The global biological safety testing market size was USD 4.32 billion in 2022 and is expected to reach USD 12.98 billion in 2032, and register a revenue CAGR of 13% during the forecast period. Growth of Biologics and Biosimilars in the pharmaceutical and Biotechnology sectors is major factor driving market revenue growth. Demand for biologics is also being driven by rising chronic diseases including cancer and autoimmune disorders, which is also creating high demand for biological safety testing. Biological safety testing is an essential step in the medication development process In order to assure the safety and efficacy of biologics and biosimilars before they are put on the market.
Rising need for innovative technology for biological safety testing is another significant driver fueling the market's expansion. Manufacturers are constantly creating innovative technologies to improve the sensitivity and accuracy of biological safety testing, including real-time Polymerase Chain Reaction (PCR), Enzyme Linked Immunosorbent Assay (ELISA), and flow cytometry, among others. In addition to offering accurate results, these technologies also help test-takers save time and money.
Furthermore, revenue growth of the market is expected to be driven by strict regulatory requirements for biological safety testing. Regulatory agencies such the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA) have established strict requirements for biological safety testing to guarantee the safety and effectiveness of biologics and biosimilars. Demand for biological safety testing is being driven by these recommendations, which require use of biological safety testing at every stage of drug development, from research and development to commercialization.
In addition, revenue growth of the market is expected to be driven by rising demand for cell and gene therapies. Emerging as a possible treatment option for a number of illnesses, including cancer and genetic abnormalities, are cell and gene therapies. However, cell and gene therapies must undergo extensive biological safety testing before they can be developed and produced to guarantee their efficacy. Demand for biological safety testing is expected to be driven by rising demand for cell and gene therapies.
However, high price of biological safety testing is a major factors, which could restrain revenue growth of the market. biological safety testing is relatively expensive due to the employment of innovative technologies and strict regulatory requirements. In addition, it is expected that a scarcity of qualified individuals in the field of biological safety testing could hamper revenue growth of the market to some extent.
Government Regulations on Biological Safety Testing:
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Assuring the safety and effectiveness of biopharmaceutical drugs, vaccines, and medical devices requires conducting biological safety testing. Instruments, kits and reagents, and services make up the three product categories that make up the biological safety testing market. While the services segment is anticipated to experience the greatest revenue increase over the projected period, the kits and reagents segment had the largest revenue share in 2021.
The growing need for safety testing of biopharmaceuticals and medical devices is what propels the kits and reagents market. In biological safety testing, the use of kits and reagents enables excellent sensitivity and specificity, quick turnaround times, and economic efficiency. Additionally, a variety of kits and reagents are readily available for a variety of biological safety testing applications, including as Endotoxin Testing, Sterility Testing, and cell-based assays, which is driving this market's expansion.
Due to the growing use of cutting-edge technologies in biological safety testing, including PCR, ELISA, and next-generation sequencing (NGS), the instruments market is also expanding significantly. The creation of cutting-edge devices with high accuracy, sensitivity, and specificity is accelerating the development of this market.
During the projection period, the services segment is anticipated to post the fastest revenue increase. The requirement for specialised knowledge, as well as the increased expense and complexity of internal testing, are driving up demand for outsourcing biological safety testing services. Additionally, by contracting out their biological safety testing needs, biopharmaceutical and medical device businesses may concentrate on their core capabilities and hasten the development and commercialization of their products.
In terms of region, North America dominated the market for biological safety testing in 2021, thanks to the region's high concentration of biopharmaceutical and medical device firms, strict regulatory standards, and well-established healthcare system. However, Asia Pacific is anticipated to experience the greatest revenue growth over the course of the forecast period due to rising biopharmaceutical R&D expenditures, an increase in the outsourcing of biological safety testing services, and supportive government policies.
In conclusion, the market for biological safety testing is expanding significantly due to rising demand for biopharmaceutical and medical device safety testing, widespread use of cutting-edge technologies, and outsourcing of biological safety testing services. The demand for biological safety testing is anticipated to rise as the biopharmaceutical and medical device sectors continue to expand and change, opening up sizable potential for market participants.
Blood and blood products, vaccines and treatments, gene therapy, tissue and tissue products, stem cell products, and other items make up the application-based segments of the market for biological safety testing. Blood and blood products represented a sizeable portion of these segments' income in 2021 as a result of the increased incidence of blood-related illnesses and the demand for secure and dependable blood products. Growth in the market is also being fueled by the implementation of strict rules by regulatory agencies like the FDA and the European Medicines Agency (EMA) to guarantee the safety and efficacy of blood and blood products.
The forecast term is expected to have the fastest revenue CAGR in the vaccines & therapeutics segment. This can be linked to the rising demand for medicines and vaccinations, particularly in the wake of the COVID-19 pandemic, as well as the growing emphasis on creating safe and efficient treatments and vaccines. Additionally, the expansion of this market is being aided by pharmaceutical and Biotechnology firms' growing investments in R&D projects to create novel vaccines and medicines.
Due to the growing use of gene therapy for the treatment of numerous genetic disorders and diseases, the gene therapy market is also anticipated to develop significantly during the forecast period. The need for gene therapy products is also being fueled by the increasing prevalence of hereditary diseases like cancer, sickle cell anemia, and cystic fibrosis. This segment is expanding as a result of the growing emphasis on targeted medicines and personalised medicine.
Due to the rising demand for tissue and tissue products for different applications, including transplantation, Regenerative Medicine, and drug discovery, the market for tissue and tissue products is also anticipated to have considerable increase during the forecast period. The demand for tissue and tissue products is also being driven by an increase in the prevalence of chronic diseases including diabetes and cardiovascular disorders. This market is also expanding as a result of the growing emphasis on creating 3D tissue models for drug discovery and toxicity assessment.
Due to the rising demand for stem cell products across a range of applications, including regenerative medicine, drug discovery, and disease modeling, the stem cell products market is anticipated to expand significantly during the projected period. The market for stem cell products is also being driven by the increasing frequency of chronic diseases like cancer, cardiovascular disease, and neurological disorders. The expansion of this market is also being aided by the rising expenditure made in research & development projects to create new stem cell medicines.
In conclusion, the market for biological safety testing is expanding significantly across all application segments. This growth is being fueled by a number of factors, including the rising incidence of chronic diseases, the rising demand for reliable and safe products, and rising investments in R&D. In the upcoming years, the market is anticipated to experience significant expansion as a result of regulatory authorities implementing strict restrictions and placing an increased emphasis on personalised medicine and targeted medicines.
During the projected period, the market for biological safety testing (BST) is anticipated to rise significantly. Due to the growing demand for biological goods and vaccines as well as the expanding number of pharmaceutical and biotechnology businesses in developing nations like China and India, the Asia Pacific region is anticipated to hold the biggest revenue share in the market.
The government's efforts to support the pharmaceutical sector in China and the expansion of contract research organisations (CROs) are anticipated to fuel demand for BST. By 2023, the nation's pharmaceutical market is anticipated to reach a value of $161 billion, propelled by rising middle-class populations and an increase in demand for novel medications. Due to a vast skill pool and advantageous government legislation, the Indian pharmaceutical industry is also anticipated to expand quickly, which will increase demand for BST.
Due to the existence of prominent pharmaceutical and biotechnology businesses as well as the growing emphasis on drug development and research activities, North America is anticipated to experience a high revenue CAGR during the forecast period. Because there are so many CROs in the area, there should be an increase in demand for BST services. The region's demand for BST is also anticipated to increase due to the adoption of strict requirements by regulatory agencies like the FDA for the licencing of biological products and pharmaceuticals.
During the projection period, Europe is anticipated to see moderate growth. The market for BST is anticipated to be driven by the presence of significant pharmaceutical businesses as well as the rising need for biologics and biosimilars in the area. The market is also anticipated to increase as a result of the region's rising CROs and growing emphasis on personalised medicine.
The global BST market is divided into many test categories, including as tests for endotoxins, sterility, cell line authenticity and characterisation, residual host contamination, and tests for the identification of adventitious agents. Due to the rising need for endotoxin testing in the pharmaceutical and biotechnology sectors, the endotoxin tests segment is anticipated to dominate the market.
In addition, the market is anticipated to develop as a result of rising demand for biologics and biosimilars as well as an increase in the number of biopharmaceutical businesses. The market is also anticipated to expand due to the usage of cutting-edge technologies like PCR, ELISA, and next-generation sequencing for biological safety assessment.
As a result of the rising pharmaceutical and biotechnology sectors as well as the rising demand for biological products, the BST market is anticipated to experience considerable expansion during the forecast period. North America is anticipated to have the quickest revenue CAGR, while the Asia Pacific region is anticipated to hold the highest revenue share in the market. Due to rising demand in the biotechnology and pharmaceutical sectors, the endotoxin testing segment is anticipated to dominate the market.
The global biological safety testing market is expected to experience significant growth over the next few years due to the increasing demand for biologics and biosimilars, which require rigorous safety testing to ensure their efficacy and safety. The market is fairly consolidated, with a few key players accounting for a majority of the market share. Some major companies included in the global biological safety testing market report are:
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