Global Pyrogen Testing Market - Segmented by Test Type, Application, End User and Geography - Growth, Trends, and Forecast (2018 - 2023)

The pyrogen testing market is expected to register a growth rate of nearly 12.5% during the forecast period, 2018 - 2023. Pyrogen testing refers to the process of determining microbes or their metabolites presence in drugs and intravenous solutions during their manufacture, which is expected to grow steadily primarily driven by increased demand for these products in pharmaceutical and biotechnology industry and rising investments in research and development. The presence of well-developed healthcare infrastructure, well-defined rules and regulations for pharmaceutical manufacturing process should help North America to dominate the market share in the forecast period.

Growing Prevalence of Chronic Diseases

The growing prevalence of chronic diseases is one of the primary factors driving the pyrogen testing market. The pyrogen testing has been found to be highly effective in case of airborne diseases such as chronic obstructive lung diseases and childhood asthma, where it quantitively assess the human-relevant airborne pyrogens. These tests are further highly useful in detecting contamination related to an inflammatory response in cases of chronic kidney disorders. The chronic diseases prevalence is high in developed countries and is growing at a high in emerging markets. Thus, the demand for pyrogen testing with increasing awareness should raise this market in the forecast period.
Other factors driving this market are high investments in research and development in the life science industry, the rise in the number of pharmaceutical and biotechnological companies and rise in the launch of biological products, and surge in new innovative drugs.

Stringent Government Regulations for Pyrogen Testing

The strict regulatory norms in the pharmaceutical industry is one of the primary factors restraining the growth of this market. The regulatory issues are majorly concerned with the differences in the functioning of big pharmaceutical companies and small companies which do not have enough budget and resources, and thus, have issues related to cross contamination, manipulation of genetically modified organisms and corresponding facility design issues particularly for the biologically derived medical products. Thus, the regulatory issues concerned with the manufacturing of drugs and biologics and involvement of pyrogen testing restricts the growth of this market.
Other factors limiting the growth of this market are reimbursement issues and rising pressure in regards to adoption of animal-free testing methods.

US is Expected to have Largest Share in the Market

The United States is expected to dominate the market share with well-established healthcare infrastructure, better regulatory framework, and government support and presence of many large biotechnological and biopharmaceutical firms, such as Roche, Merck, Amgen, and Celegene, among others. These companies have a high focus on new drug and biologics development with continuous support from the government in form of funding from several government bodies and investors, which fuel the growth of this market. Asia Pacific is expected to exhibit the highest growth rate. The healthy CAGR is expected due to rising healthcare expenditure in countries, such as India, China and Japan. This is accompanied by lesser stringency in government regulations for drug development.

Key Developments in the Market

• January 2018 - Bell Biosystems presented the results of their latest pre-clinical safety of intravascularly injected stem cells labeled for MRI tracking using a high dose of Bell's Magnelle(R) brand MRI contrast agent, as per the USP 151 pyrogenicity guidelines


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