India Hemodialysis Vascular Grafts Market Analysis

India Hemodialysis Vascular Grafts Market Executive Summary

India Hemodialysis Vascular Grafts Market was valued at $3.81 Bn in 2023 and is predicted to grow at a CAGR of 8.1% from 2023 to 2030, to $6.57 Bn by 2030. 

Hemodialysis vascular grafts are specialized devices crucial for establishing vascular access in patients, particularly those with end-stage renal disease 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 India, CKD is a major health concern, with an estimated one-third of the global CKD patient population residing in the country. A study pooling data from 33 population-based studies reported an age-standardized global prevalence of CKD stages 1–5 at 10.4% among men and 11.8% among women aged 20 years or older. CKD prevalence varies by region and income level, being around 8.6% (men) and 9.6% (women) in high-income countries and 10.6% (men) and 12.5% (women) in low- and middle-income countries. Demographically, CKD affects 16% of non-Hispanic Black adults, 13% of non-Hispanic White and Asian adults, and 14% of Hispanic adults. It is most prevalent among individuals aged 65 or older (38%), followed by those aged 45 to 64 (12%), and those aged 18 to 44 (6%).

The market therefore is driven by significant factors like the rising prevalence of chronic kidney disease, supportive government initiatives, and growing geriatric population. However, high costs, limited awareness in rural areas, and dependence on imports 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):  India faces a growing burden of CKD, a major risk factor for End-Stage Renal Disease (ESRD) requiring hemodialysis. Studies suggest a prevalence of CKD ranging from 10% to 15% in the adult population. This translates to a potentially large pool of individuals who may progress to ESRD.

Growing Aging Population: India’s aging population is contributing to a higher incidence of kidney-related disorders. By 2030, the proportion of people aged 60 and above is expected to reach 13.5%, which will increase the demand for hemodialysis vascular grafts.

Government Initiatives:  Government initiatives, such as the National Dialysis Program and funding for renal care, are driving the adoption of hemodialysis vascular grafts. These programs aim to improve kidney care accessibility and affordability across India.

Market Restraints

High Costs:  The high cost of advanced hemodialysis vascular grafts is a significant barrier, particularly in lower-income regions of India. This financial constraint limits access to these critical medical devices for many patients

Lack of Awareness in Rural Areas: Inadequate awareness and limited healthcare resources in rural areas can affect the adoption of hemodialysis vascular grafts. This disparity leads to unequal access to necessary treatments and devices across different regions.

Dependence on Imports:  India relies heavily on imports for hemodialysis vascular grafts. This makes the market vulnerable to fluctuations in foreign exchange rates and potential supply chain disruptions.

Regulatory Landscape and Reimbursement Scenario

The regulatory landscape for hemodialysis vascular grafts in India is managed by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare (MoHFW). All vascular grafts must be registered with the CDSCO, complying with safety and efficacy standards as per the Medical Devices Rules, 2017. These grafts are classified as Class C or Class D devices, requiring a detailed or stringent registration process, respectively. Manufacturers must implement a Quality Management System (QMS) meeting international standards like ISO 13485 and are responsible for post-market surveillance to monitor and report any adverse events.

The reimbursement scenario in India involves multiple stakeholders, including government and private schemes. The Pradhan Mantri National Dialysis Programme (PMNDP) provides financial assistance for hemodialysis, though specific coverage for vascular grafts may vary. State health insurance schemes and central government programs like Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) also offer coverage for medical procedures, potentially including vascular grafts. Additionally, private health insurance plans may cover hemodialysis and vascular grafts, but coverage details depend on the specific insurer and patient plan.

Competitive Landscape

Key Players

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