In 2024, the global pyrogen testing market was valued at USD 1.36 billion and is forecast to grow to USD 2.49 billion by 2030, reflecting a compound annual growth rate (CAGR) of 11.2 % from 2025 to 2030. The increasing need for pyrogen testing in the pharmaceutical and biotechnology sectors is a key factor driving this growth.
Key Market Trends & Insights
- In 2024, North America held the leading position, accounting for 36.65 % of global revenue.
- The Asia Pacific region is projected to register the fastest growth, with a CAGR of 12.4 % over the forecast period.
- Among product categories, the consumables segment commanded the largest share in 2024 at 43.60 %.
- Based on test type, the LAL test was dominant, capturing 63.15 % of the market in 2024.
- In terms of end-use, pharmaceutical and biotechnology companies accounted for 62.21 % of the market in that year.
Market Size & Forecast
- 2024 market size: USD 1.36 billion
- 2030 forecast: USD 2.49 billion
- CAGR (2025–2030): 11.2 %
North America retained the top regional share in 2024, while Asia Pacific is expected to demonstrate the fastest growth through 2030. The expansion of pharmaceutical and biotechnology industries, together with the frequent launch of new therapeutics, is expected to fuel demand for pyrogen testing tools and services. Regulatory initiatives and industry policies are increasingly promoting non-animal pyrogen testing methods. Notably, in June 2024, the 179th session of the European Pharmacopoeia Commission removed the Rabbit Pyrogen Test requirement from 57 textual revisions and introduced a general chapter on Pyrogenicity, reinforcing the shift toward in vitro testing.
Strong public and private investment in research and development also propels growth. For example, in Europe in 2022, the research-based pharmaceutical industry invested about USD 48.65 billion in R&D. As the number of drug candidates and approvals increases, pyrogen testing becomes ever more essential to ensure product safety, particularly for sterile products that must also be pyrogen-free, beyond merely sterile.
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Key Companies & Market Share Insight
The pyrogen testing market is currently at a medium growth stage, with momentum speeding up. Innovation—especially in animal-free testing approaches—and regulatory pressures are compelling firms to adopt new techniques. Market consolidation via mergers and acquisitions is common, as firms seek access to novel technologies, broader customer bases, or geographic expansion. Regulations, especially from agencies like the FDA, enforce stringent requirements for pyrogen testing as part of safety assurance in pharmaceuticals and biologics, reinforcing the reliance on alternative, non-animal testing systems.
Leading players are intensively focusing on regional expansion, partnerships, collaborations, and new product introductions to maintain or grow market presence. Their geographic reach, technological portfolios, and scale all contribute to dominance in this sector.
Key Companies
Major companies operating in the pyrogen testing industry include:
- Charles River Laboratories
- Novo Nordisk
- Merck KGaA
- GenScript
- bioMérieux SA
- Lonza Group
- Thermo Fisher Scientific, Inc.
- Seikagaku Biobusiness Corporation
- FUJIFILM Wako Chemicals U.S.A. Corporation (Pyrostar)
- MiCAN Technologies Inc.
These firms collectively hold substantial market share and set major industry trends.
Conclusion
Overall, the pyrogen testing market is projected to experience robust expansion through 2030, driven primarily by growing demand in pharmaceutical and biotech applications, rising regulatory pressure favoring non-animal testing approaches, and advancing technologies. The dominance of regions like North America, coupled with high growth in Asia Pacific, highlights the geographic dynamics at play. Key segments such as consumables and LAL-based testing remain central to market structure, supported by leaders who leverage innovation, strategic partnerships, and global reach to shape the industry’s trajectory.
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