Pyrogen Testing Market Forecasts to 2028 – Global Analysis By Product (Services, Instruments, Kits Reagents and Consumables), Test (Monocyte Activation Test (MAT), Rabbit Pyrogen Test, Limulus Amebocyte Lysate (LAL), Recombinant Factor C Assay (RFC), In V

Pyrogen Testing Market Forecasts to 2028 – Global Analysis By Product (Services, Instruments, Kits Reagents and Consumables), Test (Monocyte Activation Test (MAT), Rabbit Pyrogen Test, Limulus Amebocyte Lysate (LAL), Recombinant Factor C Assay (RFC), In Vitro Pyrogen Test and Other Tests), End User and By Geography

According to Stratistics MRC, the Global Pyrogen Testing Market is accounted for $1187.51 million in 2022 and is expected to reach $2081.91 million by 2028 growing at a CAGR of 9.8% during the forecast period. Pyrogen is a thermo stable bacterial toxin induces an immunogenic response when delivered parenterally. Pyrogen testing is a procedure used to find out whether vaccinations, biotechnological goods, and medications contain bacterial toxins that cause fever in people. As part of the production process, it also analyzes if microorganisms and their metabolites are present in medications. Pyrogen testing is done during the production of medicines and vaccines to confirm that there are no hazardous molecular by-products and to prevent contamination.

According to the reports of United Nations Educational, Scientific and Cultural Organization (UNESCO), November 2016, an estimated US$ 1.7 trillion was spent on research and development for various medical applications, globally.

Market Dynamics

Driver

Increased prevalence of infectious illnesses

Due to the rising incidence of major infectious illnesses and epidemics over the past decade, the need for pyrogen testing methods has been steadily increasing. Products for identifying endotoxins can help treat infectious illnesses better, especially in places with poor access to healthcare. The need for pyrogen testing methods used for endotoxin and microbiological identification is growing rapidly as the frequency of infectious illnesses throughout the world is elevating.

Restraint

Massive consolidation

The market for pyrogens is quite concentrated worldwide. Key market participants including Thermo Fisher Scientific, Inc., Lonza and Associates of Cape Cod, Inc., and others are very competitive. Only large businesses can afford high capital expenditures, high R&D costs, and high production costs. The leading brands in this industry are well-known, established, and have a lot of brand loyalty. This keeps new competitors out of this market.

Opportunity

Rising investments in R&D

Pharmaceutical, biotech, and other medication manufacturing organizations utilize pyrogen testing to ensure the safe production and release of infection-free medicines onto the market. The pharmaceuticals industry has seen significant investment in R&D efforts from several key businesses. To get around the limitations of the LAL test and the rabbit pyrogen testing technique, businesses are concentrating on the development of new animal-free pyrogen testing methods. This will result in a humane treatment of animals. This factor is expanding the demand of the market.

Threat

Obstacles of the rabbit pyrogen testing techniques

The pyrogen test using rabbits to identify bacterial endotoxins has a number of drawbacks. Since the test is lengthy, the animal's temperature must be recorded three hours after the injection at around 30-minute intervals. The high quantities of endotoxin present in the vaccination cause a pyrogenic reaction in rabbits when administered intravenously without any dilution, making the approach inappropriate for use as a safety test for these goods. This obstacle is restricting testing trials, which have turned out to be the principal impediment to market expansion.

Covid-19 Impact

The pandemic intensified the need for research and vaccine production. In all phases of SARS, it has been discovered that COVID-19 circulates tissue macrophages and monocytes. They are discovered to be involved in clinical infection, viral resistance, and host variables that affect the severity, prognosis, and after-effects of the disease. As a result, it is determined that the MAT test used in COVID-19 vaccine research and manufacture makes a significant contribution to ensuring human protection.

The limulus amebocyte lysate segment is expected to be the largest during the forecast period

The limulus amebocyte lysate segment is estimated to have a lucrative growth. The LAL test minimizes possible sources of error while enabling direct detection of endotoxin levels without individual variability. It is employed to guarantee the security of biologicals, implants, and parenteral medications. The Limulus Amebocyte Lysate test is used in the food business to check the quality of raw meat, milk, and dairy products. The LAL test is frequently referred to in international pharmacopeia monographs and offers extremely straightforward positive or negative results.

The monocyte activation test segment is expected to have the highest CAGR during the forecast period

The monocyte activation test segment is anticipated to witness the fastest CAGR growth during the forecast period. The monocyte activation test is used to identify or measure chemicals that cause human monocytes or monocytic cells to become activated and produce endogenous mediators, which play a part in the body's reaction to fever. Compared to the RPT, this test offers a more accurate prediction of pyrogenic activity since it can identify both endotoxin and non-endotoxin pyrogens and applies to a wider range of goods. As a result, it is more accurate as well as more cost- and time-effective

Region with largest share

North America is projected to hold the largest market share during the forecast period owing to its well-established healthcare infrastructure. Government assistance and the regulatory environment are more favourable in the region. Large biotech and biopharmaceutical companies like Merck and Lonza Group are prevalent in the US. The market share in this area has surged due to the rising incidence of infectious and chronic disorders.

Region with highest CAGR

Asia Pacific is projected to have the highest CAGR over the forecast period, owing to the availability of less stringent government regulations for drug development. As pharmaceutical drug pipelines grow, more drugs are being approved, and consumers are becoming more conscious of product safety, all of these factors are on rise in this region. Due to the unexplored prospects in this area, the Asia Pacific region is anticipated to have the greatest growth rate during the projected period.

Key players in the market

Some of the key players profiled in the Pyrogen Testing Market include Lonza Group, Associates of Cape Cod Inc, BioMerieux SA, Nelson Laboratories LLC, Charles River Laboratories Inc., Microcoat Biotechnologie GmbH, Ellab AS, Eurofins Scientific, Genscript, Fujifilm Holdings Corporation, WUXI Pharmatech (Cayman) Inc., Sanquin, Merck Kgaa, Pyrostar, Thermo Fisher Scientific Inc., Wako Chemicals USA Inc and Hyglos GMBH.

Key Developments

In July 2022, FUJIFILM Corporation announced the opening of two new “NURA” health screening centers focusing on cancer and lifestyle diseases screening in India. NURA utilizes Fujifilm's medical devices, capable of providing high-definition images, as well as medical IT systems based on AI technology that are designed to support doctors carry out screening and tests for cancer and lifestyle diseases.

In June 2022, Lonza has launched the PyroCell Monocyte Activation Test - Human Serum System (PyroCell MAT HS System), which uses human serum instead of fetal bovine serum. This new in vitro pyrogen testing system exhibits enhanced sensitivity for detection of non-endotoxin pyrogens as well as reduced interferences from complex drug products such as biologics-based pharmaceuticals.

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.

Products Covered
• Services
• Instruments
• Kits Reagents
• Consumables

Tests Covered
• Monocyte Activation Test (MAT)
• Rabbit Pyrogen Test
• Limulus Amebocyte Lysate (LAL)
• Recombinant Factor C Assay (RFC)
• In Vitro Pyrogen Test
• Other Tests

End Users Covered
• Food & Beverage Companies
• Pharmaceuticals Companies
• Medical Devices Companies
• Biotechnology Companies
• Contract Research Organizations (CROS)
• Other End Users

Regions Covered
• North America
US
Canada
Mexico
• Europe
Germany
UK
Italy
France
Spain
Rest of Europe
• Asia Pacific
Japan
China
India
Australia
New Zealand
South Korea
Rest of Asia Pacific
• South America
Argentina
Brazil
Chile
Rest of South America
• Middle East & Africa
Saudi Arabia
UAE
Qatar
South Africa
Rest of Middle East & Africa

What our report offers
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2020, 2021, 2022, 2025, and 2028
- Market Trends (Drivers, Constraints, Opportunities,Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements