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體外診斷感染疾病

市場調查報告書

商品編碼

2126348

新冠病毒診斷市場：策略性洞察與預測（2026-2035）

COVID-19 Diagnostics Market - Strategic Insights and Forecasts (2026-2035)

出版日期: 2026年08月04日 | 出版商:

Knowledge Sourcing Intelligence | 英文 171 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄

預計 COVID-19 診斷市場將從 2026 年的 162 億美元萎縮到 2035 年的 36 億美元，複合年成長率為 -15.4%。

新冠病毒診斷市場正經歷著從疫情驅動的緊急應變向永續的地方性疾病管理的根本性轉變。隨著醫療系統適應SARS-CoV-2與流感和呼吸道合胞病毒（RSV）共存的地方性疫情，市場發展呈現出從大規模人群篩檢轉向綜合呼吸系統疾病診斷的特徵。分子診斷、多參數檢測平台和檢查室自動化技術的整合，使得呼吸系統疾病管理更有效率和全面性。醫療機構優先考慮診斷效率而非檢測量，促使檢查室整合能夠透過單一流程檢測多種呼吸道病原體的設備。鑑於未來疫情需要可擴展的診斷能力而非持續的大批量檢測，政府籌資策略日益強調主動準備而非緊急儲備。法律規範正從緊急使用授權轉向傳統的診斷藥物核准流程，並加強了對臨床療效、生產品質和上市後監測的證據要求。隨著市場上對多參數呼吸道檢測板、即時檢測技術和數位連接解決方案的大量投資，COVID-19 診斷正日益不再被視為一個獨立的檢測領域，而是成為更廣泛的感染疾病控制基礎設施的一部分。

市場促進因素

綜合呼吸系統疾病檢測的擴展是推動 COVID-19 診斷市場向地方性疾病管理轉型的重要因素。由於 COVID-19 的症狀經常與流感、呼吸道合胞病毒 (RSV) 和其他病毒感染疾病重疊，醫療機構對全面的呼吸系統診斷的需求日益成長。實驗室正在用多參數分子檢測取代單一病原體檢測流程，這些檢測能夠在不增加操作複雜性的前提下提供更廣泛的臨床資訊。這種診斷整合縮短了實驗室反應時間，同時改善了呼吸系統疾病的治療決策。診斷設備製造商正在擴展其呼吸系統檢測產品組合，以最大限度地利用其現有的分子診斷設備。儘管 COVID-19 的單次檢測數量有所下降，但這種綜合檢測能力維持了對分子診斷平台的長期需求和使用。公共衛生監測仍然是國家和國際衛生組織的戰略重點。國家監測計畫持續監測病毒的演變，因為新的變異株會影響感染疾病傳播和醫療準備。由於分子診斷具有高分析靈敏度和與基因測序的兼容性，因此它在監測系統中繼續發揮核心作用。各國政府正在加強國家緊急準備策略，同時維護檢查室，以支持疫情的早期發現。診斷設備供應商正將分子診斷平台定位為重要的監測基礎設施，而非臨時的疫情應對工具。這種策略性重新定位在社區檢測量下降的情況下仍能維持機構需求。檢查室自動化正在提高營運效率並規範工作流程。由於人手不足和資金限制持續影響診斷工作，臨床檢查室正優先考慮自動化。自動化分子診斷平台減少了人工操作，同時提高了工作流程的一致性和檢測能力。醫療機構正在整合支援多種傳染病檢查的診斷系統，並透過標準化的檢測流程實現這一目標。製造商透過將樣本製備、核酸萃取、擴增和結果報告整合到整合平台中，降低了操作複雜性。自動化技術的進步正在增強客戶維繫。這是因為檢測實驗室更傾向於擴充性的診斷生態系統，而不是單一的檢測產品。不斷變化的法規環境正在推動對高品質診斷平台和長期解決方案的投資。隨著緊急使用授權框架的逐步失效，監管機構要求提供更有力的臨床證據。診斷設備製造商正增加對分析驗證、生產品質和上市後監測的投入，以滿足現有的監管要求。

市場限制因素

常規檢測量的下降導致針對單一新冠病毒診斷產品的採購合約減少。大規模篩檢的減少給依賴疫情期間檢測量的製造商帶來了巨大的收入壓力。緊急監管途徑的失效增加了臨床檢驗成本，並延長了新診斷試劑的商業化時間。常規核准框架的過渡進一步加重了診斷試劑製造商的研發負擔。診斷試劑採購的集中化限制了主要依賴單次分析新冠病毒檢測產品的製造商的商機。醫療機構正將採購重點放在多重檢測平台上，從而降低了對單一病原體檢測的需求。從緊急資金報銷轉向臨床合理性檢測，在確保獲得必要的醫療診斷服務的同時，降低了對無差別檢測的需求。

按測試類型
- 分子診斷
  - RT-PCR
  - 恒溫核酸增幅試驗（NAAT）
  - 基於 CRISPR 的分子檢測
- 抗原檢測
- 抗體（血清學）檢測
透過技術平台
- 聚合酵素鏈鎖反應（PCR）
- 等溫擴增
- 橫向流動化驗
- 酵素免疫分析法（ELISA）
- 化學冷光免疫檢測（CLIA）
- 次世代定序（NGS）
依檢體類型
- 鼻咽拭子
- 口腔和咽拭子
- 血
- 唾液
- 其他
透過測試環境
- 檢查室測試
- 照護現場偵測 (PoC)
- 首頁/自測
最終用戶
- 醫院和診所
- 診斷檢查室
- 政府和公共衛生研究機構
- 其他

第10章：全球新冠病毒診斷市場：區域分析

北美洲
歐洲
亞太地區
南美洲
中東和非洲

第11章全球新冠病毒診斷市場：國別分析

美國
加拿大
德國
英國
法國
義大利
西班牙
中國
日本
印度
韓國
澳洲
巴西
墨西哥
沙烏地阿拉伯
南非

第12章競爭格局

市佔率分析
策略趨勢
併購、合作與聯盟
新產品發布

第13章：公司簡介

Roche Holding AG
Abbott Laboratories
Danaher Corporation
Thermo Fisher Scientific Inc.
Siemens AG
Pfizer
QIAGEN NV
Becton, Dickinson and Company
QuidelOrtho Corporation
Hologic, Inc.

第14章全球新冠病毒診斷市場：商業預測分析

第15章投資與資金籌措分析

創業投資趨勢
政府資金
研發投資

第16章：未來展望

主要成長機遇
未來產業趨勢

簡介目錄

Product Code: KSI-009059

The COVID-19 Diagnostics Market is expected to grow at a CAGR of -15.4% from a market value of USD 16.2 billion in 2026 to USD 3.6 billion in 2035.

The COVID-19 diagnostics market is undergoing a fundamental transition from pandemic-driven emergency response to sustainable endemic disease management. The market's evolution is characterized by the shift from mass population screening toward integrated respiratory diagnostics, as healthcare systems adapt to the endemic circulation of SARS-CoV-2 alongside influenza and RSV. The convergence of molecular diagnostics, multiplex testing platforms, and laboratory automation is enabling more efficient and comprehensive respiratory disease management. Healthcare providers are prioritizing diagnostic efficiency instead of testing volume, leading laboratories to consolidate instruments capable of detecting multiple respiratory pathogens through a single workflow. Government procurement strategies increasingly emphasize preparedness rather than emergency stockpiling because future outbreaks require scalable diagnostic capacity instead of continuous mass testing. Regulatory frameworks are transitioning from emergency authorization toward conventional diagnostic approval pathways, increasing evidence requirements for clinical performance, manufacturing quality, and post-market surveillance. The market is witnessing significant investment in multiplex respiratory panels, point-of-care technologies, and digital connectivity solutions, positioning COVID-19 diagnostics within broader infectious disease management infrastructure rather than as a standalone testing segment.

Market Drivers

The expansion of integrated respiratory disease testing represents the primary driver for the COVID-19 diagnostics market during its transition to endemic management. Healthcare providers increasingly require comprehensive respiratory diagnostics because COVID-19 symptoms frequently overlap with influenza, RSV, and other viral infections. Laboratories are replacing single-pathogen workflows with multiplex molecular testing that delivers broader clinical information without increasing operational complexity. This diagnostic consolidation reduces laboratory turnaround times while improving treatment decisions for respiratory illnesses. Diagnostic manufacturers are expanding respiratory assay portfolios to maximize utilization of installed molecular instruments. These integrated testing capabilities strengthen long-term demand despite declining standalone COVID-19 testing volumes, resulting in sustained utilization of molecular platforms. Public health surveillance remains a strategic priority for national and global health agencies. National surveillance programs continuously monitor viral evolution because emerging variants influence disease transmission and healthcare preparedness. Molecular diagnostics remain central to surveillance systems due to their analytical sensitivity and compatibility with genomic sequencing. Governments are maintaining surveillance laboratories that support early outbreak detection while strengthening national preparedness strategies. Diagnostic suppliers are positioning molecular platforms as essential surveillance infrastructure instead of temporary pandemic assets. This strategic repositioning sustains institutional demand despite lower community testing volumes. Laboratory automation is improving operational efficiency and workflow standardization. Clinical laboratories prioritize automation because workforce shortages and financial constraints continue affecting diagnostic operations. Automated molecular platforms reduce manual processing while improving workflow consistency and testing capacity. Healthcare institutions are consolidating diagnostic systems that support multiple infectious disease assays through standardized laboratory processes. Manufacturers are integrating sample preparation, nucleic acid extraction, amplification, and reporting into unified platforms that reduce operational complexity. Higher automation strengthens customer retention because laboratories prefer scalable diagnostic ecosystems over individual testing products. Regulatory transition is encouraging high-quality diagnostic platforms and long-term investment. Regulatory authorities require stronger clinical evidence as emergency authorization frameworks gradually expire. Diagnostic manufacturers increasingly invest in analytical validation, manufacturing quality, and post-market surveillance to satisfy conventional regulatory expectations.

Market Restraints

Declining routine testing volumes are reducing procurement contracts for standalone COVID-19 diagnostic products. The reduction in mass screening creates significant revenue pressure for manufacturers reliant on pandemic-era testing volumes. Expiration of emergency regulatory pathways is increasing clinical validation costs and extending commercialization timelines for new diagnostic assays. The transition to conventional approval frameworks creates additional development burdens for diagnostic manufacturers. Consolidation of diagnostic purchasing is limiting opportunities for manufacturers that rely primarily on single-analyte COVID-19 testing portfolios. Healthcare providers are consolidating purchasing toward multiplex platforms, reducing demand for single-pathogen tests. Reimbursement evolution from emergency funding toward clinically justified testing is reducing demand for indiscriminate testing while preserving access for medically necessary diagnostic services.

Technology and Segment Insights

The technology landscape is characterized by the growing importance of multiplex molecular diagnostics and integrated respiratory testing platforms. Molecular diagnostics represent the largest value-generating segment because nucleic acid amplification directly identifies SARS-CoV-2 genetic material with superior analytical sensitivity. Clinical laboratories are increasingly utilizing RT-PCR and other molecular technologies for hospitalized patients, immunocompromised populations, and respiratory disease surveillance. Manufacturers are integrating influenza, RSV, and additional respiratory pathogen assays into existing molecular platforms. This diversification preserves recurring reagent demand despite declining standalone COVID-19 testing volumes while extending the commercial lifespan of installed molecular systems. Antigen tests continue supporting rapid community-based diagnosis, although confirmatory molecular testing remains important for high-risk patients and healthcare settings. Antibody tests support seroprevalence studies and immune response monitoring. The segment analysis reveals that saliva-based testing is becoming increasingly attractive because specimen collection is non-invasive, minimizes patient discomfort, and reduces dependence on trained healthcare personnel. Demand is expanding across community surveillance, pediatric testing, workplace screening, and decentralized healthcare environments where simplified collection improves patient compliance. Laboratory-based testing remains the principal diagnostic setting because centralized laboratories provide high-throughput processing, standardized quality assurance, and advanced molecular capabilities. Declining community testing volumes are encouraging laboratories to consolidate respiratory diagnostics onto multifunctional molecular instruments that improve operational efficiency. Point-of-care testing continues supporting high-risk patient management in emergency departments and outpatient settings. The integration of digital connectivity is becoming increasingly important because healthcare systems integrate diagnostic instruments with electronic health records and surveillance databases for real-time outbreak monitoring.

Competitive and Strategic Outlook

The competitive landscape features established molecular diagnostics companies alongside specialized rapid test and point-of-care providers. Roche is a global leader in molecular diagnostics, offering the cobas PCR platform and integrated laboratory automation solutions for respiratory disease testing, with its broad infectious disease portfolio and strong presence in clinical laboratories supporting long-term leadership. Abbott provides rapid antigen testing through BinaxNOW and molecular testing through the ID NOW platform, serving hospitals, clinics, and decentralized healthcare settings, with its diversified diagnostics portfolio enabling broad global access to respiratory testing. Danaher, through Cepheid, offers the GeneXpert molecular diagnostics platform for rapid PCR-based respiratory pathogen detection, with its automated cartridge-based systems widely deployed across hospitals and public health laboratories. Thermo Fisher Scientific supplies PCR assays, laboratory instruments, reagents, and workflow solutions for infectious disease diagnostics worldwide, supporting both clinical laboratories and research institutions with integrated molecular testing capabilities. Siemens Healthineers develops molecular and immunodiagnostic platforms, including the Atellica portfolio, for respiratory infectious disease detection, with its laboratory automation expertise strengthening diagnostic efficiency across healthcare systems. Pfizer participates in the COVID-19 ecosystem primarily through vaccines and antiviral therapies while supporting collaborations that advance disease diagnosis and patient management. Companies are pursuing product portfolio expansion through innovation in multiplex respiratory panels, point-of-care molecular tests, and digital connectivity solutions. Strategic positioning increasingly depends on platform versatility, automation, regulatory compliance, and digital connectivity rather than testing capacity alone. Recent key developments include Visby Medical receiving FDA clearance for the Visby Medical Flu and COVID-19 Test, the first at-home multi-viral PCR test for multiple respiratory viruses. Co-Diagnostics advanced its Latin American commercialization strategy with a Mexico distributor agreement for its syndromic PCR testing platforms. The WHO prequalified the first two rapid antigen detection tests for SARS-CoV-2: the SD Biosensor STANDARD Q COVID-19 Ag Test and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test. Geographic expansion remains a key strategic priority, with companies targeting regions where healthcare infrastructure continues to develop.

Short Conclusion

The COVID-19 diagnostics market is transitioning from emergency-driven demand to sustainable respiratory disease management as healthcare systems integrate SARS-CoV-2 testing into routine infectious disease workflows. The shift from mass screening toward multiplex molecular diagnostics and integrated respiratory platforms represents a fundamental evolution in diagnostic strategy. While the market faces significant revenue declines from pandemic peaks, strategic investments in platform versatility, automation, and respiratory assay expansion are creating durable value for diagnostic manufacturers. The long-term market outlook centers on the integration of COVID-19 diagnostics within broader infectious disease management infrastructure, supporting seasonal respiratory testing, surveillance, and pandemic preparedness across global healthcare systems.

Key Benefits of this Report

Insightful Analysis: Detailed market insights across regions, customer segments, policies, socio-economic factors, consumer preferences, and industry verticals.
Competitive Landscape: Understand strategic moves by key players to identify optimal market entry approaches.
Market Drivers and Future Trends: Assess major growth forces and emerging developments shaping the market.
Actionable Recommendations: Support strategic decisions to unlock new revenue streams.
Caters to a Wide Audience: Suitable for startups, research institutions, consultants, SMEs, and large enterprises.

What Businesses Use Our Reports For

Industry and market insights, opportunity assessment, product demand forecasting, market entry strategy, geographical expansion, capital investment decisions, regulatory analysis, new product development, and competitive intelligence.

Report Coverage

Historical data from 2021 to 2024, Base year 2025, and Forecast years from 2026 to 2035
Growth opportunities, challenges, supply chain outlook, regulatory framework, and trend analysis
Competitive positioning, strategies, and market share evaluation, and trade analysis
Revenue growth and forecast assessment across segments and regions
Company profiling including strategies, products, financials, and key developments

1. Executive Summary

1.1 Market Snapshot
1.2 Key Findings
1.3 Analyst Insights
1.4 Strategic Recommendations

2. Research Methodology

2.1 Research Design
2.2 Data Collection Methodology
2.3 Market Size Estimation
2.4 Forecasting Model
2.5 Assumptions & Limitations

3. Global COVID-19 Diagnostics Market Overview, Size & Forecast

3.1 Market Definition & Scope
3.2 COVID-19 Disease Overview
3.3 Industry Evolution
3.4 Key Market Trends
3.5 Historical Market Size Analysis (2021-2025)
3.6 Market Forecast (2026-2035)
3.7 Disease Burden and Diagnostic Needs Analysis
3.8 Testing Volume Analysis
3.9 Testing Landscape by Care Setting
3.10 Patient Testing Pathway Analysis

4. Market Dynamics

4.1 Market Drivers
4.2 Market Restraints
4.3 Market Opportunities
4.4 Market Challenges

5. Industry Landscape

5.1 Industry Value Chain Analysis
5.2 Pricing Analysis
5.3 Reimbursement Landscape

6. Innovation Landscape

6.1 Emerging Diagnostic Technologies
6.2 Product Innovation
6.3 Clinical Trial Analysis
6.4 Pipeline Analysis
6.5 AI Integration in COVID-19 Diagnostics
6.6 Digital Health Integration

7. Regulatory Landscape

7.1 Regulatory Framework
7.2 Approval Pathways
7.3 Compliance Requirements

8. Global COVID-19 Diagnostics Market Landscape Analysis

8.1 Analysis by Technology Platform
8.2 Analysis by Test Type
8.3 Analysis by Sample Type
8.4 Analysis by Clinical Application
8.5 Analysis by Testing Setting

9. Global COVID-19 Diagnostics Market Segment Analysis (2021-2035)

9.1 By Test Type
- 9.1.1 Molecular Diagnostics
  - 9.1.1.1 RT-PCR
  - 9.1.1.2 Isothermal Nucleic Acid Amplification Tests (NAAT)
  - 9.1.1.3 CRISPR-Based Molecular Tests
- 9.1.2 Antigen Tests
- 9.1.3 Antibody (Serology) Tests
9.2 By Technology Platform
- 9.2.1 Polymerase Chain Reaction (PCR)
- 9.2.2 Isothermal Amplification
- 9.2.3 Lateral Flow Assays
- 9.2.4 Enzyme-Linked Immunosorbent Assay (ELISA)
- 9.2.5 Chemiluminescent Immunoassay (CLIA)
- 9.2.6 Next-Generation Sequencing (NGS)
9.3 By Sample Type
- 9.3.1 Nasopharyngeal Swab
- 9.3.2 Oropharyngeal Swab
- 9.3.3 Blood
- 9.3.4 Saliva
- 9.3.5 Others
9.4 By Testing Setting
- 9.4.1 Laboratory-based Testing
- 9.4.2 Point-of-Care (PoC) Testing
- 9.4.3 At-home/Self-testing
9.5 By End User
- 9.5.1 Hospitals & Clinics
- 9.5.2 Diagnostic Laboratories
- 9.5.3 Government & Public Health Laboratories
- 9.5.4 Others

10. Global COVID-19 Diagnostics Market Geographical Analysis (2021-2035)

10.1 North America
10.2 Europe
10.3 Asia-Pacific
10.4 South America
10.5 Middle East & Africa

11. Global COVID-19 Diagnostics Market Country Analysis (2021-2035)

11.1 United States
11.2 Canada
11.3 Germany
11.4 United Kingdom
11.5 France
11.6 Italy
11.7 Spain
11.8 China
11.9 Japan
11.10 India
11.11 South Korea
11.12 Australia
11.13 Brazil
11.14 Mexico
11.15 Saudi Arabia
11.16 South Africa

12. Competitive Landscape

12.1 Market Share Analysis
12.2 Strategic Developments
12.3 Mergers & Acquisitions, Partnerships & Collaborations
12.4 Product Launches

13. Company Profiles

13.1 Roche Holding AG
- 13.1.1 Company Overview
- 13.1.2 Financials
- 13.1.3 Product Portfolio
- 13.1.4 Recent Developments
13.2 Abbott Laboratories
13.3 Danaher Corporation
13.4 Thermo Fisher Scientific Inc.
13.5 Siemens AG
13.6 Pfizer
13.7 QIAGEN N.V.
13.8 Becton, Dickinson and Company
13.9 QuidelOrtho Corporation
13.10 Hologic, Inc.