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市場調查報告書
商品編碼
1831972
熱原檢測市場報告,按產品(儀器、試劑盒和試劑、服務)、檢測類型(體外檢測、LAL 檢測、兔子檢測等)、應用(製藥和生物製劑、醫療器材等)和地區分類,2025 年至 2033 年Pyrogen Testing Market Report by Product (Instruments, Kits and Reagents, Services), Test Type (In-vitro Tests, LAL Tests, Rabbit Tests, and Others), Application (Pharmaceutical and Biologics, Medical Devices, and Others), and Region 2025-2033 |
2024年,全球熱原檢測市場規模達15億美元。展望未來, IMARC Group預計到2033年,該市場規模將達到33億美元,2025-2033年期間的複合年成長率(CAGR)為8.71%。全球製藥和生物技術產業的蓬勃發展,心臟病、癌症和糖尿病等慢性疾病的發病率不斷上升,新療法的推出以及研發資金的不斷增加,共同推動著該市場的發展。
法規遵從和安全標準
熱原檢測市場的成長在很大程度上得益於美國食品藥物管理局 (FDA) 和歐洲藥品管理局 (EMA) 等衛生當局實施的嚴格監管框架。美國醫療器材促進協會 (AAMI) ST72:2002/R2010《細菌內毒素檢測方法、常規監測和批量檢測替代方法》(AAMI ST72) 描述了凝膠凝塊法、光度法和動力學檢測方法的基本原理,並建議對相應的組件和成品進行熱原和內毒素檢測。這些法規要求對藥品、醫療器材和生物製品進行嚴格的安全測試,以確保它們不含可能引起發燒並對患者造成嚴重風險的熱原。因此,製造商正在將熱原檢測納入其生產流程。
製藥和生物技術產業的進步
製藥和生物技術行業的成長以及生物製劑產量的增加也為熱原檢測市場創造了良好的前景。源自生物體的生物製劑易受熱原污染。根據 IMARC GROUP 的數據,2023 年全球生物製劑市場規模達 3,496 億美元。展望未來,預計到 2032 年熱原檢測市場價值將達到 6,995 億美元,2024-2032 年期間的複合年成長率 (CAGR) 為 7.8%。隨著這些行業的擴張,對複雜、可靠和快速的熱原檢測方法的需求也在增加。此外,這種需求導致了檢測技術的創新,例如重組 C 因子 (rFC) 檢測,它為傳統的鱟血液衍生檢測提供了一種合成替代方法。
發展醫療基礎設施
新興經濟體醫療基礎設施的不斷發展,以及對符合國際安全標準(包括無熱原認證)的醫療產品日益成長的需求,正在推高熱原檢測的需求。這種擴張拓寬了熱原檢測的地理市場,並迫使本地製造商採用先進的檢測技術參與全球市場。此外,醫療保健體系的發展和醫療支出的增加,也促進了先進熱原檢測流程的採用和整合。此外,政府部門也正在投資醫療保健產業,以促進公共衛生發展。例如,美國疾病管制與預防中心已撥款32億美元,協助美國各州、地方和領地轄區加強公共衛生隊伍建設和基礎建設。這32億美元中,有30億美元來自《美國救援計畫法案》,用於各轄區招募、留住和培訓其員工隊伍,包括流行病學家、接觸追蹤員、實驗室科學家、社區衛生工作者和資料分析師等關鍵的第一線公共衛生工作者。這筆資金還包括從新撥款中撥出的 1.4 億美元,用於各轄區加強和振興其公共衛生基礎設施。
試劑盒和試劑佔大部分市場佔有率
試劑盒和試劑易於使用,實驗室人員無需大量專業培訓即可快速設定和執行檢測。這種便捷性縮短了檢測週期。此外,預先包裝的試劑盒和試劑比內部檢測方法更具成本效益。自製檢測試劑的研發、驗證和品質控制成本可能高得令人望而卻步,尤其對於規模較小的公司而言。此外,各公司正在透過收購、合併和推出新的先進產品來擴大其熱原檢測市場佔有率。例如,PromegaCorp. 於 2021 年 3 月推出了 XpressAmp Direct 擴增試劑。
LAL 檢測佔據業界最大佔有率
鱟試劑 (LAL) 檢測對細菌內毒素高度敏感,能夠檢測到極低濃度的內毒素。這些檢測的靈敏度對於確保藥品和醫療器材的安全至關重要。此外,由於其可靠性得到驗證,LAL 檢測已成為內毒素檢測的標準方法,並受到監管機構和製造商的廣泛信賴。此外,LAL 檢測也獲得了包括美國食品藥物管理局 (FDA) 和歐洲藥典在內的主要監管機構的認可和建議。 30 多年來,FDA 一直認可使用鱟試劑 (LAL) 檢測內毒素,以取代兔熱原檢測。
製藥和生物製劑是領先的細分市場
在生物技術進步和個人化醫療日益受到重視的推動下,生物製劑產業正在快速成長。隨著越來越多的生物製劑進入研究流程和商業化生產,這種擴張導致對熱原檢測的需求增加。此外,製藥和生技公司正在大力投資研發新藥和生物製品,這需要進行嚴格的安全測試,包括熱原檢測,以確保這些創新產品對人類使用是安全的。例如,總部位於加州的安進公司在研發活動上投入了大量資金,根據其 2021 年公司年度報告,其 2021 年、2020 年和 2019 年的研發支出分別為 48 億美元、42 億美元和 41 億美元。這些因素正在擴大這些測試在製藥和生物製劑中的應用,從而為熱原檢測市場帶來積極的預測。
北美引領市場,佔據最大熱原檢測市場佔有率
該報告還對所有主要區域市場進行了全面分析,包括北美(美國和加拿大);歐洲(德國、法國、英國、義大利、西班牙、俄羅斯等);亞太地區(中國、日本、印度、韓國、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中東和非洲。報告指出,北美是熱原檢測最大的區域市場。
北美擁有先進的醫療保健基礎設施,高度重視法規遵循和病人安全。這些基礎設施支援並要求醫療產品達到高標準,從而影響了對熱原檢測的需求,以確保藥品和醫療器材的安全。此外,北美的醫療保健支出位居世界前列,大量支出用於醫療創新,包括安全檢測。根據醫療保險和醫療補助服務中心的數據,美國醫療保健支出在 2022 年成長了 4.1%,達到 4.5 兆美元,高於 2021 年 3.2% 的增幅。此外,2022 年零售處方藥支出成長了 8.4%,達到 4,059 億美元,高於 2021 年 6.8% 的增幅。這種經濟實力正在加劇整個醫療保健和製藥業對熱原檢測的需求。
The global pyrogen testing market size reached USD 1.5 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 3.3 Billion by 2033, exhibiting a growth rate (CAGR) of 8.71% during 2025-2033. The market is propelled by the expanding pharmaceutical and biotechnology industries around the world, the increasing prevalence of chronic ailments such as heart diseases, cancer, and diabetes, and the launch of the new therapeutics and rising funding of research and development (R&D) activities.
Regulatory compliance and safety standards
The pyrogen testing market growth is significantly driven by the implementation of stringent regulatory frameworks by health authorities such as the FOOD and DRUGS ADMINISTRATION in the United States and the EUROPEAN MEDICINE AGENCY in Europe. The Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72) are documents that describe the fundamental principles of the gel clot, photometric, and kinetic test methods, and recommend that appropriate components and finished products be tested for the presence of pyrogens and endotoxins. These regulations require rigorous safety testing of pharmaceuticals, medical devices, and biological products to ensure they are free of pyrogens, which can induce fever and pose severe risks to patients. As a result, manufacturers are incorporating pyrogen testing in their production processes.
Advancements in pharmaceuticals and biotechnology industries
The growth of the pharmaceutical and biotechnology sectors and the increasing biologics production is also creating a favorable pyrogen testing market outlook. Biologics, derived from living organisms are susceptible to contamination by pyrogens. According to IMARC GROUP, the global biologics market size reached US$ 349.6 Billion in 2023. Looking forward, the pyrogen testing market value is expected to reach US$ 699.5 Billion by 2032, exhibiting a growth rate (CAGR) of 7.8% during 2024-2032. As these industries expand, the requirement for sophisticated, reliable, and rapid pyrogen testing methods is also increasing. Moreover, this demand is leading to innovations in testing technologies, such as recombinant factor C (rFC) assays, which offer a synthetic alternative to traditional horseshoe crab blood-derived tests.
Developing healthcare infrastructure
The developing healthcare infrastructure in emerging economies and the increasing need for medical products that meet international safety standards, including pyrogen-free certifications is escalating the pyrogen testing demand. This expansion broadens the geographic market for pyrogen testing and compels local manufacturers to adopt advanced testing technologies to participate in global markets. Moreover, the development of healthcare systems and the increased healthcare spending is increasing the adoption and integration of advanced pyrogen testing processes. Besides, government authorities are also investing in the healthcare industry to promote public health. For instance, CENTER for DISEASE CONTROL and PREVENTION has awarded $3.2 billion to help state, local, and territorial jurisdictions across the United States strengthen their public health workforce and infrastructure. The $3.2 billion includes $3 billion from the AMERICAN RESCUE PLAN ACT for jurisdictions to recruit, retain, and train their workforce, including critical frontline public health workers such as epidemiologists, contact tracers, laboratory scientists, community health workers, and data analysts. The funding also includes $140 million from a new appropriation for jurisdictions to strengthen and revitalize their public health infrastructure.
Kits and reagents accounts for the majority of the market share
Kits and reagents are user-friendly allowing for quick setup and execution of tests by laboratory personnel without the need for extensive specialized training. This convenience leads to faster turnaround times in testing. Besides, pre-packaged kits and reagents are more cost-effective than in-house testing methods. The costs associated with R&D, validation, and quality control of self-made tests can be prohibitively high, especially for smaller companies. Moreover, companies are acquiring and merging with other companies and launching new advanced products to expand their pyrogen testing market share. For instance, in March 2021, PromegaCorp. launched XpressAmp Direct amplification reagent.
LAL tests hold the largest share of the industry
LAL tests are highly sensitive to bacterial endotoxins, capable of detecting them at very low levels. The sensitivity of these tests is crucial for ensuring the safety of pharmaceuticals and medical devices. Moreover, due to its proven reliability, the LAL test has become the standard method for endotoxin testing and is widely trusted by regulatory authorities and manufacturers. Besides, the LAL test is recognized and recommended by major regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Pharmacopoeia. For more than 30 years, FDA has accepted the use of a Limulus Amoebocyte Lysate (LAL) test for endotoxins in lieu of the rabbit pyrogens test.
Pharmaceutical and biologics represents the leading market segment
The biologics sector is growing rapidly, driven by advancements in biotechnology and an increasing focus on personalized medicine. This expansion contributes to a greater demand for pyrogen testing as more biologics enter research pipelines and commercial production. Moreover, pharmaceutical and biotechnology companies are investing heavily in research and development to create new drugs and biological products which necessitate rigorous safety testing, including pyrogen testing, to ensure that these innovations are safe for human use. For instance, California-based Amgen Inc. invests heavily in its research and development activities and its expenditure for research and development was US$ 4.8 Billion, US$ 4.2 Billion, and US$ 4.1 Billion, for 2021, 2020, and 2019, respectively, as per its 2021 company annual report. These factors are expanding the use of these testing in pharmaceutical and biologics thus creating a positive pyrogen testing market forecast.
North America leads the market, accounting for the largest pyrogen testing market share
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for pyrogen testing.
North America boasts an advanced healthcare infrastructure with a strong emphasis on regulatory compliance and patient safety. This infrastructure supports and demands high standards for medical products, influencing the need for pyrogen testing to ensure the safety of pharmaceuticals and medical devices. Besides, the healthcare expenditure in North America is among the highest in the world, with significant spending allocated to health innovation, including safety testing. According to the CENTERS FOR MEDICARE & MEDICAID SERVICES, the United States healthcare spending grew 4 pending grew 4.1% to reach $4.5 Trillion in 2022, faster than the increase of 3.2% in 2021. Besides, retail prescription drug spending increased 8.4% to $405.9 Billion in 2022, a faster rate than in 2021 when spending increased by 6.8%. This financial capability is escalating the need for pyrogen testing, across the healthcare and pharmaceutical sectors.