According to FutureWise analysis the market for bioburden testing in 2023 is US$ 1.39 billion, and is expected to reach US$ 3.96 billion by 2031 at a CAGR of 13.9%.
Bioburden Testing is the study of the microbial count present on the surface of any material or product. The term is used for testing the contamination in pharmaceutical products, food and beverages, medical devices, etc. Bioburden testing is mandatory as per ICH (International Conference on Harmonization) guidelines for the manufacturing and distribution of food and drugs along with medical devices. For FDA (Food and Drug Administration) approval, the bioburden testing as per ICH guidelines must be followed. This is the key factor driving the bioburden testing market. Growth in pharmaceutical products, food, and beverages, and medical devices across the globe are factors contributing to bioburden market growth and are positively influencing the CAGR. The risk of microbial contamination in healthcare products and hence the related safety concerns cannot be ignored. It is the key factor driving the market.
The consumables like culture media and reagents are estimated to contribute as a major part of the market growth across the globe. Culture media and reagents are basic ingredients used for bioburden testing. Any negligence in the safety and sterility conditions of the product creates severe health problems and a huge loss in the market. To avoid such consequences, bioburden testing is the key. The contamination in raw materials is detected by anaerobic count testing. The safety and economic concerns related to raw materials have driven the preference for anaerobic count testing in the market. The rising demand for anaerobic count testing is one of the key elements driving its contribution to the market.
Pharmaceutical and biotechnology companies contribute to a large share of the bioburden testing market worldwide. Pharma companies involve bioburden testing at every step of manufacturing starting from raw materials to finished products. This is the major feature that drives the growth of the market. North America is estimated to hold a large share of the market. The rise in research and development activities and massive investments in these activities play a major role in market growth. The increasing scope for pharma industries in Asia Pacific s one of the dominating factors responsible for the market to grow.