Biological Safety Testing Market Size, Share, and Trends 2024 to 2034

Biological Safety Testing Market Size and Forecast 2024 to 2033

The global biological safety testing market size was USD 4.27 billion in 2023, calculated at USD 4.85 billion in 2024 and is expected to reach around USD 15.31 billion by 2033. The market is expanding at a solid CAGR of 13.62% over the forecast period 2024 to 2033.

Biological Safety Testing Market Key Takeaways

• The North America biological safety testing market size reached USD 1.79 billion in 2023 and is expected to attain around USD 6.52 billion by 2033, poised to grow at a CAGR of 13.75% between 2024 and 2033.
• North America dominated the biological safety testing market with the largest revenue share of with the largest revenue share of 42%in 2023.
• Europe is projected to expand notably in the market during the forecast period.
• By product, the reagents & kits segment accounted for the dominating share of the market in 2023 and is expected to continue its dominance over the forecast period.
• By product, the instruments segment is expected to witness considerable growth in the global market over the forecast period.
• By test, the endotoxin tests segment dominated the market in 2023.
• By test, the bioburden tests segment is expected to grow notably in the market during the forecast period.
• By application, the vaccines & therapeutics segment held the largest revenue share of 36% in 2023.
• By application, the cellular & gene therapy segment is expected to grow significantly in the market during the forecast period.

U.S. Biological Safety Testing Market Size and Growth 2024 to 2033

The U.S. biological safety testing market size was exhibited at USD 1.35 billion in 2023 and is projected to be worth around USD 4.92 billion by 2033, poised to grow at a CAGR of 13.78% from 2024 to 2033.

North America held the dominant share of the biological safety testing marketin 2023. The region is observed to witness prolific growth during the forecast period owing to the presence of well-established healthcare infrastructure, robust growth of the pharmaceutical and biotechnology sector, increasing production of new biologics, rising investment in R&D activities by key market players, increasing healthcare spending, rapid adoption of innovative technologies, and supportive government framework. The United States is anticipated to contribute significantly to the growth of the region's market.

Moreover, enforcement of stringent safety standards by the United States FDA and other regulatory bodies necessitates extensive safety assessments, bolstering the market’s growth in the region. Furthermore, the rise in chronic incidences such as cancer, rheumatoid arthritis, diabetes, and others led to a rising demand for biologics products such as monoclonal antibodies, vaccines, and cell treatments, which in turn increases the need for rigorous safety testing. Such factors are propelling the region’s market revenue.

• According to the CDC data published in May 2024, every year in the United States, 1.7 million people are diagnosed with cancer, and more than 600,000 die from it, making it the second leading cause of death. The cost of cancer care continues to rise and is expected to reach more than USD 240 billion by 2030. In addition, more than 38 million Americans have diabetes, and another 98 million adults in the United States have prediabetes, which puts them at risk for type 2 diabetes. Diabetes can cause serious complications, including heart disease, kidney failure, and blindness.
• In November 2022, MilliporeSigma announced that its Life Science business sector is investing more than USD 286 million in its biosafety testing capacity at the company's site in Rockville, Maryland, U.S. This will significantly increase the company's ability to conduct biosafety testing and analytical development services. Biosafety testing and analytical development are critical and fundamental requirements of the drug development and commercialization process to ensure the safety of medicines.
• In June 2024, The Department of Agriculture (DA) signed an agreement with the Department of Health (DOH), allowing its attached agency, the Bureau of Animal Industry (BAI), to assist the Food and Drug Administration (FDA) in testing animal vaccines and drugs. The DA stated that a memorandum of agreement had been signed by the four agencies. Under the agreement, the BAI is tasked to conduct evaluations to determine the safety and efficacy of both local and imported vaccines and biologics, endorse private applications to the FDA for the issuance of a certificate of product registration to local and imported veterinary products, and provide the FDA with evaluation reports.

Europe is observed to expand notably during the forecast period. The region’s growth is attributed to the increasing healthcare expenses, increasing government funding for R&D activities, growing focus on the vaccine and therapeutics development by the key market players, presence of developed healthcare along with R&D infrastructure, and increasing burden of chronic diseases. The rapid growth of the biopharmaceutical sector considerably increases the demand for comprehensive safety testing services to ensure the safety of biological products.

Additionally, the presence of regulatory agencies such as the European Medicines Agency (EMA) imposes strict guidelines for biologics safety testing to verify the efficacy, dependability, and safety of biological products. Technological innovation improves the testing procedures for biologics safety testing and accelerates the market’s growth in European countries.

• In March 2023, Clean Cells, part of the Clean Biologics group, a provider of biopharmaceutical product quality control services and manufacturer of starting materials, announced the launch of analytical activities at its new facility based in Montaigu-Vendée. With an investment of €22 million, €5.5 million of which is for new equipment, the site offers four times more laboratory space than the previous building. Covering a total of 5,300 square meters, including 2,800 square meters of laboratories, it is the largest biopharmaceutical testing site in Europe.

Market Overview

The biological safety testing market deals with testing and ensures the utmost safety of biological products, including vaccines, medical devices, therapeutics, and others. Biologics are widely used for treating several chronic diseases, and they are large and complex molecules. Biological safety testing carries out a series of various tests, including endotoxins tests, sterility tests, cell line authentication and characterization tests, residual host contamination detection tests, bioburden tests, and others. Biological safety testing assists in assuring their safety, purity, and efficacy. Several regulatory bodies, such as the FDA and EMA, have laid down stringent guidelines for the testing of biologics safety. Biological safety testing refers to the testing procedures to ensure the safety of biopharmaceuticals and vaccines by confirming that they are free from contamination and meeting regulatory requirements.

• In November 2023, MilliporeSigma, Merck KGaA’s life, a leading science and technology company, opened the second phase of its new €29 million Biologics Testing Center in China, adding 1,500 square meters to the lab opened in 2022. These are the first biosafety laboratories for the company in this market, allowing clients to locally access a broad range of testing services for cell line characterization and lot release from pre-clinical development to commercialization.

Biological Safety Testing Market Growth Factors

• The rising R&D investment by pharmaceutical and biotechnology companies is anticipated to fuel the biological safety testing market expansion during the forecast period.
• The growth of the market is primarily driven by the increasing development of mAbs and biosimilars, as well as a rising focus on the development of next-generation therapeutics.
• The rising government funding for new biologics development is expected to fuel the biological safety testing market growth revenue in the coming years. 
• Rapid technological advancements in biologics safety testing methods are expected to contribute to the growth of the biological safety testing market during the forecast period.
• There is an increasing need for safe and reliable testing methods in the healthcare sector, which is projected to create significant growth opportunities for the biological safety testing market.

Biological Safety Testing Market Scope

Biological Safety Testing Market Dynamics

Driver

The rapid growth of the pharmaceutical and biotechnology sector

The rapid expansion of the pharmaceutical and biotechnology sector is expected to drive the market’s growth during the forecast period. With the innovations surge in the pharmaceutical and biotechnological sector necessitating rigorous safety testing and stringent safety standards. Renowned regulatory bodies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) have laid down stringent safety guidelines that mandate comprehensive biological safety assessments for contaminants, efficacy, and safety before any drug reaches the patient. Therefore, the expansion of pharmaceutical and biotechnology is fueled by rising investments in R&D activities, and these industries are developing pharmaceuticals, biologic drugs, and therapies for treating chronic diseases, driving the market’s growth.

• In April 2024, the U.S. Food and Drug Administration (FDA) draft two guidances on safety testing for cell and gene therapy products. The U.S. FDA Center for Biologics Evaluation and Research (CBER) issued two draft guidances related to cell and gene therapy testing; one addresses safety testing products derived from human allogeneic cells expanded for use in cell-based products, and the other addresses testing animal- and human-derived materials in the manufacturing of cell and gene therapy and tissue engineered medical products (TEMP). Thus, the draft guidance provides recommendations to help sponsors of allogeneic cell-based medical products determine what cell safety testing is appropriate to support an investigational new drug application (IND) or a biologics license application (BLA).

Restraint

High cost

The high cost associated with biologics safety testing is anticipated to hamper the market's growth. High capital is required for safety testing for the development of drugs. In addition, the lack of well-developed healthcare in middle-lower income countries, rising ethical concerns related to animal testing, and the time-consuming approval process are some of the factors that may restrict the expansion of the global ‘biological safety testing market.

Opportunities

Increasing prevalence of chronic disorders

The rising incidence of chronic disorders is expected to boost the growth of the biological safety testing market during the forecast period. The market has witnessed the rising production of new biologics due to the high burden of chronic diseases such as cancer, rheumatoid arthritis, diabetes, and other inflammatory diseases. The demand for biologics, such as vaccines, monoclonal antibodies, gene therapies, recombinant proteins, and cell-based therapies, is escalating, which drives the demand for comprehensive testing to verify their safety for human use. As a result, the increasing prevalence of chronic disorders is accelerating the growth of the market during the forecast period.

• According to the CDC, 6 in 10 adults in the U.S. have a chronic disease, and 4 in 10 adults have two or more.
• Arthritis affects 53.2 million adults in the United States, which is about 1 in 5 adults.7 It is a leading cause of work disability in the United States, one of the most common chronic conditions, and a leading cause of chronic pain. Arthritis costs appear to be increasing and were estimated at over USD 600 billion in 2019.

Product Insights

The reagents & kits segment accounted for the dominating share of the biological safety testing market in 2023 and is expected to continue its dominance over the forecast period. The rising improvements and modifications in the formulation of reagents and kits are anticipated to increase their acceptance by professional laboratory technicians, particularly in toxicology assessment. Moreover, the growing demand for high-throughput testing has accelerated the growth of the reagents and kits segment.

The instruments segment is expected to witness considerable growth in the global biological safety testing market over the forecast period. The segment’s growth is majorly driven by the increasing demand for instruments in biological safety testing laboratories. In addition, the enforcement of strict safety standards has compelled biopharmaceutical companies to comply with safety guidelines, which has spurred the demand for instruments.

Test Insights

The endotoxin tests segment dominated the biological safety testing market in 2023. Endotoxin testing is extensively used in monoclonal antibody testing, recombinant protein drugs, cell therapy, and pharmaceutical development. Endotoxin testing is a vital safety requirement for pharmaceutical and biomedical products. Bacterial endotoxins, such as gram-negative, can lead to very serious health complications if they are introduced into the human body.

During the manufacturing of pharmaceuticals, it is critical to test products for the presence of endotoxins. Testing, detection, and removal of endotoxins is a necessary quality control step to ensure that safe pharmaceuticals are given to patients. Additionally, regulatory bodies around the world enforce rigorous endotoxin testing protocols to ensure patient safety, thereby bolstering the segment’s growth.

The bioburden tests segment is expected to grow notably in the biological safety testing market during the forecast period.  Bioburden testing or microbial testing plays an integral part in the quality control process. It is conducted to quantify microbial contamination in water systems, raw materials, and finished products. This test is performed as routine testing to ensure safety, quality, and regulatory compliance during pharmaceutical and biologics manufacturing. Bioburden testing also assists in keeping medical equipment safe for use by eradicating harmful microbes during the sterilization process. Bioburden Testing is widely used for quality control of pharmaceutical manufacturing water, process water testing (water for injection), raw material testing, medical devices, and others.

• In April 2023, STEMart announced the launch of bioburden and sterility testing for medical devices under the guidance of the ISO 11731 method. For medical device manufacturers, sterility assurance is a crucial part of producing safe products. The FDA and other regulatory agencies require validation of sterilization processes, so bioburden and sterility testing are often necessary. In addition, both tests are performed to check for microorganisms, while the latter has a deeper and broader significance.

Application Insights

The vaccines & therapeutics segment held the largest share of the biological safety testing market in 2023 and is expected to sustain the position throughout the forecast period. The growth of the segment is attributed to the rising development of vaccines and therapeutics by major biopharmaceutical and pharmaceutical companies due to the rising burden of chronic diseases. The testing and trials of vaccines are crucial for safety checks. The demand for biological safety testing has significantly increased in vaccine development due to the rising need for safe and effective vaccines such as the COVID-19 vaccine, mRNA vaccines, and others.  Regulatory bodies mandate comprehensive safety assessments to ensure that the vaccines are effective, free from contaminants, and overall safe for human use.

The cellular & gene therapy segment is expected to grow significantly in the biological safety testing market during the forecast period. Gene and cell therapy has made remarkable progress in the treatment of various diseases, such as cancer, genetic disorders, autoimmune, and others. Cellular and gene therapy requires safety testing for product safety and process understanding before patient use. Thereby fuelling the expansion of the segment.

Biological Safety Testing Market Companies

• Cytovance Biologics
• Biomerieux SA
• Promega Corporation
• Thermo Fisher Scientific
• WuXi AppTec
• Nelson Laboratories, LLC
• Almac Group
• GenScript
• InvivoGen
• Toxikon
• Maravai LifeSciences
• Merck KGaA
• Thermo Fisher Scientific Inc.
• Charles River Laboratories International, Inc.
• Lonza Group AG
• SGS SA
• WuXi AppTec
• Eurofins Scientific SE
• Cytiva
• Sartorius AG
• Charles River Laboratories
• F. Hoffmann-La Roche

Recent Developments

• In March 2022, the U.S. Food and Drug Administration approval processes comprise numerous steps to ensure the safety and efficacy of new drugs, therapies, and treatments. Navigating the process can be complex and time-consuming, and as a result, the FDA is proactively looking for methods to accelerate the pace of approval.
• In March 2023, Oxford Nanopore Technologies plc and PathoQuest announced the agreement of an MOU for a collaboration to commercialize a transformational Integration Site Analysis (ISA) test to better meet the evolving needs of the biopharmaceutical industry and the advancement of biological therapeutics.
• In February 2024, Eurofins CDMO Alphora announced the completion of a new pilot-scale biologics development facility. The facility uses mammalian cell culture for the production of therapeutic proteins and mAbs, as well as other feedstocks, including transgenic plants, transgenic milk, and plasma.

Segments Covered in the Report

By Product

• Reagents & Kits
• Instruments
• Other Products

By Application

• Vaccines & Therapeutics
• Cellular & Gene Therapy
• Blood & Blood-Based Therapy
• Other Applications

By Test

• Sterility Tests
• Bioburden Tests
• Endotoxin Tests
• Other Tests

By Geography

• North America
• Asia Pacific
• Europe
• Latin America
• Middle East & Africa