Biological Safety Testing Products And Services Market Size, Share & Trends Report

Biological Safety Testing Products And Services Market Size, Share & Trends Analysis Report By Product (Reagents & Kits, Services), By Application, By Test Type, By Region, And Segment Forecasts, 2024 - 2030

Report ID: GVR-1-68038-140-5
Number of Pages: 110
Format: Electronic (PDF)

Historical Range: 2018 - 2022
Industry: Healthcare

Market Segmentation

Biological Safety Testing Products & Services Product Outlook (Revenue, USD Million, 2018 - 2030)
- Reagents & Kits
- Services
- Instruments
Biological Safety Testing Products & Services Application Outlook (Revenue, USD Million, 2018 - 2030)
- Vaccines & Therapeutics
  - Vaccines
  - Monoclonal Antibodies
  - Recombinant Protein
- Blood & Blood-based Products
- Gene Therapy
- Tissue & Tissue-based Products
- Stem Cell
Biological Safety Testing Products & Services Test Type Outlook (Revenue, USD Million, 2018 - 2030)
- Endotoxin Tests
- Sterility Tests
- Cell Line Authentication & Characterization Tests
- Bioburden Tests
- Adventitious Agent Detection Tests
- Residual Host Contamination Detection Tests
- Others
Biological Safety Testing Products & Services Regional Outlook (Revenue, USD Million, 2018 - 2030)
- North America
  - North America Biological Safety Testing Products & Services Market, By Product
    - Reagents & Kits
    - Services
    - Instruments
  - North America Biological Safety Testing Products & Services Market, By Application
    - Vaccines & Therapeutics
      - Vaccines
      - Monoclonal Antibodies
      - Recombinant Protein
    - Blood & Blood-based Products
    - Gene Therapy
    - Tissue & Tissue-based Products
    - Stem Cell
  - North America Biological Safety Testing Products & Services Market, By Test Type
    - Endotoxin Tests
    - Sterility Tests
    - Cell Line Authentication & Characterization Tests
    - Bioburden Tests
    - Adventitious Agent Detection Tests
    - Residual Host Contamination Detection Tests
    - Others
  - U.S.
    - U.S. Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - U.S. Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - U.S. Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - Canada
    - Canada Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Canada Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Canada Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
- Europe
  - Europe Biological Safety Testing Products & Services Market, By Product
    - Reagents & Kits
    - Services
    - Instruments
  - Europe Biological Safety Testing Products & Services Market, By Application
    - Vaccines & Therapeutics
      - Vaccines
      - Monoclonal Antibodies
      - Recombinant Protein
    - Blood & Blood-based Products
    - Gene Therapy
    - Tissue & Tissue-based Products
    - Stem Cell
  - Europe Biological Safety Testing Products & Services Market, By Test Type
    - Endotoxin Tests
    - Sterility Tests
    - Cell Line Authentication & Characterization Tests
    - Bioburden Tests
    - Adventitious Agent Detection Tests
    - Residual Host Contamination Detection Tests
    - Others
  - UK
    - UK Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - UK Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - UK Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - Germany
    - Germany Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Germany Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Germany Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - France
    - France Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - France Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - France Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - Italy
    - Italy Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Italy Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Italy Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - Spain
    - Spain Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Spain Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Spain Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - Denmark
    - Denmark Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Denmark Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Denmark Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - Sweden
    - Sweden Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Sweden Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Sweden Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - Norway
    - Norway Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Norway Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Norway Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
- Asia Pacific
  - Asia Pacific Biological Safety Testing Products & Services Market, By Product
    - Reagents & Kits
    - Services
    - Instruments
  - Asia Pacific Biological Safety Testing Products & Services Market, By Application
    - Vaccines & Therapeutics
      - Vaccines
      - Monoclonal Antibodies
      - Recombinant Protein
    - Blood & Blood-based Products
    - Gene Therapy
    - Tissue & Tissue-based Products
    - Stem Cell
  - Asia Pacific Biological Safety Testing Products & Services Market, By Test Type
    - Endotoxin Tests
    - Sterility Tests
    - Cell Line Authentication & Characterization Tests
    - Bioburden Tests
    - Adventitious Agent Detection Tests
    - Residual Host Contamination Detection Tests
    - Others
  - Japan
    - Japan Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Japan Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - v Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - China
    - China Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - China Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - China Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - India
    - India Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - India Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - India Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - South Korea
    - South Korea Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - South Korea Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - South Korea Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - Australia
    - Australia Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Australia Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Australia Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - Thailand
    - Thailand Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Thailand Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Thailand Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
- Latin America
  - Latin America Biological Safety Testing Products & Services Market, By Product
    - Reagents & Kits
    - Services
    - Instruments
  - Latin America Biological Safety Testing Products & Services Market, By Application
    - Vaccines & Therapeutics
      - Vaccines
      - Monoclonal Antibodies
      - Recombinant Protein
    - Blood & Blood-based Products
    - Gene Therapy
    - Tissue & Tissue-based Products
    - Stem Cell
  - Latin America Biological Safety Testing Products & Services Market, By Test Type
    - Endotoxin Tests
    - Sterility Tests
    - Cell Line Authentication & Characterization Tests
    - Bioburden Tests
    - Adventitious Agent Detection Tests
    - Residual Host Contamination Detection Tests
    - Others
  - Brazil
    - Brazil Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Brazil Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Brazil Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - Mexico
    - Mexico Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Mexico Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Mexico Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
  - Argentina
    - Argentina Biological Safety Testing Products & Services Market, By Product
      - Reagents & Kits
      - Services
      - Instruments
    - Argentina Biological Safety Testing Products & Services Market, By Application
      - Vaccines & Therapeutics
        
        Vaccines
        
        Monoclonal Antibodies
        
        Recombinant Protein
      - Blood & Blood-based Products
      - Gene Therapy
      - Tissue & Tissue-based Products
      - Stem Cell
    - Argentina Biological Safety Testing Products & Services Market, By Test Type
      - Endotoxin Tests
      - Sterility Tests
      - Cell Line Authentication & Characterization Tests
      - Bioburden Tests
      - Adventitious Agent Detection Tests
      - Residual Host Contamination Detection Tests
      - Others
- Middle East & Africa

Biological Safety Testing Products And Services Market Dynamics

Driver: Rising number of government initiative and recommendations

The rising number of government initiatives to promote biological safety testing products is presumed to drive the overall market growth during the forecast period. The high microbial contamination rates and bioburden during the pharmaceutical & biologics manufacturing is believed to be key factor driving the government and private organizations to improve the underlying biological safety practices. Microbial contaminations are known to exert a huge impact on biologics & pharmaceuticals manufacturing generally arising in product variability, significant loss of potency, early degradation due to high levels of bacterial endotoxins. In addition to it laboratory-based contamination has stimulated the development and refinement of workstations through incorporating biological safety testing tools. The need to work with tissue cultures, maintain sterility of cell lines, and minimize cross-contamination has contributed to concerns regarding product integrity. The aforementioned factors are responsible raising the concerns of public organizations. The consistent intervention by government healthcare organizations to implement good manufacturing practices and subsequent testing and control at each production stage is believed to widen the demand for biological safety testing. These organizations are also aimed at maximizing the productivity, focusing on disease prevention and control through eliminating the possible contamination risks affecting the potency of finished products. Moreover, they are increasingly involved in issuing guidelines and microbial contamination prevention strategies in that are anticipated to promote biological safety testing globally, which is expected to contribute to the market growth throughout the forecast period. For instance, U.S.FDA issued guidelines with respect to manufacturing & testing of monoclonal antibody products for human use, viral safety evaluation of biotechnology productsof human and animal origin, guidance onquality of biological/biotechnological products, guidance on specifications pertaning to test procedures and acceptance criteria for biological products. Also, frequent number of publications relesead by organizations to promote awareness with respect to biological safety testing is broadening the future growth prospects. For instance, such U.S. Department of Health and Human Services and Centers for Disease Control and published Biosafety In Microbiological And Biomedical Laboratories (BMBL), which includes information pertaining to laboratory biosecurity and risk assessment, biological toxins and biosafety levels in laboratories. Because of the aforementioned factors, it is presumed that there will be significant rise in the overall adoption rate of biological safety testing products, which is also anticipated to fuel the market demand as well as the revenue to unprecedented heights.

Driver: Increasing production of new biologics due to high disease burden

The biological safety testing market is predominantly driven by increasing influx of biologics, which raises the requirements of highly efficient biological safety testing tools. The aforementioned is believed to be a result of biomanufacturing projects by companies such as Bristol-Myers Squibb, Boehringer Ingelheim and Astra Zeneca thus widening the adoption rate for safety testing tools. For instance, Bristol-Myers Squibb has invested in a large bio manufacturing project, to be operational in 2019, a $750 million investment for bulk biologics manufacturing and produces multiple therapies to expand immuno-oncology portfolio. Similarly, in 2015, Boehringer Ingelheim announced to invest $568 million in biopharmaceutical production facility to produce cell cultures and active pharmaceutical ingredients. Sanofi said that 72% of its research and development projects are in biologics, nearly half of which are monoclonal antibodies. The agreement will give Sanofi access to Boehringer Ingelheim’s manufacturing capabilities for therapeutic monoclonal antibodies and thereby expand global biologics supply. This increasing competition to develop therapeutically advanced drugs on large scale for wide range of indications have exerted pressure on manufacturers to gain high productivity, cost efficiency and reduce deviations thereby encourages the companies to implement good manufacturing practices that involves thorough biological safety testing at various levels of production cycles.

Restraint: Time-consuming approval process

The significant cost associated and time taken during the approval process for medical devices, biologics and pharmaceutical is the most critical restraining factor for the overall industry. Moreover, high amount of R&D investment involved in the development of new technology of these systems acts as a key factor contributing towards their high costs. Furthermore, lack of availability & funding opportunities to new players, in the emerging economies, is restricting these players from investing more in research and development. Moreover, low awareness levels associated with the biological safety testing procedures and their benefits in the emerging economies is also anticipated to exert negative impact on global level and is considered as one of the growth-restraining driver for the market.

What Does This Report Include?

This section will provide insights into the contents included in this biological safety testing products and services market report and help gain clarity on the structure of the report to assist readers in navigating smoothly.

Biological safety testing products and services market qualitative analysis

Industry overview
Industry trends
Market drivers and restraints
Market size
Growth prospects
Porter’s analysis
PESTEL analysis
Key market opportunities prioritized
Competitive landscape
- Company overview
- Financial performance
- Product benchmarking
- Latest strategic developments

Biological safety testing products and services market quantitative analysis

Market size, estimates, and forecast from 2018 to 2030
Market estimates and forecast for product segments up to 2030
Regional market size and forecast for product segments up to 2030
Market estimates and forecast for application segments up to 2030
Regional market size and forecast for application segments up to 2030
Company financial performance

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