Ophthalmic Devices Market 2014-2024

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Ophthalmic Devices Market Forecast 2014-2024 Future Prospects for Leading Companies ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.
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For an Executive Summary of this report please contact [email protected] (+44 (0)20 7549 9976) or refer to our website https://www.visiongain.com/Report/1272/Ophthalmic-Devices-Market-Forecast-2014-2024

Transcript of Ophthalmic Devices Market 2014-2024

Page 1: Ophthalmic Devices Market 2014-2024

Ophthalmic Devices Market Forecast 2014-2024

Future Prospects for Leading Companies

©noticeThis material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.

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Contents

1.1 Global Ophthalmic Devices Market Overview

1.2 Global Ophthalmic Devices Market Segmentation

1.3 Why You Should Read This Report

1.4 How This Report Delivers

1.5 Key Questions Answered by This Analytical Report

1.6 Who is This Report For?

1.7 Methodology

1.8 Frequently Asked Questions (FAQ)

1.9 Associated Reports

1.10 About Visiongain

2.1 The Eye: An Overview of Its Structure and Function

2.2 The Global Burden of Eye Disease

2.3The Diagnosis and Surgical Treatment for Eye Diseases

2.3.1Refractive errors (Myopia, Hyperopia or Astigmatism)

2.3.1.1 Lasik Eye Surgery (Laser In-Situ Keratomileusis)

2.3.1.2 Phakic Intraocular Surgery

2.3.1.3 Photorefractive keratectomy (PRK)

2.3.1.4 Conductive Keratoplasty (CK)

2.3.1.5 Refractive Lens Exchange (RLE)

2.3.2 Cataracts

2.3.2.1 Phacoemulsification and Intraocular Lens

2.3.2.2 Microincision Cataract Surgery (MICS)

2.3.3 Glaucoma

2.3.3.1 Diagnosis of Glaucoma

1. Report Overview

2. Introduction to the Ophthalmic Devices Market

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Contents 2.3.3.2 Glaucoma Surgical Treatment

2.3.4 Age-related Macular Degeneration (AMD)

2.3.4.1 Dry (non-exudative) AMD

2.3.4.1.1 Treatment for Dry AMD

2.3.4.2 Wet (exudative) AMD

2.3.4.3 Surgical Treatment of Wet AMD

2.3.4.3.1 Photodynamic Therapy

2.3.4.3.2 Laser Photocoagulation

2.3.4.3.3 Radiotherapy

2.3.4.3.4 Newer Types of Surgery

2.3.4.3.5 Wet AMD: Poor Outcomes with Surgical Procedures

2.3.5 Diabetic Retinopathy (DR)

2.3.5.1 Diagnosis of Diabetic Retinopathy

2.3.5.2 Treatment of Diabetic Retinopathy

2.3.6 Dry Eye Syndrome

2.3.6.1 Treatment of Dry Eye Syndrome

2.3.6.1.1 Punctal Occlusion

2.3.6.1.2 Salivary Gland Autotransplantation

2.4 Ophthalmic Devices

2.4.1 What are Ophthalmic Devices?

2.4.2 Devices: Classification

2.4.2.1 The US Medical Devices Classification System

2.4.2.2 The EU Medical Devices Classification System

2.4.3 Regulation of Ophthalmic Devices

2.4.3.1 The US Approval and Regulation System

2.4.3.2 The EU Approval and Regulation System

2.4.3.3 The Japanese Approval and Regulation System

2.5 Ophthalmic Devices: Market Segmentation

2.5.1 The Monitoring and Diagnostics Ophthalmic Devices Market

2.5.1.1 General Eye Health

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Contents 2.5.1.2 Refractive Error Monitoring and Diagnostics Devices

2.5.1.3 Glaucoma Monitoring and Diagnostic Devices

2.5.2 The Surgical Ophthalmic Devices Market

2.5.2.1 Cataract Surgery Devices

2.5.2.2 Glaucoma Surgery Devices

2.5.2.3 Refractive Error Surgery Devices

2.5.2.4 Vitreoretinal Surgery Devices

2.5.3 The Vision Care Devices Market

3.1 The Medical Devices Market Overview

3.1.1 The Medical Devices Market, 2013

3.1.2 The Medical Devices Market, 2014-2024

3.2 The Ophthalmic Devices Market by Submarket, 2013

3.3 The Ophthalmic Devices Market, 2014-2024

4.1 The Ophthalmic Vision Care Devices Market Overview

4.2 The Ophthalmic Vision Care Devices Market, 2014-2024

4.2.1 The Ophthalmic Vision Care Devices Market by Segment

4.2.1.1 The Ophthalmic Vision Care Devices Market by Segment, 2013

4.2.1.2 The Ophthalmic Vision Care Devices Market by Segment, 2014-2024

4.2.1.2.1 The Daily Disposable Contact Lenses Market, 2014-2024

4.2.1.2.2 The Other Contact Lenses Market, 2014-2024

4.3 Contact Lenses on the Market

4.4 The Contact Lenses Market: New Product Development and Product Pipeline

4.4.1 Clariti® 1 Day (Sauflon)

4. The Ophthalmic Vision Care Devices Market, 2014-2024

3. The Ophthalmic Devices Market, 2014-2024

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Contents 4.4.2 MyDay™ Daily Disposable Lenses (CooperVision)

4.4.3 1-DAY ACUVUE® TruEye® (Johnson & Johnson Vision Care)

4.4.4 Biotrue™ ONEday Contact Lenses (Bausch and Lomb)

4.4.5 Anti Microbial Contact Lenses (Brien Holden Vision Institute and School of

Optometry and Vision Science, University of New South Wales)

4.5 SWOT Analysis of the Vision Care Market, 2014-2024

4.5.1 Strengths

4.5.1.1 Silicone Hydrogels have Revolutionised Contact Lenses

4.5.1.2 Greater Use of Disposable Contact Lenses

4.5.2 Weaknesses

4.5.2.1 High Entry Barriers for New Entry Manufacturers

4.5.2.2 Fast Downward Pricing Pressure

4.5.2.3 Hygiene Issues

4.5.2.4 Greater Susceptibility to Global Recession

4.5.3 Opportunities

4.5.3.1 Growing Affluent Population in Emerging Economies

4.5.3.2 Contact Lenses Used as Diagnostic Tools

4.5.3.3 Sale of Cosmetic and Coloured Lenses

4.5.4 Threats

4.5.4.1 Growing Demand for Lasik Surgery

5.1 The Ophthalmic Diagnostics and Monitoring Devices Market Overview

5.2 The Ophthalmic Diagnostics and Monitoring Devices Market, 2013

5.3 The Ophthalmic Diagnostics and Monitoring Devices Market by Segment, 2014-2024

5.4 The Autorefractor/Keratometer Market, 2014-2024

5.5 The Fundus Camera Market, 2014-2024

5. The Ophthalmic Diagnostics and Monitoring Devices Market,

2014-2024

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Contents 5.6 The Slit Lamp Market, 2014-2024

5.7 The OCT Machine Market, 2014-2024

5.7.1 Ophthalmic OCT Machine Products

5.8 The Other Ophthalmic Diagnostics and Monitoring Devices Market, 2014-2024

5.9 Diagnostic Pipeline

5.9.1 Diagnostics and Monitoring Contact Lenses

5.9.1.1 Sensimed (Triggerfish)

5.9.1.2 Pro-IOP eye pressure sensor (Implandata Ophthalmic Products GmbH)

5.9.1.3 Glucose Monitoring Contact Lens (Google)

5.10 SWOT Analysis of the Ophthalmic Diagnostic and Monitoring Devices Market, 2014-2024

5.10.1 Strengths

5.10.1.1 Increasing Sophistication of Ophthalmic Diagnostic Devices

5.10.2 Weaknesses

5.10.2.1 Shortage of Ophthalmic Device Providers

5.10.3 Opportunities

5.10.3.1 Ageing Population

5.10.3.2 Increasing Demand for Advanced Optical Coherence Tomography

Machines

5.10.3.3 Increasing Demand for Advanced Ophthalmic Diagnostic Devices in

Emerging Markets

5.10.4 Threats

5.10.4.1 Increasing Cost of Healthcare

5.10.4.2 US Medical Device Excise Tax

6.1 The Ophthalmic Surgical Devices Market Overview

6.1.1 The Surgical Ophthalmic Devices Market, 2013

6.1.2 The Surgical Ophthalmic Devices Market, 2014-2024

6.2 The Intraocular Lenses Market, 2014-2024

6. The Ophthalmic Surgical Devices Market, 2014-2024

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Contents 6.2.1 Intraocular Lenses Products

6.2.2 Intraocular Lenses Product Pipeline

6.2.2.1 Smart IOL (Medennium)

6.2.2.2 NuLens Accommodating IOL (NuLens)

6.2.2.3 Flex Optic IOL (Quest Vision/AMO)

6.2.2.4 Zephyr (Anew Optics)

6.2.2.5 The FluidVision Lens (PowerVision)

6.2.2.6 Superior Accommodating IOL (HumanOptics)

6.2.2.7 KAMRA Vision (Acufocus)

6.3 The Ophthalmic Laser Market, 2014-2024

6.3.1 Laser System Products

6.3.1.1Refractive Lasers

6.3.1.2 STAR S4 IR™ Excimer Laser (Abbott Medical Optics)

6.3.1.3 WaveLight® Allegretto Wave® Eye-Q Laser (Alcon)

6.3.1.4 NIDEK Advanced Vision Excimer Laser System NAVEX Quest (Nidek)

6.3.1.5 TECHNOLAS® TENEO™ 317 Laser (Bausch and Lomb Technolas)

6.3.2 Cataract Lasers

6.3.2.1 The LenSx Laser (Alcon)

6.3.2.2 LENSAR Laser System (LENSAR)

6.3.2.3 Catalys Precision Laser System (Abbott Medical Optics)

6.3.2.4 VICTUS Femtosecond Laser Platform (Bausch and Lomb Technolas)

6.3.2.5 Lumenis Vision (InSight)

6.4 The Phacoemulsification Device Market, 2014-2024

6.5 The Ophthalmic Viscoelastic Device Market, 2014-2024

6.6 The Other Surgical Ophthalmic Devices Market, 2014-2024

6.7 Ophthalmic Drug Delivery Devices

6.7.1 Recent Approvals

6.7.1.1 Vitrasert® ganciclovir 4.5mg (Bausch + Lomb)

6.7.1.2 Retisert® fluocinolone acetonide (Bausch + Lomb)

6.7.1.3 Ozurdex® dexamethasone (Allergan)

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Contents 6.7.1.4 Iluvien® fluocinolone acetonide (Alimera Sciences)

6.7.2 Novel Ocular Drug Delivery Platform Pipeline

6.7.2.1 ECT Platform (Neurotech Pharmaceuticals)

6.7.2.2 SynBiosys® Polymer Platform (InnoCore)

6.7.2.3 Hydrogel Technology Products (Ocular Therapeutix)

6.7.2.4 Helios Ocular (ForSight Vision5)

6.7.2.5 L-PPDS Drug Delivery System (Mati Therapeutics)

6.8 Microinvasive Glaucoma Surgery (MIGS)

6.8.1 MIGS Product Approvals

6.8.1.1 Trabectome (NeoMedix Corporation)

6.8.1.2 EX-PRESS Glaucoma Filtration Devices (Alcon)

6.8.1.3 iStent (Glaukos)

6.8.2 Stents in the Glaucoma Pipeline

6.8.2.1 CyPass Micro-Stent (Transcend Medical)

6.8.2.2 Hydrus (Ivantis)

6.8.2.3 XEN Gel Stent (Aquesys)

6.9 Other Ophthalmic Surgical Devices in Development

6.9.1 Argus II Retinal Implant (Second Sight)

6.9.2 Alpha IMS (Retina Implant AG)

6.10 SWOT Analysis of the Ophthalmic Surgical Devices Market, 2014-2024

6.10.1 Strengths

6.10.1.1 Highest Growing Submarket

6.10.1.2 Fast Development of IOL Technology

6.10.1.3 Increasingly Sophisticated Laser Surgery

6.10.2 Weaknesses

6.10.2.1 Extended FDA Timelines

6.10.2.2 Challenging Reimbursement Environment

6.10.3 Opportunities

6.10.3.1 Ageing Population

6.10.3.2 Rising Diabetes Epidemic

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Contents 6.10.3.3 Large Pipeline of Products

6.10.4 Threats

6.10.4.1 Venture Capital Available to Support Early Stage Companies is

Trending Down

6.10.4.2 Pharmaceuticals Compete as Therapies for Ocular Diseases

6.10.4.3 US Medical Device Excise Tax

7.1 The Leading National Ophthalmic Devices Market, 2013

7.1.1 The Leading National Ophthalmic Devices Market Forecast, 2014-2024

7.2 The US Ophthalmic Devices Market Forecast, 2014-2024

7.3 The European Ophthalmic Devices Market, 2013

7.3.1 The European Ophthalmic Devices Market Forecast, 2014-2024

7.3.1.1 The German Ophthalmic Devices Market Forecast, 2014-2024

7.3.1.2 The French Ophthalmic Devices Market Forecast, 2014-2024

7.3.1.3 The Italian Ophthalmic Devices Market Forecast, 2014-2024

7.3.1.4 The Spanish Ophthalmic Devices Market Forecast, 2014-2024

7.3.1.5 The UK Ophthalmic Devices Market Forecast, 2014-2024

7.4 The Japanese Ophthalmic Devices Market Forecast, 2014-2024

7.5 The Brazilian Ophthalmic Devices Market Forecast, 2014-2024

7.6 The Russian Ophthalmic Devices Market Forecast, 2014-2024

7.7 The Indian Ophthalmic Devices Market Forecast, 2014-2024

7.8 The Chinese Ophthalmic Devices Market Forecast, 2014-2024

7.9 The South Korean Ophthalmic Devices Market Forecast, 2014-2024

7.10 The Mexican Ophthalmic Devices Market Forecast, 2014-2024

7. The Leading National Ophthalmic Devices Markets, 2014-2024

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Contents

8.1 Alcon (Acquired by Novartis)

8.1.1 Recent Financial Performance, 2012-2013

8.1.1.1 Surgical Segment: Financial Performance, 2012-2013

8.1.1.2 Vision Care Segment: Financial Performance, 2012-2013

8.1.2 Product Line

8.1.2.1 Surgical Products

8.1.2.1.1 The CENTURION® Vision System

8.1.2.1.2 LenSx® Laser

8.1.2.1.3 The WaveLight® Refractive Suite

8.1.2.1.4 The WaveLight® Allegretto Wave® Eye-Q Laser

8.1.2.1.5 ACRYSOF® IOLS

8.1.2.1.6 The EX-PRESS® Glaucoma Filtration Device

8.1.2.2 Vision Care Products

8.1.2.2.1 AIR OPTIX®

8.1.2.2.2 FOCUS DAILIES

8.1.3 Mergers and Acquisitions

8.1.3.1 Novartis Acquisition of Alcon

8.1.3.2 Acquisition of Endure Medical Systems

8.1.3.3 Acquisition of SensoMotoric Instruments GmbH (SMI) – Ophthalmic

Division

8.1.3.4 Acquisition of LenSx Lasers

8.1.4 Jobs Losses

8.2 Abbott Medical Optics (AMO)

8.2.1 AMO Financial Performance, 2012-2013

8.2.2 AMO Product Portfolio

8.2.3 Mergers and Acquisitions

8.2.3.1 Abbott’s Acquisition of Advanced Medical Optics

8.2.3.2 Acquisition of OptiMedica

8. The Leading Ophthalmic Devices Companies, 2014-2024

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Contents 8.2.3.3 Acquisition of VISX

8.3 Bausch and Lomb (B+L) (acquired by Valeant)

8.3.1 Bausch and Lomb Financial Performance, 2008-2012

8.3.1.1 Bausch and Lomb Financial Performance by Segment, 2010-2012

8.3.2 Mergers and Acquisitions

8.3.2.1 Acquisition of Laboratorio Pförtner Cornealent SACIF

8.3.2.2 Valeant’s Acquisition of Bausch and Lomb

8.3.2.3 Acquisition of Technolas Perfect Vision GmbH

8.3.2.4 Acquisition of Eyeonics

8.3.3 Bausch and Lomb’s Price Fixing in China

8.4 Johnson & Johnson Vision Care

8.4.1 Johnson and Johnson Vision Care Financial Performance, 2013

8.4.1.1 Johnson and Johnson Vision Care Financial Performance, 2011- 2013

8.4.2 J&J Vision Care Product Portfolio

8.4.3 Vistakon Expansion of Manufacturing Facilities

8.4.3.1 Johnson and Johnson Fined for Price Fixing Contact Lens in China

8.5 Nidek

8.5.1 Nidek Financial Performance, 2008-2012

8.5.2 Leading Product lines

8.5.2.1 Surgical Systems

8.5.2.2 Intraocular Lens

8.5.2.3 Ophthalmic Lasers

8.5.2.4 Refractive Surgery Systems

8.5.2.5 Diagnostic Equipment

8.6 Hoya Corporation

8.6.1 Hoya Financial Performance, 2007-2013

8.6.1.1 Hoya Financial Performance by Business Segment, 2013

8.6.2 Hoya IOL Product Line

8.7 STAAR Surgical (STAAR)

8.7.1 STAAR Surgical Financial Performance, 2009-2013

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Contents 8.7.2 STAAR: Revenue by Region, 2013

8.7.3 STAAR: Revenue by Segment, 2011-2013

8.7.4 STAAR: Product Line

8.7.4.1 Intracollamer Lenses

8.7.4.2 Intraocular Lenses

8.8 Carl Zeiss AG Meditec

8.8.1 Carl Zeiss Meditec Revenue Financial Performance, 2012-2013

8.8.2 Carl Zeiss Meditec Revenue by Business Unit, 2012-2013

8.8.3 Carl Zeiss Meditec Revenue by Region, 2013

8.8.4 Carl Zeiss Meditec Product Line

8.8.5 Mergers and Acquisitions

8.8.5.1 Acquisition of Aaren Scientific

8.9 TopCon

8.9.1 TopCon: Revenue by Company, 2013

8.9.2 TopCon: Major Ophthalmic Devices Products

8.9.2.1 3D OCT-2000 Spectral Domain OCT

8.9.2.2 Other Major Products

8.9.3 Mergers and Acquisitions

8.9.3.1 Acquisition of Optimedica’s Retina and Glaucoma Business

8.10 Haag-Streit Holding AG

8.10.1 Haag-Streit Holding AG Product Line

#

9.1 Porter’s Five Forces Analysis of the Ophthalmic Devices Market

9.1.1 Rivalry Among Competitors [High]

9.1.2 Threat of New Entrants [Medium]

9.1.3 Power of Suppliers [Low]

9.1.4 Power of Buyers [High]

9. Qualitative Analysis of the Ophthalmic Devices Market 2014-2024

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Contents 9.1.5 Threat of Substitutes (High)

10.1 Professor Bernard Chang, Consultant Ophthalmologist, Spire Leeds Hospital

10.1.1 The Evolution of Diagnostic and Surgical Ophthalmic Devices

10.1.2 The Needs for Advancement in Ophthalmic Therapy

10.1.3 Ophthalmic Diseases Indications and the Use of Surgery as Therapy

10.1.4 Reimbursement of Ophthalmic Devices

10.1.5 The Regulatory Concerns for Ophthalmic Devices

10.2 Will Moore, CEO and President, IRIDEX

10.2.1 M&A Increases in the Ophthalmic Devices Market

10.2.2 Iridex’s Business Strategy

10.2.3 Iridex’s Regional Sales Focus

10.2.4 High Revenue Generating Products

10.2.5 Iridex’s Pipeline Products

11.1 The World Ophthalmic Devices Market, 2013-2014

11.2 Leading Ophthalmic Devices Submarkets

11.3 World Ophthalmic Devices Market Forecast, 2014-2024

11.4 Leading Segments of the Ophthalmic Devices Submarkets

Table 2.1 Segments and Definitions of the Ophthalmic Market

Table 2.2 ICD 10 Classification of Visual Impairment, 2010

Table 2.3 The US Classification of Medical Devices

List of Tables

10. Expert Opinion

11. Conclusions

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Ophthalmic Devices Market Forecast 2014-2024: Future Prospects for Leading Companies

Table 5.6 The OCT Machine Market: Revenue ($bn), AGR (%), CAGR (%), 2013-2024 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024

OCT machine ($bn) 0.61 0.66 0.70 0.75 0.81 0.86 0.93 1.00 1.07 1.16 1.24 1.34

AGR (%) 6.8 6.9 7.0 7.2 7.4 7.4 7.5 7.6 7.6 7.7 7.7

CAGR (%) 2013-2018

CAGR (%) 2013-2024 7.3

7.1 2018-2024 7.6

Figure 5.7 The OCT Machine Market: Revenue ($bn), AGR (%), 2013-2024

5.7.1 Ophthalmic OCT Machine Products Table 5.3 identifies the leading OCT machines currently on the market and their manufacturers.

Earlier models of OCT technology use time domain OCT which was a relative slow process that

limited the quality and amount of data captured, acquiring around 400 A-scans per second. These

OCTs used time delay to determine the spatial location of reflected light. Spectral domain OCT

was the next advancement in imaging technology, developed by such companies as Heidelberg

Engineering and TopCon, and was first FDA approved in 2006. It is a much faster and non

mechanical choice of technology. It can simultaneously measure multiple wavelengths of reflected

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Source: visiongain 2014

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Ophthalmic Devices Market Forecast 2014-2024: Future Prospects for Leading Companies

7.9 The South Korean Ophthalmic Devices Market Forecast, 2014-2024 South Korea is expected to be the fastest growing ophthalmic devices national market during the

forecast period (2013-2024), with a growth rate of 12.1% in the first half and 12.2% in the second

half of the forecast period. The South Korean ophthalmic devices market was estimated to be have

generated $0.19bn in 2013 and will rise to $0.33bn in 2018 and $0.66bn in 2024.

The major driver is the government’s initiatives to increase the medical industry in South Korea.

The Korean government has announced plans to pursue a mid-to-long term plan to become one of

the top 7 countries in the medical device sector by 2020. The government has set targets to

capture 3.8% of the global medical device market share by 2020 and are aiming to hire 130,000

people in the sector, with employment in the medical device sector at 37,000 in 2013.

Table 7.16 The South Korean Ophthalmic Devices Market: Revenue ($bn), AGR (%), CAGR (%), 2013-2024

2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024

South Korea ($bn) 0.19 0.21 0.24 0.26 0.30 0.33 0.37 0.42 0.47 0.53 0.59 0.66

AGR (%) 12.0 12.1 12.1 12.2 12.2 12.2 12.3 12.2 12.2 12.2 12.3CAGR (%) 2013-2018

CAGR (%) 2013-2024 12.2

12.1 2018-2024 12.2

Figure 7.16 The South Korean Ophthalmic Devices Market: Revenue ($bn), AGR (%), 2013-2024

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Ophthalmic Devices Market Forecast 2014-2024: Future Prospects for Leading Companies

BC: To be fair, from the NHS point of viewpoint, we have kept pace with technology advances.

NICE (The National Institute of Clinical Excellence) is the government body that helps to determine

if a treatment is cost effective or not. If they say it is cost effective, then he NHS will be obliged to

buy these new devices.

On the other hand, the NHS does face financial constraints; the government says it needs to save

20% of its budget within the next 5 years. The money available from the NHS trust will be cut.

However if the new devices work very well, for example you can treat more patients more

effectively, then you can make a business case to buy the new devices.

Likewise, the private sector and insurance companies also expect improved treatments or

outcomes for the same price. Therefore any new devices must deliver improvement in some form

or they will be unaffordable.

visiongain: We have seen an increase in the growth of the ophthalmic devices market over the

last few years? Could you give any reason for this from an ophthalmologist standpoint?

BC: I think because eye conditions are so common. If we take cataracts as an example again,

because Cataract surgery is very successful in restoring vision, you have a lot of demand. Demand

drives competition to develop the best products.

10.1.5 The Regulatory Concerns for Ophthalmic Devices visiongain: As the buyers and users of diagnostic and surgical ophthalmic devices, what would

you like to address to the ophthalmic devices industry?

BC: In my opinion, we would like to see that as new products and companies come along, we want

to know that the companies are reputable, and we want to know the products have gone through

proper clinical trials, before mainstream use. Devices are not like pharmaceuticals, you only need

small sample trials in order to get a device through the market, so we have a concern that these

devices are not being properly trialled. If you look at what happened with the metal on metal hip

implants and the PIP breast implants scandal, they demonstrate how the regulation can fail the

public. So obviously, as surgeons, we want to know that the devices we are using are as safe as

possible. We certainly want more robust safeguards put in place by regulatory authorities and an

efficient and rapid reporting of problems as they arise.

visiongain: As surgeons, what is the process of transferring new technology into the surgery?