세계의 파이로젠 검사 시장 보고서(2025년)
Pyrogen Testing Global Market Report 2025
상품코드 : 1821596
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

파이로젠 검사 시장의 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년에는 CAGR 12.6%로 30억 7,000만 달러로 성장할 전망입니다. 예측기간의 성장은 맞춤형 파이로젠 검사 솔루션, 신속하고 자동화된 검사 확대, 시험관 내 파이로젠 검출 기술의 혁신, 세포 요법에서의 파이로젠 검사 채택, 환경 및 지속 가능한 검사 수행에 기인할 것으로 예상됩니다. 예측기간의 주요 동향으로는 포인트 오브 케어 파이로젠 검사, 파이로젠 검사에서의 규제 대응, AI를 활용한 파이로젠 검출 및 분석, 개별화된 환자별 파이로젠 검사, 검사 프로세스의 투명성과 추적성 등이 있습니다.

향후 5년간의 예측 성장률 12.6%는 과거 예측에서 0.2% 감소한 수치입니다. 이러한 성장세 둔화는 주로 미국과 다른 국가 간의 관세의 영향 때문입니다. 관세 인상은 한국이나 싱가포르에서 조달하는 림프구 아메바 용해액(LAL) 시약이나 자동 검사 시스템의 비용을 증가시켜 의약품 개발의 비용이나 지연을 악화시키므로 미국의 제약회사에 부담을 가할 전망입니다. 또한 상호관세와 무역의 긴장과 한계 증가로 인한 세계 경제와 무역에 대한 악영향으로 인해 그 영향이 더욱 광범위해질 것으로 보입니다.

제약 및 생명공학 분야에서의 R&D 투자 증가는 파이로젠 검사 시장의 성장에 박차를 가하고 있습니다. 파이로젠 검사는 제약, 생명공학 및 다양한 의약품 제조기업에 감염되지 않은 제품을 안전하게 제조하고 시장에 도입하는 데 필수적입니다. 예를 들어 영국을 거점으로 하는 업계단체인 영국제약공업협회(Association of the British Pharmaceutical Industry)는 2022년 혁신적인 제약업계가 영국의 연구개발(R&D)에 기여한 금액은 약 90억 파운드(약 1조 8,000억엔)이었으며, 이는 국민의 건강과 경제를 모두 향상시킬 수 있다고 보고했습니다. 따라서, 제약기업에 의한 연구개발에 시행되는 많은 투자가 파이로젠 검사 시장을 견인하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별/국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

CSM
영문 목차

영문목차

The pyrogen testing provides testing services to check the presence or absence of pyrogens in all aqueous parenteral products. Pyrogen testing determines the presence of bacterial toxins in vaccines, biotechnological products, and drugs, which induce fever in humans. It also identifies the presence of microbes and their metabolites in drugs during the manufacturing process.

The main types of pyrogen tests are the Limulus Amebocyte Lysate (LAL) test, in vitro test, and rabbit test. The LAL test is a method for determining bacterial endotoxins, utilizing the amebocyte lysate of the Limulus crab. The rabbit pyrogen test involves injecting a small amount of batched test material into a rabbit's bloodstream, and the rabbit's body temperature is monitored. The products used for pyrogen tests include assays, kits, and reagents, as well as instruments and related services. Pyrogen testing is applied in pharmaceutical and biologics, medical devices, and other industries.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

The pyrogen testing market research report is one of a series of new reports from The Business Research Company that provides pyrogen testing market statistics, including pyrogen testing industry global market size, regional shares, competitors with a pyrogen testing market share, detailed pyrogen testing market segments, market trends and opportunities, and any further data you may need to thrive in the pyrogen testing industry. This pyrogen testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The pyrogen testing market size has grown rapidly in recent years. It will grow from $1.68 billion in 2024 to $1.91 billion in 2025 at a compound annual growth rate (CAGR) of 13.5%. The growth in the historic period can be attributed to pharmaceutical and biotechnology industry growth, regulatory requirements for drug safety, advancements in testing methods, increase in infectious disease outbreaks, adoption in medical device manufacturing.

The pyrogen testing market size is expected to see rapid growth in the next few years. It will grow to $3.07 billion in 2029 at a compound annual growth rate (CAGR) of 12.6%. The growth in the forecast period can be attributed to customized pyrogen testing solutions, expansion of rapid and automated testing, innovation in in vitro pyrogen detection, adoption of pyrogen testing in cellTherapy, environmental and sustainable testing practices. Major trends in the forecast period include point-of-care pyrogen testing, regulatory compliance in pyrogen testing, ai-driven pyrogen detection and analysis, personalized and patient-specific pyrogen testing, transparency and traceability in testing processes.

The forecast of 12.6% growth over the next five years reflects a slight reduction of 0.2% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Tariff escalations are likely to burden U.S. pharmaceutical companies by driving up the cost of limulus amebocyte lysate (LAL) reagents and automated testing systems sourced from South Korea and Singapore, exacerbating drug development costs and delays. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

Increasing investments in research and development within the pharmaceutical and biotechnology sectors have fueled the growth of the pyrogen testing market. Pyrogen testing is essential for pharmaceutical, biotech, and various drug manufacturing companies to ensure the safe production and introduction of infection-free products into the market. For example, the Association of the British Pharmaceutical Industry, a trade association based in the UK, reported that in 2022, the innovative pharmaceutical industry contributed approximately £9 billion to UK research and development (R&D), which has the potential to enhance both the nation's health and economy. Consequently, substantial investments in research and development by pharmaceutical companies are driving the pyrogen testing market.

The increasing prevalence of infectious diseases is expected to drive the growth of the pyrogen testing market in the coming years. Infectious diseases are illnesses caused by pathogens that invade the human body. Pyrogen testing plays a vital role in ensuring the safety of pharmaceutical products, as it detects the presence of fever-inducing contaminants in drugs and medical devices. For instance, in April 2024, the European Centre for Disease Prevention and Control, a government health agency based in Sweden, reported 28,855 recorded cases of hepatitis B virus (HBV) infection across 30 EU/EEA Member States in 2022, marking a 78% increase from 16,187 cases in 2021. Furthermore, the 2022 total of 28,420 cases corresponds to a crude rate of 8.5 cases per 100,000 individuals. Thus, the rise in infectious diseases globally is significantly contributing to the growth of the pyrogen testing market.

Companies are actively involved in advancing animal-free pyrogen testing methods, such as the monocyte activation assay (MAT), to overcome limitations associated with traditional methods like the rabbit pyrogen testing method and the Limulus amebocyte lysate (LAL) test. This transition towards animal-free testing is driven by a commitment to ethical treatment of animals. Notably, the MAT method surpasses the LAL test by detecting both endotoxin and non-endotoxin pyrogens. Merck, for instance, has focused on MAT systems, including PyroDetect and PyroMAT.

Innovative product development remains a focal point for major companies operating in the pyrogen testing market. To enhance their business offerings and expand market reach, companies are introducing sustainable monocyte activation test (MAT) systems. Lonza, a Swiss multinational manufacturing company, exemplifies this trend by launching the PyroCell MAT Rapid System and the PyroCell MAT Human Serum (HS) Rapid System. These systems, equipped with the PeliKine Human IL-6 Rapid ELISA Kit, offer efficient MAT testing options for product safety, minimizing hands-on time and reducing time-to-results from two days to two hours. The introduction of such innovative testing options not only aids pharmaceutical manufacturers but also aligns with efforts to reduce reliance on animal testing.

Major companies operating in the pyrogen testing market include Thermo Fisher Scientific Inc., Merck KGaA, Charles River Laboratories Inc., Lonza Group Ltd., Ellab A/S, Nelson Laboratories LLC, Associates of Cape Cod Inc., GenScript Biotech Corporation, bioMerieux SA, Hyglos GmbH, Sanquin Blood Supply Foundation, Wako Chemicals USA Inc., Pyrostar International Inc., Eurofins Scientific SE, SGS SA, WuXi AppTec Group, Sigma-Aldrich Co. LLC, Bio-Rad Laboratories Inc., Microcoat Biotechnologie GmbH, Sartorius AG, Pacific Biolabs Inc., Toxikon Corporation, STERIS Corporation, Avance Biosciences Inc., BioReliance Corporation, Microbiological Consulting LLC, Microbac Laboratories Inc., North American Science Associates Inc., Pace Analytical Life Sciences LLC

North America was the largest region in the pyrogen testing market in 2024. Asia-Pacific is expected to continue to be the fastest growing region in the pyrogen testing market share during the forecast period. The regions covered in the pyrogen testing market analysis report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the pyrogen testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.

The pyrogen testing market includes revenues earned by entities by endotoxin testing and monocyte activation testing (MAT). The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Pyrogen Testing Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on pyrogen testing market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for pyrogen testing ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The pyrogen testing market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Pyrogen Testing Market Characteristics

3. Pyrogen Testing Market Trends And Strategies

4. Pyrogen Testing Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Pyrogen Testing Growth Analysis And Strategic Analysis Framework

6. Pyrogen Testing Market Segmentation

7. Pyrogen Testing Market Regional And Country Analysis

8. Asia-Pacific Pyrogen Testing Market

9. China Pyrogen Testing Market

10. India Pyrogen Testing Market

11. Japan Pyrogen Testing Market

12. Australia Pyrogen Testing Market

13. Indonesia Pyrogen Testing Market

14. South Korea Pyrogen Testing Market

15. Western Europe Pyrogen Testing Market

16. UK Pyrogen Testing Market

17. Germany Pyrogen Testing Market

18. France Pyrogen Testing Market

19. Italy Pyrogen Testing Market

20. Spain Pyrogen Testing Market

21. Eastern Europe Pyrogen Testing Market

22. Russia Pyrogen Testing Market

23. North America Pyrogen Testing Market

24. USA Pyrogen Testing Market

25. Canada Pyrogen Testing Market

26. South America Pyrogen Testing Market

27. Brazil Pyrogen Testing Market

28. Middle East Pyrogen Testing Market

29. Africa Pyrogen Testing Market

30. Pyrogen Testing Market Competitive Landscape And Company Profiles

31. Pyrogen Testing Market Other Major And Innovative Companies

32. Global Pyrogen Testing Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Pyrogen Testing Market

34. Recent Developments In The Pyrogen Testing Market

35. Pyrogen Testing Market High Potential Countries, Segments and Strategies

36. Appendix

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