Biological Safety Testing Market in 10MM – Market Outlook, Unmet Needs, Market Assessment & Forecast (2023-2030)

Biological Safety Testing Market – Report Overview

Pacific Business Consulting’s “Biological Safety Testing Market in 10MM – Market Outlook, Unmet Needs, Market Assessment & Forecast (2023-2030)” report offers a comprehensive understanding of Biological Safety Testing market, encompassing historical and projected market size data, along with market trends, market drivers, market barriers and unmet medical needs in the Ten Major Markets (10MM) of the United States, Germany, Spain, Italy, France, the United Kingdom, Japan, China, Australia, and India.

In 2022, the Biological Safety Testing market exceeded a valuation of over US$ 4.6 Billion, and it is poised for substantial growth, with a projected Compound Annual Growth Rate (CAGR) exceeding 10.0% from 2023 to 2030. The market is expected to potentially surpass US$ 9.0 Billion by 2030.

The surging demand for biologics has resulted in a significant surge in the number of biopharmaceutical companies. Intense competition to manufacture highly effective therapeutic drugs at scale has prompted manufacturers to prioritize improvements in industrial processes, emphasizing cost-effectiveness and productivity. An example of this trend occurred in July 2023 when Biocon Biologics, an Indian-based organization, introduced Humira, a biosimilar version of AbbVie’s rheumatoid arthritis drug, in the U.S. at a lower price, enhancing accessibility across the region. Many organizations are now implementing enhanced manufacturing practices, incorporating comprehensive biological assessments at various stages of the production cycle, thereby stimulating market growth. In September 2022, for instance, Novartis announced a USD 300 million investment in next-generation biotherapeutics, reinforcing the capacity for early technical expansion in biologics.

The increasing number of government initiatives aimed at stimulating the market is expected to drive overall growth. An illustration of this occurred in June 2022 when Pfizer and BioNTech collaborated with the U.S. government to provide additional vaccine supply to combat the spread of the COVID-19 virus. Consequently, government and private organizations are expected to elevate biological safety practices in response to heightened occurrences of microbial contamination and bioburden during pharmaceutical and biologics manufacturing.

The presence of regulatory authorities enforcing stringent safety standards is predicted to boost the adoption of testing tools. In June 2023, the FDA introduced the “BioRationality” guideline, encouraging biosimilar developers to adopt cost-effective evaluation approaches for a more scientifically rational and efficient development and approval process. This guideline suggests alternative evaluation methodologies to streamline development and reduce costs.

Biological safety testing services play a pivotal role in confirming the absence of bacterial contaminants and ensuring the safety of vaccines and biopharmaceuticals. These services encompass various assessments, including bioburden, toxicology, and analytical testing. Parameters such as accuracy, linearity, range, and specificity are evaluated to gauge the quality of products offered by companies in this field. The increasing prevalence of target diseases and the growing production of next-generation biologics by various biotechnology and pharmaceutical organizations are expected to propel market expansion.

Leading players in the Biological Safety Testing segment, including Sartorius AG, Eurofins Scientific, SGS Société Générale de Surveillance SA, Thermo Fisher Scientific Inc., BIOMÉRIEUX, Lonza, Charles River Laboratories, BSL Bioservice, Merck KGaA (MilliporeSigma), and Samsung Biologics, are expected to play a crucial role in shaping the future landscape of Biological Safety Testing technologies through ongoing innovation.

Scope of Report

The report addresses critical subjects such as strategic competitor evaluation, market characterization, unmet needs, and the consequences of these elements for the Biological Safety Testing market. It also delves into the analysis of present and prospective market competition within the global Biological Safety Testing market.

Furthermore, the report offers an insightful examination of the primary industry drivers, constraints, and challenges. Each trend undergoes independent research to furnish qualitative analysis regarding its implications.

Reasons to Buy

• Develop your business strategies by gaining insights into the trends that shape and drive the Biological Safety Testing market across the 10MM (Ten Major Markets).
• Increase revenue by comprehending key trends, innovative products and technologies, market segments, and companies poised to influence the future of the 10MM Biological Safety Testing market.
• Craft effective sales and marketing strategies by thoroughly understanding the competitive landscape and analyzing the performance of various competitors.
• Identify emerging players with potentially robust product portfolios and devise strategic counter-strategies to gain a competitive advantage.
• Optimize your sales and marketing efforts by pinpointing market categories and segments that offer the greatest opportunities for consolidations, investments, and strategic partnerships.

1. Executive Summary: Biological Safety Testing
   • Global Market Outlook: Biological Safety Testing
2. Competitive Intelligence Analysis: Biological Safety Testing
3. Therapeutic Sector SWOT
4. Technology Roadmap Analysis: Biological Safety Testing
5. Market Background
   • Drivers
   • Restraints
   • Opportunity
   • Key Market Trends
   • Key Unmet Needs
6. Key Marketed Products Profile – Major Approved Products: Biological Safety Testing
   • Product Profile
   • Safety and Efficacy
7. Regulatory Landscape
8. Biological Safety Testing: Ten Major Market (10MM) – Market Analysis, By Product
   • Instruments
   • Consumables (Reagents & Kits)
   • Services
9. Biological Safety Testing: Ten Major Market (10MM) – Market Analysis, By Test Type
   • Sterility Tests
   • Endotoxin Tests
   • Cell Line Authentication & Characterization Tests
   • Bioburden Tests
   • Residual Host Contamination Detection Tests
   • Others
10. Biological Safety Testing: Ten Major Market (10MM) – Market Analysis, By Application
    • Blood & Blood-based Products
    • Gene Therapy
    • Vaccines & Therapeutics
    • Tissue & Tissue-based Products
    • Stem Cells
11. Biological Safety Testing: Ten Major Market (10MM) – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Test Type
      • By Application
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Test Type
      • By Application

12. S. Biological Safety Testing – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Test Type
      • By Application
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Test Type
      • By Application

13. K. Biological Safety Testing – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Test Type
      • By Application
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Test Type
      • By Application

14. Germany Biological Safety Testing – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Test Type
      • By Application
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Test Type
      • By Application

15. France Biological Safety Testing – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Test Type
      • By Application
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Test Type
      • By Application

16. Italy Biological Safety Testing – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Test Type
      • By Application
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Test Type
      • By Application

17. Spain Biological Safety Testing – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Test Type
      • By Application
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Test Type
      • By Application

18. Japan Biological Safety Testing – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Test Type
      • By Application
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Test Type
      • By Application

19. China Biological Safety Testing – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Test Type
      • By Application
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Test Type
      • By Application

20. Australia Biological Safety Testing – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Test Type
      • By Application
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Test Type
      • By Application

21. India Biological Safety Testing – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Test Type
      • By Application
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Test Type
      • By Application

22. Competitive Landscape
    • Company Overview
    • Product Portfolio
    • Key Financials
    • Sales Footprint

Note – All Major Company Profiles (Count up to 20) will be covered in the report

23. Assumptions and Acronyms Used
24. Research Methodology
    • Secondary Research
    • Primary Research
    • Data Triangulation
25. Geographic Scope
    • The U.S., The U.K., Germany, France, Italy, Spain, Japan, China, Australia, and India
26. Copyrights and Disclaimer