Hemodialysis Vascular Grafts Market Size and Share

Hemodialysis Vascular Grafts Market Summary
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Hemodialysis Vascular Grafts Market Analysis by Mordor Intelligence

The hemodialysis vascular access grafts market was valued at USD 272.47 million in 2025 and is forecast to reach USD 345.43 million by 2030, progressing at a 4.86% CAGR. Rising chronic kidney disease (CKD) prevalence, which affected 673 million people in 2024, is enlarging the dialysis patient pool and sustaining demand for reliable vascular access. Economic incentives such as Medicare’s USD 273.82 per-treatment End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) base rate reinforce the need for durable, low-maintenance grafts[1]Source: Centers for Medicare & Medicaid Services, “Calendar Year 2025 End-Stage Renal Disease Prospective Payment System Final Rule,” cms.gov. Technological differentiation is intensifying: early-cannulation expanded polytetrafluoroethylene (ePTFE) designs, heparin-bonded coatings, and tissue-engineered vessels are key innovation fronts. Market participants are also responding to a “Fistula First, Catheter Last” clinical environment by positioning grafts as rapid back-up options for high-risk patients whose fistulas fail to mature.

Key Report Takeaways

• By material, PTFE led with 45.56% of hemodialysis vascular access grafts market share in 2024, while biosynthetic materials are forecast to expand at a 5.12% CAGR through 2030.

• By configuration, conventional grafts held 69.15% revenue share in 2024, whereas early-cannulation variants are projected to rise at a 5.78% CAGR to 2030.

• By end user, hospitals accounted for 63.45% of the hemodialysis vascular access grafts market size in 2024; dialysis centers show the fastest growth at a 6.01% CAGR.

• By geography, North America commanded 37.45% share of the hemodialysis vascular access grafts market in 2024, but APAC is poised for the quickest expansion at a 6.87% CAGR

Segment Analysis

By Material: PTFE Dominance Faces Biosynthetic Innovation

PTFE claimed 45.56% of 2024 revenues, underlining its long-standing clinical integration and manufacturing scalability. The hemodialysis vascular access grafts market size for PTFE is forecast to reach USD 155.9 million by 2030, expanding at a steady pace as proprietary surface modifications, such as Gore’s STRETCH and ACUSEAL, bolster performance. In contrast, biosynthetic and tissue-engineered vessels such as Humacyte’s acellular tissue-engineered vessel (ATEV) are projected to grow at 5.12% CAGR, supported by December 2024 FDA approval for vascular trauma and promising Phase 3 dialysis data. Mechanical attributes of silk-fibroin scaffolds mirror native vessels, strengthening the case for biologic options.

Biosynthetic progress is reshaping supplier roadmaps yet scale-up hurdles remain. Regulatory scrutiny of living-cell constructs lengthens time-to-market, and higher unit costs could constrain early uptake in price-sensitive regions. Nevertheless, early adopters are testing off-the-shelf tissue-engineered grafts for patients who lack suitable veins, signalling future share gains for biologics within the hemodialysis vascular access grafts market.

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By Configuration: Early-Cannulation Gains Despite Conventional Leadership

Conventional grafts retained 69.15% revenue share in 2024, reflecting surgeon familiarity and entrenched operating-room protocols. Early-cannulation designs, however, are forecast to deliver a 5.78% CAGR through 2030. The hemodialysis vascular access grafts market share held by early-cannulation variants could exceed 30% by the end of the decade as facilities prioritise catheter avoidance. Clinical evidence shows ACUSEAL enabling dialysis within 24 hours while maintaining 78% secondary patency at 12 months.

Adoption barriers include higher upfront device costs and learning curves, yet total cost-of-care analysis increasingly favours early access because catheter infections prolong hospital stays. Policymaker focus on home dialysis and outpatient care further strengthens the value proposition for grafts that become functional quickly, underpinning growth momentum in this configuration segment.

By End User: Hospital Dominance Shifts Toward Dialysis Centers

Hospitals captured 63.45% of 2024 revenues owing to surgical placement capabilities and complex patient management needs. The hemodialysis vascular access grafts market size attributable to hospitals is projected to reach USD 216.9 million by 2030, but their share will erode modestly as dialysis centers, expanding at 6.01% CAGR, increase procedural volumes. Center-based growth reflects decentralised care models; facilities are investing in in-house access maintenance to reduce costly hospital referrals.

Ambulatory surgical centers are gaining traction for same-day graft placements, and policy moves to boost home dialysis broaden the clinical settings requiring dependable graft options. Vendors offering streamlined training and post-operative support can capitalise on this transition across end-user categories.

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Geography Analysis

North America held 37.45% of the hemodialysis vascular access grafts market in 2024, supported by Medicare’s PPS and widespread adherence to “Fistula First, Catheter Last” guidelines. The presence of innovation hubs and accelerated FDA pathways promotes early adoption of heparin-bonded and early-cannulation designs. Merit Medical’s WRAPSODY endoprosthesis, commercialised in January 2025, illustrates ongoing domestic device advancement with a 70.1% target-lesion primary patency rate at 12 months.

APAC is forecast to expand at 6.87% CAGR to 2030, driven by large CKD populations and improving reimbursement in China, India, and Southeast Asia. Yet disparities persist; high treatment costs in lower-income countries limit utilisation, while Japan and South Korea represent mature high-value markets. Terumo’s Puerto Rico manufacturing expansion, announced in 2024, positions the firm to serve both North American and fast-growing APAC demand efficiently.

Europe remains steady, supported by coordinated reimbursement systems that favour technologies with proven clinical value. The continent’s push toward home dialysis aligns with early-cannulation adoption trends. Latin America and the Middle East & Africa offer niche growth pockets, yet constrained health budgets and lower graft penetration temper short-term prospects. Overall, regional variability emphasises the necessity of tailored commercial strategies within the hemodialysis vascular access grafts market.

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Competitive Landscape

The market presents moderate concentration, with W.L. Gore & Associates, Terumo Corporation, and B. Braun Melsungen anchoring global supply through proprietary ePTFE chemistries, heparin-bonding expertise, and expansive distribution. Gore’s portfolio spans STRETCH, ACUSEAL, and PROPATEN, enabling surgeons to match graft type to patient risk profile. Terumo’s vascular closure innovations support a complementary access hardware offering, enhancing account penetration. B. Braun’s 2024 launch of Heparin Sodium 2,000 units in saline shows the firm’s commitment to adjunct therapies that preserve graft patency bbraunusa.com.

Tissue-engineering entrants pose disruption potential. Humacyte’s FDA-cleared acellular vessel and planned Investigational New Drug (IND) filing for small-diameter coronary use expand the technology’s addressable market humacyte.gcs-web.com. 3D-bioprinted grafts achieved functional blood flow in 2025 preclinical models, foreshadowing long-term competitive pressure on synthetic demand nature.com.

M&A activity is elevating entry barriers. Teleflex’s EUR 760 million acquisition of BIOTRONIK’s devices and Merit Medical’s USD 120 million Biolife deal underscore the value of scale and product-line breadth. Suppliers combining devices, coatings, and ancillary hemostatic products can better meet integrated delivery network requirements, thereby consolidating share within the hemodialysis vascular access grafts market.

Hemodialysis Vascular Grafts Industry Leaders

  1. W. L. Gore & Associates, Inc.

  2. Vascudyne, Inc.

  3. LeMaitre

  4. Getinge AB

  5. CryoLife, Inc.

  6. *Disclaimer: Major Players sorted in no particular order
Hemodialysis Vascular Grafts Market Concentration
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Recent Industry Developments

  • February 2025: Teleflex agreed to acquire BIOTRONIK’s Vascular Intervention business for about EUR 760 million, broadening its interventional portfolio.
  • January 2025: Humacyte announced plans to file an IND for a small-diameter acellular tissue-engineered vessel in coronary bypass.
  • January 2025: Merit Medical began US rollout of the WRAPSODY Cell-Impermeable Endoprosthesis after December 2024 FDA approval

Table of Contents for Hemodialysis Vascular Grafts Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rising CKD prevalence & dialysis patient pool
    • 4.2.2 Increasing adoption of early-cannulation ePTFE grafts
    • 4.2.3 Technology shift toward heparin-bonded & bio-active coatings
    • 4.2.4 Hospital consolidation driving bulk purchasing
    • 4.2.5 Medicare “Fistula First, Catheter Last” push creating graft back-up demand
    • 4.2.6 Pipeline micro-porous silk fibroin grafts with >90 % 1-yr patency
  • 4.3 Market Restraints
    • 4.3.1 High intervention cost vs. fistula
    • 4.3.2 Reimbursement cuts on dialyzer bundle in the U.S.
    • 4.3.3 Rising antimicrobial resistance → higher infection risk (under-reported)
    • 4.3.4 3-D printed personalized grafts could cannibalize synthetic demand post-2030 (under-reported)
  • 4.4 Value / Supply-Chain Analysis
  • 4.5 Regulatory Landscape
  • 4.6 Technological Outlook
  • 4.7 Porter’s Five Forces
    • 4.7.1 Bargaining Power of Suppliers
    • 4.7.2 Bargaining Power of Buyers
    • 4.7.3 Threat of New Entrants
    • 4.7.4 Threat of Substitutes
    • 4.7.5 Competitive Rivalry

5. Market Size & Growth Forecasts (Value, USD Million)

  • 5.1 By Material
    • 5.1.1 PTFE
    • 5.1.2 Heparin-bonded ePTFE
    • 5.1.3 Polyurethane
    • 5.1.4 Biosynthetic
    • 5.1.5 Biological / Tissue-engineered
  • 5.2 By Configuration
    • 5.2.1 Early-cannulation
    • 5.2.2 Conventional
  • 5.3 By End User
    • 5.3.1 Hospitals
    • 5.3.2 Dialysis Centers
    • 5.3.3 Ambulatory Surgical Centers
    • 5.3.4 Home-care Settings
  • 5.4 By Geography
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 APAC
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 South Korea
    • 5.4.3.5 Australia
    • 5.4.3.6 Rest of APAC
    • 5.4.4 South America
    • 5.4.4.1 Brazil
    • 5.4.4.2 Argentina
    • 5.4.4.3 Rest of South America
    • 5.4.5 Middle East and Africa
    • 5.4.5.1 GCC
    • 5.4.5.2 South Africa
    • 5.4.5.3 Rest of Middle East and Africa

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
    • 6.3.1 W. L. Gore & Associates
    • 6.3.2 Terumo Corporation
    • 6.3.3 B. Braun Melsungen AG
    • 6.3.4 Merit Medical Systems Inc.
    • 6.3.5 BD (C. R. Bard)
    • 6.3.6 LeMaitre Vascular Inc.
    • 6.3.7 Cook Medical
    • 6.3.8 Getinge (Intervascular)
    • 6.3.9 Medtronic plc
    • 6.3.10 Artivion Inc.
    • 6.3.11 Vascular Flow Technologies
    • 6.3.12 Humacyte Inc.
    • 6.3.13 InnAVasc Medical
    • 6.3.14 PolyMedicure Ltd.
    • 6.3.15 Nipro Corporation
    • 6.3.16 Fresenius Medical Care
    • 6.3.17 Becton Dickinson & Co.
    • 6.3.18 Shenzhen LePu Medical
    • 6.3.19 Jotec GmbH
    • 6.3.20 Suokang Medical

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-need Assessment
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Global Hemodialysis Vascular Grafts Market Report Scope

As per the report's scope, hemodialysis vascular grafts or arteriovenous (AV) grafts are medical devices used to connect an artery and a vein in people who need hemodialysis. They are designed to be durable, provide adequate blood flow rates for efficient dialysis, and resist infection and clotting.

The hemodialysis vascular grafts market is segmented by raw material and geography. By raw material, the market is segmented into polyester, polytetrafluoroethylene, polyurethane, and biological materials. By biological material, the market is segmented into human saphenous & umbilical veins and tissue-engineered materials. By geography, the market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. The market report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD) for the above segments.

By Material
PTFE
Heparin-bonded ePTFE
Polyurethane
Biosynthetic
Biological / Tissue-engineered
By Configuration
Early-cannulation
Conventional
By End User
Hospitals
Dialysis Centers
Ambulatory Surgical Centers
Home-care Settings
By Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
APAC China
Japan
India
South Korea
Australia
Rest of APAC
South America Brazil
Argentina
Rest of South America
Middle East and Africa GCC
South Africa
Rest of Middle East and Africa
By Material PTFE
Heparin-bonded ePTFE
Polyurethane
Biosynthetic
Biological / Tissue-engineered
By Configuration Early-cannulation
Conventional
By End User Hospitals
Dialysis Centers
Ambulatory Surgical Centers
Home-care Settings
By Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
APAC China
Japan
India
South Korea
Australia
Rest of APAC
South America Brazil
Argentina
Rest of South America
Middle East and Africa GCC
South Africa
Rest of Middle East and Africa
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Key Questions Answered in the Report

What is the current size of the hemodialysis vascular access grafts market?

The market stood at USD 272.47 million in 2025 and is forecast to reach USD 345.43 million by 2030.

Which material leads the hemodialysis vascular access grafts market?

PTFE accounts for the largest revenue share at 45.56% in 2024, benefiting from decades of clinical use.

Why are early-cannulation grafts gaining popularity?

They allow dialysis to start within hours of implantation, lowering catheter-related infection risks and hospital costs.

Which region is growing fastest in this market?

Asia-Pacific is projected to expand at a 6.87% CAGR through 2030 due to rising CKD incidence and improving reimbursement.

How does antimicrobial resistance affect graft adoption?

Increasing infections by multidrug-resistant organisms elevate complication risks, pressuring manufacturers to enhance antimicrobial coatings.

What years does this Hemodialysis Vascular Grafts Market cover, and what was the market size in 2024?

In 2024, the Hemodialysis Vascular Grafts Market size was estimated at USD 259.23 million. The report covers the Hemodialysis Vascular Grafts Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Hemodialysis Vascular Grafts Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.

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