STUDY GOAL AND OBJECTIVES
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.
REASONS FOR DOING THE STUDY
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.
SCOPE AND FORMAT
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.
- 19 healthcare areas that correspond to FDA medical device review panels.
- United States, European Union, other developed nations and the rest of the world.
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. The eight types of technology addressed in this study are:
- Micro and nano.
- Protective polymer.
- Surface treatment.
Our forecasts by healthcare area follow the disciplinary divisions used by the FDA in creating its medical device review panels. The 19 healthcare areas are:
- Ear, nose and throat.
- Gastroenterology and urology.
- General and plastic surgery.
- General hospital use.
- Obstetrics and gynecology.
- Physical medicine.
COUNTRIES AND REGIONS
In this study we report both global and regional forecast values for the following countries and regions:
- United States.
- European Union.
- Other developed nations.
- The Rest of the world.
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.
The contribution of medical devices and device coatings and surface treatment is well established in the professional literature. The types of materials and processes used to manufacture medical devices are likewise known from public record filings by those seeking governmental approval to market those devices. In addition, national governments maintain records describing the prevalence of diseases and injuries rates by age group, and healthcare system delivery characteristics, including physician density, hospitalization rates and healthcare costs. Examining data from those and other public sources using data-mining techniques has enabled BCC Research to constructed dollar values demand forecasts for 2012 through 2017 for medical device coatings and surface treatments based upon consensus estimates of changes in country populations and their respective economic growth factors. That country data is aggregated into four regions based upon the existence of trade pacts and per capita gross national incomes.
In addition to the public records identified in the previous section, BCC Research has studied the capabilities and patent filings of the companies and organizations mention in this study. BCC Research also reviewed reports and studies prepared by the chemical industry and organizations representing physicians, surgeons, hospital administrators, and trade and professional associations; foreign government trade associations; insurers and non-governmental organizations.
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. His related studies for BCC include MST027H Controlled Release Technologies: Established and Emerging Markets and HLC080A Medical Device Sensors: Technologies and Global Markets.
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The information developed in this report is intended to be as reliable as possible at the time of publication and of a professional nature. This information does not constitute managerial, legal or accounting advice, nor should it serve as a corporate policy guide, laboratory manual or an endorsement of any product, as much of the information is of a speculative in nature. The author assumes no responsibility for any loss or damage that might result from reliance on the reported information or from its use.