엔도톡신 검사 시장 보고서(2025년)
Endotoxin Testing Global Market Report 2025
상품코드 : 1824659
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

엔도톡신 검사 시장 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년에는 CAGR 5.9%를 나타내 29억 1,000만 달러로 성장할 전망입니다. 예측 기간의 성장은 바이오의약품산업의 확대, 엔도톡신검사의 연구개발에 대한 투자 증가, 세계적인 헬스케어의 확대에 기인하고 있습니다. 예측 기간의 주요 동향은 혁신적인 endotoxin 검출 도구, endotoxin 검사 서비스의 채용, endotoxin 검사 서비스 수요 등이 있습니다.

향후 5년간의 성장률 5.9%라고 하는 예측은 전회 예측으로부터 0.1%의 소폭의 감소를 반영하고 있습니다. 이 감소는 주로 미국과 다른 국가 간의 관세의 영향 때문입니다. 관세 부과는 인도네시아와 말레이시아에서 수입되는 LAL(Limulus Amebocyte Lysate) 검사 시약의 비용을 상승시키고 의약품 출시를 늦추거나 QC 실험실 비용을 상승시킬 수 있으므로 미국의 의약품 안전성을 혼란시킬 수 있습니다. 또한 상호관세와 무역의 긴장과 한계 증가로 인한 세계경제와 무역에 대한 악영향으로 인해 그 영향이 더욱 광범위해질 것으로 보입니다.

건강관리 관련 감염의 발생률 증가는 엔도톡신 검사 시장 확대의 중요한 촉진요인이 될 것으로 보입니다. 의료관련 감염이란 개인이 의료를 받고 있는 동안에 감염하는 것으로, 의료시설에 입원할 때에는 존재하지 않았던 것입니다. 이러한 감염은 종종 오염된 의료기기 및 치료로 인한 것이며 환자의 안전을 보장하기 위한 철저한 검사의 필요성이 강조되고 있습니다. 엔도톡신 검사 서비스는 다양한 의료기기, 특히 주사용 의약품 및 이식형 의료기기의 박테리아 내 독소 수준을 평가함으로써 의료 관련 감염의 예방에 중요한 역할을 하고 있습니다. 예를 들어, 2022년 12월 기준 유엔 국제 아동 긴급 기금(UNICEF)의 보고서에 따르면, 폐렴은 가장 많은 어린이들의 생명을 빼앗고 있는 감염으로, 연간 70만 명 이상, 하루에 약 2,000명의 어린이들이 사망합니다. 또한 2022년 5월 세계보건기구(WHO)의 데이터에 따르면 매년 약 24%의 환자가 의료 관련 패혈증을 앓으며 집중 치료실에서 치료받은 환자의 사망률은 연간 52.3%로 높습니다. 그 결과, 건강관리 관련 감염의 만연이 엔도톡신 검사 시장 성장의 큰 원동력이 되고 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

KTH
영문 목차

영문목차

Endotoxin testing, also known as the bacterial endotoxins test (BET), is a laboratory-based assay designed to evaluate the levels of bacterial endotoxins in substances, with a particular focus on pharmaceuticals and medical devices. The primary goal of this testing is to ensure product safety and compliance with stringent quality standards, thereby reducing the risk of potential adverse effects on patients and users.

Endotoxin testing encompasses various methods, including LAL (limulus amebocyte lysate) tests, chromogenic tests, turbidimetric tests, gel clot tests, MAT tests, rabbit pyrogen tests, and recombinant factor C (rFC) assays. Among these, the LAL test stands out as a highly sensitive assay employed to detect bacterial endotoxins in medical and pharmaceutical products. This method leverages the clotting response of horseshoe crab blood components to identify the presence of endotoxins. The LAL test is applicable in diverse areas, such as medical devices, pharmaceuticals, packaging, and raw materials, and is utilized by various end-users, including hospitals, laboratories, and research institutes.

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 endotoxin testing market research report is one of a series of new reports from The Business Research Company that provides endotoxin testing market statistics, including endotoxin testing industry global market size, regional shares, competitors with an endotoxin testing market share, detailed endotoxin testing market segments, market trends and opportunities and any further data you may need to thrive in the endotoxin testing industry. This endotoxin 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 endotoxin testing market size has grown steadily in recent years. It will grow from $2.24 billion in 2024 to $2.31 billion in 2025 at a compound annual growth rate (CAGR) of 3.4%. The growth in the historic period can be attributed to increasing demand for biologics and biosimilars, growing awareness about the importance of endotoxin testing, growing prevalence of infectious diseases.

The endotoxin testing market size is expected to see strong growth in the next few years. It will grow to $2.91 billion in 2029 at a compound annual growth rate (CAGR) of 5.9%. The growth in the forecast period can be attributed to expansion of the biopharmaceutical industry, increasing investment in research and development of endotoxin testing, global healthcare expansion. Major trends in the forecast period include innovative endotoxin detection tools, adoption of endotoxin testing service, demand for endotoxin testing services.

The forecast of 5.9% growth over the next five years reflects a slight reduction of 0.1% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. The imposition of tariffs may disrupt U.S. pharmaceutical safety by increasing costs for Limulus Amebocyte Lysate (LAL) testing reagents imported from Indonesia and Malaysia, potentially delaying drug releases and raising QC lab expenses. 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.

The growing incidence of healthcare-associated infections is poised to be a significant driver for the expansion of the endotoxin testing market. Healthcare-associated infections pertain to infections that individuals acquire while receiving medical treatment and were not present at the time of their admission to a healthcare facility. These infections often result from contaminated medical equipment or procedures, emphasizing the need for thorough testing to ensure patient safety. Endotoxin testing services play a vital role in preventing healthcare-associated infections by evaluating bacterial endotoxin levels in various medical equipment, particularly in injectable pharmaceutical products and implantable medical devices. For instance, as of December 2022, reports from the United Nations International Children's Emergency Fund (UNICEF) indicated that pneumonia was the infectious disease claiming the most children's lives, causing over 700,000 annual fatalities, which equates to approximately 2,000 children per day. Moreover, according to the World Health Organization's data from May 2022, approximately 24% of patients are affected by healthcare-associated sepsis each year, and the mortality rate for patients treated in intensive care units is as high as 52.3% annually. Consequently, the increasing prevalence of healthcare-associated infections is a major driving force behind the growth of the endotoxin testing market.

The increasing demand for biologics to conduct various tests is expected to drive the growth of the endotoxin testing market. Biologics, also referred to as biopharmaceuticals, are pharmaceuticals developed using living organisms, cells, or biological processes. Endotoxin testing is critical for biologics to ensure their safety, quality, and compliance with regulatory standards. For example, in May 2022, the European Pharmaceutical Review (EPR), a UK-based non-governmental organization, reported that biologics are projected to significantly surpass sales of innovative small molecules in the next five years, with an expected $120 billion increase in sales by 2027. This signifies a notable shift in the pharmaceutical market toward biologic products. As a result, the growing demand for biologics to conduct various tests is driving the expansion of the endotoxin testing market.

Key players in the endotoxin testing market are dedicated to embracing cutting-edge technological solutions to maintain their market standing. As an example, in August 2023, Lonza Group AG, a Switzerland-based pharmaceutical, biotechnology, and nutrition manufacturing company, introduced the Nebula absorbance reader, a novel absorbance microplate reader designed to streamline endotoxin and pyrogen testing. This instrument seamlessly integrates with Lonza's latest WinKQCL software to enhance data integrity compliance, expedite training, and reduce validation requirements. Users of WinKQCL software are no longer burdened with the need to learn new software to utilize this state-of-the-art reader, resulting in reduced training efforts. The Nebula Absorbance Reader is a forward-thinking and technologically advanced replacement reader that yields results akin to those frequently obtained with the ELx808, the industry-standard absorbance reader that Lonza no longer offers for sale. Furthermore, it is designed to be fully compatible with and meet the stringent requirements of Lonza's absorbance-based endotoxin assays, including the Lonza PYROGENT 5000 Turbidimetric and Kinetic-QCL Chromogenic Endotoxin Assays.

In January 2022, Suez Water Technologies and Solutions, a prominent water treatment company based in the United States, completed the acquisition of Sentinel Monitoring Systems Inc. for an undisclosed sum. This strategic acquisition serves to enhance Veolia Water Technologies & Solutions' analytical instrument line while unlocking new opportunities in the microbiological monitoring market. Sentinel Monitoring Systems Inc., a US-based company, specializes in the development of online bioburden monitoring tools and instrument platforms designed for endotoxin testing.

Major companies operating in the endotoxin testing market are Thermo Fisher Scientific Inc., Merck KGaA, bioMerieux SA., Eurofins Scientific SE, Lonza Group Ltd., WuXi AppTec Co. Ltd., Bio-Rad Laboratories Inc., Maravai LifeSciences Holdings Inc., Cambrex Corporation, GenScript Biotech Corporation, Charles River Laboratories International Inc., Nelson Laboratories LLC, Lifecore Biomedical Inc., Stellar Biotechnologies Inc., Biovision Inc., Associates of Cape Cod Inc., FUJIFILM Wako Pure Chemical Corporation, InvivoGen Inc., Tebu-bio Nv., MatTek Corporation, Microcoat Biotechnologie GmbH, Accelagen Inc., BioAssay Systems LLC, BioThema AB, Hycult Biotech Inc., Pacific Biolabs Inc., Xiamen Bioendo Technology Co. Ltd., Zhanjiang A&C Biological Ltd., Accugen Laboratories Inc.

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

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

The endotoxin testing market consists of revenues earned by entities by providing contract testing services, ecologically sustainable testing and rapid testing. The market value includes the value of related goods sold by the service provider or included within the service offering. The endotoxin testing market also includes sales of injectable pharmaceutical products, endotoxin detection systems, limulus amebocyte lysate test reagents and polymerase chain reaction mycoplasma detection kits. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

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.

Endotoxin 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 endotoxin 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 endotoxin 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 endotoxin 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. Endotoxin Testing Market Characteristics

3. Endotoxin Testing Market Trends And Strategies

4. Endotoxin 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 Endotoxin Testing Growth Analysis And Strategic Analysis Framework

6. Endotoxin Testing Market Segmentation

7. Endotoxin Testing Market Regional And Country Analysis

8. Asia-Pacific Endotoxin Testing Market

9. China Endotoxin Testing Market

10. India Endotoxin Testing Market

11. Japan Endotoxin Testing Market

12. Australia Endotoxin Testing Market

13. Indonesia Endotoxin Testing Market

14. South Korea Endotoxin Testing Market

15. Western Europe Endotoxin Testing Market

16. UK Endotoxin Testing Market

17. Germany Endotoxin Testing Market

18. France Endotoxin Testing Market

19. Italy Endotoxin Testing Market

20. Spain Endotoxin Testing Market

21. Eastern Europe Endotoxin Testing Market

22. Russia Endotoxin Testing Market

23. North America Endotoxin Testing Market

24. USA Endotoxin Testing Market

25. Canada Endotoxin Testing Market

26. South America Endotoxin Testing Market

27. Brazil Endotoxin Testing Market

28. Middle East Endotoxin Testing Market

29. Africa Endotoxin Testing Market

30. Endotoxin Testing Market Competitive Landscape And Company Profiles

31. Endotoxin Testing Market Other Major And Innovative Companies

32. Global Endotoxin Testing Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Endotoxin Testing Market

34. Recent Developments In The Endotoxin Testing Market

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

36. Appendix

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