세계의 생물 제제 안전성 시험 시장 : 제품 유형, 용도, 최종 사용자별 예측(2025-2030년)

The Biologics Safety Testing Market was valued at USD 5.62 billion in 2023, expected to reach USD 6.43 billion in 2024, and is projected to grow at a CAGR of 14.71%, to USD 14.70 billion by 2030.

Biologics safety testing encompasses the procedures and methodologies utilized to ensure the safety of biological products, which include vaccines, blood products, and other biotechnology-derived therapeutics. Essential for safeguarding public health, these tests are imperative to confirm the absence of bacterial, viral, and other contaminants before product approval and distribution. The application of biologics safety testing spans across multiple stages, including cell bank characterization, raw materials testing, process impurities analysis, and final product testing, primarily serving the pharmaceutical and biotechnology industries. Market growth is largely driven by the escalating demand for biopharmaceuticals, coupled with stringent regulatory frameworks mandating rigorous safety studies. Technological advancements, such as the development of rapid detection tests and automation in testing processes, offer substantial potential opportunities. Businesses should focus on enhancing existing technologies and collaborating with other biotech firms to broaden their testing capabilities and meet evolving regulatory requirements. The expansion of biosimilars and personalized medicine also highlights potential growth avenues. However, the market faces limitations due to high costs associated with sophisticated testing methodologies and the requirement for expert personnel, impeding growth, especially in smaller companies. Regulatory differences across regions further complicate global test standardization, posing challenges for international market players. Innovation should center around cost-effective, rapid, and multi-parameter tests to streamline processes and reduce time-to-market. Investment in research focusing on novel diagnostic tools, biosensors, and integrating AI for predictive analysis can enhance safety outcomes, thus fortifying market presence. Given its dynamic and highly regulated nature, the biologics safety testing market necessitates adaptive strategies to navigate its complexities. Continual assessment of regulatory changes, technical innovation, and market demands is crucial to maintaining competitiveness and fostering growth in this vital sector.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Biologics Safety Testing Market

The Biologics Safety Testing 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
  • Exponential need for safety monitoring & testing in clinical trials activities
  • Growing number of drug recalls and government initiatives and standards for biologics product safety
  • Increasing production and trade of medical devices and their quality evaluation
• Market Restraints
  • High-cost requirement of safety testing for the development of drugs
• Market Opportunities
  • Technological innovation and advancements in biologic safety testing
  • Expanding research for improved safety recombinant protein and cell & gene therapy
• Market Challenges
  • Lack of skilled professionals to perform accurate testing

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

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

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

A detailed market share analysis in the Biologics Safety Testing 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 Safety Testing Market

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

A strategic analysis of the Biologics Safety Testing 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 Safety Testing Market, highlighting leading vendors and their innovative profiles. These include Accugen Laboratories, Inc., Agilent Technologies, Inc., Almac Group Limited, Associates of Cape Cod, Inc., Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., bioMerieux SA, BSL Bioservice Scientific Laboratories Munich GmbH, Charles River Laboratories International, Inc., Creative Biolabs, Inc., Eagle Analytical Services, Eurofins Scientific Limited, F. Hoffmann-La Roche Ltd., FUJIFILM Wako Pure Chemical Corporation, Laboratory Corporation of America Holdings, Lonza Group AG, Maravai Lifesciences, Merck KGaA, Microcoat Biotechnologie GmbH, Nelson Laboratories, LLC by Sterigenics International LLC, Pacific BioLabs by Northview Biosciences, Inc., Promega Corporation, PromoCell GmbH, QIAGEN GmbH, Rockland Immunochemicals, Inc., Samsung Biologics, Sartorius AG, SGS S.A., SGS Societe Generale de Surveillance SA, and Thermo Fisher Scientific, Inc..

Market Segmentation & Coverage

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

• Based on Product, market is studied across Consumable, Instruments, and Services.
• Based on Test Type, market is studied across Bioburden Tests, Endotoxin Tests, Mycoplasma Tests, Residual Host-Cell Proteins & DNA Detection Tests, Sterility Tests, and Virus Safety Tests.
• Based on Application, market is studied across Blood & Blood-Related Products Development, Cellular & Gene Therapy Products Development, Monoclonal Antibodies Development, and Vaccine & Therapeutics Development.
• Based on End-User, market is studied across Academic & Research Institutes, Contract Research Organization/ Contract Manufacturing Organization, and Pharmaceutical & Biotechnology Companies.
• 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. Exponential need for safety monitoring & testing in clinical trials activities
    • 5.1.1.2. Growing number of drug recalls and government initiatives and standards for biologics product safety
    • 5.1.1.3. Increasing production and trade of medical devices and their quality evaluation
  • 5.1.2. Restraints
    • 5.1.2.1. High-cost requirement of safety testing for the development of drugs
  • 5.1.3. Opportunities
    • 5.1.3.1. Technological innovation and advancements in biologic safety testing
    • 5.1.3.2. Expanding research for improved safety recombinant protein and cell & gene therapy
  • 5.1.4. Challenges
    • 5.1.4.1. Lack of skilled professionals to perform accurate testing
• 5.2. Market Segmentation Analysis
  • 5.2.1. Product: Cruciality of services for biopharmaceutical companies to navigate the complex regulatory landscapes
  • 5.2.2. Application: Increasing adoption in vaccine & therapeutics development to validate the effectiveness and safety of vaccines and new therapeutic drugs
• 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 Safety Testing Market, by Product

• 6.1. Introduction
• 6.2. Consumable
• 6.3. Instruments
• 6.4. Services

7. Biologics Safety Testing Market, by Test Type

• 7.1. Introduction
• 7.2. Bioburden Tests
• 7.3. Endotoxin Tests
• 7.4. Mycoplasma Tests
• 7.5. Residual Host-Cell Proteins & DNA Detection Tests
• 7.6. Sterility Tests
• 7.7. Virus Safety Tests

8. Biologics Safety Testing Market, by Application

• 8.1. Introduction
• 8.2. Blood & Blood-Related Products Development
• 8.3. Cellular & Gene Therapy Products Development
• 8.4. Monoclonal Antibodies Development
• 8.5. Vaccine & Therapeutics Development

9. Biologics Safety Testing Market, by End-User

• 9.1. Introduction
• 9.2. Academic & Research Institutes
• 9.3. Contract Research Organization/ Contract Manufacturing Organization
• 9.4. Pharmaceutical & Biotechnology Companies

10. Americas Biologics Safety Testing Market

• 10.1. Introduction
• 10.2. Argentina
• 10.3. Brazil
• 10.4. Canada
• 10.5. Mexico
• 10.6. United States

11. Asia-Pacific Biologics Safety Testing Market

• 11.1. Introduction
• 11.2. Australia
• 11.3. China
• 11.4. India
• 11.5. Indonesia
• 11.6. Japan
• 11.7. Malaysia
• 11.8. Philippines
• 11.9. Singapore
• 11.10. South Korea
• 11.11. Taiwan
• 11.12. Thailand
• 11.13. Vietnam

12. Europe, Middle East & Africa Biologics Safety Testing Market

• 12.1. Introduction
• 12.2. Denmark
• 12.3. Egypt
• 12.4. Finland
• 12.5. France
• 12.6. Germany
• 12.7. Israel
• 12.8. Italy
• 12.9. Netherlands
• 12.10. Nigeria
• 12.11. Norway
• 12.12. Poland
• 12.13. Qatar
• 12.14. Russia
• 12.15. Saudi Arabia
• 12.16. South Africa
• 12.17. Spain
• 12.18. Sweden
• 12.19. Switzerland
• 12.20. Turkey
• 12.21. United Arab Emirates
• 12.22. United Kingdom

13. Competitive Landscape

• 13.1. Market Share Analysis, 2023
• 13.2. FPNV Positioning Matrix, 2023
• 13.3. Competitive Scenario Analysis
  • 13.3.1. Oxford Nanopore Technologies and PathoQuest Collaborate on Groundbreaking Biopharmaceutical Safety Test
  • 13.3.2. Expanding Biologics Production: A Strategic Look at Teva's Ulm Facility and Future Plans
  • 13.3.3. Expansion of Clean Cells Advances Biopharmaceutical Testing Capabilities in Europe
• 13.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. Accugen Laboratories, Inc.
• 2. Agilent Technologies, Inc.
• 3. Almac Group Limited
• 4. Associates of Cape Cod, Inc.
• 5. Becton, Dickinson and Company
• 6. Bio-Rad Laboratories, Inc.
• 7. bioMerieux SA
• 8. BSL Bioservice Scientific Laboratories Munich GmbH
• 9. Charles River Laboratories International, Inc.
• 10. Creative Biolabs, Inc.
• 11. Eagle Analytical Services
• 12. Eurofins Scientific Limited
• 13. F. Hoffmann-La Roche Ltd.
• 14. FUJIFILM Wako Pure Chemical Corporation
• 15. Laboratory Corporation of America Holdings
• 16. Lonza Group AG
• 17. Maravai Lifesciences
• 18. Merck KGaA
• 19. Microcoat Biotechnologie GmbH
• 20. Nelson Laboratories, LLC by Sterigenics International LLC
• 21. Pacific BioLabs by Northview Biosciences, Inc.
• 22. Promega Corporation
• 23. PromoCell GmbH
• 24. QIAGEN GmbH
• 25. Rockland Immunochemicals, Inc.
• 26. Samsung Biologics
• 27. Sartorius AG
• 28. SGS S.A.
• 29. SGS Societe Generale de Surveillance SA
• 30. Thermo Fisher Scientific, Inc.