- Endotoxin and pyrogen testing, critical for ensuring the safety of pharmaceutical products, biologics, and medical devices, is becoming an essential component in quality control systems across Asia-Pacific. The market is experiencing rapid growth due to rising biologics production, vaccine development, and regulatory pressures demanding sterility assurance in both commercial and clinical settings
- The escalating demand for Asia-Pacific endotoxin and pyrogen testing is primarily fueled by the expansion of the biopharmaceutical and medical device industries, increasing incidence of chronic diseases, and heightened regulatory standards across emerging economies such as India, China, and Southeast Asia. In addition, the shift towards recombinant therapeutics and biosimilars is driving the need for stringent contamination detection protocols
- China dominated the Asia-Pacific endotoxin and pyrogen testing market with the largest revenue share of 37.4% in 2024, supported by a robust manufacturing base, expanding biotech hubs, and the government’s strong investment in healthcare infrastructure
- India is expected to be the fastest growing country in the Asia-Pacific endotoxin and pyrogen testing market, projected to grow at a CAGR of 24.2% from 2025 to 2032. This rapid growth is supported by the expansion of pharmaceutical manufacturing hubs, increased regulatory scrutiny, and the rising number of clinical trials. Indian companies are heavily investing in LAL testing and are increasingly outsourcing to CROs and CMOs for streamlined testing solutions
- The detection kits and reagents segment dominated the Asia-Pacific endotoxin and pyrogen testing market with a market share of 46.8% in 2024, owing to their high demand across pharmaceutical and biotechnology industries, driven by ease of use, consistent performance, and reliability in endotoxin detection processes
