Breaking the Overseas Monopoly: The Advancement Path of Domestic Medical-Grade TPU

01Technical barriers of medical polyurethane materials

The application range of TPU in the medical field is extremely broad, including medical catheters and intubation tubes, artificial blood vessels and cardiac assist devices, medical films and protective products, medical foams and auxiliary materials, tissue engineering and regenerative medicine, drug delivery systems, as well as other healthcare and medical packaging products.

According to a research report by QYResearch, the global medical-grade TPU market size is approximately USD 278 million in 2024, and is expected to reach USD 429 million by 2031, with a compound annual growth rate (CAGR) of 6.5% during the period from 2025 to 2031.

Although there are many companies globally involved in this material field, such as BASF, Covestro, Wanhua Chemical, Huntsman, Hexpol, Kuraray, Sichuan Uporui New Materials, and Meirui New Materials, Lubrizol has become the largest global supplier of medical TPU through the acquisition of Noryl and Dow's related businesses, with a very high level of market concentration.

Lubrizol and other foreign-funded enterprises have monopolized more than 80% of the global medical TPU market with decades of technological accumulation, offering a very comprehensive range of product grades. Domestic large TPU companies are also promoting some grades; however, medical-grade TPU not only comes in numerous varieties, but each grade’s consumption is relatively small, resulting in a disproportionate input-output ratio. This reduces the willingness of large domestic companies to develop these products, and there is a significant gap in product systems and performance compared to Lubrizol. Dr. Li Zhen further added that medical polyurethane must meet stringent standards such as biocompatibility and long-term stability, with R&D cycles typically lasting 5 to 10 years. Additionally, production lines must comply with certifications such as ISO 13485, with initial investments reaching hundreds of millions of yuan.

For our country, TPU is one of the "bottleneck" materials in high-end medical polymers. In addition to the high initial investment, the technical barriers associated with this material are also quite significant.

02The application of medical polyurethane materials in the field of cardiovascular medical devices.

The global wave of population aging is continuously driving the market demand for cardiovascular medical products.

Dr. Li Zhen has been deeply engaged in the research of the relationship between the structure and performance of biomedical TPU for a long time, and has recently focused his research efforts on the application development in the fields of heart valves and artificial blood vessels.

In fact, polyurethane has a long history of application in the field of artificial heart assistive implants. Heart valves are generally divided into two types: mechanical valves and biological valves. Mechanical valves are made from artificial materials such as carbon materials, synthetic fabrics, and polymers; biological valves are sourced from animal pericardium or aortic valves and are manufactured in conjunction with artificial stents and fabrics. An ideal artificial valve should possess excellent biostability, blood compatibility, endothelial cell affinity, and also have good anti-calcification capability.

Compared to traditional mechanical valves, bioprosthetic valves have the advantage of long-term use without the need to manage drug reaction issues. However, they have the drawbacks of insufficient durability and susceptibility to calcification. In recent years, the application range of polymeric materials in the field of heart valves has been continuously expanding.

Currently, Dr. Li Zhen's research team has successfully solved the problem of internal stress generated during the use of materials by optimizing the material structure and increasing the silicon content on the material's surface after 10 years of continuous efforts.

03The Development Trends of New Generation Medical Polyurethane Materials

The continuous improvement of safety and quality standards for medical devices and related materials worldwide has driven medical polyurethane materials toward high performance, functionality, and personalization.

From a long-term perspective, the biostability of polyurethane remains a core concern in the field of medical implants.

Biodegradable polyurethane has shown great potential in applications such as drug delivery carriers, wound dressings, scaffolds, and soft tissue engineering scaffolds, which will continue to attract industry attention. However, further research is needed on issues such as the regulation of its degradation rate, the long-term biocompatibility of its degradation products, and their biological effects.

Biologically active or functionalized polyurethanes are ideal materials in the field of tissue engineering, as they can be modified to achieve properties such as antibacterial and anticoagulant effects. However, how to accomplish these modifications with lower cost and higher efficiency remains a major challenge in this field.

With the widespread application of 3D printing technology in the medical industry, the importance of customized production of polyurethane materials is increasingly prominent.

This will provide patients with more personalized and precise medical solutions, thereby further enhancing its application value and market competitiveness.

Dr. Li Zhen further pointed out that some foreign medical device companies have proposed the demand for bio-based TPU, which has become another development trend in this field. However, issues such as the assurance of raw material supply and purity control still need to be addressed.

04The Advanced Path of Domestic Medical-Grade Polyurethane

In the field of medical-grade TPU, domestic universities and enterprises are making continuous efforts and achieving ongoing breakthroughs.

For example, in the “2025 Plastics Industry – Ringier Technology Innovation Awards” organized by Ringier Industrial Media, Wanhua Chemical’s Wanthane® M medical-grade TPU series stood out after fierce competition and won the award.

It is reported that the material covers a hardness range of 70A-82D and is suitable for various processing methods such as extrusion, blow molding, casting, and injection molding. Supporting products such as masterbatches and colorants are also available. The material has been widely used in medical devices including infusion sets, central venous catheters, and dental orthodontic appliances.

In addition, Sichuan Youborui New Materials Co., Ltd. has also attracted widespread attention in the relevant fields.

The company focuses on the research, development, and industrialization of medical-grade TPU and WPU. By undertaking the "13th Five-Year" major scientific and technological project of the Ministry of Science and Technology, it is committed to the localization of medical-grade TPU. Its products have passed the ISO 10993 and GB/T 16886 biocompatibility certification. The product range includes conventional intervention-grade polyether aromatic TPU, implant-grade polycarbonate aliphatic TPU, silicon-containing TPU, among others, and are widely used in cardiovascular, urology, digestive, dressing, orthodontic, and other implant/interventional medical devices. Relying on a ten-thousand-ton medical TPU manufacturing base and adopting a new generation of synthetic processes, the company has eliminated toxic organotin catalysts and easily migratable additives, achieving a complete range of domestic alternatives to international brands.

Due to the extremely long implementation cycle of medical devices, deep cooperation between universities and enterprises will help accelerate the research, development, and commercialization of new products. Taking the development of medical-grade TPU materials as an example, relying on the fundamental research resources of universities can fundamentally narrow the performance gap with foreign products. However, throughout the entire process, university resources need to be connected to the final stages of raw material development; there must be no disconnect between universities and enterprises, and it should not be a simple technical commission. If the production process lacks the support of front-end basic research from universities, it will be impossible to effectively solve the problems encountered in practical applications, resulting in prolonged product development cycles. Dr. Li Zhen shared, “In summary, in my view, to change the single model where universities are only responsible for basic theoretical research and to closely integrate it with engineering practice is the key to promoting the development of innovative products.”