![]() |
市場調查報告書
商品編碼
1822358
2032 年體外診斷市場預測:按產品類型、技術、樣本類型、檢測地點、應用、最終用戶和地區進行的全球分析In-vitro Diagnostics Market Forecasts to 2032 - Global Analysis By Product Type (Instruments, Reagents & Consumables, and Software & Services), Technology, Sample Type, Test Location, Application, End User and By Geography |
根據 Stratistics MRC 的數據,全球體外診斷市場預計在 2025 年達到 1,165.3 億美元,到 2032 年將達到 1,945.9 億美元,預測期內複合年成長率為 7.6%。
體外診斷 (IVD) 透過分析血液、尿液和組織等生物檢體來識別疾病、病症和感染疾病。這些診斷方法採用分子檢測、免疫學方法和生化檢測等技術,並透過實驗室或就地檢驗系統在外部進行。 IVD 在現代醫療保健中至關重要,能夠實現早期發現、疾病監測和治療最佳化。它們也為精準醫療做出了重要貢獻,確保提供個人化的醫療解決方案並改善病患管理效果。
根據美國疾病管制與預防中心統計,癌症、氣喘、慢性腎臟病和氣喘等呼吸系統疾病等慢性疾病每年導致美國十分之七的死亡。
慢性病和感染疾病的流行
在全球範圍內,糖尿病、心血管疾病和癌症等慢性疾病的激增,推動了對精準診斷檢測的需求。同時,復發性感染疾病也推動了快速、可擴展檢測平台的投資。分子診斷、次世代定序(NGS) 和液態切片的技術進步,正在改變早期檢測和疾病監測。已開發經濟體和新興經濟體的人口老化進一步增加了對常規診斷的需求。醫療保健系統擴大整合個人化檢測通訊協定,以指導治療決策。人口結構變化和技術創新的融合正在推動體外診斷 (IVD) 市場向前發展。
限制性報銷政策
許多醫療保健支付方對採用新技術仍持謹慎態度,尤其是那些涉及高成本分子平台的技術。缺乏統一的全球報銷標準為進入新市場的製造商帶來了不確定性。規模較小的診斷製造商面臨複雜的計費代碼以及與支付方談判的挑戰。這種經濟上的不確定性減緩了創新,並限制了醫療服務欠缺地區獲得尖端診斷技術的機會。如果不進行政策改革,報銷瓶頸可能會繼續阻礙市場擴張。
家庭診斷需求不斷成長
消費者越來越渴望獲得便攜易用的慢性病監測和傳染病篩檢套件。微流體、智慧型手機整合生物感測器和雲端基礎分析等創新技術,使得在臨床環境之外也能獲得即時結果成為可能。監管機構正在透過加快遠距遠端醫療診斷的核准來支持這一趨勢。新興市場,尤其是在農村和偏遠地區,正迅速普及居家檢測。這一發展趨勢為個人化護理和預防性健康管理開闢了新的途徑。
資料隱私和網路安全問題
雲端基礎的診斷系統和人工智慧主導的分析需要強大的加密技術,並遵守全球資料保護法。健康資料外洩會損害患者的信任,並使公司承擔法律責任。物聯網設備與診斷工作流程的整合使網路安全通訊協定變得更加複雜。透明數據處理和違規報告的要求正在加強監管審查。如果不積極投資網路安全基礎設施,數位診斷可能會面臨聲譽和營運風險。
COVID-19的影響
疫情大幅改變了體外診斷的格局,加速了對快速檢測和遠距離診斷的需求。封鎖措施擾亂了供應鏈,但也刺激了照護現場和分子診斷平台的創新。緊急使用授權使得新檢測得以快速部署,遠端醫療的整合也擴大了診斷的範圍。醫院優先考慮自動化和數位化工作流程,以有效管理檢測量。疫情後的策略著重於韌性,製造商紛紛投資分散式生產和人工智慧驅動的診斷技術。
預計設備部門將成為預測期內最大的部門
由於檢測設備在實驗室自動化和高通量檢測中發揮關鍵作用,預計在預測期內將佔據最大的市場佔有率。先進的分析儀、PCR系統和免疫測量平台是醫院和診斷實驗室臨床工作流程的核心。機器人技術、連接複用技術和連接技術的持續創新正在提高營運效率和診斷準確性。對支援多種檢測類型和遠端監控功能的整合系統的需求日益成長。製造商正專注於模組化設計和支援雲端的設備,以滿足實驗室不斷變化的需求。隨著精準診斷的日益普及,檢測設備將繼續成為可擴展檢測基礎設施的支柱。
預計感染疾病領域在預測期內將以最高複合年成長率成長
預計感染疾病領域將在預測期內實現最高成長率,這得益於全球對抗新興病原體的舉措。快速診斷套件、分子檢測和症候群面板正被用於早期檢測和疫情控制。基於 CRISPR 的診斷技術和可攜式核酸檢測技術的突破正在重塑現場診斷。各國政府和非政府組織正在投資可擴展的疫情感染疾病和抗生素抗藥性監測平台。旅行相關疾病和通用感染疾病的增加進一步推動了對敏捷檢測解決方案的需求。該領域正在快速發展,創新重點在於速度、靈敏度和可及性。
受醫療基礎設施擴張和疾病負擔上升的推動,亞太地區預計將在預測期內佔據最大的市場佔有率。中國、印度和日本等國家正在投資診斷現代化和本地製造能力。政府主導的措施正在改善農村和服務欠缺地區的檢測可及性。該地區自動化分析儀和人工智慧診斷平台的採用率正在不斷提高。全球和區域公司之間的策略合作夥伴關係正在加速技術轉移和市場滲透。
在預測期內,北美預計將呈現最高的複合年成長率,這得益於其在診斷創新和數位健康整合方面的領先地位。美國和加拿大在基因組學、液態切片和人工智慧診斷領域處於領先地位。監管機構正在簡化新檢測核准的途徑,以加快市場准入。醫院正在採用雲端基礎的實驗室管理系統和預測分析來最佳化檢測工作流程。該地區受益於強大的報銷支援和消費者對預防性診斷日益成長的認知。
According to Stratistics MRC, the Global In-Vitro Diagnostics Market is accounted for $116.53 billion in 2025 and is expected to reach $194.59 billion by 2032 growing at a CAGR of 7.6% during the forecast period. In-Vitro Diagnostics (IVD) involves analyzing biological specimens, including blood, urine, and tissue, to identify diseases, disorders, or infections. Conducted externally, either in laboratories or through point-of-care testing systems, these diagnostics utilize methods such as molecular assays, immunological techniques, and biochemical testing. IVD is essential in modern healthcare, offering early detection, disease monitoring, and treatment optimization. It also contributes significantly to precision medicine, ensuring tailored healthcare solutions and improved patient management outcomes.
According to CDC, chronic diseases such as cancer & diabetes and chronic kidney & respiratory diseases, such as asthma, are responsible for 7 in 10 deaths in the U.S. each year.
Rising prevalence of chronic and infectious diseases
The global surge in chronic illnesses such as diabetes, cardiovascular disorders, and cancer is intensifying the need for accurate diagnostic testing. Simultaneously, recurring outbreaks of infectious diseases are prompting investments in rapid and scalable testing platforms. Technological advancements in molecular diagnostics, next-generation sequencing (NGS), and liquid biopsy are transforming early detection and disease monitoring. Aging populations across developed and emerging regions are further amplifying demand for routine diagnostics. Healthcare systems are increasingly integrating personalized testing protocols to guide treatment decisions. This convergence of demographic shifts and technological innovation is propelling the IVD market forward.
Limited reimbursement policies
Many healthcare payers remain cautious about covering newer technologies, especially those involving high-cost molecular platforms. The lack of harmonized global reimbursement standards creates uncertainty for manufacturers entering new markets. Smaller diagnostic firms face challenges navigating complex billing codes and payer negotiations. This financial ambiguity slows innovation and limits access to cutting-edge diagnostics in underserved regions. Without policy reform, reimbursement bottlenecks may continue to constrain market expansion.
Rising demand for home-based diagnostics
Consumers are increasingly seeking portable, user-friendly kits for chronic disease monitoring and infectious disease screening. Innovations in microfluidics, smartphone-integrated biosensors, and cloud-based analytics are enabling real-time results outside clinical settings. Regulatory bodies are supporting this trend by fast-tracking approvals for telehealth-compatible diagnostics. Emerging markets are witnessing rapid adoption of home-based testing, especially in rural and remote areas. This evolution is opening new pathways for personalized care and preventive health management.
Data privacy and cybersecurity concerns
Cloud-based diagnostic systems and AI-driven analytics require robust encryption and compliance with global data protection laws. Breaches in health data can erode patient trust and expose companies to legal liabilities. The integration of IoT-enabled devices into diagnostic workflows adds complexity to cybersecurity protocols. Regulatory scrutiny is increasing, with mandates for transparent data handling and breach reporting. Without proactive investment in cybersecurity infrastructure, digital diagnostics may face reputational and operational risks.
Covid-19 Impact
The pandemic dramatically reshaped the IVD landscape, accelerating demand for rapid testing and remote diagnostics. Lockdowns disrupted supply chains, but also catalyzed innovation in point-of-care and molecular platforms. Emergency use authorizations enabled swift deployment of new assays, while telehealth integration expanded diagnostic reach. Hospitals prioritized automation and digital workflows to manage testing volumes efficiently. Post-pandemic strategies now emphasize resilience, with manufacturers investing in decentralized production and AI-powered diagnostics.
The instruments segment is expected to be the largest during the forecast period
The instruments segment is expected to account for the largest market share during the forecast period, due to its critical role in laboratory automation and high-throughput testing. Advanced analyzers, PCR systems, and immunoassay platforms are central to clinical workflows across hospitals and diagnostic labs. Continuous innovation in robotics, multiplexing, and connectivity is enhancing operational efficiency and diagnostic accuracy. Demand is rising for integrated systems that support multiple test types and remote monitoring capabilities. Manufacturers are focusing on modular designs and cloud-enabled instruments to meet evolving lab needs. As precision diagnostics gain traction, instruments remain the backbone of scalable testing infrastructure.
The infectious diseases segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the infectious diseases segment is predicted to witness the highest growth rate, driven by global efforts to combat emerging pathogens. Rapid diagnostic kits, molecular assays, and syndromic panels are being deployed for early detection and outbreak control. Technological breakthroughs in CRISPR-based diagnostics and portable nucleic acid testing are reshaping field diagnostics. Governments and NGOs are investing in scalable platforms for pandemic preparedness and antimicrobial resistance monitoring. The rise of travel-related infections and zoonotic diseases is further boosting demand for agile testing solutions. This segment is evolving rapidly, with innovation focused on speed, sensitivity, and accessibility.
During the forecast period, the Asia Pacific region is expected to hold the largest market share supported by expanding healthcare infrastructure and rising disease burden. Countries like China, India, and Japan are investing in diagnostic modernization and local manufacturing capabilities. Government-led initiatives are improving access to testing in rural and underserved regions. The region is witnessing strong uptake of automated analyzers and AI-powered diagnostic platforms. Strategic collaborations between global players and regional firms are accelerating technology transfer and market penetration.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, underpinned by its leadership in diagnostic innovation and digital health integration. The U.S. and Canada are pioneering developments in genomics, liquid biopsy, and AI-enhanced diagnostics. Regulatory agencies are streamlining pathways for novel test approvals, encouraging faster market entry. Hospitals are adopting cloud-based lab management systems and predictive analytics to optimize testing workflows. The region benefits from strong reimbursement support and high consumer awareness of preventive diagnostics.
Key players in the market
Some of the key players profiled in the In-Vitro Diagnostics Market include Roche, Illumina, Abbott Laboratories, Agilent Technologies, Siemens Healthineers, DiaSorin, Thermo Fisher Scientific, Hologic, Danaher Corporation, QuidelOrtho, bioMerieux, Becton Dickinson (BD), Sysmex Corporation, QIAGEN, and Bio-Rad Laboratories.
In February 2025, Shedd Aquarium and Abbott are announcing one of Shedd's largest corporate gifts in recent history - a $10 million pledge from Abbott and Abbott's philanthropic foundation, Abbott Fund. The investment cements the longstanding partnership between Shedd, Abbott, and Abbott Fund to enrich the cultural, educational and environmental fabric of Chicago and spark passion for protecting the ocean environment.
In May 2025, Roche announced a strategic collaboration with Broad Clinical Labs to develop and pilot groundbreaking applications using Roche's recently unveiled next-generation sequencing (NGS) Sequencing By Expansion (SBX) technology. This collaboration will focus on harnessing the power of the SBX technology to transform clinical genomics and biomedical discovery. It will also aim to establish the SBX technology as a routine offering for fast, scalable sequencing for Broad Clinical Lab's research community.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.