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市場調查報告書
商品編碼
1951225
切片檢查器材市場 - 全球產業規模、佔有率、趨勢、機會及預測(按產品類型、疾病類型、解剖部位、引導技術、地區和競爭格局分類,2021-2031年)Biopsy Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type, By Disease Type, By Anatomy, By Guidance Technique, By Region & Competition, 2021-2031F |
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全球切片檢查設備市場預計將從 2025 年的 66.9 億美元成長到 2031 年的 99.2 億美元,複合年成長率為 6.79%。
這些設備是取得組織樣本進行病理分析和疾病監測的重要醫療設備,在腫瘤學領域發揮關鍵作用,可透過細針穿刺等微創技術確診惡性腫瘤。市場成長的主要驅動力是全球癌症發病率的不斷上升以及臨床上對能夠最大限度縮短患者康復時間的診斷方法的日益重視。根據美國癌症協會 (ACS) 的數據,預計到 2025 年,美國將新增約 2,041,910 例癌症病例,日益加重的疾病負擔需要頻繁的診斷程序,從而推動了對先進切片檢查解決方案的需求。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 66.9億美元 |
| 市場規模:2031年 | 99.2億美元 |
| 複合年成長率:2026-2031年 | 6.79% |
| 成長最快的細分市場 | 胸部 |
| 最大的市場 | 北美洲 |
然而,由於嚴格的法規結構,該行業面臨許多重大障礙。製造商必須遵守複雜的合規標準,這往往會延緩先進創新技術的商業化。此外,自動化切片檢查系統的高成本也阻礙了其在醫療資源匱乏地區的普及。這些監管方面的複雜性,加上經濟壁壘,構成了可能阻礙全球切片檢查設備市場永續發展的重大挑戰。
全球癌症發生率的不斷上升是切片檢查設備市場的主要驅動力,顯著增加了確診和分期疾病所需的診斷干預次數。隨著惡性腫瘤趨勢的變化以及某些人群檢出率的提高,醫療機構不得不更頻繁地進行組織取樣,以便及時做出治療決策。這種需求在年輕族群中尤為突出,因為他們的疾病負擔成長速度遠超同齡人。根據美國癌症協會 (ACS) 2025 年 1 月發布的報告,50 歲以下女性的癌症發生率比同齡男性高出 82%,這確保了工作年齡人口對可靠切片檢查工具的臨床需求將持續成長。
同時,影像引導和機器人輔助切片檢查系統的技術創新正在改變市場格局。這些系統在獲取複雜病灶方面提供了無與倫比的精確度。機器人技術在切片檢查手術中的應用,透過減少患者不適和提高診斷準確性,加速了從傳統開放性手術到機器人輔助手術的轉變。 2025年1月,Intuitive Surgical公司報告稱,其Ion系統在2024年第四季的手術量年增近70%,凸顯了市場對這些技術的強勁接受度。此外,Merit Medical Systems公司於2025年1月宣布,其2024年初步銷售額已達到約13.6億美元,證實了商業性對這些關鍵介入和診斷解決方案的強勁需求。
全球切片檢查設備市場面臨許多挑戰,其中最主要的障礙在於醫療技術核准和商業化的法規結構日益嚴格。製造商必須應對日益複雜的合規標準,這需要進行嚴格且耗時的合格評定。這迫使企業投入大量資源用於臨床資料產生和安全文件編制。這種監管環境造成了嚴重的瓶頸,導致產品開發和臨床應用之間存在時間差,從而阻礙了市場成長,最終減緩了及時診斷疾病所需的創新切片檢查工具的普及。
這些延誤對產業的影響是嚴重且可衡量的。 2025 年,《歐洲醫療技術》雜誌報告稱,醫療設備技術文件審查的平均時間約為 22 個月。如此漫長的審查時間會造成營運不確定性,並擾亂供應鏈,尤其對於需要重新認證的現有器械而言更是如此。因此,這些監管障礙限制了市場的即時擴張,並阻礙了醫療服務提供者獲得應對日益嚴重的癌症負擔所需的最新診斷技術。
隨著醫療機構越來越重視感染控制和營運效率,一次性切片檢查器械的普及正在從根本上改變籌資策略。與需要耗費成本和時間進行再處理的可重複使用器械不同,一次性器械降低了交叉感染的風險,並簡化了手術流程。這種轉變在內鏡切片檢查中尤其明顯,因為無菌操作至關重要。專注於一次性技術的製造商的快速成長也印證了市場向無菌解決方案的轉變。例如,Amb公司在2024年11月報告稱,其內視鏡解決方案業務全年實現了19.7%的有機收入成長,凸顯了全球對無菌介入器材日益成長的需求。
同時,3D斷層合成技術在乳房切片引導的應用,正在為女性健康領域的診斷準確性樹立新的標竿。與傳統的2D影像相比,這項技術能夠為放射科醫師提供更清晰的組織層影像,顯著提高複雜鈣化病灶和取樣過程中病灶標靶化的準確性。斷層合成引導系統的高精度,最大限度地減少了重複切片檢查的需求,並有助於更早發現緻密乳房組織中的惡性腫瘤。這一趨勢正在推動顯著的商業活動,Hologic公司截至2024年11月的會計年度數據便印證了這一點:該公司乳腺健康部門的收入成長了6.4%,這有力地反映了其介入和診斷成像產品組合的市場滲透率。
The Global Biopsy Devices Market is anticipated to expand from a valuation of USD 6.69 Billion in 2025 to USD 9.92 Billion by 2031, reflecting a CAGR of 6.79%. These devices serve as essential medical instruments for extracting tissue samples utilized in pathological analysis and disease surveillance, playing a crucial role in oncology for confirming malignancies via minimally invasive techniques like fine needle aspiration. Market growth is largely underpinned by the escalating global prevalence of cancer and a rising clinical inclination toward diagnostic approaches that minimize patient recovery duration. Data from the American Cancer Society indicates that in 2025, approximately 2,041,910 new cancer cases were projected in the United States, a growing disease burden that necessitates frequent diagnostic procedures and bolsters demand for sophisticated biopsy solutions.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 6.69 Billion |
| Market Size 2031 | USD 9.92 Billion |
| CAGR 2026-2031 | 6.79% |
| Fastest Growing Segment | Breast |
| Largest Market | North America |
However, the industry faces substantial hurdles stemming from rigorous regulatory frameworks. Manufacturers are required to adhere to intricate compliance standards, which often prolong the commercial release of advanced innovations. Furthermore, the high costs linked to automated biopsy systems hinder their adoption in regions with limited healthcare funding. Together, these regulatory complexities and economic barriers constitute significant challenges that may impede the sustained growth of the global biopsy devices market.
Market Driver
The rising global incidence of cancer serves as the principal driver for the biopsy devices market, significantly increasing the volume of diagnostic interventions needed for disease confirmation and staging. As malignancy trends evolve and detection rates increase within specific population segments, healthcare providers are compelled to perform more frequent tissue sampling to facilitate timely treatment decisions, a necessity particularly visible in younger demographics where disease burden is unexpectedly rising. According to the American Cancer Society's January 2025 report, cancer incidence rates among women under 50 were found to be 82% higher than in their male counterparts, ensuring a continuous and growing clinical demand for reliable biopsy tools among working-age populations.
Concurrently, the market is being transformed by technological advancements in image-guided and robotic biopsy systems, which offer unmatched precision for accessing challenging lesions. The incorporation of robotics into biopsy procedures reduces patient trauma and enhances diagnostic outcomes, accelerating the transition away from conventional open surgical techniques. Intuitive Surgical reported in January 2025 that Ion procedure volumes surged by approximately 70% in the fourth quarter of 2024 compared to the previous year, highlighting the enthusiastic market adoption of these technologies. Additionally, Merit Medical Systems reported preliminary 2024 revenue of roughly $1.36 billion in January 2025, further evidencing the robust commercial demand for these essential interventional and diagnostic solutions.
Market Challenge
The global biopsy devices market confronts significant obstacles arising from strict regulatory frameworks regarding the approval and commercialization of medical technologies. Manufacturers are required to navigate increasingly intricate compliance standards, necessitating rigorous and extended conformity assessments that force companies to dedicate substantial resources to clinical data generation and safety documentation. This regulatory landscape creates a considerable bottleneck, hampering market growth by creating a delay between product development and clinical accessibility, which effectively slows the introduction of innovative biopsy tools needed for timely disease diagnosis.
The consequences of these delays are both severe and measurable for the industry. In 2025, MedTech Europe reported that the average duration for the Technical Documentation Assessment of medical devices was approximately 22 months. Such prolonged review periods introduce operational uncertainty and disrupt supply chains, especially for legacy devices that require recertification. As a result, these regulatory barriers limit the immediate expansion of the market, preventing healthcare providers from accessing the latest diagnostic technologies required to manage the increasing cancer burden.
Market Trends
The widespread adoption of single-use and disposable biopsy devices is fundamentally transforming procurement strategies as healthcare facilities place greater emphasis on infection control and operational efficiency. Unlike reusable instruments, which demand expensive and time-intensive reprocessing, disposable options mitigate cross-contamination risks and streamline procedural workflows, a shift that is especially notable in endoscopy-based biopsies where sterility is critical. The market's transition toward these sterile solutions is demonstrated by the rapid growth of manufacturers focusing on single-use technologies; for instance, Ambu reported in November 2024 that its Endoscopy Solutions business achieved 19.7% organic revenue growth for the full year, highlighting the accelerating global demand for sterile interventional tools.
In parallel, the integration of 3D tomosynthesis for breast biopsy guidance is setting new benchmarks for diagnostic precision within women's health. This technology offers radiologists superior visualization of tissue layers compared to conventional 2D imaging, significantly enhancing the targeting of complex calcifications and lesions during sampling. The improved accuracy of tomosynthesis-guided systems minimizes the necessity for re-biopsies and aids in the early detection of malignancies in dense breast tissue. This trend is driving significant commercial activity, as evidenced by Hologic's November 2024 financial results, which showed a 6.4% revenue increase in its Breast Health division, reflecting strong market uptake of its interventional and imaging portfolio.
Report Scope
In this report, the Global Biopsy 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 Biopsy Devices Market.
Global Biopsy 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: