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市場調查報告書
商品編碼
1959912
乳癌液態生物檢體設備市場 - 全球產業規模、佔有率、趨勢、機會、預測:產品、循環生物標記、應用、區域及競爭格局,2021-2031年Breast Cancer Liquid Biopsy Testing Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Offerings, By Circulating Biomarker, By Application, By Region & Competition, 2021-2031F |
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全球乳癌液態生物檢體設備市場預計將從 2025 年的 8.9536 億美元大幅成長至 2031 年的 23.4546 億美元,複合年成長率達 17.41%。
這些設備,包括診斷平台和檢測試劑盒,旨在從血液樣本中分離和分析循環性腫瘤細胞(CTC) 或循環腫瘤 DNA (ctDNA),用於腫瘤學評估。這一成長趨勢主要受乳癌發病率上升以及臨床上對頻繁、非侵入性監測以檢測治療抗藥性的需求所驅動。此外,精準醫療的興起也推動了該行業的發展,精準醫療需要進行詳細的基因組分析,但又避免了重複組織切片檢查帶來的固有風險。美國癌症協會估計,到 2025 年,美國將有約 316,950 名女性被診斷出患有侵襲性乳癌,這凸顯了可擴展診斷解決方案的緊迫性。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 8.9536億美元 |
| 市場規模:2031年 | 2,345,460,000 美元 |
| 複合年成長率:2026-2031年 | 17.41% |
| 成長最快的細分市場 | 循環腫瘤DNA |
| 最大的市場 | 北美洲 |
阻礙該市場廣泛擴張的主要挑戰之一是缺乏標準化的報銷政策以及次世代定序檢測的高成本。不同醫療體系間保險覆蓋範圍的不統一,也造成了病人取得這些分子診斷工具經濟障礙。此外,檢測靈敏度的差異以及獲得監管部門核准所需的大量臨床檢驗數據,持續減緩新參與企業進入市場的步伐,阻礙了商業性應用的快速發展。
全球乳癌發生率和盛行率的不斷上升是推動可擴展液態生物檢體解決方案需求成長的根本原因。隨著全球疾病負擔的加重,醫療衛生系統正優先考慮能夠提供頻繁基因組分析的非侵入性工具,以避免組織取樣帶來的繁瑣的後勤和臨床操作。不斷成長的患者群體需要高通量篩檢和監測能力,而分子診斷技術才能在全球範圍內有效地實現這一目標。根據世界衛生組織(WHO)於2025年8月發布的乳癌關鍵數據,2022年全球約有230萬女性被診斷出罹患乳癌,顯示先進診斷干預措施擁有巨大的市場潛力。
同時,次世代定序(NGS) 和數位 PCR 技術的進步正在消除技術准入壁壘,加速商業性化應用。這些創新顯著提高了檢測靈敏度,能夠精準檢測先前無法檢測到的低頻循環腫瘤 DNA 突變,展現了液態生物檢體在治療方案選擇和復發監測方面的臨床效用。這種技術成熟度直接體現在臨床偵測量的激增上。根據 Natera 公司於 2025 年 2 月發布的《2024 年第四季及全年財務業績報告》,該公司僅在第四季度就處理了約 15.1 萬例腫瘤檢測,年增 55%。這種快速普及表明,市場整體趨勢是經濟效益和臨床療效的雙重提升。 Gardant Health 公司報告稱,其 2025 年第三季腫瘤相關收入成長至 1.844 億美元,凸顯了基於血液的癌症診斷業務的盈利成長。
缺乏標準化的報銷政策以及次世代定序檢測的高成本是全球乳癌液態生物檢體)檢測設備市場擴張的主要障礙。保險公司通常將這些先進的分子檢測歸類為研究階段檢測而非醫療必要檢測,導致不同醫療區域的覆蓋範圍分散,支付模式也難以預測。這種財務上的不確定性使得臨床醫生不願開立液態生物檢體處方,因為他們無法保證病人不會承擔沉重的經濟負擔。因此,臨床檢查室難以證明對這些診斷平台進行必要資本投資的合理性,從而有效地減緩了市場擴張所需的企業發展勢頭。
這些經濟障礙直接限制了患者獲得精準醫療的機會,並縮小了醫療器材製造商的潛在市場。當第三方支付方拒絕收費或收取高額自付費用時,患者往往會放棄一些對制定治療方案或監測復發至關重要的檢查。根據美國癌症協會發布的《2025年癌症網路報告》,超過70%的私人保險患者需要自費進行乳癌後續診斷檢查。這種經濟負擔迫使患者選擇費用較低的侵入性替代方法,或乾脆推遲檢查,最終導致該領域商業性成長和技術創新所需的檢查數量減少。
微量殘存疾病(MRD)監測的廣泛應用正在改變臨床通訊協定,使醫生能夠比影像學復發更早檢測到微小的腫瘤碎片。這一趨勢解決了術後後續觀察的一項重大挑戰,即傳統影像學檢查往往無法識別潛在的轉移病灶,直到病情發展到臨床晚期。透過利用基於腫瘤的檢測方法,臨床醫生可以根據患者的即時復發風險進行分層,從而實現及時的治療性介入。在2025年12月Exact Sciences、NSABP基金會和德國乳癌研究小組共同發布的新聞稿中,發表了NSABP B-59子研究的結果。研究表明,早期三陰性乳癌患者術後MRD陽性會使遠端復發的風險比MRD陰性患者高出約30倍。
同時,人工智慧在生物標記發現領域的應用,正透過解讀複雜的基因組資料集來辨識新的治療靶點,從而重塑競爭格局。市場參與者日益利用機器學習演算法分析大量的臨床和分子數據,從而提高液態生物檢體檢測的靈敏度,並使大規模精準腫瘤學得以實現。隨著醫療機構採用這些人工智慧增強型平台進行更精準的分析,這種技術融合正在推動顯著的商業性成長。根據Tempus AI於2025年8月發布的報告《Tempus AI:2025年第二季財報》,該公司第二季的腫瘤檢測收入達1.332億美元,較去年同期成長32.9%。這凸顯了市場對人工智慧驅動的診斷解決方案日益成長的需求。
The Global Breast Cancer Liquid Biopsy Testing Devices Market is projected to expand significantly, rising from USD 895.36 Million in 2025 to USD 2345.46 Million by 2031, reflecting a CAGR of 17.41%. These devices, which include diagnostic platforms and assay kits, are engineered to isolate and analyze circulating tumor cells or circulating tumor DNA from blood samples for oncological evaluation. This growth trajectory is chiefly propelled by the rising incidence of breast carcinomas combined with the clinical necessity for frequent, non-invasive monitoring to detect treatment resistance. Additionally, the industry is buoyed by the transition toward precision medicine, which demands detailed genomic profiling without the inherent risks of repeated tissue biopsies. Highlighting the urgency for scalable diagnostic solutions, the American Cancer Society estimates that approximately 316,950 women in the United States will be diagnosed with invasive breast cancer in 2025.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 895.36 Million |
| Market Size 2031 | USD 2345.46 Million |
| CAGR 2026-2031 | 17.41% |
| Fastest Growing Segment | Circulating Tumor DNA |
| Largest Market | North America |
One significant challenge hampering the widespread expansion of this market is the lack of standardized reimbursement policies and the high cost associated with next-generation sequencing assays. Inconsistent coverage across different healthcare systems creates financial barriers that limit patient access to these molecular diagnostic tools. Furthermore, the variability in assay sensitivity and the requirement for substantial clinical validation data to secure regulatory approval continue to delay market entry for new entrants, thereby impeding rapid commercial adoption.
Market Driver
The Rising Global Incidence and Prevalence of Breast Cancer constitutes the foundational driver propelling the demand for scalable liquid biopsy solutions. As the burden of disease intensifies worldwide, healthcare systems are increasingly prioritizing non-invasive tools that can provide frequent genomic profiling without the logistical and clinical complications of tissue extraction. This escalating patient population necessitates high-throughput screening and monitoring capabilities that only molecular diagnostics can efficiently sustain on a global scale. According to the World Health Organization, August 2025, in the 'Breast cancer' key facts, there were an estimated 2.3 million women diagnosed with breast cancer globally in 2022, highlighting the massive addressable market for advanced diagnostic interventions.
Simultaneously, Advancements in Next-Generation Sequencing (NGS) and Digital PCR Technologies are removing technical barriers to entry and accelerating commercial adoption. These technological innovations have significantly enhanced the sensitivity of assays, allowing for the precise detection of low-frequency circulating tumor DNA mutations that were previously undetectable, thereby validating the clinical utility of liquid biopsies for treatment selection and recurrence monitoring. This technical maturation is directly reflected in the surging volume of clinical testing. According to Natera, Inc., February 2025, in the 'Fourth Quarter and Full Year 2024 Financial Results', the company processed approximately 151,000 oncology tests in the fourth quarter alone, representing a 55% increase year-over-year. This rapid uptake is indicative of a broader market trend where financial viability is improving alongside clinical efficacy; According to Guardant Health, in 2025, the company reported that its oncology revenue grew to $184.4 million in the third quarter, underscoring the lucrative expansion of blood-based cancer diagnostics.
Market Challenge
The lack of standardized reimbursement policies and the high costs associated with next-generation sequencing assays present a formidable barrier to the expansion of the Global Breast Cancer Liquid Biopsy Testing Devices Market. Insurers frequently classify these advanced molecular tests as investigational rather than medically necessary, resulting in fragmented coverage and unpredictable payment models across different healthcare regions. This financial ambiguity discourages clinicians from prescribing liquid biopsies, as they cannot ensure that patients will be insulated from significant expenses. Consequently, clinical laboratories face difficulties in justifying the capital investment required for these diagnostic platforms, effectively slowing the operational momentum needed for market expansion.
These economic hurdles directly restrict patient access to precision medicine, narrowing the addressable market for device manufacturers. When third-party payers deny claims or impose high deductibles, patients often decline testing despite its potential to guide therapy or monitor recurrence. According to the American Cancer Society Cancer Action Network, in 2025, a report indicated that over 70% of commercially-insured patients encountered out-of-pocket expenses for follow-up breast cancer diagnostic tests. This financial toxicity forces patients to opt for less expensive, invasive alternatives or delay testing entirely, thereby reducing the testing volume necessary to drive commercial growth and technological innovation in the sector.
Market Trends
The Rising Adoption of Minimal Residual Disease (MRD) Monitoring is transforming clinical protocols by enabling the detection of microscopic tumor fragments long before radiological recurrence. This trend addresses the critical gap in post-surgical surveillance, where traditional imaging often fails to identify occult metastases until they are clinically advanced. By utilizing tumor-informed assays, clinicians can now stratify patients based on their real-time recurrence risk, allowing for timely therapeutic intervention. According to Exact Sciences, December 2025, in the 'Exact Sciences, the NSABP Foundation, and the German Breast Group Present Results for the Oncodetect(R) MRD Test' press release, results from the NSABP B-59 substudy demonstrated that post-surgery MRD-positive status in early triple-negative breast cancer patients was associated with an approximate 30-fold higher risk of distant recurrence compared to MRD-negative patients.
Concurrently, the Integration of Artificial Intelligence for Enhanced Biomarker Discovery is reshaping the competitive landscape by decoding complex genomic datasets to identify novel therapeutic targets. Market players are increasingly leveraging machine learning algorithms to analyze vast amounts of clinical and molecular data, thereby improving the sensitivity of liquid biopsy panels and operationalizing precision oncology at scale. This technological convergence is driving substantial commercial growth as providers adopt these AI-enhanced platforms for more accurate profiling. According to Tempus AI, August 2025, in the 'Tempus AI: Q2 2025 Earnings' report, the company's oncology testing revenue reached $133.2 million in the second quarter, marking a 32.9% increase year-over-year, which validates the accelerating market demand for AI-driven diagnostic solutions.
Report Scope
In this report, the Global Breast Cancer Liquid Biopsy Testing Devices 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 Breast Cancer Liquid Biopsy Testing Devices Market.
Global Breast Cancer Liquid Biopsy Testing Devices 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: