According to the report by Expert Market Research (EMR), the global pyrogen testing market is projected to grow at a CAGR of 11.70% between 2024 and 2032. Aided by the stringent regulatory standards in the pharmaceutical and biotechnology industries and the increasing number of drug launches, the market is expected to grow significantly by 2032.
Pyrogens are substances, primarily endotoxins or metabolic byproducts, that can cause fever when introduced into the bloodstream. Their presence can be a concern, especially in pharmaceutical products, medical devices, and other therapeutic products.
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The pyrogen testing process is critical to ensure that these substances are absent, making the products safe for human use. It’s an indispensable part of quality control in various industries, primarily pharmaceuticals.
One of the driving factors for the pyrogen testing market growth is the rigorous standards set by regulatory bodies, like the FDA, EMA, and WHO, for product approvals. These organisations mandate a series of tests, including pyrogen testing, to ensure the safety and efficacy of drugs and medical devices. As a result, manufacturers are integrating advanced pyrogen testing techniques in their production processes.
Furthermore, the increasing number of biologics, vaccines, and other drug products entering the market amplifies the pyrogen testing market demand. The rapid advancements in biotechnology and the introduction of novel therapeutic products necessitate thorough safety evaluations, including checks for pyrogenicity.
The Limulus amoebocyte lysate (LAL) test, a primary method in pyrogen testing, has gained substantial traction due to its sensitivity, specificity, and rapid results. This test uses blood from horseshoe crabs to detect endotoxin presence, making it a preferred method over traditional rabbit tests, which are time-consuming and less efficient, further increasing the value of the pyrogen testing market size.
The growing trend of outsourcing pyrogen testing services also significantly influences the market dynamics. Many pharmaceutical companies prefer to outsource these tests to specialised labs and contract research organisations (CROs) to reduce costs, streamline operations, and benefit from the expertise of these external entities.
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As per the pyrogen testing market analysis, the expansion of the biosimilars market and the introduction of advanced therapies, like cell and gene therapies, present new avenues for pyrogen testing. These products, due to their complex nature, demand robust testing protocols to ensure their safety and effectiveness.
Pyrogen Testing Market Segmentation
The market can be divided based on product type, test type, end use, and region.
Market Breakup by Product Type
- Kits and Reagents
- Services
- Instruments
Market Breakup by Test Type
- LAL Test
- Chromogenic Tests
- Turbidimetric Tests
- Gel Clot Tests
- Rabbit Pyrogen Tests
- Monocyte Activation Test
- Others
Market Breakup by End Use
- Medical Devices
- Pharmaceutical Companies
- Biotechnology Companies
- Others
Market Breakup by Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
Competitive Landscape
The EMR report looks into the market shares, plant turnarounds, capacities, investments, and mergers and acquisitions, among other major developments, of the leading companies operating in the global pyrogen testing market. Some of the major players explored in the report by Expert Market Research are as follows:
- Charles River Laboratories International, Inc.
- Merck KGaA
- Microcoat Biotechnologie GmbH
- Ellab A/S
- Lonza Group
- Others
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