France Interventional Cardiology Market Outlook to 2020

France Interventional Cardiology Market Outlook to 2020 Reference Code: GDMECC0358DB Publication Date: May 2014 Page 1

1 Table of Contents 1 Table of Contents... 2 1.1 List of Tables... 4 1.2 List of Figures... 5 2 Introduction... 6 2.1 What Is This Report About?... 6 2.2 Interventional Cardiology Market Segmentation... 6 2.3 Definitions of Markets Covered in the Report... 7 3 Interventional Cardiology Market, France... 10 3.1 Interventional Cardiology Market, France, Revenue ($m), 2005-2012... 10 3.2 Interventional Cardiology Market, France, Revenue ($m), 2012-2020... 12 3.2.1 Arteriotomy Closure Devices Market, France, Revenue ($m), by Segment, 2005-2012... 14 3.2.2 Cardiac Catheters Market, France, Revenue ($m), by Segment, 2005-2012... 16 3.2.3 Coronary Stents Market, France, Revenue ($m), by Segment, 2005-2012... 18 3.2.4 Intravascular Ultrasound Systems (IVUS) Market, France, Revenue ($m), by Segment, 2005-2012... 20 3.2.5 PTCA Balloons Market, France, Revenue ($m), by Segment, 2005-2012... 22 3.2.6 Arteriotomy Closure Devices Market, France, Revenue ($m), by Segment, 2012-2020... 24 3.2.7 Cardiac Catheters Market, France, Revenue ($m), by Segment, 2012-2020... 26 3.2.8 Coronary Stents Market, France, Revenue ($m), by Segment, 2012-2020... 28 3.2.9 Intravascular Ultrasound Systems (IVUS) Market, France, Revenue ($m), by Segment, 2012-2020... 30 3.2.10 PTCA Balloons Market, France, Revenue ($m), by Segment, 2012-2020... 32 3.3 Interventional Cardiology Market, France, Volume (Units), 2005-2012... 34 3.4 Interventional Cardiology Market, France, Volume (Units), 2012-2020... 36 3.4.1 Arteriotomy Closure Devices Market, France, Volume (Units), by Segment, 2005-2012... 38 3.4.2 Cardiac Catheters Market, France, Volume (Units), by Segment, 2005-2012... 40 3.4.3 Coronary Stents Market, France, Volume (Units), by Segment, 2005-2012... 42 3.4.4 Intravascular Ultrasound Systems (IVUS) Market, France, Volume (Units), by Segment, 2005-2012... 44 3.4.5 PTCA Balloons Market, France, Volume (Units), by Segment, 2005-2012... 46 3.4.6 Arteriotomy Closure Devices Market, France, Volume (Units), by Segment, 2012-2020... 48 3.4.7 Cardiac Catheters Market, France, Volume (Units), by Segment, 2012-2020... 50 3.4.8 Coronary Stents Market, France, Volume (Units), by Segment, 2012-2020... 52 3.4.9 Intravascular Ultrasound Systems (IVUS) Market, France, Volume (Units), by Segment, 2012-2020... 54 3.4.10 PTCA Balloons Market, France, Volume (Units), by Segment, 2012-2020... 56 3.5 Interventional Cardiology Market, France, Average Price ($), 2005-2020... 58 3.6 Interventional Cardiology Market, France, Distribution Share by Revenue ($m), 2011-2012... 60 3.7 Interventional Cardiology Market, France, Company Share by Revenue ($m), 2011-2012... 61 4 Overview of Key Companies in France, Interventional Cardiology Market... 63 4.1 Medtronic, Inc.... 63 4.1.1 Company Overview... 63 4.2 Abbott Laboratories... 63 Page 2

4.2.1 Company Overview... 63 4.3 Boston Scientific Corporation... 63 4.3.1 Company Overview... 63 4.4 Cordis Corporation... 64 4.4.1 Company Overview... 64 4.5 Terumo Corporation... 64 4.5.1 Company Overview... 64 4.6 Biosensors International Group, Ltd... 64 4.6.1 Company Overview... 64 4.7 Biotronik SE & Co. KG... 64 4.7.1 Company Overview... 64 4.8 St. Jude Medical, Inc.... 65 4.8.1 Company Overview... 65 4.9 Volcano Corporation... 65 4.9.1 Company Overview... 65 4.10 Asahi Intecc Co., Ltd.... 65 4.10.1 Company Overview... 65 5 Interventional Cardiology Market Pipeline Products... 66 6 Financial Deals Landscape... 67 6.1 Partnerships... 67 6.1.1 Abiomed Enters Into Licensing Agreement With Opsens For Optical Sensor Technology... 67 7 Appendix... 68 7.1 Research Methodology... 69 7.1.1 Coverage... 69 7.1.2 Secondary Research... 69 7.1.3 Primary Research... 70 7.1.4 Market Modeling and Forecasting... 71 7.1.5 Company Share Analysis... 74 7.1.6 Distribution Share Analysis... 75 7.2 Expert Panel... 75 7.3 GlobalData Consulting... 76 7.4 Disclaimer... 76 Page 3

1.1 List of Tables Table 1: Interventional Cardiology Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 11 Table 2: Interventional Cardiology Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 13 Table 3: Arteriotomy Closure Devices Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 15 Table 4: Cardiac Catheters Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 17 Table 5: Coronary Stents Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 19 Table 6: Intravascular Ultrasound Systems (IVUS) Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 21 Table 7: PTCA Balloons Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 23 Table 8: Arteriotomy Closure Devices Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 25 Table 9: Cardiac Catheters Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 27 Table 10: Coronary Stents Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 29 Table 11: Intravascular Ultrasound Systems (IVUS) Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 31 Table 12: PTCA Balloons Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 33 Table 13: Interventional Cardiology Market, France, Volume (Units), Historic, 2005-2012... 35 Table 14: Interventional Cardiology Market, France, Volume (Units), Forecast, 2012-2020... 37 Table 15: Arteriotomy Closure Devices Market, France, Volume (Units), Historic, 2005-2012... 39 Table 16: Cardiac Catheters Market, France, Volume (Units), Historic, 2005-2012... 41 Table 17: Coronary Stents Market, France, Volume (Units), Historic, 2005-2012... 43 Table 18: Intravascular Ultrasound Systems (IVUS) Market, France, Volume (Units), Historic, 2005-2012... 45 Table 19: PTCA Balloons Market, France, Volume (Units), Historic, 2005-2012... 47 Table 20: Arteriotomy Closure Devices Market, France, Volume (Units), Forecast, 2012-2020... 49 Table 21: Cardiac Catheters Market, France, Volume (Units), Forecast, 2012-2020... 51 Table 22: Coronary Stents Market, France, Volume (Units), Forecast, 2012-2020... 53 Table 23: Intravascular Ultrasound Systems (IVUS) Market, France, Volume (Units), Forecast, 2012-2020... 55 Table 24: PTCA Balloons Market, France, Volume (Units), Forecast, 2012-2020... 57 Table 25: Interventional Cardiology Market, France, Average Price ($), Historic, 2005-2012... 58 Table 26: Interventional Cardiology Market, France, Average Price ($), Forecast, 2012-2020... 59 Table 27: Interventional Cardiology Market, France, Distribution Share by Revenue ($m), USD Constant, 2011-2012... 60 Table 28: Interventional Cardiology Market, France, Company Share by Revenue ($m), USD Constant, 2011-2012... 62 Table 29: Interventional Cardiology Market Pipeline Products... 66 Table 30: Abiomed Enters Into Licensing Agreement With Opsens For Optical Sensor Technology... 67 Table 31 Total Number of Primary Research Participants, Cardiovascular Devices Market, by Country... 71 Page 4

1.2 List of Figures Figure 1: Interventional Cardiology Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 10 Figure 2: Interventional Cardiology Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 12 Figure 3: Arteriotomy Closure Devices Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 14 Figure 4: Cardiac Catheters Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 16 Figure 5: Coronary Stents Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 18 Figure 6: Intravascular Ultrasound Systems (IVUS) Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 20 Figure 7: PTCA Balloons Market, France, Revenue ($m), USD Constant, Historic, 2005-2012... 22 Figure 8: Arteriotomy Closure Devices Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 24 Figure 9: Cardiac Catheters Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 26 Figure 10: Coronary Stents Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 28 Figure 11: Intravascular Ultrasound Systems (IVUS) Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 30 Figure 12: PTCA Balloons Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020... 32 Figure 13: Interventional Cardiology Market, France, Volume (Units), Historic, 2005-2012... 34 Figure 14: Interventional Cardiology Market, France, Volume (Units), Forecast, 2012-2020... 36 Figure 15: Arteriotomy Closure Devices Market, France, Volume (Units), Historic, 2005-2012... 38 Figure 16: Cardiac Catheters Market, France, Volume (Units), Historic, 2005-2012... 40 Figure 17: Coronary Stents Market, France, Volume (Units), Historic, 2005-2012... 42 Figure 18: Intravascular Ultrasound Systems (IVUS) Market, France, Volume (Units), Historic, 2005-2012... 44 Figure 19: PTCA Balloons Market, France, Volume (Units), Historic, 2005-2012... 46 Figure 20: Arteriotomy Closure Devices Market, France, Volume (Units), Forecast, 2012-2020... 48 Figure 21: Cardiac Catheters Market, France, Volume (Units), Forecast, 2012-2020... 50 Figure 22: Coronary Stents Market, France, Volume (Units), Forecast, 2012-2020... 52 Figure 23: Intravascular Ultrasound Systems (IVUS) Market, France, Volume (Units), Forecast, 2012-2020... 54 Figure 24: PTCA Balloons Market, France, Volume (Units), Forecast, 2012-2020... 56 Figure 25: Interventional Cardiology Market, France, Company Share (%), 2012... 61 Figure 26: GlobalData Epidemiology-Based Forecasting Model... 73 Figure 27: GlobalData Capital Equipment-Based Forecasting Model... 74 Figure 28: Primary Interviews by Participant Type (%)... 75 Page 5

2 Introduction Medical Equipment Market Reports are the ideal guide for anyone wishing to understand their market better in terms of revenues, unit sales, distributors and competitors. 2.1 What Is This Report About? This report provides an overview and the following information related to the country, various categories, distribution share and competitive landscape in the market: 1. Comprehensive data related to the market revenue, unit sale, average price, company share and distribution share. 2. Corporate-level profiles of key companies operating in the Interventional Cardiology market, which includes a brief overview of the company. The selection of the companies is based on their operational presence. 3. A list of key products under development by different companies. The selection of this list is based on the territory in which these products are being clinically investigated. 4. Key news and deals related to the Interventional Cardiology market. 2.2 Interventional Cardiology Market Segmentation Interventional Cardiology market is segmented as described below, in this report: 1. PTCA Coronary Drug Eluting Balloons (DEB) 2. Coronary Guidewires 3. Arteriotomy Closure Devices Arteriotomy Closure Devices includes sub-segments such as Femoral Access Devices and Radial Access Devices 4. Cardiac Catheters Cardiac Catheters includes sub-segments such as Angiography Catheters and Guiding Catheters 5. Coronary Stents Coronary Stents includes sub-segments such as Bare Metal Stents and Drug Eluting Stents (DES) 6. Intravascular Ultrasound Systems (IVUS) Intravascular Ultrasound Systems (IVUS) includes sub-segments such as Intravascular Ultrasound Catheters and Intravascular Ultrasound System Consoles 7. PTCA Balloons PTCA Balloons includes sub-segments such as FW Balloons, Over the Wire Balloons, PTCA Cutting and Scoring Balloons and Rx Balloons Page 6

2.3 Definitions of Markets Covered in the Report Interventional Cardiology Interventional cardiology includes devices used to diagnose and treat diseases related to the coronary artery using a minimally invasive procedure. These include coronary stents, cardiac catheters, Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloons, coronary guidewires, Intravascular Ultrasound Systems (IVUS) and arteriotomy closure devices. Electrophysiology products are not covered under this category. Arteriotomy Closure Devices Arteriotomy closure devices are used for carrying out hemostasis at the end of a percutaneous intervention (PCI). This is used as an alternative to manual or mechanical compression. Radial access devices and femoral access devices have been tracked under this segment. Femoral Access Devices Femoral closure devices are used for the percutaneous closure of common femoral artery access sites in patients who have undergone diagnostic endovascular catheterization devices. Hemostasis is carried out by these devices either by a clip, titanium staple or by an absorbable sealant. One unit refers to one femoral closure device. Radial Access Devices Radial closure devices provide controlled compression of the radial artery without completely occluding vessel flow. It consists of a transparent cuff, the air injection port, inflator and an adjustable band. One unit refers to one radial closure device. Cardiac Catheters Cardiac catheters are narrow hollow tubes used for guiding and visualization of the coronary vasculature or the functioning of heart valves. Cardiac catheters include guiding catheters and angiography catheters. Angiography Catheters Angiography catheters are used to administer a radio contrast dye into the chambers of the heart to detect any abnormalities related to the coronary arteries or cardiac valves. One unit refers to one angiography catheter. Guiding Catheters Guiding catheters are catheters used to navigate stents, balloons and leads during a minimally invasive procedure. One unit refers to one guiding catheter. Coronary Stents A stent is an expandable perforated tube that is inserted into a natural conduit of the body to prevent or counteract a disease-induced localized flow constriction. The main goal of the stent is to hold the inner wall in its compressed Page 7

position and retain the enlarged vessel diameter. Coronary stents are used in the coronary vasculature and include Bare Metal Stents (BMS) and Drug Eluting Stents (DES). Bare Metal Stents Bare metal stents (BMS) are uncoated stents that are permanently placed inside the artery. These stents are constructed from a range of metals, including nitinol, stainless steel, and cobalt chromium. One unit refers to one bare metal stent. Drug Eluting Coronary Stents Drug Eluting Stent (DES) is a BMS that releases drugs locally and can be coated with a polymeric material. The stent releases an anti-proliferative or immunosuppressive drug over time, leaving behind the metallic stent in the artery. One unit refers to one drug eluting stent. Coronary Guidewires A coronary guidewire is used to navigate catheters during percutaneous coronary interventions (PCIs). The guidewire has an elongated body for a degree of flexibility and a distal tip. One unit refers to one coronary guidewire Intravascular Ultrasound Systems Intravascular ultrasound system is a fiber-optic, catheter-based, near-infrared (NIR) spectroscopy and intravascular ultrasound combined system intended to identify and characterize atherosclerotic plaque in the coronary arteries. It is a combination device that uses IVUS to quantify the degree of narrowing produced by a plaque, the size of the artery and the adequacy of stent expansion. Intravascular Ultrasound Catheters Intravascular ultrasound catheter is an imaging catheter intended for evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature. It provides cross-sectional image of such vessels. It incorporates a cylindrical ultrasound transducer array used to radiate acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels. One unit refers to one Intravascular Ultrasound Catheter. Intravascular Ultrasound System Consoles Intravascular Ultrasound System Console is the base unit which is integrated into the interventionalist lab with the control panel, CPU, Color LCD Monitor, patient interface module for catheter designed to hang on bed rail. One unit refers to one Intravascular Ultrasound System Consoles. Percutaneous Transluminal Coronary Balloon (PTCA) Balloons Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheters are used to restore blood flow in occluded coronary arteries and deliver stents. PTCA balloons include Rapid Exchange (RX), Over-the-Wire, Fixed Wire (FW) and Cutting and Scoring balloons. Page 8

Fixed Wire (FW) Balloon A fixed wire angioplasty balloon catheter is an elongated, flexible, thin walled metal tube with an inflatable balloon on the distal end. A FW PTCA catheter is used to compress plaque and dilate (widen) narrowed coronary arteries to restore normal blood flow. This is often accompanied by implanting an expandable metal stent. One unit refers to one FW balloon catheter. Over the Wire Balloons An over-the-wire balloon catheter consists of two lumens including one for the guidewire and the other for balloon inflation. An over-the-wire PTCA catheter can be used compress plaque and dilate (widen) narrowed coronary arteries to restore normal blood flow. This is often accompanied by implanting an expandable metal stent. One unit refers to one over the wire balloon catheter. PTCA Cutting and Scoring Balloons Cutting and scoring balloon catheters have microsurgical blades mounted longitudinally on the angioplasty balloon catheter. They can be advanced through occluded coronary arteries and used for plaque debulking. Cutting and scoring balloon catheters exert less pressure compared with that by conventional balloon angioplasty catheters. One unit refers to one PTCA cutting and scoring balloon catheter. Rx Balloons An Rx balloon catheter has an elongated shaft, two lumens for balloon inflation and guidewire and a proximal and distal shaft. An angioplasty balloon is located on the distal shaft of the catheter. A Rx PTCA catheter is used to compress plaque and dilate (widen) narrowed coronary arteries to restore normal blood flow. One unit refers to one Rx balloon catheter. PTCA Coronary Drug Eluting Balloons (DEB) A drug eluting balloon (DEB) is an anti-restenotic drug coated PTCA (Percuatneous Transluminal Coronary Angioplasty) balloon intended to prevent re-narrowing of the coronary arteries. DEBs provide fast, short-term, homogenous, local drug delivery, preserve the anatomy of the vessel, promote enhanced vessel healing, and reduce the need for prolonged dual anti-platelet therapy without leaving any metal behind. They can be used for coronary and peripheral artery applications including treating in-stent restenosis (ISR), bifurcations, small vessels, and long lesions. One unit refers to one PTCA drug eluting balloon. Page 9

3 Interventional Cardiology Market, France 3.1 Interventional Cardiology Market, France, Revenue ($m), 2005-2012 Figure 1: Interventional Cardiology Market, France, Revenue ($m), USD Constant, Historic, 2005-2012 Source: GlobalData Page 10

Table 1: Interventional Cardiology Market, France, Revenue ($m), USD Constant, Historic, 2005-2012 Category 2005 2006 2007 2008 2009 2010 2011 2012 CAGR 05-12 Source: GlobalData Page 11

3.2 Interventional Cardiology Market, France, Revenue ($m), 2012-2020 Figure 2: Interventional Cardiology Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020 Source: GlobalData Page 12

Table 2: Interventional Cardiology Market, France, Revenue ($m), USD Constant, Forecast, 2012-2020 Category 2012 2013 2014 2015 2016 2017 2018 2019 2020 CAGR 12-20 Source: GlobalData Page 13

7 Appendix The data and analysis within this report are driven by Medical etrack. Medical etrack gives you the key information required to drive sales, investment and deal-making activity in your business. It includes the following: 15,000+ data tables showing market size across more than 780 medical equipment segments and 15 countries, from 2005 and forecast to 2020 6,000+ primary expert interviews, conducted annually to ensure data and report quality 1,100+ medical equipment conference reports 1,000+ industry-leading reports per annum, covering growing sectors, market trends, investment opportunities and competitive landscape 600+ analysis reports, covering market and pipeline product analysis, by indication; medical equipment trends and issues, and investment and M&A trends worth over $3m 50,000+ medical equipment company profiles 2,000+ private, emerging and technology start-up company profiles 4,000+ company profiles of medical equipment manufacturers in China and India 2,000+ company profiles of medical equipment manufacturers in Japan 825+ companies revenue splits and market shares 1,100+ quarterly and annual medical equipment company financials 700+ medical equipment company SWOTs 11,700+ pipeline product profiles 14,000+ marketed product profiles 16,900+ clinical trials 17,000+ trial investigators 18,000+ new product patents 3,700+ reports on companies with products in development 21,500+ reports on deals in the medical equipment industry 1,300+ surgical and diagnostic procedures by therapy area 50+ key healthcare indicators by country For more information or to receive a free demonstration of the service, please visit: http://www.medicaletrack.com/contactus.aspx?id=requestdemo Page 68

7.1 Research Methodology GlobalData s dedicated research and analysis teams consist of experienced professionals with advanced statistical expertise and marketing, market research and consulting backgrounds in the medical devices industry. GlobalData adheres to the codes of practice of the European Pharmaceutical Marketing Research Association (http://www.ephmra.org/). All GlobalData databases are continuously updated and revised. 7.1.1 Coverage The objective of updating GlobalData s coverage is to ensure that it represents the most up-to-date vision of the industry possible. Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources. Company coverage is based on three key factors: revenue; product and media attention; and innovation and market potential. The estimated revenue of all major companies, both private and public, are gathered and used to prioritize coverage. GlobalData aims to cover all major news events and deals in the medical devices industry, updated on a daily basis. The coverage is further streamlined and strengthened with additional input from GlobalData s expert panel. 7.1.2 Secondary Research The research process begins with extensive secondary research using internal and external sources to gather all relevant data and information pertaining to a particular market model for a particular country. The secondary research sources that are typically referred to include, but are not limited to: Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings Industry trade journals, scientific journals and other technical literature Association and healthcare organization websites PubMed, Medscape and other relevant services which compile extensive reviews of clinical literature Internal proprietary databases Relevant patent and regulatory databases National government documents, statistical databases and market reports Procedure registries News articles, press releases and web-casts specific to the companies operating in the market Page 69

7.1.3 Primary Research GlobalData conducts interviews with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions: Provides first-hand information on market size, market trends, growth trends, competitive landscape and future outlook Helps to validate and strengthen secondary research findings Further develops the analysis team s expertise and market understanding Primary research involves email correspondence, telephone interviews and face-to-face interviews for each market, category, segment and sub-segment across a range of geographies. The participants who typically take part in such a process include, but are not limited to: o o o o Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers Distributors, paramedics and representatives from hospital stores, laboratories and pharmacies Outside experts: investment bankers, valuation experts and research analysts that specialize in specific medical equipment markets Key opinion leaders: physicians and surgeons that specialize in the therapeutic areas in which the medical device is used The market data was validated based on the inputs from 1,771 primary research participants. The primary research participants included stakeholders from demand side such as the cardiovascular surgeons, as well as participants from the supply side such as the marketing managers, sales managers and product managers of companies manufacturing/marketing cardiovascular devices. Page 70

Table 31 Total Number of Primary Research Participants, Cardiovascular Devices Market, by Country Country Total Number of Primary Research Participants United States 136 United Kingdom 120 Germany 128 France 153 Italy 121 Spain 134 Brazil 128 China 79 India 173 Russia 89 Japan 88 Australia 122 Canada 111 Mexico 90 South Korea 99 Total 1,771 Source: GlobalData 7.1.4 Market Modeling and Forecasting GlobalData uses an epidemiology-based treatment flow model and capital equipment-based model to estimate and forecast market size. Epidemiology-Based Market Model and Forecasting The epidemiology-based forecasting model uses epidemiology data gathered from research publications and primary interviews with physicians to establish the target patient population and treatment flow pattern for individual diseases and therapies. The data covers prevalence, incidence, diseased population, diagnosed population, and treatment population. The market forecast begins with the general population, the size of which varies depending on the indication. Prevalence is the percentage of the total population that suffers from a particular disease or condition. Incidence is the number of new cases of a condition, symptom, death or injury that develop during a specific time period, such as one year. The diseased population is the population suffering from a particular disease or condition. The diagnosed population is the population that has been diagnosed with a particular disease or condition, expressed as a percentage of the prevalence population. Page 71

The treatment population is the percentage of the population that has been diagnosed with a particular disease or condition. Device uptake is the percentage of the treatment population using a particular device, determined based on the primary responses and the information available in secondary sources. The epidemiology-based forecasting model for a medical device is used to: Determine the patient segment using a particular device or procedure Determine the frequency of usage of a particular device depending on the patient type, which further helps to determine the absolute unit sales of a device in a year The market for any medical device is directly proportional to the volume of units sold and the price per unit. Market size = volumes of units sold X ASP (Average Selling Price) The volume of units sold is calculated from the number of patients using or that has been implanted with the device. Data on treatment rate, diagnosis and surgical treatment rate, if unavailable from research publications, is gathered from interviews with physicians and used to estimate the patient volume for the disease under consideration. The ASP of a device is mostly gathered from primary and secondary sources. ASP is the price at which a device is available in a target country to an end-user. For capital equipment, the end-user is typically considered to be the healthcare setting. For implants and consumables purchased by patients, the end-user is the patient. Factors such as company share, reimbursement, company type (local/domestic or multinational) are taken into consideration during ASP analysis, which uses the following sources: Company websites Annual reports/industry reports Press releases Page 72

Epidemiology-Based Forecasting Model Figure 26: GlobalData Epidemiology-Based Forecasting Model Source: GlobalData Capital Equipment-Based Market Model and Forecasting The capital equipment-based forecasting model is based on the installed base, replacements and new sales of a specific type of capital equipment in healthcare facilities such as hospitals, clinics and diagnostic centers. The installed base is calculated from the average number of units per facility. Sales for a particular year are arrived at by calculating the number of replacement units and new units (additional and first-time purchases). Secondary sources and interviews with supply-side participants and key opinion leaders from healthcare facilities are used to arrive at installed base and unit sales for a particular year. The factors typically affecting the forecast growth rates are: Growth in the number of healthcare facilities Healthcare spending and government programs and initiatives Migration from low-end equipment to high-end equipment Growth in the diagnosed population and treatment population Page 73

Capital Equipment-Based Forecasting Model Figure 27: GlobalData Capital Equipment-Based Forecasting Model Source: GlobalData 7.1.5 Company Share Analysis Company shares are calculated by analyzing a company s sales in a particular market. In the case of public companies, annual reports and regulatory filings, investor presentations, earnings call transcripts and broker reports are used to determine a company s revenue in a particular market and in a particular geography. In the case of the private companies, company share data is gathered mostly from primary interviews and secondary sources. Company share analysis is based on primary interviews with: Supply side (manufacturers) Procurement side Distributors Hospital purchasing groups Demand side (surgeons/specialists) Page 74

The benefits of this approach are: High number of respondents to validate and from which to derive accurate company shares Broad view from the supply, demand, and procurement side Prevents biased opinions being reproduced Demand-side interviews with key opinion leaders help to understand their preferences for the devices of specific companies, strengthening company share estimates Primary Interviews by Participant Type Figure 28: Primary Interviews by Participant Type (%) 25 50 25 Procurement side Supply side Demand side The final company share data is based on input from the supply side, the procurement side and the demand side, as well as secondary sources. Please note that market share for companies that are included under the Others category is not tracked on an individual basis. 7.1.6 Distribution Share Analysis Distribution share information is gathered using a combination of secondary and primary research. It is supported by primary interviews because the availability of secondary data is limited in most cases. 7.2 Expert Panel GlobalData uses a panel of experts to cross-verify its databases and forecasts. GlobalData s expert panel comprises marketing managers, product specialists, international sales managers from medical device companies, academics from research universities, key opinion leaders from hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment and supplies. Historic data and forecasts are relayed to GlobalData s expert panel for feedback and adjusted accordingly. Page 75

7.3 GlobalData Consulting We hope that the data and analysis in this brief will help you to make informed and imaginative business decisions. If you have further requirements, GlobalData s consulting team may be able to help you. GlobalData offers tailor-made analytical and advisory services to drive your key strategic decisions. 7.4 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise without the prior permission of the publisher, GlobalData. Page 76