China Hemodialysis Vascular Grafts Market Analysis

China Hemodialysis Vascular Grafts Market Executive Summary

China Hemodialysis Vascular Grafts Market was valued at $16.84 Bn in 2023 and is predicted to grow at a CAGR of 6.6% from 2023 to 2030, to $26.34 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 2019, China had approximately 150.5 Mn cases of chronic kidney disease (CKD), accounting for 10.6% of the population, a significant increase from 6.7% in 1990. CKD is slightly more common in women (14%) than in men (12%), with varying rates among different ethnic groups: 16% in non-Hispanic Black adults, 13% in non-Hispanic White and non-Hispanic Asian adults, and 14% in Hispanic adults. In 2019, CKD-related deaths in China totaled 196,726, corresponding to a mortality rate of 13.8 per 100,000 people.

The market therefore is driven by significant factors like the rising prevalence of end-stage renal disease, government initiatives, and growing aging population. However, reimbursement challenges, limited availability of specialized surgeons, and competition from established players 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): With CKD rates in China growing significantly, the demand for hemodialysis vascular grafts is increasing. Approximately 120 Mn people in China are affected by CKD, driving the need for effective dialysis solutions according to China Renal Network, 2023.

Government Healthcare Initiatives: The Chinese government has prioritized improvements in healthcare infrastructure, including nephrology and dialysis services. This focus has led to increased funding and resources for dialysis treatments, including the procurement of hemodialysis vascular grafts according to the National Health Commission of China, 2023.

Growing Aging Population: China’s rapidly aging population, with an estimated 250 million people over 60, contributes to the rising demand for hemodialysis treatments. As age is a significant risk factor for CKD, the need for vascular grafts is expected to grow according to UN Population Division, 2023.

Market Restraints

Reimbursement Challenges: Reimbursement policies for hemodialysis procedures and related materials like vascular grafts are often complex and can vary widely depending on the region and the type of insurance coverage. This complexity can create significant barriers to accessing necessary treatments for many patients, particularly those in less affluent or rural areas. As a result, inconsistent reimbursement frameworks may hinder the widespread adoption of new hemodialysis technologies.

Limited Availability of Specialized Surgeons: There is a notable shortage of surgeons who are adequately trained in the specific techniques required for hemodialysis vascular graft implantation. This shortage is particularly acute in rural and less developed regions, where healthcare infrastructure is less robust. Consequently, this lack of skilled professionals can limit the number of procedures performed and delay treatment for patients in need of hemodialysis.

Competition from Established Players: The Chinese market for hemodialysis vascular grafts is highly competitive, with well-established international medical device companies already holding a strong presence. These multinational companies benefit from established reputations, extensive distribution networks, and substantial marketing resources. As a result, domestic manufacturers face significant challenges in gaining market share and establishing trust with healthcare providers and patients.

Regulatory Landscape and Reimbursement Scenario

The National Medical Products Administration (NMPA) regulates medical devices in China, including hemodialysis vascular grafts. China employs a risk-based classification system, categorizing these grafts typically under Class II or Class III, with higher classifications necessitating more stringent evaluations. To market these devices in China, manufacturers must undergo a rigorous registration process with the NMPA, which involves submitting technical documentation, clinical trial data if applicable, and undergoing facility inspections. Clinical trial requirements vary based on the classification and novelty of the graft, with higher-risk devices often requiring trials conducted within China. Additionally, China is actively working to harmonize its medical device regulations with international standards, potentially facilitating faster market entry for innovative grafts already approved elsewhere.

China’s healthcare system features a multi-layered approach, combining public and private insurance plans. Reimbursement policies for hemodialysis procedures and related materials, such as vascular grafts, vary depending on the insurance scheme. The National Basic Medical Insurance (NBMI) program provides basic medical coverage for a significant portion of the population, covering hemodialysis treatment, though reimbursement for specific procedures and materials might be limited. Conversely, commercial health insurance plans, which are increasingly accessible, offer broader coverage and potentially higher reimbursement rates for hemodialysis vascular grafts. Hospitals often use a tendering system for purchasing medical devices, requiring manufacturers to be competitive on price and demonstrate the value proposition of their grafts to secure contracts. The Chinese government prioritizes affordability in healthcare, with reimbursement policies and tendering processes emphasizing cost control, influencing the adoption of hemodialysis vascular grafts.

Competitive Landscape

Key Players

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