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全球熱原測試市場規模：依產品類型、測試類型、應用、區域覆蓋範圍、預測

Global Pyrogen Testing Market Size By Product Type (Kits and Reagents, Instruments), By Test Type (LAL (Limulus Amebocyte Lysate) Test, MAT (Monocyte Activation Test)), By Application (Pharmaceuticals, Medical Devices), By Geographic Scope And Forecast

出版日期: 2024年08月23日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

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簡介目錄

熱原測試市場規模及預測

2024年熱原測試市場規模為11.6158億美元，預計到2031年將達到28.6578億美元，2024年至2031年複合年增長率為11.95%。熱原測試是檢測藥物和醫療器材中熱原的重要步驟，確保人類使用安全，特別是注射和靜脈輸液。熱原測試用於製藥和生物技術行業，以確保注射藥物、疫苗、靜脈注射液、單株抗體和細胞療法等生物製品不含引起發燒的污染物，從而確保患者安全。在醫療器械領域，我們驗證與血液和組織接觸的植入式和手術器械的安全性。

此外，熱原測試對於透析液至關重要，可防止腎臟治療中的反應，並確保獸藥和醫療器械可安全用於動物。此測試也適用於血液製品、腸外營養液和某些化妝品，以確保它們無熱原且可供消費者安全使用。

全球熱原測試市場動態

主要市場推動因素

製藥和生物產業的成長：

擴大注射藥物、疫苗和生物製品的開發和生產需要嚴格的熱原測試，以確保產品的安全性和有效性。根據美國食品藥物管理局（FDA）預測，2023年新藥核准數量將較上年增加15%，其中大部分為注射劑和生物製劑。

慢性病發生率增加：

慢性病的流行以及相關治療和乾預措施的增加增加了對無熱原產品的需求並推動了市場成長。世界衛生組織 (WHO) 於 2023 年底報告稱，到 2022 年，非傳染性疾病 (NCD) 佔全球死亡人數的 74%，高於 2016 年的 71%。

技術進步：

熱原測試方法的創新，例如重組 C 因子測定和單核細胞活化測定，可提供更準確、可靠和快速的結果，並正在推動採用。EDQM（European Directorate for the Quality of Medicines &HealthCare）於 2024 年 1 月報告稱，2022 年至 2023 年間，歐洲使用重組 C 因子檢測進行內毒素檢測的數量增加了 25%。

新興市場的擴張：

新興國家醫療保健投資和藥品生產的增加將推動對全面熱原測試的需求，以滿足國際安全標準。印度衛生與家庭福利部2024年3月報告稱，2023-2024財年該國藥品出口成長18%，熱原檢測服務需求相應成長22%。

主要課題

測試成本高：

先進的熱原測試方法和設備的相關成本可能令人望而卻步，並限制其採用，尤其是中小型企業。根據美國食品藥物管理局 (FDA) 2023 年底發佈的報告，檢測一批藥物熱原的平均成本在 500 美元到 2,000 美元之間，具體取決於所使用的方法。

複雜的監理環境：

監管要求因地區而異，不斷變化的法規可能難以駕馭且耗時，從而為市場進入和擴張造成障礙。國際人類使用技術要求協調委員會 (ICH) 於 2023 年 12 月報告稱，只有 60% 的成員國已將其熱原測試法規與最新的 ICH 指南完全一致。

技術限制：

儘管技術取得了進步，但一些熱原測試方法缺乏敏感性和特異性，導致假陽性和假陰性，影響可靠性。2024 年 1 月發表在《Journal of Pharmaceutical Sciences》上的一項薈萃分析發現，目前的體外熱原檢測方法在各項研究中的平均假陽性率為 5%，假陰性率為 2%。

有限的熟練勞動力：

缺乏精通先進熱原測試技術的訓練有素的專業人員可能會阻礙這些測試方法的採用和有效實施。根據美國藥學科學家協會 (AAPS) 於 2023 年底進行的一項調查，65% 的製藥公司表示很難招募合格的人員來擔任高階熱原測試職位。

主要趨勢

轉向非動物測試方法：

對倫理考慮的日益關注和來自監管機構的壓力正在推動非動物測試方法的採用，例如重組C 因子測定和單核細胞活化測試，取代傳統的基於動物的方法，例如兔子熱原測試，對檢查的依賴較少。美國食品藥物管理局 (FDA) 於 2024 年 2 月宣佈，2023 年提交藥物審批的熱原測試數據中約有 60% 使用非動物方法，高於 2020 年的 40%。

將品質控制整合到製造中：

人們越來越重視將熱原測試作為整個藥品和醫療器材製造過程中更廣泛的品質控制措施的一部分，以確保產品的安全性和合規性。國際製藥技術協會 (ISPE) 於 2024 年 1 月報告稱，2022 年至 2023 年間，生物製藥製造中連續熱原監測系統的實施量增加了 40%。

生物技術和個人化醫療的擴展：

生物製劑、個人化醫療和先進治療的興起需要客製化的熱原測試方案，以適應這些治療和患者群體的獨特特徵。根據再生醫學聯盟的報告，到 2023 年，全球臨床試驗中的細胞和基因療法數量將比前一年增加 25%，從而推動對專門熱原測試解決方案的需求。

Pyrogen Testing Market size was valued at USD 1161.58 Million in 2024 and is projected to reach USD 2865.78 Million by 2031 , growing at a CAGR of 11.95% from 2024 to 2031. Pyrogen testing is a crucial procedure to detect pyrogens in pharmaceutical products and medical devices, ensuring their safety for human use, particularly in injectable drugs and intravenous fluids. Pyrogen testing is essential in the pharmaceutical and biotechnology industries to ensure that injectable drugs, vaccines, intravenous solutions, and biologics like monoclonal antibodies and cell therapies are free from fever-inducing contaminants, ensuring patient safety. In the medical device sector, it verifies the safety of implantable devices and surgical instruments that come into contact with blood or tissues.

Additionally, pyrogen testing is crucial for dialysis fluids to prevent reactions in renal therapy, and it ensures veterinary pharmaceuticals and medical devices are safe for animal use. This testing also applies to blood products, parenteral nutrition solutions, and certain cosmetics, guaranteeing they are pyrogen-free and safe for consumer use.

Global Pyrogen Testing Market Dynamics

The key market dynamics that are shaping the global pyrogen testing market include:

Key Market Drivers

Growth in Pharmaceutical and Biotech Industries:

Expanding development and production of injectable drugs, vaccines, and biologics require rigorous pyrogen testing to ensure product safety and efficacy. According to the U.S. Food and Drug Administration (FDA), the number of new drug approvals increased by 15% in 2023 compared to the previous year, with a significant portion being injectable and biologic products.

Rising Incidence of Chronic Diseases:

The growing prevalence of chronic conditions and the corresponding increase in medical treatments and interventions bolster the need for pyrogen-free products, fueling market growth. The World Health Organization (WHO) reported in late 2023 that non-communicable diseases (NCDs) were responsible for 74% of global deaths in 2022, up from 71% in 2016.

Technological Advancements:

Innovations in pyrogen testing methods, such as recombinant Factor C assays and monocyte activation tests, offer more accurate, reliable, and rapid results, encouraging adoption. The European Directorate for the Quality of Medicines & HealthCare (EDQM) reported in January 2024 that the use of recombinant Factor C assays for endotoxin testing increased by 25% in Europe between 2022 and 2023.

Expansion in Emerging Markets:

Increase in healthcare investments and pharmaceutical production in emerging economies drive demand for comprehensive pyrogen testing to meet international safety standards. India's Ministry of Health and Family Welfare reported in March 2024 that the country's pharmaceutical exports grew by 18% in the fiscal year 2023-2024, with a corresponding 22% increase in demand for pyrogen testing services.

Key Challenges:

High Testing Costs:

The expense associated with advanced pyrogen testing methods and equipment can be prohibitive, limiting their adoption, especially by smaller companies. According to a report by the U.S. Food and Drug Administration (FDA) in late 2023, the average cost of pyrogen testing for a single batch of pharmaceutical products ranged from $500 to $2,000, depending on the method used.

Complex Regulatory Landscape:

Navigating varying and evolving regulatory requirements across different regions can be challenging and time-consuming, posing a barrier to market entry and expansion. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) reported in December 2023 that only 60% of its member countries had fully aligned their pyrogen testing regulations with the latest ICH guidelines.

Technological Limitations:

Despite advancements, certain pyrogen testing methods may lack sensitivity or specificity, leading to potential false positives or negatives, impacting reliability. A meta-analysis published in the Journal of Pharmaceutical Sciences in January 2024 found that current in vitro pyrogen testing methods had an average false-positive rate of 5% and a false-negative rate of 2% across various studies.

Limited Skilled Workforce:

A shortage of trained professionals skilled in advanced pyrogen testing techniques can hinder the adoption and effective implementation of these methods. A survey by the American Association of Pharmaceutical Scientists (AAPS) in late 2023 found that 65% of pharmaceutical companies reported difficulties in hiring qualified personnel for advanced pyrogen testing roles.

Key Trends

Shift Towards Non-animal Testing Methods:

Increasing focus on ethical considerations and regulatory pressures are driving the adoption of non-animal testing methods, such as recombinant Factor C assays and monocyte activation tests, reducing reliance on traditional animal-based tests like the rabbit pyrogen test. The U.S. Food and Drug Administration (FDA) reported in February 2024 that approximately 60% of pyrogen test data submitted for drug approvals in 2023 used non-animal methods, up from 40% in 2020.

Integration of Quality Control in Manufacturing:

Growing emphasis on integrating pyrogen testing as part of broader quality control measures throughout pharmaceutical and medical device manufacturing processes to ensure product safety and compliance. The International Society for Pharmaceutical Engineering (ISPE) reported in January 2024 that implementation of continuous pyrogen monitoring systems in biopharmaceutical manufacturing increased by 40% between 2022 and 2023.

Expansion in Biotechnology and Personalized Medicine:

The rise of biologics, personalized medicine, and advanced therapies necessitates tailored pyrogen testing protocols to accommodate the unique characteristics of these treatments and patient population. The Alliance for Regenerative Medicine reported that the number of cell and gene therapies in clinical trials globally increased by 25% in 2023 compared to the previous year, driving demand for specialized pyrogen testing solutions.

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Global Pyrogen Testing Market Regional Analysis

Here is a more detailed regional analysis of the global pyrogen testing market:

North America

North America currently dominates as a significant regional segment. According to a report by the American Association of Pharmaceutical Scientists (AAPS) in early 2024, the North American pyrogen testing market was valued at approximately $450 million in 2023, with the United States accounting for about 80% of this value. The region's dominance is primarily driven by stringent regulatory standards enforced by agencies like the FDA, which mandate rigorous testing for pyrogens in pharmaceuticals, biologics, and medical devices.

The United States, in particular, houses a mature healthcare sector with advanced pharmaceutical and biotechnology industries that heavily rely on pyrogen testing to ensure product safety and regulatory compliance. The U.S. Food and Drug Administration (FDA) reported in late 2023 that pyrogen testing was required for approximately 65% of all new drug applications (NDAs) and biologics license applications (BLAs) submitted in that year.

This demand is bolstered by a robust framework of quality control measures and a strong emphasis on adhering to international standards, making North America a critical hub for pyrogen testing services and technologies.

Asia Pacific

Asia Pacific is rapidly emerging as a growing regional segment in the pyrogen testing market. The region is experiencing rapid industrialization, economic growth, and increasing investments in healthcare infrastructure, particularly in countries like China, India, Japan, and South Korea.

These nations are witnessing expanding pharmaceutical manufacturing capabilities and rising adoption of advanced healthcare practices, which necessitate stringent quality control measures including pyrogen testing.

Moreover, outsourcing of clinical trials and pharmaceutical production to Asia Pacific countries further propels the demand for pyrogen testing services. As regulatory frameworks in the region evolve and align more closely with international standards, the market for pyrogen testing is expected to continue its rapid growth trajectory in Asia Pacific.

Global Pyrogen Testing Market: Segmentation Analysis

The Global Pyrogen Testing Market is Segmented on the basis of Product Type, Test Type, Application, and Geography.

Pyrogen Testing Market, By Product Type

Kits and Reagents
Instruments
Services

Based on Product Type, the Global Pyrogen Testing Market is bifurcated into Kits and Reagents, Instruments, and Services. In the pyrogen testing market, services is expected to dominate over the forecast period. This is primarily due to the critical need for specialized expertise and regulatory compliance in conducting pyrogen testing across pharmaceutical, biotechnology, and medical device industries. Services encompass a range of offerings including testing protocols, validation services, and consulting, catering to the stringent requirements for product safety and quality assurance. Secondarily, kits and reagents are rapidly growing in the pyrogen testing market.

Pyrogen Testing Market, By Test Type

LAL (Limulus Amebocyte Lysate) Test
MAT (Monocyte Activation Test)
rFC (recombinant Factor C) Assay

Based on Test Type, the Global Pyrogen Testing Market is bifurcated into LAL (Limulus Amebocyte Lysate) Test, MAT (Monocyte Activation Test), rFC (recombinant Factor C) Assay. In the market, the LAL (Limulus Amebocyte Lysate) Test currently dominates as the leading test type. LAL is widely adopted due to its sensitivity in detecting bacterial endotoxins, which are a common type of pyrogen found in pharmaceuticals, medical devices, and biologics. The test's established reliability and validation by regulatory authorities such as the FDA contribute to its widespread use across the pharmaceutical and biotechnology industries. Secondarily, the MAT (Monocyte Activation Test) is rapidly growing in the pyrogen testing market. MAT offers an alternative method to LAL for pyrogen detection, particularly for non-endotoxin pyrogens.

Pyrogen Testing Market, By Application

Pharmaceuticals
Medical Devices
Biologics
Cosmetics and Personal Care Products

Based on Application, the Global Pyrogen Testing Market is bifurcated into Pharmaceuticals, Medical Devices, Biologics, Cosmetics and Personal Care Products. In the pyrogen testing market by application, pharmaceuticals dominate as the leading segment. Pyrogen testing is critically important in pharmaceutical manufacturing to ensure that drugs are free from pyrogenic contaminants, which could cause adverse reactions in patients. Stringent regulatory requirements worldwide mandate thorough testing of pharmaceutical products, driving the demand for pyrogen testing services and technologies across the entire drug development and manufacturing process. The medical devices are rapidly growing in the pyrogen testing market. As medical devices become more complex and integrated with biological materials or patient interfaces, ensuring they are free from pyrogens is essential to prevent infections and ensure patient safety.

Pyrogen Testing Market, By Geography

North America
Europe
Asia Pacific
Rest of the World

Based on Geography, the Global Pyrogen Testing Market is classified into North America, Europe, Asia Pacific, and the Rest of the World. In the pyrogen testing market, North America currently dominates as the leading segment. This is primarily driven by stringent regulatory requirements and well-established pharmaceutical and biotechnology industries in the United States and Canada. The FDA regulations in the U.S. mandate rigorous pyrogen testing to ensure product safety and compliance, leading to a substantial demand for testing services and technologies across pharmaceuticals, biologics, and medical devices sectors. The region's advanced healthcare infrastructure and emphasis on quality control further support its dominant position in the global pyrogen testing market. The region is experiencing rapid growth in the pyrogen testing market.

Key Players

The "Global Pyrogen Testing Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
Charles River Laboratories, Lonza Group, Merck KGaA, Thermo Fisher Scientific, Associates of Cape Cod, Inc., GenScript, WuXi AppTec, bioMerieux, Eurofins Scientific.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Global Pyrogen Testing Market Key Developments

In December 2020, Charles River Laboratories International, Inc., a leading provider of essential products and services for the pharmaceutical and biotechnology industries, announced the acquisition of Cognate BioServices, Inc. This acquisition expanded Charles River's cell and gene therapy capabilities, enhancing its position in the growing field of advanced therapeutics.
In May 2021, Lonza Group AG, a Swiss multinational, announced the expansion of its manufacturing capacity for clinical and commercial supply of cell and gene therapies. This expansion aimed to meet the increasing demand for these therapies globally, supporting the growing biopharmaceutical market.
In September 2021, Merck KGaA, Darmstadt, Germany, launched a new BioContinuum(TM) Buffer Delivery Platform. This platform aimed to simplify buffer preparation and management in biomanufacturing processes, addressing key challenges in downstream bioprocessing.
In January 2022, Thermo Fisher Scientific, Inc., a global leader in serving science, completed the acquisition of PPD, Inc., a leading global contract research organization (CRO). This acquisition enhanced Thermo Fisher's capabilities in providing end-to-end solutions for the pharmaceutical and biotech industries, including clinical trial services and laboratory testing.