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The pyrogen testing market was valued at approximately USD 985 million in 2020, and it is expected to reach USD 1,895 million by 2026, registering a CAGR of 9.8% during the forecast period, 2021-2026. The market is primarily driven by increased demand for pyrogenic testing products in the pharmaceutical and biotechnology industries and rising R&D expenditure in life science.
With the rising COVID-19 pandemic, the demand for pyrogen testing techniques has witnessed steady growth during the past decade due to the increasing prevalence of infectious diseases. With an increase in the incidence of infectious diseases, the demand for pyrogen testing is expected to increase during the forecast period. The endotoxin identification products can help improve the management of infectious diseases, especially in areas with inadequate healthcare infrastructure. This has led to an increase in the adoption of pyrogen testing products that helps the market grow.
Pyrogen testing is being used by pharmaceutical, biotech, and various drug manufacturing companies for the safe manufacturing and release of infection-free products into the market. Biotechnology industries have become pivotal for R&D efforts for newer healthcare and biological applications. It is thus expected to become a critical factor for determining microbes or the presence of metabolites in drugs during their manufacture.
The rising demand for pyrogen products and partnerships are expected to boost the market growth. For instance, Fujifilm Wako Chemicals provides instruments for endotoxin testing, which include Toxinometer ET-6000. This instrument can incorporate basically three testing methods Gel-clot, KTA (Kinetic Turbidimetric Assay), and KCA (Kinetic Chromogenic Assay). The toxinometer provides ease of use during the testing process as it can start a new assay while another assay is still running, which helps in the retesting of a sample. In addition, Fujifilm Wako Chemicals planned to launch the Toxinometer ET-7000 Series in 2019, which is a computer-operated instrument and has been made more user-friendly. Therefore, the increasing product launches ultimately lead to the market growth.
There are also rising R&D expenditure that has helped in driving the overall market growth. According to the 2019 European Federation of Pharmaceutical Industries and Associations (EFPIA) report, in Europe, the pharmaceutical industry invested around EUR 36,500 million in R&D in 2018. The rapidly growing pharmaceutical and biotechnology industries are expected to drive the growth of the market studied. Pyrogen testing is used by pharmaceutical, biotech, and various drug manufacturing companies for the safe manufacturing and release of infection-free products into the market.
There is also a rising need for biologics that have resulted in unprecedented growth in the number of biopharmaceutical companies. This has helped to develop therapeutically advanced drugs on a large scale, which has compelled manufacturers to improve on aspects, such as productivity, cost-efficiency, and deviations. Companies are, thus, implementing good manufacturing practices through biological testing at various levels of production cycles, thereby contributing toward the growth of the market.
Furthermore, the increase in chronic disease prevalence in developed countries has also boosted the demand for pyrogen testing along with the increasing awareness that is expected to result in high growth during the forecast period.
Scope of the Report
As per the scope of the report, pyrogen testing refers to the process of determining microbes or the presence of their metabolites in drugs and intravenous solutions during their manufacture. A pyrogen is a foreign substance that causes a fever (temperature elevation) in an animal’s body. Typically, pyrogenic substances include endotoxin and other bacterial byproducts. Vaccines and other injectable drugs must be confirmed to be pyrogen-free according to regulatory requirements of 21CFR, USP, and EP. The pyrogen testing market is segmented by product, test type (LAL Tests, rabbit pyrogen test, monocyte activation test, and other test types), end user (pharmaceutical and biotechnology companies, medical device companies, and other end users), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.
|Kits and Reagents|
|By Test Type|
|Rabbit Pyrogen Test|
|Monocyte Activation Test|
|Other Test Types|
|By End User|
|Pharmaceutical and Biotechnology Companies|
|Medical Device Companies|
|Other End Users|
Key Market Trends
The Monocyte Activation Test Segment is Expected to Witness Good Growth Over the Forecast Period
The monocyte activation test is used to detect or quantify substances that activate human monocytes or monocytic cells to release endogenous mediators, which have a role in the human fever response. This test provides a more relevant prediction of pyrogenic activity than the RPT; it can detect endotoxin and non-endotoxin pyrogens and applies to a greater variety of products than the RPT. Therefore, it is more accurate as well as more cost- and time-effective than the RPT test.
With the rising COVID-19 pandemic, the market is expected to grow as there is an increased demand for testing and vaccine manufacturing that further boosts the overall market growth. Based on the 2020 study, it has been found that the circulating monocytes and tissue macrophages participate in all stages of SARS COVID-19. They are found to contribute to clinical infection, virus resistance, and to host factors that determine disease severity, recovery, and sequelae. Therefore, the MAT test during COVID-19 vaccine development and manufacturing is found to be an important contribution to ensure human protection.
As per the publication in the Brazilian Journal of Pharmaceutical Science, the monocyte activation test is getting more attention across the pharmaceutical industry, which is boosting the growth.
In July 2020, Lonza and Sanquin Reagents entered a strategic partnership for the commercialization of a range of specialized reagents for pyrogen testing of parenteral pharmaceuticals and medical devices using the monocyte activation test. This partnership has helped expand Lonza’s extensive portfolio of endotoxin testing products. Hence, all these factors are found to boost the overall market growth.
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North America is Expected to Dominate the Pyrogen Testing Market in the Forecast Period
North America is found to dominate the overall market due to the well-established healthcare infrastructure, better regulatory framework and government support, and presence of many large biotechnological and biopharmaceutical firms, such as Merck and Lonza Group, among others. There is also a well-established healthcare infrastructure, better regulatory framework, increasing prevalence of chronic and infectious diseases, which are some of the factors expected to drive the overall market.
With the rising burden of COVID-19 and other infectious diseases, there is an increasing number of pharmaceutical and biopharmaceutical companies that have looked forward to developing treatments and vaccines that target the infection caused by the novel coronavirus.
There is also a rise in the awareness initiatives for healthcare in the region that support the growth of the pyrogen testing market. For instance, in June 2019, the Global Endotoxin Testing Summit was being held, which brought together the community to explore the most pertinent topics in the industry that included the Recombinant Factor C, the history of pyrogen detection and future trends, the evolution of endotoxin standards, and many others. Hence, all such factors have raised awareness and are expected to drive the overall pyrogen testing market in the United States.
Furthermore, with the growing importance of healthcare and rising awareness regarding toxicity in drugs and medical devices, the demand for pyrogen testing has increased drastically in the pharmaceutical and biological products industries. Moreover, pyrogen testing plays a crucial role in ensuring safety measures in medical devices and pharmaceutical products with parenteral administration.
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The market for pyrogen testing is moderately competitive and is dominated by a few major players, such as Merck KGaA, Lonza Group, BioMérieux, and GenScript. The major companies are found undertaking various strategy initiatives, such as new product developments, mergers, acquisitions, collaborations, and regional expansions to serve the unmet needs of their customers. Along with this, the rising innovations have promoted the entry of novel players who are also entering the market and throwing competition to gain the market share. Partnerships with multinational companies to strengthen their market reach and goodwill are also anticipated to be a major market strategy in the pyrogen testing market.
In October 2020, Lonza Bioscience announced the commercial release of the PyroCell MAT System, a sustainable and reliable solution for in vitro pyrogen testing. The new offering expands upon Lonza’s experience in primary cells and endotoxin testing, combined with Sanquin’s expertise in MAT production, helping ensure the safety of parenteral pharmaceuticals during development, manufacture, and product release.
In July 2020, Lonza Sales AG and Sanquin Reagents BV entered a strategic partnership for the commercialization of a range of specialized reagents for pyrogen testing of parenteral pharmaceuticals and medical devices using the monocyte activation test (MAT).
Table of Contents
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rapid Growth in Pharmaceutical and Biotechnology Industries
4.2.2 Rising R&D Expenditure in Life Science
4.3 Market Restraints
4.3.1 Stringent Government Regulations
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION
5.1 By Product
5.1.1 Kits and Reagents
5.2 By Test Type
5.2.1 LAL Tests
22.214.171.124 Chromogenic Tests
126.96.36.199 Turbidimetric Tests
188.8.131.52 Gel Clot Tests
5.2.2 Rabbit Pyrogen Test
5.2.3 Monocyte Activation Test
5.2.4 Other Test Types
5.3 By End User
5.3.1 Pharmaceutical and Biotechnology Companies
5.3.2 Medical Device Companies
5.3.3 Other End Users
5.4.1 North America
184.108.40.206 United States
220.127.116.11 United Kingdom
18.104.22.168 Rest of Europe
22.214.171.124 South Korea
126.96.36.199 Rest of Asia-Pacific
5.4.4 Middle-East and Africa
188.8.131.52 South Africa
184.108.40.206 Rest of Middle-East and Africa
5.4.5 South America
220.127.116.11 Rest of South America
6. COMPETITIVE LANDSCAPE
*List Not Exhaustive
6.1 Company Profiles
6.1.1 Associates of Cape Cod Inc. (Seikagaku Biobusiness Corporation)
6.1.2 BioMerieux SA
6.1.3 Charles River Laboratories Inc.
6.1.4 Ellab AS
6.1.6 Lonza Group
6.1.7 Merck Kgaa
6.1.8 Thermo Fisher Scientific Inc.
6.1.9 Fujifilm Holdings Corporation (FUJIFILM Wako Pure Chemical Corporation)
6.1.10 WUXI Pharmatech (Cayman) Inc.
6.1.11 Eurofins Scientific
6.1.12 Microcoat Biotechnologie GmbH
6.1.13 Sotera Health (Nelson Laboratories LLC)
6.1.16 Microcoat Biotechnologie GmbH
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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Frequently Asked Questions
What is the study period of this market?
The Global Pyrogen Testing Market market is studied from 2018 - 2026.
What is the growth rate of Global Pyrogen Testing Market?
The Global Pyrogen Testing Market is growing at a CAGR of 9.8% over the next 5 years.
What is Global Pyrogen Testing Market size in 2018?
The Global Pyrogen Testing Market is valued at 985 Million USD in 2018.
What is Global Pyrogen Testing Market size in 2026?
The Global Pyrogen Testing Market is valued at 1895 Million USD in 2026.
Which region has highest growth rate in Global Pyrogen Testing Market?
Asia Pacific is growing at the highest CAGR over 2021- 2026.
Which region has largest share in Global Pyrogen Testing Market?
North America holds highest share in 2020.
Who are the key players in Global Pyrogen Testing Market?
- Merck KGaA
- Lonza Group
- Ellab A/S
Are the major companies operating in Global Pyrogen Testing Market.