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市场调查报告书
商品编码
1861119
全球防回流装置市场:市场规模、份额和趋势分析(2022-2028)Anti-Reflux Devices Market Size, Share, and COVID-19 Impact Analysis | Global | 2022-2028 |
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2025年全球回流防止装置市场规模约1.99亿美元。预计到2032年,该市场规模将超过5.67亿美元,年复合成长率为16.2%。
本报告涵盖了基于手术的胃食道逆流症 (GERD) 器械治疗方法,包括经口无切口腹腔镜手术 (TIF)、经食道射频消融术 (TEF) 和 LINX 逆流管理系统。报告量化了销售量、平均售价 (ASP)、市场价值、成长率和企业市场占有率,并分析了市场驱动因素和限制因素、近期併购活动以及技术趋势。报告提供截至 2022 年的历史数据,并预测至 2032 年。
本次调查范围反映了随着人们对胃食道逆流症 (GERD) 的认识不断提高、证据不断增加以及患者偏好转向持久缓解症状和可预测康復的背景下,医院和专科中心的医疗保健提供者如何评估基于器械的 GERD 干预措施与药物治疗和腹腔镜手术的比较。
市场概览
抗逆流装置透过增强胃食道连接屏障或重塑下食道括约肌来治疗持续性胃食道逆流症。这些治疗方法为寻求长期质子帮浦阻断剂治疗替代方案或儘管接受药物治疗但症状仍持续存在的患者提供了选择。
三大因素推动了成长。首先,主要厂商针对医师所进行的定向教育和病患行销提高了产品认知度。随着越来越多的医疗中心采用经食道瘘(TIF)、射频消融和磁增强等技术,手术操作熟练度不断提高,转诊途径途径也日益成熟。其次,人们对长期使用质子帮浦抑制剂(PPI)的担忧日益加剧。研究表明,长期使用PPI与低镁血症和骨折风险有关,这促使许多患者和医生重新评估其长期用药方案。第三,肥胖症的盛行率持续上升,而中央肥胖与胃食道逆流症(GERD)症状加重以及仅靠生活方式干预难以控制密切相关。这些因素共同导致了器械治疗咨询量的稳定成长和目标市场的扩大。
不同机构的实施模式各不相同。大学附属医院和大型胃肠病中心通常会建立结构化的反流治疗项目,包括治疗前评估、标准化的患者筛选和协调的追踪。社区中心则倾向于专注于一到两种符合当地技术和患者需求的治疗方法,并逐步扩大规模。无论在何种情况下,患者筛选都至关重要。临床医师会根据症状严重、解剖结构、是否存在食道裂孔疝气及其大小、胃肠动力状态以及药物反应的全面评估,指导患者选择最适合的治疗方案。
价格和价值动态反映了设备初始成本与后续效益之间的平衡。医疗服务提供者重视手术成功率、症状缓解的持久性、再次手术率以及减少常规药物使用的能力。支付者和综合医疗系统则重视总医疗成本、住院时长以及避免併发症。随着证据的累积和编码规范的完善,预计2025年至2032年间,市场将持续成长。
市场驱动因素
提高产品认知度
主要企业持续不断的市场推广和教育活动正在提高外科医生、胃肠病学家和患者对反流预防装置的认知。同行评审的出版物、研讨会和指导计画正在提升反流预防装置的知名度和信誉度。随着认知度的提高,越来越多对长期药物治疗不满意并希望寻求手术解决方案的患者开始接受包括经食道逆流装置(TIF)、射频消融术和磁增强术在内的治疗方案。外科医师对TIF的熟悉程度越高,就越能提高手术准备度,并减少手术推广的障碍。
PPI药物的副作用
质子帮浦抑制剂(PPI)仍是治疗胃食道逆流(GERD)的第一线药物,但长期使用的担忧影响着治疗决策。长期使用与血清镁水平降低有关,这可能导致心律不整、肌肉痉挛和癫痫发作。高剂量使用与骨质疏鬆症和骨折风险增加有关,包括腕部、脊椎和髋部骨折。这些安全隐患并非否定PPI的作用,而是鼓励医病共用决定用药时长和替代药物。随着越来越多的患者寻求持久的症状控制,而不是依赖长期药物治疗,PPI的需求正在增加。
肥胖症日益严重
中央肥胖与胃食道逆流症(GERD)症状的严重程度之间有显着相关性。随着全球肥胖率的上升,频繁逆流、夜间症状以及药物治疗效果不佳的患者数量也在增加。已在处理肥胖相关併发症的医疗机构正在扩大基于器械的GERD治疗的转诊途径。随着器械可靠性的提高,部分新增需求正从慢性药物治疗转向介入治疗,从而推动了整体市场成长。
证据和工作流程成熟度
临床规范在病患选择、麻醉、设备选用和追踪等方面不断改进。越来越多的中心正在规范术前检查并采用一致的患者报告结局指标。这有助于更精准的病例选择、更可预测的治疗结果以及更高的患者满意度。随着工作流程的日益稳定,各中心也更愿意投资于员工培训和设备支持,加速了这些规范的推广应用。
市场限制
竞争产品
儘管人们的担忧日益加剧,但质子帮浦抑制剂(PPI)对许多患者而言仍然有效且易于取得。学名药降低了患者的自付费用,并有助于维持患者的用药依从性。新的製剂和给药策略可以减少突破性症状,从而延缓或取代器械治疗。如果新型药物能够改善无反应患者的疗效,则器械治疗的普及可能会受到抑制,尤其是在对成本较为敏感的市场,因为在这些市场中,支付方通常要求在核准手术前优化药物治疗方案。
患者的不适感和期望
所有植入和能量疗法都存在手术风险和恢復期的考量。部分患者在植入或能量治疗后会出现吞嚥困难、腹胀和胸部不适。吞嚥困难和饮食调整可能会影响患者早期的满意度。少数情况下,需要取出植入装置。此外,术后可能出现持续性症状以及需要继续每日服药,这些因素可能会降低患者完全摆脱药物依赖的慾望。
后续用药
部分患者在接受器械治疗后仍需每日服用抑酸药物,儘管剂量较低或服用频率降低。对于注重性价比的支付者和患者而言,这缩小了单纯药物治疗与器械治疗合併药物治疗之间的差距。管理患者预期并就实际疗效达成共识至关重要。沟通不良会导致转换率低和口碑不佳。
范围和采购限制
编码的清晰度和范围因地区而异。在报销途径分散的市场中,医院面临着许多行政障碍,阻碍了它们对相关项目的投资。此外,某些集团采购和竞标流程,尤其是在美国以外的地区,限制了新设备的快速普及,并限制了价格的实现。
目标市场和数据范围
定量范围
市场规模、市占率、市场预测、市场成长率、销售量、平均售价
定性范围
市场成长趋势和限制因素、主要竞争对手的竞争分析和SWOT分析、併购、公司简介和产品系列、FDA召回、颠覆性技术以及与胃食道逆流症相关的疾病概述
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
对行业领袖和医生的初步调查、政府医生数据、监管数据、私人医院数据、进出口数据、iData Research 内部资料库
方法
收入模型为单位乘以平均售价,并透过手术量、设备利用率以及按手术类别分類的更换或移除假设检验。
护理机构
医院、专科中心和一些门诊机构具备先进的内视镜检查和上消化道手术能力。
竞争分析
强生公司
强生公司的LINX逆流管理系统将一个由相互连接的钛珠组成的柔性环置于食道下段,该钛珠内部带有磁性核心。吞嚥时,钛珠会分离,而磁力则可有效防止逆流。 LINX系统吸引着那些寻求能够维持正常食道解剖结构的机械解决方案的患者。其品牌知名度、临床成功案例和清晰的作用机制,使其能够持续获得合格的患者。公司已扩大了其在外科产品分销和培训方面的规模,从而巩固了其市场竞争力。
胃内解决方案
EndoGastric Solutions是第二大竞争对手,其EsophyX系统用于经口无切口胃包裹术。该公司透过密集的计画、病患推广和外科医生培训,扩大了其在美国的市场份额。其成长与医疗机构广泛采用无切口手术密切相关,这些机构倾向于选择恢復期短、创伤小的手术方案。儘管该公司正透过伙伴关係和培训网路拓展其在美国以外的业务,但在美国市场仍然最为活跃。
瑞斯泰克
Restech在2025年排名第三。该公司于2018年收购了Mederi Therapeutics,从而获得了Curon Medical的资产和Stretta射频技术。 Stretta利用射频能源重塑下食道括约肌和上腹部区域。 Restech透过将Stretta定位为无需植入的微创替代方案,在欧洲及其他地区不断扩大市场份额。持续发布疗效数据和严格的培训体系为其稳步扩张提供了支持。
总体而言,竞争主要集中在少数几家拥有强大临床讯息和系统化培训的专业供应商之间。成功与否取决于能否建立实证医学基础、拓展转诊管道,以及提供持续的术前术后护理,从而取得持久的疗效。
科技与临床趋势
根据患者表型调整治疗方案正变得越来越普遍:医生会评估疝气的大小、食道炎的程度、动力和体重指数,并根据患者的解剖结构和症状模式调整器械治疗方法。
使用 pH 监测仪、电阻、测压仪等进行标准化术前测试,将有助于改善选择,并为支付方提供支援性文件。
术前和术后护理方案,包括饮食建议、吞嚥困难管理和药物减量,可以提高患者满意度并减少非计划就诊次数。
透过结构化的追踪和检验的症状评分来追踪持久性,可以提高对长期结果和发表品质的信心。
内视镜和腹腔镜成像和视觉化技术的进步提高了器械放置和故障排除的准确性。
培训和指导网路缩短了学习曲线,并扩大了有资格安全执行这些手术的医生团队。
该计划的经济重点在于病例捆绑、吞吐量和库存管理,帮助中心证明其投资的合理性并保持可预测的利润率。
地区
本期内容涵盖北美、欧洲、亚太地区、拉丁美洲以及中东和非洲等全球范围。
调查方法附录与简称
图表清单
图表列表
调查方法
全球关税的影响
回流防止装置市场
The global anti-reflux device market was valued at nearly $199 million in 2025. The market is projected to grow at a compound annual growth rate of 16.2 percent, reaching over $567 million by 2032.
This report covers procedure-based device approaches for gastroesophageal reflux disease (GERD), including transoral incisionless fundoplication (TIF), transesophageal radiofrequency therapy, and the LINX Reflux Management System. It quantifies unit sales, average selling prices (ASPs), market values, growth rates, and company shares, and it analyzes market drivers and limiters, recent mergers and acquisitions, and technology trends. It provides historical data to 2022 and forecasts to 2032.
The scope reflects how providers evaluate device-based GERD interventions relative to drug therapy and laparoscopic surgery across hospitals and specialty centers, as awareness rises, evidence grows, and patient preferences shift toward durable symptom relief with predictable recovery.
Market Overview
Anti-reflux devices address persistent GERD by reinforcing the barrier function at the gastroesophageal junction or by remodeling the lower esophageal sphincter. These interventions offer an option for patients who seek alternatives to long-term proton-pump inhibitor therapy or who remain symptomatic despite medication.
Growth is supported by three converging forces. First, product awareness has improved through targeted physician education and patient marketing by leading manufacturers. As more centers adopt TIF, radiofrequency therapy, and magnetic augmentation, procedural familiarity grows and referral pathways mature. Second, concerns about long-term PPI use have increased. Studies linking extended PPI therapy to hypomagnesemia and fracture risk have prompted many patients and physicians to reassess long-term medication plans. Third, obesity prevalence continues to rise, and central adiposity is associated with higher GERD symptom burden and reduced control with lifestyle changes alone. Together these forces support a steady increase in consultations for device-based therapy and a larger addressable market.
Adoption patterns vary by setting. Academic hospitals and high-volume GI centers often build structured reflux programs that include pre-procedure diagnostics, standardized patient selection, and coordinated follow-up. Community facilities tend to scale more gradually, focusing on one or two techniques that fit local skills and patient demand. Across settings, patient selection remains central. Clinicians weigh symptom severity, anatomy, hiatal hernia presence and size, motility status, and medication response to direct patients to the most suitable option.
Price and value dynamics reflect a balance between up-front device cost and downstream benefits. Providers emphasize procedural success rates, durability of symptom relief, reintervention rates, and the ability to reduce daily medication use. Payors and integrated systems focus on total cost of care, length of stay, and complication avoidance. As evidence accumulates and coding clarity improves, the market signals continued expansion from 2025 through 2032.
Market Drivers
Increased product awareness
Sustained marketing and education by leading companies have raised recognition of anti-reflux devices among surgeons, gastroenterologists, and patients. Peer-reviewed publications, conference workshops, and proctorship programs have improved visibility and confidence. As awareness rises, more candidates who are dissatisfied with long-term medication or who prefer a procedural solution are entering care pathways that include TIF, radiofrequency therapy, or magnetic augmentation. Surgeon familiarity increases procedure readiness and reduces perceived barriers to adoption.
Side effects of PPI medication
PPIs remain the first-line therapy for GERD, but concerns about long-term use are influencing treatment decisions. Extended exposure is associated with low serum magnesium levels, which can lead to irregular heartbeats, muscle spasms, and seizures. High-dose therapy is linked to increased risk of osteoporosis and fractures involving the wrist, spine, and hip. These safety signals do not eliminate the role of PPIs, but they prompt shared decision-making around duration and alternatives. As more patients seek durable symptom control without indefinite medication, device demand rises.
Increasing obesity
There is a well-documented relationship between central obesity and GERD symptom severity. As global obesity rates increase, the pool of patients with frequent reflux, nocturnal symptoms, and reduced medication response grows. Providers who already manage obesity-related comorbidities are expanding referral pathways to include device-based GERD treatments. As device credibility increases, a portion of this rising demand shifts from chronic medication toward procedural solutions, supporting total market growth.
Evidence and workflow maturation
Clinical protocols for patient selection, anesthesia, device sizing, and follow-up are improving. More centers standardize pre-procedure testing and use consistent patient-reported outcome measures. This leads to better case selection, more predictable results, and stronger satisfaction scores. As workflows stabilize, facilities are more willing to invest in staff training and capital support, which accelerates adoption.
Market Limiters
Pharmaceutical competition
Despite growing concerns, PPIs remain accessible and effective for many patients. Generics lower out-of-pocket costs and maintain adherence. New formulations and dosing strategies can reduce breakthrough symptoms, which delays or replaces referral for device therapy. If novel medications improve response in non-responders, device adoption may be tempered, especially in cost-sensitive markets where payors require medication optimization before authorizing a procedure.
Patient discomfort and expectations
All implant and energy-based procedures carry surgical risks and recovery considerations. Some patients report dysphagia, bloating, and chest discomfort after implantation or energy delivery. Difficulty swallowing and diet adjustments can affect early satisfaction. In a minority of cases, device removal occurs. The possibility of symptom persistence and the prospect of continuing daily medication even after a procedure can also reduce interest among patients who expect complete independence from drugs.
Follow-up medication usage
A share of patients will still need daily acid suppression after device therapy, although at lower doses or less frequently. For value-focused payors and patients, this reduces the perceived gap between medication-only care and procedure plus medication. Managing expectations and aligning on realistic outcomes is essential. Where communication is inconsistent, conversion rates fall and word-of-mouth slows.
Coverage variation and procurement limits
Coding clarity and coverage policies vary by region. In markets where reimbursement pathways are fragmented, hospitals face administrative hurdles that discourage program investment. In addition, certain group purchasing or tender processes limit rapid introduction of new devices and constrain price realization, particularly outside the United States.
Market Coverage and Data Scope
Quantitative coverage
Market size, market shares, market forecasts, market growth rates, units sold, and average selling prices.
Qualitative coverage
Market growth trends and limiters, competitive analysis and SWOT for top competitors, mergers and acquisitions, company profiles and product portfolios, FDA recalls, disruptive technologies, and disease overviews relevant to GERD.
Time frame
Base year 2025, forecasts 2026 to 2032, historical data 2022 to 2024.
Data sources
Primary interviews with industry leaders and physicians, government physician data, regulatory data, hospital private data, import and export data, and the iData Research internal database.
Method note
Revenue is modeled from units multiplied by ASP, validated with procedure volumes, device utilization rates, and replacement or removal assumptions for each procedural category.
Care settings
Hospitals, specialty centers, and select ambulatory facilities with advanced endoscopy or foregut surgery capabilities.
Competitive Analysis
Johnson & Johnson
Johnson & Johnson offers the LINX Reflux Management System, a flexible ring of interlinked titanium beads with magnetic cores placed around the lower esophagus. The magnetic attraction resists reflux while allowing the beads to separate during swallowing. LINX appeals to patients seeking a mechanical solution that preserves normal anatomy. Its brand recognition, clinical track record, and clear mechanism of action support steady uptake in qualified candidates. The company's scale in surgical distribution and training strengthens its competitive position.
EndoGastric Solutions
EndoGastric Solutions is the second-leading competitor with the EsophyX system used for transoral incisionless fundoplication. The company has expanded market share through focused U.S. programs, patient outreach, and surgeon training. Growth is tied to broader adoption of incisionless approaches in centers that favor less invasive options with short recovery. Its presence outside the United States is growing through partnerships and training networks, but the company remains most active in the U.S. market.
Restech
Restech ranked third in 2025. The company acquired Mederi Therapeutics in 2018, which had previously acquired the Curon Medical assets and Stretta radiofrequency technology. Stretta delivers radiofrequency energy to remodel the lower esophageal sphincter and gastric cardia. Restech has increased share in Europe and other geographies by positioning Stretta as a minimally invasive alternative that can be performed without implants. Continued publication of outcomes data and disciplined training support gradual expansion.
Overall, the competitive field remains concentrated among a few specialized vendors with strong clinical messaging and structured training. Success depends on evidence generation, referral development, and consistent peri-procedural care to deliver durable outcomes.
Technology and Practice Trends
Procedure matching to patient phenotype is more common. Providers assess hernia size, esophagitis grade, motility, and BMI to align the device approach with anatomy and symptom pattern.
Standardized pre-procedure testing using pH monitoring, impedance, and manometry improves selection and supports payor documentation.
Peri-procedural pathways that include diet coaching, dysphagia management, and medication tapering improve satisfaction and reduce unplanned visits.
Durability tracking with structured follow-up and validated symptom scores builds confidence in long-term outcomes and publication quality.
Imaging and visualization advances in endoscopy and laparoscopy improve accuracy in device placement and troubleshooting.
Training and proctoring networks shorten the learning curve and expand the number of credentialed physicians who can perform these procedures safely.
Program economics emphasize case bundling, throughput, and inventory control, which helps centers justify investment and maintain predictable margins.
Geography
This edition provides global coverage for North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa
Methodology Appendix and Acronym Glossary
Where are the largest and fastest growing opportunities within anti-reflux devices and how will volumes evolve as awareness and coverage expand
How do PPI safety concerns and obesity trends translate into device referrals and long-term demand
What are the key barriers to adoption, including patient discomfort, continued medication use after procedures, and variable coverage policies
Which devices are best suited for specific patient profiles and how should centers structure reflux programs to improve throughput and outcomes
How do leading companies Johnson & Johnson, EndoGastric Solutions, and Restech position their portfolios and training to defend and expand share
What are the pricing and procurement dynamics that shape ASPs, from tenders to payor approvals, and how do facilities build a sustainable business case
The Global Anti-Reflux Device Market Report from iData Research answers these questions with procedure-aware models, company share analysis, and pricing detail. Use it to quantify demand, align portfolio strategy with patient selection pathways, and plan commercial execution that matches program economics and referral behavior.
Table Of Contents
List Of Figures
List Of Charts
Research Methodology
Impact Of Global Tariffs
Anti-Reflux Device Market