US Hemodialysis Vascular Grafts Market Analysis

US Hemodialysis Vascular Grafts Market Executive Summary

US Hemodialysis Vascular Grafts Market was valued at $87.97 Bn in 2023 and is predicted to grow at a CAGR of 3.1% from 2023 to 2030, to $108.93 Bn by 2030. 

Hemodialysis vascular grafts are specialized devices crucial for establishing vascular access in patients, particularly those with end-stage renal disease (ESRD) undergoing hemodialysis. These grafts function as conduits, linking an artery to a vein to facilitate blood movement to and from the dialysis machine during treatment. They are designed to provide durable and reliable access, replacing or augmenting natural blood vessels that may not withstand the frequent punctures required in dialysis sessions. Common types include synthetic grafts made from materials like polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE), and biological grafts derived from treated animal tissue. Surgical implantation involves connecting the graft in the arm or leg, ensuring proper placement and meticulous care to maintain sufficient blood flow and mitigate complications such as infection or clotting.

In the US, the prevalence of CKD rises sharply with age, ranging from 6% among individuals aged 18-44 years to 38% among those aged 65 and older. The incidence of end-stage renal disease (ESRD) has shown a complex trend, with a 7.6% decrease in adjusted incidence from 2000 to 2019, despite an increase in newly registered ESRD cases from 94,466 to 134,862 during the same period, marking a 42.8% rise. As of 2021, nearly 786,000 people in the US were living with ESRD.

The market therefore is driven by significant factors like the rising prevalence of chronic kidney disease, the aging population, and rising awareness and early detection. However, the patient non-complaince, shortage of qualified healthcare professionals, and limited availability of donor veins restrict the growth and potential of the market.

Prominent players in this field are W. L. Gore who offers the PROPATEN graft with a special heparin surface to fight clotting and the ACUSEAL graft designed for early use after implantation and C. R. Bard provides traditional ePTFE grafts and the innovative Vectra graft made from a different material that may allow for quicker access compared to standard options. Other contributors include Vascudyne, Inc., and LeMaitre among others.

Market Dynamics

Market Growth Drivers

Rising prevalence of chronic kidney disease (CKD):  In 2021, nearly 786,000 had end-stage renal disease (ESRD), with diabetes and hypertension contributing significantly to the rising prevalence of chronic kidney disease (CKD). This trend highlights an increasing need for hemodialysis and vascular grafts as essential treatments for kidney-related complications, driven by the growing patient population affected by these conditions.

Aging population:   The aging US population is driving revenue growth in kidney dialysis centers and expanding the hemodialysis market. With US center revenues projected to rise 5.2% annually through 2027, this growth correlates with a global and US demographic shift towards an aging population. This demographic trend is expected to increase kidney-related diseases, boosting demand for hemodialysis and vascular grafts to manage kidney failure and related conditions in elderly patients, thus driving market expansion.

Rising Awareness and Early Detection: Increased awareness about CKD and early detection efforts lead to earlier intervention and treatment. This results in a higher incidence of patients needing vascular access for dialysis, fueling demand for hemodialysis vascular grafts.

Market Restraints

Patient Non-Compliance: Non-compliance with prescribed dialysis and graft care protocols can lead to complications and reduced effectiveness. This issue limits the overall success rates of hemodialysis vascular grafts and affect market growth

Shortage of Qualified Healthcare Professionals: The US is experiencing a shortage of nephrologists and vascular surgeons, who are essential for performing hemodialysis access procedures and managing related complications. This limited workforce can lead to longer wait times for procedures, potentially hindering the broader adoption of hemodialysis and negatively impacting the market for vascular grafts.

Limited Availability of Donor Veins: For patients who require vascular access, the availability of suitable donor veins can be a challenge. This limitation affects the feasibility and timing of graft procedures, impacting market growth

Regulatory Landscape and Reimbursement Scenario

In the United States, hemodialysis vascular grafts are classified as medical devices and are regulated by the Food and Drug Administration (FDA). Manufacturers must obtain FDA approval or clearance before these grafts can be marketed and sold, adhering to strict guidelines that ensure their safety, efficacy, and proper labeling for patient use.

Regarding reimbursement, hemodialysis treatment costs, including vascular grafts, are predominantly covered by government-funded programs such as Medicare and Medicaid. Medicare, as the largest payer for dialysis services in the US, plays a crucial role in covering the expenses for a majority of patients with end-stage renal disease (ESRD). However, specific reimbursement policies for vascular grafts may vary depending on the patient's insurance plan and the healthcare setting where treatment is provided, whether in hospitals or outpatient dialysis clinics. Private insurance plans may offer additional coverage for hemodialysis-related expenses, including vascular grafts, depending on the terms of each policy.

Competitive Landscape

Key Players

Here are some of the major key players in the US Hemodialysis Vascular Grafts Market

• W. L. Gore & Associates, Inc.,
• C. R. Bard, Inc.,
• Vascudyne, Inc.,
• LeMaitre,
• Getinge AB,
• Vascular Genesis,
• InnAVasc Medical, Inc.
• CryoLife, Inc.
• Merit Medical Systems
• Biovic Sdn Bhd.