The global medical device coating market reached $4.8 billion in 2010 and $5.4 billion in 2011. The market is expected to grow from $5.7 billion in 2012 to nearly $8 billion in 2017, a five-year compound annual growth rate (CAGR) of 6.7%.
The United States market for medical device coatings reached $2.7 billion in 2011, is expected to reach nearly $3 billion in 2012, and should total nearly $4.4 billion by 2017, a five-year CAGR of 8.1%.
The European Union market for medical device coatings reached $1.3 billion in 2011, is expected to reach $1.4 billion in 2012, and should surpass $2 billion in 2017, a five-year CAGR of 7.0%.
GLOBAL REQUIREMENT FOR MEDICAL DEVICE COATINGS BY
REGION, 2010-2017 ($ MILLIONS)
Source: BCC Research
This study examines the medical device coating and surface modification treatment industry, a global enterprise that BCC Research anticipates will reach nearly $8 billion by 2017. It describes the eight coating and surface treatment technologies that add value to more than 1,000 types of medical devices used in 19 healthcare areas. Forecasts for each healthcare area project demand from 2012 through 2017. In addition to global summaries, separate forecasts are provided for the United States, the European Union, other developed nations and the rest of the world.
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 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.
We present forecasts for the seven basic types of coatings plus surface treatment technologies. Coatings are grouped on the basis of their most distinguishing chemical or physical characteristic. Surface treatments are defined as those processes that alter the surface of a device without adding a chemical or physical agent. For example, we characterize chrome plating as a type of alloy coating, rather than a surface treatment.
Our forecasts by healthcare area follow the disciplinary divisions used by the FDA in creating its medical device review panels.
In this study we report both global and regional forecast values for the following countries and regions:
The forecast values for the United States include Puerto Rico, a major manufacturing center for many medical devices labeled as made in the United States. The EU forecast contains only those 27 countries that were full members on March 1, 2012. Assignment to one of the remaining groups is based on the World Bank's determination of each economy's per capita gross national income (GNI) on July 1, 2011. Other developed nations are those where the per capita GNI is $12,276 and above. The rest of the world forecast group contains countries for which the World Bank reported a per capita GNI of $12,275 and below.
Each of the 191 countries for which BCC Research deemed there was sufficient forward-looking healthcare information to permit forecasting has been assigned to one and only one regional group. Thus, the developed nations group excludes the United States and EU member countries. In tables that identify countries, we use their common rather than formal names; for example, Venezuela rather than The Bolivarian Republic of Venezuela. We also distinguish among Communist China-Mainland and its two special administrative regions of China-Hong Kong and China-Macau. We refer to Taiwan as China-Taiwan.
Technology analyst James Wilson prepared both the original 2006 version of this study, Medical Device Coating (HLC049A), and its 2008 revision (HLC049B). He is the author of more than 300 articles and several books dealing with science, medicine, technology and business. Formerly the editor of the Princeton Business Journal and a senior science and technology editor for Hearst Magazines, he is a past member of the National Association of Science Writers and American Medical Writers Association. He has served on the adjunct faculty of Temple University and on the staffs of Drexel University and the Academy of Natural Sciences.