Pyrogen Testing Market: by Product, by Test Type, by End Use Industry - Forecast to 2030
Overview
The Pyrogen Testing Market size was valued at USD 1410 Million in 2023 and the total Pyrogen Testing Market revenue is expected to grow at a CAGR of 10% from 2024 to 2030, reaching nearly USD 2750 Million.
Pyrogen Testing Market Overview-
Pyrogen testing means to detect the presence of pyrogen in parenteral pharmaceutical products. Pyrogens are small particles that are derived from viruses, bacteria, yeast, or fungi they are chemical substances. Pyrogen induces an inflammatory response when it enters the human body. There are two types of pyrogens endotoxin and non-endotoxin, examples of endotoxin pyrogens are found in Gram-Negative bacteria and non-endotoxin pyrogens are found in Gram-positive bacteria viruses or yeast. Non-microbial pyrogenic substances are rubber or metal compounds. Pyrogen contamination occurs in various pharmaceutical products, biotherapeutics, and medical devices. The pyrogen testing market is growing due to increased production and testing of pharmaceutical products and medical devices, innovations, and increased spending on research and development. Lack of standardization and the high cost of research and development hinder the pyrogen testing market.
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Pyrogen Testing Market Dynamics-
Increasing disease and innovation for testing drives pyrogen market growth.
The pyrogen testing industry is being driven by the development in pharmaceutical and medical device sectors, as more products and devices are produced demand for pyrogen testing also increases which drives the pyrogen testing market growth. The increasing acceptance of pyrogen testing during drug and medical devices before commercialization and marketing of the product for confirming the safety of the product. Also, the rising prevalence of serious infectious diseases has increased the demand for pyrogen diagnostic procedures. Continuous innovations in testing technologies, such as increased specificity and sensitivity of pyrogen testing procedures, help to drive market expansion. For Example In October 2020, Lonza launched the PyroCell Monocyte Activation Test System, this more sensitive and suitable than previous methods used. The use of more efficient and precise testing methodologies improves the ability to detect pyrogens, assuring greater product safety. Endotoxin detection in products can help to improve the management of infectious diseases, especially in areas where healthcare infrastructure is inadequate.
Increased spending on the pharmaceutical industry and robust quality control increases demand for pyrogen testing
Increased government spending on the life science industry makes the pyrogen testing market more profitable. The growing number of serious diseases such as cancer and diabetes emphasize the importance of medication research and development, the development of pharmaceutical products and medical devices used in the treatment of these diseases requires pyrogen testing kits to make sure products are safe for use as treatment for the disease. For Example, in the world around 3 million permanent pacemakers are used as solutions for cardiac diseases. As stricter the process becomes for approval of drugs and other medical devices, demand increases for pyrogen testing kits.
Lack of standardization and the high cost of research and development hinder the pyrogen testing market
The lack of standardized testing procedures makes meeting regulatory standards difficult, limiting market expansion. Regulatory authorities, such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), frequently issue instructions for pyrogen testing. The development cost of pyrogen tests is high so it affects the market growth of pyrogen testing kits. The federal government spends around USD 15 Billion every year on research that involves animal. Innovation in the field of pyrogen testing requires huge investment which hinders the pyrogen testing market growth which increases the cost of products for example PyroMAT cells is a product of Sigma Aldrich company, costs around 1052 USD. Animal welfare organizations are now going against animal trials which disrupts the testing procedure. Animal welfare organizations are calling for a ban on rabbit pyrogen testing. Each type of pyrogen testing has limitations for Example (LAL) Limulus Amoebocyte Lysate fails to detect non-endotoxin pyrogens such limitations hinder the market growth of the pyrogen testing market.
Recent developments-
1. In 2023 Lonza Group launched the Nebula absorbance reader, a new absorbance microplate reader, which joins the company portfolio of optimized instruments for streamlined endotoxin and pyrogen testing.
2. In 2021 FUJIFILM Wako Pure Chemical Corporation launched recombinant protein reagent PYROSTAR Neo for detection of bacterial endotoxin.
3. In October 2020, Lonza launched the PyroCell Monocyte Activation Test System. The test system is a highly sensitive and sustainable monocyte activation test for reliable and sustainable in vitro pyrogen testing.
Pyrogen Testing Market Segment Analysis –
Based on Test type-
The test type market is segmented into vitro, Limulus amoebocyte lysate, and rabbit pyrogen test. It is the most common test used for pyrogen testing in pharmaceutical companies for testing products. Rabbit pyrogen testing has been replaced by the LAL test. The main reason for the replacement of rabbit pyrogen testing with LAL tests is that it avoids harming live animals during both production and testing. This type of testing method is used by various pharmaceutical and biotechnology industries. Increasing demand for LAL test kits due to increased use for testing of medical devices, and pharmaceutical products, drives market growth.
Based on End-Use Industry-
The pharmaceutical and biotechnology businesses sector held the largest market share in the pyrogen testing market, due to increased research and development activities in the pharmaceutical and biotechnology sectors, which has increased the demand for pyrogen testing. However, the medical device business segment is expected to have the highest CAGR during the forecast period. Demand for medical equipment is increasing due to technological advancement in the medical device industry This is due to the quality control procedure for medical devices becoming stringent. Growing demand for safe and effective medical equipment is driving the market.
Pyrogen Testing Market Regional Insights-
North America dominates the pyrogen testing market and will dominate the segment in the forecast period. The growing number of cases of heart-related diseases requires more products and medical devices for treating the disease which eventually increases the demand of pyrogen testing kits. Best infrastructure, technological developments in testing procedures, innovation in the pharmaceutical sector, and increased spending on research and development activities have a good impact on the market.
Asia-Pacific gives a better chance for key players in pyrogen testing due to the expanding pharmaceutical and biotechnology sectors in countries like China, and India. In 2023 more than ten Chinese companies like Biokin and Hanosh signed many deals for pyrogen testing with multinational companies. The rise of contract manufacturing and research activities, and increased healthcare investments. India has established itself as the global leader in contract development and manufacturing organizations capabilities, but allocation of funds and resources for basic research is not there which hinders innovations and negatively affects the market growth. China has a market size of USD 85778 million which makes it a huge market for pyrogen testing kits.
The report aims to provide industry stakeholders with a thorough study of the global market. The research presents the industry's historical and present state together with projected market size and trends, analyzing complex data in an easy-to-read manner. The research includes PORTER and PESTEL analyses along with the possible effects of market microeconomic factors. The analysis of both internal and external elements that could have a good or negative impact on the firm will provide decision-makers with a clear picture of the industry's future. By understanding the market segments and projecting the size of the global market, the reports also help in understanding the market's dynamics and structure.
Pyrogen Testing Market Scope: Inquire before buying
| Pyrogen Testing Market | |||
|---|---|---|---|
| Report Coverage | Details | ||
| Base Year: | 2023 | Forecast Period: | 2024-2030 |
| Historical Data: | 2018 to 2023 | Market Size in 2023: | US$ 1410 Mn. |
| Forecast Period 2024 to 2030 CAGR: | 10% | Market Size in 2030: | US$ 2750 Mn. |
| Segments Covered: | by Product | Instruments Kits and Reagents Services |
|
| by Test Type | In Vitro Tests Limulus Amoebocyte Lysate Rabbit Pyrogen Tests |
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| by End Use Industry | Pharmaceuticals and Biotechnology Medical Devices Others |
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Pyrogen Testing Market, by Region:
Asia Pacific (China, South Korea, Japan, India, Australia, Indonesia, Malaysia, Vietnam, Taiwan, Bangladesh, Pakistan and Rest of APAC)
Europe (UK, France, Germany, Italy, Spain, Sweden, Austria and Rest of Europe)
North America (United States, Canada and Mexico)
Middle East and Africa (South Africa, GCC, Egypt, Nigeria and Rest of ME&A)
South America (Brazil, Argentina Rest of South America)
Pyrogen Testing Key Players
1. Associates of Cape Cod Inc.
2. Lonza Group
3. Charles River Laboratories International Inc.
4. ENDONEXT
5. Merck & Co. Inc
6. Ellab
7. Genscript
8. Sigma-Aldrich Corporation
9. Wako Chemicals USA Inc.
10. Thermo Fisher Scientific Inc
11. BioMérieux
12. Wuxi PharmaTech
13. Hycult Biotech
14. InvivoGen
15. Pyrostar
16. Lucideon Limited
17. Creative Bioarray
18. INDOOR Biotechnologies Inc.
Frequently Asked Questions:
1] What segments are covered in the Global Pyrogen Testing Market report?
Ans. The segments covered in the Market report are based on Product Type, Test Type, and End-Use Industry.
2] Which region held the largest Pyrogen Testing Market share in 2023?
Ans. The North America region held the largest Market share in 2023 .
3] What is the expected Pyrogen Testing Market size by 2030?
Ans. The Pyrogen Testing Market size is expected to reach US$ 2750 Mn by 2030.
4] What was the key driver of the Global Pyrogen Testing Market?
Ans. The pyrogen testing market is growing due to increased production and testing of pharmaceutical products and medical devices, new innovations, and increased spending on research and development.
5] What is the expected CAGR of the Global Market during the forecast period?
Ans. The expected CAGR of the Pyrogen Testing Market is 10% during the forecast period.
