Abstract
The economic cost of cardiovascular disease (CVD) and stroke, a potential consequence of CVD, is of staggering proportions, estimated by the American Heart Association and the National Heart, Lung, and Blood Institute to be $403.1 billion in 2006. As a result of such high demand the cardiovascular segment is one of the most fiercely fought over by medical device companies which are investing heavily in device-based therapies that have the capability to cost effectively treat CVD patients.
Competition between medical device companies in the market is increasingly intense and as a consequence merger and acquisition activity rose dramatically in the sector in 2006 and has continued into 2007. Part of this rise can be attributed to an expanding US economy, increases in corporate profits and stock prices, technological improvements, and growing product demand. The large cardiovascular deals in 2006 were Boston Scientific taking Guidant in a landmark $27 billion deal, the acquisition of Guidant' s vascular and endovascular businesses by Abbott for $4.1 billion and J&J' s purchase of stent maker Conor Medsystems for $1.4 billion. However there have been a number of smaller but also significant deals such as ATS Medical, in a bid to flesh out its cardiac surgery product line, acquiring 3F Therapeutics, an early-stage company specialising in minimally-invasive, beating heart tissue valve replacements, and, in 2007 acquiring the surgical cryoablation business of CryoCath Technologies.
The two big sectors of the cardiovascular market where there are the most valuable markets to conquer are coronary stents and cardiac rhythm management devices.
This report examines the impact of new technologies and the growth of the various sectors of the cardiovascular device market in addition to describing the main geographical markets and the emerging ones such as India, South East Asia, China, which, due to their rapid economic growth are attracting the attention of market players of all sizes. However gaining access to a market with a novel or even a "me too" cardiovascular device is no easy procedure as, in addition to being costly products to reimburse, they frequently fall into the highest of the risk class of devices and the report therefore examines the barriers and procedures required for entering these markets.
Table of Contents
CHAPTER 1 INTRODUCTION
- 1.1 Aims of the report
- 1.2 Scope of the report
- 1.2.1 Products included
- 1.2.2 Markets included
- 1.2.3 Years covered
- 1.2.4 Methodology
- 1.2.5 Forecasting
- 1.3 Conditions influencing the cardiovascular market
- 1.4 Lifestyle issues
- 1.5 Emerging markets
- 1.6 Regulation and reimbursement issues
- 1.7 Safety issues
- 1.8 Emergence of devices vs drugs
- 1.9 Cardiovascular device manufacturers
- 1.10 Technology trends
CHAPTER 2 MARKET OVERVIEW
- 2.1.1 Drivers and limiters
CHAPTER 3 CARDIAC RHYTHM MANAGEMENT
- 3.1 Cardiac rhythm background
- 3.2 Arrhythmias
- 3.2.1 Types of arrhythmia
- 3.2.1.1 Bradycardia
- 3.2.1.2 Tachycardia
- 3.2.1.3 Ventricular fibrillation
- 3.2.1.4 Atrial fibrillation
- 3.2.1.5 Tachyarrhythmias
- 3.2.1.6 Bradytachycardia
- 3.2.1.7 Heart block
- 3.2.1.8 Premature ventricular contractions
- 3.2.1 Types of arrhythmia
- 3.3 Diagnosis of arrhythmias
- 3.4 Drug therapy
- 3.5 Pacemakers
- 3.5.1 Single-chamber pacemakers
- 3.5.2 Dual-chamber pacemakers
- 3.5.3 Rate responsive pacemakers
- 3.5.4 Cardiac resynchronisation therapy pacemaker
- 3.5.5 Programming
- 3.5.6 New clinical applications of pacemakers
- 3.5.7 Companies and products
- 3.5.7.1 Biotronik
- 3.5.7.2 Boston Scientific
- 3.5.7.3 Medtronic
- 3.5.7.4 Sorin Group
- 3.5.7.5 St Jude Medical
- 3.5.8 Factors driving growth
- 3.5.9 Market data
- 3.6 Implantable cardioverter defibrillators
- 3.6.1 Effectiveness and clinical studies
- 3.6.2 New clinical applications
- 3.6.3 Companies and products
- 3.6.3.1 Biotronik
- 3.6.3.2 Boston Scientific
- 3.6.3.3 Medtronic
- 3.6.3.4 Sorin Group
- 3.6.3.5 St Jude Medical
- 3.6.4 Factors driving growth
- 3.6.5 Market data
- 3.7 Automatic external defibrillators
- 3.7.1 Effectiveness and clinical studies
- 3.7.2 Companies and products
- 3.7.2.1 Cardiac Science
- 3.7.2.2 GE Healthcare
- 3.7.2.3 Medtronic
- 3.7.2.4 Philips Medical
- 3.7.2.5 Schiller
- 3.7.2.6 Zoll
- 3.7.3 Market data
- 3.8 Pacemaker and defibrillator programmers
- 3.8.1 Companies and products
- 3.8.1.1 Biotronik
- 3.8.1.2 Boston Scientific
- 3.8.1.3 Medtronic
- 3.8.1.4 St Jude Medical
- 3.8.1.5 Sorin
- 3.8.2 Market dynamics
- 3.8.1 Companies and products
- 3.9 Cardiac ablation devices
- 3.9.1 Companies and products
- 3.9.1.1 Boston Scientific
- 3.9.1.2 CryoCath Technologies
- 3.9.1.3 CryoCor
- 3.9.1.4 Medtronic
- 3.9.1.5 St Jude Medical
- 3.9.1.6 Factors driving growth
- 3.9.2 Market data
- 3.9.1 Companies and products
CHAPTER 4 CORONARY ARTERY DISEASE
- 4.1 Myocardial infarction
- 4.2 Acute myocardial infarction
- 4.3 Post-myocardial infarction
- 4.3.1 First line therapies
- 4.3.1.1 Beta-blockers
- 4.3.1.2 ACE Inhibitors
- 4.3.1.3 Aspirin
- 4.3.1.4 Thrombolytic therapy
- 4.3.1 First line therapies
- 4.4 Diagnosis
- 4.4.1 Cardiac markers
- 4.4.2 Intravascular ultrasound
- 4.4.3 Magnetic resonance imaging
- 4.4.4 Computed tomography imaging
- 4.4.5 Catheters
- 4.5 Surgery
- 4.5.1 Coronary artery bypass graft surgery
- 4.5.2 Anastomosis devices
- 4.5.3 Robotic surgery
- 4.5.4 Beating heart surgery devices
- 4.5.5 Factors driving growth
- 4.5.6 Market data
- 4.6 Angioplasty devices
- 4.6.1 Factors driving growth
- 4.6.2 Market
- 4.7 Stents
- 4.7.1 Stent types
- 4.7.2 Stent delivery
- 4.7.3 Companies and products
- 4.7.4 Factors driving growth
- 4.7.5 Market data
- 4.8 Embolic protection systems
- 4.8.1 Factors driving growth
- 4.8.2 Market data
CHAPTER 5 HEART VALVE DISORDERS
- 5.1 Introduction
- 5.2 Valve repair annuloplasty devices
- 5.2.1 Products
- 5.3 Mechanical valves
- 5.4 Tissue valves
- 5.4.1 Human tissue valves
- 5.4.2 Animal tissue valves
- 5.5 PFO devices and devices for closing other types of holes in the heart
- 5.5.1 Patent foramen ovale
- 5.5.2 Patent ductus arteriosus
- 5.5.3 Ventricular septal defects
- 5.6 Factors driving growth
- 5.7 Market data
CHAPTER 6 END-STAGE HEART FAILURE
- 6.1 Available therapies
- 6.1.1 Angiotensin receptor blockers (ARBs)
- 6.1.2 Beta-blockers
- 6.1.3 Digoxin
- 6.1.4 Diuretics
- 6.1.5 Aldosterone antagonists
- 6.1.6 Left ventricular reduction surgery
- 6.1.7 Intra-aortic balloon pumps
- 6.1.8 Ventricular reshaping devices
- 6.1.9 Ventricular assist devices
- 6.1.10 Artificial hearts
- 6.2 Companies and products
- 6.2.1 Abiomed
- 6.2.2 Arrow International
- 6.2.3 Berlin Heart
- 6.2.4 CardiacAssist
- 6.2.5 MicroMed Technology
- 6.2.6 Jarvik Heart
- 6.2.7 MEDOS Medizintechnik AG
- 6.2.8 SynCardiac Systems
- 6.2.9 Thoratec
- 6.2.10 Ventracor
- 6.2.11 WorldHeart
- 6.3 Factors driving growth
- 6.4 Market data
CHAPTER 7 MARKET ANALYSIS BY COUNTRY
- 7.1 The US
- 7.1.1 Customer profile
- 7.1.2 Regulations
- 7.1.3 Reimbursement
- 7.1.4 CRM device market
- 7.1.5 Coronary artery disease device market
- 7.1.6 Valve disorders market
- 7.1.7 Congestive heart failure device market
- 7.2 Japan
- 7.2.1 Customer profile
- 7.2.2 Regulations
- 7.2.3 Reimbursement
- 7.2.3.1 Type A
- 7.2.3.2 Type B
- 7.2.3.3 Type C
- 7.2.3.4 Type F
- 7.2.4 CRM device market
- 7.2.5 Coronary artery disease device market
- 7.2.6 Valve disorders market
- 7.2.7 Congestive heart failure device market
- 7.3 Germany
- 7.3.1 Customer profile
- 7.3.2 Regulations
- 7.3.3 Reimbursement
- 7.3.4 CRM device market
- 7.3.5 Coronary artery disease device market
- 7.3.6 Valve disorders market
- 7.3.7 Congestive heart failure device market
- 7.4 France
- 7.4.1 Customer profile
- 7.4.2 Regulations
- 7.4.3 Reimbursement
- 7.4.4 CRM device market
- 7.4.5 Coronary artery disease device market
- 7.4.6 Valve disorders market
- 7.4.7 Congestive heart failure device market
- 7.5 The UK
- 7.5.1 Customer profile
- 7.5.2 Regulations
- 7.5.3 Reimbursement
- 7.5.4 CRM device market
- 7.5.5 Coronary artery disease device market
- 7.5.6 Valve disorders market
- 7.5.7 Congestive heart failure device market
- 7.6 Italy
- 7.6.1 Customer profile
- 7.6.2 Regulations
- 7.6.3 Reimbursement
- 7.6.4 CRM device market
- 7.6.5 Coronary artery disease device market
- 7.6.6 Valve disorders market
- 7.6.7 Congestive heart failure device market
- 7.7 Spain
- 7.7.1 Customer profile
- 7.7.2 Regulations
- 7.7.3 Reimbursement
- 7.7.4 CRM device market
- 7.7.5 Coronary artery disease device market
- 7.7.6 Valve disorders market
- 7.7.7 Congestive heart failure device market
- 7.8 China
- 7.8.1 Customer profile
- 7.8.2 Regulations
- 7.8.3 Reimbursement
- 7.8.4 CRM device market
- 7.8.5 Coronary artery disease device market
- 7.8.6 Valve disorders market
- 7.8.7 Congestive heart failure device market
- 7.9 India
- 7.9.1 Customer profile
- 7.9.2 Regulations
- 7.9.3 Reimbursement
- 7.9.4 CRM device market
- 7.9.5 Coronary artery disease device market
- 7.9.6 Valve disorders market
- 7.9.7 Congestive heart failure device market
- 7.10 The rest of the world
- 7.10.1 South America
- 7.10.1.1 Customer profile
- 7.10.1.2 Argentina
- 7.10.1.3 Brazil
- 7.10.1.4 Chile
- 7.10.1.5 Columbia
- 7.10.1.6 Mexico
- 7.10.1.7 Peru
- 7.10.1.8 Venezuela
- 7.10.2 South East Asia
- 7.10.2.1 Customer profile
- 7.10.2.2 Indonesia
- 7.10.2.3 Malaysia
- 7.10.2.4 Philippines
- 7.10.2.5 Singapore
- 7.10.2.6 South Korea
- 7.10.2.7 Taiwan
- 7.10.2.8 Thailand
- 7.10.2.9 Vietnam
- 7.10.3 Australia
- 7.10.3.1 Customer profile
- 7.10.3.2 Regulations
- 7.10.3.3 Reimbursement
- 7.10.3.4 The market
- 7.10.1 South America
CHAPTER 8 COMPANY PROFILES
LIST OF TABLES
- Table 1.1 Prevalence of hypertension in major medical device markets 2004-2011
- Table 2.1 US Versus non-US sales of key industry players in 2006
- Table 2.2 Cardiac rhythm management
- Table 2.3 Interventional cardiology
- Table 2.4 Stents
- Table 2.5 Angioplasty balloons and catheters
- Table 2.6 Vascular closure devices
- Table 3.1 Major suppliers of pacemakers and their brands
- Table 3.2 Pacemaker prices in 2005 ($)
- Table 3.3 European pacing centres per million population
- Table 3.4 European countries with the highest rates of implanted pacemakers per million population, in 2005
- Table 3.5 European countries with the lowest rates of implanted pacemakers per million population in 2005
- Table 3.6 Major suppliers of ICDs and their brands
- Table 4.1 MRI and CT installed base per million of population
- Table 4.2 Trends in average costs by hospital procedure and volume 1988-2000
- Table 6.1 ACC/AHA Classification of chronic heart failure
- Table 6.2 New York Heart Association Heart Failure Symptom Classification System
- Table 6.3 Principal indications for intra-aortic balloon pump
- Table 6.4 VAD by manufacturer 2007
- Table 7.1 Cardiovascular operations (thousands) in the US in 2004
- Table 7.2 Estimated direct costs ($ billion) of cardiovascular disease and Stroke, U.S. 2004
- Table 7.3 510(k) v PMA approval process in the US
- Table 7.4 Cardiovascular HRGs in the UK
LIST OF FIGURES
- Figure 1.1 Deaths by cause 2005
- Figure 2.1 Medical device market by sector 2007
- Figure 2.2 Segmentation of cardiovascular market 2007
- Figure 2.3 Segmentation of cardiovascular market 2011
- Figure 3.1 Value of the world pacemaker market ($ millions)
- Figure 3.2 Company share of the world pacemaker market 2007
- Figure 3.3 Value of the world ICD market ($ millions)
- Figure 3.4 Company share of the world ICD market 2007
- Figure 3.5 Value of the world AED market ($ millions)
- Figure 3.6 Company share of the world AED market 2007
- Figure 3.7 Value of the world cardiac ablation market ($ millions)
- Figure 3.8 Company share of the world cardiac ablation market 2007
- Figure 4.1 Value of the world cardiac surgical equipment & tools market ($ millions)
- Figure 4.2 Value of the world bypass & disposables market ($ millions)
- Figure 4.3 Value of the world minimally invasive coronary artery bypass market ($ millions)
- Figure 4.4 Value of the world angioplasty and balloon catheter market ($ millions)
- Figure 4.5 Value of the world bare metal stent market ($ millions)
- Figure 4.6 Value of the world drug eluting stent market ($ millions)
- Figure 4.7 Value of the world embolic protection market ($ millions)
- Figure 5.1 Value of the world tissue heart valve market $ millions
- Figure 5.2 Company share of the world tissue heart valve market 2007
- Figure 5.3 Value of the world mechanical heart valve market $ millions
- Figure 5.4 Company share of the world mechanical heart valve market 2007
- Figure 5.5 Value of the world heart valve repair market $ millions
- Figure 5.6 Company share of the world heart valve repair market 2007
- Figure 6.1 Value of the world VAD market $ millions
- Figure 6.2 Value of the world intra aortic balloon pump market $millions
