Global LAL And Pyrogen Testing Market Size By Product (Instruments, Services, Consumables), By Test Type (LAL Test, In Vitro Pyrogen Test, Rabbit Test), By End User (Pharmaceutical & Biotechnology, Medical Devices), By Geographic Scope And Forecast

LAL And Pyrogen Testing Market Size And Forecast

LAL And Pyrogen Testing Market size was valued at USD 1.9 Billion in 2024 and is projected to reach USD 3 Billion by 2031, growing at a CAGR of 8.66% from 2024 to 2031.

Increasing demand for pyrogen testing products in the pharmaceutical and biotechnology industry is a major factor contributing to the growth of the market. Rapidly growing pharmaceutical and biotechnology industries along with the escalating number of new therapeutics launched are expected to boost the demand for LAL and pyrogen testing products. The Global LAL And Pyrogen Testing Market report provides a holistic evaluation of the market. The report offers a comprehensive analysis of key segments, trends, drivers, restraints, competitive landscape, and factors that are playing a substantial role in the market.

Global LAL And Pyrogen Testing Market Definition

Pyrogens are molecular products of microbial origin that induce immunologic reactions in humans or test animals when administered parenterally. Pyrogens, being fever-inducing organic substances, play a vital role when dealing with different diseases. Pyrogen testing, especially Limulus amebocyte lysate (LAL) testing, is highly recommended and is an integral part of pharmaceutical microbiology to test bacterial endotoxin. The Limulus amebocyte lysate (LAL) test is used to measure the concentration of endotoxins of gram-negative bacteria.

Pyrogens are substances that cause fever, post-administration of an injection. An increase in body temperature and body ache are prominent reactions caused by to injection of harmful pyrogens into the body. Pyrogen testing determines the presence of endotoxin substances. The test has become important for the analysis of fever-inducing substances in parenteral drugs. Monocyte activation test (MAT), LAL test and rabbit pyrogen test are various types of pyrogen tests. Pyrogen testing is used by pharmaceutical, biotechnological companies and medical devices companies to ensure the absence of these toxic molecular products.

LAL and Pyrogen testing is an imperative and mandatory process, which is performed in drug and medical device manufacturing units. Pyrogen contamination is usually present in both drugs and medical devices, which can be sometimes responsible for infecting patients with certain life-threatening conditions. Pyrogen testing protocol is thus necessary and continues to drive the market for LAL and pyrogen testing globally.

Global LAL And Pyrogen Testing Market Overview

The major drivers for the market are rapid growth in the pharmaceutical and biotechnology industries and a strong trend of R&D investments in the life sciences industry. An increasing number of new drug launches, rise in chronic disease burden, and increasing government support for the pharmaceutical and biotechnology industries will also aid the growth of the market. Rising investment in R&D by manufacturing companies and the government for new product development is another major factor that contributed to the growth of the market.

New product development and launch is a key strategy acquired by manufacturers to maintain their dominance and to get maximum revenue share in the sector. Thus, the demand for LAL and pyrogen testing products is expected to upsurge in the near future, which is projected to boost the market growth. Furthermore, the rising demand for such in vitro assays to detect the presence and concentration of bacterial endotoxins in biological products and drugs is expected to drive the growth of the market for LAL and pyrogen testing.

A recent trend among biopharmaceutical companies observes an increase in new drug approvals in the areas of high unmet needs. In addition, regulatory authorities such as the FDA has also undertaken a number of steps to enhance the first action approval rate. Thus, with the increase in the number of drug approvals, the demand for pyrogen testing will grow and will continue to drive the market in the forecast period. Moreover, increasing per capita healthcare expenditure is also likely to increase the growth of the LAL And Pyrogen Testing Market.

Increasing healthcare spending is expected to result in rising demand for better quality pharmaceuticals and medical devices, and in turn, will create lucrative growth opportunities for market players in the Global LAL And Pyrogen Testing Market. However, the increasing application for animal-free tests is a predominant factor that could hinder the use of this test type to some extent in the near future. The popularity of animal-free tests is increasing because of their ability to assess the product without harming living organisms.

Global LAL And Pyrogen Testing MarketSegmentation Analysis

The Global LAL And Pyrogen Testing Market is Segmented on the basis of Product, Test Type, End User, and Geography.

LAL And Pyrogen Testing Market, By Product

• Instruments
• Services
• Consumables

Based on Product, The market is segmented into Instruments, Services, Consumables. In 2019, the consumables segment was the largest revenue-generating segment and is also estimated to maintain its dominance during the forecast period. The rising prevalence of chronic diseases boosts the production of pharmaceuticals, biologics, and medical devices products. Thus, the increasing production of these products propels the application of pyrogen testing consumables including kits and reagents.

LAL And Pyrogen Testing Market, By Test Type

• LAL Test
• In Vitro Pyrogen Test
• Rabbit Test

Based on Test Type, The market is bifurcated into LAL Test, In Vitro Pyrogen Test, and Rabbit Test. LAL test is further categorized into a turbidimetric test, chromogenic test, and gel clot test. LAL test is expected to showcase the fastest growth during the forecast period due to rising demand for animal-free detection tests along with its high reliability and reproducibility during detection.

LAL And Pyrogen Testing Market, By End User

• Pharmaceutical & Biotechnology
• Medical Devices
• Other

Based on End User, The market is bifurcated into Pharmaceutical & Biotechnology, Medical Devices, and Other. The pharmaceutical and biotechnology companies dominated the overall market in 2019 due to the rising production of pharmaceuticals, biopharmaceuticals, and other biologic products. Hence, the increasing need for pyrogen testing consumables and instruments in these companies propels the growth of the LAL And Pyrogen Testing Market. The medical devices companies’ segment is expected to witness significant growth over the forecast period. The introduction of technologically advanced products and rising demand for high-quality medical devices for therapeutic and diagnostics applications is anticipated to increase the usage of pyrogen testing in the near future.

LAL And Pyrogen Testing Market, By Geography

• North America
• Europe
• Asia Pacific
•  Rest of the world

Based on Regional Analysis, The Global LAL And Pyrogen Testing Market is classified into North America, Europe, Asia Pacific, and Rest of the world. North America dominated the Global LAL And Pyrogen Testing Market in 2019, followed by Europe. North America accounted for a major share of the Global LAL And Pyrogen Testing Market in 2019, owing to the increase in the availability of technologically advanced research & development platforms for the diagnosis test and rapid adoption of new technologies. The LAL And Pyrogen Testing Market in the Asia Pacific is anticipated to expand at a high CAGR from 2019 to 2027. This can be attributed to rapid economic growth in developing economies such as India, China, rise in healthcare expenditure, and expansion of the pharmaceutical industry.

Key Players

The “Global LAL And Pyrogen Testing Market” study report will provide valuable insight with an emphasis on the global market. The major players in the market are Thermo Fisher Scientific, Inc., Associates of Cape Cod, Inc., Merck KGaA, Charles River Laboratories International, Inc., GenScript, Lonza Group, Ellab A/S, Sanquin, Wako Chemicals USA, Inc., and WuXi AppTec. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Key Developments

Partnerships, Collaborations and Agreements

• Lonza Sales AG and Sanquin Reagents BV announced a strategic collaboration in July 2020 to commercialise a set of specialised reagents for pyrogen testing of parenteral pharmaceuticals and medical devices using the monocyte activation test (MAT).

Mergers and Acquisitions

• Eurofins Scientific purchased EAG Laboratories in December 2018. Eurofins’ global offering in the biopharmaceutical testing sectors will be bolstered by this acquisition.

Product Launches and Product Expansions

• Lonza (Switzerland) launched the PyroCell Monocyte Activation Test System for reliable and long-term in vitro pyrogen testing in October 2020.
• ENDOZYMEII GO, a revolutionary test for identifying endotoxins in pharmaceutical grade water, injectable pharmaceuticals, and other pharmaceutical items, was launched in May 2018 by bioMérieux SA (France).

Report Scope

Research Methodology of Market Research

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Reasons to Purchase this Report

• Qualitative and quantitative analysis of the market based on segmentation involving both economic as well as non-economic factors• Provision of market value (USD Billion) data for each segment and sub-segment• Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market• Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region• Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions and acquisitions in the past five years of companies profiled• Extensive company profiles comprising of company overview, company insights, product benchmarking and SWOT analysis for the major market players• The current as well as the future market outlook of the industry with respect to recent developments (which involve growth opportunities and drivers as well as challenges and restraints of both emerging as well as developed regions• Includes an in-depth analysis of the market of various perspectives through Porter’s five forces analysis• Provides insight into the market through Value Chain• Market dynamics scenario, along with growth opportunities of the market in the years to come• 6-month post-sales analyst support

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