France Hemodialysis Vascular Grafts Market Analysis

France Hemodialysis Vascular Grafts Market Executive Summary

France Hemodialysis Vascular Grafts Market was valued at $5.76 Bn in 2023 and is predicted to grow at a CAGR of 4.1% from 2023 to 2030, to $7.63 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 France, chronic kidney disease (CKD) is prevalent, particularly in older age groups, with CKD stage 3–5 affecting between 4.83% and 4.98% of the population and an annual incidence rate of 0.49%. Women tend to have a higher prevalence of CKD compared to men across different age groups. End-stage kidney disease (ESKD) necessitating renal replacement therapy (RRT) is significant in Europe, including France, where 83,311 individuals initiated RRT in 2016. By the end of that year, the total number of individuals requiring RRT reached 564,638, with over 80% receiving hemodialysis (HD) as the primary treatment modality.

The market therefore is driven by significant factors like the rising prevalence of end-stage renal diseases, government investment in healthcare, and technological advancements. However, cost control measures, risk of complications, and competitive from alternatives 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 End-Stage Renal Disease (ESRD): France has high prevalence of diabetes and hypertension, both significant risk factors for ESRD. According to the French Renal Network (RESAN), over 73,000 people in France were receiving renal replacement therapy (including hemodialysis) in 2021. The increasing ESRD population will require consistent hemodialysis treatment, driving the demand for vascular grafts to create access points for blood flow.

Government Investment in Healthcare:  France has a universal healthcare system that covers a significant portion of the costs associated with hemodialysis treatment, including vascular graft procedures. This financial support facilitates patient access to these procedures.

Technological Advancements:  Development of new graft materials and designs with improved patency rates (ability to remain open for blood flow) and lower infection risks can make hemodialysis procedures more efficient and encourage their use.

Market Restraints

Risk of Complications: Complications associated with hemodialysis vascular grafts, such as infections or thrombosis, deter their use. These risks affect patient outcomes and impact the acceptance of grafts in clinical practice.

High Cost of Vascular Grafts: The high cost of advanced hemodialysis vascular grafts is a significant barrier to widespread adoption. Expensive grafts limit access for some patients and healthcare facilities, affecting overall market growth.

Competition from Alternative Therapies: The availability of alternative dialysis options, such as peritoneal dialysis, provides competition for hemodialysis vascular grafts. Some patients and providers opt for these alternatives based on preference or clinical suitability.

Regulatory Landscape and Reimbursement Scenario

In France, the regulatory landscape for hemodialysis vascular grafts is governed by the Agence nationale de sécurité du médicament et des produits de santé (ANSM). ANSM employs a risk-based approach to classify medical devices, with hemodialysis vascular grafts falling under Class IIa (medium risk) or Class III (high risk) based on their design and complexity. To market these grafts in France, compliance with the European Union Medical Device Regulation (MDR) is essential, necessitating a CE marking that confirms adherence to safety and performance standards. The extent of clinical evaluation required varies with the risk classification, with higher-risk devices demanding more comprehensive clinical data to establish safety and efficacy.

France's universal healthcare system significantly subsidizes hemodialysis treatment costs, including procedures involving vascular grafts. The Liste des Produits et Prestations de Santé (LPPS), established by the French Ministry of Health, enumerates reimbursable medical devices and procedures, likely encompassing hemodialysis vascular grafts. Reimbursement rates are negotiated between manufacturers and public health insurance bodies, ensuring transparency and predictability in reimbursement policies, which are vital for market access and manufacturers' financial planning.

Competitive Landscape

Key Players

Here are some of the major key players in the France 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.