Biological Safety Testing Products and Services Market Size, Share & Trends Analysis Report By Product (Test kits and reagents, Instruments, Services), By Application (Blood and blood-based products, Vaccines and therapeutics, Stem cells), By Test (Endotoxin test, Sterility test, Adventitious agent and virus testing) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Market Overview

The biological safety testing products and services market size was valued at USD 2.93 billion in 2019 and is anticipated to grow with a CAGR of 12.29%.

Biological safety testing is conducted to ensure that biopharmaceutical products such as therapeutics, drugs, blood, and blood-derived products, vaccines, stem cells, and tissue banks are contamination-free. The biological safety testing products include a set of assays using preclinical and clinical vector products. These products must undergo preclinical testing reviewed by the Food and Drug Administration (FDA) to ensure optimum safety.

Market Dynamics

The biological safety products and services market’s most prominent driver is the rising production of new generation biologics by major pharmaceutical and biotechnology companies. Additionally, the manufacturers are channelizing efforts to improve their productivity to sustain in the raging competition. Thus, they are implementing good manufacturing practices (GMP) and employing biological testing at various levels of the production cycle to ensure the utmost safety and efficiency of the products.

Rising Drug Approvals by the U.S. Food and Drug Administration (USFDA)  

The rising number of drug approvals by the USFDA accelerates the market growth. The Center for Drug Evaluation and Research (CDER), in 2018, approved more than 50 novel drugs and biologics. In 2019, the FDA approved ‘Balversa’ (Erdafitinib) tablet for the treatment of metastatic bladder cancer. The FDA also approved the ‘Therascreen FGFR RGQ-PCR Kit,’ used for therapeutic indication. Apart from this, the growing focus of pharmaceutical manufacturing companies to avoid transmission and maximize drug safety drives the adoption of biological safety testing instruments.

Globally, the incidences of biological hazards are increasing at a concerning rate, which is further surging the need for biological safety testing kits. The governments have imposed stringent regulations on the pharmaceutical sector to control the incidences of microbial contamination.  The FDA has also announced several regulatory standards and guidelines, which include establishing a strong quality management system, obtaining appropriate quality raw materials, establishing robust operating procedures, and maintaining reliable testing laboratory. Similarly, bio-safety levels have been established to address the issue of contamination, which ranges from level one to four with a high focus on the control of specific microbe containment.

Regional Analysis

North America’s Robust Healthcare Infrastructure and Favorable Government Regulations

North America’s biological safety testing products and services market is backed by the presence of the U.S., which is bolstered by the rapidly expanding pharmaceutical sector. Additionally, favorable government regulations, robust healthcare infrastructure, increasing R&D spending, and the development of innovative technologies drive regional market growth. The first automated biological safety procedure was conducted in the U.S., which offered high accuracy with minimum human interference. The country is also witnessing rapid growth in the number of biosafety laboratories, further driving the market growth.

China: Hotspot for Outsourcing Pharmaceutical Drug Development and Manufacturing 

China’s biological safety testing products and services market was valued at USD 90.3 million in 2019.  The country is a hotspot in terms of outsourcing pharmaceutical drug development and manufacturing at lower costs. Several pharmaceutical and biotechnology companies outsource core functions such as manufacturing test kits, clinical trials, and drug discovery to the CROs. Thus, the contract development and research organizations (CROs) in the country are driving the demand for biological safety testing products and services.

Segmental Analysis

Test Kits and Reagent Segment to Hold the Largest Market Share

Based on the product, the market is segmented into test kits and reagents, services, and instruments. The test kits and reagents segment is expected to hold the largest market share during the forecast period. Reagents are extensively used in biological safety and testing, R&D activities, and clinical laboratories. The various types of reagents include freezing & dissociation reagents, and miscellaneous reagents.

COVID-19 Outbreak to Drive the Demand for Vaccines and Therapeutics 

By application, the vaccines and therapeutics segment is projected to witness lucrative growth during the forecast period. Growing disease burden and increasing R&D activities for the development of new vaccines and therapies contribute to the segment growth. Several guidelines and recommendations have been issued by the regulatory authorities such as the USFDA about the selection of raw materials for the production of vaccines, further driving the segment growth.

The COVID-19 outbreak is rising the need for vaccines across the globe. As of July 2019, the Association of British Pharmaceutical Industry (ABPI) announced that there are more than 260 vaccines in the pipeline for the treatment and prevention of various infectious diseases. Several research institutes are providing affordable third part services for maintaining the quality and efficiency of drug manufacturing.

Growing Number of Animal and Microbe-Derived Biologics to Provide an Impetus to the Adventitious Agent and Virus Testing Segment

By test, the adventitious agent and virus testing segment are gaining traction in the biological safety testing products and services market. The segment’s most prominent driver is the rising number of service providers in the field of adventitious agent and virus testing. Adventitious agent detection testing is required during cell culture to avoid contamination by viruses, endotoxins, and mycoplasma. The burgeoning number of animal and microbe-derived biologics necessitates the use of adventitious agents and virus testing, further driving the segment growth. 

Impact of covid-19

The COVID-19 has severely impacted the world, with the death toll rising at a concerning rate every day. As per the Center for Disease Control and Prevention (CDC), new laboratory tests have been introduced to identify the COVID-19 specimens, which is further accelerating market growth. The state and local public health departments are actively working to collect the specimens, which is further driving the demand for biological safety testing kits. The World Health Organization (WHO) recommended the use of new point-of-care immunodiagnostic tests in the research settings. 

The Indian Council of Medical Research (ICMR) enabled subsidized tests due to National Public Health Emergency. The market players are supplying their diagnostic test kits to the private labs to make test operations feasible. The ICMR instructed the laboratories to undertake appropriate biosafety and biosecurity precautions while collecting samples. For biological safety testing, ICMR has urged the laboratories and hospitals to create a separate disease-specific sample collection site.