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市场调查报告书
商品编码
1822358
2032 年体外诊断市场预测:按产品类型、技术、样本类型、检测地点、应用、最终用户和地区进行的全球分析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 |
根据 Stratistics MRC 的数据,全球体外诊断市场预计在 2025 年达到 1,165.3 亿美元,到 2032 年将达到 1,945.9 亿美元,预测期内复合年增长率为 7.6%。
体外诊断 (IVD) 透过分析血液、尿液和组织等生物检体来识别疾病、病症和感染疾病。这些诊断方法采用分子检测、免疫学方法和生化检测等技术,并透过实验室或就地检验系统在外部进行。 IVD 在现代医疗保健中至关重要,能够实现早期发现、疾病监测和治疗优化。它们也为精准医疗做出了重要贡献,确保提供个人化的医疗解决方案并改善病患管理效果。
根据美国疾病管制与预防中心统计,癌症、气喘、慢性肾臟病和气喘等呼吸系统疾病等慢性疾病每年导緻美国十分之七的死亡。
慢性病和感染疾病的流行
在全球范围内,糖尿病、心血管疾病和癌症等慢性疾病的激增,推动了对精准诊断检测的需求。同时,復发性感染疾病也推动了快速、可扩展检测平台的投资。分子诊断、次世代定序(NGS) 和液态切片的技术进步,正在改变早期检测和疾病监测。已开发经济体和新兴经济体的人口老化进一步增加了对常规诊断的需求。医疗保健系统越来越多地整合个人化检测通讯协定,以指导治疗决策。人口结构变化和技术创新的融合正在推动体外诊断 (IVD) 市场向前发展。
限制性报销政策
许多医疗保健支付方对采用新技术仍持谨慎态度,尤其是那些涉及高成本分子平台的技术。缺乏统一的全球报销标准为进入新市场的製造商带来了不确定性。规模较小的诊断製造商面临复杂的计费代码以及与支付方谈判的挑战。这种经济上的不确定性减缓了创新,并限制了医疗服务欠缺地区获得尖端诊断技术的机会。如果不进行政策改革,报销瓶颈可能会继续阻碍市场扩张。
家庭诊断需求不断成长
消费者越来越渴望获得便携易用的慢性病监测和传染病筛检套件。微流体、智慧型手机整合生物感测器和云端基础分析等创新技术,使得在临床环境之外也能获得即时结果成为可能。监管机构正在透过加快远距远端医疗诊断的核准来支持这一趋势。新兴市场,尤其是在农村和偏远地区,正迅速普及居家检测。这一发展趋势为个人化护理和预防性健康管理开闢了新的途径。
资料隐私和网路安全问题
云端基础的诊断系统和人工智慧主导的分析需要强大的加密技术,并遵守全球资料保护法。健康资料外洩会损害患者的信任,并使公司承担法律责任。物联网设备与诊断工作流程的整合使网路安全通讯协定变得更加复杂。透明数据处理和违规报告的要求正在加强监管审查。如果不积极投资网路安全基础设施,数位诊断可能会面临声誉和营运风险。
COVID-19的影响
疫情大幅改变了体外诊断的格局,加速了对快速检测和远距离诊断的需求。封锁措施扰乱了供应链,但也刺激了照护现场和分子诊断平台的创新。紧急使用授权使得新检测得以快速部署,远端医疗的整合也扩大了诊断的范围。医院优先考虑自动化和数位化工作流程,以有效管理检测量。疫情后的策略着重于韧性,製造商纷纷投资分散式生产和人工智慧驱动的诊断技术。
预计设备部门将成为预测期内最大的部门
由于检测设备在实验室自动化和高通量检测中发挥关键作用,预计在预测期内将占据最大的市场份额。先进的分析仪、PCR系统和免疫测量平台是医院和诊断实验室临床工作流程的核心。机器人技术、多路復用技术和连接技术的持续创新正在提高营运效率和诊断准确性。对支援多种检测类型和远端监控功能的整合系统的需求日益增长。製造商正专注于模组化设计和支援云端的设备,以满足实验室不断变化的需求。随着精准诊断的日益普及,检测设备将继续成为可扩展检测基础设施的支柱。
预计感染疾病领域在预测期内将以最高复合年增长率成长
预计感染疾病领域将在预测期内实现最高成长率,这得益于全球对抗新兴病原体的倡议。快速诊断套件、分子检测和综合征面板正被用于早期检测和疫情控制。基于 CRISPR 的诊断技术和可携式核酸检测技术的突破正在重塑现场诊断。各国政府和非政府组织正在投资可扩展的疫情感染疾病和抗生素抗药性监测平台。旅行相关疾病和通用感染疾病的增加进一步推动了对敏捷检测解决方案的需求。该领域正在快速发展,创新重点在于速度、灵敏度和可及性。
受医疗基础设施扩张和疾病负担上升的推动,亚太地区预计将在预测期内占据最大的市场份额。中国、印度和日本等国家正在投资诊断现代化和本地製造能力。政府主导的措施正在改善农村和服务欠缺地区的检测可及性。该地区自动化分析仪和人工智慧诊断平台的采用率正在不断提高。全球和区域公司之间的策略合作伙伴关係正在加速技术转移和市场渗透。
在预测期内,北美预计将呈现最高的复合年增长率,这得益于其在诊断创新和数位健康整合方面的领先地位。美国和加拿大在基因组学、液态切片和人工智慧诊断领域处于领先地位。监管机构正在简化新检测核准的途径,以加快市场准入。医院正在采用云端基础的实验室管理系统和预测分析来优化检测工作流程。该地区受益于强大的报销支援和消费者对预防性诊断日益增长的认识。
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.