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市場調查報告書
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1886472

熱原檢測市場－全球產業規模、佔有率、趨勢、機會和預測，按檢測類型、最終用戶、地區和競爭格局分類，2020-2030年預測

Pyrogen Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test Type, By End User, By Region and Competition, 2020-2030F
出版日期: | 出版商: TechSci Research | 英文 184 Pages | 商品交期: 2-3個工作天內

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簡介目錄

2024年全球熱原檢測市場規模為15.5億美元，預計2030年將以9.60%的複合年成長率成長至26.9億美元。熱原檢測是一項關鍵的品質控制流程，旨在檢測和量化藥品、醫療器材和其他無菌材料中的熱原（致熱物質），從而確保患者免受發熱反應的侵害。全球熱原檢測市場的成長主要受製藥和生物技術研發活動日益成長的推動，同時全球衛生監管機構也提出了嚴格的監管要求，這些要求對產品安全和品質保證提出了更高的要求。

市場概覽
預測期 2026-2030
市場規模：2024年 15.5億美元
市場規模：2030年 26.9億美元
複合年成長率：2025-2030年 9.60%
成長最快的細分市場 LAL 試驗
最大的市場 北美洲

主要市場促進因素

製藥和生物技術產業的擴張是全球熱原檢測市場的主要驅動力，因為新藥研發，特別是生物製劑和先進療法的研發，都需要全面的品質控制。這些產業的強勁成長直接轉化為對熱原檢測日益成長的需求，以確保整個生產過程中的產品安全。

主要市場挑戰

先進的熱原檢測設備和試劑的高昂成本嚴重阻礙了全球熱原檢測市場的成長。這一經濟障礙限制了必要檢測能力的普及，尤其對於規模較小的企業和資源有限的環境而言更是如此。

主要市場趨勢

受倫理考量、科學認知提升和監管環境變化的影響，全球市場正經歷著向體外熱原檢測方法的顯著轉變。這些無需動物實驗的替代方法，例如單核細胞活化試驗 (MAT) 和重組因子 C (rFC) 檢測，具有更高的重複性和可靠性，並且能夠同時檢測內毒素和非內毒素熱原。

目錄

第1章：產品概述

第2章：研究方法

第3章：執行概要

第4章：顧客之聲

第5章：全球熱原檢測市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 依檢測類型（LAL 試驗、兔熱原試驗、單核細胞活化試驗、其他）
    • 依最終用戶分類（製藥和生技公司、醫療器材公司、其他）
    • 按地區
    • 按公司（2024 年）
  • 市場地圖

第6章：北美熱原檢測市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國家分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲熱原檢測市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國家分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區熱原檢測市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國家分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲熱原檢測市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東和非洲：國家分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲熱原檢測市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國家分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章：市場動態

  • 促進要素
  • 挑戰

第12章：市場趨勢與發展

  • 併購
  • 產品發布
  • 最新進展

第13章：全球熱原偵測市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商議價能力
  • 顧客的力量
  • 替代產品的威脅

第15章：競爭格局

  • Merck KGaA
  • Genscript Corporation
  • Lonza Group AG
  • bioMerieux SA
  • Novo Holdings A/S
  • Eurofins Scientific SE
  • Charles River Laboratories International, Inc.
  • WuXi AppTec Co., Ltd.

第16章：策略建議

第17章調查會社について,免責事項

簡介目錄
Product Code: 23540

The Global Pyrogen Testing Market, valued at USD 1.55 Billion in 2024, is projected to experience a CAGR of 9.60% to reach USD 2.69 Billion by 2030. Pyrogen testing is a critical quality control process designed to detect and quantify pyrogens, fever-inducing substances, in pharmaceutical products, medical devices, and other sterile materials, thereby ensuring patient safety against febrile reactions. The global pyrogen testing market's growth is primarily driven by the increasing volume of pharmaceutical and biotechnology research and development activities, coupled with stringent regulatory mandates from health authorities worldwide that necessitate rigorous product safety and quality assurance.

Market Overview
Forecast Period2026-2030
Market Size 2024USD 1.55 Billion
Market Size 2030USD 2.69 Billion
CAGR 2025-20309.60%
Fastest Growing SegmentLAL Tests
Largest MarketNorth America

Key Market Drivers

The expansion of the pharmaceutical and biotechnology industries constitutes a primary driver for the global pyrogen testing market, as the increasing volume of new drug development, particularly biologics and advanced therapies, necessitates comprehensive quality control. The robust growth in these sectors directly translates into a heightened demand for pyrogen detection to ensure product safety throughout the manufacturing process.

Key Market Challenges

The high cost associated with advanced pyrogen testing equipment and reagents significantly impedes the growth of the global pyrogen testing market. This financial barrier limits the adoption of necessary testing capabilities, particularly for smaller entities and in environments with constrained resources. Implementing sophisticated pyrogen testing methodologies requires substantial initial capital investment for purchasing specialized instruments and ongoing expenditure for consumables, maintenance, and skilled personnel training. Such costs can be prohibitive for small to medium-sized enterprises, which often operate with tighter budgets and fewer financial reserves compared to larger pharmaceutical corporations.

Key Market Trends

The global market is experiencing a notable shift towards in vitro pyrogen testing methods, driven by ethical considerations, increased scientific understanding, and evolving regulatory landscapes. These animal-free alternatives, such as the Monocyte Activation Test (MAT) and recombinant Factor C (rFC) assays, provide enhanced reproducibility, reliability, and the capacity to detect both endotoxin and non-endotoxin pyrogens. The adoption of these methods has been strongly supported by regulatory bodies.

Key Market Players

  • Merck KGaA
  • Genscript Corporation
  • Lonza Group AG
  • bioMerieux SA
  • Novo Holdings A/S
  • Eurofins Scientific SE
  • Charles River Laboratories International, Inc.
  • WuXi AppTec Co., Ltd.

Report Scope:

In this report, the Global Pyrogen Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Pyrogen Testing Market, By Test Type:

  • LAL Tests
  • Rabbit Pyrogen Test
  • Monocyte Activation Test
  • Others

Pyrogen Testing Market, By End User:

  • Pharmaceutical and Biotechnology Companies
  • Medical Device Companies
  • Others

Pyrogen Testing Market, By Region:

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Pyrogen Testing Market.

Available Customizations:

Global Pyrogen Testing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Pyrogen Testing Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Test Type (LAL Tests, Rabbit Pyrogen Test, Monocyte Activation Test, Others)
    • 5.2.2. By End User (Pharmaceutical and Biotechnology Companies, Medical Device Companies, Others)
    • 5.2.3. By Region
    • 5.2.4. By Company (2024)
  • 5.3. Market Map

6. North America Pyrogen Testing Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Test Type
    • 6.2.2. By End User
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Pyrogen Testing Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Test Type
        • 6.3.1.2.2. By End User
    • 6.3.2. Canada Pyrogen Testing Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Test Type
        • 6.3.2.2.2. By End User
    • 6.3.3. Mexico Pyrogen Testing Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Test Type
        • 6.3.3.2.2. By End User

7. Europe Pyrogen Testing Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Test Type
    • 7.2.2. By End User
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Pyrogen Testing Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Test Type
        • 7.3.1.2.2. By End User
    • 7.3.2. France Pyrogen Testing Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Test Type
        • 7.3.2.2.2. By End User
    • 7.3.3. United Kingdom Pyrogen Testing Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Test Type
        • 7.3.3.2.2. By End User
    • 7.3.4. Italy Pyrogen Testing Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Test Type
        • 7.3.4.2.2. By End User
    • 7.3.5. Spain Pyrogen Testing Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Test Type
        • 7.3.5.2.2. By End User

8. Asia Pacific Pyrogen Testing Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Test Type
    • 8.2.2. By End User
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Pyrogen Testing Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Test Type
        • 8.3.1.2.2. By End User
    • 8.3.2. India Pyrogen Testing Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Test Type
        • 8.3.2.2.2. By End User
    • 8.3.3. Japan Pyrogen Testing Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Test Type
        • 8.3.3.2.2. By End User
    • 8.3.4. South Korea Pyrogen Testing Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Test Type
        • 8.3.4.2.2. By End User
    • 8.3.5. Australia Pyrogen Testing Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Test Type
        • 8.3.5.2.2. By End User

9. Middle East & Africa Pyrogen Testing Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Test Type
    • 9.2.2. By End User
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Pyrogen Testing Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Test Type
        • 9.3.1.2.2. By End User
    • 9.3.2. UAE Pyrogen Testing Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Test Type
        • 9.3.2.2.2. By End User
    • 9.3.3. South Africa Pyrogen Testing Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Test Type
        • 9.3.3.2.2. By End User

10. South America Pyrogen Testing Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Test Type
    • 10.2.2. By End User
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Pyrogen Testing Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Test Type
        • 10.3.1.2.2. By End User
    • 10.3.2. Colombia Pyrogen Testing Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Test Type
        • 10.3.2.2.2. By End User
    • 10.3.3. Argentina Pyrogen Testing Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Test Type
        • 10.3.3.2.2. By End User

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Pyrogen Testing Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Merck KGaA
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Genscript Corporation
  • 15.3. Lonza Group AG
  • 15.4. bioMerieux SA
  • 15.5. Novo Holdings A/S
  • 15.6. Eurofins Scientific SE
  • 15.7. Charles River Laboratories International, Inc.
  • 15.8. WuXi AppTec Co., Ltd.

16. Strategic Recommendations

17. About Us & Disclaimer