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Viewpoints About This Technology Biomaterials are substances (including polymers, metals, ceramics, and composites) that are produced synthetically or biologically for use in the treatment or management of a disease, condition, or injury. 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. Improved devices and drug-delivery systems can improve 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 in technology and industry structure can affect the profitability of biomaterials in medical products. Analysts from the EU Competitive and Sustainable Growth Program estimate that the worldwide market for biomaterials was some $23 billion in 2000 and predict that the market will grow some 12% per year. The United States is the major market, with a value of some $9 billion and a growth rate of 20%. Europe's market is some $6 billion. Biomaterials feature in a range of established medical devices, such as implants to replace diseased joints, and as surgical-repair materials such as sutures and repair meshes. For these established products, continuing R&D will improve key requirements for the product, such as more durable joint implants. Such developments improve medical outcomes for patients, differentiate broadly similar products, and enable manufacturers to gain competitive advantage. Biomaterials also make a significant contribution in the growing field of drug-delivery systems. Biomaterials have properties that enhance drug delivery and provide technologies for alternative delivery routes and release mechanisms. Finely tuned drug delivery is becoming a reality with the support of biomaterials, particularly for the growing range of protein therapeutics emerging from research in genomics and proteomics. Regenerative medicine offers patients products that repair or replace worn-out tissues. A range of 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 and heart valves are not likely to be on the market before 2010. For the foreseeable future, biomaterials will have an important place in medical technologies. Biomaterials have no shortage of potential applications in medical devices and drug-delivery systems. In the future, biomaterials may face competition from stem-cell technology that has the potential for "natural" replacement tissues and organs (that do not use biomaterials), but this technology is a distant and somewhat uncertain prospect. Three main factors constrain the expansion of the biomaterials market: the high costs of development and achieving regulatory approval, availability of funds to pay for more sophisticated and expensive health care, and the specter of litigation. |
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