Biological Safety Testing for Monoclonal Antibodies Market Size to Grow At 13.3% CAGR From 2024 to 2030

Biological Safety Testing for Monoclonal Antibodies Market Size (2024 - 2030)

As per our research Report, the Biological Safety Testing for Monoclonal Antibodies Market is forecasted to be growing at a CAGR of 13.3% from 2024 to 2030.

Monoclonal antibodies are proteins made unnaturally to look like the antibodies our immune system generates. They operate by targeting particular foreign substances named antigens and assisting in their elimination to increase our immune response. Monoclonal antibodies, as opposed to polyclonal antibodies, which may bind to multiple antigens and originate from other immune cells, are on-point duplicates of a single antibody that adheres to a single antigen. They can be used for a multitude of applications, consisting of laboratory testing, tissue and blood matching for transplants, disease diagnosis, and treatment of several health scenarios, such as cancer, organ transplant rejection, inflammatory disorders, infections like COVID-19, osteoporosis, problems with vision, migraines, high cholesterol, and nervous system disorders. Over time, the application of monoclonal antibodies in medical therapy has grown gradually.

Monoclonal antibodies are particularly administered through intravenous infusion, often in infusion centers along with other patients. They may be offered subcutaneously in certain situations, with patients guided to self-administer the injections. Monoclonal antibodies can be used alone as therapy, integrated with other drugs, or engineered to aim multiple antigens simultaneously. They provide benefits such as greater accuracy in treatment, higher effectiveness, and standardized quality throughout production batches. The ability to manufacture monoclonal antibodies in bulk quantities has further widened their potential utilisations. Monoclonal antibodies, lab-manufactured proteins, mimic our natural antibodies and aid in eliminating disease-causing organisms. Like our body's antibodies, they aim for specific substances. In cancer treatment, monoclonal antibodies are utilized for targeted therapy. They interact with particular targets to fight cancer cells. Some also act as immunotherapy, activating the immune system against cancer. For example, rituximab marks CD20 protein on B cells and certain cancer cells, prompting their removal. Other antibodies, like blinatumomab, provide T cells close to cancer cells by binding to CD19 and CD3 proteins. This facilitates T cells to effectively react and combat leukemia cells. Monoclonal antibodies give promising approaches to cancer treatment by leveraging the immune system's abilities. Consequently, the requirement for biological safety testing for these antibodies is directed by their therapeutic potential.

In May 2021, the FDA gave emergency use authorization for Sotrovimab, an investigational monoclonal antibody treatment, to cure mild-to-moderate COVID-19 in adults and pediatric patients (12 years and older, weighing at least 40 kilograms). This authorization is for patients who have tested positive for SARS-CoV-2 and are highly prone to the severity of COVID-19, involving hospitalization or death, particularly those who are 65 years and greater or have specific medical conditions. Sotrovimab targets the spike protein of the virus, targeting to prevent its attachment and invasion into human cells. This authorization is dedicated to the requirement for biological safety testing for monoclonal antibodies.

Heightening CRO outsourcing for biopharmaceutical activities offers a lucrative opportunity in the global biological safety testing for the monoclonal antibodies market. Contract research organizations (CROs) serve as external partners for pharmaceutical and biotechnology companies and academic institutions, providing an extensive range of services including cell and virus bank characterization, genetic stability testing, analytical services for biologics, and more. Outsourcing to CROs has become a famous option as advancements in technology make it tough for companies to handle all testing in-house. CROs can deploy advanced infrastructure and techniques, such as quick mycoplasma tests and robotic systems, affecting cost savings and optimal staffing. The outsourcing of security testing services to CROs offers benefits like lowered costs and commercial sustainability, and as pharmaceutical pipelines expand, the requirement for CROs for biologics safety testing is expected to grow.

The pandemic resulted in disruptions in supply chains and distribution of goods and services, which highly disturbed the supply of essential items like reagents and testing devices for biological security testing for monoclonal antibodies. This factor detrimentally impacted the growth of the world's biological safety testing for the monoclonal antibodies market. However, in reaction to the urgent necessity for effective treatments, there has been a quick improvement of multiple neutralizing monoclonal antibodies (mAbs) particularly designed to aim at the SARS-CoV-2 virus. These elements positively affected the market's growth. Hence, the global biological safety testing for monoclonal antibodies market observed both challenges and opportunities during the tough time of the COVID-19 pandemic.

Key Market Insights: 

  • In 2023, the consumables dominated the market owing to the highest market share. The growth can be attributed to the extensive use of consumables, such as assays, kits, and reagents, for the detection of several contaminants in test samples. Assays, kits, and reagents are pivotal components of biological safety testing, serving objectives such as process validation, quality checks, raw material testing, and final product release. Biopharmaceutical Organisations favor kits due to their convenience, long shelf life, and premeasured elements. The reagents market is enhancing as biosciences and biotechnology observe more applications in the pharmaceutical and healthcare sectors. This widening is propelled by the growing demand for reagents in research and testing across various activities.

  • In 2023, the bioburden tests segment held the largest market share. The growth can be dedicated to the growing demand for proper sterilization, instructed by organizations like the World Health Organization (WHO. Contamination can come from different sources, leading to variations in bioburden levels between product batches. Routine testing is important for quality control, detecting and measuring microbial contamination throughout production. Bioburden testing is a special quality control technique that assesses microbial contamination at different manufacturing stages. Precise testing and quality control are pivotal to minimizing consumer risks, especially in regulated environments.

  • Based on the end-user, the global biological safety testing for monoclonal antibodies market is divided into academic and research institutes, contract development and manufacturing companies, and biotechnology and pharmaceutical companies. In 2023, the pharmaceutical and biotechnology companies segment held the largest market share. The growth can be dedicated to their large involvement in development and production, adherence to regulatory requirements, and in-house testing abilities. These businesses deploy resources in research, production, and commercialization, needing comprehensive safety testing to facilitate quality and efficacy.

  • North America held the biggest share of the global biological safety testing for monoclonal antibodies market in the year 2023. The growing incidence of health situations, such as cancer, organ transplant rejection, inflammatory disorders, COVID-19 infection, osteoporosis, eye concerns, migraines, high cholesterol, and nervous system disorders, the existence of well-established healthcare infrastructure in countries, such as the United States and Canada, and the growing investments in research and development activities are some of the elements influencing the region's growth. Moreover, North America is home to many major market players, including Charles River Laboratories International, Inc., Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Nelson Laboratories, LLC, and Laboratory Corporation. 

Market Segmentation of Biological Safety Testing for Monoclonal Antibodies:

By Products and Services

  • Consumables

  • Instruments

  • Services

By Test Type

  • Bioburden Tests

  • Endotoxin Tests

  • Sterility Tests

  • Others

By End-User

  • Academic and Research Institutes

  • Contract Development and Manufacturing Companies

  • Biotechnology and Pharmaceutical Companies

By Region

  • North America

  • Europe

  • Asia-Pacific

  • South America

  • Middle East & Africa

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