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市場調查報告書
商品編碼
1949481
新興感染疾病診斷市場-全球產業規模、佔有率、趨勢、機會及預測(按應用、技術、感染類型、疾病類型、最終用戶、地區和競爭格局分類,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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全球新興感染疾病診斷市場預計將從 2025 年的 167 億美元成長到 2031 年的 274.1 億美元,複合年成長率達到 8.61%。
此細分市場包含專門用於檢測新出現的病原體或發病率和地理範圍迅速擴大的病原體的檢測方法和平台。該市場的成長主要受通用和媒介感染疾病日益普遍的推動,這促使人們需要建立健全的監測系統。此外,政府對生物防禦基礎設施和疫情防範計畫的大量投入也成為重要的經濟催化劑,推動了產品的持續創新和應用。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 167億美元 |
| 市場規模:2031年 | 274.1億美元 |
| 複合年成長率:2026-2031年 | 8.61% |
| 成長最快的細分市場 | 實驗室檢測 |
| 最大的市場 | 北美洲 |
儘管存在這些促進因素,但該行業仍面臨著許多障礙,例如疫情爆發期間檢驗的高成本和複雜的監管要求。這些財務和營運方面的難題可能會阻礙關鍵檢測套組在最需要的時候及時商業化。世界衛生組織(世衛組織)預測,2024年全球將報告超過1460萬例登革熱病例,凸顯了迫切需要可及且擴充性的診斷解決方案,以有效應對這種廣泛的公共衛生威脅。
新興和復發感染疾病的日益頻繁是推動市場發展的主要因素,因此亟需快速部署專業檢測解決方案以應對跨境威脅。病原體的地理擴散促使公共衛生機構加快部署分子診斷和免疫檢測平台,以促進早期發現和接觸者追蹤。病毒活動的激增催生了對高通量篩檢盒和照護現場設備的即時需求,這些設備需能在資源匱乏的環境中運作。例如,根據非洲疾病管制與預防中心(非洲疾管中心)統計,截至2024年8月,非洲大陸總合報告了2,1466例疑似猴痘病例,這凸顯了便捷的診斷基礎設施對於遏制感染傳播的重要性。
同時,政府加大對疾病監測的投入,顯著提升了該領域的創新能力。聯邦機構正投入大量資金研發下一代醫療對策,從而降低了新型病原體檢測複雜檢驗流程帶來的風險。這些投資使私人企業能夠增強研發能力,並維持應對未來生物威脅的準備。一個顯著的例子是,2024年1月,美國先進檢測與控制中心(ATCC)向生物醫學高級研究與發展局(BARDA)授予了一項為期五年、金額達8700萬美元的津貼,用於開發新型診斷工具。這項財政支持確保了市場的穩定;截至2024年10月,羅氏公司報告稱,其診斷部門在前九個月的銷售額達到107億瑞士法郎,這反映了其傳染病檢查產品組合的持續價值。
檢驗新型病原體檢測方法所需的高成本和複雜的監管程序,對市場擴張構成重大障礙。製造商在開發針對偶發性疫情的檢測方法時,面臨著巨大的財務風險,因為在監管部門完全核准之前,市場需求可能就會下降。這種經濟上的不確定性阻礙了企業對新興威脅的研發進行持續投資,並促使他們優先考慮收入來源穩定的成熟市場,而非波動性較大的感染疾病領域。因此,衛生當局要求的嚴格檢驗程序延長了產品上市時間,往往導致醫療系統在疫情初期缺乏必要的工具。
這種監管負擔直接影響產品的供應,並阻礙產品線的持續發展。小規模的開發商尤其容易受到這些資源壓力的影響,迫使它們進行業務整合,甚至完全停止產品開發。根據歐洲醫療技術協會(MedTech Europe)預測,到2024年,約有17%的體外診斷試劑將因遵守新的監管標準所需的大量成本和資源而停產。已通過核准試劑供應量的減少將限制整個診斷產業的成長潛力。
多重診斷檢測板的擴展正在革新臨床管理,它能夠從單一檢體同時檢測多種病原體,從而解決呼吸道和胃腸道感染疾病鑑別的難題。透過以綜合檢測板取代系列檢測,這種調查方法能夠快速提供針對共同流行病毒的可操作結果,並提高醫療機構的運作效率。專業多重診斷平台的強勁表現支撐了這一趨勢的市場可行性。根據生物梅里埃公司於2024年9月發布的“2024年上半年財務業績”,BIOFIRE呼吸道檢測板的銷售額在第二季度成長了17%,這主要得益於該解決方案的競爭優勢及其現有用戶群的利用。
同時,分散式和照護現場(POC)的加速發展正在改變診斷格局,將複雜的分子檢測能力從中心檢查室轉移到更靠近患者的場所,例如急診診所和醫生辦公室。這項轉變的驅動力在於縮短治療時間的需求,使醫療服務提供者能夠即時做出臨床決策,而無需承受送往中心檢查室帶來的物流延誤。業界領導企業正透過不斷擴展的緊湊型自動化系統產品組合來滿足這一需求。根據丹納赫公司於2024年10月發布的“2024會計年度第三季財務業績”,Sepede呼吸系統診斷部門的季度銷售額達到4.25億美元,這證實了市場對快速、分散式分子檢測解決方案的持續依賴。
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: