생물학적 안전성 시험 제품 및 서비스 시장 : 제품 유형별, 용도별 - 세계 예측(2025-2030년)

The Biological Safety Testing Products & Services Market was valued at USD 5.65 billion in 2023, expected to reach USD 6.28 billion in 2024, and is projected to grow at a CAGR of 11.16%, to USD 11.86 billion by 2030.

The scope of the Biological Safety Testing Products & Services market encompasses a range of products and services designed to ensure the safety and efficacy of biological materials utilized in pharmaceuticals, biotechnology, and healthcare. These include reagents, instruments, services for sterility testing, bioburden testing, endotoxin testing, and adventitious agent testing among others. The necessity for biological safety testing is underscored by stringent regulatory frameworks mandating compliance with safety standards to prevent contamination, ensure product integrity, and protect public health. The key applications revolve around pharmaceuticals and biologics manufacturing, expanding research environments, and vaccine production. End-use entities include pharmaceutical companies, biotech firms, contract research organizations, and academic institutions. Market growth is predominantly driven by the escalating biotechnology and pharmaceutical sectors, increased focus on new drug development, and heightened demand for biologics and biosimilars. Moreover, growing incidences of infectious diseases and a wave of innovations in medical treatments drive demand for robust safety testing practices. Opportunities arise in the development and adoption of automated and point-of-use biological testing technologies, expanding preventative measures for emerging infectious diseases, and increased investment in research for advanced biologics. Conversely, market growth is challenged by the high costs associated with testing equipment and services, stringent and dynamic regulatory landscapes, and the need for highly skilled personnel. For business growth, investing in innovative testing methodologies, such as high-throughput and rapid testing techniques, coupled with AI-based analytics, represents a valuable avenue. Strategic partnerships to enhance geographical reach in emerging markets could also leverage market potential. Despite being competitive, the market is characterized by its continual innovation and the inevitable need for safety assurance, making it a critical component of the pharmaceutical and biotechnology industries.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Biological Safety Testing Products & Services Market

The Biological Safety Testing Products & Services 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
  • Increasing incidences of chronic diseases with changing lifestyle globally
  • Government intervention in adoption of good manufacturing practices during drug development
  • Increasing development and commercialization of drugs
• Market Restraints
  • Lack of skilled professionals for biological safety testing
• Market Opportunities
  • Research and development in tissue cultures and viral safety testing
  • Growing outsourcing of testing services to specialized service providers
• Market Challenges
  • Concerns regarding strict regulations and complex procedures

Porter's Five Forces: A Strategic Tool for Navigating the Biological Safety Testing Products & Services Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Biological Safety Testing Products & Services 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 Biological Safety Testing Products & Services Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Biological Safety Testing Products & Services 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 Biological Safety Testing Products & Services Market

A detailed market share analysis in the Biological Safety Testing Products & Services 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 Biological Safety Testing Products & Services Market

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

A strategic analysis of the Biological Safety Testing Products & Services 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 Biological Safety Testing Products & Services Market, highlighting leading vendors and their innovative profiles. These include Asahi Kasei Corporation, Avance Biosciences Inc., BBF Sterilisationsservice GmbH, BSL Bioservice Scientific Laboratories Munich GmbH, Charles River Laboratories International, Inc., Creative Biogene, Eurofins Scientific SE, Labquality Oy, Lonza Group AG, Merck KGaA, North American Science Associates, Inc., North American Science Associates, LLC, NuAire, Inc., Pace Analytical Services, LLC, Samsung Biologics, Sartorius AG, SGS Societe Generale de Surveillance SA, Thermo Fisher Scientific Inc., Toyobo Co., Ltd., UL LLC, ViruSure GmbH, and WuXi Biologics Co., Ltd..

Market Segmentation & Coverage

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

• Based on Product, market is studied across Instruments, Reagents & Kits, and Services.
• Based on Test Type, market is studied across Adventitious Agent Detection Tests, Bioburden Tests, Cell Line Authentication & Characterization Tests, Endotoxin Tests, Residual Host Contamination Detection Tests, and Sterility Tests.
• Based on Application, market is studied across Blood & Blood-Based Products, Gene Therapy, Stem Cell, Tissue & Tissue-Based Products, and Vaccines & Therapeutics.
• 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. Increasing incidences of chronic diseases with changing lifestyle globally
    • 5.1.1.2. Government intervention in adoption of good manufacturing practices during drug development
    • 5.1.1.3. Increasing development and commercialization of drugs
  • 5.1.2. Restraints
    • 5.1.2.1. Lack of skilled professionals for biological safety testing
  • 5.1.3. Opportunities
    • 5.1.3.1. Research and development in tissue cultures and viral safety testing
    • 5.1.3.2. Growing outsourcing of testing services to specialized service providers
  • 5.1.4. Challenges
    • 5.1.4.1. Concerns regarding strict regulations and complex procedures
• 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. Biological Safety Testing Products & Services Market, by Product

• 6.1. Introduction
• 6.2. Instruments
• 6.3. Reagents & Kits
• 6.4. Services

7. Biological Safety Testing Products & Services Market, by Test Type

• 7.1. Introduction
• 7.2. Adventitious Agent Detection Tests
• 7.3. Bioburden Tests
• 7.4. Cell Line Authentication & Characterization Tests
• 7.5. Endotoxin Tests
• 7.6. Residual Host Contamination Detection Tests
• 7.7. Sterility Tests

8. Biological Safety Testing Products & Services Market, by Application

• 8.1. Introduction
• 8.2. Blood & Blood-Based Products
• 8.3. Gene Therapy
• 8.4. Stem Cell
• 8.5. Tissue & Tissue-Based Products
• 8.6. Vaccines & Therapeutics

9. Americas Biological Safety Testing Products & Services Market

• 9.1. Introduction
• 9.2. Argentina
• 9.3. Brazil
• 9.4. Canada
• 9.5. Mexico
• 9.6. United States

10. Asia-Pacific Biological Safety Testing Products & Services Market

• 10.1. Introduction
• 10.2. Australia
• 10.3. China
• 10.4. India
• 10.5. Indonesia
• 10.6. Japan
• 10.7. Malaysia
• 10.8. Philippines
• 10.9. Singapore
• 10.10. South Korea
• 10.11. Taiwan
• 10.12. Thailand
• 10.13. Vietnam

11. Europe, Middle East & Africa Biological Safety Testing Products & Services Market

• 11.1. Introduction
• 11.2. Denmark
• 11.3. Egypt
• 11.4. Finland
• 11.5. France
• 11.6. Germany
• 11.7. Israel
• 11.8. Italy
• 11.9. Netherlands
• 11.10. Nigeria
• 11.11. Norway
• 11.12. Poland
• 11.13. Qatar
• 11.14. Russia
• 11.15. Saudi Arabia
• 11.16. South Africa
• 11.17. Spain
• 11.18. Sweden
• 11.19. Switzerland
• 11.20. Turkey
• 11.21. United Arab Emirates
• 11.22. United Kingdom

12. Competitive Landscape

• 12.1. Market Share Analysis, 2023
• 12.2. FPNV Positioning Matrix, 2023
• 12.3. Competitive Scenario Analysis
• 12.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. Asahi Kasei Corporation
• 2. Avance Biosciences Inc.
• 3. BBF Sterilisationsservice GmbH
• 4. BSL Bioservice Scientific Laboratories Munich GmbH
• 5. Charles River Laboratories International, Inc.
• 6. Creative Biogene
• 7. Eurofins Scientific SE
• 8. Labquality Oy
• 9. Lonza Group AG
• 10. Merck KGaA
• 11. North American Science Associates, Inc.
• 12. North American Science Associates, LLC
• 13. NuAire, Inc.
• 14. Pace Analytical Services, LLC
• 15. Samsung Biologics
• 16. Sartorius AG
• 17. SGS Societe Generale de Surveillance SA
• 18. Thermo Fisher Scientific Inc.
• 19. Toyobo Co., Ltd.
• 20. UL LLC
• 21. ViruSure GmbH
• 22. WuXi Biologics Co., Ltd.