Biologics Safety Testing Market by Product (Consumable, Instruments, Services), Test Type (Bioburden Tests, Endotoxin Tests, Mycoplasma Tests), Application, End-User - Global Forecast 2023-2030
The Biologics Safety Testing Market is projected to reach USD 14.70 billion by 2030 from USD 4.92 billion in 2022, at a CAGR of 14.65% during the forecast period.
Market Segmentation & Coverage:
This research report analyzes various sub-markets, forecasts revenues, and examines emerging trends in each category to provide a comprehensive outlook on the Biologics Safety Testing Market.
- Based on Product, market is studied across Consumable, Instruments, and Services. The Instruments commanded largest market share of 48.75% in 2022, followed by 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. The Bioburden Tests commanded largest market share of 22.77% in 2022, followed by Endotoxin 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. The Vaccine & Therapeutics Development commanded largest market share of 28.63% in 2022, followed by Blood & Blood-Related Products Development.
- Based on End-User, market is studied across Academic & Research Institutes, Contract Research Organization/ Contract Manufacturing Organization, and Pharmaceutical & Biotechnology Companies. The Contract Research Organization/ Contract Manufacturing Organization commanded largest market share of 41.24% in 2022, followed by 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 Americas commanded largest market share of 38.45% in 2022, followed by Europe, Middle East & Africa.
The report provides market sizing and forecasts across 7 major currencies - USD, EUR, JPY, GBP, AUD, CAD, and CHF; multiple currency support helps organization leaders to make well-informed decisions. In this report, 2018 to 2021 are considered as historical years, 2022 is base year, 2023 is estimated year, and years from 2024 to 2030 are considered as forecast period.
FPNV Positioning Matrix:
The FPNV Positioning Matrix is an indispensable tool for assessing the Biologics Safety Testing Market. It comprehensively evaluates vendors, analyzing key metrics related to Business Strategy and Product Satisfaction. This enables users to make informed decisions tailored to their specific needs. Through advanced analysis, vendors are categorized into four distinct quadrants, each representing a different level of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V). Be assured that this insightful framework empowers decision-makers to navigate the market with confidence.
Market Share Analysis:
The Market Share Analysis offers invaluable insights into the vendor landscape Biologics Safety Testing Market. By evaluating their impact on overall revenue, customer base, and other key metrics, we provide companies with a comprehensive understanding of their performance and the competitive environment they confront. This analysis also uncovers the level of competition in terms of market share acquisition, fragmentation, dominance, and industry consolidation during the study period.
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., bioMérieux 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 Société Générale de Surveillance SA, and Thermo Fisher Scientific, Inc..
The report offers valuable insights on the following aspects:
- Market Penetration: It provides comprehensive information about key players' market dynamics and offerings.
- Market Development: In-depth analysis of emerging markets and penetration across mature market segments, highlighting lucrative opportunities.
- Market Diversification: Detailed information about new product launches, untapped geographies, recent developments, and investments.
- Competitive Assessment & Intelligence: Exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of leading players.
- Product Development & Innovation: Intelligent insights on future technologies, R&D activities, and breakthrough product developments.
- What is the market size and forecast for the Biologics Safety Testing Market?
- Which products, segments, applications, and areas hold the highest investment potential in the Biologics Safety Testing Market?
- What is the competitive strategic window for identifying opportunities in the Biologics Safety Testing Market?
- What are the latest technology trends and regulatory frameworks in the Biologics Safety Testing Market?
- What is the market share of the leading vendors in the Biologics Safety Testing Market?
- Which modes and strategic moves are suitable for entering the Biologics Safety Testing Market?
Note: PDF & Excel + Online Access - 1 Year
- 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. Limitations
- 1.7. Assumptions
- 1.8. 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
- 4.1. Introduction
- 4.2. Biologics Safety Testing Market, by Region
- 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
- 5.3. Market Trend Analysis
- 5.4. Cumulative Impact of COVID-19
- 5.5. Cumulative Impact of Russia-Ukraine Conflict
- 5.6. Cumulative Impact of High Inflation
- 5.7. Porter’s Five Forces Analysis
- 5.7.1. Threat of New Entrants
- 5.7.2. Threat of Substitutes
- 5.7.3. Bargaining Power of Customers
- 5.7.4. Bargaining Power of Suppliers
- 5.7.5. Industry Rivalry
- 5.8. Value Chain & Critical Path Analysis
- 5.9. Regulatory Framework
- 5.10. Client Customization
- 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. FPNV Positioning Matrix
- 13.2. Market Share Analysis, By Key Player
- 13.3. Competitive Scenario Analysis, By Key Player
- 13.3.1. Merger & Acquisition
- 13.3.1.1. Solvias acquires Cergentis to boost biologics testing capabilities.
- 13.3.1.2. Charles River to acquire Cognate BioServices for USD 875 Million.
- 13.3.2. Agreement, Collaboration, & Partnership
- 13.3.2.1. Oxford Nanopore and Pathoquest Announce the First Steps in a Strategic Collaboration to Bring the First Gmp-Accredited, Nanopore-Based Biologics Genetic Characterisation Test to Market.
- 13.3.2.2. Nykode Therapeutics and Richter-Helm BioLogics Announce Partnership.
- 13.3.3. New Product Launch & Enhancement
- 13.3.3.1. Identifysensors Biologics Partners with Jabil Healthcare to Manufacture Digital Diagnostic Platform.
- 13.3.4. Investment & Funding
- 13.3.4.1. Why Teva is Investing Over One Billion Dollars in Biologics in Europe.
- 13.3.5. Award, Recognition, & Expansion
- 13.3.5.1. Clean Cells Launches Biopharmaceutical Quality Control Facility.
- 13.3.5.2. Abzena Opens a New Biologics Testing Lab.
- 14. Competitive Portfolio
- 14.1. Key Company Profiles
- 14.1.1. Accugen Laboratories, Inc.
- 14.1.2. Agilent Technologies, Inc.
- 14.1.3. Almac Group Limited
- 14.1.4. Associates of Cape Cod, Inc.
- 14.1.5. Becton, Dickinson and Company
- 14.1.6. Bio-Rad Laboratories, Inc.
- 14.1.7. bioMérieux SA
- 14.1.8. BSL Bioservice Scientific Laboratories Munich GmbH
- 14.1.9. Charles River Laboratories International, Inc.
- 14.1.10. Creative Biolabs, Inc.
- 14.1.11. Eagle Analytical Services
- 14.1.12. Eurofins Scientific Limited
- 14.1.13. F. Hoffmann-La Roche Ltd.
- 14.1.14. FUJIFILM Wako Pure Chemical Corporation
- 14.1.15. Laboratory Corporation of America Holdings
- 14.1.16. Lonza Group AG
- 14.1.17. Maravai Lifesciences
- 14.1.18. Merck KGaA
- 14.1.19. Microcoat Biotechnologie GmbH
- 14.1.20. Nelson Laboratories, LLC by Sterigenics International LLC
- 14.1.21. Pacific BioLabs by Northview Biosciences, Inc.
- 14.1.22. Promega Corporation
- 14.1.23. PromoCell GmbH
- 14.1.24. QIAGEN GmbH
- 14.1.25. Rockland Immunochemicals, Inc.
- 14.1.26. Samsung Biologics
- 14.1.27. Sartorius AG
- 14.1.28. SGS S.A.
- 14.1.29. SGS Société Générale de Surveillance SA
- 14.1.30. Thermo Fisher Scientific, Inc.
- 14.2. Key Product Portfolio
- 15. Appendix
- 15.1. Discussion Guide
- 15.2. License & Pricing
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