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市场调查报告书
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全球体外大肠直肠癌筛检市场:2032 年预测 - 按测试类型、影像类型、交付方式、应用、最终用户和地区进行分析In-vitro Colorectal Cancer Screening Tests Market Forecasts to 2032 - Global Analysis By Test Type, Imaging Type, Mode of Offering, Application, End User and By Geography |
根据 Stratistics MRC 的数据,全球体外大肠癌筛检市场预计在 2025 年将达到 12.9 亿美元,预计到 2032 年将达到 21.7 亿美元,预测期内的复合年增长率为 7.7%。
体外大肠直肠癌筛检检测是一种非侵入性诊断方法,可透过分析粪便或血液等体外生物样本来检测大肠直肠癌的早期征兆。这些检测可以识别潜血、DNA突变以及与恶性肿瘤和癌前息肉相关的蛋白质指标等生物标记。常用方法包括大便潜血试验(FOBT)、粪便免疫化学检测 (FIT) 和基于 DNA 的检测。这些检测旨在用于常规筛检,有助于早期发现癌症,改善治疗效果,并在症状出现之前发现癌症,从而降低死亡率。
根据《柳叶刀肿瘤学》的报导,多目标粪便 DNA 测试(例如 Cologuard)在检测结肠直肠癌方面的灵敏度超过 90%,在检测晚期腺瘤方面的灵敏度约为 42%。
大肠直肠癌发生率和盛行率上升
对于寻求改善患者治疗效果并降低治疗成本的医疗保健提供者而言,早期检测正成为首要任务。随着公共卫生计画持续强调对45岁及以上人口进行定期筛检,预计检测量将大幅成长。此外,癌症协会和政府机构的宣传活动也推动了对非侵入性检测的需求。人们日益认识到筛检是一种预防策略,而非被动应对,这进一步佐证了这一趋势。
常规检测的敏感性和特异性降低
传统的筛检方法,例如癒创木脂检测和过时的粪便检测,通常敏感性和特异性有限,导致假阳性和漏诊。这些缺陷降低了临床医生和患者对检测的信心,并阻碍了采用大肠镜检查等更明确的诊断方法。此外,由于生物标记可见度较差,检测延迟的风险可能导致无症状患者的病情进展。
向服务不足和资源匮乏的环境扩张
农村和资源匮乏的地区通常缺乏先进的诊断基础设施,这构成了一个尚未开发的庞大市场。携带式、无需专业知识的自助式试剂套件可以填补这一空白,尤其是透过政府支持的社区健康计画进行分发。随着官民合作关係的扩展,相关人员越来越注重透过根据不同的社会经济背景客製化筛检解决方案来改善医疗保健公平性。
对结果的误解和过度诊断/诊断不足
不准确的结果可能导致过度诊断,使患者面临侵入性干预,或诊断不足,从而延误治疗并降低疗效。不同族群检测结果的差异增加了临床的复杂性,需要谨慎应用并由专家监督。此外,医疗系统中指南的不标准化也导致结果解释和追踪通讯协定的混乱。这些因素引发了人们对责任问题的担忧,并凸显了对临床医生进行培训和製定更完善的检验通讯协定的必要性。
COVID-19 疫情扰乱了全球癌症筛检服务,并延迟了大肠直肠疾病的早期诊断。封锁和医院就诊限制减少了常规筛检,导致大量未确诊病例积压。另一方面,疫情凸显了居家和远距离诊断的价值,促使人们对自助采集套件以及与远端医疗结合的检测方法重新燃起兴趣。此类行为变化可能会对筛检策略产生持久影响,并可能加速体外诊断解决方案的发展。
预计大便潜血试验(FOBT)部分在预测期内将占据最大的份额。
大便潜血试验(FOBT) 因其成本效益高、普及性强且非侵入性,预计将在预测期内占据最大的市场占有率。 FOBT 在许多国家癌症预防计画中被用作第一线筛检工具,易于分发和管理。其便利性和极低的基础设施要求使其成为在已开发市场和新兴市场大规模部署的理想选择。
MarCarePlex 部门预计在预测期内实现最高复合年增长率
在预测期内,MarCarePlex 细分市场预计将呈现最高成长率,这得益于其多重生物标记方法和高诊断准确性。这些先进的检测方法能够同时检测多种癌症特异性标记物,从而提供更全面的风险评估。它们能够有效识别早期恶性肿瘤,因此对于寻求精准且可扩展的检测解决方案的临床实验室而言极具吸引力。
由于完善的筛检指南和广泛的医疗保险计划,北美预计将在预测期内占据最大的市场占有率。美国疾病管制与预防中心 (CDC) 和美国癌症协会 (ACS) 等机构进行的广泛宣传宣传活动和积极的筛检计画正在提高各年龄层的参与率。雄厚的癌症预防研究资金和早期技术应用进一步提升了该地区的市场前景。
在预测期内,由于公共卫生计画的不断增加以及对预防性诊断的日益重视,预计欧洲地区将呈现最高的复合年增长率。德国、英国和法国等国家正在扩大其国家癌症筛检计划,将高风险族群纳入其中。技术创新,尤其是生物标记发现和人工智慧主导的分析,正在该地区的医疗科技生态系统中日益受到关注。
According to Stratistics MRC, the Global In-vitro Colorectal Cancer Screening Tests Market is accounted for $1.29 billion in 2025 and is expected to reach $2.17 billion by 2032 growing at a CAGR of 7.7% during the forecast period. In-vitro colorectal cancer screening tests are non-invasive diagnostic procedures that analyze biological samples typically stool or blood outside the body to detect early signs of colorectal cancer. These tests identify biomarkers such as occult blood, DNA mutations, or protein indicators associated with malignancies or precancerous polyps. Common methods include fecal occult blood tests (FOBT), fecal immunochemical tests (FIT), and DNA-based assays. Designed for routine screening, they support early detection, improve treatment outcomes, and reduce mortality by identifying cancer before symptoms appear
According to article in The Lancet Oncology, multitarget stool DNA tests (such as Cologuard) showed a sensitivity of over 90% for detecting colorectal cancer and around 42% for advanced adenomas.
Rising incidence and prevalence of colorectal cancer
Early detection is becoming a top priority for healthcare providers aiming to improve patient outcomes and reduce treatment costs. As public health programs continue emphasizing routine screening for individuals aged 45 and above, test volumes are expected to rise substantially. Moreover, awareness initiatives by cancer associations and governmental bodies are bolstering demand for non-invasive testing. This trend is further supported by the growing recognition of screening as a preventive strategy rather than a reactive measure.
Lower sensitivity and specificity of traditional tests
Conventional screening options, such as guaiac-based tests or outdated fecal assays, often suffer from limited sensitivity and specificity, resulting in false positives or missed diagnoses. These shortcomings can erode clinician and patient confidence in the tests, discouraging adoption in favor of more definitive diagnostics like colonoscopy. Additionally, the risk of under-detection due to low biomarker visibility may lead to disease progression in asymptomatic patients.
Expansion into underserved and low-resource settings
Populations in rural or low-resource settings often lack access to advanced diagnostic infrastructure, creating a large untapped market. Portable, self-administered kits that require minimal expertise can bridge this gap, especially when distributed through government-backed community health programs. As public-private partnerships expand, stakeholders are increasingly focused on improving healthcare equity by tailoring screening solutions to diverse socioeconomic contexts.
Misinterpretation of results and over-diagnosis/under-diagnosis
Inaccurate results may lead to over-diagnosis, subjecting patients to invasive interventions, or under-diagnosis, delaying treatment and worsening prognosis. Variability in test performance across populations adds to clinical complexity, requiring cautious application and expert oversight. Additionally, non-standardized guidelines across healthcare systems contribute to confusion in result interpretation and follow-up protocols. These factors heighten liability concerns and emphasize the need for clinician training and better validation protocols.
The COVID-19 pandemic introduced disruptions to cancer screening services worldwide, delaying early diagnosis of colorectal conditions. Lockdowns and restricted hospital access led to a decline in routine check-ups, causing a backlog of undiagnosed cases. On the other hand, the pandemic highlighted the value of home-based and remote diagnostics, prompting renewed interest in self-collection kits and telehealth-integrated testing. This shift in behavior is likely to have lasting effects on screening strategies and could serve as a growth accelerator for in-vitro solutions.
The fecal occult blood test (FOBT) segment is expected to be the largest during the forecast period
The fecal occult blood test (FOBT) segment is expected to account for the largest market share during the forecast period due to its cost-effectiveness, wide availability, and non-invasive nature. Used as a frontline screening tool in numerous national cancer prevention programs, FOBTs are easily distributed and administered. Their convenience and minimal infrastructure requirements make them ideal for large-scale deployments across both developed and emerging markets.
The marcareplex segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the marcareplex segment is predicted to witness the highest growth rate driven by its multiplex biomarker approach and high diagnostic precision. These advanced assays can detect multiple cancer-specific markers simultaneously, providing a more comprehensive risk assessment. Their efficiency in identifying early-stage malignancies makes them attractive for clinical labs seeking accurate yet scalable testing solutions.
During the forecast period, the North America region is expected to hold the largest market share attributed to well-established screening guidelines and expansive health coverage systems. Widespread awareness campaigns and proactive screening initiatives by agencies like the CDC and ACS have boosted participation rates across demographics. Strong funding for cancer prevention research and early technology adoption further enhance the regional market outlook.
Over the forecast period, the Europe region is anticipated to exhibit the highest CAGR owing to increased public health initiatives and growing emphasis on preventive diagnostics. Countries such as Germany, the U.K., and France are expanding national cancer screening programs to include high-risk populations. Technological innovation, particularly in biomarker discovery and AI-driven analytics, is gaining traction in the region's med-tech ecosystem.
Key players in the market
Some of the key players in In-vitro Colorectal Cancer Screening Tests Market include Sysmex Corporation, Siemens Healthcare GmbH, Randox Laboratories Ltd., Quest Diagnostics Incorporated, OncoCyte Corporation, Merck KGaA, Kyowa Kirin Co., Ltd., Invitae Corporation, Immunostics Inc., Illumina, Inc., Hologic, Inc., Genomic Health, Inc., F. Hoffmann-La Roche AG, Exact Sciences Corporation, Epigenomics AG, Eiken Chemical Co., Ltd., Bio-Rad Laboratories, Inc., Beckman Coulter Inc. and Abbott Laboratories.
In June 2025, Illumina agreed to buy proteomics company SomaLogic for $350 million plus milestones, bolstering its multiomics capabilities. The deal enhances its strategy across genomics, proteomics, and personalized medicine
In May 2025, Siemens Healthineers launched the first U.S. Mobile Stroke Unit equipped with a Somatom On.site CT scanner to deliver advanced stroke diagnostics at UCLA Health. This rapid-response ambulance aims to reduce treatment delays and improve outcomes.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.