The Global Market for Medical Devices, 3rd. Edition.pdf
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1、Global Market for Med. Devices May 2012 Kalorama Information A division of MarketR 38 East 29th Street Sixth Floor New York, New York 10016 212.807 .2660 t 800.298.5603 t 212.807 .2676 f Editor: Bruce Carlson THEGLOBALMARKETFORMEDICAL DEVICES,3RDEDITION AKALORAMA INFORMATION MARKETINTELLIGENCE REPO
2、RT The Global Market for Medical Devices has been prepared by Kalorama Information. We serve business and industrial clients worldwide with a complete line of information services and research publications. Kalorama Information Market Intelligence Reports are specifically designed to aid the action-
3、oriented executive by providing a thorough presentation of essential data and concise analysis. Editor: Bruce Carlson Publication Date: May 2012 TABLE OF CONTENTS CHAPTER ONE: EXECUTIVE SUMMARY 1? Size of the Market and Forecast . 2? Top Companies . 3? Scope and Methodology . 3? Conclusions . 4? CHA
4、PTER TWO: INTRODUCTION .7? Definition 7? Classification of Medical Devices 8? Categorization of Medical Devices . 10? Regulation . 12? United States 12? Recent Approvals . 15? European Union . 18? EU System and Approval Time .19? Japan 19? China 20? Medical Device Buyers. 21? Trends . 22? Demographi
5、cs 22? Mergers And Acquisitions . 24? J export and import sales, unit estimates and price averaging, but Kalorama Information considers estimates of manufacturer revenues the most important and valid methodology for business planning. .In many of the largest One: Executive Summary 3 Copyright 2012 K
6、alorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited TOPCOMPANIES Because of the variety of types of medical devices, there are many competitors. Most companies operate in just a few markets
7、 though the top companies such as J export and import sales, unit estimates and price averaging, but Kalorama Information considers estimates of manufacturer revenues the most important and valid methodology for business planning. .In many of the largest One: Executive Summary 4 Copyright 2012 Kalor
8、ama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited One: Executive Summary 4 Copyright 2012 Kalorama Information Reproduction without written permission, in any media now in existence or hereaf
9、ter developed, in whole or in any part, is strictly prohibited device markets, Kalorama Information has already conducted studies and have examined manufacturer revenue estimates, rendering the total market visible. This report was assembled using data from Kalorama Informations previous medical dev
10、ice reports. As with all Kalorama reports, primary and secondary research was used. Research into company annual reports, trade publications, government and medical literature was used as a foundation. Interviews with executives at medical device companies were conducted and are the key source of es
11、timates. CONCLUSIONS The following are the major conclusions of the report: ?2011 was a year of cost control. Medicare, Medicaid, as well as state governments implemented policies unfavorable to device makers. Hospitals continued to purchase through group organizations and insist on transparent pric
12、es. ?Device industry sales were impacted by these measures, though positively impacted by the aging population. The market grew at 5% between 2010 and 2011. ?In some cases, prominent companies grew at levels lower than the device market as a whole. Johnson and Johnson (3%), Medtronic (1%) and Siemen
13、s (1%) were among those seeing lower growth in 2011. ?Kalorama projects 4.5 percent growth average in the next two years, largely on lower government reimbursements. ?Medical device makers were aggressive on acquisitions, continuing the trend of 2010. Johnson and these, therefore, require additional
14、 safety measures after general controls and special controls. Medical devices in this category include life-supporting or life-sustaining devices, such as replacement heart valves, implanted cerebellar stimulators, implantable pacemaker pulse generators, endosseous (intra-bone) implants, etc. In add
15、ition to Class I and Class II requirements, the manufacture and supply of these devices entails the following: ?A scientific review to ensure the safety and effectiveness of a device ?Pre-market approval (mandatory) In some countries, a device-tracking system to maintain and update information about
16、 the recipients of the device is necessary for certain Class III devices such as implantable pacemakers. Two: Introduction 10 Copyright 2012 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohib
17、ited Two: Introduction 10 Copyright 2012 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited CATEGORIZATION OF MEDICAL DEVICES Medical devices can be broadly divided into medical consumabl
18、es and medical equipment. The products in these categories range from consumables such as surgical gloves to high-end imaging equipment such as Magnetic Resonance Imaging (MRI) machines. Medical devices may also be categorized on the basis of their core function. Some of these functions are as follo
19、ws: ?Diagnostic equipment: Medical imaging machines to aid diagnosis ultrasound, MRI, CAT-scans, PET, and X-ray machines ?Therapeutic equipment: Infusion pumps, medical lasers, and LASIK surgical machines ?Life support equipment: To maintain a patients bodily functions medical ventilators, heart-lun
20、g machines, ECMO, and dialysis machines ?Medical monitors: To measure a patients medical state, such as vital signs, ECG, EEG, blood pressure, and dissolved gases in the blood ?Medical laboratory equipment: Blood, urine, and gene analyzers Typical industry medical device categories are distinguished
21、 on the basis of the technical description and medical application of the devices such as surgical equipment, orthopedic equipment, anesthetic and respiratory equipment and electromedical and imaging equipment. Figure 2-2 Two: Introduction 11 Copyright 2012 Kalorama Information Reproduction without
22、written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited Figure 2-1 Two: Introduction 11 Copyright 2012 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in
23、any part, is strictly prohibited Figure 2-1 Medical Device Categories Source: Eucomed Devices included in each of the aforementioned categories include the following: ?Surgical equipment These are designed for performing specific actions during a surgery/operation; which may include modification of
24、biological tissue. Surgical equipment may also be used only to access or view biological tissue. ? ?Active and non-active implantable devices These include stents, cardiac pacemakers, hip implants, neurostimulators and insulin pumps. ?Anesthetic and respiratory equipment This includes oxygen masks,
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