Driven by the increasing need for safe and efficient medical devices and drug delivery systems, the pharmaceutical polymers / medical grade polymers domain is advancing significantly. There has been a rise in the development of polymers for biopharma with improved biocompatibility, biodegradability and functionality. It is worth highlighting that the manufacturing of polymers for biopharma application needs to be carried out in a controlled environment with strict adherence to regulatory guidelines in order to prevent deterioration of the product quality.
Overview of Polymers
Polymers are synthetic substances comprising of long, repeating chains of structural units/monomers that are bound together by strong covalent bonds. Various synthetic polymers were later discovered in 1900s in order to manufacture tyres, parachutes and other military supplies, as well as insulate the electrical components of aircraft radars. The advancement in this domain was observed in the 20th century, with the evolution of synthetic plastics; this further created new opportunities for the use of medical grade polymers for biopharma.
Presently, polymers are employed in various fields, including agricultural, aircraft, automotive, consumer science, medicine, packaging, and sports. Specifically, in case of the pharmaceutical / medical sector, polymers have been used as excipients in formulations (binders, viscosity enhancers and taste masking agents), packaging of dosage forms and coating material for medical devices. In addition, they offer a number of benefits in drug delivery applications, including controlled drug sustained release, modified pharmacokinetic and biodistribution profile, and improved drug safety. Various medical polymer companies in this domain have undertaken several initiatives in order to further develop / improve the currently available pharmaceutical polymers / medical grade polymers.
Owing to their large number and different behaviors, polymers can be categorized in a variety of ways. The below given figure provides an illustrative summary of the various types of polymers.
Applications Of Polymers in Pharmaceutical Domain
Owing to the rising demand for safe and effective medical devices, such as implants and drug delivery systems, the pharmaceutical / medical grade polymers field is constantly evolving. In the past few years, there has been an upsurge in the research and development of polymers for biopharma with improved biocompatibility, biodegradability and functionality. It is believed that the advancements in the domain of pharmaceutical / medical grade polymers have the potential to improve patient outcomes, as well as quality of life, thereby attracting the attention of stakeholders in biomedical engineering. The medical, biomedical, and pharmaceutical industries rely on high-performance materials like thermoplastic polymers, elastomers, and fluoroelastomers for numerous applications. The various applications of medical grade polymers in pharmaceutical domain are as follows:
Excipients in Pharmaceutical Formulations: Polymers have been extensively used in conventional immediate and sustained release oral dosage forms as excipients in order to facilitate the production process as well as prevent the degradation of the medication during storage.
Delivery of Genes in Gene Delivery: Polymers consisting of a cationic charge (at physiological pH) are considered to be promising candidates with enormous potential and advantages, for transferring genes across major biological barriers.
Vaccine Adjuvants: Polymers often serve as carriers for releasing the antigen and thereby regulating the immunological responses. In addition, polymer-based nano vaccines asre emerging these days and they offer various advantages, such as incorporation of a range of antigens, prolonged antigen circulation and secretion of chemokines, cytokines and proteases.
Dentistry: Owing to the desirable mechanical and biological properties, easy production process and low manufacturing cost, the use of thermoplastic polymers and polymeric films in medicine and dentistry has increased significantly.
Self-Adaptive Wound Care Dressing: An innovative wound care dressing can be prepared using a super-absorbent synthetic smart polymer which can be immobilized onto a 3D fiber matrix having hydration functionality; the dressing functions by detecting and adapting to changes in humidity and fluid content in the wound area.
Recent Trends in Pharmaceutical Domain
In recent years, pharmaceutical / medical polymers have emerged as a key component for the development of new treatments and devices in the healthcare domain. Some innovations related to pharmaceutical / medical grade polymers have been mentioned in the following sections.
Biodegradable Polymers: Biodegradable polymers refer to the polymers composed of monomeric units, which are linked to one another through unstable links. These biodegradable polymers are broken down into biologically acceptable forms (through hydrolytic degradation, enzymatic degradation or both) that can be absorbed without causing any harm or toxicity, or are eliminated completely from the human body. These biodegradable polymers have significant role in the development of stents and occluders, sutures, vascular scaffolds, wound care dressings, implants and many more.
Smart Polymers: Smart polymers, also known as intelligent or responsive polymers, are a class of materials that have the ability to produce detectable responses under the influence of an external stimuli. The various types of smart polymers includes, thermos-responsive, electro-responsive, pH-responsive, temperature-responsive polymers and others. Further, the applications of smart polymers includes their usage in minimal invasive surgery, treatment of cancer, development of personalized medicines and orthodontic wires.
Recycling Of Pharmaceutical Polymers / Medical Grade Polymers: Recycling of polymers can be defined as the activities by which the energy from post-consumer plastics can be easily recovered. There are various processes that can be selected for the recycling of polymers, from mechanical to chemical recycling. Through mechanical recycling processes secondary polymers can be easily obtained; the chemical recycling allows monomers to be used to synthesize a mixture of monomers. Several processes are involved in all these different recycling operations including, sorting, melt processing, thermomechanical degradation and pyrolysis. As a result, stakeholders in the polymers domain have started employing advanced technologies to recycle the polymer products; this initiative provides various benefits, including low production costs, optimization of resource usage and creation of a sustainable environment.
3D Printing in Medical Devices: 3D printing technology is being employed to manufacture personalized medical devices and implants using medical grade polymers. This allows for precise customization and faster production of medical devices.
Antimicrobial Polymers: With the rise of antibiotic resistance, there is a growing demand for antimicrobial polymers that can inhibit the growth of bacteria on medical devices and surfaces, reducing the risk of infections.
Pharmaceutical Polymers / Medical Polymers Manufacturers – Current Market Landscape
Owing to the unique properties and versatile applications of polymers, they have become an essential part of the pharmaceutical / medical industry. Stakeholders involved in this domain manufacture pharmaceutical polymers for use as excipients in medicinal formulations, such as binders, disintegrants, emulsifiers, film formers, lubricants, solubility enhancers and taste maskers Presently, more than 145 players claim to manufacture pharmaceutical polymers / medical grade polymers. The pharmaceutical polymers market is highly fragmented, featuring the presence of established companies, as well as emerging start-ups. Majority of the players engaged in this domain are based in Asia-Pacific; this is primarily due to the low cost of labor and raw material, rising demand for functional pharmaceutical polymers / medical polymers and favorable government initiatives that boost the manufacturing sector in Asian countries. This is followed by pharmaceutical polymer / medical polymer manufacturers located in Europe and North America.
Most of the companies manufacture amino-based polymers, including collagen, gelatin, poly-lysines, polyglutamic acid and poly-sarcosines. Additionally, 60% of the companies engaged in this domain manufacture synthetic polymers; this can be attributed to the various advantages offered by them, including high versatility, good flexibility, reasonable strength and chemical inertness.
Competitiveness of Pharmaceutical Polymers / Medical Polymer Manufacturers
In pursuit of building a competitive edge, medical polymer companies are actively upgrading their existing capabilities to enhance their respective product offerings and comply with the evolving industry benchmarks.
Company strength (Px) on the X axis is representative of the relative strength of the companies based on the year of establishment and company size. Further, portfolio competitiveness (Py) on the Y axis is representative of the relative strength of the companies based on the source of polymer, number of unique types of polymers, biodegradability of polymer and number of application area.
Industry Stakeholders Are Striking Partnerships to Strengthen Their Product Portfolio
Partnership activity has increased steadily over the years, involving the participation of both indigenous and international medical polymer companies. The maximum number of partnerships were inked in 2021 and 2022, majorly for the development, manufacturing and commercialization of thermoplastic polymers which are known to have numerous advantages, including easy mouldability, energy-efficient processing, high strength and light weight. Product development agreements emerged as the most common type of partnership model adopted by stakeholders in pharmaceutical polymers / medical polymers.
Likely Pharmaceutical Polymers Global Market Growth
During our research, we estimated the medical polymers market size under conservative, base and optimistic scenarios. As per the base case forecast scenario, medical polymers market size is estimated to grow at a CAGR of ~9%, forecast period during 2023 – 2035.
Polymers, with their wide array of applications, have a major impact on our day-to-day life. In case of the pharmaceutical / medical domain, they have been used for a variety of purposes, including excipients in pharmaceutical dosage forms, controlled and targeted delivery of drugs, packaging systems for medications and medical device coatings. Additionally, a variety of novel polymers have been developed that respond to external stimulus, including electric or magnetic field, enzymes, pH, temperature and ultrasound waves, thereby modifying the sustained release of the medication. The ongoing technological advances in this field and the rising demand for innovative drug delivery systems in the near future is likely to provide the necessary impetus to the medical polymers market.