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Pyrogen Testing Market Analysis

The Global Pyrogen Testing Market size is estimated at USD 1.48 billion in 2024, and is expected to reach USD 2.09 billion by 2029, growing at a CAGR of 7.13% during the forecast period (2024-2029).

The market is primarily driven by increased demand for pyrogenic testing products in the pharmaceutical and biotechnology industries and rising R&D expenditure in life science.

With the rising COVID-19 pandemic, the demand for pyrogen testing techniques has witnessed steady growth during the past decade due to the increasing prevalence of infectious diseases. With an increase in the incidence of infectious diseases, the demand for pyrogen testing is expected to increase during the forecast period. The endotoxin identification products can help improve the management of infectious diseases, especially in areas with inadequate healthcare infrastructure. This has led to an increase in the adoption of pyrogen testing products that helps the market grow.

Pyrogen testing is being used by pharmaceutical, biotech, and various drug manufacturing companies for the safe manufacturing and release of infection-free products into the market. Biotechnology industries have become pivotal for R&D efforts for newer healthcare and biological applications. It is thus expected to become a critical factor for determining microbes or the presence of metabolites in drugs during their manufacture.

The rising demand for pyrogen products and partnerships are expected to boost the market growth. For instance, Fujifilm Wako Chemicals provides instruments for endotoxin testing, which include Toxinometer ET-6000. This instrument can incorporate basically three testing methods Gel-clot, KTA (Kinetic Turbidimetric Assay), and KCA (Kinetic Chromogenic Assay). The toxinometer provides ease of use during the testing process as it can start a new assay while another assay is still running, which helps in the retesting of a sample. In addition, Fujifilm Wako Chemicals planned to launch the Toxinometer ET-7000 Series in 2019, which is a computer-operated instrument and has been made more user-friendly. Therefore, the increasing product launches ultimately lead to the market growth.

There are also rising R&D expenditure that has helped in driving the overall market growth. According to the 2019 European Federation of Pharmaceutical Industries and Associations (EFPIA) report, in Europe, the pharmaceutical industry invested around EUR 36,500 million in R&D in 2018. The rapidly growing pharmaceutical and biotechnology industries are expected to drive the growth of the market studied. Pyrogen testing is used by pharmaceutical, biotech, and various drug manufacturing companies for the safe manufacturing and release of infection-free products into the market.

There is also a rising need for biologics that have resulted in unprecedented growth in the number of biopharmaceutical companies. This has helped to develop therapeutically advanced drugs on a large scale, which has compelled manufacturers to improve on aspects, such as productivity, cost-efficiency, and deviations. Companies are, thus, implementing good manufacturing practices through biological testing at various levels of production cycles, thereby contributing toward the growth of the market.

Furthermore, the increase in chronic disease prevalence in developed countries has also boosted the demand for pyrogen testing along with the increasing awareness that is expected to result in high growth during the forecast period.

Pyrogen Testing Industry Segmentation

As per the scope of the report, pyrogen testing refers to the process of determining microbes or the presence of their metabolites in drugs and intravenous solutions during their manufacture. A pyrogen is a foreign substance that causes a fever (temperature elevation) in an animal's body. Typically, pyrogenic substances include endotoxin and other bacterial byproducts. Vaccines and other injectable drugs must be confirmed to be pyrogen-free according to regulatory requirements of 21CFR, USP, and EP. The pyrogen testing market is segmented by product, test type (LAL Tests, rabbit pyrogen test, monocyte activation test, and other test types), end user (pharmaceutical and biotechnology companies, medical device companies, and other end users), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.