According to the current analysis of Reports and Data, the endotoxin testing Market has an estimated value of USD 767.1 Million in 2020 and with a CAGR of 11.5% is projected to reach USD 1,843.4 Million by 2028. Endotoxin monitoring takes place at various phases of the manufacturing and development of bulk lot release testing, raw material testing, and final product release testing. Endotoxin testing has its application in multiple industries such as medical devices, biopharmaceuticals, research, and the pharmaceutical industry on a larger scale. Limulus Amebocyte Lysate assay is the preferred choice of endotoxin test used in the parenteral pharmaceuticals. A bacterial endotoxin test involves several processes, including analyses of the liquid sample or sample extract using Limulus Amebocyte Lysate (LAL). Generally, LAL is a reagent that is made from horseshoe crab blood. In the presence of bacterial endotoxins, the lysate reacts to form a clot or causes a color change depending on the technique.
Tachypleus Amebocyte Lysate is one more approved test; however, it is only limited to Asia. The demand for biologics has triggered the need for more Limulus amebocyte lysate and Tachypleus amebocyte lysate testing in every industry. The rising demand for the endotoxins market is expected to propel market growth in the near future as industry players are bringing in newer methods. For instance, techniques such as USP chromogenic method by Sigma-Aldrich Co. LLC or the Endosafe-PTS test by Charles River Laboratories, Inc have been developed. Moreover, the industry is consolidating by acquiring companies’ expertise in proving the endotoxin test. For instance, in December 2016, Fujifilm agreed to acquire Wako Pure Chemical Industries, Ltd. for USD 1.40 billion. The acquisition is expected to help Fujifilm in the field of regenerative medicine, contract development and manufacturing organization, and in-vitro diagnostics.
Availability of a wide range of products such as endotoxin detection removal kits, endotoxin removal products, and low endotoxin recovery (LER) products will gain traction all over the world. Additionally, preference for animal-free tests is gaining popularity; new product launches along with increasing partnerships will drive the market growth successfully during the forecast period. However, less availability of advanced kits and instruments, strict regulations for medical devices, high investment for research, and affordability issues are the key factors limiting the market growth during the forecast period.
In-depth Study of the Competitive Landscape:
The global Endotoxin Testing market consists of various market players, which make this business sphere highly competitive. In this section of the report, the authors have provided authentic information on product portfolios, new product innovations, technological capabilities, and product pricing strategies of each of these players. Moreover, it discusses the key strategies implemented by these players, such as mergers acquisitions, joint ventures, collaborations, partnerships, and agreements, to build on their market presence.
Top companies profiled in the report include:
Lonza, Charles River, Associates Of Cape Cod, Inc., Fujifilm Wako Chemicals U.S.A. Corporation, Pacific BioLabs, Fuzhou Xinbei Biochemical Industrial Co., Ltd, Hyglos GmbH , Steris Laboratories, Avantor, Merck Millipore and Sigma-Aldrich, Nelson Labs, and Sartorius AG
Key Market Regions Covered in the Report:
- North America (U.S., Canada)
- Europe (U.K., Italy, Germany, France, Rest of EU)
- Latin America (Chile, Brazil, Argentina, Rest of Latin America)
- Asia Pacific (India, Japan, China, South Korea, Australia, Rest of APAC)
- The Middle East Africa (Saudi Arabia, U.A.E., South Africa, Rest of MEA)
Test Methods Outlook (Revenue, USD Million; 2020-2028)
- Gel-Clot Test
- Instrument
- Reagent/Kits
- Consumables Accessories
- Turbidimetry Test Method
- Instrument
- Reagent/Kits
- Consumables Accessories
- Chromogenic Test method
- Instrument
- Reagent/Kits
- Consumables Accessories
- Rabbit Pyrogen Testing Method
- Instrument
- Reagent/Kits
- Consumables Accessories
Application Outlook (Revenue, USD Million; 2020-2028)
- Biopharmaceutical Raw Materials
- Parenteral Medicines
- Implantable Devices
- Tissue Culture Medium
- Thickening Agents
- Buffer Chelating Agents
- Antioxidants Reducing Agents
- Preservatives
- Bulking Agents
- Air Filters
- Bulk/Finished Products
End Use Outlook (Revenue, USD Million; 2020-2028)
- Biopharmaceutical Pharmaceutical Companies
- Contract Research Organization (CRO)
- Contract Manufacturing Organization (CMO)
- Cell Banks
- Academic Research Institutes
Frequently asked questions addressed in the report:
- What is the revenue growth rate of the global Endotoxin Testing market over the forecast period?
- What are the major factors driving the growth of the Global Endotoxin Testing Market?
- What are the key challenges impacting the global Endotoxin Testing market growth?
- What are the outcomes of the SWOT Analysis and Porter’s Five Forces Analysis conducted in the report?
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