on End User, market is studied across Biotechnology Companies, Contract Research Organizations (CROs), Pharmaceutical Companies, and Research Institutes.
• Based on Therapeutic Area, market is studied across Cancer, Cardiovascular Diseases, Infectious Diseases, Inflammatory And Immune Disorders, Metabolic Disorders, and Neurological Conditions.
• 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. Stringent regulatory requirements and the need for compliance expertise in biologics production
    • 5.1.1.2. Cost-efficiency and time reduction benefits driving outsourcing of biologics manufacturing
    • 5.1.1.3. Expansion of biologics pipelines by pharmaceutical companies necessitating external manufacturing support
    • 5.1.1.4. Adoption of single-use technologies and continuous bioprocessing by outsourcing firms
  • 5.1.2. Restraints
    • 5.1.2.1. Limited availability of skilled workforce for specialized biologics manufacturing and process development
    • 5.1.2.2. Variability in biological product quality during outsourcing leading to potential risks and liabilities
  • 5.1.3. Opportunities
    • 5.1.3.1. Partnership opportunities with smaller biotechnology firms seeking affordable biologics manufacturing solutions
    • 5.1.3.2. Growing need for specialized biologics development services in niche therapeutic areas
    • 5.1.3.3. Rising collaboration between pharmaceutical companies and contract research organizations for biologics development
  • 5.1.4. Challenges
    • 5.1.4.1. Managing supply chain disruptions and logistics challenges in the biologics outsourcing market
    • 5.1.4.2. Ensuring cost efficiency while maintaining high quality standards in biologics outsourcing services
• 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. Biologics Outsourcing Market, by Product Type

• 6.1. Introduction
• 6.2. Antisense, RNAi, And Molecular Therapy
• 6.3. Monoclonal Antibodies
• 6.4. Other Biologics
• 6.5. Recombinant Proteins
• 6.6. Vaccines

7. Biologics Outsourcing Market, by Application

• 7.1. Introduction
• 7.2. Cardiovascular Diseases
• 7.3. Immunology
  • 7.3.1. Allergic Disorders
  • 7.3.2. Autoimmune Diseases
• 7.4. Infectious Diseases
  • 7.4.1. Bacterial Infections
  • 7.4.2. Viral Infections
• 7.5. Neurology
• 7.6. Oncology
  • 7.6.1. Cancer Biomarker Studies
  • 7.6.2. Personalized Cancer Treatments
• 7.7. Other Applications

8. Biologics Outsourcing Market, by Source

• 8.1. Introduction
• 8.2. Mammalian
• 8.3. Non-Mammalian
  • 8.3.1. Bacteria
  • 8.3.2. Insect Cells
  • 8.3.3. Plant Cells
  • 8.3.4. Yeast

9. Biologics Outsourcing Market, by Service Type

• 9.1. Introduction
• 9.2. Analytical And Quality Control
• 9.3. Clinical Trials
• 9.4. Fill And Finish Operations
• 9.5. Process Development
• 9.6. Regulatory Services

10. Biologics Outsourcing Market, by End User

• 10.1. Introduction
• 10.2. Biotechnology Companies
• 10.3. Contract Research Organizations (CROs)
• 10.4. Pharmaceutical Companies
• 10.5. Research Institutes

11. Biologics Outsourcing Market, by Therapeutic Area

• 11.1. Introduction
• 11.2. Cancer
• 11.3. Cardiovascular Diseases
• 11.4. Infectious Diseases
• 11.5. Inflammatory And Immune Disorders
• 11.6. Metabolic Disorders
• 11.7. Neurological Conditions

12. Americas Biologics Outsourcing Market

• 12.1. Introduction
• 12.2. Argentina
• 12.3. Brazil
• 12.4. Canada
• 12.5. Mexico
• 12.6. United States

13. Asia-Pacific Biologics Outsourcing Market

• 13.1. Introduction
• 13.2. Australia
• 13.3. China
• 13.4. India
• 13.5. Indonesia
• 13.6. Japan
• 13.7. Malaysia
• 13.8. Philippines
• 13.9. Singapore
• 13.10. South Korea
• 13.11. Taiwan
• 13.12. Thailand
• 13.13. Vietnam

14. Europe, Middle East & Africa Biologics Outsourcing Market

• 14.1. Introduction
• 14.2. Denmark
• 14.3. Egypt
• 14.4. Finland
• 14.5. France
• 14.6. Germany
• 14.7. Israel
• 14.8. Italy
• 14.9. Netherlands
• 14.10. Nigeria
• 14.11. Norway
• 14.12. Poland
• 14.13. Qatar
• 14.14. Russia
• 14.15. Saudi Arabia
• 14.16. South Africa
• 14.17. Spain
• 14.18. Sweden
• 14.19. Switzerland
• 14.20. Turkey
• 14.21. United Arab Emirates
• 14.22. United Kingdom

15. Competitive Landscape

• 15.1. Market Share Analysis, 2023
• 15.2. FPNV Positioning Matrix, 2023
• 15.3. Competitive Scenario Analysis
• 15.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. AbbVie Inc.
• 2. Amgen Inc.
• 3. Biocon Limited
• 4. Boehringer Ingelheim GmbH
• 5. Catalent, Inc.
• 6. Charles River Laboratories International, Inc.
• 7. Covance Inc.
• 8. Eli Lilly and Company
• 9. Fujifilm Diosynth Biotechnologies
• 10. Genentech, Inc.
• 11. Icon plc
• 12. Lonza Group AG
• 13. Merck KGaA
• 14. Novartis AG
• 15. Parexel International Corporation
• 16. Pfizer Inc.
• 17. Samsung Biologics Co., Ltd.
• 18. Sandoz International GmbH
• 19. Thermo Fisher Scientific Inc.
• 20. WuXi AppTec Co., Ltd.