Endotoxin Testing Market By Product (Endotoxin Detection Kits & Reagents, Instruments & Systems, Consumables & Accessories), By Test (LAL Test, MAT Test, Rabbit Pyrogen Test, Recombinant Factor C (rFC) Assay), By Application (Medical Device Manufacturing, Pharmaceutical Manufacturing, Raw Materials Production) - Growth, Future Prospects & Competitive Analysis, 2021 – 2029

02 Mar 2021 Format PDF icon PPT icon XLS icon Request Sample

The global endotoxin testing market is developing significantly with an expected CAGR of 8.5% from 2019 - 2029. Advances in technological processes are the key growth factor. For example:  Limulus Amebocyte Lysate (LAL) test has been recommended by European and American pharmacopeia to identify bacterial endotoxins in the drugs through LAL test. This method was introduced in 1960s however, introduction on various kinds of reagents, kits and devices have simplified the process, thereby increasing the revenues and creating significant opportunities. The impact of covid 19 was severe in healthcare, though this market is not directly related to healthcare delivery institution, however, struggled due to pause on clinical trials across pharma and medical devices during the pandemic. The devices and drugs related to covid 19 were given utmost priority and further delays are expected for other range of devices and drugs awaiting FDA approvals. The report discusses impact of covid 19 over the market revenues and operational impact by geography  in  further detail. 

Endotoxin Testing Market

Investment in Medical Devices Propelling Market Growth 

The transition of medical device industry post the medical outsourcing has led to increased avenues in the developing economies as a result of increased and favorable public initiatives, regulations and increased market penetration for medical devices. Apart from widening scope of medical devices there has been tremendous growth and advances in automation of data entry, data management and reporting. Emerging technological advancement withrespect to laboratory testing has expanded the demand in Europe and Asia pacific. The key methods included in the endotoxin testing include turbidimetric method, gel clot method and custom method development. The key application areas include medical device manufacturing, pharmaceutical manufacturing, packaging manufacture and raw materials production. Advancements in products offering strong linearity and high sensitivity with reproducibility have led to higher revenues across the globe.  Increasing developments withrespect to the entire healthcare industry and its infrastructure and emerging regulatory framework in developing economies such as China and India are expected to increase market revenues. However there is high cost involved in endotoxicin testing systems, apart from complexity in low endotixin recovery and stringent regulation in animal testing are expected to hamper the development in the market during the forecast period. 

LAL Test Leads the Current and the Future Market 

The endotoxin test uses methods such as Limulus amoeba cell lysate (LAL), rabbit pyrogen test (RPT), monocyte activation test (MAT), and recombinant factor C test, are deployed in the endotoxin testing. The LAL method has been used in pyrogen testing for over 30 years to detect endotoxins and is still expected to witness highest CAGR during the forecast period of 2019 to 2029.  Monocyte activation testing is an in vitro method, is a comparatively newer method in the industry. Increasing Demand for animal-free testing methods and higher precision for LAL testing contributed to the growth of this segment. It has been observed that the LAL test continues to replace RBT and is recommended by pharmaceutical companies and international organizations. In addition, introduction of various testing methods, such as chromogenic endotoxin assay, gel clot endotoxin assay, and turbidimetric method are expected to expand the opportunities and market revenues. LAL test and tachypleus amebocyte lysate testing are evidencing upward curve due to increasing demand for biologics across the globe. 

North America Remains the Key Market 

North America gained the largest share in 2019, followed by Europe in the endotoxin testing market in 2019, and the region is expected to remain strong during the 2019-2029. U.S. remains the key geographic region for endotoxin testing, the country offers a wide range of services, including scientific and manufacturing research. FDA-approved endotoxin testing techniques, increasing investment in pharmaceutical and biotechonology industries in APAC, Increasing adoption of advanced kits and systems have expanded the global market widely.  The rapid growth in endotoxin testing market is therefore associated with large investments in the pharmaceutical industries by adopting high end testing systems for vaccines, biologics drug development, cancer research and other research programs. Increasing incidences of chronic disease in developed countries are expected to rise the focus on technological advancements during the forecast period, 2019 to 2029. 

Key Players to Focus on R&D 

Endotoxin testing is crucial in drug development and medical device development to contain the presence of pyrogenic substances. The key systems in the industry include ToxinSensor™ endotoxin discovery framework, PyroMAT™ System, Kinetic-QCLTM Kinetic Chromogenic LAL Assay, PYROGENTTM Gel Clot LAL Assay and others. The key players include Accugen Labs, Wako Chemicals USA, Inc., Charles River Laboratories, Inc., Pacific BioLabs, Sigma-Aldrich Co. LLC. Lonza, STERIS, Nelson Laboratories, LLC, Bio-Synthesis Inc, Biogenuix, Ellab A/S, GenScript Corporation, Thermo Fisher Scientific, Inc., Merck KGaA and others. The key strategy of these companies include R&D investment leading to increased FDA approvals of endotoxin testing systems and kits.

Historical & Forecast Period

This study report represents analysis of each segment from 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.

The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.

Research Methodology

The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Endotoxin Testing market are as follows:

  • Research and development budgets of manufacturers and government spending
  • Revenues of key companies in the market segment
  • Number of end users and consumption volume, price and value.
  • Geographical revenues generate by countries considered in the report
  • Micro and macro environment factors that are currently influencing the Endotoxin Testing market and their expected impact during the forecast period.

Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.

Research Period  2022-2032
Base Year 2023
Forecast Period  2024-2032
Historical Year  2022
Unit  USD Million
  • Endotoxin Detection Kits & Reagents
  • Instruments & Systems
  • Consumables & Accessories

  • LAL Test
    •     Chromogenic Tests
    •     Turbidimetric Tests
    •     Gel Clot Tests
  • MAT Test
  • Rabbit Pyrogen Test
  • Recombinant Factor C (rFC) Assay

  • Medical Device Manufacturing
  • Pharmaceutical Manufacturing
  • Raw Materials Production

 Region Segment (2022-2032; US$ Million)

  • North America
    • U.S.
    • Canada
    • Rest of North America
  • UK and European Union
    • UK
    • Germany
    • Spain
    • Italy
    • France
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East and Africa
    • GCC
    • Africa
    • Rest of Middle East and Africa

Key questions answered in this report

  • What are the key micro and macro environmental factors that are impacting the growth of Endotoxin Testing market?
  • What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?
  • Estimated forecast and market projections up to 2032.
  • Which segment accounts for the fastest CAGR during the forecast period?
  • Which market segment holds a larger market share and why?
  • Are low and middle-income economies investing in the Endotoxin Testing market?
  • Which is the largest regional market for Endotoxin Testing market?
  • What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?
  • Which are the key trends driving Endotoxin Testing market growth?
  • Who are the key competitors and what are their key strategies to enhance their market presence in the Endotoxin Testing market worldwide?
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