Lubrizol Life Science Health Transforms from Medical Polymer Supplier to CDMO, Offering End-to-End Product Development Solutions for Thousands of Healthcare Clients
As a global leader in the specialty chemicals industry and the inventor of various polymers, including thermoplastic polyurethane (TPU), Carbopol® (carbomer), and chlorinated polyvinyl chloride (CPVC), Lubrizol is committed to making the world run cleaner, smarter, and better.
In the medical field, Lubrizol is also a well-known supplier of medical-grade polymers. Medical-grade polymers are critical materials for the development of medical devices, particularly disposable medical supplies. Although the vast majority of polymers worldwide are used in industrial and consumer applications, with only a small fraction dedicated to medical devices, medical-grade polymers still hold significant importance. Major global chemical companies are actively expanding their presence in the medical polymer market, and Lubrizol is one of them.
As a leader in China’s medical polymer market, particularly in medical-grade thermoplastic polyurethane (TPU) materials, Lubrizol entered the Chinese healthcare market as early as the last century. The company has strategically positioned itself across multiple healthcare segments, including orthodontics and nursing care, drug-device combinations, medical implantables and disposables, and ophthalmology. Its developed medical-grade TPU materials exhibit excellent biological stability, biocompatibility, water resistance, and non-solubility, are free of plasticizers, and serve as an ideal alternative to PVC, earning recognition from numerous healthcare clients. Meanwhile, Lubrizol has actively participated in the drafting and revision of regulations and industry standards related to China’s medical polymer market, promoting standardized development within the industry.
Over the years, Lubrizol has increasingly prioritized the Chinese medical polymer market. It has not only launched a new brand and established a dedicated Life Sciences Health business team to provide local customers with technical and regulatory support, but also transformed from a single-source polymer material supplier into a one-stop solution provider offering polymers, product design and development, and contract manufacturing services. This strategic shift enables Lubrizol to better meet the needs of healthcare customers, helping them shorten product development cycles and reduce costs.
How Is Lubrizol Strategizing Its Position in China’s Medical Polymer Market? What Opportunities and Challenges Exist in China’s Healthcare Sector? Recently, VCBeat conducted an exclusive interview with Yan Ge, Senior Business Manager for Greater China at Lubrizol Life Science Health.
For medical industry clients, when procuring raw materials, it is essential to look beyond the intrinsic properties of the polymer materials themselves and place greater emphasis on the supplier’s capabilities in supporting downstream medical device manufacturers during product development and regulatory registration, as well as their provision of technical support and risk management throughout the manufacturing process. These areas represent the core strengths of Lubrizol Life Science Health.
Yan Ge stated that, compared with other industries, the medical sector is subject to stringent regulation, features long product development cycles, and involves complex customer requirements with generally low volumes. Furthermore, during product registration, manufacturers must submit biological evaluation data for relevant polymer materials, documentation of production control systems, and evidence of similar application cases, among other requirements. Therefore, medical-grade polymer manufacturers must not only ensure the basic physicochemical properties of their raw materials but also provide extensive additional support throughout customers’ product development, registration, manufacturing, and regulatory compliance processes, thereby facilitating successful product development, registration approval, and commercialization.
However, in the current polymer industry, major enterprises typically organize their departments by product lines, such as TPU and PVC business units. This structure requires teams to simultaneously address applications across multiple sectors, including medical, aerospace, industrial, and automotive, which often leads to insufficient specialization and focus. Consequently, it becomes challenging to provide medical clients with long-term, professional, and comprehensive services.
Lubrizol is one of the few companies that has established a dedicated team specifically for the healthcare market. As early as 2012, recognizing the professionalism, specificity, and stringent requirements of the medical sector, Lubrizol formed an independent operational team to provide specialized services to the medical and pharmaceutical industries. This includes expert regulatory and technical support, as well as comprehensive laboratory capabilities. In particular, all members of the China business team have over ten years of experience in the medical and pharmaceutical sectors, enabling them to professionally meet the diverse needs of healthcare customers.
Meanwhile, to better serve customers in the medical and pharmaceutical sectors, Lubrizol has successively acquired several companies in these fields in recent years, including Vesta, Particle Sciences, and BMT. By integrating resources across the industry’s upstream and downstream segments, Lubrizol has transformed from a polymer supplier into a Contract Development and Manufacturing Organization (CDMO), providing customers with one-stop solutions that span polymers, product design and development, and contract manufacturing services. This approach helps customers plan their product development cycles, improve development efficiency, reduce costs, and ensure product quality.
Currently, leveraging its extensive product portfolio, Lubrizol has provided one-stop solutions to thousands of customers across numerous niche segments of China’s medical and pharmaceutical industries. For instance, in the orthodontics sector, Lubrizol’s medical-grade TPU features unique mechanical properties, excellent resistance to stress cracking, and superior abrasion resistance, which enhance orthodontic outcomes while making aligners more durable. Furthermore, Lubrizol offers support with local medical regulations and TPU processing and manufacturing, making Lubrizol TPU materials an increasingly preferred choice for orthodontic manufacturers. In the combination drug-device sector, Lubrizol provides services covering the entire value chain, from early-stage development of combination products to commercialization.
Data from iiMedia Research shows that since 2013, the market size of China's medical device industry has been continuously expanding, reaching RMB 628.5 billion in 2019 and is projected to reach RMB 765.5 billion in 2020, representing a year-on-year growth of 17.9%. Among these, medical consumables, as a segment of medical devices, have already achieved a market size of RMB 320 billion. With the continuous expansion of China's medical device and medical consumables markets, the demand for medical-grade polymers has also developed rapidly in recent years.
As the demand for medical-grade polymers continues to expand, the Chinese market is also facing challenges stemming from stringent regulatory oversight. China is one of the countries with the most rigorous regulations for medical polymers; registering innovative products requires submitting extensive documentation, including raw material certifications, safety proofs, and clinical data, resulting in prolonged product development and registration cycles. For example, although Lubrizol’s medical-grade thermoplastic polyurethane (TPU) materials have been used in infusion devices such as central venous catheters and indwelling needles for over two decades, when a Chinese customer first applied TPU to infusion sets, they were still required to submit substantial safety documentation and clinical data during the review process. The entire development process took more than two years.
Yan Ge stated, “As the market size of medical devices continues to expand, alongside national economic development and heightened public safety awareness, future regulation of medical devices will become increasingly stringent. Regulatory oversight of raw materials will also be intensified, making risk control a major pressure facing the medical raw materials industry.”
“It is important to clarify that although the stringent approval system has, to some extent, dampened the innovation enthusiasm of medical device companies, it serves as a crucial safeguard for the safety of medical device products and provides momentum for the healthy and sustainable development of the entire industry,” said Yan Ge. “Meanwhile, Chinese regulations have been continuously updated and improved in recent years, with the successive introduction of favorable policies such as the Guidelines for Evaluating Changes in Raw Materials for Passive Medical Device Products. We believe that China will be able to enhance innovation vitality while ensuring the standardized development of the industry.”
Looking ahead, Lubrizol, as a global specialty chemicals company, will continue to deepen its presence in China’s medical and pharmaceutical markets. By staying close to local customer needs, the company will consistently provide Chinese clients with one-stop solutions encompassing polymers, product design and development, and contract manufacturing services. Furthermore, Yan Ge stated that emerging opportunities in the medical polymer market include biodegradable biomaterials, 3D printing, and drug-eluting devices. Lubrizol will strategically position itself around these growth areas to deliver more innovative solutions that support the rapid development of the broader healthcare industry.