With recorded sales of US$ 1.32 Bn in 2020, the global pyrogen testing market is predicted to experience high growth over the years ahead, owing to high product adoption globally. Demand for pyrogen testing is estimated to surge at a CAGR of 12.2% from 2021 to 2031.
Pyrogen testing determines the presence or absence of pyrogen in parenteral medicines and medical devices to avoid life-threatening problems that are induced by foreign substances (pyrogens). Sterility of the product does not mean that it is pyrogen-free. Since life expectancy has been increasing over the past decades, incidence of critical illnesses has risen worldwide. With the rising need for novel healthcare products and regulations, demand for pyrogen testing is expected to steadily rise over the forecast period.
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As the European Pharmacopoeia is actively doing, the long process of international validation, acceptance, and implementation of the test, now known as the Monocyte Activation Test (MAT), affects animal numbers and it has reduced the number of animals by more than 70%, at least in Europe. MAT availability discusses LAL / deficiency, BET, including restrictions on gram-negative bacteria, lack of reflection of efficacy in the human body, interference and masking by many products, and reservations for horseshoe crab animal care.
The obvious benefits of MAT in all these areas should lead to the transition from LAL / BET to MAT. This is already evident in vaccines and medical products and services, but other areas such as blood transfusion safety testing, cell therapy and nanomaterials, and aerial pyrogen evaluation are not yet aware of the potential of MAT.
Key pyrogen testing service providers are focusing on increasing their market penetration into untapped markets via collaborations and launching of new products. Companies are also focusing on enhancement of products and services, and investing in R&D. For instance, the R&D investment of Lonza group during the year 2019 was somewhere around US$ 199 Mn.
The pyrogen testing market is consolidated with a few prominent market players, and presents several lucrative opportunities for new entrants to create a foothold in this industry. Increased product adoption rate can be a beneficial factor for the manufacturers of these medical devices to expand into regional as well as emerging markets.
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Key Takeaways from Market Study
- Test kits & reagents, under the product and service category for pyrogen testing, is growing tremendously. Owing to high adoption of test kits and reagents, which is relatively higher in terms of volume compared to consumables or instruments, this segment held 43.2% market share by value in 2021.
- Pharmaceutical companies are steadily transitioning toward other testing methods owing to the low sensitivity offered by RPT, along with the fact that the results obtained are non-human specific and are qualitative in nature. Thus, pharmaceutical companies held the highest market share of 44.7% by value in 2021.
- Animal-based tests are mostly preferred for detecting pyrogens. The animal-based segment accounted for market share of around 86.5% in 2021, which is the highest of all measured across the market.
- Increased demand for biologics, considering their wide range of application, will provide lucrative opportunities for manufacturers in the near future. The segment held 16.6% of total market share by value in 2021.
- The North America pyrogen testing market accounted for 38% of the global market share in 2021.
“Increased prevalence of chronic diseases, rising demand for biopharmaceuticals, and innovations in medicines & vaccines will drive the growth of the pyrogen testing market over the coming years,” says an analyst of Persistence Market Research.
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Market Competition
Key players in the pyrogen testing market are investing in innovating cost-effective, user-friendly devices to gain the attention of healthcare providers. Along with product innovation, market players are also aiming for various collaborations to create goodwill and successfully market their products.
- For instance, PerkinElmer, Inc. collaborated with Insightful Science in March 2021, a software company serving the global life sciences community, to expand its existing capabilities in the biologics drug discovery space.
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