Pyrogen Testing Market

Global Pyrogen Testing Market Size (2024 to 2029)

As per our report, the global pyrogen testing market size is estimated to be worth USD 2295.43 million by 2029 and USD 1023.22 million in 2024, registering a CAGR of 13.73% during the forecast period.

MARKET DRIVERS

The growing response for pyrogen testing produced in the pharmaceutical and biotechnology trade primarily drives global market growth.

Rapidly growing pharmaceutical and biotechnology manufacturing and a growing number of new therapeutics promotions are expected to increase the demand for pyrogen testing products. Growing investment in R&D by manufacturing syndicates and the government for new product development is one more significant factor subsidizing the growth of the marketplace. New product development and launch is a key strategy attained by manufacturers to sustain their dominance and gain maximum revenue share in the division.

The growing number of biological products, increasing support from governmental organizations and the arrival of new drugs fuel the growth rate of the pyrogen testing market. The growing need for rehabilitative drugs for life-threatening diseases like cancer and diabetes emphasizes the need for drug research and development. Hence, the need for pyrogen testing kits for effective quality monitoring and regulation is expected to offer lucrative growth opportunities for the market. Furthermore, expanding outsourcing operations in the pharmaceutical sector in developed countries and increased understanding of pyrogen testing, and rising per capita healthcare spending further boost the market growth. Hence, increased healthcare spending, providing attractive growth opportunities for players in the global pyrogen testing market.

The growing patient population suffering from infectious and chronic diseases contributes to the pyrogen testing market growth. The population suffering from infectious and chronic diseases is on the rise owing to the increasing adoption of unhealthy habits, sedentary lifestyles and changing environments causing weakened immune systems. To combat this situation, scientists, researchers, and the government have been investing in research and development for the discovery of novel drugs. With increasing research and manufacturing of drugs, it will eventually lead to the high use of pyrogen testing kits and result in market growth. With increasing cases of adverse reactions through parenteral pharma products, there is an increased awareness of patient safety and well-being. Therefore, pyrogen testing has become a top priority for pharmaceutical and biotech companies. This led to stringent compliance with guidelines by the USFDA and EMA for the demand for regular pyrogen testing to ensure patient safety and maintenance of the quality of the products, leading to demand for the pyrogen testing.

MARKET RESTRAINTS

However, complex regulatory policies and unclear reimbursement issues are restraining market growth. Strong government control of the tests, a lack of in-depth awareness of the experiments, and a growing revolution in existing technology could threaten the growth rate of the market.

Impact of COVID-19 on the Global Pyrogen Testing Market

COVID-19 is a recently found novel coronavirus that causes an infectious disease. Within a short period, it had exploded all over the world. Since the World Health Organization (WHO) proclaimed COVID-19 a pandemic, several established pharmaceutical and biopharmaceutical firms and small start-ups have come forward to produce therapies and vaccines to combat the infection caused by the novel coronavirus. According to the WHO, there are currently 70 vaccine candidates in production, with three being evaluated in clinical trials. The social and economic costs of the pandemic have encouraged governments around the world to raise funding for vaccine production, resulting in a rise in the use of pyrogen testing materials in COVID-19 research. The outbreak of COVID-19 has fuelled the growth of the pyrogen testing market as there was a rise in the demand for pharmaceutical products including vaccines and therapeutic drugs, and continuous manufacturing required continuous screening for pyrogen contamination, the accelerated growth of products, giving rise to the demand for pyrogen kits. This positively affected the market share of the pyrogen market. During the pandemic, healthcare, pharmaceutical, and biotech industries shifted their focus on Covid-19 research and development. And this contributed to the demand for pyrogen testing kits. The global pyrogen testing market is projected to grow as COVID-19 levels increase, owing to increased demand for research and vaccine production, fuelling the overall market growth.

REPORT COVERAGE

SEGMENTAL ANALYSIS

Global Pyrogen Testing Market Analysis By Product

Based on the product, the kits and reagents segment had the largest share of the pyrogen testing market in 2023. Pharmaceuticals, biologics, and medical device development are increasing as the prevalence of chronic diseases increases. As a result of the increased production of these products, pyrogen-measuring consumables such as kits and reagents are becoming more widely used. Furthermore, because of technical advancements in goods, the instruments segment is projected to rise at a healthy rate over the forecast period. The PyroDetect System, for example, is a non-animal alternative to the rabbit test that provides high-quality in vitro identification of non-endotoxin and endotoxin contamination.

Global Pyrogen Testing Market Analysis By Application

Based on the application, owing to the expanded production of pharmaceuticals, biopharmaceuticals, and other biologic products, pharmaceuticals and biotechnology firms led the overall demand in 2020. As a result, the growing need for pyrogen testing consumables and instruments in these industries propels the pyrogen testing industry forward. Over the projected era, the medical device companies segment is expected to rise dramatically. Pyrogen research is likely to become more widespread in the near future due to the launch of technologically innovative products and the increasing demand for high-quality medical instruments for therapeutic and diagnostic uses.

Global Pyrogen Testing Market Analysis By Test Type

Due to the growing demand for animal-free detection tests and their high reliability and reproducibility during detection, LAL tests are projected to rise faster during the forecast period. The most popular pyrogen testing technique was the rabbit pyrogen test. However, the rising need for animal-free testing is a major factor that may restrict the use of this test form in the near future. In addition, the opportunity to evaluate a substance without damaging live animals is increasing the success of animal-free testing.

REGIONAL ANALYSIS

Geographically, the North American pyrogen testing market is estimated to dominate the global market for pyrogen testing during the forecast period owing to an increasing number of new biologics in the region. Because of the presence of many major biotechnology and biopharmaceutical companies in this field, such as Pfizer Inc., F. Hoffmann-La Roche AG, and Amgen Inc., North America led the market with the highest sales share. In addition, North America's well-developed healthcare and science infrastructure and a strong emphasis on innovative drug production have driven regional demand expansion.

Asia-Pacific is estimated to be the fastest-growing region due to the continuously growing population and growing healthcare expenditure. Due to untapped opportunities in the area, Asia Pacific is expected to expand faster during the forecast period. Many manufacturers focus on drug discovery, growth, and production efforts in Asian countries such as China and India. In addition, clinical research organizations are now concentrating their clinical trials in Asian countries. Some of the key factors driving the sector's growth in this area are the availability of less strict government regulations for drug production, a large gene pool, and a rapidly expanding healthcare infrastructure.

Europe is a prominent regional market for pyrogen testing and is anticipated to witness a notable CAGR during the forecast period. The growing number of pharmaceuticals and biotech companies, increasing demand for pyrogen tests, government funding, and investment for research and development for introducing and manufacturing new drugs and the growing number of patients with chronic diseases drive the European market.

Latin America is expected to occupy a considerable share of the worldwide market during the forecast period owing to the rising prevalence of chronic diseases among the elderly population, increasing safety for food, and growing focus on manufacturing.

In the Middle East and Africa, the market share of pyrogen testing is still growing, the steady growth of this region is because only major companies can afford high investments for regular testing of pyrogen, and also, there are no stringent rules and regulations for compliance towards guidelines for safety and quality.

KEY MARKET PARTICIPANTS

In 2020, Charles River Laboratories, Inc. (US), Merck KGaA, Thermo Fisher Scientific, Inc. (the US), and Associates of Cape Cod, Inc. (the US) accounted for the majority of the market share. Some of the major companies discussed in the report are Associates of Cape Cod, Inc., Lonza Group, Merck Kgaa, Ellab A/S, Genscript, Hyglos GmbH, Thermo Fisher Scientific, Inc., Charles River Laboratories, Inc., Wako Chemicals Usa, Inc., and WUXI Pharmatech (Cayman) Inc.

Consolidation to a high degree, strict rules on animals' use, and proven players will serve as a big impediment to newcomers. The global pyrogen testing market has fierce competition, and only major corporations can bear heavy capital expenditures as well as high R&D and production costs. Thus, it is further discouraging other companies from entering the market. Furthermore, the market's top players are big and well-established, with a high brand loyalty level.

RECENT HAPPENINGS IN THE MARKET

• In June 2022, Lonza launched the Pyrocell Monocyte Activation Test for the detection of non-endotoxin pyrogens, this new Invitro system requires human serum instead of bovine serum, reducing the need for animals for testing. It produces more accurate results with enhanced sensitivity. It also reduces interferences of drugs such as biologics.

DETAILED SEGMENTATION OF THE GLOBAL PYROGEN TESTING MARKET INCLUDED IN THIS REPORT

This research report on the global pyrogen testing market has been segmented and sub-segmented based on the product, application, test type, and region.

By Product

• Kits and Reagents
• Services
• Instruments

By Application

• Pharmaceutical and Biological Manufacturing
• Medical Device Manufacturing
• Other Applications

By Test Type

• LAL Tests
• Chromogenic Tests
• Turbidimetric Tests
• Gel Clot Tests
• In-Vitro Tests
• Rabbit Tests

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• The Middle East and Africa