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市场调查报告书
商品编码
1561634

按产品（仪器、试剂盒和试剂、服务）、测试类型（体外测试、LAL 测试、兔子测试等）、应用（药品和生物製品、医疗器材等）和地区分類的热原测试市场报告2024 -2032

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 2024-2032
出版日期: | 出版商: IMARC | 英文 137 Pages | 商品交期: 2-3个工作天内

价格

2023 年，全球热原测试市场IMARC Group达到 14 亿美元。该市场受到全球製药和生物技术行业不断扩张、心臟病、癌症和糖尿病等慢性病患病率不断上升、新疗法的推出以及研发 (R&D) 活动资金不断增加的推动。

热原测试市场分析：

  • 主要市场驱动因素：市场受到需要治疗干预的慢性病发病率上升以及製药和医疗设备製造不断增加的推动。此外，要求在医疗保健产品製造中进行热原测试的政府措施的实施也创造了有利的热原测试市场前景。
  • 主要市场趋势：目前，在道德考量和监管政策的推动下，采用无动物测试方法的趋势日益明显。此外，市场正在向自动化和高级资料分析整合转变，以提高测试效率。
  • 地理趋势：北美因其先进的医疗基础设施和严格的 FDA 法规而成为领先地区之一。此外，在中国和印度等国家扩大药品製造和增加医疗保健支出的推动下，亚太地区热原测试市场收入也在增加。
  • 竞争格局：热原测试产业的一些主要市场参与者包括 Charles River Laboratories International Inc.、Ellab A/S、Fujifilm Wako Pure Chemical Corporation (Fujifilm Holdings Corporation)、Lonza Group AG、Merck KGaA、Microcoat Biotechnologie GmbH、Nelson Laboratories LLC (Sotera Health)、North American Science Associates Inc.、Pacific Biolabs Inc.、Sanquin、Thermo Fisher Scientific Inc.、Toxikon Corporation Wuxi Apptec. 等。
  • 挑战与机会：热原测试市场研究显示了挑战，例如与先进热原测试方法相关的高成本以及需要熟练人员进行高级测试。然而，这些挑战为市场参与者提供了创新具有成本效益的解决方案和培训计划以填补技能差距的机会。

热原测试市场趋势：

监理合规性和安全标准

热原测试市场的成长很大程度上受到卫生当局（例如美国食品药物管理局以及欧洲药品管理局）实施严格监管框架的推动。医疗仪器促进协会 (AAMI) ST72:2002/R2010，细菌内毒素测试方法、常规监测和批量测试替代方案 (AAMI ST72) 是描述凝胶凝块、光度测定和检测的基本原理的文件。方法，并建议测试适当的成分和成品是否有热原和内毒素。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，以确保它们不含热原，热原会引起发烧，对患者造成严重风险。因此，製造商正在将热原测试纳入其生产流程。

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品产量的增加也创造了有利的热原测试市场前景。来自活生物体的生物製剂容易受到热原污染。根据 IMARC GROUP 的数据，2023 年全球生物製品市场规模达到 3,496 亿美元。 展望未来，热原测试市场价值预计到 2032 年将达到 6,995 亿美元，2024 年复合年增长率 (CAGR) 为 7.8%。 .随着这些产业的扩张，对复杂、可靠和快速热原测试方法的需求也不断增加。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，它为传统的鲎血源检测提供了一种合成替代品。

发展医疗保健基础设施

新兴经济体不断发展的医疗保健基础设施以及对符合国际安全标准（包括无热原认证）的医疗产品的需求不断增加，正在增加热原测试的需求。这项扩张拓宽了热原测试的地理市场，并迫使当地製造商采用先进的测试技术来参与全球市场。此外，医疗保健系统的发展和医疗保健支出的增加正在增加先进热原测试流程的采用和整合。此外，政府当局也正在投资医疗保健产业，以促进公众健康。例如，疾病管制与预防中心已拨款 32 亿美元，帮助美国各州、地方和地区司法管辖区加强公共卫生人力和基础设施。这 32 亿美元中包括《美国救援计画法案》提供的 30 亿美元，用于各司法管辖区招募、保留和培训劳动力，包括流行病学家、接触追踪者、实验室科学家、社区卫生工作者和资料分析师等重要的第一线公共卫生工作者。该资金还包括为各司法管辖区提供的 1.4 亿美元新拨款，用于加强和振兴其公共卫生基础设施。

热原测试市场细分：

IMARC Group提供了每个细分市场的主要趋势的分析，以及 2024-2032 年全球、区域和国家层面的预测。我们的报告根据产品、测试类型和应用对市场进行了分类。

按产品划分：

  • 仪器仪表
  • 试剂盒和试剂
  • 服务

试剂盒和试剂占大部分市场份额

该报告根据产品提供了详细的市场细分和分析。这包括仪器、套件和试剂以及服务。根据该报告，试剂盒和试剂占了最大的份额。

试剂盒和试剂对使用者友好，让实验室人员快速设定和执行测试，而无需进行广泛的专业培训。这种便利性可以缩短测试週转时间。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。与自製测试的研发、验证和品质控制相关的成本可能非常高，特别是对于小公司而言。此外，公司正在收购和合併其他公司，并推出新的先进产品，以扩大其热原测试市场份额。例如，2021 年 3 月，PromegaCorp。推出XpressAmp Direct扩增试剂。

按测试类型划分：

  • 体外测试
  • 鲎试剂测试
  • 兔子测试
  • 其他的

鲎试剂测试占据业界最大份额

报告中还提供了基于测试类型的详细市场区隔和分析。这包括体外测试、鲎试剂测试、兔子测试等。报告称，LAL测试占据了最大的市场份额。

鲎试剂检测对细菌内毒素高度敏感，能够检测出极低的细菌内毒素。这些测试的灵敏度对于确保药品和医疗器材的安全至关重要。此外，由于其经过验证的可靠性，鲎试剂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任。此外，LAL测试得到主要监管机构的认可和推荐，包括美国食品药物管理局（FDA）和欧洲药典。 30 多年来，FDA 一直接受使用鲎变形细胞裂解物 (LAL) 检测内毒素来取代兔热原检测。

按应用划分：

  • 製药和生物製品
  • 医疗器材
  • 其他的

製药和生物製剂代表了领先的细分市场

该报告根据应用程式提供了详细的市场细分和分析。这包括药品和生物製剂、医疗器材等。根据该报告，製药和生物製品占最大的部分。

在生物技术进步和对个人化医疗日益关注的推动下，生物製品产业正在快速成长。随着越来越多的生物製剂进入研究管道和商业生产，这种扩展导致了对热原测试的更大需求。此外，製药和生技公司正在大力投资研发，以创造新的药物和生物製品，这需要严格的安全测试，包括热原测试，以确保这些创新产品可供人类安全使用。例如，总部位于加州的安进公司在研发活动上投入巨资，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，根据其 2021 年公司年度报告。这些因素正在扩大这些测试在药物和生物製品中的使用，从而创造了积极的热原测试市场预测。

按地区划分：

  • 北美洲
    • 美国
    • 加拿大
  • 亚太
    • 中国
    • 日本
    • 印度
    • 韩国
    • 澳洲
    • 印尼
    • 其他的
  • 欧洲
    • 德国
    • 法国
    • 英国
    • 义大利
    • 西班牙
    • 俄罗斯
    • 其他的
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 其他的
  • 中东和非洲

北美市场领先，占据最大的热原测试市场份额

该报告还对所有主要区域市场进行了全面分析，其中包括北美（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。报告称，北美是热原测试最大的区域市场。

北美拥有先进的医疗保健基础设施，非常重视监管合规性和病人安全。此基础设施支援并要求医疗产品的高标准，影响热原测试的需求，以确保药品和医疗器材的安全。此外，北美的医疗保健支出是世界上最高的，其中大量支出用于健康创新，包括安全测试。根据医疗保险和医疗补助服务中心的数据，美国医疗保健支出将成长4，到2022 年将成长4.1%，达到45 兆美元，高于2021 年3.2% 的增幅。 ，达到4059 亿美元2022 年，支出增幅将快于 2021 年 6.8%。这种财务能力正在增加整个医疗保健和製药业对热原测试的需求。

（请注意，这只是关键参与者的部分列表，报告中提供了完整列表。）

  • 热原测试市场研究报告显示，领先的公司正在不断投资于研发，以改善现有产品并创造新的、更有效率、更灵敏的热原测试方法。这包括开发快速测试和替代方法，例如单核细胞活化测试 (MAT) 和重组 C 因子 (rFC) 测定。此外，公司越来越注重扩大在亚太和拉丁美洲等高成长地区的业务，因为这些地区的製药和医疗器材製造业迅速扩张，提供了巨大的机会。根据IMARC Group统计，2023年印度医药市场规模达546亿美元。这些数值将在未来几年继续影响热原测试市场统计数据。

热原测试市场新闻：

  • 2020 年 10 月，Lonza Bioscience 宣布商业发布 PyroCell MAT 系统，这是一个可持续且可靠的体外热原测试解决方案。新产品确保了注射药物在开发、製造和产品发布过程中的安全性。
  • 2020 年 7 月，Sanquin Reagents BV 和 Lonza Sales AG 建立了战略合作伙伴关係，致力于一系列用于注射药物和医疗器械热原测试的专用试剂的商业化。

本报告回答的关键问题：

  • 迄今为止，全球热原测试市场表现如何，未来几年将如何表现？
  • 全球热原测试市场的驱动因素、限制因素和机会是什么？
  • 每个驱动因素、限制因素和机会对全球热原测试市场有何影响？
  • 主要区域市场有哪些？
  • 哪些国家代表了最具吸引力的热原测试市场？
  • 基于产品的市场区隔是什么？
  • 热原测试市场上最具吸引力的产品是什么？
  • 根据测试类型，市场的细分是什么？
  • 热原测试市场中哪种测试类型最具吸引力？
  • 基于应用的市场区隔是什么？
  • 热原测试市场中最具吸引力的应用是什么？
  • 市场竞争结构如何？
  • 全球热原测试市场的主要参与者/公司有哪些？

本报告回答的关键问题：

  • 迄今为止，全球热原测试市场表现如何，未来几年将如何表现？
  • 全球热原测试市场的驱动因素、限制因素和机会是什么？
  • 每个驱动因素、限制因素和机会对全球热原测试市场有何影响？
  • 主要区域市场有哪些？
  • 哪些国家代表了最具吸引力的热原测试市场？
  • 基于产品的市场区隔是什么？
  • 热原测试市场上最具吸引力的产品是什么？
  • 根据测试类型，市场的细分是什么？
  • 热原测试市场中哪种测试类型最具吸引力？
  • 基于应用的市场区隔是什么？
  • 热原测试市场中最具吸引力的应用是什么？
  • 市场竞争结构如何？
  • 全球热原测试市场的主要参与者/公司有哪些？

目录

第一章：前言

第 2 章：范围与方法

  • 研究目的
  • 利害关係人
  • 数据来源
    • 主要来源
    • 二手资料
  • 市场预测
    • 自下而上的方法
    • 自上而下的方法
  • 预测方法

第 3 章：执行摘要

第 4 章：简介

  • 概述
  • 主要行业趋势

第 5 章：全球热原测试市场

  • 市场概况
  • 市场表现
  • COVID-19 的影响
  • 市场预测

第 6 章：市场区隔：依产品

  • 仪器仪表
    • 市场趋势
    • 市场预测
  • 试剂盒和试剂
    • 市场趋势
    • 市场预测
  • 服务
    • 市场趋势
    • 市场预测

第 7 章：市场区隔：按测试类型

  • 体外测试
    • 市场趋势
    • 市场预测
  • 鲎试剂测试
    • 市场趋势
    • 市场预测
  • 兔子测试
    • 市场趋势
    • 市场预测
  • 其他的
    • 市场趋势
    • 市场预测

第 8 章：市场区隔：按应用

  • 製药和生物製品
    • 市场趋势
    • 市场预测
  • 医疗器材
    • 市场趋势
    • 市场预测
  • 其他的
    • 市场趋势
    • 市场预测

第 9 章：市场区隔：按地区

  • 北美洲
    • 美国
    • 加拿大
  • 亚太
    • 中国
    • 日本
    • 印度
    • 韩国
    • 澳洲
    • 印尼
    • 其他的
  • 欧洲
    • 德国
    • 法国
    • 英国
    • 义大利
    • 西班牙
    • 俄罗斯
    • 其他的
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 其他的
  • 中东和非洲
    • 市场趋势
    • 市场细分：按国家/地区
    • 市场预测

第 10 章：SWOT 分析

  • 概述
  • 优势
  • 弱点
  • 机会
  • 威胁

第 11 章：价值链分析

第 12 章：波特五力分析

  • 概述
  • 买家的议价能力
  • 供应商的议价能力
  • 竞争程度
  • 新进入者的威胁
  • 替代品的威胁

第 13 章：价格分析

第14章：竞争格局

  • 市场结构
  • 关键参与者
  • 关键参与者简介
    • Charles River Laboratories International Inc.
    • Ellab A/S
    • Fujifilm Wako Pure Chemical Corporation (Fujifilm Holdings Corporation)
    • Lonza Group AG
    • Merck KGaA
    • Microcoat Biotechnologie GmbH
    • Nelson Laboratories LLC (Sotera Health)
    • North American Science Associates Inc.
    • Pacific Biolabs Inc.
    • Sanquin
    • Thermo Fisher Scientific Inc
    • Toxikon Corporation
    • Wuxi Apptec
Product Code: SR112024A4601

The global pyrogen testing market size reached US$ 1.4 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 3.1 Billion by 2032, exhibiting a growth rate (CAGR) of 9.2% during 2024-2032. 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.

Pyrogen Testing Market Analysis:

  • Major Market Drivers: The market is driven by the rising incidence of chronic diseases that require therapeutic intervention and the increasing pharmaceutical and medical device manufacturing. Moreover, the implementation of government initiatives requiring pyrogen testing in the manufacturing of healthcare products also creating a favorable pyrogen testing market overview.
  • Key Market Trends: At present, there is a growing trend toward adopting animal-free testing methods, driven by ethical considerations and regulatory policies. Additionally, the market is seeing a shift toward automation and integration of advanced data analytics to enhance testing efficiency.
  • Geographical Trends: North America is among the leading regions due to its advanced healthcare infrastructure and stringent FDA regulations. Moreover, Asia Pacific is also experiencing growing pyrogen testing market revenue, fueled by expanding pharmaceutical manufacturing and increasing healthcare spending in countries like China and India.
  • Competitive Landscape: Some of the major market players in the pyrogen testing industry include Charles River Laboratories International Inc., Ellab A/S, Fujifilm Wako Pure Chemical Corporation (Fujifilm Holdings Corporation), Lonza Group AG, Merck KGaA, Microcoat Biotechnologie GmbH, Nelson Laboratories LLC (Sotera Health), North American Science Associates Inc., Pacific Biolabs Inc., Sanquin, Thermo Fisher Scientific Inc, Toxikon Corporation Wuxi Apptec., among many others.
  • Challenges and Opportunities: The pyrogen testing market research showed challenges such as high costs associated with advanced pyrogen testing methods and the need for skilled personnel to conduct advanced tests. However, these challenges present opportunities for market players to innovate cost-effective solutions and training programs to fill the skills gap.

Pyrogen Testing Market Trends:

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.

Pyrogen Testing Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on product, test type, and application.

Breakup by Product:

  • Instruments
  • Kits and Reagents
  • Services

Kits and reagents accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the product. This includes instruments, kits and reagents, and services. According to the report, kits and reagents represented the largest segment.

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.

Breakup by Test Type:

  • In-vitro Tests
  • LAL Tests
  • Rabbit Tests
  • Others

LAL tests hold the largest share of the industry

A detailed breakup and analysis of the market based on the test type have also been provided in the report. This includes in-vitro tests, LAL tests, rabbit tests, and others. According to the report, LAL tests accounted for the largest market share.

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.

Breakup by Application:

  • Pharmaceutical and Biologics
  • Medical Devices
  • Others

Pharmaceutical and biologics represents the leading market segment

The report has provided a detailed breakup and analysis of the market based on the application. This includes pharmaceutical and biologics, medical devices, and others. According to the report, pharmaceutical and biologics represented the largest 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.

Breakup by Region:

  • North America
    • United States
    • Canada
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa

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.

Competitive Landscape:

  • The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the pyrogen testing industry include Charles River Laboratories International Inc., Ellab A/S, Fujifilm Wako Pure Chemical Corporation (Fujifilm Holdings Corporation), Lonza Group AG, Merck KGaA, Microcoat Biotechnologie GmbH, Nelson Laboratories LLC (Sotera Health), North American Science Associates Inc., Pacific Biolabs Inc., Sanquin Reagents BV, Thermo Fisher Scientific Inc, Toxikon Corporation and Wuxi Apptec.

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

  • The pyrogen testing market research report shows that leading companies are continually investing in research and development to improve existing products and create new, more efficient, and sensitive pyrogen testing methods. This includes the development of rapid tests and alternative methods like the monocyte activation test (MAT) and recombinant factor C (rFC) assay. Moreover, companies are increasingly focusing on expanding their presence in high-growth regions such as Asia-Pacific and Latin America as these regions offer significant opportunities due to their rapidly expanding pharmaceutical and medical device manufacturing sectors. According to IMARC Group, the India pharmaceutical market size reached US$ 54.6 Billion in 2023. Looking forward, it is expected to reach US$ 163.1 Billion by 2032, exhibiting a growth rate (CAGR) of 12.3% during 2024-2032. These values will continue to impact the pyrogen testing market statistics in the coming years.

Pyrogen Testing Market News:

  • In October 2020, Lonza Bioscience announced the commercial release of the PyroCell MAT System, a sustainable and reliable solution for in vitro pyrogen testing. The new offering ensures the safety of parenteral pharmaceuticals during development, manufacture, and product release.
  • In July 2020, Sanquin Reagents BV and Lonza Sales AG entered a strategic partnership for the commercialization of a range of specialized reagents for pyrogen testing of parenteral pharmaceuticals and medical devices.

Key Questions Answered in This Report:

  • How has the global pyrogen testing market performed so far, and how will it perform in the coming years?
  • What are the drivers, restraints, and opportunities in the global pyrogen testing market?
  • What is the impact of each driver, restraint, and opportunity on the global pyrogen testing market?
  • What are the key regional markets?
  • Which countries represent the most attractive pyrogen testing market?
  • What is the breakup of the market based on the product?
  • Which is the most attractive product in the pyrogen testing market?
  • What is the breakup of the market based on the test type?
  • Which is the most attractive test type in the pyrogen testing market?
  • What is the breakup of the market based on the application?
  • Which is the most attractive application in the pyrogen testing market?
  • What is the competitive structure of the market?
  • Who are the key players/companies in the global pyrogen testing market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Pyrogen Testing Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Product

  • 6.1 Instruments
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Kits and Reagents
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Services
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast

7 Market Breakup by Test Type

  • 7.1 In-vitro Tests
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 LAL Tests
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 Rabbit Tests
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast
  • 7.4 Others
    • 7.4.1 Market Trends
    • 7.4.2 Market Forecast

8 Market Breakup by Application

  • 8.1 Pharmaceutical and Biologics
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Medical Devices
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Others
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast

9 Market Breakup by Region

  • 9.1 North America
    • 9.1.1 United States
      • 9.1.1.1 Market Trends
      • 9.1.1.2 Market Forecast
    • 9.1.2 Canada
      • 9.1.2.1 Market Trends
      • 9.1.2.2 Market Forecast
  • 9.2 Asia-Pacific
    • 9.2.1 China
      • 9.2.1.1 Market Trends
      • 9.2.1.2 Market Forecast
    • 9.2.2 Japan
      • 9.2.2.1 Market Trends
      • 9.2.2.2 Market Forecast
    • 9.2.3 India
      • 9.2.3.1 Market Trends
      • 9.2.3.2 Market Forecast
    • 9.2.4 South Korea
      • 9.2.4.1 Market Trends
      • 9.2.4.2 Market Forecast
    • 9.2.5 Australia
      • 9.2.5.1 Market Trends
      • 9.2.5.2 Market Forecast
    • 9.2.6 Indonesia
      • 9.2.6.1 Market Trends
      • 9.2.6.2 Market Forecast
    • 9.2.7 Others
      • 9.2.7.1 Market Trends
      • 9.2.7.2 Market Forecast
  • 9.3 Europe
    • 9.3.1 Germany
      • 9.3.1.1 Market Trends
      • 9.3.1.2 Market Forecast
    • 9.3.2 France
      • 9.3.2.1 Market Trends
      • 9.3.2.2 Market Forecast
    • 9.3.3 United Kingdom
      • 9.3.3.1 Market Trends
      • 9.3.3.2 Market Forecast
    • 9.3.4 Italy
      • 9.3.4.1 Market Trends
      • 9.3.4.2 Market Forecast
    • 9.3.5 Spain
      • 9.3.5.1 Market Trends
      • 9.3.5.2 Market Forecast
    • 9.3.6 Russia
      • 9.3.6.1 Market Trends
      • 9.3.6.2 Market Forecast
    • 9.3.7 Others
      • 9.3.7.1 Market Trends
      • 9.3.7.2 Market Forecast
  • 9.4 Latin America
    • 9.4.1 Brazil
      • 9.4.1.1 Market Trends
      • 9.4.1.2 Market Forecast
    • 9.4.2 Mexico
      • 9.4.2.1 Market Trends
      • 9.4.2.2 Market Forecast
    • 9.4.3 Others
      • 9.4.3.1 Market Trends
      • 9.4.3.2 Market Forecast
  • 9.5 Middle East and Africa
    • 9.5.1 Market Trends
    • 9.5.2 Market Breakup by Country
    • 9.5.3 Market Forecast

10 SWOT Analysis

  • 10.1 Overview
  • 10.2 Strengths
  • 10.3 Weaknesses
  • 10.4 Opportunities
  • 10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis

  • 12.1 Overview
  • 12.2 Bargaining Power of Buyers
  • 12.3 Bargaining Power of Suppliers
  • 12.4 Degree of Competition
  • 12.5 Threat of New Entrants
  • 12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape

  • 14.1 Market Structure
  • 14.2 Key Players
  • 14.3 Profiles of Key Players
    • 14.3.1 Charles River Laboratories International Inc.
      • 14.3.1.1 Company Overview
      • 14.3.1.2 Product Portfolio
      • 14.3.1.3 Financials
      • 14.3.1.4 SWOT Analysis
    • 14.3.2 Ellab A/S
      • 14.3.2.1 Company Overview
      • 14.3.2.2 Product Portfolio
    • 14.3.3 Fujifilm Wako Pure Chemical Corporation (Fujifilm Holdings Corporation)
      • 14.3.3.1 Company Overview
      • 14.3.3.2 Product Portfolio
    • 14.3.4 Lonza Group AG
      • 14.3.4.1 Company Overview
      • 14.3.4.2 Product Portfolio
      • 14.3.4.3 Financials
      • 14.3.4.4 SWOT Analysis
    • 14.3.5 Merck KGaA
      • 14.3.5.1 Company Overview
      • 14.3.5.2 Product Portfolio
      • 14.3.5.3 Financials
      • 14.3.5.4 SWOT Analysis
    • 14.3.6 Microcoat Biotechnologie GmbH
      • 14.3.6.1 Company Overview
      • 14.3.6.2 Product Portfolio
    • 14.3.7 Nelson Laboratories LLC (Sotera Health)
      • 14.3.7.1 Company Overview
      • 14.3.7.2 Product Portfolio
    • 14.3.8 North American Science Associates Inc.
      • 14.3.8.1 Company Overview
      • 14.3.8.2 Product Portfolio
    • 14.3.9 Pacific Biolabs Inc.
      • 14.3.9.1 Company Overview
      • 14.3.9.2 Product Portfolio
    • 14.3.10 Sanquin
      • 14.3.10.1 Company Overview
      • 14.3.10.2 Product Portfolio
    • 14.3.11 Thermo Fisher Scientific Inc
      • 14.3.11.1 Company Overview
      • 14.3.11.2 Product Portfolio
      • 14.3.11.3 Financials
      • 14.3.11.4 SWOT Analysis
    • 14.3.12 Toxikon Corporation
      • 14.3.12.1 Company Overview
      • 14.3.12.2 Product Portfolio
    • 14.3.13 Wuxi Apptec
      • 14.3.13.1 Company Overview
      • 14.3.13.2 Product Portfolio
      • 14.3.13.3 Financials

List of Figures

  • Figure 1: Global: Pyrogen Testing Market: Major Drivers and Challenges
  • Figure 2: Global: Pyrogen Testing Market: Sales Value (in Billion US$), 2018-2023
  • Figure 3: Global: Pyrogen Testing Market Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 4: Global: Pyrogen Testing Market: Breakup by Product (in %), 2023
  • Figure 5: Global: Pyrogen Testing Market: Breakup by Test Type (in %), 2023
  • Figure 6: Global: Pyrogen Testing Market: Breakup by Application (in %), 2023
  • Figure 7: Global: Pyrogen Testing Market: Breakup by Region (in %), 2023
  • Figure 8: Global: Pyrogen Testing (Instruments) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 9: Global: Pyrogen Testing (Instruments) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 10: Global: Pyrogen Testing (Kits and Reagents) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 11: Global: Pyrogen Testing (Kits and Reagents) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 12: Global: Pyrogen Testing (Services) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 13: Global: Pyrogen Testing (Services) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 14: Global: Pyrogen Testing (In-vitro Tests) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 15: Global: Pyrogen Testing (In-vitro Tests) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 16: Global: Pyrogen Testing (LAL Tests) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 17: Global: Pyrogen Testing (LAL Tests) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 18: Global: Pyrogen Testing (Rabbit Tests) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 19: Global: Pyrogen Testing (Rabbit Tests) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 20: Global: Pyrogen Testing (Other Test Types) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 21: Global: Pyrogen Testing (Other Test Types) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 22: Global: Pyrogen Testing (Pharmaceutical and Biologics) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 23: Global: Pyrogen Testing (Pharmaceutical and Biologics) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 24: Global: Pyrogen Testing (Medical Devices) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 25: Global: Pyrogen Testing (Medical Devices) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 26: Global: Pyrogen Testing (Other Applications) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 27: Global: Pyrogen Testing (Other Applications) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 28: North America: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 29: North America: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 30: United States: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 31: United States: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 32: Canada: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 33: Canada: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 34: Asia-Pacific: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 35: Asia-Pacific: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 36: China: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 37: China: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 38: Japan: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 39: Japan: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 40: India: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 41: India: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 42: South Korea: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 43: South Korea: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 44: Australia: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 45: Australia: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 46: Indonesia: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 47: Indonesia: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 48: Others: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 49: Others: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 50: Europe: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 51: Europe: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 52: Germany: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 53: Germany: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 54: France: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 55: France: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 56: United Kingdom: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 57: United Kingdom: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 58: Italy: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 59: Italy: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 60: Spain: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 61: Spain: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 62: Russia: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 63: Russia: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 64: Others: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 65: Others: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 66: Latin America: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 67: Latin America: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 68: Brazil: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 69: Brazil: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 70: Mexico: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 71: Mexico: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 72: Others: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 73: Others: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 74: Middle East and Africa: Pyrogen Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 75: Middle East and Africa: Pyrogen Testing Market: Breakup by Country (in %), 2023
  • Figure 76: Middle East and Africa: Pyrogen Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 77: Global: Pyrogen Testing Industry: SWOT Analysis
  • Figure 78: Global: Pyrogen Testing Industry: Value Chain Analysis
  • Figure 79: Global: Pyrogen Testing Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Pyrogen Testing Market: Key Industry Highlights, 2023 and 2032
  • Table 2: Global: Pyrogen Testing Market Forecast: Breakup by Product (in Million US$), 2024-2032
  • Table 3: Global: Pyrogen Testing Market Forecast: Breakup by Test Type (in Million US$), 2024-2032
  • Table 4: Global: Pyrogen Testing Market Forecast: Breakup by Application (in Million US$), 2024-2032
  • Table 5: Global: Pyrogen Testing Market Forecast: Breakup by Region (in Million US$), 2024-2032
  • Table 6: Global: Pyrogen Testing Market: Competitive Structure
  • Table 7: Global: Pyrogen Testing Market: Key Players