Pyrogen Testing Market to Reach US$ 4.58 Bn by 2031, Driven by Biologics and Safety Demand

✅Overview of the Global Pyrogen Testing Market

The global pyrogen testing market was valued at US$ 1.45 billion in 2021 and is poised to grow at a robust CAGR of 12.2% over the next ten years. By 2031, the market is projected to achieve a valuation of US$ 4.58 billion, driven by increasing pharmaceutical and biotechnology R&D, strict regulatory standards, and the growing need for safe biologics and medical devices.

The endotoxin testing segment dominates the market due to its high adoption rate across drug development and manufacturing. Regionally, North America leads the global market, propelled by strong investment in biotechnology, stringent FDA regulations, and a mature healthcare infrastructure that emphasizes product safety and compliance.

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✅Key Highlights from the Report

➤The market is projected to grow at a CAGR of 12.2% between 2021 and 2031.
➤Endotoxin testing remains the most widely adopted pyrogen detection method.
➤North America is the leading region due to regulatory compliance and biotech growth.
➤Rising biologics production is a key growth catalyst for the market.
➤In-vitro testing methods are gaining traction over animal-based tests.
➤The pharmaceutical and medical device industries are primary end-users of pyrogen testing.

✅Frequently Searched Question

What are the different types of pyrogen tests and how do they work?

Pyrogen testing involves detecting substances that cause fever when present in the bloodstream, especially in injectable drugs and medical devices. There are three primary types of pyrogen tests: the Rabbit Pyrogen Test (RPT), the Bacterial Endotoxin Test (BET), and the Monocyte Activation Test (MAT).

RPT uses live rabbits to monitor body temperature after exposure to the test substance, offering broad-spectrum detection but is time-consuming and ethically sensitive. BET, often conducted using the Limulus Amebocyte Lysate (LAL) assay, is specific to bacterial endotoxins and is widely accepted due to its high sensitivity and efficiency. MAT is a modern in-vitro method that detects a broader range of pyrogens, including non-endotoxin ones, by assessing cytokine release in human immune cells. Each method has its advantages and applications, but industry trends increasingly favor in-vitro tests due to ethical considerations and regulatory shifts toward animal-free alternatives.

✅Market Segmentation

The pyrogen testing market is segmented by product type, including instruments, kits & reagents, and services. Kits and reagents dominate due to their recurring demand in routine testing and their vital role in facilitating rapid and accurate results. The increasing number of drug approvals and biologic therapies has further propelled the demand for these consumables.

By end-user, the market is categorized into pharmaceutical companies, biotechnology firms, medical device manufacturers, and others. Pharmaceutical companies represent the largest share, driven by the strict safety requirements for injectable drugs and vaccines. Additionally, with the rise in biologics and biosimilars, biotechnology firms are also significantly contributing to the demand for advanced pyrogen detection technologies.

✅Regional Insights

North America holds the largest market share due to its well-established regulatory framework, high R&D investment, and technological advancements in pharmaceutical manufacturing. The presence of major players and increasing adoption of in-vitro testing methods further fuels regional growth.

Asia Pacific is expected to witness the fastest growth during the forecast period. Increasing pharmaceutical production, regulatory reforms, and the expansion of clinical trials in countries like India, China, and South Korea are accelerating demand for pyrogen testing solutions in the region.

✅Market Drivers

A key driver for the pyrogen testing market is the increasing global demand for biologics and injectable drugs. With the growth of therapeutic monoclonal antibodies, vaccines, and cell therapies, the need for stringent quality control to detect pyrogens is critical. In parallel, regulatory authorities like the FDA and EMA have reinforced compliance frameworks mandating pyrogen testing before product approval.

✅Market Restraints

Despite positive growth prospects, the market faces ethical and operational challenges related to animal-based testing, especially the Rabbit Pyrogen Test. Additionally, high costs associated with in-vitro methods and the need for specialized laboratories can be barriers for small-scale manufacturers. Regulatory complexity in emerging economies may also slow adoption.

✅Market Opportunities

The market presents strong opportunities in the development of animal-free pyrogen testing methods such as the MAT. Increasing awareness about animal welfare and regulatory shifts are expected to promote these alternatives. Moreover, technological advancements and automation in testing platforms are expected to reduce costs and improve test turnaround times, opening doors for widespread market penetration.

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✅Company Insights

✦Thermo Fisher Scientific Inc.
✦Lonza Group Ltd.
✦Charles River Laboratories International, Inc.
✦Merck KGaA
✦Wako Chemicals USA, Inc. (FUJIFILM Holdings Corporation)
✦Associates of Cape Cod, Inc.
✦Nelson Laboratories, LLC
✦Sanquin
✦Sartorius AG
✦bioMérieux

■In April 2023, Lonza expanded its endotoxin testing solutions by integrating advanced automation into its platform to enhance productivity and accuracy.

■In June 2022, Merck KGaA announced the launch of its PyroMAT® system for monocyte activation testing, aligning with global moves toward animal-free safety testing.

✅Conclusion

The global pyrogen testing market is on a strong growth trajectory, fueled by the rising demand for safe pharmaceuticals and medical devices, evolving regulatory frameworks, and increasing investments in biologics. As companies continue to transition from traditional to advanced, animal-free testing methods, the market is expected to witness technological evolution and wider adoption. With North America leading the charge and Asia Pacific emerging rapidly, stakeholders must align with innovation and regulatory compliance to tap into future growth opportunities.

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This release was published on openPR.