A biomaterial is a substance intended to interface with biological systems to evaluate, treat, augment, or replace any tissue, organ, or function of the body for a lifetime, such as, total hip replacements, as well as those that interact with the body for short periods of time, such as, soft contact lenses. The sources of biomaterials can be natural or synthetic and their selection is dependent on the application and properties of materials. Biomaterials are segmented depending on source i.e. Metal and Metal alloys, Synthetic Polymers, Ceramics, Natural biomaterials and Composite biomaterials. An ideal biomaterial should possess properties like biocompatibility (non-toxic and non-carcinogenic), Biostability (chemical inertness), Tribological properties (wear and corrosion resistant), Electrical, Thermal and Optical properties etc. According to IQ4I analysis, the Implantable Biomaterials global market is expected to be worth $21,124.2 million by 2022.
The increasing aging population, increasing demand for minimally invasive procedures, increasing research and development investments, growing demand for plastic surgery, miniaturization of implant devices, advanced technologies and reimbursements are the factors driving the implantable biomaterials global market. However, stringent regulations imposed on biomaterial-based products, complications due to implant rejection, cytotoxicity, and corrosion of biomaterials implant are restraining the growth of the implantable biomaterials global market. Geographically, developed regions of North America followed by Europe dominates in revenues, however, Asia-Pacific region is propelling with fast growth due to the increased patient pool of orthopaedic and cardiovascular diseases, and increased government investments in healthcare infrastructure.
Metals are used as implant materials because of their bio-inert, high biocompatible and durable properties. Metallic and ceramic materials have been broadly applied in biomedical engineering in the form of implants and devices because of their excellent mechanical performances such as high moduli and stiffness. However, the metallic ion generated from the dissolution of metallic materials in body fluid can lead to allergy, poisoning, cellar reaction and so on, which are often detrimental to human health and result in failure of the implant. Besides, many metallic materials have higher moduli than human bones; thus, they can generate stress-shielding effect and result in loosening of the implant. Ceramic materials also have some disadvantages such as low fracture toughness. Therefore, polymer-based biomaterials have become a promising alternative material for metallic and ceramic material in biomedicine. When compared to metals and ceramics polymer-based materials have many advantages such as cost-efficiency, easy preparation, self-lubrication, superior tribological properties, etc.
Currently, the implantable biomaterials market is dominated by the synthetic polymers occupying the largest market share. Among synthetic polymers, Resorbable polymers are emerging biomaterials expected to grow significantly reason being using of biodegradable or resorbable polymers as implant devices requires only one implantation surgery. Whereas, in case of a non-resorbable implant, two surgeries (i.e. implantation and extraction of the implant later) are performed. The use of resorbable polymer can vastly improve a patient’s quality of life during operations and reduce risk to the patient. The Polylactic acid (PLA), Polyglycolic acid (PGA), PCL (Polycaprolactone), PGS (Poly (glycerol sebacate)) and Poly (lacticcoglycolic) acid (PLGA) are contributing strongly to the development of biodegradable medical implants. The increase in popularity can be attributed to a general increase in demand for resorbable biomaterials and in turn drives implantable biomaterials market.
The demand for natural biomaterials are expected to grow in future due to their bioabsorbability, ease of processing and compatibility when compared to other biomaterials, but presently their use is limited mainly due to their apparent variations in quality of material from batch-to-batch which basically depend on species and tissues of origin or harvesting procedure. Apart from these limitations, the nature of protein based natural biomaterials makes them more vulnerable to the immune response.
Emerging technology such as 3D printing is making an impact on consumption of biomaterials by reducing the cost and time required for manufacturing. 3D Printing promises to produce complex biomedical devices using computer design based on patient-specific anatomical data. Before 3D Printing can be used routinely for the regeneration of complex tissues (e.g. bone, cartilage, muscles, vessels, nerves in the craniomaxillofacial complex), and complex organs with intricate 3D microarchitecture (e.g. liver, lymphoid organs). Technological limitations of 3D printing are accuracy, depends on the images or operators, intraoperative measure to test accuracy, expensive software. 3D printing of medical implants has an immense advantage over traditional implants. One of the major advantages of 3D printing is the low cost of manufacturing and high precision, patient-specificity. With the increase adoption in 3D printing technology, better and anatomically accurate implants can be manufactured which directly affects the consumption of biomaterials by medical implants manufacturing companies.
In February 2016, BioArchitects received 510(k) clearance by the U.S. Food and Drug Administration – FDA, for the company’s 3D printed patient specific titanium cranial/craniofacial plate implant. Designed for the repair of defects in the non-load bearing bones of the head and face, each custom designed plate is permanently attached to the skull and/or face with self-tapping titanium screws.
Biomaterials and biomaterial-based products used as implantable medical devices have to clear stringent regulatory processes for e.g. USP Class VI standards, FDA 21 CFR 820 Compliance, ISO 13485, ISO 22442-1:2015, sterilization process etc. Various standard tests have been imposed for a medical device or for material for evaluation of biocompatibility. Biomaterials should clear regulatory tests like genotoxicity, carcinogenicity, reproductive toxicity, hemocompatibility, degradation tests for polymers, ceramics, metals, and alloys, etc. The stringent and overlapping regulatory requirements are threat to the growth of biomaterials market.
The global Implantable Biomaterials market is fragmented and major players such as Solvay S.A., Royal DSM, Johnson Matthey Plc, Carpenter Technology Corp., Evonik Industries AG and others control only a small percentage of the market. The pricing pressure among the competitors is high, because lack of product differentiation. As new biomaterials are emerging competitive manufacturing processes like 3D printing are being adopted by new players to overcome the entry barrier and aid in capturing market share.
Some of the major players in global implantable biomaterials market are Solvay Advanced Polymers, LLC (Belgium), Evonik Industries AG (Germany), Carpenter Technology Corporation (U.S.), Royal DSM (Netherlands), Johnson Matthey Plc (U.K.), Morgan Advanced Materials plc (U.K.), Materion (U.S.), Victrex PLC (Invibio Biomaterial Solutions ) (U.K.) and Collagen solutions (U.K.), Corbion N.V. (Netherlands), Landec Corporation (U.S.), Merck (Sigma-Aldrich) (Germany), Amedica Corporation (U.S.), Noble Biomaterials Inc. (U.S.), Ulbrich stainless steels & special metals inc (U.S.), Zeus Biomaterials (U.S.), etc.