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パイロジェン試験市場レポート：製品、試験タイプ、用途、地域別、2024年～2032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 2024-2032

出版日
発行
IMARC
ページ情報
英文 137 Pages
納期
2～3営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=146.82円
パイロジェン試験市場レポート：製品、試験タイプ、用途、地域別、2024年～2032年
出版日: 2024年09月10日
発行: IMARC
ページ情報: 英文 137 Pages
納期: 2～3営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界のパイロジェン試験市場の市場規模は2023年に14億米ドルに達しました。今後、IMARC Groupは、市場は2032年までに31億米ドルに達し、2024年から2032年の間に9.2％の成長率（CAGR）を示すと予測しています。同市場は、世界中の製薬・バイオテクノロジー産業の拡大、心臓病、がん、糖尿病などの慢性疾患の有病率の増加、新治療薬の上市、研究開発（R&D）活動の資金調達の増加によって推進されています。

パイロジェン試験市場分析：

  • 主な市場促進要因：市場を牽引するのは、治療介入を必要とする慢性疾患の罹患率の上昇と、医薬品・医療機器製造の増加です。さらに、ヘルスケア製品の製造にパイロジェン試験を義務付ける政府の取り組みも、好ましいパイロジェン試験市場の概観を生み出しています。
  • 主な市場動向：現在、倫理的配慮と規制政策により、動物を使用しない試験法を採用する傾向が強まっています。また、検査効率を高めるため、自動化や高度なデータ分析の統合へのシフトが見られます。
  • 地理的動向：北米は、先進的なヘルスケアインフラと厳格なFDA規制により、主要地域のひとつとなっています。また、アジア太平洋地域は、医薬品製造の拡大や中国やインドなどにおけるヘルスケア支出の増加により、収益が伸びています。
  • 競合情勢：パイロジェン試験業界の主要市場プレーヤーには、Charles River Laboratories International Inc.、Ellab A/S、富士フイルム和光純薬（富士フイルムホールディングス）、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.などがあります。
  • 課題と機会：パイロジェン試験市場調査では、高度なパイロジェン試験法に関連する高コストや、高度な検査を実施するための熟練者の必要性などの課題が示されました。しかし、これらの課題は、市場関係者にとって、費用対効果の高いソリューションやスキルギャップを埋めるトレーニングプログラムを革新する機会となります。

パイロジェン試験市場傾向

規制遵守と安全基準

パイロジェン試験市場の成長は、米国のFOOD and DRUGS ADMINISTRATION（食品医薬品庁）や欧州のEUROPEAN MEDICINE AGENCY（欧州医薬品庁）などの保健当局による厳格な規制枠組みの実施によって大きく牽引されています。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）は、ゲルクロット法、光度法、速度論的試験法の基本原理を説明し、適切な成分や最終製品について発熱物質やエンドトキシンの存在を試験することを推奨する文書です。これらの規制は、医薬品、医療機器、生物学的製剤に発熱を誘発し、患者に深刻なリスクをもたらす可能性のあるパイロジェンが含まれていないことを確認するために、厳格な安全性試験を義務付けています。その結果、メーカーは製造工程にパイロジェン試験を組み込んでいます。

医薬品・バイオテクノロジー産業の進歩

製薬・バイオテクノロジー分野の成長と生物製剤の生産量の増加も、良好なパイロジェン試験市場見通しを生み出しています。生物に由来する生物製剤は、発熱性物質による汚染を受けやすいです。IMARC GROUPによると、世界の生物製剤市場規模は2023年に3,496億米ドルに達しました。今後、パイロジェン試験市場値は2032年までに6,995億米ドルに達し、2024年から2032年の間に7.8％の成長率（CAGR）を示すと予想されます。これらの産業が拡大するにつれて、洗練された信頼性の高い迅速なパイロジェン試験法に対する要求も高まっています。さらに、この需要は、従来のカブトガニ血液由来の検査に代わる合成検査法を提供する組換え第C因子（rFC）アッセイなどの検査技術の革新につながっています。

発展するヘルスケアインフラ

新興経済諸国ではヘルスケアインフラが発展しており、パイロジェンフリーの認証を含む国際的な安全基準を満たす医療製品に対するニーズが高まっているため、パイロジェン試験需要が拡大しています。この拡大は、パイロジェン試験の地理的市場を拡大し、国内メーカーに世界市場に参入するための高度な検査技術の採用を促しています。さらに、ヘルスケアシステムの発展と医療費の増加は、高度なパイロジェン試験プロセスの採用と統合を増加させています。さらに、政府当局も公衆衛生を促進するためにヘルスケア産業に投資しています。例えば、米国疾病予防管理センター（CENTER for DISEASE CONTROL and PREVENTION）は、米国内の州、地方、地域の管轄区域が公衆衛生の労働力とインフラを強化するのを支援するために32億米ドルを授与しました。この32億米ドルには、AMERICAN RESCUE PLAN ACTによる30億米ドルが含まれ、管轄区域が、疫学者、接触追跡者、実験室科学者、地域保健員、データ分析者などの重要な第一線の公衆衛生従事者を含む、労働力を確保、維持、訓練するためのものです。また、この資金には、管轄区域が公衆衛生のインフラを強化し、活性化するための新たな予算1億4,000万米ドルも含まれています。

本レポートで扱う主な質問

  • 世界のパイロジェン試験市場はこれまでどのように推移してきたか？
  • パイロジェン試験市場の世界における促進要因、抑制要因、機会は何か？
  • 促進要因、抑制要因、機会が世界のパイロジェン試験市場に与える影響は？
  • 主要な地域市場とは？
  • 最も魅力的なパイロジェン試験市場はどの国か？
  • 製品別の市場内訳は？
  • パイロジェン試験市場で最も魅力的な製品は？
  • 検査タイプ別の市場内訳は？
  • パイロジェン試験市場で最も魅力的な検査タイプは？
  • アプリケーション別の市場内訳は？
  • パイロジェン試験市場で最も魅力的なアプリケーションは？
  • 市場の競合構造は？
  • 世界のパイロジェン試験市場における主要プレイヤー／企業は？

目次

第1章 序文

第2章 調査範囲と調査手法

  • 調査の目的
  • ステークホルダー
  • データソース
    • 一次情報
    • 二次情報
  • 市場推定
    • ボトムアップアプローチ
    • トップダウンアプローチ
  • 調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

  • 概要
  • 主要業界動向

第5章 世界のパイロジェン試験市場

  • 市場概要
  • 市場実績
  • COVID-19の影響
  • 市場予測

第6章 市場内訳：製品別

  • 機器
    • 市場動向
    • 市場予測
  • キットと試薬
    • 市場動向
    • 市場予測
  • サービス
    • 市場動向
    • 市場予測

第7章 市場内訳：試験タイプ別

  • 体外試験
    • 市場動向
    • 市場予測
  • LAL試験
    • 市場動向
    • 市場予測
  • ウサギ試験
    • 市場動向
    • 市場予測
  • その他
    • 市場動向
    • 市場予測

第8章 市場内訳：用途別

  • 医薬品および生物製剤
    • 市場動向
    • 市場予測
  • 医療機器
    • 市場動向
    • 市場予測
  • その他
    • 市場動向
    • 市場予測

第9章 市場内訳：地域別

  • 北米
    • 米国
    • カナダ
  • アジア太平洋地域
    • 中国
    • 日本
    • インド
    • 韓国
    • オーストラリア
    • インドネシア
    • その他
  • 欧州
    • ドイツ
    • フランス
    • 英国
    • イタリア
    • スペイン
    • ロシア
    • その他
  • ラテンアメリカ
    • ブラジル
    • メキシコ
    • その他
  • 中東・アフリカ
    • 市場動向
    • 市場内訳：国別
    • 市場予測

第10章 SWOT分析

  • 概要
  • 強み
  • 弱み
  • 機会
  • 脅威

第11章 バリューチェーン分析

第12章 ポーターのファイブフォース分析

  • 概要
  • 買い手の交渉力
  • 供給企業の交渉力
  • 競合の程度
  • 新規参入業者の脅威
  • 代替品の脅威

第13章 価格分析

第14章 競合情勢

  • 市場構造
  • 主要企業
  • 主要企業のプロファイル
    • 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
図表

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
目次
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