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Medical Device Coatings

  • September 2014
  • -
  • BCC Research
  • -
  • 389 pages

Summary

Table of Contents

This BCC Research report examines the medical device coating and surface modification treatment industry and describes the eight coating and surface treatment technologies that add value to medical devices used in 19 healthcare areas. Forecasts for each healthcare area are provided for the period 2014 through 2019.

Use this report to:
- Examine the medical device coating and surface modification treatment industry.
- Receive forecasts for healthcare area project demands from 2014 through 2019, for the United States, the European Union, other developed nations as well as the rest of the
world.
- Receive information about how the FDA impacts the structure the global market.
- Learn about the FDA’s major regulatory pathways.

Highlights
- The global medical device coating market reached about $6.1 billion in 2013. This market is expected to grow to $6.3 billion in 2014 and $9 billion in 2019, a compound annual growth rate (CAGR) of 7.3% from 2014 to 2019.
- The United States market reached nearly $3 billion in 2013. This market is expected to grow to $3.1 billion in 2014 and $4.8 billion in 2019, a CAGR of 8.9% from 2014 to 2019.
- The European Union market reached $1.5 billion in 2013. This market is expected to grow to $1.6 billion in 2014 and $2.3 billion in 2019, a CAGR of 7.6% from 2014 to 2019.

Introduction & Scope

INTRODUCTION

STUDY GOAL AND OBJECTIVES
This study examines the medical device coating and surface modification treatment industry, a global enterprise that BCC Research anticipates will exceed $9 billion by
2019. It describes the eight coating and surface treatment technologies that add value to medical devices used in 19 healthcare areas. Forecasts for each healthcare area
project demand from 2014 through 2019, for the United States, the European Union, other developed nations and the rest of the world.

REASONS FOR DOING THE STUDY
In the eight 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, the most recent of which is an expansion of the number of Americans who have healthcare insurance. At the
same time, coating suppliers have entered a period of heightened uncertainty created by announced but yet unspecified changes in the federal regulations that cover how
new medical devices are evaluated prior to being permitted to be sold in the United States, the largest and most profitable of the world’s healthcare markets. Against that
backdrop of regulatory uncertainty, the industry has been forced to confront the unanticipated change in company business models as long-established suppliers
renounce their American roots and flee to more tax-friendly European countries.

INTENDED AUDIENCE
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 that supply the materials, the medical device companies that use it and the members of the healthcare community who 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 2012 and 2013, and the five-year period from 2014 through 2019. Separate sets of forecasts are presented for the:

- Eight types of coatings and surface treatment technologies.
- Nineteen healthcare areas that correspond to FDA medical device review panels.
- United States, European Union, other developed nations and the rest of the world.

In addition to forecast tables, the report includes informational tables. These summarize FDA Freedom of Information act data about generic types of devices, their
use within each healthcare area, and the regulatory pathway and burdens imposed upon them. Supplier detail includes the global distribution of production facilities,
location and coating-related proprietary names. An appendix contains the abstract of major coating-related patents, including their initial assignees.

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