Philippines Hemodialysis Vascular Grafts Market Analysis

Philippines Hemodialysis Vascular Grafts Market Executive Summary

Philippines Hemodialysis Vascular Grafts Market was valued at $460 Mn in 2023 and is predicted to grow at a CAGR of 5.6% from 2023 to 2030, to $670 Mn 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.

As of 2021, chronic kidney disease (CKD) affects an estimated 7 Mn Filipinos, indicating a significant health challenge in the country. CKD prevalence in the Philippines is notable, with one new diagnosis occurring approximately every hour. Globally, CKD impacts various populations similarly, affecting approximately 1 in 7 adults in the US across different ethnic groups, including non-Hispanic Black, non-Hispanic White, non-Hispanic Asian, and Hispanic adults, with prevalence rates ranging from 13% to 16% among these groups.

The market therefore is driven by significant factors like the rising prevalence of chronic kidney disease (CKD), aging population, and increasing government focus on healthcare. However, limited PhilHealth coverage, infrastructure and resource constraints, and price sensitivity 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): The Philippines faces a growing burden of CKD, a major risk factor for ESRD requiring hemodialysis. Studies suggest a prevalence of CKD ranging from 8.5% to 16.4% in the adult population. This translates to a potentially large pool of individuals at risk of progressing to ESRD.

Aging Population: The Philippines' population is aging, with a growing number of people aged 65 and above. As age increases, the risk of CKD and ESRD also rises, further fueling the market for hemodialysis vascular grafts.

Increasing Government Focus on Healthcare: The Philippine government has implemented various initiatives to improve access to healthcare, including dialysis treatment. This includes expanding PhilHealth coverage and investing in healthcare infrastructure development.

Market Restraints

Limited PhilHealth Coverage: PhilHealth, the National Health Insurance Program, covers a significant portion of hemodialysis treatment costs. However, coverage details for hemodialysis vascular grafts might be limited, potentially creating a financial burden for patients.

Infrastructure and Resource Constraints: The Philippines faces challenges with limited healthcare infrastructure and a shortage of qualified medical professionals, including surgeons trained in hemodialysis vascular graft implantation.

Price Sensitivity: Healthcare providers in the Philippines might be price-sensitive when considering new vascular graft technologies, potentially hindering the adoption of innovative but more expensive options.

Regulatory Landscape and Reimbursement Scenario

The regulatory landscape for hemodialysis vascular grafts in the Philippines is overseen by the Food and Drug Administration (FDA), which implements a risk-based classification system to ensure safety and efficacy. Manufacturers must undergo a rigorous registration process that includes submitting detailed technical documentation and, for higher-risk devices, clinical data, and facility inspections. The FDA accepts conformity assessment reports from accredited bodies abroad, facilitating expedited market entry while ensuring compliance with local standards.

Regarding reimbursement, the Philippine Health Insurance Corporation (PhilHealth) plays a crucial role in covering hemodialysis costs, recently increasing benefits to PhP 4,000 per session with extended annual coverage. However, clarity on coverage specifics for hemodialysis vascular grafts remains limited, potentially impacting patient access and necessitating closer collaboration between manufacturers and healthcare providers to navigate procurement practices effectively. Clarifying coverage details and enhancing transparency could optimize patient access to essential medical technologies in the country's healthcare landscape.

Competitive Landscape

Key Players

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