Biological Safety Testing Products And Services Market Size To Hit USD 13.53 Bn By 2033
The global biological safety testing products and services market size was estimated at USD 4.85 billion in 2023 and is projected to hit around USD 13.53 billion by 2033, growing at a CAGR of 10.8% during the forecast period from 2024 to 2033.
Key Takeaways:
Biological Safety Testing Products And Services Market Growth
The growing prevalence of target diseases and rising production of next-generation biologics by various biotechnology and pharmaceutical organizations are anticipated to boost the market. For instance, in September 2022, Novartis announced its investment of USD 300 million in next-generation biotherapeutics, bolstering the capacity for the early technical expansion of biologics.
The growing demand for biologics has led to an extraordinary increase in the number of biopharmaceutical companies. The rising competition to produce highly effective therapeutic drugs on a large scale has enabled manufacturers to focus on enhancing aspects of industrial processes, including cost-effectiveness and productivity. For instance, in July 2023, Biocon Biologics, an Indian-based organization, announced the launch of the rheumatoid arthritis drug Humira, a biosimilar version of AbbVie in the U.S. at a lower price that would be easily available across the region. Several organizations are thus executing better manufacturing practices involving thorough biological evaluation at various levels of the production cycle with easy accessibility, thereby fueling the growth of the market.
The growing number of government initiatives to stimulate the market is anticipated to propel overall growth over the forecast period. For instance, in June 2022, Pfizer and BioNTech announced their collaboration with the U.S. government to offer additional vaccine supply to control the spread of COVID-19 virus. Thus, government and private organizations are anticipated to enhance underlying biological safety practices in response to the elevated occurrence of microbial contamination and bioburden during the manufacturing of pharmaceuticals and biologics.
The presence of regulatory authorities enforcing stringent safety standards is expected to drive the adoption of testing tools. For instance, 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 proposes alternative evaluation methodologies to streamline development and reduce costs.
Biological safety testing services play a crucial role in verifying the absence of bacterial contaminants and ensuring the safety of vaccines and biopharmaceuticals. These services encompass a range of assessments, including bioburden, toxicology, and analytical testing. Parameters such as accuracy, linearity, range, and specificity are evaluated to assess the quality of products offered by companies in this field.
Biological Safety Testing Products And Services Market Report Scope
| Report Attribute | Details |
| Market Size in 2024 | USD 5.37 Billion |
| Market Size by 2033 | USD 13.53 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 10.8% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered |
Product, application, test type, region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | Charles River Laboratories; BSL Bioservice; Merck KGaA (MilliporeSigma); Samsung Biologics; Sartorius AG; Eurofins Scientific; SGS Société Générale de Surveillance SA; Thermo Fisher Scientific Inc.; BIOMÉRIEUX; Lonza |
Segments Insights:
Product Insights
The reagents and kits segment held a leading revenue share of over 39.19% in 2023. Reagents are major components in biological safety testing and hence are extensively used in research and clinical laboratories. These reagents are antibiotics, attachments & matrix factors, biological buffers, freezing & dissociation reagents, and miscellaneous reagents. Rapid advancements and modifications in the formulation of reagents and kits are expected to increase their adoption by laboratory technicians, especially in toxicology assessment. Additionally, the increasing demand for high-throughput testing has contributed to the popularity of reagents and kits.
The instruments segment is expected to show lucrative growth through 2033 due to rising demand for instruments in biological safety testing laboratories. Additionally, the increasing regulatory pressure on biopharmaceutical companies to adhere to safety guidelines drives the demand for instruments. They play a crucial role in conducting biological assays, including toxicology and bioburden tests.
Moreover, the market is witnessing a rising demand for specialized biological safety testing, such as genetic testing, cell-based assays, and flow cytometry. These testing methods require specific instruments to carry out the procedures accurately and efficiently. The increasing adoption of personalized medicine and targeted therapies also contributes to the demand for instruments that are suitable for specialized testing needs.
Application Insights
The vaccines & therapeutics segment accounted for the largest revenue share in 2023. This dominance is attributed to the presence of clearly defined guidelines ensuring the safety of developed vaccines with unaltered therapeutic value and reduced toxicity. In January 2023, BioNTech SE announced their collaboration Memorandum of Understanding with the UK Government, which would help patients by fast-tracking clinical trials for mRNA personalized immunotherapies.
This collaboration is anticipated to focus on three things, including cancer immunotherapies, infectious disease, and vaccines, thus, strengthening their presence in the UK. Thus, the growth of this segment is expected to be fueled by the issuance of various guidelines and recommendations by regulatory authorities, such as the U.S. FDA, regarding the characterization and qualification of materials utilized in the production of vaccines for infectious disease indications.
The gene therapy segment is estimated to register the fastest CAGR through 2033 due to the heightened risk of contamination with residual DNA. The presence of residual DNA is considered a potential risk to the final product due to its high potential for infectivity. Furthermore, mAbs play a vital role in the identification and characterization of critical quality attributes (CQAs) of biopharmaceuticals. These CQAs are specific characteristics that define the product’s safety, purity, and potency.
Monoclonal antibodies are used in assays to assess parameters like product-related impurities, degradation products, and host cell proteins, ensuring that the biopharmaceuticals meet the required quality standards. Thus, the demand for monoclonal antibodies (mAbs) in the biological safety testing products & services market is experiencing a significant increase.
Test Type Insights
The endotoxin tests segment dominated the market in 2023 with a significant revenue share. This share can be attributed to the rising usage of these tests in various areas, such as the manufacturing and producing drugs to reduce the threat of endotoxins. In August 2022, Lonza announced the launch of Nebula Multimode Reader, the first qualified reader for use in the company’s recombinant endotoxin, turbidimetric, and chromogenic detection methods.
The accessibility of several types of endotoxin tests, such as turbidimetric method, gel clot endotoxin testing, and USP chromogenic endotoxin testing, which are designed for different requirements, is likely to boost segment growth. In addition, endotoxin testing plays a crucial role in ensuring patient safety by preventing the release of pyrogen-contaminated products into the market. Manufacturers prioritize patient safety by implementing rigorous endotoxin testing protocols, thereby driving the demand for these tests.
The bioburden tests segment has been anticipated to show lucrative growth over the forecast period. This can be attributed to the high adoption of these tests to determine the bioburden limit in a wide range of biologics and medical devices. In April 2023, STEMart, a U.S.-based provider, announced the launch of bioburden and sterility testing for medical devices under the regulation of the ISO 11731 technique. Moreover, integrating cutting-edge colorimetric methods and computation has facilitated the rapid generation of results and accurate bioburden quantification. Rapid advancements in this segment are further expected to aid in segment growth.
Regional Insights
North America dominated the overall market with a revenue share of 35.19% in 2023. This region’s significant market share can be attributed to substantial investments in biotechnology, growing adoption in cancer research, and the advancement of novel biologics, vaccines, and drugs. Additionally, increasing research and development (R&D) investments by companies is a key factor driving growth. Furthermore, the market is boosted by major market players undertaking extensive expansion strategies aided by the rising prevalence of chronic diseases in this region is expected to drive the adoption of advanced technologies by researchers and healthcare professionals, thereby expanding the market growth.
The U.S. held the largest share in the North American market in 2023 and is maintaining this dominance due to the presence of a robust and highly advanced biopharmaceutical industry in the country, along with a considerable focus on research and development. Additionally, the continuous presence of numerous pharmaceutical and biotechnology companies, along with academic and research institutions, generates a sustained demand for rigorous safety testing, further reinforcing the country's leadership in the field.
The Asia Pacific region is anticipated to grow at the fastest CAGR during the forecast period. Factors such as the growth in healthcare spending and rising awareness of the advantages associated with these products are anticipated to contribute to market growth. Additionally, the presence of organizations such as the Asia Pacific Biosafety Association, which plays a pivotal role in providing training on biosafety principles and practices to professionals throughout the region, is further expanding growth opportunities in the region.
Within the Asia Pacific region, Japan held the largest market share in 2023. The country has made substantial investments in research and development activities, fostering innovations in biotechnology and pharmaceuticals. This commitment to cutting-edge research and technology positions Japanese companies at the forefront of biological safety product development and services.
Recent Developments
Key Companies & Market Share Insights
Key Biological Safety Testing Products And Services Companies:
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Biological Safety Testing Products And Services market.
By Product
By Application
By Test Type
By Region
Chapter 1. Biological Safety Testing Products And Services Market: Methodology and Scope
1.1. Market Segmentation and Scope
1.1.1. Segment Definitions
1.1.1.1. Product Segment
1.1.1.2. Application Segment
1.1.1.3. Test Type Segment
1.2. Regional Scope
1.3. Estimates and Forecast Timeline
1.4. Objectives
1.4.1. Objective - 1
1.4.2. Objective - 2
1.5. Research Methodology
1.6. Information Procurement
1.6.1. Purchased Database
1.6.2. nova one advisor’s Internal Database
1.6.3. Secondary Sources
1.6.4. Primary Research
1.7. Information or Data Analysis
1.7.1. Data Analysis Models
1.8. Market Formulation & Validation
1.9. Model Details
1.9.1. Commodity Flow Analysis
1.10. List of Primary Sources
1.11. List of Abbreviations
Chapter 2. Biological Safety Testing Products & Services Market: Executive Summary
2.1. Market Snapshot
2.2. Products and Services Snapshots
2.3. Application And End-use Snapshot
2.4. Competitive Landscape Snapshot
Chapter 3. Biological Safety Testing Products & Services Market: Variables, Trends, & Scope
3.1. Market Segmentation and Scope
3.2. Market Lineage Outlook
3.2.1. Parent Market Outlook
3.2.2. Related/Ancillary Market Outlook
3.3. Market Dynamics
3.4. Market Drivers Analysis
3.4.1. Increase number of government initiatives and recommendations
3.4.2. Increasing production of new biologics due to high disease burden
3.4.3. High R&D investments in clinical research and life sciences research
3.5. Market Restraint Analysis
3.5.1. Time-consuming approval process
3.6. Biological Safety Testing Products & Services Market Analysis Tools
3.6.1. Industry Analysis - Porter’s Five Forces
3.6.1.1. Supplier Power
3.6.1.2. Buyer Power
3.6.1.3. Substitution Threat
3.6.1.4. Threat of New Entrant
3.6.1.5. Competitive Rivalry
3.6.2. PESTLE Analysis
3.6.2.1. Political Landscape
3.6.2.2. Economic Landscape
3.6.2.3. Social Landscape
3.6.2.4. Technological Landscape
3.6.2.5. Environmental Landscape
3.6.2.6. Legal Landscape
Chapter 4. Biological Safety Testing Products & Services Market: Products Estimates & Trend Analysis
4.1. Product Market Share, 2024 & 2033
4.2. Segment Dashboard
4.3. Global Biological Safety Testing Products & Services Market By Product Outlook
4.4. Market Size & Forecasts and Trend Analyses, 2018 To 2030 For The Following
4.4.1. Reagents & Kits
4.4.1.1. Market Estimates and Forecasts 2018 To 2030, (USD Million)
4.4.2. Services
4.4.2.1. Market Estimates and Forecasts 2018 To 2030, (USD Million)
4.4.3. Instruments
4.4.3.1. Market Estimates and Forecasts 2018 To 2030, (USD Million)
Chapter 5. Biological Safety Testing Products & Services Market: Application Estimates & Trend Analysis
5.1. Application Market Share, 2024 & 2033
5.2. Segment Dashboard
5.3. Global Biological Safety Testing Products & Services Market By Application Outlook
5.4. Market Size & Forecasts And Trend Analyses, 2018 To 2030 For The Following
5.4.1. Vaccine & Therapeutics Market Revenue Estimates and Forecasts 2020 - 2033
5.4.1.1. Market Estimates And Forecasts 2020 - 2033
5.4.1.1.1. Vaccines Market Estimates And Forecasts 2020 - 2033
5.4.1.1.1.1. Market Estimates And Forecasts 2020 - 2033
5.4.1.1.2. Monoclonal Antibodies Market Estimates And Forecasts 2020 - 2033
5.4.1.1.2.1. Market Estimates And Forecasts 2020 - 2033
5.4.1.1.3. Recombinant Protein Market Estimates And Forecasts 2020 - 2033
5.4.1.1.3.1. Market Estimates And Forecasts 2020 - 2033
5.4.2. Blood & Blood-based Products Market Revenue Estimates and Forecasts 2020 - 2033
5.4.2.1. Market Estimates And Forecasts 2020 - 2033
5.4.3. Gene Therapy Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.4.3.1. Market Estimates And Forecasts 2020 - 2033
5.4.4. Tissue & Tissue-based Products Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.4.4.1. Market Estimates And Forecasts 2020 - 2033
5.4.5. Stem Cells Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.4.5.1. Market Estimates And Forecasts 2020 - 2033
Chapter 6. Biological Safety Testing Products & Services Market: Test Type Estimates & Trend Analysis
6.1. Test Type Market Share, 2024 & 2033
6.2. Segment Dashboard
6.3. Global Biological Safety Testing Products & Services Market By Test Type Outlook
6.4. Market Size & Forecasts And Trend Analyses, 2018 To 2030 For The Following
6.4.1. Endotoxin Tests
6.4.1.1. Market Estimates And Forecasts 2020 - 2033
6.4.2. Sterility Tests
6.4.2.1. Market Estimates And Forecasts 2020 - 2033
6.4.3. Cell Line Authentication & Characterization Tests
6.4.3.1. Market Estimates And Forecasts 2020 - 2033
6.4.4. Bioburden Tests
6.4.4.1. Market Estimates And Forecasts 2020 - 2033
6.4.5. Adventitious Agent Detection Tests
6.4.5.1. Market Estimates And Forecasts 2020 - 2033
6.4.6. Residual Host Contamination Detection Tests
6.4.6.1. Market Estimates And Forecasts 2020 - 2033
6.4.7. Others
6.4.7.1. Market Estimates And Forecasts 2020 - 2033
Chapter 7. Regional Business Analysis
7.1. Regional Market Share Analysis, 2024 & 2033
7.2. Regional Market Dashboard
7.3. Global Regional Market Snapshot
7.4. Marker Size, & Forecasts Trend Analysis, 2018 To 2030:
7.5. North America
7.5.1. U.S.
7.5.1.1. Key Country Dynamics
7.5.1.2. Competitive Scenario
7.5.1.3. Regulatory Framework
7.5.1.4. U.S. Market Estimates And Forecasts 2020 - 2033
7.5.2. Canada
7.5.2.1. Key Country Dynamics
7.5.2.2. Competitive Scenario
7.5.2.3. Regulatory Framework
7.5.2.4. Canada Market Estimates And Forecasts 2020 - 2033
7.6. Europe
7.6.1. UK
7.6.1.1. Key Country Dynamics
7.6.1.2. Competitive Scenario
7.6.1.3. Regulatory Framework
7.6.1.4. UK Market Estimates And Forecasts 2020 - 2033
7.6.2. Germany
7.6.2.1. Key Country Dynamics
7.6.2.2. Competitive Scenario
7.6.2.3. Regulatory Framework
7.6.2.4. Germany Market Estimates And Forecasts 2020 - 2033
7.6.3. Spain
7.6.3.1. Key Country Dynamics
7.6.3.2. Competitive Scenario
7.6.3.3. Regulatory Framework
7.6.3.4. Spain Market Estimates And Forecasts 2020 - 2033
7.6.4. France
7.6.4.1. Key Country Dynamics
7.6.4.2. Competitive Scenario
7.6.4.3. Regulatory Framework
7.6.4.4. France Market Estimates And Forecasts 2020 - 2033
7.6.5. Italy
7.6.5.1. Key Country Dynamics
7.6.5.2. Competitive Scenario
7.6.5.3. Regulatory Framework
7.6.5.4. Italy Market Estimates And Forecasts 2020 - 2033
7.6.6. Denmark
7.6.6.1. Key Country Dynamics
7.6.6.2. Competitive Scenario
7.6.6.3. Regulatory Framework
7.6.6.4. Denmark Market Estimates And Forecasts 2020 - 2033
7.6.6.5.
7.6.7. Sweden
7.6.7.1. Key Country Dynamics
7.6.7.2. Competitive Scenario
7.6.7.3. Regulatory Framework
7.6.7.4. Sweden Market Estimates And Forecasts 2020 - 2033
7.6.8. Norway
7.6.8.1. Key Country Dynamics
7.6.8.2. Competitive Scenario
7.6.8.3. Regulatory Framework
7.6.8.4. Norway Market Estimates And Forecasts 2020 - 2033
7.7. Asia Pacific
7.7.1. Japan
7.7.1.1. Key Country Dynamics
7.7.1.2. Competitive Scenario
7.7.1.3. Regulatory Framework
7.7.1.4. Japan Market Estimates And Forecasts 2020 - 2033
7.7.2. China
7.7.2.1. Key Country Dynamics
7.7.2.2. Competitive Scenario
7.7.2.3. Regulatory Framework
7.7.2.4. China Market Estimates And Forecasts 2020 - 2033
7.7.3. India
7.7.3.1. Key Country Dynamics
7.7.3.2. Competitive Scenario
7.7.3.3. Regulatory Framework
7.7.3.4. India Market Estimates And Forecasts 2020 - 2033
7.7.4. South Korea
7.7.4.1. Key Country Dynamics
7.7.4.2. Competitive Scenario
7.7.4.3. Regulatory Framework
7.7.4.4. South Korea Market Estimates And Forecasts 2020 - 2033
7.7.5. Thailand
7.7.5.1. Key Country Dynamics
7.7.5.2. Competitive Scenario
7.7.5.3. Regulatory Framework
7.7.5.4. Thailand Market Estimates And Forecasts 2020 - 2033
7.7.6. Australia
7.7.6.1. Key Country Dynamics
7.7.6.2. Competitive Scenario
7.7.6.3. Regulatory Framework
7.7.6.4. Australia Market Estimates And Forecasts 2020 - 2033
7.8. Latin America
7.8.1. Brazil
7.8.1.1. Key Country Dynamics
7.8.1.2. Competitive Scenario
7.8.1.3. Regulatory Framework
7.8.1.4. Brazil Market Estimates And Forecasts 2020 - 2033
7.8.2. Mexico
7.8.2.1. Key Country Dynamics
7.8.2.2. Competitive Scenario
7.8.2.3. Regulatory Framework
7.8.2.4. Mexico Biological Safety Testing Products & Services Market, 2018 - 2030 (USD Million)
7.8.3. Argentina
7.8.3.1. Key Country Dynamics
7.8.3.2. Competitive Scenario
7.8.3.3. Regulatory Framework
7.8.3.4. Argentina Market Estimates And Forecasts 2020 - 2033
7.9. MEA
7.9.1. South Africa
7.9.1.1. Key Country Dynamics
7.9.1.2. Competitive Scenario
7.9.1.3. Regulatory Framework
7.9.1.4. South Africa Market Estimates And Forecasts 2020 - 2033
7.9.2. Saudi Arabia
7.9.2.1. Key Country Dynamics
7.9.2.2. Competitive Scenario
7.9.2.3. Regulatory Framework
7.9.2.4. Saudi Arabia Market Estimates And Forecasts 2020 - 2033
7.9.3. UAE
7.9.3.1. Key Country Dynamics
7.9.3.2. Competitive Scenario
7.9.3.3. Regulatory Framework
7.9.3.4. UAE Market Estimates And Forecasts 2020 - 2033
7.9.4. Kuwait
7.9.4.1. Key Country Dynamics
7.9.4.2. Competitive Scenario
7.9.4.3. Regulatory Framework
7.9.4.4. Kuwait Market Estimates And Forecasts 2020 - 2033
Chapter 8. Competitive Landscape
8.1. Recent Developments & Impact Analysis, By Key Market Participants
8.2. Company /Competition Categorization
8.3. Vendor Landscape
8.3.1. List of Key Distributors And Channel Partners
8.3.2. Key Customers
8.3.3. Key Company Market Share Analysis, 2023
8.3.4. Charles River Laboratories
8.3.4.1. Overview
8.3.4.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
8.3.4.3. Product Benchmarking
8.3.4.4. Strategic Initiatives
8.3.5. BSL Bioservice
8.3.5.1. Overview
8.3.5.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
8.3.5.3. Product Benchmarking
8.3.5.4. Strategic Initiatives
8.3.6. Merck KGaA
8.3.6.1. Overview
8.3.6.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
8.3.6.3. Product Benchmarking
8.3.6.4. Strategic Initiatives
8.3.7. Samsung Biologics
8.3.7.1. Overview
8.3.7.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
8.3.7.3. Product Benchmarking
8.3.7.4. Strategic Initiatives
8.3.8. Sartorius AG
8.3.8.1. Overview
8.3.8.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
8.3.8.3. Product Benchmarking
8.3.8.4. Strategic Initiatives
8.3.9. Eurofins Scientific
8.3.9.1. Overview
8.3.9.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
8.3.9.3. Product Benchmarking
8.3.9.4. Strategic Initiatives
8.3.10. SGS Société Générale de Surveillance SA
8.3.10.1. Overview
8.3.10.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
8.3.10.3. Product Benchmarking
8.3.10.4. Strategic Initiatives
8.3.11. Thermo Fisher Scientific Inc.
8.3.11.1. Overview
8.3.11.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
8.3.11.3. Product Benchmarking
8.3.11.4. Strategic Initiatives
8.3.12. BIOMÉRIEUX
8.3.12.1. Overview
8.3.12.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
8.3.12.3. Product Benchmarking
8.3.12.4. Strategic Initiatives
8.3.13. Lonza
8.3.13.1. Overview
8.3.13.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
8.3.13.3. Product Benchmarking
8.3.13.4. Strategic Initiative
Cross-segment Market Size and Analysis for Mentioned Segments
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