Pyrogen Testing Market

Key Market Overview:

Pyrogen Testing Market size was valued at USD 1.33 Billion in 2022, registering a CAGR growth of 11.6% during the forecast period (2023-2030), and the market is projected to be valued at USD 3.19 Billion by 2030.

Pyrogen testing is a critical process that ensures the safety of parenteral pharmaceuticals. It is a type of in vitro testing that assesses the presence of pyrogens in pharmaceutical products. Pyrogens are substances that can cause fever and other adverse reactions in patients, and their detection is essential to ensure that pharmaceutical products are safe for human use.

The rise in new product innovations in the market is expected to propel the growth of the market. For instance, in 2019, Fujifilm Wako Chemicals is set to release the Toxinometer ET-7000 Series, a computer-operated instrument designed to make pyrogen testing more user-friendly. The instruments introduction is expected to contribute to the growth of the pyrogen testing market by providing a new and innovative solution for pyrogen detection.
Overall, the market is expected to witness growth in the upcoming years as companies continue to launch new products and improve existing solutions. This growth is expected to benefit the pharmaceutical industry by ensuring the safety and efficacy of parenteral pharmaceuticals and protecting patients from the adverse effects of pyrogens.

Pyrogen testing Report Coverage:

Report Attributes	Report Details
Study Timeline	2017-2030
Market Size in 2030 (USD Billion)	3.19 Billion
CAGR (2022-2030)	11.6 %
Base Year	2022
By Testing Type	Bacterial Endotoxin Testing (BET), Rabbit Pyrogen Testing, Monocyte Activation Test, Recombinant Factor C (rFC) Testing, and Others
By Product Type	Kits and Reagents, Instruments, and Others
By End-use	Pharmaceutical and Biotechnology Companies, Medical Devices Companies, Biomedical Companies, Food and Beverages Companies, Test Service and Diagnostic Laboratories, Clinical Research Organizations (CRO), and Others
By Geography	Asia-Pacific [China, Southeast Asia, India, Japan, Korea, Western Asia] Europe [Germany, UK, France, Italy, Russia, Spain, Netherlands, Turkey] North America [United States, Canada, Mexico] Middle East & Africa [GCC, North Africa, South Africa] South America [Brazil, Argentina, Columbia, Chile, Peru]
Key Players	Lonza Group, Merck KGaA (E. Merck KG), Genscript Biotech Corp, Ellab A/S, Charles River Laboratories, Thermo Fisher Scientific Inc., FUJIFILM Wako Chemicals U.S.A. Corporation (FUJIFILM Wako Pure Chemical Corporation), Associates of Cape Cod, Inc., Sanquin, and Microcoat Biotechnologie GmbH

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Market Dynamics:

Driver:

The rising prevalence of chronic diseases such as cancer and autoimmune disorders is increasing over past years, leading to the growing demand for parenteral pharmaceuticals and, consequently, pyrogen testing. For instance. The rate of new cases of cancer is significant, with 442.4 cases per 100,000 men and women per year, while the cancer death rate is 158.3 per 100,000 men and women per year. In the United States alone, an estimated 1,806,590 new cases of cancer were diagnosed in 2020, and 606,520 people died from the disease. The need for effective pyrogen testing to prevent adverse reactions and ensure the quality of cancer treatments is a key driver of the pyrogen testing market.

Furthermore, the innovation of new testing solutions by the companies foster the growth the market over the forecast period. For instance, the introduction of new products such as bioMérieux SAs ENDOZYMEII GO test in May 2018 is expected to drive demand for pyrogen testing, as the test offers a novel solution for detecting endotoxins in pharmaceutical grade water, injectable drugs, and other pharmaceutical products.
Overall, these developments demonstrate the focus and emphasis of companies in the market to innovate and provide new solutions for the pharmaceutical industry, which is driving growth in the market. As the industry continues to expand along with the rise of safe and effective pharmaceutical products, the market for pyrogen testing is expected to expand in the upcoming years.

Restraint:

The high cost of pyrogen testing is a significant restraint to the growth of the market, especially for small and medium-sized enterprises with limited financial resources. Additionally, regulatory compliance requirements such as testing facilities, equipment, and personnel meet regulatory standards and guidelines impose significant financial and time constraints on companies. This has resulted in some companies refraining from investing in pyrogen testing, thereby limiting the overall expansion of the market.

Opportunities:

The pyrogen testing market is expected to witness significant business opportunities due to advancements in endotoxin testing technology. Owing to the increasing sensitivity and specificity of testing methods, the detection of pyrogens, a crucial parameter for product safety and quality, is expected to become more accurate. As a result, there will be a surge in demand for advanced pyrogen testing products and services, which will create new opportunities for companies operating in this market.

Pyrogen testing Market Segmentation:



By Testing Type

The fabric type segment is categorized into bacterial endotoxin testing (BET), rabbit pyrogen testing, monocyte activation test, recombinant factor C (rFC) testing, and others. The bacterial endotoxin testing (BET) testing type holds the largest market share in the year 2022. The BET method is an in vitro test that uses the Limulus amebocyte lysate (LAL) assay to detect bacterial endotoxins. The largest market share of the bacterial endotoxin testing is attributed to its extensive usage in the pharmaceutical industry and this is also considered the gold standard for pyrogen testing.

However, the recombinant factor C (rFC) testing is anticipated to witness fastest growth rate over the forecast period. This is attributed to recombinant factor C (rFC) test\\\'s popularity as a sustainable alternative to the LAL test, which relies on the blood of horseshoe crabs. The recombinant factor C (rFC) test uses a recombinant version of the horseshoe crab factor C protein, which are produced in large quantities without harming the crabs. The use of recombinant factor C (rFC) testing is expected to increase as more companies and regulatory bodies adopt it as a standard pyrogen testing method, and it may eventually overtake the LAL test in terms of market share.

By Product Type

The product type segment of the pyrogen testing market is divided into kits and reagents, instruments, and others. The kits and reagents segment is accounted for the largest market share in the year 2022. This is attributed to the requirement of several kits and reagents for pyrogen testing, these include LAL reagents, control standard endotoxins, and pyrogen detection kits. These products are widely used in the pharmaceutical and biotechnology industries for quality control and product safety testing.
However, the instruments segment is anticipated to witness fastest CAGR over the forecast period. This is owing to the increasing demand for automated and standardized pyrogen testing processes. Automated systems offer several advantages over manual testing, such as increased efficiency, reproducibility, and reliability, which are essential in the pharmaceutical and biotechnology industries where product safety is critical.

By End-User

The end-use segment is classified into pharmaceutical and biotechnology companies, medical devices companies, biomedical companies, food and beverages companies, test service and diagnostic laboratories, clinical research organizations (CRO), and others. The pharmaceutical and biotechnology companies hold the largest market share in the year 2022. This is attributed to the rising requirement of these companies to ensure the safety of their products, such as drugs and vaccines, for human use. Pyrogen testing is essential for these businesses to comply with regulatory requirements and avoid the risk of adverse reactions in patients.
However, the medical devices companies are anticipated to witness fastest CAGR over the forecast period. This is attributed to the need for pyrogen testing in medical device companies to ensure the safety of their products, such as implants and instruments, which come into contact with the human body.

By Region

By region, the market is categorized into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America holds the largest market share in the year 2022. This due to the presence of a large number of pharmaceutical and biotechnology companies, as well as stringent regulatory requirements related to product safety and quality.



However, Asia Pacific is projected to witness the fastest CAGR over the forecast period. This is driven by factors such as the increasing demand for pharmaceutical products, rising healthcare expenditure, and the growing focus on drug safety and quality in emerging economies. The increasing investments in healthcare infrastructure propels the growth in this region. Additionally, growing government initiatives to promote research and development activities in the healthcare sector, particularly in countries such as China and India, are expected to further boost market growth in the Asia Pacific region.

Pyrogen testing Market Competitive Landscape:

The market is highly competitive, with a large number of players operating at the global and regional levels. The players compete on various parameters such as price, quality, innovation, and customer service. They are constantly investing in research and development to improve their products and expand their market share. Mergers, acquisitions, and partnerships are also common strategies employed by companies to enhance their market position and expand their product portfolio. Key players in the market include-

• Lonza Group
• Merck KGaA (E. Merck KG)
• Genscript Biotech Corp
• Ellab A/S
• Charles River Laboratories
• Thermo Fisher Scientific Inc.
• FUJIFILM Wako Chemicals U.S.A. Corporation (FUJIFILM Wako Pure Chemical Corporation)
• Associates of Cape Cod, Inc.
• Sanquin
• Microcoat Biotechnologie GmbH

Recent Developments:

• In April 2021, Associates of Cape Cod, Inc. (ACC), a US-based company specializing in chromogenic and turbidimetric reagent technologies, has launched its innovative product, Pyro Smart NextGen for Bacterial Endotoxin Testing (BET). The product is designed to be a highly effective solution for BET and is expected to provide improved outcomes for customers in the pharmaceutical industry.

• In October 2020, Lonza Bioscience has announced the launch of PyroCell MAT System, which is a sustainable and reliable solution for in vitro pyrogen testing. The system is the result of the collaboration between Lonza, which has experience in primary cells and endotoxin testing, and Sanquin, which specializes in MAT production. This new offering will ensure the safety of parenteral pharmaceuticals during development, manufacture, and product release.