Biologics Safety Testing Market Trends, Industry & Size 2031

Report Description

The Global Biologics Safety Testing Market size was valued at USD 3.83 Billion in 2022 and is expected to surpass USD 11.06 Billion by 2031, expanding at a CAGR of 12.5% during the forecast period, 2023 – 2031. The market growth is attributed to the rising demand for safety testing procedures in the biotechnology and pharmaceutical industries.

Biologics safety testing is performed to declare contamination-free biopharmaceutical products such as vaccines and drugs. Biologics are complex molecules derived from a living organism. Complex molecules produced from genes by using advanced DNA technologies are identified as biologics. Biology safety testing is essential for new product launching categories.

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Biologics are used in the treatment of cancer, rheumatoid arthritis, cardiovascular disease, and others. Biologics includes several molecules with recombinant proteins and monoclonal antibodies, and the safety of these molecules ensures patient well-being. Biology safety testing is conducted to control the level of safety. Drugs and vaccines are tested on two or more species in the laboratory, such as mice, rabbits, rats, dogs, or chickens.

Biologic products are manufactured from living organisms and have the desired characteristics. Biologics include recombinant proteins, allergens, tissues, blood components, cells, vaccines, and genes. Biologic safety testing is important for new product launching and agreed to confirm the non-contamination of vaccines and biopharmaceuticals & safety quality norms.

Dangerous and unapproved biologics can cause immense damage to the human population as drugs resulting from them can make new irregularities for patients, and add complications to their health conditions. Thus, government authorities in several countries are carefully controlled these manufacturing processes, which include product testing, efficacy evaluation, and drug development.

COVID-19 Impact on Biologics Safety Testing Market

The COVID-19 pandemic has spread to numerous countries around the world. The transportation and manufacturing industries have to bear huge financial losses. However, the biologics safety testing market has taken part in an important role in several vaccines and drug testing during the pandemic.

Biologics safety testing has vital importance in quality assurance, as vaccine manufacturing is anticipated to rise due to the rising number of COVID-19 cases. The COVID-19 research and drug development increase the adoption of endotoxin testing.

Biologics Safety Testing Market Dynamics

The research report presents a complete overview by providing detailed information about the current market trends, existing drivers, growth opportunities and potentials, and emerging challenges. The biologics safety testing market report has up-to-date insights about market dynamics and market scenarios that can shape the overall market performance and output during the forecast period, 2022 to 2030.

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Key Drivers: Strict government regulations for bioburden testing

World Health Organization (WHO) has released instructions for healthcare workers and health service managers on mandatory infrastructures and standard procedures for effective sterilization, and decontamination of medical devices.

Bioburden testing is a quality control procedure used to quantify microbial contamination in raw materials, water, or finished products. This procedure is conducted during production to ensure the safety of a manufactured product. Thus, the strict government regulations for bioburden testing are anticipated to drive market growth.

Key Drivers:  Development in the biologics and biosimilars market

Several companies are investing heavily in the development of biosimilars and the biologics testing safety market. The development in the biologics and biosimilars market is anticipated to propel the market expansion during the forecast period. According to the food and drug administration (FDA), the number of new biologics accepted in the US increased from 22 in 2016 to 48 in 2019. Biologics are projected to constitute half of the revenue generated by the top 100 pharmaceutical products.

Current Restraints: Lack of skilled professionals

The Biologics safety testing market is continuously growing with advancements in technology and the development of improved safety testing programs across several industries. Moreover, the progress in the biologics safety testing market depends upon the optimum conditions under which the test is performed and on the expertise of the analysts.

A lack of skilled professionals is expected to hinder market growth. Skilled workers are required to accept the changes in safety testing methodologies and analytical technology. These workers need to understand the efficacy, usability, and safety of equipment including spectrophotometers, PCR and fully automated mycoplasma detection systems.

Market Opportunities: Emerging biologics market in the Asia Pacific offers new opportunities

The life science industry has lucrative opportunities in several countries from the Asia Pacific. For instance, India is taking substantial initiatives to promote public-private partnerships in biopharmaceutical R&D projects. These initiatives are expected to establish India as the world’s prominent biopharmaceutical innovation hub. Emerging markets offers room for innovation. Major companies including biotechnology and biopharmaceutical invest in research to develop advanced molecules.

Scope of Biologics Safety Testing Market Report

The global biologics safety testing market research report includes an assessment of the market trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Biologics Safety Testing Market Segment Insights

Monoclonal antibodies segment to expand at a significant growth rate

Based on application, the market is divided into tissue and tissue-related product testing, stem cell research, blood products testing, cellular & gene therapy, and vaccine development. The monoclonal antibodies segment is expected to expand at a significant growth rate during the projected period, owing to the increasing prevalence of cardiovascular diseases. The rising government initiatives for the development of monoclonal antibody medicine.

The vaccine development segment is anticipated to hold a key share of the market in the coming years, due to rising investments by major companies in research and development. Vaccine development is conducted by government authorities to prevent mortality and morbidity from serious infections.

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Sterility tests segment to register a considerable CAGR

On the basis of test type, the global biologics safety testing market is segregated into bioburden tests, cell line authentication, residual host contaminant detection tests, adventitious agent detection tests, endotoxin tests, sterility tests, cell line authentication and characterization tests, and others.

The sterility tests segment is projected to register a considerable CAGR during the forecast period, owing to the rising number of government initiatives and recommendations. Sterility testing is performed to demonstrate the presence or absence of microorganisms in biologics or drugs parenteral designed for human use.

The cell line authentication segment is expected to hold a significant share of the market. Cell line authentication is the procedure of verifying the identity of the cells used in laboratory experiments. This procedure is widely used to confirm cell lines derived from the correct species and donor. The important test for authenticating cell lines is short tandem repeat profiling.

Kits & reagents segment to hold a significant market share

Based on product, the market is divided into services, instruments, and kits & reagents. The kits & reagents segment is expected to hold a significant share of the market in the coming years, due to the rising product demand from various pharmaceutical industries or research laboratories. The increasing adoption of kits & reagents in comparison to laboratory instruments is expected to boost the segment growth.

The services segment accounts for a significant market share, due to the increasing drugs pipeline, inadequate finances of biopharmaceutical manufacturers, capacity constraints, and complex manufacturing processes. Moreover, the need for high investments to establish manufacturing facilities is boosting the outsourcing of biologics safety testing to service providers.

North America dominates the market

In terms of regions, the market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market during the forecast period, owing to increasing demand for high-quality research tools for data reproducibility and increasing government and academic investments.

The rising adoption of cancer research and high investments in biotechnology by companies and government authorities is projected to drive market expansion in the region. Moreover, the rising prevalence of chronic diseases in this region is projected to surge the usage of advanced technologies by healthcare professionals and researchers.

The market in the Asia Pacific is anticipated to expand at a rapid pace during the forecast period. The rising awareness about the benefits of these products is expected to drive market growth in the region. Asia Pacific Biosafety Association trains specialists on biosafety principles and practices across the region, consequently widening growth prospects in the Asia Pacific. Furthermore, the increasing healthcare spending is projected to boost market expansion in the coming years.

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