Medical Devices Industry and Market Prospects 2013-2023

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1. Executive Summary
1.1 Industry Highlights 1.2 Overview of the Report Content 1.3 Research and Analysis Methods 1.4 Glossary of Terms Related to Medical Devices

2. An Introduction to the Medical Device Industry

2.1 Classifying Medical Devices 2.1.1 The US Medical Devices Classification System 2.1.2 The EU Medical Devices Classification System 2.2 Regulation of Medical Devices 2.2.1 The US Approval and Regulation System 2.2.2 The EU Approval and Regulation System 2.2.2.1 Post-marketing Surveillance in the EU 2.3 Coronary Artery Disease and Coronary Stents 2.3.1 Bare Metal Stents 2.3.2 Drug Eluting Stents (DES) 2.3.3 Drugs Used in DES 2.3.3.1 Sirolimus: The first drug to be used on a DES 2.3.3.2 Everolimus 2.3.3.3 Zotarolimus 2.3.3.4 Paclitaxel: the only non-sirolimus deravative In the US market 2.4 Neuromodulation 2.4.1 Chronic Pain and Spinal Cord Stimulation 2.4.2 Parkinsons Disease and Deep Brain Stimulation 2.4.2.1 Parkinsons Disease 2.4.2.2 Deep Brain Stimulation 2.4.2.3 Epilepsy and Vagus Nerve Stimulation

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3. The Global Medical Device Market 2013-2023
3.1 Medical Devices: Market Overview 3.1.1 Size of the Medical Device Market in 2012 3.1.2 Medical Devices: Revenue Analysis by Company, 2012 3.1.2.1 Johnson & Johnson: Largest Market Share in the Medical Device Sector 3.1.2.2 GE Healthcare: Strong Growth in Emerging Markets 3.1.2.3 Siemens Healthcare: Third Largest Medical Device Company in 2012 3.1.2.4 Medtronic: Largest Company Solely Manufacturing Medical Devices 3.1.2.5 Baxter International: Major Player in the Renal Devices Sector 3.1.2.6 Philips Healthcare: Specialist in Medical Imaging Systems 3.1.2.7 Roche: Major Player in the European Medical Device Market 3.1.2.8 Abbott Laboratories: Market Leader in the Coronary DES Sector 3.1.2.9 Stryker Corporation: Strong Growth in Neurovascular Business 3.1.2.10 Becton, Dickinson & Co. 3.1.2.11 Samsung: A New Entry Into The Market 3.2 World Medical Device Market Forecast, 2013-2017 3.3 World Medical Device Market Forecast, 2017-2023 3.4 Regional Medical Device Market Forecast, 2013-2023 3.4.1 US, EU5 and Japan The Leading Regions in the Medical Device Market 3.4.1.1 The US Market: Represents Over a Third of the Global Market 3.4.1.2 The EU5 Markets: Fiscal Restrictions Affecting Market Growth 3.4.1.3 Japan: The Second Largest National Medical Device Market in the World 3.4.2 The Chinese and Indian Markets 3.4.2.1 China: Double Digit CAGR in 2013-2023 3.4.2.2 India: A Rapidly Growing Medical Device Market 3.4.3 Russia and Brazil: New Power Players in the Medical Device Global Market 3.4.3.1 The Russian Market 3.4.3.2 The Brazilian Market 3.4.4 The EU5 Medical Device Markets

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3.4.4.1 Germany: The Biggest Medical Device Market in Europe 3.4.4.2 France: A Rapidly Rising over-65 Population 3.4.4.3 UK: An Import-led Market 3.4.4.4 Italy: Decentralisation of Medical Services will Drive Growth 3.4.4.5 Spain: Cost-Containment Measures Impacting Growth 3.5 Changing Market Shares by Region, 2012-2023

4. Issues Affecting the Medical Device Market

4.1 SWOT Analysis of the Medical Device Industry and Market, 2013-2023 4.2 Strengths 4.2.1 Strong Government Support Across Major International Markets 4.2.2 Sustained Market Segmentation 4.2.3 Large Number of Participating Companies 4.3 Weaknesses 4.3.1 The Market is Susceptible to Economic Pressures 4.3.2 Much of the Market Has Reached Maturity 4.4 Opportunities 4.4.1 An Aging Global Population 4.4.2 Personalised Medicine Providing Growth Opportunities 4.4.3 Regulatory Harmonisation Across Major International Markets 4.4.4 Increased Incidence and Prevalence of Many Diseases 4.4.5 Rapid Growth in Emerging Markets 4.5 Threats 4.5.1 Changes to Reimbursement Globally 4.5.2 Comparative Effectiveness Research as an Added Expense 4.5.3 US Medical Device Excise Tax 4.6 Porters Five Force Analysis of the Medical Device Market 4.6.1 Power of Suppliers: Low 4.6.2 Threat of Substitutes: Low 4.6.3 Rivalry Among Competitors: High

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4.6.4 Bargaining Power of Buyers: High 4.6.5 Threat of New Entrants: Low

5. The Cardiology Devices Market 2013-2023

5.1 Cardiology Devices: Market Overview 5.1.1 Cardiology Devices Market in 2012 5.1.2 Cardiology Devices Market Forecast, 2013-2023 5.2 The Drug Eluting Coronary Stent Market: Analysis & Forecast 2013-2023 5.2.1 The DES Market, 2012 5.2.2 The DES Market Forecast, 2013-2017 5.2.3 The DES Market Forecast, 2017-2023 5.3 Leading Coronary Stents: Product Analysis 5.3.1 Biomatrix (Biosensors International) 5.3.2 Xience Family of Everolimus-Eluting Stents (Abbott Vascular) 5.3.3 Taxus Paclitaxel-Eluting Stent (Boston Scientific) 5.3.4 Promus Everolimus-Eluting Stent (Boston Scientific) 5.3.5 Endeavor (Medtronic) 5.4 Coronary Stent Pipeline 5.4.1 Genous Combo (OrbusNeich) 5.4.2 Jactax (Boston Scientific) 5.4.3 Catania (CeloNova Biosciences) 5.4.4 MiStent SES (MiCell Technologies) 5.4.5 BioFreedom (Biosensors International) 5.4.6 Synergy (Boston Scientific) 5.5 SWOT Analysis of the DES Market, 2013-2023 5.5.1 Strengths 5.5.1.1 Competition: A Catalyst for DES Market Growth 5.5.1.2 DES: Proven Effectiveness over BMS 5.5.1.3 Continuous Innovation

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5.5.1.3.1 Polyzene-F Coated Stents: Potential Game Changer for the Stent Market? 5.5.2 Weaknesses 5.5.2.1 The Success of DES Compared with Other Treatments 5.5.2.2 The Risk of Stent Thrombosis 5.5.3 Opportunities 5.5.3.1 Rising Incidences of Coronary Artery Disease 5.5.3.2 Dual Antiplatelet Therapy: An Avoidable Expense? 5.5.4 Threats 5.5.4.1 The DES Market is Still Emerging 5.5.4.2 US and Japan DES Markets are Dominated by a Small Number of Companies 5.5.4.3 The Stent May Become Secondary to the Eluted Drug

6. The Neurological Device Market 2013-2023

6.1. Neurological Devices: Market Overview 6.2 Neurological Device Market Forecast, 2013-2023 6.3 Neuromodulation Market Analysis 6.3.1 The Neuromodulation Market Forecast, 2013-2023 6.3.2 SCS Market Forecast, 2013-2017 6.3.3 SCS Market Forecast, 2017-2023 6.3.4 DBS Market Forecast, 2013-2017 6.3.5 DBS Market Forecast, 2017-2023 6.3.6 VNS Market Forecast, 2013-2017 6.3.7 VNS Market Forecast, 2017-2023 6.3.8 Other Neuromodulation Devices Forecast, 2013-2023 6.4 Changing Market Shares of the Leading Neuromodulation Segments 6.5 Neuromodulation Device Pipeline 6.5.1. NeuroPace 6.5.2 Apnex Medical

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6.5.3 Intelect Medical (acquired by Boston Scientific Corporation) 6.5.4 CVRx 6.5.5. ImThera Medical 6.5.6 Devices Treating Obesity 6.5.6.1 IntraPace 6.5.6.2 EnteroMedics 6.5.6.3 MetaCure 6.6 SWOT Analysis of the Neuromodulation Device Industry, 2013-2023 6.6.1 Strengths 6.6.1.1 Provides a Safer Alternative 6.6.1.2 Neuromodulation Often Means Less Medication 6.6.1.3 Neuromodulation as a Cost-Effective Treatment Option 6.6.2 Weaknesses 6.6.2.1 Mechanisms are Not Fully Understood 6.6.2.2 Delayed FDA approvals 6.6.2.3 A Few Large Companies Dominate the Market 6.6.2.4 Devices Failing in Clinical Trials 6.6.3 Opportunities 6.6.3.1 Neuromodulation Market Set for Rapid Growth due to Expanding Disease Indications 6.6.3.2 Expansion into Emerging Markets 6.6.3.3 Increasing Prevalence of Neurological Diseases 6.6.3.4 The Potential of Personalised Medicine 6.6.4 Threats 6.6.4.1 Increasing Regulatory and Pricing Scrutiny 6.6.4.2 The Emergence of Stem Cell Therapies 6.6.4.3 SCS Faces Competition from Other Treatment Options

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7. Expert Opinion
7.1 Interview with Dr. Simon Thomson, Consultant in Pain medicine and Neuromodulation, and President of the International Neuromodulation Society (INS) 7.1.1 The Fast Growing Neuromodulation Market 7.1.2 Potential Advancements in Neuromodulation Technology 7.1.3 Electro-ceuticals: Possible New Treatment? 7.1.4 Strategies To Tackle Negative Perception of Interventional Devices 7.1.5 Medical Devices Excise Tax: Friend or Foe? 7.1.6 Influencing Market Penetration of Neuromodulation Devices 7.1.7 Neuromodulation Market: Future Projection 7.2 Interview with Dr. Mateusz Zelewski, Chief Executive Officer, MetaCure 7.2.1 Current State of the Gastrostimulation Market 7.2.2 Impact of New Tax Legislations 7.2.3. MetaCures DIAMOND System: New Model 7.2.4 Changing Perception of Interventional Diabetology 7.2.5 Product Distribution and Potential Collaborations 7.2.6 Future Projection for the Gastrostimulation Sector 7.3 Interview with Spokesperson From Boston Scientific Corporation 7.3.1 Current Perspective on the Medical Devices Industry 7.3.2 Boston Scientifics Position in the DES Market 7.3.3 FDA Approval: An Unnecessarily Long-winded Process? 7.3.4 Boston Scientifics Neuromodulation Market Consolidation and Growth Strategies 7.3.5 Influencing Public Oppinion on Interventional Devices 7.3.6 US Excise Tax: A Restraint to Product Innovation? 7.3.7 The Future of the Medical Devices Market

8. Conclusions
8.1 The Medical Device Industry, 2013-2023 8.1.1 Personalised Medicine: Possible Growth Driver in the Coming Decade

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8.1.2 Emerging Markets: Urbanisation-Driven Growth 8.2 The Coronary Stent Market, 2013-2023 8.3 The Neurology Market 2013-2023 8.3.1 Neuromodulation: A Rapidly Growing Sector 8.3.2 New Indications Driving Neuromodulation Market Growth 8.4 Alternative Treatment Options: Potential Restraint on Market Growth

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List of Tables
Table 2.1 The US Classification of Medical Devices Table 2.2 The EU Classification of Medical Devices Table 3.1 The Medical Devices Market: Revenues ($bn) and Market Shares (%) by Sector, 2012 Table 3.2 The Top 10 Medical Device Companies: Revenues ($bn) and Market Shares (%), 2012 Table 3.3 Johnson & Johnson Medical Devices and Diagnostics: Revenue ($bn) and Revenue Shares (%) by Franchise, 2012 Table 3.4 Johnson & Johnson: Medical Devices Revenue Forecast ($bn, AGR%, CAGR%), 20122023 Table 3.5 GE Healthcare: Medical Devices Revenue Forecast ($bn, AGR%, CAGR%), 2012-2023 Table 3.6 Siemens Healthcare Medical Devices: Revenues ($bn) and Revenue Shares (%) by Region, 2011 and 2012 Table 3.7 Siemens Healthcare: Medical Devices Revenue Forecast ($bn, AGR%, CAGR%), 20122023 Table 3.8 Medtronic: Revenues ($bn) and Revenue Shares (%) by Franchise, 2012 Table 3.9 Medtronic: Revenues ($bn) and Revenue Shares (%) by Region, 2012 Table 3.10 Medtronic: Medical Devices Revenue Forecast ($bn, AGR%, CAGR%), 2012-2023 Table 3.11 Baxter International: Revenues ($bn) and Revenue Shares (%) by Business Sector, 2012 Table 3.12 Baxter International: Revenues ($bn) and Revenue Shares (%) by Region, 2012 Table 3.13 Baxter International: Medical Devices Revenue Forecast ($bn, AGR%, CAGR%), 20122023 Table 3.14 Philips Healthcare: Revenues ($bn) and Revenue Shares (%) by Sector, 2012 Table 3.15 Philips Healthcare Medical Devices: Revenues ($bn) and Revenue Shares (%) by Region, 2012 Table 3.16 Philips Healthcare: Medical Devices Revenue Forecast ($bn, AGR%, CAGR%), 20122023 Table 3.17 Roche Medical Devices and Diagnostics: Revenues ($bn) and Revenue Shares (%) by Sector, 2012 Table 3.18 Roche: Medical Devices Revenue Forecast ($bn, AGR%, CAGR%), 2012-2023

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Table 3.19 Abbott Medical Devices and Diagnostics: Revenues ($bn) and Revenue Shares (%) by Region, 2012 Table 3.20 Abbott Laboratories: Medical Devices Revenue Forecast ($bn, AGR%, CAGR%), 20122023 Table 3.2 Stryker Corporation Medical Devices: Total Revenue Shares (%) by Franchise, 2012 Table 3.22Stryker Corporation: Medical Devices Revenue Forecast ($bn, AGR%, CAGR%), 20122023 Table 3.23 Becton Dickinson & Co: Medical Devices Revenues ($bn) and Revenue Shares (%) by Sector, 2012 Table 3.24 Becton Dickinson & Co: Medical Devices Revenue Forecast ($bn, AGR%, CAGR%), 2012-2023 Table 3.25 The Global Medical Device Market: Drivers and Restraints, 2013-2023 Table 3.26 The Global Medical Devices Market: Revenue Forecast ($bn, AGR%, CAGR%) by Region, 2012-2017 Table 3.27 The Global Medical Devices Market: Revenue Forecast ($bn, AGR%, CAGR%) by Region, 2017-2023 Table 3.28 The EU5 Medical Devices Markets: Revenues ($bn) and Market Shares (%) by Country, 2012 Table 3.29 The EU5 Medical Devices Markets: Revenue Forecast ($bn, AGR%, CAGR%) by Country, 2012-2017 Table 3.30 The EU5 Medical Devices Markets: Revenue Forecast ($bn, AGR%, CAGR%) by Country, 2017-2023 Table 3.3 The Medical Device Market: Revenue ($bn) by Region, 2012, 2017 and 2023 Table 3.32 The Medical Device Market: Market Shares (%) by Region, 2012, 2017 and 2023 Table 4.1 SWOT Analysis for the Medical Device Industry, 2013-2023 Table 5.1 Cardiology Devices: Market Revenue Forecast ($bn, AGR%, CAGR%), 2012-2017 Table 5.2 Cardiology Devices: Market Revenue Forecast ($bn, AGR%, CAGR%), 2017-2023 Table 5.3 Drug Eluting Stents: Market Revenue Forecast ($bn, AGR%, CAGR%), 2012-2017 Table 5.4 Drug Eluting Stents: Market Revenue Forecast ($bn, AGR%, CAGR%), 2017-2023 Table 5.5 Growth Drivers and Restraints for the Drug Eluting Stent Market, 2013-2023 Table 5.6 Boston Scientifics Taxus Stent Revenue ($bn) by Region, 2011 & 2012

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Table 5.7 Coronary Stent Development Pipeline, 2013 Table 5.8 SWOT Analysis for the DES Market, 2013-2023 Table 6.1 Neurological and Neuromodulation Markets: Revenue ($bn) by Sector, 2012 Table 6.2 Neurological Devices: Market Revenue Forecast ($bn, AGR%, CAGR%), 2012-2017 Table 6.3 Neurological Devices: Market Revenue Forecast ($bn, AGR%, CAGR%), 2017-2023 Table 6.4 Neuromodulation Devices: Revenue Forecast ($bn, AGR%, CAGR%) by Sector, 20122017 Table 6.5 Neuromodulation Devices Revenue Forecast ($bn, AGR%, CAGR%) by Sector, 2017-2023 Table 6.6 SCS Devices: Revenue Forecast ($bn, AGR%, CAGR%), 2012-2017 Table 6.7 SCS Devices: Revenue Forecast ($bn, AGR%, CAGR%), 2017-2023 Table 6.8 DBS Devices: Revenue Forecast ($bn, AGR%, CAGR%), 2012-2017 Table 6.9 DBS Devices: Revenue Forecast ($bn, AGR%, CAGR%), 2017-2023 Table 6.10 VNS Devices: Revenue Forecast ($bn, AGR%, CAGR%), 2012-2017 Table 6.11 VNS Devices: Revenue Forecast ($bn, AGR%, CAGR%), 2017-2023 Table 6.12 Other Neuromodulation Devices: Revenue Forecast ($bn, AGR%, CAGR%), 2012-2023 Table 6.13 Neuromodulation Devices: Market Shares (%) by Sector, 2012-2023 Table 6.14 Neuromodulation Devices: Industry Pipeline, 2013 Table 6.15 SWOT Analysis of the Neuromodulation Devices Industry, 2013-2023

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List of Figures
Figure 2.1 The Structure of Sirolimus Figure 2.2 The Structure of Everolimus Figure 2.3 The Structure of Zotarolimus Figure 2.4 The Structure of Paclitaxel Figure 3.1 The Medical Device Market: Market Shares (%) by Sector, 2012 Figure 3.2 Johnson & Johnson Medical Devices and Diagnostics: Revenue Shares (%) by Franchise, 2012 Figure 3.3 Johnson & Johnson Medical Devices and Diagnostics: Revenue ($bn) by Franchise, 2012 Figure 3.4 Johnson & Johnson: Medical Devices Revenue Forecast ($bn), 2012-2023 Figure 3.5 GE Healthcare: Medical Devices Revenue Forecast ($bn), 2012-2023 Figure 3.6 Siemens Healthcare Medical Devices: Revenue Shares (%) by Region, 2012 Figure 3.7 Siemens Healthcare Medical Devices: Revenue ($bn) by Region, 2011 and 2012 Figure 3.8 Siemens Healthcare: Medical Devices Revenue Forecast ($bn), 2012-2023 Figure 3.9 Medtronic: Revenue Shares (%) by Franchise, 2012 Figure 3.10 Medtronic: Revenue ($bn) by Region, 2012 Figure 3.11 Medtronic: Medical Devices Revenue Forecast ($bn), 2012-2023 Figure 3.12 Baxter International: Revenues ($bn) by Business Sector, 2012 Figure 3.13 Baxter International: Revenue Shares (%) by Region, 2012 Figure 3.14 Baxter International: Medical Devices Revenue Forecast ($bn), 2012-2023 Figure 3.15 Philips Healthcare Medical Devices: Revenue Shares (%) by Sector, 2012 Figure 3.16 Philips Healthcare: Revenues ($bn) by Region, 2012 Figure 3.17 Philips Healthcare: Medical Devices Revenue Forecast ($bn), 2012-2023 Figure 3.18 Roche Medical Devices and Diagnostics: Revenue ($bn) by Sector, 2012 Figure 3.19 Roche: Medical Devices Revenue Forecast ($bn), 2012-2023 Figure 3.20 Abbott Medical Devices and Diagnostics: Revenue ($bn) by Region, 2012 Figure 3.21 Abbott Medical Devices and Diagnostics: Revenue Shares (%) by Region, 2012 Figure 3.22 Abbott Laboratories: Medical Devices Revenue Forecast ($bn), 2012-2023 Figure 3.23 Stryker Corporation Medical Devices: Total Revenue Shares (%) by Franchise, 2012

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Figure 3.24 Stryker Corporation: Medical Devices Revenue Forecast ($bn), 2012-2023 Figure 3.25 Becton Dickinson & Co: Medical Devices Revenue Shares (%) by Sector, 2012 Figure 3.26 Becton Dickinson & Co: Medical Devices Revenue Forecast ($bn), 2012-2023 Figure 3.27 The Global Medical Devices Market: Revenue Forecast ($bn), 2012-2017 Figure 3.28 The Global Medical Devices Market: Revenue Forecast ($bn), 2017-2023 Figure 3.29 US, EU5 and Japan Medical Devices Markets: Revenue Forecast ($bn), 2012-2017 Figure 3.30 US, EU5 and Japan Medical Devices Markets: Revenue Forecast ($bn), 2017-2023 Figure 3.31 China and India: Medical Devices Revenue Forecast ($bn), 2012-2017 Figure 3.32 China and India: Medical Devices Revenue Forecast ($bn), 2017-2023 Figure 3.33 Brazil and Russia: Medical Devices Revenue Forecast ($bn), 2012-2017 Figure 3.34 Brazil and Russia: Medical Devices Revenue Forecast ($bn), 2017-2023 Figure 3.35 The EU5 Medical Devices Markets: Market Shares (%) by Country, 2012 Figure 3.36 The EU5 Medical Devices Markets: Revenue Forecast ($bn), 2012-2017 Figure 3.37 The EU5 Medical Devices Markets: Revenue Forecast ($bn), 2017-2023 Figure 3.38 Medical Device Market: Revenue ($bn) by Region, 2013, 2017 and 2023 Figure 3.39 The Medical Devices Market: Market Shares (%) by Region, 2012 Figure 3.40 The Medical Devices Market: Market Shares (%) by Region, 2017 Figure 3.41 The Medical Devices Market: Market Shares (%) by Region, 2023 Figure 5.1 Cardiology Devices: Market Revenue Forecast ($bn), 2012-2017 Figure 5.2 Cardiology Devices: Market Revenue Forecast ($bn), 2017-2023 Figure 5.3 Drug Eluting Stents: Market Revenue Forecast ($bn), 2012-2017 Figure 5.4 Drug Eluting Stents: Market Revenue Forecast ($bn), 2017-2023 Figure 5.5 Boston Scientifics Taxus Stent Revenue ($bn) by Region, 2011 & 2012 Figure 6.1 Neurological Devices: Market Revenue Forecast ($bn), 2012-2017 Figure 6.2 Neurological Devices: Market Revenue Forecast ($bn), 2017-2023 Figure 6.3 Neuromodulation Devices: Revenue Forecast ($bn), 2012-2017 Figure 6.4 Neuromodulation Devices: Revenue Forecast ($bn), 2017-2023 Figure 6.5 SCS Devices: Revenue Forecast ($bn), 2012-2017 Figure 6.6 SCS Devices: Revenue Forecast ($bn), 2017-2023 Figure 6.7 DBS Devices: Revenue Forecast ($bn), 2012-2017 Figure 6.8 DBS Devices: Revenue Forecast ($bn), 2017-2023

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Figure 6.9 VNS Devices: Revenue Forecast ($bn), 2012-2017 Figure 6.10 VNS Devices: Revenue Forecast ($bn), 2017-2023 Figure 6.11 Other Neuromodulation Devices: Revenue Forecast ($bn), 2012-2023 Figure 6.12 Neuromodulation Devices: Market Shares (%) by Sector, 2012 Figure 6.13 Neuromodulation Devices: Market Shares (%) by Sector, 2017 Figure 6.14 Neuromodulation Devices: Market Shares (%) by Sector, 2023

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Organisations Mentioned in this Report
Abbott Laboratories Angiotech Pharmaceuticals Apnex Medical Inc Association of Indian Medical Device Industry (AIMED) Baxter International Becton Dickinson & Co Biosensors International Biotronik SE & Co Boston Scientific Brazilian National Agency for Sanitary Surveillance (ANVISA) Bristol Myers Squibb CeloNova BioSciences Inc Center for Devices and Radiological Health (CDRH) [US] Central Drug Standard Control Organisation (CDSCO) [India] Cerbomed Cerebral Rx China Food and Drug Administration (CFDA) ClearStream Technologies Cochlear Ltd. Conor Medsystems Inc Cordis Corporation CVRx Inc Cyberonics Inc. DePuy Inc Economic Committee for Medical Products [France] ElectroCore EnteroMedics Inc Ethicon Endo-Surgery Inc Eucomed

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European Commission (EC) Food & Drug Administration (FDA) [US] GE Healthcare Gemeinsame Bundesausschuss (G-BA) [Germany] GlaxoSmithKline (GSK) Global Harmonisation Task Force (GHTF) Guidant Corporation Impulse Dynamics ImThera Medical Inc Insightra Medical Intelect Medical Inc International Medical Device Regulators Forum (IMDRF) International Neuromodulation Society (INS) IntraPace Inc Johnson & Johnson (J&J) JW Medical Systems KangHui Medical Kiestra Lab Automation Labcoat Ltd Lupin Pharmaceuticals Inc Medison Co Ltd Medical Device Regulatory Authority (MDRA) [India] Medtronic Inc MetaCure Inc MiCell Technologies Inc Ministry of Health, Labour, and Welfare (MHLW) [Japan] MIV Therapeutics Inc National Epilepsy Foundation [US] National Institute for Health and Clinical Excellence (NICE) [UK] NeuroPace Inc Northstar Neuroscience Inc

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Novartis OrbusNeich Ortho-Clinical Diagnostics Inc Patient-Centered Outcomes Research Institute (PCORI) [US] Pharmaceuticals and Medical Devices Agency (PMDA) [Japan] Pfizer Philips Healthcare Roszdravnadzor [Russia] Roche Samsung Sanofi-aventis Servizio Sanitario Nazionale (SSN) [Italy] Siemens Healthcare Sistema Unico de Saude (SUS) [Brazil] St Jude Medical St. Michaels Hospital, Toronto, Canada Stryker Corporation Synthes Terumo Medical Corporation Teva Pharmaceutical Industries Ltd Third Wave Technologies Inc Transneuronix Inc Trauson Holding United Nations (UN) United State Patent and Trademark Office (USPTO) UCB Biopharma Vitality Devices World Health Organisation (WHO)

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Medical Devices Industry and Market Prospects 2013-2023

3.1.2.1 Johnson & Johnson: Largest Market Share in the Medical Device Sector
Johnson & Johnson had the largest market share in the medical devices sector in 2012. J&Js medical devices division generated total global revenues of $27.4bn in the year to 1 January 2013. This $27.4bn accounted for 40.8% of J&Js global net sales and was also equivalent to 8.5% of the medical devices global sales for 2012. The orthopaedic devices arm of the business remains the highest grossing submarket for J&Js medical devices portfolio with sales of $7.8bn in 2012 (Table 3.3, Figures 3.2 and 3.3). This represents a 34.3% increase on its 2011 net sales figure.

Table 3.3 Johnson & Johnson Medical Devices and Diagnostics: Revenue ($bn) and Revenue Shares (%) by Franchise, 2012
Business Segment Orthopaedics Surgical care Vision care Diabetes care Speciality Surgery Diagnostics Cardiovascular care Infection Prevention/other Total medical devices sales Revenue ($bn) 2012 7.8 6.5 3.0 2.6 2.5 2.1 2.0 1.0 27.4 Revenue Share (%) 2012 28.4 23.6 10.9 9.5 9.2 7.5 7.2 3.5 100.0

Source: J&J 2013, Visiongain 2013

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Medical Devices Industry and Market Prospects 2013-2023

4.4 Opportunities 4.4.1 An Aging Global Population
The over-65 age group is an important demographic group in the medical device industry. The future fate of the medical device industry will be largely determined by whatever happens to the people within this demographic. A large proportion of the products in the medical device market are targeted at the over-65s. This is especially true for neurological and orthopaedic devices, where many of the conditions treated using medical devices is most prevalent in the over-65s.

With reports estimating the global over 65 population to reach 1billion by 2030, the aging population globally provides a strong opportunity to expand revenue base in a number of device sectors. The UN estimates the global over-65 population to have tripled over the last 50 years. It also estimates this number to increase by more than 50% in the next four decades to reach 418m by 2050 in developed regions of the world. Moreover, the UN estimates that, in developing countries, the over-65 population will reach 1.6bn by 2050, representing a third of the total population in these countries.

While an aging population will expand the market for devices targeted at diagnosing and treating age-related problems, other therapeutic needs will become present in younger generations. It is expected that growth in the orthopaedic market will also be driven by younger patients undergoing surgery. Research published in 2010 found that the average of patients undergoing knee replacement in the US dropped by two years from the early 1990s to the early 2000s. Such trends will continue to drive the orthopaedic devices market from 2012 onwards, visiongain concludes.

4.4.2 Personalised Medicine Providing Growth Opportunities

The issue of tailored medicine is currently a growing area in the medical devices R&D sector. Personalised medicines represent a good opportunity to boost the total revenue in the medical devices sector, especially in the biomarkers submarket where researchers are currently reporting positive prospects for the future use of biomarkers in the diagnosis of various conditions.

Personalised medicine provides two key opportunities in the medical devices market. The first of this is that therapeutic devices can be tailored to individual patient needs. An example of personalised medicine is the December 2012 release of crizotinib by Pfizer for the treatment of lung cancer. Furthermore, neuromodulation devices have already been designed, tested, and approved using this technology. Medtronics RestoreSensor, given CE approval in 2010, uses

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Medical Devices Industry and Market Prospects 2013-2023

6. The Neurological Device Market 2013-2023
The neurological sector covers devices that interact with, or are used to treat the central nervous system. A number of neurological disorders are treated with neurological devices, including neurodegenerative diseases such as Alzheimers and Parkinsons. For the purposes of this report, neurological devices have been categorised as the following:

Neuromodulation devices. By far the largest subsector, this covers devices used to stimulate the central nervous system in the treatment of conditions ranging from Parkinsons disease to major depressive disorder. The three main types of neuromodulation are:

Spinal Cord Stimulation (SCS) Deep Brain Stimulation (DBS) Vagus Nerve Stimulation (VNS)

Neurovascular devices, such as neurovascular catheters and neurovascular stents. The stents are used to open arteries in the neck or brain that have closed due to atherosclerosis. Neurovascular stents are more flexible than coronary stents, discussed in chapter 5.

Cerebrospinal fluid devices. This includes devices used to remove fluid that has accumulated in the ventricles of the brain, a condition known as hydrocephalus.

Other neurological devices include those used in brain biopsies, liquid embolics and detachable units, both of which are used for treating aneurysms.

6.1. Neurological Devices: Market Overview

The neurology devices market is one of the fastest growing sectors of the global medical devices market, owing to the ongoing major unmet clinical need in the treatment of neurological disorders. This sector covers devices that interact with, or are used to treat, diseases of the central, peripheral and autonomic nervous system, including degenerative diseases such as, Alzheimers and Parkinsons. The sector generated sales of $5.2bn in 2012, representing 1.6% of the global medical devices market (Figure 3.1). With continuous improvements in the device technology, the neurology devices market is set to witness double digit growth rate in the next decade.

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