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市場調査レポート
商品コード
1801251
大腸菌検査の市場規模、シェア、動向、予測:製品、検査タイプ、エンドユーザー、地域別、2025~2033年E. Coli Testing Market Size, Share, Trends and Forecast by Product, Test Type, End User, and Region, 2025-2033 |
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大腸菌検査の市場規模、シェア、動向、予測:製品、検査タイプ、エンドユーザー、地域別、2025~2033年 |
出版日: 2025年08月01日
発行: IMARC
ページ情報: 英文 147 Pages
納期: 2~3営業日
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大腸菌検査の世界市場規模は2024年に23億米ドルとなりました。今後、IMARC Groupは、同市場が2033年までに40億米ドルに達し、2025~2033年にかけて6.4%のCAGRを示すと予測しています。現在、北米が市場を独占しており、2024年の市場シェアは35.8%を超えます。この地域市場は主に、厳格な規制プロトコル、強固なヘルスケアインフラ、水と食品の安全性検査に対する要求の高まりの影響を受けています。
世界の大腸菌検査市場は、主に水と食中毒に関する意識の高まりと、水と食品の安全性に関する規制枠組みの厳格化によって拡大が見られます。大腸菌アウトブレイクの拡大により、先進地域だけでなく新興地域でも革新的な検査法のニーズが加速しています。これに加えて、分子診断における技術革新と自動検査システムの利用拡大が、市場の成長をさらに促進しています。さらに、特に都市部では公衆衛生と健康が重視されるようになり、先進的検査インフラへの投資が活発化し、世界中で大腸菌検査ソリューションの採用が拡大しています。
米国は大腸菌検査の世界市場において重要なシェアを占めており、食品安全施策の厳格な実施、回復力のある医療インフラ、食中毒に関連する人々の意識の高まりがその主要因となっています。飲食品セクタにおける大腸菌アウトブレイクの増加により、信頼性の高い検査ソリューションへの要求が著しく高まっています。例えば、2024年11月、米国を拠点とする著名なニンジン生産者であるGrimmway Farmsは、大腸菌アウトブレイクにより有機ベビーニンジンをリコールし、その結果、米国の18州で39件の症例が発生しました。さらに、研究プロジェクトへの投資の増加や迅速検査技術の進歩が、市場の拡大をさらに後押ししています。さらに、米国農務省(USDA)や食品医薬品局(FDA)をはじめとする規制機関が厳格な遵守を義務付けているため、いくつかの企業はリスクに対処し、顧客の安全を促進するために、最先端の診断ツールを急速に選択するようになっています。この弾力的な規制状況は、市場の絶え間ない成長を支えています。
迅速診断検査への需要の高まり
大腸菌を代表とする消化器感染症における迅速な診断に対する需要の高まりは、高速検査手法へとつながっています。大腸菌の同定には古典的な実験室培養では2週間かかりますが、サーモフィッシャーのTaqPath Enteric Bacterial Select Panelのような新しいPCRベース検査では約2時間以内に結果が得られます。この迅速な結果によって、医療提供者は感染症をより迅速に診断・治療できるようになり、その結果、患者の待ち時間や入院期間が短縮されます。例えば、ある調査紙製によれば、TaqPathパネルの感度と特異度は98%以上であり、常に信頼できる結果が得られます。迅速な診断法の動向は、感染の広がりや影響を抑えるためにタイムリーに介入できることで、食中毒の発生を制御する上で極めて重要です。また、1回の検査で93サンプルを検査できるため、検査室のスループットが向上し、大量の臨床現場でも迅速診断の可能性が高まります。
食品安全規制への注目の高まり
世界的に厳しい食品安全規制が、先進的な大腸菌検査ソリューションの需要を促進しています。規制機関は、食品生産と流通チェーンにおける汚染のリスクを軽減するために、検査プロトコルの遵守を重視しています。例えば、産業の報告によると、大腸菌汚染は米国で毎年約7万3,000件の疾病を引き起こし、約2,200件の入院と61件の死者を出しています。さらに、この動向は、信頼性と再現性の高い結果を提供し、業務効率を最適化しながらコンプライアンスを確保する自動検査システムの採用を促進しています。さらに、食品の安全性と衛生に関する消費者の意識の高まりは、公衆衛生を守り、ブランドの完全性を維持するために、堅牢な検査フレームワークへの投資を産業に促しています。
ポイントオブケア検査の拡大
大腸菌のポイントオブケア(POC)検査は、PCR、LAMP、質量分析のような分子診断技術によってますます支持されるようになっており、水、食品、便のサンプルに含まれる病原体について、その場で迅速に結果を得ることができます。特にPCR法は、水や便のサンプルから大腸菌を検出するために不可欠であり、ヘルスケアプロバイダが感染症を診断し、リアルタイムで治療を開始するため、より信頼性の高い方法を記載しています。LAMP DNA増幅技術は、食品、便、環境サンプル中の大腸菌の存在をワンステップで検出することができます。研究紙製によると、質量分析の使用は、大腸菌のような細菌やウイルスのタイピングにおいても実現され、亜型や感染源を詳細に調査することができます。IMS(免疫磁気分離)は、アウトブレイク研究に不可欠な環境水サンプルからの大腸菌O157:H7の回収率の向上を促進します。CRISPR/Casプラットフォームやスマートフォンベースデジタルメソッドなど、その他の新たな技術は、大腸菌検出のアクセシビリティとスピードを向上させ、POC環境における分子診断の採用をさらに後押しします。これらの技術革新は、より効率的でタイムリーな診断、ヘルスケアコストの削減、特に緊急医療や遠隔地における患者の転帰の改善に貢献します。
The global E. coli testing market size was valued at USD 2.3 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 4.0 Billion by 2033, exhibiting a CAGR of 6.4% from 2025-2033. North America currently dominates the market, holding a market share of over 35.8% in 2024. This regional market is mainly influenced by strict regulatory protocols, robust healthcare infrastructure, and magnified requirement for water and food safety testing.
The global E. coli testing market is witnessing expansion chiefly due to heightening awareness regarding water and foodborne illnesses, combined with stricter regulatory frameworks for water and food safety. Amplifying incidents of E. coli outbreaks have incentivized accelerated need for innovative testing methods in emerging as well as developed regions. In addition to this, technological innovations in molecular diagnostics and the bolstering utilization of automated testing systems are further fueling market growth. Moreover, the growing emphasis on public sanitation and health, specifically in urban zones, is prompting heavy investments in advanced testing infrastructure, magnifying the adoption of E. coli testing solutions worldwide.
The United States accounts for a crucial share in the global E. coli testing market, majorly propelled by stringent implementation of food safety policies, resilient healthcare infrastructure, and amplifying public awareness associated with foodborne illnesses. The heightening occurrence of E. coli outbreaks in the food and beverage sector has significantly strengthened the requirement for dependable testing solutions. For instance, in November 2024, Grimmway Farms, a prominent U.S.-based carrot producer, recalled organic baby carrots due to E. coli outbreak, resulting in 39 cases across 18 U.S. states. In addition, elevating investments in research projects and advancements in rapid testing technologies further aid in market expansion. Furthermore, with regulatory bodies, encompassing the USDA and FDA enforcing stringent adherence, several businesses are rapidly opting for leading-edge diagnostic tools to address risks and facilitate customer safety. This resilient regulatory landscape supports constant market growth.
Growing Demand for Rapid Diagnostic Tests
Increases in the demand for quicker diagnostics in gastrointestinal infections, with the pathogen E. coli among the most relevant, have led towards high-speed testing methodologies. While classical laboratory culture takes two weeks for identification of the organism E. coli, newer PCR-based tests, such as Thermo Fisher's TaqPath Enteric Bacterial Select Panel, yield results within approximately two hours. This rapid turnaround allows health providers to diagnose and treat infections more promptly, which consequently decreases patient wait times and hospital stays. For instance, according to a research article, the TaqPath panel provides sensitivity and specificity of over 98%, ensuring that the results are always dependable. The trending towards fast diagnostic methods has been crucial in controlling foodborne disease outbreaks by being able to intervene in a timely manner to reduce the spread and effect of infections. It also allows for testing 93 samples in one run, which can improve laboratory throughput and increase the possibility of rapid diagnosis even with high-volume clinical settings.
Increasing Focus on Food Safety Regulations
Stringent food safety regulations globally are propelling the demand for advanced E. coli testing solutions. Regulatory bodies are emphasizing compliance with testing protocols to mitigate risks of contamination in food production and distribution chains. For instance, as per industry reports, E. coli contamination causes approximately 73,000 illnesses each year in the U.S., resulting in around 2,200 hospitalizations and 61 fatalities. Moreover, this trend is driving the adoption of automated testing systems that deliver reliable and reproducible results, ensuring compliance while optimizing operational efficiency. In addition, rising consumer awareness regarding food safety and hygiene is further encouraging industries to invest in robust testing frameworks to safeguard public health and maintain brand integrity.
Expansion of Point-of-Care Testing
Point-of-care (POC) testing for E. coli increasingly gains support through molecular diagnostic technologies like PCR, LAMP, and mass spectrometry, which provide rapid, on-site results for pathogens in water, food, and stool samples. PCR, particularly, is requisite for the detection of E. coli from water and stool samples, providing a more reliable method for healthcare providers to diagnose infections and initiate treatment in real time. The LAMP DNA amplification technique can also sense the presence of E. coli in food, stool and environmental samples in one step using a process that could be suited for field applications as well as resource-limited settings. According to a research article, the use of mass spectrometry is also realized in the typing of bacteria and viruses, such as E. coli, to study the subtypes and sources of infection in detail. IMS (immunomagnetic separation) facilitates the increase in the yield of recovery of E. coli O157:H7 from environmental water samples essential for outbreak studies. Other emerging technologies, including CRISPR/Cas platforms and smartphone-based digital methods, improve the accessibility and speed of E. coli detection, further pushing the adoption of molecular diagnostics in POC settings. These innovations contribute to more efficient and timely diagnosis, reducing healthcare costs and improving patient outcomes, particularly in urgent care and remote areas.
Consumables leads the market with around 83.7% of market share in 2024. This domination is principally propelled by the elevated frequency of test utilization and the requirement for disposable items to guarantee contamination-free and precise results. This category encompasses media, reagents, and test kits leveraged across variety of testing platforms. The recurring profile of consumables in diagnostics prompts a stable need, specifically in major industries, typically including water quality and food safety testing. Furthermore, with the magnifying cases of E. coli outbreaks, the market is actively witnessing amplified utilization of ready-to-use testing kits that adhere to laboratory workflows. Advancements in consumable design, like automated and pre-packaged systems, further improve both precision and efficacy, positioning them as requisite component for on-site as well as laboratory testing. This segment's expansion is highlighted by the extensive demand for constant testing protocols to cater to the safety and regulatory standards on a global level.
Environmental testing (enzyme substrate methods) leads the market with around 61.8% of market share in 2024. This testing exhibits a critical role in assessing E. coli contamination in soil and water, with enzyme substrate methods emerging as an ideal testing procedure. Such methods utilize enzyme-based reactions to detect E. coli with elevated speed and specificity, facilitating feasible evaluations in crucial purposes, including agricultural safety and municipal water testing. Moreover, the cost-efficiency and user-friendliness of enzyme substrate methods have supported their broad range deployment, especially in regions with stringent environmental policies. Furthermore, the test includes adding a substrate to a sample, which exhibits a measurable fluorescence or color change upon interacting with the enzymes of E. coli. This technique significantly lowers the requirement for sophisticated laboratory infrastructure while sustaining resilience, establishing it as a keystone of environmental testing tactics. Additionally, constant innovations in enzyme-based technologies are poised to further solidify this segment's market share.
Hospitals and clinics lead the market with around 65.8% of market share in 2024. This dominant end user is mainly impacted by their critical role in diagnosing and managing infections. These facilities handle a high volume of patients presenting symptoms of E. coli-associated illnesses, necessitating prompt and accurate diagnostic services. The prevalence of healthcare-associated infections (HAIs) further bolsters the demand for E. coli testing in clinical settings. Moreover, advanced diagnostic tools and rapid testing technologies are extensively employed in hospitals and clinics to ensure timely treatment, reducing complications and preventing outbreaks. In addition, the growing burden of foodborne diseases globally amplifies the need for reliable testing in healthcare institutions. The segment's leadership is further reinforced by stringent regulatory requirements mandating infection control and reporting, which place hospitals and clinics at the forefront of adopting comprehensive E. coli testing protocols.
In 2024, North America accounted for the largest market share of over 35.8%. This regional market is typically driven by a well-established healthcare infrastructure and resilient regulatory systems. The region's strict food safety frameworks, implemented by agencies like the CDC or FDA, have prompted the utilization of cutting-edge testing solutions across the key sectors, such as healthcare, food, or water. Heightening customer awareness related to foodborne illnesses further magnifies need for robust diagnostics. Moreover, technological innovations, encompassing automated detection systems and rapid testing kits, support the market expansion by providing effective and accurate solutions. In addition, substantial investments in research and development initiatives by leading market players fortify the region's domination on a global level. Furthermore, with accelerating incidences of E. coli outbreaks and a resilient emphasis on preemptive measures to guarantee public health, North America continues to bolster advancement and establish benchmarks for global E. coli testing strategies. For instance, as per industry reports, in the 2024-2025 fiscal year, 139 recalls were recorded in Canada, including those related to E. coli risks.
United States E. Coli Testing Market Analysis
In 2024, United States accounted for the 87.60% of the market share in North America. E. coli infections are an important public health concern in the United States because it causes around 265,000 cases and 100 deaths per year. According to a research article, outbreaks and serious illnesses most often occur by Shiga toxin-producing E. coli, or about 40% of all infections from STEC are due to E. coli O157:H7. It shows the symptoms of infection in cases, including diarrhea, abdominal cramps, nausea, vomiting, and low-grade fever; its complications may be kidney failure or HUS. Young children, the elderly, and others who may be suffering from other illnesses fall within those at a higher risk of complications. E. coli further causes UTIs in up to 80% to 90% cases; this is especially seen among women. Recent outbreaks in the U.S. have included contaminated organic carrots and a severe outbreak linked to McDonald's Quarter Pounders in Mountain West states. Due to that, the demand for good E. coli testing in food safety, healthcare, and water treatment continues to grow.
Europe E. Coli Testing Market Analysis
The E. coli testing market in Europe is growing because of strict food safety regulations and increasing health care issues. According to the European Centre for Disease Prevention and Control, in 2023, the EU had the incidence of third-generation cephalosporin-resistant E. coli bloodstream infections at 10.35 per 100,000 people, which is a problem that is increasing with respect to antimicrobial resistance. The ECDC also reported that E. coli isolates harbouring the blaNDM-5 gene were associated with travel abroad from the EU/EEA to Africa and Asia countries. STEC continues to remain a risk, and a recommendation has been made through ECDC to maintain correct hand hygiene, food preparation, and washing of the vegetables. E. coli continues to be a prominent cause of bacterial infections related to enteritis, urinary tract infections, septicaemia, and neonatal meningitis. The above factors increase the demand for high-tech diagnostic tools. Moreover, the countries driving the most demand and innovation are Germany, France, and the UK. Furthermore, food traceability and sustainability have gained focus, leading to investment in novel testing technologies, hence supporting the growth of this market.
Asia Pacific E. Coli Testing Market Analysis
Asia Pacific E. coli testing market is growing at a higher rate due to increased food production and awareness of food safety. According to China's National Health Commission, rapid urbanization and industrial agriculture increase foodborne illnesses including E. coli infections. India reported more than 500 outbreaks of diarrheal diseases in 2023. Among the patient samples, the most common bacteria isolated were E. coli. This means that the governments and private sectors are focusing more on installing efficient testing systems, especially for food and beverage companies. Multiplex PCR and lateral flow immunoassays are popular emerging technologies. In addition, states like Japan and South Korea are actively introducing the most advanced testing processes for food exports. Furthermore, India is increasingly improving the testing infrastructure for domestic purposes. Asia Pacific is considered to be the key region for E. coli testing market growth due to continuously increasing regulatory pressure.
Latin America E. Coli Testing Market Analysis
Rising food safety concerns and increasing outbreaks of foodborne diseases in Latin America is anticipated to increase the demand for E. coli testing. According to a 2023 industrial report, Brazil is a leading country in Latin America in food production and exports, which fuels the E. coli testing market. The meta-analysis of 4,286 samples found that the general prevalence rate of Shiga toxin-producing E. coli (STEC) in Brazil was 1%, with the highest rate in Mato Grosso at 9%. Hot carcasses had the highest rate of positive samples for STEC at 8%. The Ministry of Health in Brazil has stressed the need for testing in the face of food safety requirements, whether for local consumption or for export. Argentina and Mexico are also investing more in food safety and diagnostics. Furthermore, as awareness of foodborne pathogens increases, the region experiences a shift toward faster, more automated testing solutions. Moreover, harsher regulations and standards instituted by governments also complement demand for advanced testing technologies in the market. Regional cooperation furthers the market growth process, as local manufacturers find partnerships with global players to enhance testing capabilities.
Middle East and Africa E. Coli Testing Market Analysis
The Middle East and Africa E. coli testing market is expected to grow due to increasing health issues and the increasing regulatory demands for food safety. According to the World Health Organization, foodborne diseases, including E. coli infection, are among the most concerning in the region and rise annually. The health ministry of Saudi Arabia in 2020 reported 1,270 cases of foodborne diseases, prompting the government to enforce stronger food safety regulations. Even in South Africa, where home-based producers export agricultural produce around the world, E. coli testing becomes important to reach international standards for food safety. Additionally, there is an expansion of both public and private investments in testing infrastructure within the region. Furthermore, the region's diverse geography as well as infrastructure challenges support widespread adoption of emerging technologies especially portable and rapid test kits.
The market is highly competitive, with leading players focusing on innovation and strategic partnerships to gain market share. Major companies are actively investing in the development of advanced rapid testing solutions to meet the growing demand for efficient and accurate diagnostics. Furthermore, the market features fierce competition among established as well as emerging firms providing niche solutions. In addition, competitive differentiation is typically bolstered by adherence to regulatory policies, technological innovations, and cost-efficiency. Moreover, several companies are augmenting their geographic reach and improving product lines to address the evolving demands of a broader customer base, further magnifying competition in this dynamic market. For instance, in July 2024, Alden, a biotechnology firm, launched its new food safety and quality testing method Suspended Simultaneous Sandwich Assay. This method can efficiently detect E. coli O157 in beef products.