Pyrogen Testing Market

Pyrogen Testing Market Outlook (2024 to 2034)

The global pyrogen testing market is projected to increase from a valuation of US$ 1.96 billion in 2024 to US$ 6.53 billion by the end of 2034. Demand for pyrogen testing is analyzed to advance at a remarkable CAGR of 12.8% from 2024 to 2034.

As medical device usage becomes more widespread worldwide, with advanced technologies, there is an increasing necessity for pyrogen testing. Pyrogen testing, which helps determine the presence or absence of pyrogens in pharmaceutical devices and products, is regulated by esteemed organizations such as the Food and Drug Administration (FDA), United States Pharmacopeia, and European Pharmacopeia. Need for pyrogen testing becomes very important due to its ill effects on the body, pyrogen is a group of chemically diverse substances that cause fever and shock in severe cases. The most common pyrogenic substances in the pharmaceutical industry are bacterial endotoxins.

To make sure pharmaceutical products are fit for final use, governments prompt medical companies to go through this testing, driving pyrogen testing market growth. Many of the key players are focusing on introducing more effective and efficient testing methods to improve the quality of medical products.

• For instance, to expedite and simplify rabbit-free pyrogen testing, Lonza has introduced two new fast monocyte activation test (MAT) systems: the PyroCell® MAT fast System and the PyroCell® MAT Human Serum (HS) Rapid System. The systems come with the new PeliKine Human IL-6 Rapid ELISA Kit, which shortens the time it takes to get results from two days to two hours. These systems will replace Lonza's current MAT system kit offerings.

Report Attribute	Detail
Pyrogen Testing Market Size (2024E)	US$ 1.96 Billion
Forecasted Market Value (2034F)	US$ 6.53 Billion
Global Market Growth Rate (2024 to 2034)	12.8% CAGR
Canada Market Growth Rate (2024 to 2034)	14.3% CAGR
China Market Value (2034F)	US$ 636 Million
North America Market Share (2024E)	37.4%
East Asia Market Share (2034F)	19.1%
Key Companies Profiled	Promega Corporation; GenScript; ASSOCIATES OF CAPE COD, INC.,; BioMérieux SA; Ellab A/S; Hycult Biotech; Eurofins Biolab Srl; SOLVIAS AG, Wickham Laboratories Ltd.; Nelson Laboratories, LLC; Charles River Laboratories, Creative Biolabs.

Where is the Need for Pyrogen Testing Stemming From?

“Growing Cases of Chronic Diseases and Focus on Enhancing Pyrogen Testing Efficiency”

Prevalence of chronic, non-communicable illnesses is increasing worldwide, which constitutes a major global cause of mortality and disability.

• Six out of ten Americans, according to the Centers for Disease Control and Prevention, suffer from at least one chronic illness, including diabetes, cancer, heart disease, and stroke. Due to this, there is a considerable requirement for pyrogen testing, to make sure the medical devices used in the treatment meet quality standards.
• The Nebula Absorbance Reader is a new absorbance microplate reader from Lonza that enhances their lineup of devices designed to make testing for endotoxins and pyrogens easier and more efficient.
• A new animal-free testing option has been added to the endotoxin testing (BET) portfolio by Charles River, a US-based provider of microbiological solutions. By improving testing efficiency, this new solution expands upon Charles River's current Trillium rCR vial product.

“Increasing Demand for Medication R&D for Corrective Therapies”

To position itself as the world's global hub for biopharmaceutical innovation, India has been making tremendous strides, such as promoting PPPs in biopharmaceutical R&D projects. Moreover, South Korea is taking steps to establish itself as a global center for biotechnology, with an emphasis on stem cell therapy, biosimilars, and vaccine manufacturing. Key players are capitalizing on these pyrogen testing market trends.

Necessity for medication R&D and, consequently, pyrogen testing kits for efficient quality control and testing is highlighted by the rising need for corrective therapies for serious illnesses like diabetes and cancer.

What is Limiting Opportunities for Pyrogen Testing Providers?

“Strict Regulations Governing Animal-Based Pyrogen Testing”

Complexity and cost associated with pyrogen testing procedures, as well as the regulatory requirements, can limit market opportunities for pyrogen testing providers. Advancements in alternative testing methods and technologies may pose challenges to traditional pyrogen testing approaches.

• The European Pharmacopoeia's general chapter 2.6.30 mandates the gradual replacement of rabbit pyrogen tests with alternative methods, aligning with animal welfare standards.

Following the European Pharmacopoeia's initiative, global regulatory bodies have also adopted this change, reducing the demand for rabbit pyrogen testing. The most recent advancement in pyrogen testing is the MAT. However, limited financial resources in underdeveloped countries are hindering the rapid adoption of novel technologies.

• In Germany, despite the availability of animal-free testing for over a decade, around 6,000 rabbits endure and perish in pyrogen tests annually, as reported by Doctors Against Animal Experiments.
• Responding to appeals from organizations like the Environment & Animal Society of Taiwan (EAST) and PETA, the Taiwanese government has transitioned to animal-free techniques in swine fever vaccine production, abandoning rabbit use.
• The FDA in the United States has issued guidelines favoring the Limulus Amebocyte Lysate (LAL) assay over rabbit pyrogen tests for evaluating pharmaceutical product pyrogenicity.
• Regulatory bodies including the USP, European Pharmacopeia, Japanese Pharmacopeia, and FDA collaborated to update LAL assay guidelines, withdrawing outdated FDA guidelines from 1987 in 2012.

Country-wise Evaluation

The pyrogen testing market size is projected to expand at a significant rate over the forecast period across the United States, China, Mexico, Japan, and South Korea. According to Fact.MR, the market in Japan is forecasted to expand at a CAGR of 16% from 2024 to 2034. The country is analyzed to occupy a market share of 39.1% in East Asia by the end of 2034.

Why is the United States Attracting Providers of Pyrogen Testing Solutions?

“Streamlined Approval Processes for Testing Equipment”

Attribute	United States
Market Value (2024E)	US$ 685 Million
Growth Rate (2024 to 2034)	11.8% CAGR
Projected Value (2034F)	US$ 2.09 Billion

The United States government's streamlined approval processes have facilitated swift market entry for industry players, fueling market growth significantly.

• In July 2021, the FDA approved Promega's OncoMate MSI Dx Analysis System (OncoMateTM MSI), bolstering the company's position in the laboratory and life science sectors.
• For over 30 years, the FDA has sanctioned the use of Limulus Amoebocyte Lysate (LAL) tests for endotoxin detection instead of rabbit pyrogen tests. Federal Register notice (42 FR 57749), issued on November 4, 1977, delineated the guidelines for LAL utilization as a finished product test.

How is China Able to Expand its Market Share in the East Asia Region?

“Rising Investments in Medical Infrastructure Development”

Attribute	China
Market Value (2024E)	US$ 128 Million
Growth Rate (2024 to 2034)	17.4% CAGR
Projected Value (2034F)	US$ 636 Million

Development of medical infrastructure and strategic joint ventures are crucial for China's industry success.

• For example, to develop a COVID-19 vaccine, the National Research Council of Canada announced a partnership with CanSino Biologics, a firm located in China. Such research initiatives are expected to support the development of the pyrogen test market in China, which presents profitable prospects for regional producers.
• The second phase of Merck's US$ 31.37 million Biologics Testing Center in China, which added 1,500 square meters to the lab's opening last year, was completed recently. Merck is a major scientific and technology firm.

Category-wise Insights

Based on application, demand for dialysis liquids is forecasted to rise at a CAGR of 11.1% from 2024 to 2034.

Which Product Finds Widespread Usage for Pyrogen Testing?

“Test Kits & Reagents Simplifying Testing Procedures”

Attribute	Test Kits & Reagents
Segment Value (2024E)	US$ 877.4 Million
Growth Rate (2024 to 2034)	14.1% CAGR
Projected Value (2034F)	US$ 3.28 Billion

Pyrogen detection is required in the pharmaceutical sector to prevent potentially fatal fever responses caused by microorganisms and non-microbial chemicals. Because test kits and reagents make this procedure simpler, they are finding extensive usage.

Why are We Seeing a Shift toward In-Vitro Testing Systems?

“Ethical Considerations and Environmental Concerns Restricting Animal-based Testing”

Attribute	In-Vitro Based
Segment Value (2024E)	US$ 274.6 Million
Growth Rate (2024 to 2034)	14.3% CAGR
Projected Value (2034F)	US$ 1.04 Billion

Even though animal-based testing accounts for 86% of the pyrogen testing market share in 2024, the rise of in-vitro-based testing systems, supported by government and NGO initiatives, is notable. These systems reduce animal suffering and environmental impact. Increasingly, industry players recognize the importance of animal welfare and are transitioning to alternative testing methods.

Market Rivalry

Key players in the pyrogen testing market are focusing on obtaining regulatory licenses, launching new products, and making acquisitions to expand their market position by adapting themselves to the evolving market trends such as focus on medical device cleaning.

• Swiss pharmaceutical and biotech company Lonza announced that it had acquired a majority share in Octane Biotech, with the option to purchase the firm outright. Octane Biotech is a medical technology firm based in Kingston, Ontario. It provided cutting-edge bioreactors, bioprocesses, and biomaterials for bioengineering and regenerative medicine solutions.
• Eurofins introduced PFAS exposure to the United States market in January 2022. This was the first direct-to-consumer at-home test that measured 47 of the "forever chemical" PFAS compounds and assessed blood PFAS levels.
• Associates of Cape Cod, Inc. (ACC) announced in April 2021 the release of PyroSmart NextGen, a novel, environmentally friendly recombinant LAL reagent for bacterial endotoxin testing (BET).

Fact.MR provides detailed information about the price points of key pyrogen testing companies positioned across the world, sales growth, production capacity, and speculative technological expansion, in this new market report.

Key Segments of Pyrogen Testing Market Research

• By Product & Service :

  • Instruments
    • Digital Tele Thermometer Equipment
    • Automated Endotoxin Testing Equipment
    • Portable Endotoxin Testing Equipment
    • Microplate Readers
  • Test Kits & Reagents
    • Recombinant Factor C Assays
    • Limulus Amebocyte Lysate (LAL) Tests
      • Chromogenic Tests
      • Turbid metric Tests
      • Gel-Clot Tests
    • Rabbit Pyrogen Tests
    • Monocyte Activity Assays
  • Consumables
  • Services
    • Endotoxin Testing Services
    • Monocyte Activation Testing Services

• By Source :

  • In-vitro-based Pyrogen Testing
    • Whole Blood-based Monocytes
    • Peripheral Blood Mononuclear Cell (PBMC)-based Monocytes
    • Cell Line-based Monocytes
  • Animal-based Pyrogen Testing
    • Recombinant Factor (rFC )
    • Bacterial Endotoxins (BET)
    • Rabbit Pyrogen Tests

• By Application :

  • Injectable Therapeutics
  • Vaccines
  • Orally-dosed Pharmaceuticals
  • Biologics
  • Implanted Medical Devices
  • Dialysis Liquids
  • Toxic/Immune-modulatory Drugs
  • Blood-Based Products

• By End User :

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Medical Device Companies
  • Diagnostic Laboratories
  • Clinical Research Organizations (CROs)
  • Clinical Manufacturing Organizations (CMOs)

• By Region :

  • North America
  • Latin America
  • Eastern Europe
  • Western Europe
  • East Asia
  • South Asia & Pacific
  • Middle East & Africa