Viewpoints

About Biomaterials

Biomaterials are substances (including polymers, metals, ceramics, and composites) that form part of a living structure or medical device or that are themselves wholly a medical device. Biomaterials can treat or substitute for biological functions that disease or injury or other conditions have impaired, or they can serve an aesthetic function in elective cosmetic procedures to alter appearances. In short, biomaterials can directly repair, augment, or replace the biological function. New R&D, testing methods, and manufacturing processes can lower the cost of developing new biomaterials. New breakthroughs in biocompatible materials and coatings can markedly lower the risk of device failure or adverse immune reactions to the structure or device. Improved devices and drug-delivery systems can improve individuals' health and lower long-term treatment costs to consumers and insurers. Broader markets, industry changes, population demographics, supply chains, health-care financing, tort reform/product-liability legislation, and international regulatory standards will all have a major impact on the profitability of biomaterials. This Technology Map examines how changes and developments in materials, medical and surgical techniques, user demands, regulations, and industry structure can provide opportunities for biomaterials developers to establish products in a still fast-growing market for medical products.

Biomaterials already see use in a range of established medical applications, including implants to replace diseased joints, surgical-repair materials such as sutures and repair meshes, and tissue such as breast implants. For these established products, continuing R&D will improve key requirements, such as more durable joint implants. Such developments improve medical outcomes for patients, differentiate broadly similar products, and enable manufacturers to gain competitive advantage. Further developments in biomaterials' design and biocompatibility will enable production of novel implant structures. Biomaterials also make a significant contribution in the fast-growing field of drug‑delivery systems. Biomaterials have properties that enhance drug delivery and provide technologies for alternative release mechanisms. Finely tuned drug delivery is possible with the support of biomaterials, particularly for the growing range of medical devices and implants that can deliver superior performance with improved biointegration with the surrounding tissue.

Regenerative medicine offers patients products that repair or replace malfunctioning or worn-out tissues. Numerous applications for biomaterials in regenerative medicine are emerging in response to the aging population of the more economically advanced countries. Regenerative medicine will also benefit people with autoimmune and early-onset degenerative diseases and people who require treatment for trauma injuries. The first products (synthetic and natural biomaterial scaffolds to enable tissue repair and regeneration) were available commercially in 2000, but products such as tissue-engineered blood vessels are unlikely to be on the market until the late 2020s, with major organ replacements not likely for at least another ten years thereafter. For the foreseeable future, biomaterials will have an important place in medical technologies. Biomaterials have no shortage of potential applications in implants, medical devices, and drug-delivery systems. However, in the future, established biomaterials will face competition from stem-cell technology, which has the potential for "natural" repair and replacement of tissues and organs (that do not use biomaterials). Several treatments are in clinical trials in the United States and Europe, and therapies are already available in regions such as Asia and Latin America, where their entry to market faces less regulatory scrutiny. Three main factors constrain the expansion of the biomaterials market: the high costs of development and achievement of regulatory approval, availability of funds to pay for more sophisticated and expensive health care, and the specter of litigation following failure.