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市场调查报告书
商品编码
1914661
卵巢癌诊断市场-全球产业规模、份额、趋势、机会及预测(按诊断类型、癌症类型、最终用户、地区和竞争格局划分,2021-2031年)Ovarian Cancer Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Diagnosis Type, By Cancer Type, By End User, By Region & Competition, 2021-2031F |
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全球卵巢癌诊断市场预计将从2025年的22.1亿美元成长到2031年的30.2亿美元,复合年增长率(CAGR)为5.34%。该市场涵盖旨在透过基因筛检、肿瘤生物标记检测和超音波等技术识别卵巢、输卵管和腹膜恶性肿瘤的各项检测和医疗程序。这一成长主要受全球妇科癌症发生率上升以及高风险族群BRCA基因突变检测普及率提高的推动。根据美国癌症协会(ACS)报告,预计2025年美国将有20,890名女性被诊断出患有卵巢癌,这凸显了精准诊断解决方案对于及时治疗和改善患者预后的迫切需求。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 22.1亿美元 |
| 市场规模:2031年 | 30.2亿美元 |
| 复合年增长率:2026-2031年 | 5.34% |
| 成长最快的细分市场 | 电脑断层扫描 |
| 最大的市场 | 北美洲 |
儘管有这些正面迹象,但基因组检测成本高昂,且缺乏针对一般人群早期筛检的标准化、高灵敏度筛检通讯协定,这给市场带来了许多挑战。疾病往往在发展到晚期才被发现,降低了现有治疗方案的有效性,并有效阻碍了常规诊断筛检措施的广泛应用。因此,这些挑战限制了大规模筛检计画的实施,并将市场潜在覆盖范围限制在有症状患者和高风险族群之外。
市场成长主要得益于诊断影像和生物标记分析技术的快速发展,尤其是人工智慧 (AI) 和非侵入性液态生物检体的兴起。这些创新技术利用多组体学平台提高了早期恶性肿瘤的检测灵敏度,有效弥补了传统 CA-125 检测的不足。此外,机器学习演算法能够精准检测肿瘤来源的细胞外囊泡和循环神经节苷脂,最大限度地减少过去阻碍筛检成功的假阳性结果。例如,AOA Dx 在 2025 年美国癌症研究协会 (AACR) 年会上公布的数据显示,该公司基于人工智慧的液态生物检体平台在约 1000 例真实世界患者样本中实现了超过 90% 的曲线下面积(AUC)。这标誌着在识别转移前癌症方面,通讯协定正朝着可扩充性、微创的方向迈出重要一步。
此外,公共和私人对癌症研究的资金投入激增,是推动这些先进诊断工具持续开发和市场化的关键因素。政府机构和慈善组织正日益将资金集中用于高风险、高回报的研究,并专注于早期检测和提高存活率,从而降低诊断技术研发相关的风险。根据2025年1月的新闻稿,卵巢癌研究联盟在上年度津贴超过920万美元,用于推进检测和治疗方面的进展。这些资金支持着向个人化医疗的加速转型,罗氏公司2025年的报告也指出,“目前已有超过60种获得FDA核准的肿瘤伴随诊断测试”,这凸显了人们对生物标誌物主导的精准医疗日益增长的依赖。
全球卵巢癌诊断市场扩张的主要障碍在于缺乏适用于一般人群的敏感且标准化的筛检方法。与其他肿瘤亚专科已采用成熟的预防性筛检通讯协定不同,卵巢癌目前缺乏可靠的非侵入性检测方法,无法用于无症状女性。这项技术缺口导致市场活动主要局限于确诊有症状的患者,阻碍了其大规模应用于预防目的。因此,潜在市场规模受到显着限制,製造商也无法充分利用常规人群筛检计画所蕴含的高收益潜力。
这种不足与晚期诊断的高发生率直接相关,降低了人们对现有诊断工具早期疗育成本效益和临床效用。根据卵巢癌研究联盟的数据,截至2024年,仅有16%的卵巢癌病例在早期被发现。如此低的检出率凸显了现有方法(例如CA-125检测和超音波)在早期恶性肿瘤检测方面的限制。因此,保险公司和支付方仍然不愿核准这些诊断测试在普通人群中的广泛报销,进一步阻碍了商业性成长和市场渗透。
临床上对附件肿块的评估决策正经历变革,从单一标记检测转向指标检测和多变量生物标记组合检测。这些多变量指标检测(MIA)采用专有演算法,除了CA-125外,还能评估多种蛋白质,包括载脂蛋白A1和转铁蛋白,与标准免疫检测相比,在恶性肿瘤风险评估方面具有更高的特异性。这项变革满足了术前精准分诊的关键需求,确保将高风险患者适当地转介至妇科肿瘤专家,同时最大限度地减少良性病例中不必要的手术。 Aspira Women's Health于2025年3月报告称,其2024年第四季产品收入年增9.5%,这主要得益于妇科专业诊断服务的日益普及。
同时,随着次世代定序(NGS)技术在广泛基因谱分析的应用,传统的BRCA基因检测已不再局限于简单的基因检测。临床医生越来越多地利用同源重组缺陷(HRD)状态和基因组不稳定性评分来决定是否使用聚(ADP-核糖)聚合酵素(PARP)抑制剂。这种对全面分子特征分析的需求推动了高通量定序平台的应用,这些平台能够在单一流程中检测体细胞突变和种系突变,这对于制定个人化治疗方案至关重要。顺应此趋势,Myriad Genetics公司于2025年2月宣布,其2024财年营收达8.38亿美元,较前一年成长11%,这主要得益于肿瘤谱分析及遗传性癌症检测的强劲需求。
The Global Ovarian Cancer Diagnostics Market is projected to expand from USD 2.21 Billion in 2025 to USD 3.02 Billion by 2031, registering a compound annual growth rate of 5.34%. This sector comprises laboratory assays and medical procedures aimed at identifying malignant neoplasms in the ovaries, fallopian tubes, and peritoneum through methods such as genetic screening, tumor biomarker testing, and transvaginal ultrasound. A primary catalyst for this growth is the rising global incidence of gynecological cancers alongside the increasing uptake of genetic testing for BRCA mutations in high-risk groups. As reported by the American Cancer Society, an estimated 20,890 women in the United States will be diagnosed with ovarian cancer in 2025, highlighting the urgent need for precise diagnostic solutions to enable timely treatment and enhance patient outcomes.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 2.21 Billion |
| Market Size 2031 | USD 3.02 Billion |
| CAGR 2026-2031 | 5.34% |
| Fastest Growing Segment | CT Scan |
| Largest Market | North America |
Despite these positive indicators, the market confronts substantial hurdles arising from the expensive nature of genomic testing and the lack of a standardized, sensitive screening protocol for early-stage detection in the general public. Because the disease is frequently identified only after reaching advanced stages, the effectiveness of existing therapeutic options is reduced, which effectively prevents the widespread adoption of routine diagnostic screening initiatives. Consequently, these challenges limit the implementation of mass screening programs, thereby constraining the market's potential reach beyond symptomatic or high-risk populations.
Market Driver
The primary engine propelling market growth is the rapid advancement of diagnostic imaging and biomarker analysis technologies, specifically the rise of artificial intelligence (AI) and non-invasive liquid biopsy. These innovations utilize multi-omic platforms to enhance sensitivity in detecting early-stage malignancies, effectively addressing the shortcomings of conventional CA-125 testing. Furthermore, machine learning algorithms facilitate the accurate detection of tumor-derived extracellular vesicles and circulating gangliosides, minimizing false positives that have historically impeded screening success. For instance, data presented by AOA Dx at the 2025 AACR Annual Meeting revealed that their AI-driven liquid biopsy platform achieved an area under the curve (AUC) exceeding 90% across roughly 1,000 real-world patient samples, signaling a major transition toward scalable, minimally invasive protocols capable of identifying cancer before metastasis.
Additionally, the surge in public and private funding for cancer research serves as a vital catalyst, supporting the continued development and market entry of these advanced diagnostic tools. Government agencies and philanthropic groups are increasingly directing funds toward high-risk, high-reward research centered on early detection and survivorship, which helps mitigate the risks associated with diagnostic R&D. According to a January 2025 press release, the Ovarian Cancer Research Alliance awarded over $9.2 million in grants during the previous year to foster advancements in detection and treatment. This financial support underscores the growing shift toward personalized medicine, a trend further illustrated by Roche's 2025 report of over 60 FDA-approved companion diagnostic tests currently available in oncology, highlighting the sector's reliance on precision medicine driven by biomarkers.
Market Challenge
A major obstacle hindering the expansion of the Global Ovarian Cancer Diagnostics Market is the lack of a sensitive and standardized screening method suitable for detecting the disease within the general population. In contrast to other oncology sectors that utilize established preventative screening protocols, ovarian cancer does not have a dependable, non-invasive test for women who are asymptomatic. This technological gap restricts market activity primarily to confirming diagnoses in patients presenting with symptoms, rather than enabling mass adoption for preventative purposes. As a result, the total addressable market is notably constrained, preventing manufacturers from tapping into the high-volume revenue potential inherent in routine, population-based screening programs.
This deficiency is directly linked to the high prevalence of late-stage diagnoses, which diminishes the perceived cost-effectiveness and clinical utility of current diagnostic instruments for early intervention. Data from the Ovarian Cancer Research Alliance indicates that in 2024, merely 16% of ovarian cancer cases were identified during the early stages. This low detection rate highlights the limitations of existing modalities, such as CA-125 testing and transvaginal ultrasound, in spotting early-onset malignancies. Consequently, insurers and healthcare payers remain reluctant to authorize widespread reimbursement for these diagnostics across the general public, further inhibiting commercial growth and market penetration.
Market Trends
Clinical decision-making regarding adnexal mass evaluation is being transformed by the shift from single-marker tests to index assays and multi-parametric biomarker panels. These Multivariate Index Assays (MIAs) employ proprietary algorithms to evaluate multiple proteins, including apolipoprotein A1 and transferrin alongside CA-125, providing enhanced specificity for assessing malignancy risk compared to standard immunoassays. This evolution meets the critical demand for precise pre-surgical triage, ensuring high-risk patients are correctly referred to gynecologic oncologists while minimizing unnecessary surgeries for benign cases. As reported by Aspira Women's Health in March 2025, the company saw a 9.5% year-over-year increase in product revenue for the fourth quarter of 2024, attributed to the growing uptake of its specialized gynecologic diagnostic offerings.
Concurrently, the integration of Next-Generation Sequencing (NGS) for extensive genetic profiling is pushing the standard of care beyond simple BRCA testing. Clinicians are increasingly utilizing Homologous Recombination Deficiency (HRD) status and genomic instability scores to guide the prescription of poly (ADP-ribose) polymerase (PARP) inhibitors. This requirement for comprehensive molecular characterization is fueling the adoption of high-throughput sequencing platforms that can detect both somatic and germline mutations within a single workflow, which is vital for personalized treatment plans. Highlighting this trend, Myriad Genetics announced in February 2025 that it achieved an 11% year-over-year revenue growth for the full year 2024, totaling $838 million, driven by strong volumes in its tumor profiling and hereditary cancer testing segments.
Report Scope
In this report, the Global Ovarian Cancer 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 Ovarian Cancer Diagnostics Market.
Global Ovarian Cancer 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: