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市场调查报告书
商品编码
1949481
新兴感染疾病诊断市场-全球产业规模、份额、趋势、机会及预测(按应用、技术、感染类型、疾病类型、最终用户、地区和竞争格局划分,2021-2031年)Emerging Infectious Disease Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application, By Technology, By Type of Infection, By Disease Type, By End user, By Region & Competition, 2021-2031F |
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全球新兴感染疾病诊断市场预计将从 2025 年的 167 亿美元成长到 2031 年的 274.1 亿美元,复合年增长率达到 8.61%。
此细分市场包含专门用于检测新出现的病原体或发病率和地理范围迅速扩大的病原体的检测方法和平台。该市场的成长主要受通用和媒介感染疾病日益普遍的推动,这促使人们需要建立健全的监测系统。此外,政府对生物防御基础设施和疫情防范计画的大量投入也成为重要的经济催化剂,推动了产品的持续创新和应用。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 167亿美元 |
| 市场规模:2031年 | 274.1亿美元 |
| 复合年增长率:2026-2031年 | 8.61% |
| 成长最快的细分市场 | 实验室检测 |
| 最大的市场 | 北美洲 |
儘管存在这些驱动因素,但该行业仍面临着许多障碍,例如疫情爆发期间检验的高成本和复杂的监管要求。这些财务和营运方面的难题可能会阻碍关键检测套组在最需要的时候及时商业化。世界卫生组织(世卫组织)预测,2024年全球将报告超过1460万例登革热病例,凸显了迫切需要可及且扩充性的诊断解决方案,以有效应对这种广泛的公共卫生威胁。
新兴和復发感染疾病的日益频繁是推动市场发展的主要因素,因此亟需快速部署专业检测解决方案以应对跨境威胁。病原体的地理扩散促使公共卫生机构加快部署分子诊断和免疫检测平台,以促进早期发现和接触者追踪。病毒活动的激增催生了对高通量筛检盒和照护现场设备的即时需求,这些设备需能在资源匮乏的环境中运作。例如,根据非洲疾病管制与预防中心(非洲疾管中心)统计,截至2024年8月,非洲大陆总合报告了2,1466例疑似猴痘病例,这凸显了便捷的诊断基础设施对于遏制感染传播的重要性。
同时,政府加大对疾病监测的投入,显着提升了该领域的创新能力。联邦机构正投入大量资金研发下一代医疗对策,从而降低了新型病原体检测复杂检验流程带来的风险。这些投资使私人企业能够增强研发能力,并维持应对未来生物威胁的准备。一个显着的例子是,2024年1月,美国先进检测与控制中心(ATCC)向生物医学高级研究与发展局(BARDA)授予了一项为期五年、金额达8700万美元的津贴,用于开发新型诊断工具。这项财政支持确保了市场的稳定;截至2024年10月,罗氏公司报告称,其诊断部门在前九个月的销售额达到107亿瑞士法郎,这反映了其传染病检查产品组合的持续价值。
检验新型病原体检测方法所需的高成本和复杂的监管程序,对市场扩张构成重大障碍。製造商在开发针对偶发性疫情的检测方法时,面临着巨大的财务风险,因为在监管部门完全核准之前,市场需求可能就会下降。这种经济上的不确定性阻碍了企业对新兴威胁的研发进行持续投资,并促使他们优先考虑收入来源稳定的成熟市场,而非波动性较大的感染疾病领域。因此,卫生当局要求的严格检验程序延长了产品上市时间,往往导致医疗系统在疫情初期缺乏必要的工具。
这种监管负担直接影响产品的供应,并阻碍产品线的持续发展。小规模的开发商尤其容易受到这些资源压力的影响,迫使它们进行业务整合,甚至完全停止产品开发。根据欧洲医疗技术协会(MedTech Europe)预测,到2024年,约有17%的体外诊断试剂将因遵守新的监管标准所需的大量成本和资源而停产。已通过核准试剂供应量的减少将限制整个诊断产业的成长潜力。
多重诊断检测板的扩展正在革新临床管理,它能够从单一检体同时检测多种病原体,从而解决呼吸道和胃肠道感染疾病鑑别的难题。透过以综合检测板取代系列检测,这种调查方法能够快速提供针对共同流行病毒的可操作结果,并提高医疗机构的运作效率。专业多重诊断平台的强劲表现支撑了这一趋势的市场可行性。根据生物梅里埃公司于2024年9月发布的“2024年上半年财务业绩”,BIOFIRE呼吸道检测板的销售额在第二季度增长了17%,这主要得益于该解决方案的竞争优势及其现有用户群的利用。
同时,分散式和照护现场(POC)的加速发展正在改变诊断格局,将复杂的分子检测能力从中心检查室转移到更靠近患者的场所,例如急诊诊所和医生办公室。这项转变的驱动力在于缩短治疗时间的需求,使医疗服务提供者能够即时做出临床决策,而无需承受送往中心检查室带来的物流延误。业界领导企业正透过不断扩展的紧凑型自动化系统产品组合来满足这一需求。根据丹纳赫公司于2024年10月发布的“2024财年第三季财务业绩”,Sepede呼吸系统诊断部门的季度销售额达到4.25亿美元,这证实了市场对快速、分散式分子检测解决方案的持续依赖。
The Global Emerging Infectious Disease Diagnostics Market is projected to expand from USD 16.70 Billion in 2025 to USD 27.41 Billion by 2031, achieving a CAGR of 8.61%. This sector comprises specialized assays and platforms engineered to detect pathogens that have recently appeared or are experiencing rapid increases in incidence and geographic reach. The market is largely driven by the rising prevalence of zoonotic and vector-borne diseases, which necessitates the development of robust surveillance capabilities. Additionally, significant government funding dedicated to biodefense infrastructure and pandemic preparedness programs acts as a vital economic catalyst, encouraging continuous product innovation and deployment.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 16.70 Billion |
| Market Size 2031 | USD 27.41 Billion |
| CAGR 2026-2031 | 8.61% |
| Fastest Growing Segment | Laboratory Testing |
| Largest Market | North America |
Despite these drivers, the industry encounters major obstacles regarding the high costs and complex regulatory requirements involved in validating tests for novel pathogens during active outbreaks. These financial and operational hurdles can impede the timely commercialization of essential testing kits when they are most critical. According to the World Health Organization, more than 14.6 million dengue cases were reported worldwide in 2024, underscoring the urgent need for accessible and scalable diagnostic solutions to effectively manage such widespread public health threats.
Market Driver
The rising frequency of emerging and re-emerging infectious outbreaks serves as a primary catalyst for the market, requiring the rapid implementation of specialized testing solutions to mitigate cross-border threats. As pathogens extend their geographic footprint, public health agencies are increasingly procuring molecular and immunoassay platforms to facilitate early detection and contact tracing. This surge in viral activity drives immediate demand for high-throughput screening kits and point-of-care devices designed to function in resource-limited environments. For example, according to the Africa Centres for Disease Control and Prevention, a total of 21,466 potential Mpox cases were reported across the continent by August 2024, emphasizing the critical need for accessible diagnostic infrastructure to control escalating transmission rates.
Simultaneously, increased government funding for disease surveillance is significantly strengthening the sector's capacity for innovation. Federal agencies are directing substantial capital toward developing next-generation medical countermeasures, thereby reducing the risks associated with the complex validation process for tests targeting novel agents. These investments allow private enterprises to enhance their research capabilities and maintain readiness for future biological threats. A prominent example of this support occurred in January 2024, when ATCC received a five-year, $87 million award from the Biomedical Advanced Research and Development Authority to advance new diagnostic tools. This financial backing ensures market stability; according to Roche, in October 2024, its Diagnostics division reported sales of CHF 10.7 billion for the first nine months of the year, reflecting the enduring value of infectious disease testing portfolios.
Market Challenge
The substantial costs and regulatory intricacies involved in validating tests for novel pathogens present significant barriers to market expansion. Manufacturers encounter considerable financial risk when developing assays for sporadic outbreaks, as demand may decline before regulatory approval is fully finalized. This economic uncertainty deters sustained investment in research and development for emerging threats, prompting companies to prioritize established markets with predictable revenue streams over volatile infectious disease segments. Consequently, the rigorous validation procedures required by health authorities prolong the time it takes to bring products to market, often leaving healthcare systems without necessary tools during the initial stages of infection waves.
This regulatory burden directly affects product availability and disrupts portfolio continuity. Smaller developers are particularly susceptible to these resource demands, which can compel them to consolidate or withdraw products entirely. According to MedTech Europe, approximately 17 percent of in vitro diagnostic tests were expected to be discontinued in 2024 due to the extensive costs and resources required to comply with new regulatory standards. This reduction in the availability of approved tests limits the overall growth potential of the diagnostics sector.
Market Trends
The expansion of Syndromic Multiplex Diagnostic Panels is revolutionizing clinical management by facilitating the simultaneous detection of multiple pathogens from a single sample, thereby addressing the difficulty of distinguishing symptoms in respiratory and gastrointestinal infections. This methodology improves operational efficiency in healthcare facilities by replacing sequential testing with comprehensive panels that provide rapid, actionable results for co-circulating viruses. The market viability of this trend is highlighted by the strong performance of specialized syndromic platforms; according to bioMerieux's 'First-Half 2024 Results' in September 2024, sales of BIOFIRE respiratory panels rose by 17 percent in the second quarter, driven by the solution's competitiveness and the utilization of the existing installed base.
In parallel, the acceleration of decentralized and Point-of-Care (POC) testing is reshaping the diagnostic landscape by moving complex molecular testing capabilities from reference laboratories to near-patient settings, such as urgent care clinics and physician offices. This shift is fueled by the need to shorten turnaround times for treatment initiation, enabling providers to make immediate clinical decisions without the logistical delays associated with central lab transport. Industry leaders are capitalizing on this demand by broadening their portfolios of compact, automated systems. According to Danaher's 'Third Quarter 2024 Results' in October 2024, Cepheid's diagnostics revenue for respiratory products reached $425 million for the quarter, underscoring the sustained market reliance on rapid, decentralized molecular testing solutions.
Report Scope
In this report, the Global Emerging Infectious Disease Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Emerging Infectious Disease Diagnostics Market.
Global Emerging Infectious Disease Diagnostics 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: