microbiology cro services Market

The microbiology CRO services market size is expected to grow from US$ 11.51 billion by 2031 from US$ 5.52 billion in 2023. The market is expected to register a CAGR of 9.6% during 2023–2031. 

According to the World Health Organization (WHO), the clinical pipeline of antibacterial agents saw an increase from 80 in 2021 to 97 in 2023. There is a growing need for new, innovative agents to treat serious infections as well as replace those that are becoming ineffective due to widespread use. The research and development of antibiotics and bacterial vaccines require various microbiological tests during their preclinical and clinical studies. Various CROs such as Pacific Biolabs, SSI, and Charles River Laboratories offer screening tests for bacterial organisms, LAL, and bacterial endotoxins testing clinical and preclinical drug testing. 

Antimicrobial effectiveness, bioburden testing, disinfectant efficacy testing, sterility testing, parasite testing, growth promotion testing, antimicrobial susceptibility testing, microbial identification, and toxicological testing are a few of the crucial microbial testing methods required for clinical and preclinical drug development studies. These methods are recommended by regulatory bodies such as the Food and Drug Association (FDA) and the European Medicines Agency (EMA) for the detection and quantification of microbial contamination, medical device sterilization, and preclinical studies. Bioburden testing, or total viable count testing, measures microbial contamination levels in a product. It can come from raw materials, the workforce, or the manufacturing environment. Due to multiple sources of contamination, regular testing is advisable. STERIS is one of the leading bioburden testing services for medical devices, pharmaceuticals, animal tissue, and cosmetics. Pharmaceutical companies can improve drug development by outsourcing toxicological testing to CROs. CROs have the expertise and resources to efficiently conduct studies, allowing developers to focus on other aspects. Notable CROs offering toxicological services include Altasciences and AmplifyBio. 

Surging Research and Development Investments Propels Microbiology CRO Services

Research is a significant and essential part of the pharmaceutical, biopharmaceutical, and medical device industries, among others, which enables them to develop new solutions for various therapeutic applications with significant medical and commercial potential. The pharmaceutical industry is one of the most research and development-intensive industries in the world. Efforts are being made to achieve greater effectiveness and efficiency in fulfilling patients' needs. The cost of medicines has been a prime concern for pharmaceutical companies as they bank on their research and development activities to achieve intended cost targets. Over the last decade, the number of new drugs approved yearly has also increased. The Food and Drug Administration (FDA) approved 37 new drugs annually in 2022. Globally, the US is a leading country in terms of research and development investments, and the country produced over 50% of the world's new molecules in the past decade. As per the European Federation of Pharmaceutical Industries and Associations (EFPIA), in 2021, North America accounted for 49.1% of global pharmaceutical sales. The US accounted for 64.4% of sales of new medicines launched during 2016–2021.

End User-Based Insights

The demand for specialized expertise in niche therapeutic areas such as oncology, rare diseases, immunology, and personalized medicine is growing. Pharmaceutical and biotechnology companies seek CROs showcasing knowledge and experience in specific areas to support their research and development efforts. These companies have started to prefer small to medium-sized CROs for their clinical development requirements as they are beginning to adopt a more agile and innovative business model. By outsourcing research activities, companies can save time and costs by not investing in research infrastructure and workforce.

In a few cases, CROs may even take the lead in innovation by establishing early chemistry and biology entry points into diseases and then seek collaboration with pharmaceutical companies. In September 2023, Cerba HealthCare acquired CIRION BioPharma Research to enhance its bioanalytical capabilities for clinical trials. This strengthened the company's expertise in Pharmacokinetic/Pharmacodynamic (PKPD) and Immunogenicity testing and expanded its presence in North America.

The European Center for Disease Prevention and Control, Association of the British Pharmaceutical Industry, Food and Drug Administration, and Association of the British Pharmaceutical Industry are among the primary and secondary sources referred to while preparing the Microbiology CRO Services market report.