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市场调查报告书
商品编码
1914537
快速检测套组市场 - 全球产业规模、份额、趋势、竞争格局、机会和预测:按类型、产品类型、技术、週转时间、应用、最终用户、地区和竞争情况划分,2021-2031年Rapid Test Kit Market - Global Industry Size, Share, Trends, Competition, Opportunity, and Forecast, Segmented By Type, By Product Type, By Technology, By Duration, By Application, By End User, By Region & Competition, 2021-2031F |
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全球快速检测套组市场预计将从 2025 年的 283.6 亿美元成长到 2031 年的 503.8 亿美元,复合年增长率达到 10.05%。
该行业专注于一次性诊断设备,这些设备可在数分钟内针对特定疾病提供定性或半定量结果,从而无需复杂的实验室设备即可实现即时临床决策。感染疾病日益流行以及医疗保健模式向分散化方向的重大转变推动了市场成长,进而刺激了对便捷的就地检验的需求。例如,全球基金报告称,2024年透过伙伴关係分发了超过640万份HIV自检检测套组,凸显了这些工具在疾病控制和公共卫生监测中的重要性。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 283.6亿美元 |
| 市场规模:2031年 | 503.8亿美元 |
| 复合年增长率:2026-2031年 | 10.05% |
| 成长最快的细分市场 | 快速抗原检测 |
| 最大的市场 | 亚太地区 |
然而,该市场面临许多障碍,包括严格的监管核准程序和品质保证问题。製造商必须谨慎应对复杂的合规环境,以降低假阳性或假阴性结果带来的风险。产品准确性的不一致可能导致强制召回和卫生当局更严格的审查,从而延缓产品上市,并为试图进入市场的新竞争者设置准入壁垒。
感染疾病日益普及是全球快速检测套组市场的主要驱动力,也催生了紧急疫情管理解决方案的需求。虫媒传染病的捲土重来加剧了人们对快速检测的依赖,因为快速检测能够有效避免检查室检测的延误,并在需要时提供结果。这种情况需要大规模筛检工具来遏止感染率。根据泛美卫生组织 (PAHO) 2024 年 10 月发布的《流行病学警报—美洲登革热病例增加》,到第 36 个流行病学週,各国将记录超过 1,170 万例登革热病例,是 2023 年病例总数的 2.5 倍。这种情况直接推动了对快速诊断试剂盒的采购,以便早期疗育。
同时,由于家用和非处方(OTC)诊断试剂盒的日益普及,市场正在扩张,这反映了医疗保健分散化的大趋势。监管机构正在检验自测平台,允许製造商将产品作为标准非处方产品销售。例如,美国食品药物管理局(FDA)于2024年10月核准了Healgen Rapid Check COVID-19/流感A&B抗原检测检测套组,使其成为首个通过传统上市前审查途径而非紧急使用授权核准的商用联合检测套组。雅培于2024年2月发布的2023年度报告进一步印证了该领域的韧性。报告指出,剔除新冠疫情相关因素后,2023年快速诊断产品的销售额成长了1.3%,证实了市场对照护现场解决方案的持续需求。
全球快速检测套组市场面临严峻的挑战,这主要归因于严格的监管核准流程和持续的品质保证难题。製造商必须应对复杂的合规框架,这些框架要求进行全面的临床检验和详细的文件记录,以确保产品的准确性。这些严格的标准给企业带来了巨大的财务和营运负担,尤其对中小企业而言,实际上提高了市场进入门槛。因此,为了避免错误结果,企业必须对检测结果的绝对精确性进行大量投资,这迫使企业在品管投入巨资,从而延长了研发週期,并推迟了新诊断工具的上市。
这种法规环境透过延误产品商业化直接阻碍了市场成长,并抑制了对某些地区的投资。根据欧洲医疗技术协会(MedTech Europe)预测,到2024年,选择欧盟作为首选产品上市地区的主要製造商比例将比以往监管时期下降33%,这主要是由于认证过程的不确定性和资源需求。这些延误限制了快速检测解决方案的广泛应用,并阻碍了企业快速应对突发公共卫生事件的能力。此外,由于品质不符而导致的强制召回威胁造成了不稳定的环境,迫使製造商将资源用于合规管理,而不是扩大产能。
人工智慧 (AI) 与智慧型手机连接的融合正在从根本上改变全球快速检测套组市场,提高诊断准确性并增强用户便利性。製造商正加速将 AI 演算法整合到诊断平台中,以实现结果自动解读,从而最大限度地减少人工判读横向流动化验中固有的主观性和人为误差。这种技术融合促进了即时数据数位化和互联互通,从而能够即时报告和监测感染疾病。一个值得关注的例子是 Predictmedix AI 公司于 2025 年 4 月发布的“智能健康 AI 工作站”,该工作站利用计算机视觉和机器学习技术完成了超过 50 万次独立扫描,并能高精度地检测健康指标。
同时,受动物保健和供应链监控领域对快速照护现场方案的需求驱动,市场正显着多元化发展,涵盖兽医诊断和食品安全检测领域。这一趋势正将先进的诊断技术从人类医学领域转移到兽医和工业领域,使用户能够在传统实验室环境之外获得实验室级的检测结果。为了彰显这一发展趋势,硕腾宣布将于2024年12月在全球推出Vetscan OptiCell,这是首款以晶片为基础的AI赋能型兽医血液分析仪。该设备利用其专有的微流体技术,可在数分钟内完成全血细胞计数分析,凸显了硕腾致力于将快速诊断技术应用于伴侣动物护理的决心。
The Global Rapid Test Kit Market is projected to expand from USD 28.36 Billion in 2025 to USD 50.38 Billion by 2031, achieving a CAGR of 10.05%. This industry focuses on disposable diagnostic devices that deliver qualitative or semi-quantitative results for specific medical conditions within minutes, enabling immediate clinical decisions without the need for complex laboratory equipment. The market's growth is anchored by the increasing prevalence of infectious diseases and a significant shift toward decentralized healthcare, which fuels the demand for accessible point-of-care testing. For instance, The Global Fund reported in 2024 that the partnership distributed more than 6.4 million HIV self-test kits, highlighting the heavy reliance on these tools for disease management and public health monitoring.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 28.36 Billion |
| Market Size 2031 | USD 50.38 Billion |
| CAGR 2026-2031 | 10.05% |
| Fastest Growing Segment | Rapid Antigen Test |
| Largest Market | Asia Pacific |
Conversely, the market encounters substantial obstacles related to rigorous regulatory approval procedures and quality assurance issues. Manufacturers are required to maneuver through complicated compliance environments to mitigate the risks associated with false positive or negative results. Inconsistent product accuracy can precipitate mandatory recalls and intensify scrutiny from health authorities, which subsequently delays commercialization and establishes formidable barriers to entry for new competitors attempting to penetrate the market.
Market Driver
The rising prevalence of infectious diseases serves as a primary propellant for the Global Rapid Test Kit Market, creating an urgent need for immediate outbreak management solutions. The resurgence of vector-borne illnesses has deepened reliance on rapid assays that provide results at the point of need, effectively circumventing laboratory processing delays. This situation necessitates high-volume screening tools to limit transmission rates. According to the Pan American Health Organization's 'Epidemiological Alert - Increase in dengue cases in the Americas Region' from October 2024, countries recorded over 11.7 million dengue cases by epidemiological week 36, a figure 2.5 times greater than the total for 2023, directly driving the procurement of rapid diagnostics for early intervention.
Concurrently, the market is expanding due to increased adoption of home-based and over-the-counter (OTC) diagnostic kits, reflecting a broader trend toward decentralized healthcare. Regulatory authorities are validating self-testing platforms, allowing manufacturers to move products into standard commercial availability. For example, the U.S. Food and Drug Administration authorized the Healgen Rapid Check COVID-19/Flu A&B Antigen Test in October 2024, marking the first OTC combination test approved through the traditional premarket pathway rather than emergency use authorities. This segment's resilience is further evidenced by Abbott's '2023 Annual Report' from February 2024, which noted that Rapid Diagnostics saw a 1.3 percent sales increase in 2023 when excluding COVID-19 volatility, confirming ongoing demand for point-of-care solutions.
Market Challenge
The Global Rapid Test Kit Market confronts significant difficulties stemming from strict regulatory approval processes and ongoing quality assurance challenges. Manufacturers must navigate intricate compliance frameworks that require exhaustive clinical validation and detailed documentation to guarantee product accuracy. These rigorous standards place heavy financial and operational strains on companies, particularly smaller enterprises, effectively establishing high barriers to entry. Consequently, the imperative for absolute precision to prevent false results compels firms to invest substantially in quality control, which prolongs development schedules and delays the launch of new diagnostic tools.
This regulatory climate directly hinders market growth by slowing commercialization efforts and deterring investment in certain regions. According to MedTech Europe, in 2024, the choice of the European Union as the priority region for initial product launches dropped by 33% among large manufacturers compared to prior regulatory periods, largely due to the unpredictability and resource demands of the certification process. Such delays restrict the accessibility of rapid testing solutions and hamper the industry's capacity to respond swiftly to health crises. Additionally, the threat of mandatory recalls arising from quality inconsistencies generates a volatile atmosphere, forcing manufacturers to direct resources toward compliance management rather than expanding capacity.
Market Trends
The integration of Artificial Intelligence and smartphone connectivity is fundamentally transforming the Global Rapid Test Kit Market by improving diagnostic accuracy and enhancing user accessibility. Manufacturers are increasingly incorporating AI algorithms into diagnostic platforms to automate result interpretation, which minimizes the subjectivity and potential for human error inherent in visual readings of lateral flow assays. This technological convergence facilitates real-time data digitization and connectivity, enabling immediate reporting and surveillance of infectious diseases. A notable example is Predictmedix AI Inc., which announced in April 2025 that its Smart Health AI Stations had completed over 500,000 individual scans, employing computer vision and machine learning to detect health indicators with high precision.
Simultaneously, the market is experiencing significant diversification into veterinary diagnostics and food safety testing, propelled by the demand for rapid, point-of-care solutions in animal health and supply chain monitoring. This trend involves the transfer of advanced diagnostic technologies from human healthcare to veterinary and industrial sectors, allowing for lab-quality results outside traditional laboratory environments. Highlighting this expansion, Zoetis announced the global launch of the Vetscan OptiCell in December 2024, marking the first cartridge-based, AI-powered hematology analyzer for point-of-care veterinary use. Utilizing proprietary microfluidic technology to deliver complete blood count analysis in minutes, this device underscores the industry's dedication to extending rapid diagnostic applications to companion animal care.
Report Scope
In this report, the Global Rapid Test Kit 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 Rapid Test Kit Market.
Global Rapid Test Kit 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: