A lack of standardised testing methods and subsequent delayed product approvals is limiting growth of the pyrogen testing market, according to a report.
A report by Allied Market Research has predicted that the global pyrogen testing market will value $3.3 billion by 2032.
The market is predicted to grow at a CAGR of 8.2 percent from 2023 to 2032, according to the research.
Drivers of the pyrogen testing market
Increased R&D activities within the pharmaceutical and biopharmaceutical sector and a focus on biologics, were reported to hold significant growth opportunities for the pyrogen testing market.
A higher incidence of infectious diseases is a major contributing factor for the expansion of the pyrogen testing market. This has heightened demand for pyrogen testing methods, the report observed.
The instruments segment within the pyrogen testing market is expected to register the highest CAGR during the forecast period, the report explained. This is due to the sector’s requirement for “efficiency, precision, and scalability in testing processes.” For example, advanced instruments facilitate faster turnaround, increase reliability of test results and also offer benefit in terms of reducing human error, the authors shared.
Several products have launched in the pyrogen testing market in recent years. For example, in 2023, Lonza Group launched several new solutions for endotoxin and pyrogen testing, the report highlighted.
Considering technology advancements, an “increasing focus on enhancing the sensitivity and relevance of pyrogen testing”, is also a contributing factor to the growth of the market during the forecast period, the authors stated.
In the report, LAL tests were highlighted preferred method for pyrogen testing in the pharmaceutical and biotechnology industries. This was attributed to their “highly sensitive and specific” testing capabilities.
Additionally, the authors highlighted that a greater number of pharmaceutical and biotechnology contract manufacturing organisations (CMOs) has broadened the opportunities for providers of pyrogen testing services.
Market challenges
a lack of standardised testing methods means that fully meeting regulatory compliance requirements is challenging… this impedes growth of the [pyrogen testing] market because of the resulting delay in product approvals”
According to the report, a lack of standardised testing methods means that fully meeting regulatory compliance requirements is challenging. In turn, this impedes growth of the market because of the resulting delay in product approvals. The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor.
During a market recession, companies put less investment in R&D and consequently, this potentially slows the production of drugs, the authors shared. As such, this “could impact the need for rigorous quality control measures, such as pyrogen testing”.
However, due to the importance of pyrogen testing for the safety of pharmaceutical products, the report stated that this will help to drive market growth.
Regional status
North America is expected to be the dominant regional market between 2023-2032, the authors wrote. Contributing factors include a “robust healthcare infrastructure, advanced technological capabilities, and a well-established regulatory framework”.
The report anticipated however that the Asia-Pacific region will see “notable growth”, due to influences such as increased population and more prevalence of chronic diseases. A subsequent increased demand for a broader range of drugs and therefore a need for quality control measures including pyrogen testing, will expand the market too, the report asserted.
Major market players include: Lonza Group, Merck KGaA, Thermo Fisher Scientific Inc., FUJIFILM Holdings Corporation, Charles River Laboratories, GenScript, STERIS, WuXi AppTec, and Eurofins Scientific.
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