![]() |
市场调查报告书
商品编码
1831972
热原检测市场报告,按产品(仪器、试剂盒和试剂、服务)、检测类型(体外检测、LAL 检测、兔子检测等)、应用(製药和生物製剂、医疗器材等)和地区划分,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,全球热原检测市场规模达15亿美元。展望未来, IMARC Group预计到2033年,该市场规模将达到33亿美元,2025-2033年期间的复合年增长率(CAGR)为8.71%。全球製药和生物技术产业的蓬勃发展,心臟病、癌症和糖尿病等慢性疾病的发病率不断上升,新疗法的推出以及研发资金的不断增加,共同推动着该市场的发展。
法规遵从和安全标准
热原检测市场的成长在很大程度上得益于美国食品药物管理局 (FDA) 和欧洲药品管理局 (EMA) 等卫生当局实施的严格监管框架。美国医疗器材促进协会 (AAMI) ST72:2002/R2010《细菌内毒素检测方法、常规监测和批量检测替代方法》(AAMI ST72) 描述了凝胶凝块法、光度法和动力学检测方法的基本原理,并建议对相应的组件和成品进行热原和内毒素检测。这些法规要求对药品、医疗器材和生物製品进行严格的安全测试,以确保它们不含可能引起发烧并对患者造成严重风险的热原。因此,製造商正在将热原检测纳入其生产流程。
製药和生物技术产业的进步
製药和生物技术行业的成长以及生物製剂产量的增加也为热原检测市场创造了良好的前景。源自生物体的生物製剂易受热原污染。根据 IMARC GROUP 的数据,2023 年全球生物製剂市场规模达 3,496 亿美元。展望未来,预计到 2032 年热原检测市场价值将达到 6,995 亿美元,2024-2032 年期间的复合年增长率 (CAGR) 为 7.8%。随着这些行业的扩张,对复杂、可靠和快速的热原检测方法的需求也在增加。此外,这种需求导致了检测技术的创新,例如重组 C 因子 (rFC) 检测,它为传统的鲎血液衍生检测提供了一种合成替代方法。
发展医疗基础设施
新兴经济体医疗基础设施的不断发展,以及对符合国际安全标准(包括无热原认证)的医疗产品日益增长的需求,正在推高热原检测的需求。这种扩张拓宽了热原检测的地理市场,并迫使本地製造商采用先进的检测技术参与全球市场。此外,医疗保健体系的发展和医疗支出的增加,也促进了先进热原检测流程的采用和整合。此外,政府部门也正在投资医疗保健产业,以促进公共卫生发展。例如,美国疾病管制与预防中心已拨款32亿美元,协助美国各州、地方和领地辖区加强公共卫生队伍建设和基础建设。这32亿美元中,有30亿美元来自《美国救援计画法案》,用于各辖区招募、留住和培训其员工队伍,包括流行病学家、接触追踪员、实验室科学家、社区卫生工作者和资料分析师等关键的第一线公共卫生工作者。这笔资金还包括从新拨款中拨出的 1.4 亿美元,用于各辖区加强和振兴其公共卫生基础设施。
试剂盒和试剂占大部分市场份额
试剂盒和试剂易于使用,实验室人员无需大量专业培训即可快速设定和执行检测。这种便捷性缩短了检测週期。此外,预先包装的试剂盒和试剂比内部检测方法更具成本效益。自製检测试剂的研发、验证和品质控製成本可能高得令人望而却步,尤其对于规模较小的公司而言。此外,各公司正在透过收购、合併和推出新的先进产品来扩大其热原检测市场份额。例如,PromegaCorp. 于 2021 年 3 月推出了 XpressAmp Direct 扩增试剂。
LAL 检测占据业界最大份额
鲎试剂 (LAL) 检测对细菌内毒素高度敏感,能够检测到极低浓度的内毒素。这些检测的灵敏度对于确保药品和医疗器材的安全至关重要。此外,由于其可靠性得到验证,LAL 检测已成为内毒素检测的标准方法,并受到监管机构和製造商的广泛信赖。此外,LAL 检测也获得了包括美国食品药物管理局 (FDA) 和欧洲药典在内的主要监管机构的认可和建议。 30 多年来,FDA 一直认可使用鲎试剂 (LAL) 检测内毒素,以取代兔热原检测。
製药和生物製剂是领先的细分市场
在生物技术进步和个人化医疗日益受到重视的推动下,生物製剂产业正在快速成长。随着越来越多的生物製剂进入研究流程和商业化生产,这种扩张导致对热原检测的需求增加。此外,製药和生技公司正在大力投资研发新药和生物製品,这需要进行严格的安全测试,包括热原检测,以确保这些创新产品对人类使用是安全的。例如,总部位于加州的安进公司在研发活动上投入了大量资金,根据其 2021 年公司年度报告,其 2021 年、2020 年和 2019 年的研发支出分别为 48 亿美元、42 亿美元和 41 亿美元。这些因素正在扩大这些测试在製药和生物製剂中的应用,从而为热原检测市场带来积极的预测。
北美引领市场,占据最大热原检测市场份额
该报告还对所有主要区域市场进行了全面分析,包括北美(美国和加拿大);欧洲(德国、法国、英国、义大利、西班牙、俄罗斯等);亚太地区(中国、日本、印度、韩国、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中东和非洲。报告指出,北美是热原检测最大的区域市场。
北美拥有先进的医疗保健基础设施,高度重视法规遵循和病人安全。这些基础设施支援并要求医疗产品达到高标准,从而影响了对热原检测的需求,以确保药品和医疗器材的安全。此外,北美的医疗保健支出位居世界前列,大量支出用于医疗创新,包括安全检测。根据医疗保险和医疗补助服务中心的数据,美国医疗保健支出在 2022 年增长了 4.1%,达到 4.5 兆美元,高于 2021 年 3.2% 的增幅。此外,2022 年零售处方药支出成长了 8.4%,达到 4,059 亿美元,高于 2021 年 6.8% 的增幅。这种经济实力正在加剧整个医疗保健和製药业对热原检测的需求。
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.