Opting for the right material to use in a medical device is no longer a complex procedure, barring the fact that such medical devices fabricated using these materials are biocompatible, which can be ensured by upping the ante for tests needed to be passed by designers and engineers, if they want regulatory approval for their devices, as per Industry Experts. Advancements in medical technology have taken a heavy toll on plastic materials that are used in medical applications, which has been further exacerbated by developments in the fields of medical plastic, titanium/stainless steel metal replacement implant materials, being primarily driven by issues of biocompatibility, in addition to demand for enhanced implant mechanical performance. The global biomaterials market for 2011 is estimated at US$37.6 bln and is projected to increase at a CAGR of 14% (2007-2017) to reach US$83.9 bln by 2017.
According to a report by Global Industry Analysts, Inc, the global market for biocompatible materials is forecast to reach US$63.3 bln by the year 2015. Growing ageing population, increase in average life expectancy, relatively shorter medical device product life cycles, increasing deployment of biocompatible materials, new product approvals, enhanced patient benefits as well as increased awareness, broader application areas of biomaterials are the key factors driving market growth. Robust growth is likely in major areas of biomaterial application, including cardiovascular, orthopedic, neurological, and drug delivery. The market for biocompatible materials continues to witness strong growth, considering the fact that annually, one million orthopedic devices, and 200,000 pacemakers are implanted, across the world. Technological advancements coupled with greater insight into the body’s functions are major factors propelling growth. In addition to demographic and technology trends, growth in the market is derived from the advent of new healthcare developments that minimize surgical and recovery times. Future growth in the market is expected to depend upon fabrication technology improvements and development of new products at competitive prices. Robust growth is likely in major areas of biomaterial application, including cardiovascular, orthopedic, neurological and drug delivery. However, factors such as dearth in reimbursement facilities and tissue availability are expected to dampen growth in the market to a certain extent. The orthopedic biocompatible materials market is expected to dominate, followed by cardiovascular biocompatible materials. The magnificent growth in these segments is attributed to rise in the number of ageing population in emerging economies and in developed countries, as over 20% of the total global population by 2050 is forecast to be aged 60 years or more. Other potential end-use segments for biomaterials include urology, plastic surgery and wound care. North America represents the largest regional market for biocompatible materials worldwide, Europe constitutes the second largest market worldwide. However, growth is primarily expected to emanate from developing markets in Asia-Pacific and Latin America. Material wise, Polymeric Biomaterials dominate the global market for biocompatible materials. Future growth in the market, however, is expected to be propelled primarily by natural biomaterials, including collagen, and hyaluronic acid-based biomaterials. Global demand for metallic biomaterials is projected to post a compounded annual growth rate of close to 10% during the analysis period. Natural substances such as human or animal tissues are being increasingly employed in the development of novel biomaterials for use in various surgical interventions. Rapid advancements in tissue processing technologies have provided considerable thrust to the use of natural substances in treatment of several chronic ailments including organ failure or malfunction. Natural substances are combined with synthetic materials to develop innovative hybrid products that incorporate biocompatible properties of both materials. In the dental arena, ceramic promises to be a potential biomaterial for the development and manufacture of teeth crowns. Materials offering key applications in crown development, include porous alumina, porous zirconia impregnated with glass, porous spinel impregnated with glass, and leucite reinforced feldspathic porcelain.
US demand for biocompatible materials will increase 6.6% pa to US$3.7 bln in 2010, as per Freedonia. Gains will match the overall upward pace of end-use product shipments as stricter FDA pre-market approval and production standards mandate the upgrading of materials used in medical and dental implants and drug delivery systems. Due to quality, performance and versatility advantages, synthetic and natural polymers will continue to dominate the overall market for biocompatible materials. However, metals and ceramics will continue to build niche opportunities in specialty devices and equipment such as orthopedic and dental implants, pacemaker and defibrillator components and stents. Synthetic polymers will continue to record more than half of revenues and post slightly better than average gains in demand. Based on quality and safety advantages in catheters, IV administration sets, IV and blood containers, and orthopedic implants, engineered resins - especially polycarbonate, thermoplastic elastomers, silicone and sulfone compounds - will provide the best growth opportunities. By contrast, demand for polyvinyl chloride in biocompatible products will expand at a below average pace due to ongoing concerns about DEHP plasticizer migration. Increasing use in pharmaceutical excipients, drug delivery systems, cosmetic implants, tissue engineering and wound dressings will boost demand for natural polymers. Hyaluronic acid and collagen will post the strongest gains as new improved bioengineered formulations broaden applications in cosmetic and orthopedic surgery as well as in wound management. Based on well-established performance results, cellulose polymers and starch blends will continue to record substantial gains in pharmaceutical excipients and controlled-release drug delivery systems. Precious metals will sustain the largest demand value among biocompatible metals based on high price and widespread use in dental repair and restoration products. However, reflecting advantages of high strength, low modulus and strong body fluid resistance, titanium and titanium alloys will provide the best growth opportunities. These metals will extend applications in joint replacement systems; dental implants; fusion cages; trauma fixation devices; pacemaker and defibrillator cases; cochlear implant houses; stents; and mechanical heart valves. The penetration of titanium and titanium alloys into new and existing uses will weaken the growth potential of stainless steel and other biocompatible metals, such as cobalt chromium alloys. Ceramics will realize the strongest growth among all biocompatible materials as advances in the properties and processing ease of these compounds broaden their uses. New generations of alumina-zirconia nanocomposites are expected to see the strongest gains. These high density structures incorporate greater resistance to cracking, an important advantage in orthopedic implants, fixation devices, and dental repair and restoration products