The global pyrogen testing market size was expanded at USD 1.31 billion in 2023 and is projected to hit around USD 3.06 billion by 2033, expanding at a CAGR of 8.91% during the forecast period from 2024 to 2033. Increased activity in biotechnology and growing pharmaceutical and biotechnology industries are primary drivers driving the growth of pyrogen testing market.
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Major Key Insights of the Pyrogen Testing Market
- By region, North America dominated the pyrogen testing market share by 40.60% in 2023.
- North America holds 525.22 million revenues in 2023.
- By product, the consumables segment held the largest share of the market in 2023.
- By test type, the LAL test segment dominated the market by 45.01% in 2023.
- By end-use, the pharmaceutical and biotechnologies companies segment held the largest share of the market in 2023.
Recent News and Developments in Pyrogen Testing Market
Year | Companies & Their Developments |
October 2023 | Lonza introduced new MAT systems for pyrogen testing |
October 2023 | Wickham Micro expands capabilities for endotoxin testing |
September 2023 | Intravacc & Sanquin collaborate to improve MAT for OMV vaccines |
June 2023 | Novo Holdings acquires Ellab A/S to advance pyrogen testing |
Pyrogen Testing Market: Safeguarding Patient Health
Pyrogen is a critical process of process in the pharmaceutical and medical device industries, designed to detect substances that can cause fever when introduced into the body. These substances, known as pyrogens, are typically byproducts of bacterial contamination. Ensuring that drugs, vaccines and medical devices are free from pyrogens is essential for patient safety, as their presence can lead to severe febrile reactions.
The pyrogen testing market has evolved significantly due to the increasing need for safe pharmaceuticals and medical devices. This market encompasses various testing methods, including the traditional rabbit pyrogen test, the more recent limulus amebocyte lysate (LAL) test, and the monocyte activation test (MAT), which is gaining popularity due to its ethical and scientific advantages. As regulatory bodies continue to emphasize stringent safety standards, the demand for advanced pyrogen testing methods is expected to rise.
Driver
Increasing Incidents of Chronic Diseases
The pyrogen testing market is significantly driven by the increasing incidence of chronic diseases, which require advanced therapeutic interventions. As the global population ages, the prevalence of chronic conditions like diabetes, cardiovascular diseases, and cancer is on the rise. These diseases often necessitate the use of complex biologics and other pharmaceuticals products, which must be thoroughly tested for pyrogens to ensure patient safety. Pyrogen testing is crucial because pyrogens, such as bacterial endotoxins, can cause serve fever and other harmful reactions if they contaminate medical products. As the demand for these therapeutic interventions grows, so does the need for rigorous pyrogen testing, driving the market forward.
For instance, India’s pharmaceutical sector has seen remarkable growth, with the Government of India’s “Make in India” initiative bolstering local manufacturing capabilities. The Indian pharmaceutical market was valued approximately USD 42 billion in 2021, with expectations for continued growth. This expansion has heightened the demand for pyrogen testing as manufacturers strive to meet global safety standards.
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Restraint
High Cost Restraining the Pyrogen Testing Market
The pyrogen testing market, while growing, faces notable challenges that impact the expansion of the market. One of the primary challenges that pyrogen testing faces is the high cost associated with advanced pyrogen testing methods. Techniques such as recombinant Factor C assays and other sophisticated tests offer higher accuracy and reliability but come at a significant expense. These costs can be prohibitive, especially for smaller pharmaceuticals companies or manufacturers in emerging markets. For Instance, the transition from traditional Limulus Amebocyte Lysate (LAL) tests to newer methods like recombinant Factor C has been slower than anticipated due to the higher costs involved. This shift requires not only investment in new testing kits but also in the necessary equipment and infrastructure to support these advanced methods.
Opportunity
The Role of Automation in the Pyrogen Testing Market
The pyrogen testing industry is witnessing a significant shift with the growing adoption of automation technologies. This trend presents a promising opportunity for the market players to enhance efficiency, reduce errors, and meet the increasing demand for high-throughput testing. Automation in pyrogen testing is becoming a game change, especially as the complexity and volume of tests required by pharmaceuticals and medical device manufacturers continue to rise.
For instance, in 2023, a leading pharmaceutical company in Europe implemented an automated pyrogen testing systems that reduced their testing time by nearly 50%. These advancements not only improved their production efficiency but also ensured that their products reached the market faster without compromising safety.
Consumables Kits Leads Product Segment in the Market
In the product segment of the pyrogen testing market Consumables dominated the market. Consumables include kits reagents and other disposable items used during testing processes. For conducting tests such as Limulus Amebocyte test, which is widely used for detecting bacterial endotoxins, these products are necessary and essential. The high demand for consumables is driven by the fact that they are used in every single test, requiring constant replenishment. As testing volumes increase, especially with the growing production of pharmaceuticals and medical devices, the need for consumables continues to rise.
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Limulus Amebocyte Test Dominated in Test Type in 2023
With in the test type segment, the Limulus Amebocyte Lysate (LAL) test dominated the market. The Limulus Amebocyte Lysate test is the gold standard for detecting bacterial endotoxins in pharmaceuticals products, medical devices, and other healthcare-related items. It had been widely adopted across the industry due to its high reliability and sensitivity. The test is derived from the blood of horseshoe crabs, which contains a clotting agent that reacts with endotoxins, making it a crucial tool in ensuring producy safety.
Pharmaceutical-Biotechnology companies in the End-use
Pharmaceutical and biotechnology companies dominated the pyrogen testing market in 2023. These companies are primary users of pyrogen testing due to the crucial need to ensure that their products are safe for human use. With the increasing production of vaccines, biologics turn other injectable medicines, the demand for goodness pharmaceutical pyrogen testing has intensified. Pharmaceutical and biotechnology companies are under strict regulatory scrutiny making it essential for them to conduct thorough testing to avoid contamination by pyrogens, which can lead to severe adverse effects in patients. The high volume of products these companies produce, coupled with the stringent quality control measures they must adhere to, makes them the dominant segment in the pyrogen testing market.
North America Holds the market share by 40.60% in 2023
North America dominated the pyrogen testing market in 2023 by 40.60%. This is a huge number for a region to have such dominance over a specific market. In the region The United States is the most dominant force. The lead of North America is primarily due to its advanced healthcare infrastructure and strong presence of biotechnology and pharmaceutical industries. North America’s focus on strict regulatory standards, coupled with drug iron medicine safety, has boomed the demand for pyrogen testing.
For instance, in North America the use of recombinant factor assays, which provide an animal-free alternative to the to the traditional Limulus Amebocyte Lysate test, has gained traction. This method, recently adopted by several U.S. firms, reflects a border industry move towards more ethical and sustainable testing practices, a trend that is also beginning to influence Indian manufacturers.
Asia-Pacific on to Grow at Rapid Rate in the Market
The region Asia Pacific is expected to exhibit the fastest growth in the pyrogen testing market during the forecast period. The growth of the pyrogen testing market is driven by several factors such as the expansion of pharmaceutical and biotechnology sectors, particularly in countries like Japan, China and India. Asia Pacific is witnessing significant investments in healthcare infrastructure, not to buy just private but also by the government which is fostering the demand for advanced pyrogen testing methods.
The Pharmaceutical industry in India has seen substantial growth, particularly in the production of generic medicines and vaccines. India is also the third largest producer of pharmaceuticals by volume globally. With the rise in drug manufacturing, there is an increasing need for rigorous quality assurance, including pyrogen testing.
In 2021-2022 the Indian Pharmaceutical industry achieved a turnover of approximately USD 42.34 billion, underscoring the country’s pivotal role in the global market.
New Advancements and Developments in Pyrogen Testing
- In January 2024, to introduce the Endosafe® TrilliumTM rCR cartridge product, Charles River Laboratories International, Inc. took their innovation a step further and integrated it with their recombinant cascade reagent (rCR). By adding a new animal-free testing option to its already extensive bacterial endotoxin testing (BET) portfolio, this product shortens manufacturing lead times and improves testing effectiveness.
- In June 2024, Fumir, the PYROSTAR Neo+ recombinant protein reagent, was used to identify bacterial endotoxins, and the LumiMAT Pyrogen Detection Kit (LumiMAT) was utilized for in vitro2 pyrogen testing. The LumiMAT is a next-generation monocyte activation test (MAT)1. FUJIFILM Wako Pure Chemicals Corporation is conducting these experiments. July 2024 saw the global introduction of the new PYROSTARTM Neo+ and LumiMAT testing kits, which superseded the previous pyrogen and endotoxin tests.
- In October 2023, the Cormica Group company Wickham Micro increased its capabilities for evaluating bacterial endotoxins. The decision to expand was made in response to the growing need in the pharmaceutical and medical device sectors for superior microbiological services. The laboratory space has increased by 40% because of this enlargement. This expansion is a result of the business’s unwavering commitment to providing top-notch microbial testing services.
- In September 2023, Intravacc and Sanquin Diagnostic Services joined forces to improve a test called the Monocyte Activation Test (MAT). This test, which uses human white blood cells, will replace animal testing for a type of vaccine called OMV.
- Novo Holdings bought Ellab A/S in June 2023. This deal will help Novo Holdings grow its business in testing products for harmful substances, replacing older methods that involve animals.
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Top Companies and Players in the Pyrogen Testing Market
· FUJIFILM Wako Chemicals U.S.A. Corporation (Pyrostar)
· Ellab A/S
· Merck KGaA
· bioMérieux SA
· GenScript Biotech
· Thermo Fisher Scientific, Inc.
· Charles River Laboratories (CRL)
· Lonza Group
· Associates of Cape Cod, Inc.
Segments Covered in the Report
By Product
- Consumables
- Instruments
- Services
By Test Type
- LAL Test
- Chromogenic Test
- Turbidimetric Test
- Gel Clot Test
- In Vitro Pyrogen Test
- Rabbit Test
By End-use
- Pharmaceutical and Biotechnology Companies
- Medical Devices Companies
- Others
By Region
- North America
- U.S.
- Canada
- Asia Pacific
- China
- Japan
- India
- South Korea
- Thailands
- Europe
- Germany
- UK
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
- Latin America
- Brazil
- Mexico
- Argentina
- Middle East and Africa (MEA)
- South Africa
- UAE
- Saudi Arabia
- Kuwait
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