In the six years since BCC Research undertook its first comprehensive study of the medical device coatings and surface modification treatment industry, the business has responded to a shifting balance of driving and limiting forces originating from within and outside the healthcare and coating communities. During that time, the fast pace of technological advances that originally drove the industry has slowed.
While innovation continues, its focus has shifted away from new coating materials to improving products already in use. The regulatory environment likewise evolved. Requirements that were vague at the beginning of the new century formalized with the creation of a new U.S. Food and Drug Administration (FDA) office created to oversee so-called combination products. Earlier this year (2012), the National Academy of Sciences' Institute of Medicine (IOM), the nation's leading independent authority on medical science, called for a complete overhaul of the FDA regulatory process through which new products come to market. The announcement came as new studies raised questions not only about the comparative efficacy of two major types of coated metal products, arterial stents and artificial hip joints, but also the FDA's mechanism for identifying poorly performing products.
Against that backdrop of regulatory uncertainty, the industry has been forced to confront unanticipated economic times stemming from the "jobless recovery" following the 2008 recession and the sovereign debt crisis in Europe. Greater regulatory and economic uncertainty looms on the horizon. As this study goes to press, the U.S. Supreme Court is deliberating the legality of a federal law that, beginning in 2014, would fine Americans who refuse to purchase private health insurance.
This study will be of interest to stakeholders in the medical device industry; the coatings and surface treatments industries; suppliers of alloys, ceramics, polymers, and other materials used in the manufacture of coatings; manufacturers of chemicals, pharmaceuticals, and energy sources that can be incorporated into coatings; coating and medical device importers; medical device contract manufacturers; and the regulatory community and healthcare policy analysts. It will also provide useful insights for those exploring investments opportunities in what despite regulatory and economic uncertainty remains a vibrant and growing segment of the medical device industry.
This study looks at medical device coatings and surface treatments from the perspective of both the supply and demand side of the equation, that is from coating manufacturers who supply the materials, the medical device companies which use it and the members of the healthcare that influence purchases.
Consistent with the scope of the study, the format of this report is arranged to present its five-year forecasts as a series of tables. Each of those tables presents U.S. current dollar demand values for coatings and surface processes for 2010 and 2011 and a five-year period from 2012 through 2017. Separate sets of forecasts are presented for the eight types of coatings and surface treatment technologies; the 19 healthcare areas that correspond to FDA medical device review panels; the United States, European Union, other developed nations and the rest of the world.