Biological Safety Testing Market – By Product and Services (Consumables, Instruments, Services, Reagents & Kits), Application (Gene Therapy, Stem Cells), Test Type (Endotoxin Test, Sterility Test, Bioburden Tests) – Global Forecast (2024 – 2032)

Biological Safety Testing Market – By Product and Services (Consumables, Instruments, Services, Reagents & Kits), Application (Gene Therapy, Stem Cells), Test Type (Endotoxin Test, Sterility Test, Bioburden Tests) – Global Forecast (2024 – 2032)

Biological Safety Testing Market Size

Biological Safety Testing Market size was valued at around USD 4.1 billion in 2023 and is estimated to register of 13.6% CAGR from 2024 to 2032. Biological safety testing products and services refer to a comprehensive range of offerings designed to assess the safety, quality, and efficacy of biological products, including pharmaceuticals, biologics, vaccines, medical devices, and other biological materials.

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These products and services are essential for ensuring compliance with regulatory standards, safeguarding public health, and maintaining the integrity of biological products throughout their lifecycle. Rising number of government initiatives and recommendations has emerged as a significant driver for the market. For instance, in 2020, the U.S. Food and Drug Administration (FDA) announced the inception of the Coronavirus Treatment Acceleration Program (CTAP), aimed at expediting the testing and evaluation of therapeutics and drugs for COVID-19 treatment. Thus, this illustrates the substantial influence of government initiatives in propelling progress and boosting the growth of the market.
 

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Furthermore, high R&D investments in clinical research and life sciences research and increasing production of new biologics due to high disease burden, are contributing factors stimulating the growth of the market.

Biological Safety Testing Market Trends

Increased research and development (R&D) investments in clinical research and life sciences are instrumental in propelling the advancement of biological safety testing products and services. These investments ignite innovation within the field, empowering researchers to pursue exploratory projects aimed at uncovering and refining pioneering technologies and methodologies.

• Increased R&D investments foster innovation and the development of advanced technologies for biological safety testing. This can lead to the creation of novel assays, improved testing methodologies, and enhanced instrumentation, allowing for more accurate, sensitive, and efficient testing of biological products.
• R&D investments contribute to the improvement of quality control measures and the standardization of testing protocols in biological safety testing. This results in greater reliability and consistency of test results, reducing variability and ensuring the reproducibility of findings across different laboratories and testing facilities.
• Thus, robust R&D efforts in clinical and life sciences research facilitate the expedited development and approval of new drugs, biologics, and medical devices. By streamlining the biological safety testing process and providing timely and reliable data on product safety, R&D investments contribute to faster regulatory approval and commercialization of innovative therapies and products, thereby stimulating market growth.

Biological Safety Testing Market Analysis

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Based on product and services, the market is bifurcated into consumables, instruments, services, and reagents and kits. The reagents and kits segment is estimated to account for USD 4.9 billion by 2032.

• Reagents and kits provide standardized components and protocols for biological safety testing, ensuring consistency and reproducibility across different laboratories and testing facilities. This standardization minimizes variability in test results and facilitates comparison between studies.
• Further, reagents and kits undergo rigorous quality control measures to ensure reliability and performance consistency. This quality assurance minimizes the risk of reagent-related errors and ensures the accuracy of test results, enhancing confidence in the validity of biological safety testing outcomes, thereby escalating the segment of the market.

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Based on application, the biological safety testing market is divided into vaccine and therapeutics, blood and blood-based products, gene therapy, tissue and tissue-based products, and stem cells. Further, vaccine and therapeutics segment is bifurcated into vaccines, monoclonal antibodies, and recombinant protein. The vaccine and therapeutics segment accounted for USD 540.1 million in 2023.

• Biological safety testing ensures that vaccines and therapeutics are free from harmful contaminants, toxins, or adventitious agents, minimizing the risk of adverse reactions or safety concerns in patients.
• Further, this evaluates the efficacy of vaccines and therapeutics by confirming their ability to elicit the desired immune response or therapeutic effect in preclinical and clinical studies.
• Moreover, biological safety testing includes screening for adventitious agents such as viruses or other pathogens that may inadvertently contaminate vaccines or therapeutics during manufacturing, safeguarding public health, thereby propelling the segment growth of the market.

Based on test type, the biological safety testing market is segmented into endotoxin tests, sterility tests, mycoplasma tests, bioburden tests, residual host-cell proteins and DNA detection tests, virus safety tests, adventitious agent detection tests, and other test types. The endotoxin tests segment is estimated to account for USD 2.7 billion revenue by 2032.

• Endotoxin testing ensures the safety of pharmaceuticals, medical devices, and biological products by detecting the presence of endotoxins, potent inflammatory substances produced by certain bacteria. Ensuring products are free from endotoxin contamination minimizes the risk of adverse reactions or infections in patients.
• The testing serves as a critical component of quality control in manufacturing processes. By implementing endotoxin testing protocols, manufacturers can monitor and verify the cleanliness and purity of raw materials, in-process samples, and finished products, ensuring consistent product quality and integrity.
• Additionally, endotoxin testing serves as a critical component of quality control in manufacturing processes. By implementing endotoxin testing protocols, manufacturers can monitor and verify the cleanliness and purity of raw materials, in-process samples, and finished products, ensuring consistent product quality and integrity.

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North America biological safety testing market accounted for USD 1.7 billion revenue in 2023 and is predicted to witness substantial market growth over the analysis timeline.

• North America boasts a well-developed healthcare infrastructure, with sophisticated laboratory facilities, research institutions, and regulatory agencies. This infrastructure supports robust demand for biological safety testing products and services across various sectors, including pharmaceuticals, biotechnology, healthcare, and academia.
• Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and Health Canada enforce stringent standards for biological safety testing to ensure the safety, efficacy, and quality of healthcare products.
• Furthermore, the region is at the forefront of technological innovation in the life sciences and biotechnology sectors. Advancements in areas such as genomics, proteomics, and molecular diagnostics have led to the development of novel testing methodologies and platforms, further fueling demand for biological safety testing in the market.

Biological Safety Testing Market Share

The biological safety testing industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced products and services based on different technologies is among a key market strategy. Some of the leading industry players have a notable presence in the market.

Biological Safety Testing Market Companies

Some of the eminent market participants operating in the biological safety testing industry include

• bioMérieux S.A.
• Charles River Laboratories International, Inc.
• Eurofins Scientific SE
• F. Hoffmann-La Roche Ltd
• Lonza Group Ltd
• Merck KGaA
• Samsung Biologics
• Sartorius AG
• SGS Societe Generale de Surveillance SA
• Thermo Fisher Scientific Inc.

Biological Safety Testing Industry News

• In January 2023, Charles River Laboratories International, Inc. announced its acquisition of SAMDI Tech, Inc., a leading provider of high-quality, label-free high-throughput screening (HTS) solutions for drug discovery research. The acquisition allowed Charles River to enhance its position in the market and provide additional value to its clients in the pharmaceutical and biotechnology industries.
• In September 2022, Thermo Fisher Scientific Inc. introduced the Thermo Scientific 1500 Series Biological Safety Cabinet (BSC), designed to cater to the diverse needs of laboratories while offering robust protection against biological hazards and contamination. This strategic move expanded Thermo Fisher Scientific's portfolio of laboratory safety equipment, further solidifying its position in the market, and providing enhanced value to customers in the life sciences and research sectors.

The biological safety testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments

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Market, By Product and Services

• Consumables
• Instruments
• Services
• Reagents and kits

Market, By Application

• Vaccine and therapeutics
  • Vaccines
  • Monoclonal antibodies
  • Recombinant protein
• Blood and blood-based products             
• Gene therapy
• Tissue and tissue-based products
• Stem cells    

Market, By Test Type

• Endotoxin tests                            
• Sterility tests                               
• Mycoplasma tests                                   
• Bioburden tests                                      
• Residual host-cell proteins and DNA detection tests                                     
• Virus safety tests                         
• Adventitious agent detection tests
• Other test types

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • South Africa   
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa