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市場調查報告書
商品編碼
1914537
快速檢測套組市場 - 全球產業規模、佔有率、趨勢、競爭格局、機會和預測:按類型、產品類型、技術、週轉時間、應用、最終用戶、地區和競爭情況分類,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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全球快速檢測套組市場預計將從 2025 年的 283.6 億美元成長到 2031 年的 503.8 億美元,複合年成長率達到 10.05%。
該行業專注於一次性診斷設備,這些設備可在數分鐘內針對特定疾病提供定性或半定量結果,從而無需複雜的實驗室設備即可實現即時臨床決策。感染疾病日益流行以及醫療保健模式向分散化方向的重大轉變推動了市場成長,進而刺激了對便捷的就地檢驗的需求。例如,全球基金報告稱,2024年透過夥伴關係分發了超過640萬份HIV自檢檢測套組,凸顯了這些工具在疾病控制和公共衛生監測中的重要性。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 283.6億美元 |
| 市場規模:2031年 | 503.8億美元 |
| 複合年成長率:2026-2031年 | 10.05% |
| 成長最快的細分市場 | 快速抗原檢測 |
| 最大的市場 | 亞太地區 |
然而,該市場面臨許多障礙,包括嚴格的監管核准程序和品質保證問題。製造商必須謹慎應對複雜的合規環境,以降低假陽性或假陰性結果帶來的風險。產品準確性的不一致可能導致強制召回和衛生當局更嚴格的審查,從而延緩產品上市,並為試圖進入市場的新競爭者設置准入壁壘。
感染疾病日益普及是全球快速檢測套組市場的主要驅動力,也催生了緊急疫情管理解決方案的需求。蟲媒傳染病的捲土重來加劇了人們對快速檢測的依賴,因為快速檢測能夠有效避免檢查室檢測的延誤,並在需要時提供結果。這種情況需要大規模篩檢工具來遏止感染率。根據泛美衛生組織 (PAHO) 2024 年 10 月發布的《流行病學警報—美洲登革熱病例增加》,到第 36 個流行病學週,各國將記錄超過 1,170 萬例登革熱病例,是 2023 年病例總數的 2.5 倍。這種情況直接推動了對快速診斷試劑盒的採購,以便早期療育。
同時,由於家用和非處方(OTC)診斷試劑盒的日益普及,市場正在擴張,這反映了醫療保健分散化的大趨勢。監管機構正在檢驗自測平台,允許製造商將產品作為標準非處方產品銷售。例如,美國食品藥物管理局(FDA)於2024年10月核准了Healgen Rapid Check COVID-19/流感A&B抗原檢測檢測套組,使其成為首個通過傳統上市前審查途徑而非緊急使用授權核准的商用聯合檢測套組。雅培於2024年2月發布的2023年度報告進一步印證了該領域的韌性。報告指出,剔除新冠疫情相關因素後,2023年快速診斷產品的銷售額成長了1.3%,證實了市場對照護現場解決方案的持續需求。
全球快速檢測套組市場面臨嚴峻的挑戰,這主要歸因於嚴格的監管核准流程和持續的品質保證難題。製造商必須應對複雜的合規框架,這些框架要求進行全面的臨床檢驗和詳細的文件記錄,以確保產品的準確性。這些嚴格的標準給企業帶來了巨大的財務和營運負擔,尤其對中小企業而言,實際上提高了市場進入門檻。因此,為了避免錯誤結果,企業必須對檢測結果的絕對精確性進行大量投資,這迫使企業在品管投入巨資,從而延長了研發週期,並推遲了新診斷工具的上市。
這種法規環境透過延誤產品商業化直接阻礙了市場成長,並抑制了對某些地區的投資。根據歐洲醫療技術協會(MedTech Europe)預測,到2024年,選擇歐盟作為首選產品上市地區的主要製造商比例將比以往監管時期下降33%,這主要是由於認證過程的不確定性和資源需求。這些延誤限制了快速檢測解決方案的廣泛應用,並阻礙了企業快速應對突發公共衛生事件的能力。此外,由於品質不符而導致的強制召回威脅造成了不穩定的環境,迫使製造商將資源用於合規管理,而不是擴大產能。
人工智慧 (AI) 與智慧型手機連接的融合正在從根本上改變全球快速檢測套組市場,提高診斷準確性並增強用戶便利性。製造商正加速將 AI 演算法整合到診斷平台中,以實現結果自動解讀,從而最大限度地減少人工判讀橫向流動化驗中固有的主觀性和人為誤差。這種技術融合促進了即時數據數位化和互聯互通,從而能夠即時報告和監測感染疾病。一個值得關注的例子是 Predictmedix AI 公司於 2025 年 4 月發布的“智慧健康 AI 工作站”,該工作站利用電腦視覺和機器學習技術完成了超過 50 萬次獨立掃描,並能高精度地檢測健康指標。
同時,受動物保健和供應鏈監控領域對快速照護現場方案的需求驅動,市場正顯著多元化發展,涵蓋獸醫診斷和食品安全檢測領域。這一趨勢正將先進的診斷技術從人類醫學領域轉移到獸醫和工業領域,使用戶能夠在傳統實驗室環境之外獲得實驗室級的檢測結果。為了彰顯這一發展趨勢,碩騰宣布將於2024年12月在全球推出Vetscan OptiCell,這是首款以晶片為基礎的AI賦能型獸醫血液分析儀。該設備利用其專有的微流體技術,可在數分鐘內完成全血細胞計數分析,凸顯了碩騰致力於將快速診斷技術應用於伴侶動物護理的決心。
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: