WASHINGTON, Sept. 18, 2023 (GLOBE NEWSWIRE) -- As per Vantage Market Research, the development of the biotechnology, medical device, and pharmaceutical industries, as well as rising investments in R&D and favorable government regulations, are significant drivers of the global Pyrogen Testing market.
According to Vantage Market Research, the Global Pyrogen Testing Market is estimated to be valued at USD 3.2 Billion by 2030 and is expected to exhibit a CAGR of 13.2% from 2023 to 2030. The global Pyrogen Testing market grew to USD 1.2 billion in 2022.
Pyrogen is a thermally stable bacterial toxin capable of triggering an immunogenic response when injected into the body. Pyrogen Testing is essential for identifying the presence of bacterial toxins that may cause human fever in vaccinations, biotechnological goods, and medications. Additionally, this testing procedure identifies the existence of microorganisms and their byproducts in medications throughout the manufacturing process. The primary objective of Pyrogen Testing during drug and vaccine production is to prevent contamination and guarantee the absence of harmful molecular components, thus ensuring product safety and efficacy.
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Key Highlights
- By the segment Product & Services, the Instruments segment is anticipated to mention the market’s fastest growth during the forecast period.
- By Test Type, the Rabbit Tests segment is expected to witness maximum market growth over the projected period.
- By End User, the Medical Device Companies is expected to lead the market during the projected period.
- North America commanded the market in 2022 with a 42.2% sales share.
- The Asia Pacific region is expected to witness maximum market growth during the forecast period.
The global Pyrogen Testing market is primarily propelled by the upsurge in infectious diseases and the heightened occurrence of pandemics. Over the past decade, there has been a consistent escalation in the demand for Pyrogen Testing methods, primarily driven by the increasing prevalence of significant infectious diseases and epidemics. Furthermore, substantial investments in research and development by manufacturing companies and government entities to foster new product development have significantly bolstered market growth.
Top Companies in The Global Pyrogen Testing Market
- Associates of Cape Cod Inc. (U.S.)
- BioMerieux SA (France)
- Charles River Laboratories Inc. (U.S.)
- Ellab AS (Denmark)
- Genscript Biotech Corp. (U.S.)
- Lonza Group AG (Switzerland)
- Merck KGAA (Germany)
- Thermo Fisher Scientific Inc. (U.S.)
- Fujifilm Holdings Corporation (Japan)
- WUXI Pharmatech (Cayman) Inc. (China)
- Eurofins Scientific (Luxembourg)
- Microcoat Biotechnologie GmbH (Germany)
- Sotera Health (U.S.)
- Sanquin (Netherlands)
- Pyrostar (U.S.)
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Factors Affecting the Growth of the Pyrogen Testing Industry
Several variables can impact the development of the Pyrogen Testing sector. Some of these factors include:
- Rising demand for safe and effective pharmaceutical products: Pyrogen Testing is crucial in ensuring the safety of pharmaceutical products, as pyrogens can cause fever and other adverse effects in humans. The growing concern for patient safety and the need for high-quality medicines propel the demand for Pyrogen Testing in the pharmaceutical industry.
- Stringent regulations and guidelines: Regulatory bodies such as the U.S. FDA and European Pharmacopoeia have set strict guidelines for Pyrogen Testing in the pharmaceutical and biotechnology industries. The purpose of these rules is to guarantee the efficacy and safety of pharmaceutical goods. The adherence to these regulations by manufacturers is driving the adoption of Pyrogen Testing methods, thus contributing to market growth.
- Increasing adoption of in vitro Pyrogen Testing methods: In vitro, Pyrogen Testing methods are gaining popularity due to their advantages over traditional animal-based tests, such as reduced costs, faster results, and ethical concerns associated with animal testing. In the upcoming years, market growth is anticipated to be driven by the rising popularity of in vitro Pyrogen Testing techniques.
- Growing biotechnology and pharmaceutical industries: The aging population, rising prevalence of chronic diseases, and technological breakthroughs are all driving the rapid growth of the biotechnology and pharmaceutical industries. To meet regulatory standards and guarantee the safety of their products, businesses are placing a greater emphasis on Pyrogen Testing due to this expansion.
- Increasing investments in research and development: The focus on developing new and improved Pyrogen Testing methods and products drives investments in research and development activities. This is leading to technological advancements and the introduction of innovative Pyrogen Testing solutions, thereby contributing to market growth.
Top Trends in the Global Pyrogen Testing Market
One of the top market trends in Pyrogen Testing is the increasing adoption of in-vitro methods. In-vitro Pyrogen Testing refers to testing methods performed outside a living organism, typically using cell cultures or reconstituted systems. The advantages of in-vitro testing, such as reduced reliance on animal models, faster results, and cost-effectiveness, drive this trend. This trend can be seen in the growing use of monocyte activation tests (MAT) for Pyrogen Testing. MAT is an in-vitro assay that measures the release of pro-inflammatory cytokines from human monocytes when exposed to pyrogens. It is considered a more reliable and sensitive alternative to the traditional rabbit pyrogen test. Another market trend is the development of automated Pyrogen Testing systems. As the demand for Pyrogen Testing increases, there is a need for more efficient and streamlined testing processes. Mechanical systems help reduce human error, increase throughput, and improve testing efficiency. An example of this trend is the introduction of robotic systems that can perform various steps of the Pyrogen Testing process, such as sample preparation, assay set-up, and data analysis. These automated systems save time and ensure standardization and reproducibility of results.
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Recent Development of the Global Pyrogen Testing Market
- August 2023: Lonza has introduced the Nebula® Absorbance Reader, a brand-new absorbance microplate reader that expands the company's lineup of instruments specially designed for quick endotoxin and Pyrogen Testing.
- April 2023: Complete Technical Solutions (CQV) Ltd. ("CTS") has undergone a merger and purchase announced by Ellab. Ellab's corporate objective of growing its field services to become a full-solution provider in essential areas within the biotech and pharmaceutical industries is being further executed with the purchase of CTS.
- June 2022: The PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System), developed by Lonza, employs human serum instead of fetal bovine serum. This brand-new in vitro Pyrogen Testing method shows improved sensitivity for non-endotoxin pyrogen identification and diminished interference from complicated medicinal items such as biologics-based medications.
Market Drivers
Over the past decade, there has been a consistent rise in the demand for Pyrogen Testing techniques. The rising occurrence of serious infectious diseases and epidemics is to blame for this expansion. The demand for Pyrogen Testing methods, which are crucial for detecting endotoxins and identifying bacteria, is expected to expand shortly as the incidence of infectious diseases around the world continues to climb. These products designed for endotoxin identification can enhance the management of infectious diseases, particularly in regions with limited healthcare infrastructure.
Market Restraints
A significant obstacle is the substantial cost associated with Pyrogen Testing. Given the sensitive and intricate nature of Pyrogen Testing techniques, they necessitate expensive equipment and highly skilled personnel, thereby driving up the overall testing expenditure. This cost burden can prove challenging, particularly for small and medium-sized pharmaceutical and biotechnology enterprises, as they may need more financial resources for such testing endeavors.
Market Opportunities
The Asia-Pacific (APAC) region presents desirable opportunities for the life sciences industry. One notable example is India, which has taken significant steps, including promoting public-private partnerships (PPPs) in biopharmaceutical research and development (R&D) projects, to position itself as a leading global hub for biopharmaceutical innovation. Similarly, South Korea is actively pursuing initiatives to establish itself as a prominent global biotechnology center, focusing on biosimilars, vaccine manufacturing, and stem cell therapies. The increasing demand for therapeutic solutions for life-threatening ailments like cancer and diabetes underscores the necessity for drug R&D, consequently driving the need for Pyrogen Testing kits to ensure adequate quality testing and control.
Browse market data Tables and Figures spread through 146 Pages and in-depth TOC on Pyrogen Testing Market Forecast Report (2023-2030).
Report Segmentation of the Global Pyrogen Testing Market
Product & Service Analysis
Because of the rising demand for Pyrogen Testing, technological advancements, growing awareness of quality control, expansion of the medical device and pharmaceutical industries, and rising regulations and guidelines, it is anticipated that the instruments segment will hold the largest market share during the forecast period. In addition, with the rising number of pharmaceutical and medical device products being developed and manufactured, the demand for Pyrogen Testing is also increasing. Pyrogen Testing is necessary to comply with regulatory guidelines and ensure the safety of these products before being released into the market.
Test Type Analysis
The most significant rise in the market is projected for Rabbit Tests throughout the forecast period. This growth can be attributed to its high sensitivity, regulatory acceptance, and cost-effectiveness. Additionally, the rabbit test is well-established and has been used for many years in Pyrogen Testing. It has a long history of use and has been validated by regulatory authorities such as the European Pharmacopoeia and the United States Pharmacopeia. Regulatory bodies' familiarity and acceptance of the rabbit test contribute to its continued use in the industry.
End User Analysis
Due to the growing regulatory emphasis on patient safety, the requirement for sterility in medical devices, improvements in medical device technology, and outsourcing testing services, medical device companies are anticipated to experience the highest market growth throughout the projection period. As the medical device industry continues to expand, the demand for Pyrogen Testing is expected to rise due to its critical role in ensuring the safety and quality of medical devices. In addition, many medical device companies outsource their Pyrogen Testing services to specialized laboratories or contract research organizations (CROs). Outsourcing allows companies to access expertise and advanced testing facilities, thereby improving the efficiency and reliability of their Pyrogen Testing processes. This trend has further contributed to the growth of the Pyrogen Testing market.
Market Segmentation
By Product & Service
- Assays, Kits, & Reagents
- Instruments
- Services
By Test Type
- LAL Tests
- Chromogenic Tests
- Turbidimetric Tests
- Gel Clot Tests
- In Vitro Tests
- Rabbit Tests
By End User
- Pharmaceutical & Biotechnology Companies
- Medical Device Companies
- Other End Users
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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Scope of the Report:
| Report Attributes | Details |
| Market Size in 2022 | USD 1.2 Billion |
| Revenue Forecast by 2030 | USD 3.2 Billion |
| CAGR | 13.2% from 2023 to 2030 |
| Base Year | 2022 |
| Forecast Year | 2023 to 2030 |
| Key Players | Associates of Cape Cod Inc., BioMerieux SA, Charles River Laboratories Inc., Ellab AS, Genscript Biotech Corp., Lonza Group AG, Merck KGAA, Thermo Fisher Scientific Inc., Fujifilm Holdings Corporation, WUXI Pharmatech (Cayman) Inc., Eurofins Scientific, Microcoat Biotechnologie GmbH, Sotera Health, Sanquin, Pyrostar |
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Regional Analysis
North America asserts its dominance in the global market in 2022, mainly owing to its well-established healthcare infrastructure, robust regulatory framework, substantial government support, and the significant presence of major biotechnological and biopharmaceutical corporations, including but not limited to Merck and Lonza Group. Furthermore, the region benefits from an advanced healthcare system, strong regulatory oversight, and an increasing incidence of chronic and infectious diseases, all of which are anticipated to act as pivotal drivers for the overall market's growth. Additionally, increased awareness initiatives for healthcare in the region significantly support developing the Pyrogen Testing market. As an illustrative example, in June 2019, the Global Endotoxin Testing Summit convened, serving as a platform for the community to delve into crucial industry topics. These discussions encompassed subjects such as Recombinant Factor C, the historical evolution of pyrogen detection and its future trends, the development of endotoxin standards, and more. Consequently, these factors have heightened awareness and are anticipated to propel the overall Pyrogen Testing market in the United States.
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