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市场调查报告书
商品编码
1951225
切片检查器材市场 - 全球产业规模、份额、趋势、机会及预测(按产品类型、疾病类型、解剖部位、引导技术、地区和竞争格局划分,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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全球切片检查设备市场预计将从 2025 年的 66.9 亿美元成长到 2031 年的 99.2 亿美元,复合年增长率为 6.79%。
这些设备是取得组织样本进行病理分析和疾病监测的重要医疗设备,在肿瘤学领域发挥关键作用,可透过细针穿刺等微创技术确诊恶性肿瘤。市场成长的主要驱动力是全球癌症发病率的不断上升以及临床上对能够最大限度缩短患者康復时间的诊断方法的日益重视。根据美国癌症协会 (ACS) 的数据,预计到 2025 年,美国将新增约 2,041,910 例癌症病例,日益加重的疾病负担需要频繁的诊断程序,从而推动了对先进切片检查解决方案的需求。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 66.9亿美元 |
| 市场规模:2031年 | 99.2亿美元 |
| 复合年增长率:2026-2031年 | 6.79% |
| 成长最快的细分市场 | 胸部 |
| 最大的市场 | 北美洲 |
然而,由于严格的法规结构,该行业面临许多重大障碍。製造商必须遵守复杂的合规标准,这往往会延缓先进创新技术的商业化。此外,自动化切片检查系统的高成本也阻碍了其在医疗资源匮乏地区的普及。这些监管方面的复杂性,加上经济壁垒,构成了可能阻碍全球切片检查设备市场永续发展的重大挑战。
全球癌症发生率的不断上升是切片检查设备市场的主要驱动力,显着增加了确诊和分期疾病所需的诊断干预次数。随着恶性肿瘤趋势的变化以及某些人群检出率的提高,医疗机构不得不更频繁地进行组织取样,以便及时做出治疗决策。这种需求在年轻族群中尤为突出,因为他们的疾病负担增长速度远超同龄人。根据美国癌症协会 (ACS) 2025 年 1 月发布的报告,50 岁以下女性的癌症发生率比同龄男性高出 82%,这确保了工作年龄人口对可靠切片检查工具的临床需求将持续增长。
同时,影像引导和机器人辅助切片检查系统的技术创新正在改变市场格局。这些系统在获取复杂病灶方面提供了无与伦比的精确度。机器人技术在切片检查手术中的应用,透过减少患者不适和提高诊断准确性,加速了从传统开放性手术到机器人辅助手术的转变。 2025年1月,Intuitive Surgical公司报告称,其Ion系统在2024年第四季的手术量年增近70%,凸显了市场对这些技术的强劲接受度。此外,Merit Medical Systems公司于2025年1月宣布,其2024年初步销售额已达到约13.6亿美元,证实了商业性对这些关键介入和诊断解决方案的强劲需求。
全球切片检查设备市场面临许多挑战,其中最主要的障碍在于医疗技术核准和商业化的法规结构日益严格。製造商必须应对日益复杂的合规标准,这需要进行严格且耗时的合格评定。这迫使企业投入大量资源用于临床资料产生和安全文件编制。这种监管环境造成了严重的瓶颈,导致产品开发和临床应用之间存在时间差,从而阻碍了市场成长,最终减缓了及时诊断疾病所需的创新切片检查工具的普及。
这些延误对产业的影响是严重且可衡量的。 2025 年,《欧洲医疗技术》杂誌报告称,医疗设备技术文件审查的平均时间约为 22 个月。如此漫长的审查时间会造成营运不确定性,并扰乱供应链,尤其对于需要重新认证的现有器械而言更是如此。因此,这些监管障碍限制了市场的即时扩张,并阻碍了医疗服务提供者获得应对日益严重的癌症负担所需的最新诊断技术。
随着医疗机构越来越重视感染控制和营运效率,一次性切片检查器械的普及正在从根本上改变筹资策略。与需要耗费成本和时间进行再处理的可重复使用器械不同,一次性器械降低了交叉感染的风险,并简化了手术流程。这种转变在内镜切片检查中尤其明显,因为无菌操作至关重要。专注于一次性技术的製造商的快速成长也印证了市场向无菌解决方案的转变。例如,Amb公司在2024年11月报告称,其内视镜解决方案业务全年实现了19.7%的有机收入成长,凸显了全球对无菌介入器材日益增长的需求。
同时,3D断层合成技术在乳房切片引导的应用,正在为女性健康领域的诊断准确性树立新的标竿。与传统的2D影像相比,这项技术能够为放射科医师提供更清晰的组织层影像,显着提高复杂钙化病灶和取样过程中病灶标靶化的准确性。断层合成引导系统的高精度,最大限度地减少了重复切片检查的需求,并有助于更早发现緻密乳房组织中的恶性肿瘤。这一趋势正在推动显着的商业活动,Hologic公司截至2024年11月的财年数据便印证了这一点:该公司乳腺健康部门的收入增长了6.4%,这有力地反映了其介入和诊断成像产品组合的市场渗透率。
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: