Biological Safety Testing Products and Services Market

Executive Summary

The global biological safety testing products and services market was valued at USD 4.77 billion in 2023 and is expected to increase at a compound annual growth rate (CAGR) of 9.22% between 2023 and 2033. The rising prevalence of target diseases, as well as the increased manufacturing of next-generation biologics by various biotechnology and pharmaceutical companies, are expected to enhance the market. For example, in September 2022, Novartis announced a USD 300 million investment in next-generation biotherapeutics, increasing the capability for biologics' early technical expansion.

The increased demand for biologics has resulted in a significant growth in the number of biopharmaceutical companies. The increased competition to develop highly effective medicinal medications on a big scale has allowed manufacturers to concentrate on improving aspects of industrial processes such as cost-effectiveness and productivity. For example, in July 2023, Biocon Biologics, an Indian company, announced the sale of the rheumatoid arthritis medicine Humira, a biosimilar version of AbbVie, in the United States at a cheaper price that would be widely available throughout the region. Several firms are thus implementing superior manufacturing processes that include full biological evaluation at various stages of the production cycle with easy access, thereby boosting market growth.

Biological safety testing services are critical in determining the absence of bacterial contamination and assuring the safety of vaccines and biopharmaceuticals. These services include a variety of assessments, including bioburden, toxicity, and analytical testing. Parameters like as accuracy, linearity, range, and specificity are used to measure the quality of products offered by companies in this industry.

Biological Safety Testing Products and Services Market Dynamics

Growth Drivers

Rising investments in the biopharmaceutical space

The present biological safety testing products and services market trends suggest an enormous potential for market growth during the projected period, as corporations increase their investments in biopharmaceutical production. For example, in June 2023, Upstream Bio, a private healthcare investment firm, raised $200 million in a Series B round, which will most likely be utilized to advance the development of UPB-101, a monoclonal antibody for allergic and inflammatory illnesses, into the clinical trial phase.

Rising government initiatives to promote biopharmaceutical safety

The COVID-19 pandemic necessitated the development of sophisticated vaccines and medications by researchers in order to reduce the severity of the spread, as well as an increased requirement for government institutions to analyze the negative effects of those drugs through clinical studies. For example, the United States Food and pharmacological Administration established the Coronavirus Treatment Acceleration Programme in 2020 to accelerate therapy and pharmacological testing.

Restraint

Regulatory Barriers and Complex Testing Procedures

The demand for improved testing infrastructure for biopharmaceutical goods, particularly cell and gene treatments, is projected to limit market expansion in the biological safety testing products and services market. The biological safety testing products and services market's expansion is hampered by a dearth of skilled professionals with extensive understanding of biopharmaceutical product testing.

Biological Safety Testing Products and Services Market Segmentation

In 2023, the reagents and kits segment had the highest revenue share, accounting for more than 39.9%. Reagents are essential components of biological safety assessment and are thus widely utilized in research and clinical laboratories. These reagents include antibiotics, attachments and matrix factors, biological buffers, freezing and dissociation agents, and miscellaneous agents. Rapid advances and adjustments in the formulation of reagents and kits are predicted to expand their use by laboratory professionals, particularly in toxicity assessments. Furthermore, the growing demand for high-throughput testing has boosted the appeal of reagents and kits. The instruments segment is predicted to develop significantly through 2030, owing to increased demand for instruments in biological safety testing laboratories. Furthermore, the growing regulatory pressure on biopharmaceutical businesses to follow safety rules fuels the market for instruments. They play an important role in biological assays such as toxicology and bioburden tests. Furthermore, the market is seeing an increase in demand for specialist biological safety testing, including genetic testing, cell-based tests, and flow cytometry. These testing methods necessitate the use of specific tools to ensure that the operations are completed precisely and efficiently. The growing use of personalized medicine and targeted medicines adds to the demand for devices designed for specialty testing needs.

The vaccines and medicines segment had the highest revenue share in 2023. This supremacy is due to the establishment of well-defined guidelines that ensure the safety of created vaccinations with unaltered therapeutic value and reduced toxicity. In January 2023, BioNTech SE announced a Memorandum of Understanding with the UK Government to benefit patients by expediting clinical trials for mRNA tailored immunotherapies. This collaboration is expected to focus on three areas: cancer immunotherapies, infectious diseases, and vaccines, thereby strengthening their presence in the UK. As a result, the issuance of various guidelines and recommendations by regulatory authorities, such as the United States Food and Drug Administration, regarding the characterization and qualification of materials used in the production of vaccines for infectious disease indications is expected to drive growth in this segment. The gene therapy market is expected to grow the fastest through 2030 due to the increased danger of contamination with residual DNA. The presence of leftover DNA is seen as a potential risk to the final product due to its high infectivity. Furthermore, mAbs are essential for identifying and characterizing important quality characteristics (CQAs) in biopharmaceuticals. These CQAs are precise features that determine a product's safety, purity, and potency. Monoclonal antibodies are employed in assays to evaluate factors such as product-related contaminants, degradation products, and host cell proteins, ensuring that biopharmaceuticals meet quality requirements. As a result, the demand for monoclonal antibodies (mAbs) in the biological safety testing products and services market is rapidly increasing.

Endotoxin testing led the market in 2023, accounting for a sizable portion of the revenue. This share can be ascribed to the increased use of these tests in a variety of fields, including medicine manufacture and production to lower the hazard of endotoxins. Lonza announced the release of the Nebula Multimode Reader in August 2022, making it the first qualified reader for use with the company's recombinant endotoxin, turbidimetric, and chromogenic detection methodologies. The availability of several types of endotoxin tests, such as the turbidimetric method, gel clot endotoxin testing, and USP chromogenic endotoxin testing, which are tailored to meet varied needs, is expected to enhance segment expansion. Endotoxin testing also helps to ensure patient safety by preventing the release of pyrogen-contaminated products into the market. Manufacturers prioritize patient safety by developing stringent endotoxin testing techniques, resulting in increased demand for these tests. The bioburden tests segment is expected to have profitable expansion during the forecast period.This can be due to the widespread use of these tests to evaluate bioburden limits in a variety of biologics and medical devices. STEMart, a supplier based in the United States, announced in April 2023 the availability of bioburden and sterility testing for medical devices using the ISO 11731 technique. Furthermore, incorporating cutting-edge colorimetric methodologies and computing has resulted in faster findings and more accurate bioburden quantification. Rapid developments in this category are projected to help drive segment growth.

Biological Safety Testing Products and Services Market Competitive Landscape

• Charles River Laboratories

• BSL Bioservice

• Merck KGaA

• Samsung Biologics

• Sartorius AG

• Eurofins Scientific

• SGS Société Générale de Surveillance SA

• Thermo Fisher Scientific Inc.

• BIOMÉRIEUX

• Lonza

Recent Developments

In September 2023, Technical Safety Services, a portfolio company of Levine Leichtman Capital, entered a partnership with Controlled Environment Management, LLC, to enhance its testing capabilities in the pharmaceutical, biotechnology, and healthcare fields.

In August 2023, the World Health Organization and the National Agency of Drug and Food Control, Indonesia, announced their plan to unveil new radioactive pharmaceutical product guidelines in early 2024.

In May 2023, Merck KGaA announced that it would be allocating a significant investment of USD 37.7 million for biosafety testing at its Glasgow and Stirling sites in Scotland, with the goal of strengthening the company's global testing capacity

In January 2023, Charles River Laboratories, Inc. acquired SAMDI Tech, Inc., a company specializing in high-throughput screening (HTS) solutions. This acquisition aims to enhance drug discovery processes by leveraging SAMDI Tech's technologies to expedite the identification of potential drug candidates.

Regional Insights

In 2023, North America dominated the market, accounting for 35.13% of total revenue. This region's high market share can be ascribed to significant biotechnology investments, increased cancer research adoption, and the development of novel biologics, vaccines, and medicines. Furthermore, growing company R&D investments is a crucial driver of growth. Furthermore, the market is being boosted by major market players implementing extensive expansion strategies, which are expected to drive the adoption of advanced technologies by researchers and healthcare professionals, thereby expanding market growth.

The United States had the highest share of the North American market in 2023 and is retaining its dominance due to the presence of a substantial and highly advanced biopharmaceutical industry in the country, as well as a significant focus on research and development. Furthermore, the ongoing presence of several pharmaceutical and biotechnology businesses, as well as academic and research institutions, creates a consistent demand for thorough safety testing, supporting the country's leadership in the field.

Biological Safety Testing Products and Services Market Segmentation

By Product

• Reagents & Kits

• Instruments

• Services

By Application

• Vaccines & Therapeutics

  • Vaccines

  • Monoclonal Antibodies

  • Recombinant Protein

• Blood & Blood-based Products

• Gene Therapy

• Tissue & Tissue-based Products

• Stem Cell

By Test Type

• Endotoxin Tests

• Sterility Tests

• Cell Line Authentication & Characterization Tests

• Bioburden Tests

• Adventitious Agent Detection Tests

• Residual Host Contamination Detection Tests

• Others

By Region

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East & Africa