Biological Safety Testing Market Size, Share, Industry, Forecast and outlook (2024-2031)

Biological Safety Testing Market is segmented By Product (Reagents and Kits, Instruments, Other Products), By Application (Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy, Other Applications), By Test (Bioburden Tests, Sterility Tests, Endotoxin Tests, Other Tests), By Region (North America, Europe, South America, Asia-Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Biological Safety Testing Market Overview

Biological Safety Testing Market is expected to reach at a CAGR of 5.1% during the forecast period (2024-2031). Biological safety testing refers to the testing procedures that are carried out to ensure non-contamination of biopharmaceuticals and vaccines and to comply with regulations regarding the same. This includes sterility tests, cell line authentication and characterization tests, bioburden tests, endotoxin tests, adventitious agent detection tests, and residual host contamination detection tests.

Biological Safety Testing Market Summary and Scope

Biological Safety Testing Market Dynamics and Trends

The biological safety testing market growth is driven by the rapidly increasing pharmaceutical and biotechnology industries, along with increasing investments, and rising production of new biologics due to the high disease burden.

Rising drug approvals by the U.S. FDA will create huge demand for biological safety testing

The biological safety testing market will foresee robust demand in the future owing to the rising number of drug approvals coupled with numerous drugs in the pipeline by leading biopharmaceutical companies. The Center for Drug Evaluation and Research (CDER) approved more than 50 novel drugs and biologics in 2018. In addition, the number of new products approved in 2018 increased by two-fold than the average number of annual drug approvals. For instance, in 2019, biologics accounted for six of the top-eight drugs in terms of revenue. Humira (adalimumab), which was developed by AbbVie for the treatment of rheumatoid arthritis, psoriasis, Crohn’s, and other autoimmune diseases, led to USD 19 billion sales, as per the Top 15 Best-selling Drugs of 2019 report. Humira was also the fastest-growing biological drug. Thus, with the growing need for pharmaceutical manufacturing companies to avoid disease transmission and maximize drug safety, the adoption of biological safety testing instruments and services will escalate over the coming years.

With the increasing burden of biological hazards, the need for biological safety testing is estimated to boost in the upcoming period significantly. Governmental associations and regulatory bodies have set standards and guidelines for laboratories and manufacturing facilities to ensure minimal contamination. Similarly, biosafety levels have been established for laboratory practices, facilities and equipment, including biological safety cabinets, to limit contamination. The biosafety levels range from one to four, with an increasing degree of specific controls for microbe containment. Hence, with the rising need for biopharmaceutical firms to be cGMP-compliant, the demand for biologics safety testing will significantly expand.

Lack of skilled professional is likely to hinder the market growth

However, lack of skilled professional for conducting biological safety testing procedure and the biological safety process is quite time consuming and complex which is expected to hinder the market growth.

COVID-19 Impact Analysis on Biological Safety Testing Market

With the emergence of COVID-19, most of the pharmaceutical and biotechnology companies began developing new treatments and vaccines against COVID-19. These increasing R&D activities impacted positively on the biological safety testing market studied. For example, in March 2020, Regeneron and Sanofi started the development of their biologic Kevzara to treat patients with COVID-19. Kevzara (Sarilumab), jointly developed by Regeneron and Sanofi, also inhibits the IL-6 pathway. Biological safety testing plays an important role in ensuring the purity of vaccines and other biological products. Thus, with the development of novel treatment for COVID-19, the demand for biological safety testing has also increased.

Biological Safety Testing Market Segmentation Analysis

The reagents and kits segment are expected to hold largest share in this market segment

Reagents are a major component in biological safety testing and are extensively used in research and clinical laboratories. These reagents are antibiotics, attachments & matrix factors, biological buffers, freezing & dissociation reagents, and various reagents. Rapid advancements and modifications in the formulation of reagents and kits are expected to increase their adoption by laboratory technicians, especially in toxicology assessment.

The vaccine and therapeutics segment are expected to hold largest share in this market segment

Vaccine and therapeutics held the largest share. Clearly defined guidelines ensuring the safety of developed vaccines with unaltered therapeutic value and reduced toxicity are among the factors responsible for the largest share held by this segment. Several guidelines and recommendations issued by regulatory authorities, such as the U.S. FDA, about the characterization and qualification of materials used in the production of vaccines for infectious disease indications, are expected to fuel segment growth.

The bioburden testing segment are expected to hold largest share in this market segment

Bioburden Testing Segment is expected to hold the largest share in the test segment of the market over the forecast period. Organizations like the World Health Organization have also released instructions for health managers and health workers on required infrastructures and standard procedures for effective sterilization and decontamination of medical devices. These factors are expected to raise the demand for proper sterilization, which is expected to boost the demand for Bioburden testing as it acts as an efficient tool in the validation of validation and revalidation of sterilization processes, assessment of the efficiency of cleaning processes, routine monitoring of manufacturing processes to ensure safety.

Bioburden testing is an integral part of validation and revalidation of sterilization processes, assessment of the efficiency of cleaning processes, routine monitoring of manufacturing processes, monitoring of raw materials, components, or packaging, and overall environmental monitoring programs—the high adoption rate, to determine bioburden limits in wide-ranging biologics and medical devices. Moreover, the development of new products in the market is expected to accelerate the market studied. For example, in December 2019, the company has launched the BD Kiestra IdentifA system in Europe and Canada, which is used for microbial identification. It has incorporated automated sample processing steps that ensure accuracy and minimal error.

Moreover, there are high bioburden and microbial contamination rates during pharmaceutical and biologics manufacturing, which is expected to drive government and private organizations to improve underlying biological safety practices. Thus, all these practices performed might drive the overall market.

Biological Safety Testing Market Geographical Share

North America region holds the largest market share of global biological safety testing market

North America dominates the Market and is expected to do the same in the forecast period. The United States is expected to contribute majorly to the market growth of this region. Due to the outbreak of COVID-19, the rising R&D activities related to the COVID-19 have impacted positively on the market growth.

The growth of the biological safety testing market in this region can be directly attributed to the growing biotechnology and pharmaceutical industries in the region. The high growth of these industries is further attributable to factors, such as innovative technologies and the presence of favorable government initiatives. Also, the emerging need for validation of drugs and devices process of manufacturing is expected to boost the demand for the market studied. According to the United States Food & Drug Administration (FDA) report, in 2019, the United States had about 4,676 manufacturing sites for drugs. 

Additionally, the advanced healthcare infrastructure and rising R&D spending are expected to increase the revenue size further. According to the data of Pharmaceutical Research and Manufacturers of America (PhRMA), in the United States, about USD 83 billion were spent by the pharmaceutical industry on the R&D. Thus, this is expected to boost the market growth over the forecast period.

Biological Safety Testing Companies and Competitive Landscape

The global biological safety testing market is highly competitive with presence of global companies.  Some of the key players which are contributing to the growth of the market include Avance Biosciences, Cytovance Biologics, Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation, Thermo Fisher Scientific, Toxikon, and WuXi AppTec, Charles River Laboratories among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the market globally. For instance, In December 2020, Redberry introduced a new product ''Red One Automated Bioburden Detection'' that enables instantaneous bioburden detection of microorganisms and has been designed for water and pharmaceutical testing.

Biological Safety Testing Market Key Companies to Watch

Lonza

Overview: Lonza is a leading global provider of integrated healthcare solutions. Lonza Group comprises two segments: Pharma, Biotech & Nutrition segment provides a wide range of services and products from early phase discovery to custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms for the pharma and consumer health and nutrition industries. Specialty Ingredients segment offer custom development and manufacturing of specialty chemicals and composites to support the electronics, aerospace, food and agrochemical industries. Lonza has entered into a definitive agreement with Bain Capital and Cinven to acquire Lonza's Specialty Ingredients business and operations for an enterprise value of $ 4.57 billion.

Product Portfolio: The Company’s portfolio comprised of include Primary & Stem Cells, CellBioServices, Culture Media & Reagents, 3D Culture Products, ADME & Toxicology, Transfection, Cell Analysis, Electrophoresis, Endotoxin Detection.

Key developments: In April 2021, Lonza expanded its product ''PyroTec PRO Automated Robotic Solution'' for endotoxin testing. It is compatible with the company's product PYROGENT-5000 Turbidimetric LAL (Limulus Amebocyte Lysate) Assay, Kinetic-QCL Chromogenic LAL Assay, and the PyroGene rFC Assay.

The global biological safety testing market report would provide an access to an approx. 61 market data table, 54 figures and 180 pages.