Medical Devices Industry and Market Propects 2013-2023.pdf

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Medical Devices Industry and Market Prospects 2013-2023

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Contents

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

2.1 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 Parkinson’s Disease and Deep Brain Stimulation

2.4.2.1 Parkinson’s Disease

2.4.2.2 Deep Brain Stimulation

2.4.2.3 Epilepsy and Vagus Nerve Stimulation

1. Executive Summary

2. An Introduction to the Medical Device Industry

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Contents

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

3. The Global Medical Device Market 2013-2023

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Contents 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

4.1 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 Porter’s 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

4. Issues Affecting the Medical Device Market

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Contents 4.6.4 Bargaining Power of Buyers: High

4.6.5 Threat of New Entrants: Low

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

5. The Cardiology Devices Market 2013-2023

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Contents 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

6.1. 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

6. The Neurological Device Market 2013-2023

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Contents 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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Contents

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. MetaCure’s 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 Scientific’s Position in the DES Market

7.3.3 FDA Approval: An Unnecessarily Long-winded Process?

7.3.4 Boston Scientific’s 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

8.1 The Medical Device Industry, 2013-2023

8.1.1 Personalised Medicine: Possible Growth Driver in the Coming Decade

7. Expert Opinion

8. Conclusions

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Contents 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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Contents

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%), 2012-

2023

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%), 2012-

2023

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%), 2012-

2023

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%), 2012-

2023

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

List of Tables

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Contents 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%), 2012-

2023

Table 3.2 Stryker Corporation Medical Devices: Total Revenue Shares (%) by Franchise, 2012

Table 3.22Stryker Corporation: Medical Devices Revenue Forecast ($bn, AGR%, CAGR%), 2012-

2023

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 Scientific’s Taxus Stent Revenue ($bn) by Region, 2011 & 2012

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Contents 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, 2012-

2017

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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Contents

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

List of Figures

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Contents 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 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 Scientific’s 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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Contents 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



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Contents

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

Organisations Mentioned in this Report

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Contents 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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Contents 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. Michael’s 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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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&J’s

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&J’s 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&J’s 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 Revenue ($bn) 2012 Revenue Share (%) 2012

Orthopaedics 7.8 28.4Surgical care 6.5 23.6Vision care 3.0 10.9Diabetes care 2.6 9.5Speciality Surgery 2.5 9.2Diagnostics 2.1 7.5Cardiovascular care 2.0 7.2Infection Prevention/other 1.0 3.5Total medical devices sales 27.4 100.0

Source: J&J 2013, Visiongain 2013

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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. Medtronic’s RestoreSensor, given CE approval in 2010, uses

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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 Alzheimer’s and Parkinson’s. 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

Parkinson’s 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, Alzheimer’s

and Parkinson’s. 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.

Medical Devices Industry and Market Propects 2013-2023.pdf

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