MEDICAL ENGINEERED MATERIALS MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2023 - 2030)

Market Challenges And Opportunities

Global Medical Engineered Materials Market- Drivers

• Growing prevalence of chronic diseases: Rising prevalence of chronic diseases such as cardiovascular diseases, neurological disorders, orthopedic conditions, and cancers is a major factor driving the global medical engineered materials market. Chronic diseases are on the rise globally due to sedentary lifestyles, unhealthy diets, pollution, and higher life expectancy. Engineered biomaterials are increasingly used for treatment and management of various chronic disorders. For instance, cardiovascular stents made of metallic alloys improve blood circulation in blocked arteries. Polymeric materials are used to develop drug delivery systems for targeted therapy of cancer. The demand for such engineered biomaterials is expected to grow as the burden of chronic diseases increases globally.
• Technological advancements in engineered biomaterials: Significant advances made in material science and engineering technologies are facilitating development of novel engineered biomaterials with enhanced properties and performance. Technologies like 3D printing/additive manufacturing allow fabrication of intricate designs and customized engineered biomaterials suitable for patient-specific needs. Nanotechnology is enabling engineering of nano-scale biomaterials with superior mechanical, electrical and biological properties. Tissue engineering has led to development of scaffolds using biomaterials that can regenerate damaged tissues and organs. Such technological innovations are creating new growth avenues for engineered biomaterials in treatments like regenerative medicine, biosensors, bioprinting of organs and implants. For instance, according to the U.S. Environmental Protection Agency, municipal solid waste generation had increased by over 4% from 235 million tons in 2018 to 245 million tons in 2020, necessitating sustainable biomaterial alternatives.
• Growth in aging population: Growing geriatric population worldwide susceptible to various age-related disorders is expected to boost demand for medical engineered materials. Older people are more likely to develop chronic illnesses like arthritis, cardiovascular diseases, neurodegenerative diseases, vision/hearing loss, osteoporosis, and others. These conditions require engineered biomaterials like strong lightweight prosthetics, artificial joints, dental implants, cochlear implants and intraocular lenses for treatment. Moreover, engineered scaffolds and matrices stimulate tissue regeneration in the elderly. Rising geriatric population is likely to propel the growth of the market in the near future.
• Investments and research in engineered biomaterials: Increasing investments by public and private players in research activities for development of novel engineered biomaterials for medical use is poised to fuel the market growth. Various academic and research institutes are undertaking studies to engineer advanced biomaterials with desired mechanical properties, biocompatibility and functionality. Moreover, leading medical device and pharmaceutical companies are channelizing funds to establish R&D centers focused on biomaterials research. Partnerships between academia and industry players are also increasing to translate innovative research into commercially viable engineered biomaterials, thereby, offering growth opportunities for the market.

Global Medical Engineered Materials Market- Opportunities

• Applications in personalized medicine: The emerging field of personalized medicine presents significant growth opportunities for engineered biomaterials. Customized biomaterials that match the specific genetic makeup of patients can lead to improved therapeutic outcomes. 3D bioprinting technology enables fabrication of patient-specific organs, tissues and devices using tailored biomaterials and cells sourced from the patients themselves. Companies are also developing drug delivery systems containing engineered biomaterials that can release medicines at a rate aligned to the patient's physiological conditions. Such innovations in precision medicine are creating prospects for engineered biomaterials. For instance, according to National Cancer Institute, the percentage of cancers with a driver mutation identified through genomic profiling will increase from 50% in 2020 to 70% by 2023.
• Rising demand in developing regions: Developing regions worldwide exhibit huge demand potential for medical engineered materials due to improving healthcare infrastructure and increasing healthcare spending. Emerging economies like China, India, Brazil, Mexico, Indonesia, and others have a high patient pool and rising incidence of chronic and lifestyle diseases that require interventions using engineered biomaterials. Local players as well as leading medical device companies are expanding their manufacturing facilities in these regions. Moreover, growing middle class populations, adoption of advanced technologies, favorable government initiatives and policies are key factors likely to serve the market growth in developing regions. For instance, according to United Nations Population Division, the middle class population in India will grow over three times to about 800 million people by 2030, providing a sizable customer segment for medical devices.
• Shifting focus towards bio-based materials: Increasing environmental concerns associated with traditional engineered biomaterials derived from non-renewable sources is steering research efforts towards development of sustainable bio-based materials. Naturally derived biomaterials from marine organisms, microbial sources, agricultural waste, food waste, and others are gaining interest. Biopolymers like collagen, chitosan, silk fibroin, cellulose, starch, and others are being explored for tissue engineering and drug delivery. Bio-based composites mimicking the structure and function of native extracellular matrix are also being developed. The shift towards such renewable and eco-friendly biomaterials is paving new avenues in the market.
• Widening applications in diagnostics: Engineered biomaterials exhibit tremendous scope for use in diagnostic platforms like biosensors, lab-on-chip devices, microfluidic chips, and others due to their biocompatibility, versatility in modifications and tuneable physical/chemical properties. For instance, quantum dots, hydrogels, nanocomposites and conductive polymers are being engineered into platforms for rapid diagnostics, home testing kits, wearable sensors, and others. Companies are also developing injectable nanosensors made from biomaterials for real-time monitoring of biomarkers. Thus, potential use of engineered biomaterials in point-of-care and molecular diagnostics is creating lucrative prospects.

Global Medical Engineered Materials Market- Restraints

• Stringent clinical & regulatory requirements: Lengthy and stringent approval processes mandated by regulatory agencies like FDA for newly developed engineered biomaterials poses key challenges for manufacturers in terms of time and costs. Biomaterials must undergo rigorous preclinical and clinical evaluation to establish safety and efficacy before approval for commercialization. Moreover, the regulatory landscape is continuously evolving with changing validation requirements, calling for expensive modifications. The complex and ambiguous regulatory scenario across different geographies acts as a major barrier for uptake of latest engineered biomaterials. For instance, according to the European Commission, between 2020-2022, the EU has invested 297 million US$  in Horizon Europe to support research on advanced therapies and novel materials for implants and prosthetics. While ensuring patient welfare, such initiatives aim to spur growth by helping worthy projects overcome regulatory hurdles more efficiently.
• High development and production costs: High capital requirements for R&D and manufacturing of engineered biomaterials along with long timelines from concept to realization is a major restraint faced by developers and suppliers. Significant investments are required for establishing advanced material engineering facilities, acquiring latest fabrication and characterization technologies, and recruiting skilled researchers. Moreover, scale-up from lab to commercial batches involves substantial expenses. Lack of proper funding resources hampers innovation and adoption of novel engineered biomaterials, thereby hindering the market growth. For instance, in 2022, according to the report published by National Institutes of Health, 3D printing of titanium implants involve specialized multi-step processes like powder production, part fabrication, heat treatment and surface modification which increases the cost by 5-10 times as compared to conventional implants. Similarly, development of new bio absorbable materials require careful tuning of material properties like degradation rate through modifications in chemical composition and microstructure which is a costly trial-and-error process.
• Reimbursement challenges: Limited reimbursement coverage provided by healthcare payers like Medicare, Medicaid and private insurers for treatments involving newer engineered biomaterials poses challenges for market growth. Due to lack of medical evidences from long-term clinical studies, insurers hesitate to provide payment approval for newly introduced biomaterials. Patients are reluctant to adopt treatments using latest biomaterials, owing to high out-of-pocket costs, unless reimbursement policies are improved. Lack of reimbursement infrastructure especially in developing regions negatively impacts the product adoption.