The pyrogen testing market is projected to register a CAGR of 9.8% during the forecast period, with a revenue of approximately USD 985 million in 2020 and expected to reach USD 1,895 million by 2026. The market is primarily driven by increased demand for pyrogenic testing products in the pharmaceutical and biotechnology industry and rising R&D expenditure in life science.
With the rising COVID-19, 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 to 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 to 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 retesting of a sample. In addition, the Fujifilm Wako Chemicals has 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 driving 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 has invested around EUR 36,500 million in R&D in 2018. The rapidly increasing 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 has compelled manufacturers to improve on aspects, such as productivity, cost-efficiency, and deviations. Companies are, thus, implementing good manufacturing practices involving thorough biological testing at various levels of production cycles, thereby, contributing toward the growth of the market.
Furthermore with the increase in chronic disease prevalence in developed countries has also boosted the demand for pyrogen testing along with increasing awareness that is expected to result in high growth during the forecast period.
Key Market Trends
Monocyte Activation Test is Expected to Witness a 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, the market is expected to increase 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 on 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 have found to enter in a strategic partnership for the commercialisation of a range of specialised reagents for pyrogen testing of parenteral pharmaceuticals and medical devices using the Monocyte Activation Test. This partnership has helped to expand the Lonza's extensive portfolio of endotoxin testing products. Hence all these factors are found to boost the overall market growth.
North America is Expected to Dominate the Pyrogen Testing Market in 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 the many large biotechnological and biopharmaceutical firms, such as Merck, Lonza Group, among others. There is also a well-established healthcare infrastructure, better regulatory framework, increasing prevalence of chronic and infectious diseases that 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 health care in the region that supports 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 this has raised the awareness and is expected to drive the overall pyrogen testing market in United States.
Furthermore, with the growing importance of health care 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.
The market for pyrogen testing is moderately competitive and is dominated by a few major players, such as Merck KGaA, Lonza Group, BioMerieux, and GenScript. The major companies are found undertaking various strategy initiatives, such as new product development, mergers, acquisitions, collaborations, and regional expansion for serving the unmet needs of their customers. Along with this, the rising innovations in have promoted the entry of novel players who are also entering the market and throwing competition to gain the market share. Partnership with multinational companies to strengthen their market reach and goodwill is also anticipated to be a major market strategy in the global pyrogen testing market.
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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 Force 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
- 5.1.2 Services
- 5.1.3 Instruments
- 5.2 By Test Type
- 5.2.1 LAL Tests
- 188.8.131.52 Chromogenic Tests
- 184.108.40.206 Turbidimetric Tests
- 220.127.116.11 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 Others
- 5.4 Geography
- 5.4.1 North America
- 18.104.22.168 United States
- 22.214.171.124 Canada
- 126.96.36.199 Mexico
- 5.4.2 Europe
- 188.8.131.52 Germany
- 184.108.40.206 United Kingdom
- 220.127.116.11 France
- 18.104.22.168 Italy
- 22.214.171.124 Spain
- 126.96.36.199 Rest of Europe
- 5.4.3 Asia-Pacific
- 188.8.131.52 China
- 184.108.40.206 Japan
- 220.127.116.11 India
- 18.104.22.168 Australia
- 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 GCC
- 184.108.40.206 South Africa
- 220.127.116.11 Rest of Middle East and Africa
- 5.4.5 South America
- 18.104.22.168 Brazil
- 22.214.171.124 Argentina
- 126.96.36.199 Rest of South America
6 COMPETITIVE LANDSCAPE
- 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 A/S
- 6.1.5 Genscript
- 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)
- 6.1.14 Sanquin
- 6.1.15 Pyrostar
- 6.1.16 Microcoat Biotechnologie GmbH
7 MARKET OPPORTUNITIES AND FUTURE TRENDS