全球胶囊内视镜市场：市场规模、份额和趋势分析（2025-2032 年）

2025年全球胶囊内视镜市场价值超过4.87亿美元。预计到2031年，该市场将达到6.23亿美元，年复合成长率为3.6%。

本报告涵盖用于胃肠道诊断程序的胶囊内视镜设备和资料记录器。报告量化了销售量、平均售价、市场价值、成长率和企业市场占有率。此外，报告还分析了市场驱动因素和限制因素、近期併购、召回事件和技术趋势。报告提供截至2021年的历史数据，并预测至2031年。

这反映了医疗系统如何将胶囊内视镜技术融入小肠、食道和结肠的各种诊断流程。这项技术不仅因其能够取代某些传统手术而受到评估，还因其在提高患者舒适度、扩大筛检覆盖范围和改善疾病早期发现方面的作用而受到关注。

市场概览

胶囊内视镜技术使医生能够利用可吞嚥的摄影胶囊观察胃肠道，可将数千张影像无线传输至外部记录仪。此技术属于非侵入性检查，患者只需极少的准备工作，即可获得传统内视镜通常无法触及的部位的放大影像。

预计到2025年，胶囊内视镜将占据全球市场的大部分份额。其成长主要得益于临床应用的不断扩大、医保覆盖范围的扩大以及影像解析度和电池续航能力的持续提升。胶囊内视镜已从最初用于诊断不明原因消化道出血的小众工具，发展成为小肠评估、发炎性肠道疾病（IBD）和疑似克隆氏症的主流诊断工具。

预计在预测期内，食道和结肠领域应用范围的扩大将进一步推动市场需求。正在进行的临床试验表明，这些领域具有强大的诊断优势，尤其是在将胶囊平台与磁性控制系统整合以实现部分导航引导时。同时，对机器人驱动和基于人工智慧的病变检测的研究正在为下一代完全可控的半自动诊断胶囊奠定基础。

• 儘管胶囊内视镜目前仍主要用于诊断，但随着製造商持续投资克服两大技术瓶颈——对胶囊运动的控制有限以及无法进行治疗性介入——市场前景依然光明。为解决这些问题，目前的研究方向包括外部磁力转向、可变影格速率摄影机以及能够进行组织取样和标靶治疗的繫绳式胶囊原型。

医疗机构报告称，胶囊内视镜检查比传统内视镜检查更舒适，所需资源更少。传统内视镜检查需要镇静、专门的设施和恢復时间。简化的工作流程符合门诊病人和日间护理的发展趋势，使医院能够将胃肠道诊断扩展到非急性护理环境和家庭监测项目。

人口老化、胃肠道疾病盛行率上升以及人们对非侵入性诊断方案的日益关注，进一步推动了市场的发展势头。随着胶囊内视镜系统的影像品质、人工智慧辅助分析和资料整合能力的不断提升，预计其在已开发经济体和新兴经济体的医疗保健市场中的应用将不断增长。

市场驱动因素

最低限度的培训

医生只需接受少量额外训练即可进行胶囊内视镜检查。其核心技能与传统内视镜检查基本相同，尤其是在影像判读方面。学习曲线主要集中在操作胶囊设备以及用于影像检视和记录的配套软体平台。这种简单性使其易于在医院和门诊机构快速推广，并支援在专科医生资源有限的胃肠病学网路中部署。

患者的偏好和舒适度

患者接受度是胶囊内视镜市场的关键驱动因素。作为一种非侵入性检查，胶囊内视镜插入、镇静和充气过程均不会引起不适。此检查通常可在患者的日常生活中完成，从而减轻焦虑并提高后续检查的依从性。在大规模筛检计画中，尤其是在小肠和早期大肠疾病的筛检中，患者的舒适度是决定参与率的关键因素。

扩大报销范围

优惠的报销政策正在扩大全球范围内的医疗服务覆盖范围。在许多地区，如果传统内视镜检查结果不明确，胶囊内视镜检查已纳入健保报销范围，用于小肠检查。专业胃肠病学会的持续倡议促成了食道和结肠胶囊内视镜检查的医保报销，这有望进一步扩大公立和私立医疗体系的医疗服务覆盖范围。

技术进步

相机解析度、电池续航时间和无线资料传输技术的进步显着提高了诊断准确率。能够识别出血、溃疡和息肉等异常情况的人工智慧软体缩短了阅片时间，并降低了阅片者之间的差异。同时，磁导航系统和机器人平台正被评估其提供即时定位控制的潜力，这是实现全面手术流程整合的关键一步。

市场限制

技术限制

胶囊内视镜仅提供诊断功能，无法像传统内视镜那样采集切片检查样本。如果检测到病灶或息肉，则需要进行后续的传统内视镜检查以确认诊断并进行组织取样。这种两步骤流程增加了成本，也给患者带来了不便。在基于胶囊的切片检查和治疗功能实现商业性化之前，这一限制可能会继续限制其作为传统内视镜的完全替代方案的潜力。

设备成本高且重复使用性有限

虽然胶囊内视镜检查省去了镇静和恢復设备的相关费用，但胶囊本身仍然是一种高成本的一次性医疗器材。在对成本较为敏感的地区，医院和门诊诊所可能不愿大规模采用胶囊内视镜检查，尤其是在报销不全或延迟的情况下。

资料处理负担

每个胶囊都会产生数千张需要临床医生审核的影像。虽然人工智慧辅助软体有助于缩短阅片时间，但仍需人工审核，这会加重繁忙中心的诊断工作负担。因此，亟需持续开放自动化、云端基础分析和整合工作流程管理工具。

对胶囊运输的控制有限

胶囊在胃肠道内的被动移动可能导致检查不完整，并可能在肠狭窄患者中造成胶囊滞留。儘管磁控和基于感测器的定位技术取得了显着进展，但这些风险仍然存在，并持续阻碍传统医疗机构采用该技术。

竞争分析

到了2025年，全球胶囊内视镜市场将由美敦力主导，该公司凭藉其PillCam™平台占据大部分市场份额。Medtronic在北美和西欧保持了领先地位，在全球范围内位居第二，仅次于建山科技。Medtronic的市场地位源自于2015年对柯惠医疗的收购，而柯惠医疗先前已收购了胶囊内视镜技术的原创者Given Imaging公司。

2025年，建山科技（OMOM™）在全球排名第二。该公司总部位于中国当地，其胶囊内视镜系统销往亚洲、澳洲和拉丁美洲。其产品系列包括采用专有资料记录技术的小肠和食道胶囊内视镜。

安康医疗科技公司预计到2025年将跻身全球市占率第三名。安康总部位于中国武汉，已研发并商业化了NaviCam™可控胃胶囊系统。该系统是一种取得专利的磁性机器人胶囊引导平台，可使临床医生控制胶囊在胃内的移动。目前，该系统已在中国100多家医疗中心投入使用，并正在评估其国际推广的可能性。

到2025年，这三家公司将占据全球市场份额的大部分。规模较小的参与企业和区域经销商活跃于细分市场和早期市场，尤其是在东南亚、拉丁美洲和中东地区。市场集中度仍然很高，这反映了胶囊成像系统相关的技术复杂性和监管要求。

目标市场和数据范围

定量覆盖

市场规模、市占率、市场预测、成长率、销售量、平均售价

定性覆盖

市场成长趋势、市场限制因素、竞争分析及主要竞争对手的SWOT分析、併购、公司简介、产品系列、FDA召回事件、颠覆性技术以及影响需求的疾病概述

时期

基准年为2025年，预测期间为2026-2032年，历史资料为2022-2024年。

数据来源

对行业领袖的初步访谈、政府医生资料、监管资料、私人医院资料、进出口资料以及iData Research的内部医疗技术资料库。

调查方法注记

它透过一手和二手资料以及跨区域的程式资料、装置量和使用假设检验。

医疗环境

医院、专科诊所、门诊手术中心及诊断影像中心

地区

北美、欧洲、亚太地区、拉丁美洲、中东和非洲

调查方法附录和缩写词彙表提供了定义和假设。

目录

图表清单

图表列表

调查方法

全球关税的影响

胶囊内视镜市场

• 执行摘要
  • 全球胶囊内视镜市场概览
  • 竞争分析
  • 目标区域
• 介绍
• 手术次数
• 市场概览
  • 按细分市场
  • 按地区
• 市场分析与预测
  • 胶囊内视镜市场整体状况
  • 相机胶囊市场
  • 资料记录器市场
• 驾驶员和约束装置
• 竞争市占率分析

简称

The global capsule endoscopy market was valued at over $487 million in 2025. The market is expected to grow at a compound annual growth rate (CAGR) of 3.6%, reaching $623 million by 2031.

This report covers camera capsule endoscopy devices and data recorders used in gastrointestinal diagnostic procedures. It quantifies unit sales, average selling prices (ASPs), market values, growth rates, and company shares, and analyzes market drivers and limiters, recent mergers and acquisitions (M&A), recalls, and technology trends. It includes historical data to 2021 and provides forecasts until 2031.

The scope reflects how healthcare systems are integrating capsule endoscopy into broader diagnostic pathways for the small intestine, esophagus, and colon. The technology is being evaluated not only for its ability to replace certain conventional procedures but also for its role in enhancing patient comfort, expanding screening access, and improving early disease detection.

Market Overview

Capsule endoscopy enables physicians to visualize the gastrointestinal (GI) tract using a swallowable camera capsule that transmits thousands of images wirelessly to an external recorder. The procedure is noninvasive, requires minimal patient preparation, and offers extended imaging of regions often inaccessible by conventional endoscopes.

In 2025, the camera capsule segment accounted for the majority of global market value. Growth is supported by expanding clinical adoption, broader reimbursement coverage, and continued advances in imaging resolution and battery life. Capsule endoscopy has evolved from a niche tool for obscure GI bleeding to a mainstream diagnostic modality for small bowel evaluation, inflammatory bowel disease (IBD), and suspected Crohn's disease.

Over the forecast period, expansion into esophageal and colonic applications is expected to further accelerate demand. Ongoing trials are demonstrating strong diagnostic yield in these areas, particularly as capsule platforms integrate with magnetic control systems that allow partial navigational guidance. In parallel, research into robotic actuation and AI-based lesion detection is laying the groundwork for the next generation of fully controllable and semi-automated diagnostic capsules.

• Although capsule endoscopy remains primarily diagnostic, the market outlook is positive as manufacturers continue to invest in overcoming its two main technical constraints: limited control over capsule movement and the inability to perform therapeutic interventions. Efforts to address these issues include external magnetic steering, variable frame-rate cameras, and tethered capsule prototypes capable of sampling tissue or delivering targeted therapy.

Healthcare providers value capsule endoscopy for its patient comfort and reduced resource requirements compared to traditional endoscopy, which demands sedation, specialized facilities, and recovery time. The simplified workflow aligns with outpatient and ambulatory care trends, enabling hospitals to extend GI diagnostics to non-acute environments and even home-based monitoring programs.

Market momentum is further supported by aging populations, increasing gastrointestinal disease prevalence, and growing awareness of noninvasive diagnostic options. As capsule systems continue to improve in image quality, AI-assisted analytics, and data integration, adoption is expected to broaden across developed and emerging healthcare markets.

Market Drivers

Minimal Training Required

Physicians require little additional training to perform capsule endoscopy. The core skill set overlaps with conventional endoscopy, particularly in image interpretation. The incremental learning curve primarily involves the operation of capsule devices and associated software platforms for image review and documentation. This simplicity facilitates faster adoption in hospital and outpatient settings and supports deployment across gastroenterology networks with limited specialist capacity.

Patient Preference and Comfort

Patient acceptance is a significant driver of the capsule endoscopy market. The noninvasive nature of the procedure eliminates discomfort associated with insertion, sedation, or air insufflation. The test can often be completed within the patient's daily routine, reducing anxiety and improving compliance for follow-up examinations. In population screening programs, particularly for small bowel and early colorectal disease detection, patient comfort is a critical determinant of participation rates.

Reimbursement Expansion

Favorable reimbursement policies are broadening global access. In many regions, capsule endoscopy is now reimbursed for small bowel investigation following inconclusive traditional endoscopy results. Continued advocacy by professional gastroenterology societies is helping establish reimbursement for esophageal and colonic capsule procedures, which will further expand utilization across both public and private healthcare systems.

Technological Advancements

Improvements in camera resolution, battery life, and wireless data transmission have greatly enhanced diagnostic accuracy. AI-based software capable of identifying abnormalities such as bleeding, ulcers, and polyps is reducing interpretation time and variability among readers. Meanwhile, magnetic navigation systems and robotic platforms are being evaluated for their potential to provide real-time positioning control, a key step toward full procedural integration.

Market Limiters

Technological Limitations

Capsule endoscopy serves only a diagnostic function and cannot collect biopsy samples, a feature readily available with conventional endoscopy. When lesions or polyps are detected, a follow-up traditional endoscopy is required for confirmation and tissue sampling. This two-step workflow increases cost and patient inconvenience. Until capsule-based biopsy or therapeutic capabilities are commercially available, this limitation will continue to constrain its full replacement potential.

High Device Cost and Reusability Constraints

While capsule endoscopy eliminates costs related to sedation and recovery facilities, the capsule itself remains a high-cost, single-use device. Hospitals and outpatient clinics in cost-sensitive markets may hesitate to adopt capsule endoscopy at scale, particularly where reimbursement remains incomplete or delayed.

Data Processing Burden

Each capsule produces thousands of images that require review by clinicians. Although AI-assisted software helps reduce reading time, manual verification is still necessary, which can strain diagnostic workloads in busy facilities. This creates a need for continued development in automation, cloud-based analysis, and integrated workflow management tools.

Limited Control Over Capsule Transit

The capsule's passive movement through the GI tract can result in incomplete studies or retention in patients with strictures. Despite significant progress in magnetic control and sensor-based localization, these risks persist and represent ongoing barriers to adoption among conservative providers.

Competitive Analysis

The global capsule endoscopy market in 2025 was dominated by Medtronic, which accounted for the majority of market share through its PillCam(TM) platform. Medtronic maintained leading positions in North America and Western Europe, while ranking second globally behind Jianshan Science and Technology. Medtronic's position stems from its acquisition of Covidien in 2015, which previously acquired Given Imaging, the original innovator of capsule endoscopy.

Jianshan Science and Technology (OMOM(TM)) ranked second globally in 2025. Headquartered in mainland China, the company distributes its capsule endoscopy systems across Asia, Australia, and Central and South America. Its product portfolio includes both small bowel and esophageal capsules supported by proprietary data-recording technology.

Ankon Medical Technologies held the third-largest global share in 2025. Based in Wuhan, China, Ankon developed and commercialized the NaviCam(TM) Controllable Stomach Capsule System, a patented magnetic robotic capsule guidance platform that allows clinicians to direct capsule movement within the stomach. This system is now deployed in over one hundred medical centers in China and is being evaluated for broader international expansion.

Together, these three companies accounted for the vast majority of global market share in 2025. Smaller participants and regional distributors are active in niche or early-stage markets, particularly in Southeast Asia, Latin America, and the Middle East. Market concentration remains high, reflecting the technological complexity and regulatory requirements associated with capsule-based imaging systems.

Market Coverage and Data Scope

Quantitative Coverag

Market size, market shares, market forecasts, growth rates, units sold, and average selling prices.

Qualitative Coverag

Market growth trends, market limiters, competitive analysis and SWOT for top competitors, mergers and acquisitions, company profiles, product portfolios, FDA recalls, disruptive technologies, and disease overviews influencing demand.

Time Frame

Base year 2025, forecasts 2026-2032, historical data 2022-2024.

Data Source

Primary interviews with industry leaders, government physician data, regulatory data, hospital private data, import and export data, and iData Research's internal MedTech database.

Methodology Note

Revenue is modeled from units multiplied by ASP, validated through primary and secondary sources, and cross-checked with procedure data, installed base, and utilization assumptions across regions.

Care Settings

Hospitals, specialty clinics, ambulatory surgical centers, and diagnostic imaging centers.

Geography

This edition covers the global market with analysis across North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

Methodology appendix and acronym glossary documenting definitions and assumptions.

Why This Report

Where is the largest and fastest-growing opportunity within capsule endoscopy, and which product categories are most likely to gain share over the forecast period?

How does the capsule endoscopy market relate to the broader GI diagnostic landscape, including traditional endoscopy, imaging, and AI-assisted detection platforms?

What forces will shape the market going forward, including reimbursement coverage, magnetic navigation systems, AI-based lesion detection, and integration into hospital and outpatient diagnostic workflows?

How do technological advancements in capsule design, power management, and image processing influence pricing, adoption, and replacement cycles?

Which product designs are gaining traction in capsule navigation and data recorders, and how are hospitals prioritizing image quality and workflow efficiency?

What is the impact of diagnostic-only limitations and device retention on purchasing decisions and technology preference among gastroenterologists?

How can suppliers strengthen their business case by linking noninvasive diagnostics, patient satisfaction, and workflow optimization to cost control and clinical productivity?

How should commercial teams plan for market expansion across emerging regions, reimbursement variations, and competition from conventional endoscopy platforms?

Where are the key risks to growth, including pricing pressure, incomplete reimbursement, and technological constraints on therapeutic functionality?

The Global Capsule Endoscopy Market Report from iData Research answers these questions with procedure-based models, company share analysis, and detailed pricing data. Use it to quantify demand by segment, forecast technology trends, plan product launches, and set pricing and partnership strategies aligned with evolving clinical practice.

TABLE OF CONTENT

Table Of Contents

List Of Figures

List Of Charts

Research Methodology

• Step 1: Project Initiation & Team Selection
• Step 2: Prepare Data Systems And Perform Secondary Research
• Step 3: Preparation For Interviews & Questionnaire Design
• Step 4: Performing Primary Research
• Step 5: Research Analysis: Establishing Baseline Estimates
• Step 6: Market Forecast And Analysis
• Step 7: Identify Strategic Opportunities
• Step 8: Final Review And Market Release
• Step 9: Customer Feedback And Market Monitoring

Impact Of Global Tariffs

Capsule Endoscopy Market

• 5.1 Executive Summary
  • 5.1.1 Global Capsule Endoscopy Market Overview
  • 5.1.2 Competitive Analysis
  • 5.1.3 Regions Included
• 5.2 Introduction
• 5.3 Procedure Numbers
• 5.4 Market Overview
  • 5.4.1 By Segment
  • 5.4.2 By Region
• 5.5 Market Analysis And Forecast
  • 5.5.1 Total Capsule Endoscopy Market
  • 5.5.2 Camera Capsule Market
  • 5.5.3 Data Recorder Market
• 5.6 Drivers And Limiters
  • 5.6.1 Market Drivers
  • 5.6.2 Market Limiters
• 5.7 Competitive Market Share Analysis

Abbreviations

LIST OF CHARTS

• Chart 5-1: Capsule Endoscopy Market, Global, 2025 & 2032
• Chart 5-2: Capsule Endoscopy Procedures, Global, 2025
• Chart 5-3: Capsule Endoscopy Procedures by Region, Global, 2022 - 2032
• Chart 5-4: Capsule Endoscopy Market, Global, 2022 - 2032
• Chart 5-5: Capsule Endoscopy Market by Region, Global, 2022 - 2032
• Chart 5-6: Leading Competitors, Capsule Endoscopy Market, Global, 2025

LIST OF FIGURES

• Figure 5-1: Capsule Endoscopy Regions Covered, Global (1 of 2)
• Figure 5-2: Capsule Endoscopy Regions Covered, Global (2 of 2)
• Figure 5-3: Capsule Endoscopy Procedures by Region, Global, 2022 - 2032
• Figure 5-4: Capsule Endoscopy Procedures by Country, North America, 2022 - 2032
• Figure 5-5: Capsule Endoscopy Procedures by Country, Latin America, 2022 - 2032 (1 of 2)
• Figure 5-6: Capsule Endoscopy Procedures by Country, Latin America, 2022 - 2032 (2 of 2)
• Figure 5-7: Capsule Endoscopy Procedures by Country, Western Europe, 2022 - 2032
• Figure 5-8: Capsule Endoscopy Procedures by Country, Central & Eastern Europe, 2022 - 2032 (1 of 2)
• Figure 5-9: Capsule Endoscopy Procedures by Country, Central & Eastern Europe, 2022 - 2032 (2 of 2)
• Figure 5-10: Capsule Endoscopy Procedures by Country, Middle East, 2022 - 2032
• Figure 5-11: Capsule Endoscopy Procedures by Country, Asia-Pacific, 2022 - 2032 (1 of 3)
• Figure 5-12: Capsule Endoscopy Procedures by Country, Asia-Pacific, 2022 - 2032 (2 of 3)
• Figure 5-13: Capsule Endoscopy Procedures by Country, Asia-Pacific, 2022 - 2032 (3 of 3)
• Figure 5-14: Capsule Endoscopy Procedures by Country, Africa, 2022 - 2032
• Figure 5-15: Capsule Endoscopy Market by Segment, Global., 2022 - 2032 (US$M)
• Figure 5-16: Capsule Endoscopy Market by Region, Global, 2022 - 2032 (US$M)
• Figure 5-17: Capsule Endoscopy Market, U.S., 2022 - 2032
• Figure 5-18: Units Sold by Region, Capsule Endoscopy Market, Global, 2022 - 2032
• Figure 5-19: Average Selling Price by Region, Capsule Endoscopy Market, Global, 2022 - 2032 (US$)
• Figure 5-20: Market Value by Region, Capsule Endoscopy Market, Global, 2022 - 2032 (US$M)
• Figure 5-21: Camera Capsule Market, U.S., 2022 - 2032
• Figure 5-22: Units Sold by Region, Camera Capsule Market, Global, 2022 - 2032
• Figure 5-23: Average Selling Price by Region, Camera Capsule Market, Global, 2022 - 2032 (US$)
• Figure 5-24: Market Value by Region, Camera Capsule Market, Global, 2022 - 2032 (US$M)
• Figure 5-25: Data Recorder Market, U.S., 2022 - 2032
• Figure 5-26: Units Sold by Region, Data Recorder Market, Global, 2022 - 2032
• Figure 5-27: Average Selling Price by Region, Data Recorder Market, Global, 2022 - 2032 (US$)
• Figure 5-28: Market Value by Region, Data Recorder Market, Global, 2022 - 2032 (US$M)
• Figure 5-29: Leading Competitors, Capsule Endoscopy Market, Global, 2025