Biological Safety Testing Products & Services Market - Size, Share | Industry Trend & Forecast 2024 - 2030

Biological Safety Testing Products & Services Market Overview

The biological safety testing products & services market size is forecast to reach USD 9,090.51 million by 2030, after growing at a CAGR of 11.08% during 2024-2030. The market for biological safety testing goods and services is expanding due to the growing interest in creating cell and gene therapies. The rising prevalence of some diseases and the ever-increasing production of innovative biologics by various biotechnology and pharmaceutical businesses are expected to drive market growth. The market for biological safety testing goods and services is expanding due to the growing interest in creating cell and gene therapies. Companies are investing in assessing the biological safety of pharmaceuticals because of the growing requirement to test the drug before approving it for widespread use in the market.

Report Coverage

The report “Biological Safety Testing Products & Services Market– Forecast (2024-2030)”, by IndustryARC, covers an in-depth analysis of the following segments of the Biological Safety Testing Products & Services market.

By Product: Reagents & Kits, Services and, Instruments.

By Application: Vaccine & Therapeutics, Blood & Blood-based Products, Gene Therapy, Tissue & Tissue-based Products and, Stem Cells.

By Test Type: Endotoxin Tests, Sterility Tests, Cell Line Authentication & Characterization Tests, Bioburden Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests, and Others

By Geography:  North America, South America, Europe, Asia-Pacific, RoW

Key Takeaways

• The MRC Biostatistics Unit (BSU) and the Metabolic Diseases Unit (MDU) received grants of £30 million ($32.47 million) from the United Kingdom Research and Innovation (UKRI) in 2024 to assist with their research for the course of the next five years. Researchers at both institutions are conducting groundbreaking studies to promote public health, and the grant program will last until March 2029. The increasing government investments are anticipated to drive market growth.
• In 2020, the Indian government assisted Pune-based Mylab Discovery Solutions boost up its manufacturing and research of COVID-19 pathodetect diagnostic kit with proactive support from the Department of Biotechnology's National Biopharma Mission. The business introduced the Compact XL Molecular Laboratory Machine, which can produce numerous reagents and execute numerous biological tests in one machine set. Thus, the rising government initiatives and support are also anticipated to drive market growth. In addition, in 2020, a new biological reagent has become accessible to labs in the UK and worldwide, allowing researchers to establish and improve reliable coronavirus detection assays. The rising number of research and development activities in the pharmaceutical, biotechnology, and healthcare industries has led to a growing demand for biological safety testing reagents and kits.
• In September 2023, the United States Agency for International Development (USAID) announced an investment in local South African partners for HIV vaccine R&D, marking progress in localization commitment. In March 2024, the European Commission (EC) approved Pfizer Inc's 20-valent pneumococcal conjugate vaccine, marketed in the European Union under the brand name PREVENAR 20, for active immunization to prevent pneumonia, and acute otitis media caused in infants, children, and adolescents aged 6 weeks to less than 18 years. These new platforms and methods for drug development and vaccine production necessitate tailored safety testing solutions, thereby driving the market growth in the forecast period.

By Product - Segment Analysis

Reagents & Kits dominated the biological safety testing products & services market in 2023. With consumers becoming more aware and conscious of the safety and quality of healthcare products, companies are placing a greater emphasis on quality control measures. This includes the use of reliable biological safety testing reagents and kits to ensure the safety and efficacy of their products. For instance, in 2020, the Indian government assisted Pune-based Mylab Discovery Solutions boost up its manufacturing and research of COVID-19 pathodetect diagnostic kit with proactive support from the Department of Biotechnology's National Biopharma Mission. The business introduced the Compact XL Molecular Laboratory Machine, which can produce numerous reagents and execute numerous biological tests in one machine set. Thus, the rising government initiatives and support are also anticipated to drive market growth. In addition, in 2020, a new biological reagent has become accessible to labs in the UK and worldwide, allowing researchers to establish and improve reliable coronavirus detection assays. The rising number of research and development activities in the pharmaceutical, biotechnology, and healthcare industries has led to a growing demand for biological safety testing reagents and kits.

By Application - Segment Analysis

Vaccine & Therapeutics dominated the biological safety testing products & services market in 2023. The significant growth in the biological safety testing for vaccine & therapeutics applications is attributable to growing immunization programs in developed & developing countries, strong government support in vaccine development, and robust products under clinical trials. For instance, in April 2024, Bavarian Nordic A/S launched the mpox vaccine in the United States which is the first FDA-approved mpox vaccine. According to CDC estimates, two million people in the US are eligible for the pox vaccine. According to the company's announcement, this will significantly increase access to the vaccine by creating new avenues for vaccination procurement, distribution, and reimbursement by both public and commercial payers.

By Test Type - Segment Analysis

Endotoxin Tests dominated the biological safety testing products & services market in 2023. The market for endotoxin tests is anticipated to be driven by factors such as stringent regulatory requirements for product safety, rising incidence of infectious diseases, and technological advancements in testing methodologies. For instance, Lonza revealed the release of the Nebula Multimode Reader in 2022, making it the first certified reader for use with the company's proprietary endotoxin, turbidimetric, and chromogenic detection methodologies. The availability of multiple kinds of endotoxin tests tailored to meet varied needs is projected to promote segment expansion. Endotoxin testing also helps to ensure the security of patients by avoiding the diffusion of pyrogen-contaminated commodities into the market. Producers emphasize the health of patients by developing stringent endotoxin testing techniques, resulting in greater demand for endotoxin testing which in turn anticipated to drive the biological safety testing products and services market.

By Geography - Segment Analysis

North America dominated the biological safety testing products & services market in 2023. North America has a high level of healthcare spending, which supports extensive research and development activities. This investment leads to increased production and testing of biological products, boosting the market. North America, particularly the United States and Canada, has stringent regulations and standards for biological safety testing in the pharmaceutical, biotechnology, and medical device industries. Regulatory bodies such as the FDA (Food and Drug Administration) and Health Canada enforce strict compliance, driving the demand for safety testing services and products. 

The surge in research and development of novel biotherapeutics, like gene therapies and cell-based therapies, necessitates robust safety testing. This is evident in the recent $200 million funding secured by Upstream Bio, a healthcare investment company focused on gene therapy development. The Canadian government actively supports the biopharmaceutical sector through funding programs and research initiatives. A recent example is the $500 million Biomanufacturing and Life Sciences Strategy launched in 2022, which aims to accelerate biomanufacturing capabilities in Canada. This strategy indirectly encourages investment in biological safety testing infrastructure and services.

Drivers – Biological Safety Testing Products & Services Market

• Increasing Number of Government Initiatives and Recommendations

The market for biological safety testing products and services is expected to rise in tandem with the increasing number of government programs supporting biological safety and testing of goods and services. For instance, in 2023, the Centers for Disease Control and Prevention (CDC) created the Extension for Community Healthcare Outcomes (ECHO) Biosafety Program, which aims to address difficulties in clinical and public health laboratories by establishing a community of practice. The ECHO Model encourages peers to routinely interact in a virtual setting where they may share support, guidance, and criticism. The ECHO Biosafety project aims to improve biosafety in clinical and public health laboratories by strengthening the knowledge and abilities of the biosafety conference of the party members to close previously identified biosafety gaps.

Also, several initiatives and forum discussions are being launched by governments worldwide to promote the usage of biological safety testing products. For instance, in August 2022, under the Department of Health Research (DHR) Scheme-Setting up a Nationwide network of Laboratories for Managing Epidemics and Natural Calamities (VRDL), 138 biosafety laboratories were established throughout India. Every biosafety laboratory, including BSL-4 and BSL-3 laboratories, is educated in the operationalization of biosafety laboratories. For example, in 2023, the United States Government Accountability Office (GAO) and the National Science Advisory Board for Biosecurity (NSABB) reviewed U.S. policies related to research involving dual-use research of concern (DURC), enhanced potential pandemic pathogens (ePPPs), the Federal Select Agent Program (FSAP), and broader biosafety and biosecurity issues related to life sciences research.

• Increasing Production of New Biologics Due to High Disease Burden

The growing production capacity of biotechnology and pharmaceutical businesses to produce next-generation biologics is driving the industry and creating a need for highly efficient biological safety testing instruments. For example, Aragen Life Sciences committed $30 million to establish a new biologics production plant in Bangalore, India. The laboratory will be operational by the third quarter of 2024, with the first production suite projected to be operational in the third quarter of 2025.  In March 2033, Sandoz, a Novartis business, signed a Memorandum of Understanding (MoU) to build a new biologics production factory in Lendava, Slovenia, to meet the rising global demand for biosimilar medicines. Sandoz expects to invest at least $400 million in the new factory.

Biologics are transforming modern healthcare. For example, the Elecsys immunoassays which include hepatitis and Chagas disease tests, offer substantial diagnostic advances in early illness diagnosis. AMTAGVI, a new biologic for advanced melanoma, represents the innovative therapies emerging in 2024, is offering targeted treatment options where conventional therapies like PD-1 blocking antibodies have been inadequate.

For example, CASGEVY provides new hope to patients suffering from ß-thalassemia, a blood condition that traditionally required lifelong blood transfusions. Established immune globulin medicines, such as GAMMAGARD LIQUID (human immunoglobulin G) and HYQVIA (human immunoglobulin G + hyaluronidase) represent a significant advancement in the management of this chronic disease. Furthermore, there is an ever-increasing footprint of biologics, both in published journal articles and patent applications as shown in the below figure.

Challenges – Biological Safety Testing Products & Services Market

• Time-Consuming Approval Process

The lengthy approval process prolongs the time it takes for new safety testing products to reach the market. This delay can stifle innovation and slow the introduction of new technologies, which is expected to hinder market growth.

Different countries have varying regulatory standards and approval processes, complicating global market entry and increasing the time and cost of compliance for multinational companies. For instance, biological safety cabinets must comply with standards such as NSF/ANSI 49 in the U.S. or EN 12469 in Europe. To achieve compliance with these criteria, extensive testing is necessary, such as aerosol containment testing, airflow testing, and filter efficiency testing, all of which take time. The time-consuming approval procedure may discourage corporations from exploring new ventures owing to the perceived risk of lengthy and unclear approval deadlines.

Market Landscape

Technology launches and R&D activities are key strategies adopted by players in the Biological Safety Testing Products & Services market. In 2023, the Biological Safety Testing Products & Services market share has been consolidated by the major players accounting for 63.91% of the share. Major players in the biological safety testing products & services are Thermo Fisher Scientific Inc., Lonza, Merck KGaA, Samsung Biologics, Sartorius AG, Agilent Technologies, Inc., Eurofins Scientific, SGS Societe Generale de Surveillance SA, Almac Group, Charles River Laboratories, GenScript, among others.

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