Pyrogen Testing Market Size, Share, Opportunities, And Trends By Product (Kits And Reagents, Instruments, Services), By Test Type (LAL Test, In Vitro Pyrogen Test, Rabbit Test), By End-User (Pharmaceutical And Biotechnology Companies, Medical Devices Companies, Others), And By Geography - Forecasts From 2024 To 2029

The pyrogen testing market is anticipated to show steady growth during the forecast period.

Pyrogen testing is a procedure used to verify the absence of pyrogens in pharmaceutical products, which are known to induce fevers if present in medical devices or drugs. Pyrogen testing ensures the safety of products designed for injection into the body (parenteral products), such as injectable medications, IV fluids, vaccines, insulin, and implantable medical devices. The growing prevalence of chronic diseases, increasing demand for pharmaceuticals and medical devices, and favorable initiatives in pyrogen testing are driving the pyrogen market growth.

Market Drivers:

• The growing prevalence of chronic diseases drives the pyrogen testing market growth.

Infections are frequently brought about by microorganisms such as bacteria, viruses, or fungi which can produce pyrogens, which are harmful substances that trigger fever and inflammation within the body. The rising chronic diseases are expected to drive the usage of pyrogen testing for developing effective medical devices for preventing such diseases.  According to the World Health Organization published article on non-communicable diseases in September 2023, it is stated that Cardiovascular diseases are responsible for the majority of deaths caused by non-communicable diseases, with an annual toll of 17.9 million individuals. This is followed by cancers, which claim the lives of 9.3 million people each year. Chronic respiratory diseases account for 4.1 million deaths annually, while diabetes, including kidney disease deaths caused by diabetes, contributes to 2.0 million fatalities. According to the Centers for Disease Control and Prevention (CDS) published article, six out of every ten individuals in the United States are affected by a chronic illness, such as heart disease, stroke, cancer, or diabetes.

• The booming pharmaceutical and medical device industry drives the pyrogen testing market growth.

The pharmaceutical and medical device sectors depend on pyrogen testing to guarantee the safety of patients. The type of testing is crucial for identifying pyrogens, which are toxins responsible for causing fever, in injectable medications and devices. The Limulus Amebocyte Lysate (LAL) test and the Monocyte Activation Test (MAT) are the two most frequently used methods, providing viable alternatives to traditional animal testing. For instance, according to the Annual Report of the Department of Pharmaceuticals India in the fiscal year 2021-22, the pharmaceutical sector witnessed total exports amounting to Rs. 1,74,955 crore (USD 23.5 Bn) and total imports valued at Rs. 60,060 crore (USD 8.06 Bn). This led to a trade surplus of Rs. 1,14,895 crore (USD 15.44 Bn).

• Favorable initiatives boost the pyrogen testing market growth.

Pyrogen testing is undergoing innovation, as the research and development is currently prioritizing the substitution of animal tests with cell-based (MAT) and bacterial (BET) methods, which provide a more ethical and all-encompassing approach. According to the European Directorate For The Quality Of Medicines and Health Care, In June of 2021, the European Pharmacopoeia Commission (EPC) determined to initiate a procedure that will result in the full replacement of the rabbit pyrogen test (RPT) in the European Pharmacopoeia (Ph. Eur.) in around 5 years. The action demonstrates a dedication to gradually eliminating the use of animal testing and advocating for alternative approaches such as the Bacterial Endotoxins Test (BET) and Monocyte-Activation Test (MAT).

North America is anticipated to grow gradually.

North America is projected to account for a significant share of the pyrogen test market due to increasing consciousness regarding product and food safety. According to the U.S. Food and Drug Administration (FDA), September is dedicated to “Food Safety Education Month” for raising awareness about the importance of preventing foodborne illness, commonly referred to as "food poisoning." According to the Federal government, approximately 48 million cases of foodborne illness occur each year, affecting about 1 in 6 Americans. These illnesses lead to an estimated 128,000 hospitalizations and 3,000 deaths annually.

Market Restraints

• Ethical issues surrounding animal experimentation restrain the pyrogen test market growth.

The rabbit pyrogen test (RPT) highlights ethical considerations surrounding animal experimentation, particularly for the well-being of animals. There is an increasing trend towards adopting alternative in-vitro testing techniques.

Testing is associated with a significant financial burden which hinders the market expansion.

Traditional methods for testing pyrogens, such as the Rabbit Pyrogen Test, can prove costly and time-consuming. This can pose a significant challenge for smaller manufacturers or those operating with limited resources.

Key Developments

• October 2023: Lonza introduced two MAT systems, PyroCell MAT Human Serum (HS) Rapid System and PyroCell MAT Rapid System. Enhance efficiency and simplify pyrogen testing without the need for rabbits. The new systems, set to replace Lonza's existing MAT system kit options, feature the innovative PeliKine Human IL-6 Rapid ELISA Kit, which decreases manual labor and shortens the time to results from 48 hours to just 2 hours.
• June 2023: Intravacc partnered with Sanquin Diagnostic Services aimed at enhancing the in vitro MAT and substituting the animal pyrogen test for OMV vaccines.

Company Products

• Pyrotell: The product called Pyrotell® lysate, offered by Associates of Cape Cod Incorporated company, offers convenience and ease of use. It is accessible in cost-effective multi-test vials as well as convenient Single Test Vials (STVs). Pyrotell lysate is a reliable reagent that generates well-defined clots, ensuring readability, and exhibits resistance to potential interfering substances.
• Pyrogent Plus: Lonza Group offers pyrogent plus, in which the Gel streamlines the process of pyrogen testing in injectable drugs and medical devices by integrating the lysate (detection reagent) and endotoxin (control standard) into a single kit, ensuring convenient and dependable detection of pyrogens.
• Pierce Pyrogen-free Glass Test Tubes: The product offered by ThermoFisher Scientific where the test tubes have been guaranteed to have extremely low levels of endotoxin (less than 0.005 EU/mL), making them perfect for pyrogen testing or for the safe handling of injectable drugs and other solutions that require pyrogen-free environments.
• ToxinSensors Endotoxin Free Tube:  The Product offered by GenScript called ToxinSensor™ Endotoxin-free Tubes have been specifically crafted to protect delicate samples from pyrogens, harmful substances that have the potential to induce fever. They are made from high-quality research-grade glass.

Segmentation

• By Product
  • Kits and Reagents
  • Instruments
  • Services
• By Test Type
  • LAL Test
  • In Vitro Pyrogen Test
  • Rabbit Test
• By End-User
  • Pharmaceutical and Biotechnology Companies
  • Medical Devices Companies
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • South America
    • Brazil
    • Argentina
    • Others
  • Europe
    • United Kingdom
    • Germany
    • France
    • Italy
    • Spain
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • UAE
    • Others
  • Asia Pacific
    • Japan
    • China
    • India
    • South Korea
    • Taiwan
    • Thailand
    • Indonesia
    • Others