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市場調查報告書
商品編碼
1561634

按產品（儀器、試劑盒和試劑、服務）、測試類型（體外測試、LAL 測試、兔子測試等）、應用（藥品和生物製品、醫療器材等）和地區分類的熱原測試市場報告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個工作天內

價格

2023 年，全球熱原測試市場IMARC Group達到 14 億美元。該市場受到全球製藥和生物技術行業不斷擴張、心臟病、癌症和糖尿病等慢性病患病率不斷上升、新療法的推出以及研發 (R&D) 活動資金不斷增加的推動。

熱原測試市場分析：

  • 主要市場促進因素：市場受到需要治療干預的慢性病發病率上升以及製藥和醫療設備製造不斷增加的推動。此外，要求在醫療保健產品製造中進行熱原測試的政府措施的實施也創造了有利的熱原測試市場前景。
  • 主要市場趨勢：目前，在道德考量和監管政策的推動下，採用無動物測試方法的趨勢日益明顯。此外，市場正在向自動化和高級資料分析整合轉變，以提高測試效率。
  • 地理趨勢：北美因其先進的醫療基礎設施和嚴格的 FDA 法規而成為領先地區之一。此外，在中國和印度等國家擴大藥品製造和增加醫療保健支出的推動下，亞太地區熱原測試市場收入也在增加。
  • 競爭格局：熱原測試產業的一些主要市場參與者包括 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。
  • 挑戰與機會：熱原測試市場研究顯示了挑戰，例如與先進熱原測試方法相關的高成本以及需要熟練人員進行高級測試。然而，這些挑戰為市場參與者提供了創新具有成本效益的解決方案和培訓計劃以填補技能差距的機會。

熱原測試市場趨勢：

監理合規性和安全標準

熱原測試市場的成長很大程度上受到衛生當局（例如美國食品藥物管理局以及歐洲藥品管理局）實施嚴格監管框架的推動。醫療儀器促進協會 (AAMI) ST72:2002/R2010，細菌內毒素測試方法、常規監測和批量測試替代方案 (AAMI ST72) 是描述凝膠凝塊、光度測定和檢測的基本原理的文件。方法，並建議測試適當的成分和成品是否有熱原和內毒素。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，以確保它們不含熱原，熱原會引起發燒，對患者造成嚴重風險。因此，製造商正在將熱原測試納入其生產流程。

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品產量的增加也創造了有利的熱原測試市場前景。來自活生物體的生物製劑容易受到熱原污染。根據 IMARC GROUP 的數據，2023 年全球生物製品市場規模達到 3,496 億美元。 展望未來，熱原測試市場價值預計到 2032 年將達到 6,995 億美元，2024 年複合年成長率 (CAGR) 為 7.8%。 .隨著這些產業的擴張，對複雜、可靠和快速熱原測試方法的需求也不斷增加。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，它為傳統的鱟血源檢測提供了一種合成替代品。

發展醫療保健基礎設施

新興經濟體不斷發展的醫療保健基礎設施以及對符合國際安全標準（包括無熱原認證）的醫療產品的需求不斷增加，正在增加熱原測試的需求。這項擴張拓寬了熱原測試的地理市場，並迫使當地製造商採用先進的測試技術來參與全球市場。此外，醫療保健系統的發展和醫療保健支出的增加正在增加先進熱原測試流程的採用和整合。此外，政府當局也正在投資醫療保健產業，以促進公眾健康。例如，疾病管制與預防中心已撥款 32 億美元，幫助美國各州、地方和地區司法管轄區加強公共衛生人力和基礎設施。這 32 億美元中包括《美國救援計畫法案》提供的 30 億美元，用於各司法管轄區招募、保留和培訓勞動力，包括流行病學家、接觸追蹤者、實驗室科學家、社區衛生工作者和資料分析師等重要的第一線公共衛生工作者。該資金還包括為各司法管轄區提供的 1.4 億美元新撥款，用於加強和振興其公共衛生基礎設施。

熱原測試市場細分：

IMARC Group提供了每個細分市場的主要趨勢的分析，以及 2024-2032 年全球、區域和國家層面的預測。我們的報告根據產品、測試類型和應用對市場進行了分類。

按產品分類：

  • 儀器儀表
  • 試劑盒和試劑
  • 服務

試劑盒和試劑佔大部分市場佔有率

該報告根據產品提供了詳細的市場細分和分析。這包括儀器、套件和試劑以及服務。根據該報告，試劑盒和試劑佔了最大的佔有率。

試劑盒和試劑對使用者友好，讓實驗室人員快速設定和執行測試，而無需進行廣泛的專業培訓。這種便利性可以縮短測試週轉時間。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。與自製測試的研發、驗證和品質控制相關的成本可能非常高，特別是對於小公司而言。此外，公司正在收購和合併其他公司，並推出新的先進產品，以擴大其熱原測試市場佔有率。例如，2021 年 3 月，PromegaCorp。推出XpressAmp Direct擴增試劑。

按測試類型分類：

  • 體外測試
  • 鱟試劑測試
  • 兔子測試
  • 其他

鱟試劑測試佔據業界最大佔有率

報告中還提供了基於測試類型的詳細市場區隔和分析。這包括體外測試、鱟試劑測試、兔子測試等。報告稱，LAL測試佔據了最大的市場佔有率。

鱟試劑檢測對細菌內毒素高度敏感，能夠檢測出極低的細菌內毒素。這些測試的靈敏度對於確保藥品和醫療器材的安全至關重要。此外，由於其經過驗證的可靠性，鱟試劑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任。此外，LAL測試得到主要監管機構的認可和推薦，包括美國食品藥物管理局（FDA）和歐洲藥典。 30 多年來，FDA 一直接受使用鱟變形細胞裂解物 (LAL) 檢測內毒素來取代兔熱原檢測。

按應用分類：

  • 製藥和生物製品
  • 醫療器材
  • 其他

製藥和生物製劑代表了領先的細分市場

該報告根據應用程式提供了詳細的市場細分和分析。這包括藥品和生物製劑、醫療器材等。根據該報告，製藥和生物製品佔最大的部分。

在生物技術進步和對個人化醫療日益關注的推動下，生物製品產業正在快速成長。隨著越來越多的生物製劑進入研究管道和商業生產，這種擴展導致了對熱原測試的更大需求。此外，製藥和生技公司正在大力投資研發，以創造新的藥物和生物製品，這需要嚴格的安全測試，包括熱原測試，以確保這些創新產品可供人類安全使用。例如，總部位於加州的安進公司在研發活動上投入巨資，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，根據其 2021 年公司年度報告。這些因素正在擴大這些測試在藥物和生物製品中的使用，從而創造了積極的熱原測試市場預測。

按地區分類：

  • 北美洲
    • 美國
    • 加拿大
  • 亞太
    • 中國
    • 日本
    • 印度
    • 韓國
    • 澳洲
    • 印尼
    • 其他
  • 歐洲
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙
    • 俄羅斯
    • 其他
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 其他
  • 中東和非洲

北美市場領先，佔據最大的熱原測試市場佔有率

該報告還對所有主要區域市場進行了全面分析，其中包括北美（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。報告稱，北美是熱原測試最大的區域市場。

北美擁有先進的醫療保健基礎設施，非常重視監管合規性和病人安全。此基礎設施支援並要求醫療產品的高標準，影響熱原測試的需求，以確保藥品和醫療器材的安全。此外，北美的醫療保健支出是世界上最高的，其中大量支出用於健康創新，包括安全測試。根據醫療保險和醫療補助服務中心的數據，美國醫療保健支出將成長4，到2022 年將成長4.1%，達到45 兆美元，高於2021 年3.2% 的增幅。 ，達到4059 億美元2022 年，支出增幅將快於 2021 年 6.8%。這種財務能力正在增加整個醫療保健和製藥業對熱原測試的需求。

（請注意，這只是關鍵參與者的部分列表，報告中提供了完整列表。）

  • 熱原測試市場研究報告顯示，領先的公司正在不斷投資於研發，以改善現有產品並創造新的、更有效率、更靈敏的熱原測試方法。這包括開發快速測試和替代方法，例如單核細胞活化測試 (MAT) 和重組 C 因子 (rFC) 測定。此外，公司越來越注重擴大在亞太和拉丁美洲等高成長地區的業務，因為這些地區的製藥和醫療器材製造業迅速擴張，提供了巨大的機會。根據IMARC Group統計，2023年印度醫藥市場規模達546億美元。這些數值將在未來幾年繼續影響熱原測試市場統計數據。

熱原測試市場新聞：

  • 2020 年 10 月，Lonza Bioscience 宣布商業發布 PyroCell MAT 系統，這是一個永續且可靠的體外熱原測試解決方案。新產品確保了注射藥物在開發、製造和產品發布過程中的安全性。
  • 2020 年 7 月，Sanquin Reagents BV 和 Lonza Sales AG 建立了戰略合作夥伴關係，致力於一系列用於注射藥物和醫療器械熱原測試的專用試劑的商業化。

本報告回答的關鍵問題：

  • 迄今為止，全球熱原測試市場表現如何，未來幾年將如何表現？
  • 全球熱原測試市場的促進因素、限制因素和機會是什麼？
  • 每個促進因素、限制因素和機會對全球熱原測試市場有何影響？
  • 主要區域市場有哪些？
  • 哪些國家代表了最具吸引力的熱原測試市場？
  • 基於產品的市場區隔是什麼？
  • 熱原測試市場上最具吸引力的產品是什麼？
  • 根據測試類型，市場的細分是什麼？
  • 熱原測試市場中哪種測試類型最具吸引力？
  • 基於應用的市場區隔是什麼？
  • 熱原測試市場中最具吸引力的應用是什麼？
  • 市場競爭結構如何？
  • 全球熱原測試市場的主要參與者/公司有哪些？

本報告回答的關鍵問題：

  • 迄今為止，全球熱原測試市場表現如何，未來幾年將如何表現？
  • 全球熱原測試市場的促進因素、限制因素和機會是什麼？
  • 每個促進因素、限制因素和機會對全球熱原測試市場有何影響？
  • 主要區域市場有哪些？
  • 哪些國家代表了最具吸引力的熱原測試市場？
  • 基於產品的市場區隔是什麼？
  • 熱原測試市場上最具吸引力的產品是什麼？
  • 根據測試類型，市場的細分是什麼？
  • 熱原測試市場中哪種測試類型最具吸引力？
  • 基於應用的市場區隔是什麼？
  • 熱原測試市場中最具吸引力的應用是什麼？
  • 市場競爭結構如何？
  • 全球熱原測試市場的主要參與者/公司有哪些？

目錄

第1章：前言

第 2 章：範圍與方法

  • 研究目的
  • 利害關係人
  • 數據來源
    • 主要來源
    • 二手資料
  • 市場預測
    • 自下而上的方法
    • 自上而下的方法
  • 預測方法

第 3 章：執行摘要

第 4 章：簡介

  • 概述
  • 主要行業趨勢

第 5 章：全球熱原測試市場

  • 市場概況
  • 市場表現
  • COVID-19 的影響
  • 市場預測

第 6 章：市場區隔：依產品

  • 儀器儀表
    • 市場趨勢
    • 市場預測
  • 試劑盒和試劑
    • 市場趨勢
    • 市場預測
  • 服務
    • 市場趨勢
    • 市場預測

第 7 章：市場區隔：按測試類型

  • 體外測試
    • 市場趨勢
    • 市場預測
  • 鱟試劑測試
    • 市場趨勢
    • 市場預測
  • 兔子測試
    • 市場趨勢
    • 市場預測
  • 其他
    • 市場趨勢
    • 市場預測

第 8 章：市場區隔：按應用

  • 製藥和生物製品
    • 市場趨勢
    • 市場預測
  • 醫療器材
    • 市場趨勢
    • 市場預測
  • 其他
    • 市場趨勢
    • 市場預測

第 9 章：市場區隔：按地區

  • 北美洲
    • 美國
    • 加拿大
  • 亞太
    • 中國
    • 日本
    • 印度
    • 韓國
    • 澳洲
    • 印尼
    • 其他
  • 歐洲
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙
    • 俄羅斯
    • 其他
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 其他
  • 中東和非洲
    • 市場趨勢
    • 市場細分：按國家/地區
    • 市場預測

第 10 章：SWOT 分析

  • 概述
  • 優勢
  • 弱點
  • 機會
  • 威脅

第 11 章：價值鏈分析

第 12 章：波特五力分析

  • 概述
  • 買家的議價能力
  • 供應商的議價能力
  • 競爭程度
  • 新進入者的威脅
  • 替代品的威脅

第 13 章：價格分析

第14章：競爭格局

  • 市場結構
  • 關鍵參與者
  • 關鍵參與者簡介
    • 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