Pyrogen Testing Market
Number of pages: 100 | Report Format: PDF | Published date: March 14, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
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Report Attribute |
Details |
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Market Size Value in 2022 |
US$ 1.14 billion |
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Revenue Forecast in 2031 |
US$ 2.60 billion |
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CAGR |
9.5% |
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Base Year for Estimation |
2022 |
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Forecast Period |
2023-2031 |
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Historical Year |
2021 |
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Segments Covered |
Test, Product, End-user, and Region |
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Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global pyrogen testing market was valued at US$ 1.14 billion in 2022 and is expected to register a revenue CAGR of 9.5% to reach US$ 2.60 billion by 2031.
Pyrogen Testing Market Fundamentals
Pyrogen testing detects the presence or absence of pyrogens in parenteral pharmaceutical products. It is governed by several standards established by organizations such as the Food and Drug Administration (FDA), the United States Pharmacopeia (USP), and the European Pharmacopeia (EP). The product’s sterility does not indicate that it is free of pyrogens. Medications meant to be sterile should be screened for pyrogens to prevent febrile reactions in patients. Pyrogen contamination can occur during the manufacturing or administration of medicines, biotherapeutics, and medical devices. However, pyrogens can also be an inherent product feature, such as adjuvants in vaccines or synthetic lipopeptides.
Pyrogen is a chemical that triggers fever after receiving an injection. Body discomfort and temperature rise are atypical reactions caused by infusing toxic pyrogen into the body. Pyrogen testing determines the presence of endotoxin and other bacterial by-products that cause the body temperature to rise. Vaccines and other injectable medications must be pyrogen-free according to 21CFR, USP, and EP regulations. Pyrogen testing is important in providing improved healthcare since it identifies the presence of pyrogen in an animal that produces fever. The parenteral route commonly uses two pyrogen test procedures - the rabbit pyrogen test (RPT) and the bacterial endotoxin test (BET) based on limulus amebocyte lysate (LAL) - to detect the presence of pyrogen. It contributes to the safety of parenteral pharmaceutical products and medical devices and the prevention of life-threatening disorders and fatal endotoxic shock caused by pyrogenic chemicals. The regularly used Pyrogen testing procedures include the LAL test, recombinant factor C (rFC) test, RPT, and monocyte activation test (MAT). Its demand has consistently risen globally due to its robustness, sensitivity, and scalability.
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Pyrogen Testing Market Dynamics
Pharmaceutical, biotech, and other pharmaceutical manufacturing companies use pathogen testing to ensure the safe manufacture and distribution of infection-free medicines to the market. Biotechnology companies have become essential for research and development activities for newer healthcare and biological applications. It is thus predicted to become a crucial component in determining the presence of microorganisms or metabolites in pharmaceuticals throughout their manufacturing.
Rising demand for pyrogen products, as well as partnerships, are projected to drive market expansion. Fujifilm Wako Chemicals, for instance, offers endotoxin testing tools, such as the Toxinometer ET-6000. This equipment can perform three tests: gel-clot, Kinetic Turbidimetric Assay, and Kinetic Chromogenic Assay. The toxinometer makes testing easier as it can start a new assay while another is still running, which aids in the retesting of a sample. Furthermore, Fujifilm Wako Chemicals intended to debut the Toxinometer ET-7000 Series in 2019, a computer-controlled equipment with improved usability. As a result, increased product launches led to market expansion.
Rising R&D expenditure has also contributed to the overall market expansion. According to the 2019 European Federation of Pharmaceutical Industries and Associations report, the pharmaceutical industry in Europe invested over EUR 36,500 million in research and development in 2018. The constantly expanding pharmaceutical and biotechnology sectors are likely to boost market revenue growth. Pharmaceutical, biotech, and other medication manufacturing companies utilize pyrogen testing to ensure the safe manufacture and delivery of infection-free products to the market.
However, the availability of many generics is projected to hinder market revenue growth due to the high degree of consolidation. Furthermore, the pyrogen testing market is expected to face severe competition and a rise in the popularity of sustainable chemistry throughout the forecast period.
Pyrogen Testing Market Ecosystem
The global pyrogen testing market has been analyzed from four perspectives: test, product, end-user, and region.
Pyrogen Testing Market by Test
Based on the test, the global pyrogen testing market has been segmented into oncology monocyte activation test (MAT), limulus amebocyte lysate (LAL), rabbit pyrogen test (RPT), and recombinant factor C assay (RFC).
Due to the increased demand for animal-free detection tests and their excellent reliability and repeatability during detection, LAL tests are predicted to grow faster during the projection period. The most prevalent pyrogen testing method was RPT. However, the growing demand for animal-free tests is a major issue that could limit the usage of this test type in the near future. Animal-free testing is becoming more common due to its ability to evaluate products without causing harm to living organisms.
Pyrogen Testing Market by Product
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Based on product, the global pyrogen testing market has been segmented into consumables and instruments.
The consumables segment generated the most revenue and is expected to maintain its dominance during the forecast period. The increased prevalence of chronic diseases drives demand for pharmaceuticals, biologics, and medical devices. As a result, the increased manufacture of these items drives the usage of pyrogen testing consumables, such as kits and reagents. Due to technical product advancements, the instruments segment is likely to experience profitable growth during the forecast period.
Pyrogen Testing Market by End-user
Based on end-user, the global pyrogen testing market has been segmented into food & beverage companies, medical devices companies, pharmaceuticals & biotechnology companies, contract research organizations (CROs), and others.
The pharmaceutical & biotechnology companies segment is likely to dominate the market during the forecast period due to the increased manufacture of medicines, biopharmaceuticals, and other biologic products. Thus, the growing demand for pyrogen testing consumables and instruments in these businesses drives the expansion of the pyrogen testing market.
The medical devices companies segment is also expected to increase significantly over the projection period. The launch of technologically improved products and the increased need for high-quality medical equipment for therapeutic and diagnostic applications are expected to boost pyrogen testing utilization in the near future.
Pyrogen Testing Market by Region
Based on region, the global pyrogen testing market has been segmented into North America, Europe, Asia Pacific, Latin America, the Middle East & Africa.
North America dominates the market due to its well-established healthcare infrastructure, better regulatory environment and government support, and the existence of several significant biotechnological and biopharmaceutical firms, such as Merck and Lonza Group. A growing prevalence of chronic and infectious diseases is likely to drive market revenue growth in North America. Moreover, an increase in healthcare awareness campaigns in the region is supporting the development of the pyrogen testing market. Furthermore, as the importance of healthcare has grown, so has public knowledge about the toxicity of pharmaceuticals and medical devices. Pyrogen testing is critical in establishing safety precautions in medical devices and pharmaceutical products that require parenteral administration.
Due to untapped opportunities in Asia Pacific, this region is expected to develop fastest during the projection period. Many pharmaceutical companies target Asian countries, such as China and India, for drug discovery, development, and production. Furthermore, clinical research institutions are focusing on clinical trials in Asian countries. Some of the primary factors responsible for the sector’s success in this region are the less stringent government regulations for drug research, a large genome pool, and the expansion of the healthcare infrastructure.
Pyrogen Testing Market Competitive Landscape
Large corporations are launching numerous strategies to fulfill their customers’ unmet requirements, such as new product development, mergers, acquisitions, collaborations, and regional expansions. Strategic alliances and investments enable manufacturers to increase their product offerings and geographical reach. Partnerships with global corporations to increase market reach and awareness are also expected to be a prominent market strategy in the pyrogen testing market.
The prominent market players in the global pyrogen testing market include:
Pyrogen Testing Market Strategic Developments
Pyrogen testing detects the presence or absence of pyrogens in parenteral pharmaceutical products. It is governed by several standards established by organizations, such as the Food and Drug Administration (FDA), the United States Pharmacopeia (USP), and the European Pharmacopeia (EP).
Asia Pacific is the key regional market for pyrogen testing that is expected to grow at the fastest revenue CAGR during the forecast period.
The rapid growth in the pharmaceutical and biotechnology industries and the increase in the R&D expenditure in life science are the prime revenue-driving factors in the market.
The global pyrogen testing market is expected to register a revenue CAGR of 9.5% during the forecast period.
Some prominent players in the global pyrogen testing market include Merck KGaA, Lonza Group, and Thermo Fisher Scientific, Inc.
*Insights on financial performance are subject to the availability of information in the public domain