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

Biologics Safety (Biosafety) Testing Market – Report Overview

Pacific Business Consulting’s “Biologics Safety (Biosafety) Testing Market in 10MM – Market Outlook, Unmet Needs, Market Assessment & Forecast (2023-2030)” report offers a comprehensive understanding of Biologics Safety (Biosafety) 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 Biologics Safety (Biosafety) Testing market exceeded a valuation of over US$ 3.8 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$ 6.5 Billion by 2030.

Biologics encompass intricate medications crafted from living organisms, comprising proteins, tissues, genes, and blood components. Given the intricacies of biologics production within biological systems, rigorous testing is essential to guarantee their quality, safety, and efficacy. This entails comprehensive examination for viruses, fungi, bacteria, and toxins at every developmental and manufacturing stage to prevent contamination.

Biological products derived from mammalian cell lines inherently pose a risk of introducing microbial or viral contaminants. Furthermore, impurities may be introduced by the manufacturing process or the product itself, necessitating thorough characterization.

Biopharmaceutical manufacturers must conduct stringent testing to ensure the safety, contamination-free nature, and characterization of all biologic materials throughout the development process. This includes evaluating starting materials like cell banks and viral seed stocks, as well as products progressing through clinical and commercialization phases.

The escalating prevalence of chronic diseases, such as cancer, neurological disorders, and cardiovascular diseases, has spurred global research and development efforts toward innovative biologics. Regulatory testing mandates contribute to an extensive examination of biological samples, driving the adoption of biologics safety testing products and services. With biopharma companies increasing R&D budgets, the demand for contamination testing is poised to rise.

Contract research organizations (CROs) offer outsourced services covering bulk product testing, sterility assessments, analytical testing, endotoxin detection, and cleaning validation studies. Increased outsourcing by biomanufacturers allows for significant cost and time savings, enabling a greater focus on core operations. The flourishing biosafety testing industry presents lucrative opportunities for CROs to capture larger market shares, given the expanding pipelines of biopharmaceutical firms.

The surging demand for biologics has led to a remarkable increase in the number of biopharmaceutical companies. Intense competition in producing highly effective therapeutic drugs on a large scale has prompted manufacturers to enhance industrial processes, emphasizing cost-effectiveness and productivity. For example, in July 2023, Biocon Biologics, an Indian-based organization, introduced the rheumatoid arthritis drug Humira, a biosimilar version of AbbVie in the U.S., at a lower price for wider accessibility in the region. Organizations are adopting improved manufacturing practices with thorough biological evaluation at various production cycle stages, fueling market growth.

Government initiatives are expected to stimulate overall market growth. For instance, in June 2022, Pfizer and BioNTech collaborated with the U.S. government to provide additional vaccine supply to control the spread of the COVID-19 virus. Consequently, both government and private entities are anticipated to enhance biological safety practices in response to the heightened occurrence of microbial contamination and bioburden during pharmaceutical and biologics manufacturing.

The presence of regulatory authorities enforcing stringent safety standards is projected to drive 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.

Biologics safety testing services play a pivotal role in verifying the absence of bacterial contaminants and ensuring the safety of vaccines and biopharmaceuticals. These services cover various assessments, including bioburden, toxicology, and analytical testing, evaluating parameters such as accuracy, linearity, range, and specificity to assess the quality of products offered by companies in this field.

Leading players in the Biologics Safety (Biosafety) Testing segment, including Lonza, Merck KGaA, Promega Corporation, Thermo Fisher Scientific, Toxikon, WuXi AppTec, Avance Biosciences, Cytovance Biologics, Eurofins Scientific, Sartorius, are expected to play a crucial role in shaping the future landscape of Biologics Safety (Biosafety) 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 Biologics Safety (Biosafety) Testing market. It also delves into the analysis of present and prospective market competition within the global Biologics Safety (Biosafety) 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 Biologics Safety (Biosafety) 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 Biologics Safety (Biosafety) 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: Biologics Safety (Biosafety) Testing
   • Global Market Outlook: Biologics Safety (Biosafety) Testing
2. Competitive Intelligence Analysis: Biologics Safety (Biosafety) Testing
3. Therapeutic Sector SWOT
4. Technology Roadmap Analysis: Biologics Safety (Biosafety) Testing
5. Market Background
   • Drivers
   • Restraints
   • Opportunity
   • Key Market Trends
   • Key Unmet Needs
6. Key Marketed Products Profile – Major Approved Products: Biologics Safety (Biosafety) Testing
   • Product Profile
   • Safety and Efficacy
7. Regulatory Landscape
8. Biologics Safety (Biosafety) Testing: Ten Major Market (10MM) – Market Analysis, By Product
   • Instruments
   • Consumables
   • Services
9. Biologics Safety (Biosafety) Testing: Ten Major Market (10MM) – Market Analysis, By Application
   • Vaccines
   • Monoclonal Antibodies
   • Recombinant Protein
   • Blood & Blood-based Products
   • Cell & Gene Therapy
   • Other Applications
10. Biologics Safety (Biosafety) Testing: Ten Major Market (10MM) – Market Analysis, By Test Type
    • Endotoxin Tests
    • Sterility Tests
    • Cell Line Authentication & Characterization Tests
    • Bioburden Tests
    • Adventitious Agent Detection Tests
    • Residual Host Contamination Detection Tests
    • Others
11. Biologics Safety (Biosafety) Testing: Ten Major Market (10MM) – Market Analysis
    • Historical Market Analysis (US$ million), 2020-2022
      • By Product
      • By Application
      • By Test Type
    • Current and Future Market Projections (US$ million), 2023-2030
      • By Product
      • By Application
      • By Test Type

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

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

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

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

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

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

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

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

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

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

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