Industry Overview
The Global pyrogen Testing Market is expected to grow from USD 1.1 billion to USD 3.5 billion by 2030 at a CAGR of 12.5% during the forecast period ranging from 2025 to 2030.
Pyrogen testing refers to a specific testing phase in the manufacturing process. This is a mandatory testing phase that helps in detecting latent bacterial contaminants in a product and to deactivate or eliminate them. Different products are also used for diagnostic and treatment purposes. Different methods are followed for pyrogen testing, but the most commonly used procedure is the Limulus Amoebocyte Lysate test. In this particular process, the blood of the horseshoe crab is used to detect endotoxins. Other methods include the rabbit test and monocyte activation test (MAT). However, the rabbit test is performed less often due to ethical concerns. The market includes different participants, such as testing laboratories, manufacturers of testing products, and contract research organizations (CROs).
The global pyrogen testing market is growing mainly due to the expansion of the pharmaceutical and biotechnology industries. Apart from that, a large number of drug and product launches and a rise in the implementation of kit-based testing push the market further forward.
The strict regulatory standards by the government prevent new entries to the market and hinder its growth significantly. However, the growing trend of pharmaceutical outsourcing especially in developing countries is also creating new growth opportunities.
Market Segmentation
Insight by Product
The global pyrogen testing market is divided by-products into kits and reagents, instruments, and services segments. Out of these segments, the kits and reagents segment is expected to grow due to higher implementation in testing and purchase of kits.
Insight by Application
The global pyrogen testing market is divided by application into pharmaceutical and biological manufacturing, medical device manufacturing, and other applications. Out of these segments, the pharmaceutical and biological manufacturing segment will grow more due to faster growth of these industries, higher investment in R&D by companies for drug development, and more production of therapeutics.
Insight by Test Type
The global pyrogen testing market is also segmented by test type into LAL (Limulus Amebocyte Lysate) tests, rabbit tests, and in vitro test segments. The LAL segment is expected to grow more due to cost-effectiveness, faster results, higher accuracy, lower sample requirement, ability to detect low levels of endotoxins, more flexibility, and ease of use.
Insight by End Users
The end users also divide the global pyrogen testing market into pharmaceutical and biotechnology companies, medical devices companies, and other segments. Out of them, the pharmaceutical and biotechnology companies will dominate the market due to increased production of pharmaceuticals and other biologic products.
Global Pyrogen Testing Market Report Coverage
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Report Metric
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Details
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Historical Period
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2018 - 2023
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Base Year Considered
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2024
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Forecast Period
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2025 - 2030
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Market Size in 2023
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U.S.D. 1.1 Billion
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Revenue Forecast in 2030
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U.S.D. 3.5 Billion
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Growth Rate
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12.5%
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Segments Covered in the Report
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By Product, By Application, By Test Type and by End User
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Report Scope
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Market Trends, Drivers, and Restraints; Revenue Estimation and Forecast; Segmentation Analysis; Impact of COVID-19; Companies’ Strategic Developments; Market Share Analysis of Key Players; Company Profiling
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Regions Covered in the Report
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North America, Europe, Asia-Pacific, Middle East, and Rest of the World
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Industry Dynamics
Industry Trends
The most significant trend noticed in the market is the shift from animal-based testing to in-vitro testing. There is also a significant development noticed in the life sciences industry and government support for pharmaceutical and biotechnology industries. In addition, manufacturing companies worldwide are also showing their interest to enter into this specific market.
Growth Factors
The growth factors of the global pyrogen testing market is attributed to the rising drug and product development initiatives as well as the growing demand for kits and reagents and their growing implementation. The rise in demand among people for more effective and safer healthcare products and the government's emphasis on drafting strict regulations and guidelines for patient safety and quality assurance have also propelled market growth.
Challenges
The significantly high cost of pyrogen testing, along with the substantial capital investment required, discourages widespread adoption in the healthcare sector. Smaller healthcare facilities and organizations, in particular, find it difficult to justify the expense. Furthermore, the higher degree of consolidation within the market results in fewer players, which stifles competition and innovation. This market concentration leads to slower growth and limits the ability of new entrants to establish themselves, ultimately hindering the overall expansion of the global pyrogen testing market.
Opportunities
The rise in the number of incidents of chronic diseases such as diabetes, cancer, and cardiovascular diseases is driving the demand for pyrogen testing. With an aging global population and increasing prevalence of these conditions, healthcare providers are seeking more reliable and efficient testing methods. This trend creates significant growth opportunities for the pyrogen testing market, as new technologies and improved testing methods can better meet the needs of this expanding patient population. Additionally, government initiatives and increased healthcare spending in emerging economies further boost the potential for market growth.
Geographic Overview
North America dominates the market due to higher government investment in the healthcare and pharmaceutical industries. Companies also invest more in R&D activities to develop new drugs and products, and the rising number of chronic diseases pushes the market in this region.
The Asia-Pacific market will also grow at a higher rate due to higher research and development initiatives to create new drugs, the growing occurrence of chronic diseases, and higher healthcare spending.
Competitive Insight
Key players in the pyrogen testing market are catering to the demand for these devices by investing in technologically advanced products in their product portfolio across the globe.
The Merck Group is a branded and commonly known as Merck, is a German multinational science and technology company headquartered in Darmstadt with a presence in 66 countries.
Thermo Fisher Scientific Inc. is an American-headquartered life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services.
Associates of Cape Cod, Inc., Merck KGaA, Thermo Fisher Scientific, Inc., GenScript, Charles River Laboratories, Inc., Ellab A/S, Lonza Group, and WUXI Pharmatech (Cayman) Inc. are the key players offering pyrogen testing.
Recent Developments by Key Players
Thermo Fisher Scientific Inc. and Mirxes (a Singapore-headquartered RNA technology company) entered into partnership. The agreement formalizes the commitment to collaborate, develop and clinically validate advanced, next-generation sequencing (NGS) genomic testing solutions and cancer research tailored specifically to address the needs of the Southeast Asian population.
Lonza has launched two new rapid monocyte activation test (MAT) systems, the PyroCell MAT Rapid System and PyroCell MAT Human Serum (HS) Rapid System, to streamline and simplify rabbit-free pyrogen testing. The systems, which will replace Lonza’s current MAT system kit offerings, contain the new PeliKine Human IL-6 Rapid ELISA Kit that minimizes hands-on time and reduces time-to-results from two days to two hours. The new tests give pharma manufacturers easier, faster, and more efficient MAT testing options for product safety testing while helping to reduce the reliance on animals.
The Pyrogen Testing Market report offers a comprehensive market segmentation analysis along with an estimation for the forecast period 2025–2030.
Segments Covered in the Report
- By Product
- Kits and Reagents
- Instruments and Services
- By Application
- Pharmaceutical and Biological Manufacturing
- Medical Device Manufacturing
- Others
- By Test Type
- LAL Tests
- Rabbit Tests
- In Vitro Tests
- By End-Users
- Pharmaceutical
- Biotechnology companies
- Medical devices companies
- Other
Region Covered in the Report
- North America
- Europe
- Germany
- U.K.
- France
- Italy
- Spain
- Russia
- Rest of Europe
- Asia-Pacific (APAC)
- China
- Japan
- India
- South Korea
- Rest of Asia-Pacific
- Rest of the World (RoW)
- Brazil
- Saudi Arabia
- South Africa
- U.A.E.
- Other Countries
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Source: VynZ Research
