The global pyrogen testing market was valued at USD 1,406.4million in 2023, and it is projected to reach USD 2,284.2 million by 2030, advancing at a CAGR of 7.3% between 2024 and 2030. This can be attributed to the growing pharmaceutical and medical device industries, the rising adoption of pyrogen testing during the production and before the marketing of pharmaceutical drugs and medical devices, and the increasing incidence of chronic and infectious diseases.
Furthermore, over the years, the burden of severe long-term disorders has increased across the globe, which has resulted in significant dependence on advanced medicine that led to the high need for pyrogenic testing. For instance, the World Health Organization has stated that non-contagious ailments kill 41 million people every year, thereby accounting for 71% of all deaths across the world. Therefore, the rising disease burden has resulted in constant development in pharmaceutical drugs and biologics, which positively drives the growth of the market.
Based on test type, the LAL tests category accounted for the largest revenue share, of 30%, in 2023, and it is further expected to maintain its dominance in the future. This is attributed to the increasing need for animal-free detection tests, as well as their high accuracy and consistency during detection. Also, these tests offer several advantages over other methods, such as direct quantification of endotoxin levels without individual variability while minimizing potential sources of error.
On the other hand, the in-vitro tests category is expected to witness the highest CAGR, of 7.6%, over the forecast period. This can be due to the rising initiatives for animal-free tests. The popularity of animal-free pyrogen testing is growing because of its capability to detect pyrogen without injuring living organisms. Moreover, it helps in decreasing the need for experienced laboratory personnel in animal handling and avoiding cruelty toward animals. Additionally, this method is based on a semi-permeable membrane system to produce monoclonal antibodies in concentrations often as high as those found in ascitic fluids.
Furthermore, technological advancements have been observed in in-vitro testing in recent years, one such prominent example is an organ-on-a-chip (OOC), which mimics human organs and their functions. These chips can be used to test how different drugs will interact with an organ, and how that organ’s functions will change as a result.
On the other hand, the demand for rabbit tests is witnessing significant growth. This is ascribed to their advantages such as easy tracking of mental behavioural changes and side effects.
Geographically, the APAC pyrogen testing market is expected to witness the fastest growth. This can be ascribed to the escalating advancement of healthcare infrastructure, the expanding new research activities, the rising prevalence of targeted diseases, and the growing aging population in the region. Additionally, China and India have a larger patient pool that leads to an increase in the production of pharmaceutical drugs and biologics, which, in turn, drives the need for pyrogen testing.
Moreover, the market in Latin America and the Middle East & Africa is projected to grow at a significant rate in the forecast period. This can be due to the surging prevalence of various diseases and the rising number of clinical trials in these regions.
Some of the major market players are Charles River Laboratories International Inc., Merck KGaA, Thermo Fisher Scientific Inc., FUJIFILM Wako Pure Chemical Corporation, WuXi AppTec Co. Ltd., Microcoat Biotechnologie GmbH, Nelson Laboratories LLC, Lonza Group Ltd., Ellab A/S, and GenScript Biotech Corporation.