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市場調查報告書
商品編碼
1914661
卵巢癌診斷市場-全球產業規模、佔有率、趨勢、機會及預測(按診斷類型、癌症類型、最終用戶、地區和競爭格局分類,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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全球卵巢癌診斷市場預計將從2025年的22.1億美元成長到2031年的30.2億美元,複合年成長率(CAGR)為5.34%。該市場涵蓋旨在透過基因篩檢、腫瘤生物標記檢測和超音波等技術識別卵巢、輸卵管和腹膜惡性腫瘤的各項檢測和醫療程序。這一成長主要受全球婦科癌症發生率上升以及高風險族群BRCA基因突變檢測普及率提高的推動。根據美國癌症協會(ACS)報告,預計2025年美國將有20,890名女性被診斷出患有卵巢癌,這凸顯了精準診斷解決方案對於及時治療和改善患者預後的迫切需求。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 22.1億美元 |
| 市場規模:2031年 | 30.2億美元 |
| 複合年成長率:2026-2031年 | 5.34% |
| 成長最快的細分市場 | 電腦斷層掃描 |
| 最大的市場 | 北美洲 |
儘管有這些正面跡象,但基因組檢測成本高昂,且缺乏針對一般人群早期篩檢的標準化、高靈敏度篩檢通訊協定,這給市場帶來了許多挑戰。疾病往往在發展到晚期才被發現,降低了現有治療方案的有效性,並有效阻礙了常規診斷篩檢措施的廣泛應用。因此,這些挑戰限制了大規模篩檢計畫的實施,並將市場潛在覆蓋範圍限制在有症狀患者和高風險族群之外。
市場成長主要得益於診斷影像和生物標記分析技術的快速發展,尤其是人工智慧 (AI) 和非侵入性液態生物檢體的興起。這些創新技術利用多組體學平台提高了早期惡性腫瘤的檢測靈敏度,有效彌補了傳統 CA-125 檢測的不足。此外,機器學習演算法能夠精準檢測腫瘤來源的細胞外囊泡和循環神經節苷脂,最大限度地減少過去阻礙篩檢成功的假陽性結果。例如,AOA Dx 在 2025 年美國癌症研究協會 (AACR) 年會上公佈的數據顯示,該公司基於人工智慧的液態生物檢體平台在約 1000 例真實世界患者樣本中實現了超過 90% 的曲線下面積(AUC)。這標誌著在識別轉移前癌症方面,通訊協定正朝著可擴充性、微創的方向邁出重要一步。
此外,公共和私人對癌症研究的資金投入激增,是推動這些先進診斷工具持續開發和市場化的關鍵因素。政府機構和慈善組織正日益將資金集中用於高風險、高回報的研究,並專注於早期檢測和提高存活率,從而降低診斷技術研發相關的風險。根據2025年1月的新聞稿,卵巢癌研究聯盟在上年度津貼超過920萬美元,用於推進檢測和治療方面的進展。這些資金支持著向個人化醫療的加速轉型,羅氏公司2025年的報告也指出,“目前已有超過60種獲得FDA核准的腫瘤伴隨診斷測試”,這凸顯了人們對生物標記主導的精準醫療日益成長的依賴。
全球卵巢癌診斷市場擴張的主要障礙在於缺乏適用於一般人群的敏感且標準化的篩檢方法。與其他腫瘤亞專科已採用成熟的預防性篩檢通訊協定不同,卵巢癌目前缺乏可靠的非侵入性檢測方法,無法用於無症狀女性。這項技術缺口導致市場活動主要局限於確診有症狀的患者,阻礙了其大規模應用於預防目的。因此,潛在市場規模受到顯著限制,製造商也無法充分利用常規人群篩檢計畫所蘊含的高收益潛力。
這種不足與晚期診斷的高發生率直接相關,降低了人們對現有診斷工具早期療育成本效益和臨床效用。根據卵巢癌研究聯盟的數據,截至2024年,僅有16%的卵巢癌病例在早期被發現。如此低的檢出率凸顯了現有方法(例如CA-125檢測和超音波)在早期惡性腫瘤檢測方面的限制。因此,保險公司和支付方仍然不願核准這些診斷測試在普通人群中的廣泛報銷,進一步阻礙了商業性成長和市場滲透。
臨床上對附件腫塊的評估決策正經歷變革,從單一標記檢測轉向指標檢測和多變量生物標記組合檢測。這些多變量指標檢測(MIA)採用專有演算法,除了CA-125外,還能評估多種蛋白質,包括載脂蛋白A1和轉鐵蛋白,與標準免疫檢測相比,在惡性腫瘤風險評估方面具有更高的特異性。這項變革滿足了術前精準分診的關鍵需求,確保將高風險患者適當地轉介至婦科腫瘤專家,同時最大限度地減少良性病例中不必要的手術。 Aspira Women's Health於2025年3月報告稱,其2024年第四季產品收入年增9.5%,這主要得益於婦科專業診斷服務的日益普及。
同時,隨著次世代定序(NGS)技術在廣泛基因譜分析的應用,傳統的BRCA基因檢測已不再侷限於簡單的基因檢測。臨床醫生擴大利用同源重組缺陷(HRD)狀態和基因組不穩定性評分來決定是否使用聚(ADP-核糖)聚合酵素(PARP)抑制劑。這種對全面分子特徵分析的需求推動了高通量定序平台的應用,這些平台能夠在單一流程中檢測體細胞突變和種系突變,這對於制定個人化治療方案至關重要。順應此趨勢,Myriad Genetics公司於2025年2月宣布,其2024會計年度營收達8.38億美元,較前一年成長11%,這主要得益於腫瘤譜分析及遺傳性癌症檢測的強勁需求。
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: