GLOBAL POLYMERIC BIOMATERIALS MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2023 - 2030)

Market Challenges And Opportunities

Global Polymeric Biomaterials Market- Drivers

• Increasing orthopedic and dental applications: Orthopedic and dental applications are prominent drivers for the growth of the global polymeric biomaterials market. Polymers are increasingly being used in orthopedic implants, joint replacements, and other medical devices that go inside the human body. Their biocompatibility and ability to replicate the properties of bone and teeth tissues have made them the material of choice for applications that involve integration with living tissues. Many commonly used polymers like polyetheretherketone (PEEK), polycaprolactone (PCL) and polylactic-co-glycolic acid (PLGA) exhibit characteristics like strength, durability and flexibility that mimic natural tissues. They help in faster healing of fractures as implants made from these materials allow for bone ingrowth. This promotes integration of the implant with the surrounding tissue, thereby leading to long term stability and minimal rejection by the body. Polymeric biomaterials also alleviate the need for repeated surgeries to replace failing metallic implants over time. On the dental front, polymers are revolutionizing applications like dental fillings, crowns, bridges and aligners through 3D printing technologies. Resins and composites formed by polymerization processes enable custom modeling of dental structures. For example, clear aligners made of advanced polymers can straighten teeth without inflicting the discomfort of metal wires as in traditional braces. They are removing barriers to aesthetic orthodontic treatment. According to the American Association of Orthodontists, the number of cases using clear aligners grew by 50% between 2015-2019.
• Rising awareness about benefits of biomaterials: Rising awareness about the benefits of biomaterials is a key driver for the growth of the global polymeric biomaterials market. Biomaterials are increasingly being used in various medical applications due to their biocompatibility and ability to mimic natural body tissues. Polymeric biomaterials, in particular, have gained popularity due to their flexibility in material design, manufacturing process ability, and structural properties. Polymers can be easily synthesized and modified chemically to achieve desired properties matching natural tissues. This allows them to be tailored for specific applications. For example, biodegradable polymeric biomaterials have been formulated to degrade gradually and allow new tissue growth as the implant dissolves. Others are designed for permanent implantation such as polymeric hip and knee replacements. The customizability of polymers enables creating materials for minimally invasive procedures as well as organ regeneration applications. Rising disease burden along with an aging global population is increasing demand for medical devices and implants. At the same time, innovation in the field of tissue engineering and regenerative medicine is accelerating. Polymers are increasingly being researched and developed for advanced applications such as 3D bioprinting of tissues and organs. For instance, scientists are researching the use of polymeric biomaterials combined with living cells as "bio-inks" to print functional tissues such as ligaments, bones, and skin grafts. This is expected to transform treatment of chronic diseases and injuries in the future. According to the recent data by the United Nations, the percentage of global population aged over 65 will rise from 9% to 16% from 2020 to 2050. Elders are more prone to chronic diseases and injuries requiring polymeric medical implants and devices. According to the World Health Organization (WHO), chronic diseases accounted for 71% of global deaths in 2019. Cardiovascular diseases lead to over 18 Mn deaths annually worldwide. Such trends underscore the vast unmet need for advanced biomaterial based therapies.

Global Polymeric Biomaterials Market- Opportunities

• Emerging markets in Asia Pacific and Latin America: Emerging economies in the Asia Pacific and Latin American regions provide immense opportunities for growth in the global polymeric biomaterials market. These developing nations are witnessing rapid urbanization and economic development which has bolstered the growth of their healthcare sectors tremendously. According to the statistics published by the World Bank, in 2022, healthcare expenditure as a percentage of gross domestic product (GDP) has increased substantially in countries such as India, Indonesia, Brazil, and Mexico, indicating greater government focus and investments to strengthen healthcare infrastructure and facilitate improved access to advanced medical treatments for more people. With the continual expansion of medical services across urban and rural populations alike in these regions, the demand for advanced biomaterial-based technologies for applications such as surgical repair and replacement of tissues is projected to multiply. Bioresorbable polymeric biomaterials that assist in tissue regeneration are gaining widespread acceptance for use in various surgical specialties including orthopedics, dentistry, cardiology and wound care. Their ability to degrade naturally in the body post implantation, eliminating the need for subsequent surgical removal of permanent prostheses, makes them extremely suitable for healthcare delivery in developing nations. Some notable biomaterial-based products gaining ground include biodegradable polymeric scaffolds for bone and cartilage regeneration, absorbable sutures and staples for wound closure, and biodegradable stents prominently featuring in interventional cardiology procedures. For example, according to the World Health Statistics published by the World Health Organization (WHO) in 2022, India witnessed a massive 41% increase in the number of percutaneous coronary intervention (PCI) procedures between 2015 to 2020, thereby cementing its position as one of the highest PCI performing countries worldwide. Such rapidly evolving clinical landscapes prove conducive for the uptake of advanced biodegradable biomaterial technologies that is aimed at simplifying treatment paths. Considering factors such as the growing economic ability of populations to access private and public healthcare combined with governments prioritizing healthcare development, the polymeric biomaterials market is expected to harness significant gains across Asia Pacific and Latin American countries.
• Innovation of new biomaterial-based products: Innovation of new biomaterial-based products could provide a major opportunity in the global polymeric biomaterials market. Biomaterials are developed using polymers to be biocompatible and biofunctional for medical applications. Polymeric biomaterials have an edge as they can be molded easily into various medical devices and implants. The demand for biomaterials is expected to grow significantly in the near future due to rapid advancements in medical technology as well as rising healthcare needs worldwide. According to the recent estimates by World Health Organization, globally non-communicable diseases are projected to burden 70% of overall disease by 2030. This increasing disease prevalence will fuel the demand for advanced treatments like tissue engineering and regenerative medicines that utilize biomaterials. Various new polymers are under research that can replicate properties of human tissues much better than existing biomaterials. Researchers are also working on designing smart biomaterials that can dynamically interface with biological tissues for improved therapeutic outcomes. 3D printing technology in particular holds promise for customized prosthetics, implants and tissue scaffolds by using such candidate biomaterials. The market players are continuously investing in R&D to develop biomaterial-based products for various applications like orthopedics, cardiology, dentistry, neurological disorders etc. For instance, a new bio-compatible and biodegradable polymeric biomaterial was under clinical trial in 2020-21 for minimally invasive spinal disc replacement according to study published in Biomaterials Journal. Such innovations not only provide new treatment solutions but also have capability to disrupt existing medical devices market in long run. As disorders affecting musculoskeletal system and cardiac health become more prevalent worldwide, demand for next-gen biomaterial-based implants and assistive devices will keep rising in future.

Global Polymeric Biomaterials Market - Restraints

• High cost of biomaterial-based products: The high cost of biomaterial-based products is significantly restraining the growth of the global polymeric biomaterials market. Biomaterial-based medical devices and implants are generally much more expensive than conventional treatment options since they require expensive raw materials and an intricate manufacturing process. For example, according to the data by the World Bank, the average cost of a hip replacement surgery utilizing a biomaterial implant in the U.S. is over US$ 40,000. In comparison, traditional joint replacement procedures without polymers typically cost under US$ 15,000. Similarly, in Europe, the average costs of heart valves made from biomaterials are 3-4 times higher than tissue/metal valves according to Eurostat. This high price tag that is associated with biomaterial-based offerings poses affordability challenges, especially in developing regions with lower per capita incomes and limited healthcare budgets. Many patients in these areas are unable to afford such expensive treatments and procedures upfront due to inadequate insurance coverage or high deductibles. As a result, a significant proportion of the global population has very limited or no access to the benefits of advanced polymeric biomaterials. Even in developed markets, the increasing healthcare expenditures associated with these high-priced products place considerable financial burdens on patients as well as public and private insurance providers. This unfavorably impacts the growth and widespread adoption of biomaterial technologies. To make biomaterial-based medical solutions more economically viable and expand their reach, companies are investing heavily in research and development activities aimed at reducing manufacturing costs through process optimization and automation. For instance, in 2020, according to a report by the World Health Organization, researchers are exploring new techniques like3D-printing of biomaterials that could lower production costs by 40-60% as compared to traditional techniques. Continued innovations to drive down costs through such technological advancements will be vital for the polymeric biomaterials industry to overcome affordability barriers over the long-run and unlock its true market potential on a global scale.

Counterbalance: The key market players should implement proper and adequate insurance coverages for the patients who are unable to afford the biomaterial based treatments due to high costs.

• Stringent regulatory environment: The stringent regulatory environment across the globe is presenting significant challenges for the growth of the global polymeric biomaterials market. Complying with regulations related to biocompatibility, toxicity, and safety has become increasingly complex. Polymeric biomaterials are extensively utilized in medical applications ranging from artificial implants and devices to tissue engineering constructs. However, obtaining regulatory approval for new polymeric biomaterials and related medical products has become a lengthy and expensive process. Regulatory agencies across regions like North America, Europe, and Asia Pacific have made revisions to existing norms and introduced new guidelines to ensure the materials and technologies that are used inside the human body do not cause any adverse health effects. For example, in Europe the Medical Device Regulation 2017/745 replaced the earlier medical device directive and imposed stricter pre-market scrutiny and post-market surveillance protocols for manufacturers. Complying with the new regulation involved significant investments into upgrading quality management systems, conducting detailed clinical trials, and providing richer technical documentation for submissions. This increased the costs and timelines for bringing new polymeric biomaterial-based products to the European market. Similarly, the U.S. Food and Drug Administration (FDA) have taken up steps to strengthen oversight of Class III medical devices which are generally implanted inside the body for long term use. According to a report by the U.S. FDA, in 2020, the median time taken for review and approval for such high-risk devices was increased to 208 days as compared to 180 days. Such review times can be detrimental for technologies depending on rapid uptake in the market. The policies by regulators aim to ensure patient safety but end up delaying market access for companies. This regulatory hurdle is proving to be a restraint that is slowing the adoption of advanced polymeric biomaterials and curbing the growth momentum of this market globally.