Analysis of the US Retinal Therapeutics Market
Improvements in Administration and Efficacy Drive Growth

NC77–52
December ...
Contents
This research service examines the US market for age-related macular degeneration
(AMD), diabetic macular edema (...
Methodology
• The information contained in this research service was derived from a variety of relevant
primary and second...
Scope and Segmentation

Geographic Coverage
Study Period
Base Year

US
2009–2017
2012

Forecast Period

2013–2017

Monetar...
Key Questions This Study Will Answer

Is the market growing, how long will it continue to grow, and at what rate?

Are the...
Market Segmentation
Total Retinal Therapeutics Market: Market Segmentation, US, 2012

Total Retinal Therapeutics Market

A...
New Market Opportunities
Current Participant Strategies
• As is typical with treatment decisions, efficacy
trumps all othe...
Competitive Landscape
Total Retinal Therapeutics Market: Competitive Landscape, US, 2013
Phase 1

AMD

LD22-4
(Advanced Re...
Marketed Product Analysis
Total Retinal Therapeutics Market: Marketed Product Analysis, US, 2013
US
Launch

Patent
Expiry
...
Pipeline Analysis
Total Retinal Therapeutics Market: Pipeline Analysis, US, 2013
Product

Company

Class

Fovista
(E 10030...
Pipeline Analysis (continued)

Product

Company

MOA/Class

Phase

Indication

CNTO 2476

Janssen

Danazol

Dose/Administr...
Pipeline Analysis (continued)

Product

Company

MOA/Class

ACU 3223

Acucela

Vitamin A derivative

AKB 9778

Aerpio Ther...
Timeline of Key Events
Key Takeaway: Ophthotech’s Fovista has the potential to become an add-on therapy to VEGF
treatment ...
Learn More—Next Steps
Included below please find the detailed Table of Contents for Analysis of the US Retinal Therapeutic...
For More Information

Jennifer Carson
Corporate Communications
(+1) 210.247.2450

jennifer.carson@frost.com

NC77-52

15
Contents
Section

Slide Number

Executive Summary

8

Market Overview

18

Competitive Playbook

21

Total Retinal Therape...
List of Exhibits
Exhibit

Slide Number

Total Retinal Therapeutics Market: Market Engineering Measurements, US, 2012

13

...
List of Exhibits (continued)
Exhibit

Slide Number

Total Retinal Therapeutics Market: Company Market Share Analysis of To...
List of Exhibits (continued)
Exhibit

Slide Number

DME Segment: Penetration Analysis, US, 2009–2017

64

RVO Segment: Mar...
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Analysis of the US Retinal Therapeutics Market

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Revamped Therapies Preventing Visual Impairment Primed to Revolutionize US Retinal Therapeutics Market

Frost & Sullivan: Ripe for innovative, non-invasive treatments, the market will almost double by 2017

The need for effective and patient-friendly treatment of retinal diseases to avoid visual impairment is driving the retinal therapeutics market in the U.S. Vascular endothelial growth factor (VEGF) inhibitors dominate the market as they are a safe and effective option to treat age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Although highly efficacious, existing VEGF treatments require frequent, invasive intravitreal injections. Thus, growth opportunities exist for new therapies with comparable efficacy but improved dosing and administration.

New analysis from Frost & Sullivan's (http://www.lifesciences.frost.com) Analysis of the US Retinal Therapeutics Market finds the market earned revenue of $2.45 billion in 2012 and estimates this to almost double to $4.15 billion in 2017.

For more information on this research, please email Jennifer Carson, Corporate Communications, at jennifer.carson@frost.com, with your full name, company name, job title, telephone number, company email address, company website, city, state and country.

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Analysis of the US Retinal Therapeutics Market

  1. 1. Analysis of the US Retinal Therapeutics Market Improvements in Administration and Efficacy Drive Growth NC77–52 December 2013
  2. 2. Contents This research service examines the US market for age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) therapeutics. Topics covered include the following: • US market sizing and forecasting including breakdown by disease segment • Competitive landscape including comprehensive product and development pipeline analysis • Launch timelines and patent expirations • Important trends, unmet needs, opportunities and risks in retinal disease therapeutics • Conclusions, recommendations, and companies to watch Source: Frost & Sullivan NC67-52 2
  3. 3. Methodology • The information contained in this research service was derived from a variety of relevant primary and secondary sources. • Secondary data sources include company publications (annual reports, US Securities and Exchange Commission (SEC) filings, investor presentations, earnings transcripts, and press releases); US government public sources (clinicaltrials.gov, FDA.gov, Orange Book); pharmaceutical industry databases; and published articles in scientific and medical journals. • Revenue forecasting is performed using a robust, data-driven, bottom-up, patient-based approach. Marketed drugs and potential new entrants in Phase 3 of development and beyond are individually forecast, and aggregate figures are provided. • Revenue from off-label usage is not included, but is accounted for in forecast models. Source: Frost & Sullivan NC77-52 3
  4. 4. Scope and Segmentation Geographic Coverage Study Period Base Year US 2009–2017 2012 Forecast Period 2013–2017 Monetary Unit US Dollars • This research service evaluates the United States market for pharmaceutical treatments for the following retinal diseases: AMD, DME, and RVO. • Units are defined as patients. Treated patient numbers, when estimated, are derived from annual sales revenue and annual cost of therapy. • The price is the annual cost of therapy, and the average annual cost of therapy is based on the average wholesale price (AWP) per drug, as reported in Thomson Reuters Red Book. Hospital or clinic-associated expenses are not included in the cost of therapy. • Indication-specific annual revenue, as reported, is used when available. Otherwise, estimates are used. Source: Frost & Sullivan NC77-52 4
  5. 5. Key Questions This Study Will Answer Is the market growing, how long will it continue to grow, and at what rate? Are the existing competitors structured correctly to meet customer needs? What pipeline candidates have the greatest potential? When are they expected to reach market? Which treatments are set to dominate the market? How much market share for each competitor? What is the peak sales potential for AMD, DME, and RVO market? What the strengths and weaknesses of current and future therapies? Source: Frost & Sullivan NC77-52 5
  6. 6. Market Segmentation Total Retinal Therapeutics Market: Market Segmentation, US, 2012 Total Retinal Therapeutics Market AMD DME RVO Market Segmentation This research service evaluates the US markets for prescription medications for the retinal disorders age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. It does not include other retinal disorders, such as Stargardt’s disease, retinitis pigmentosa, retinopathy of prematurity, or cytomegalovirus retinitis. Source: Frost & Sullivan NC77-52 6
  7. 7. New Market Opportunities Current Participant Strategies • As is typical with treatment decisions, efficacy trumps all other measures and VEGF treatments dominate the market due to their high efficacy. • There is very limited competition for VEGF treatments such as Eylea and Lucentis. • Eylea differentiates from Lucentis on the promise of less frequent dosing; hence the focus of their marketing strategy on dose frequency. • Compounding pharmacies continue to get high demand for their low cost Avastin VEGF treatment. Unmet Needs • Although new treatments are highly efficacious, all VEGF treatments are administered via intravitreal injection, an invasive procedure. • Further improvements are needed to drug administration methods to reduce the frequency of intravitreal injection, such as with Allergan’s AGN-150998 which has the potential to be dosed every 3 months. • New treatments which can be administered orally or topical drops would revolutionize treatment and garner significant market adoption in place of intravitreal injections. • Combination treatment to further increase efficacy such as Ophthotech’s Fovista (PDGF inhibitor) with a VEGF inhibitor such as Avastin are promising. Source: Frost & Sullivan NC77-52 7
  8. 8. Competitive Landscape Total Retinal Therapeutics Market: Competitive Landscape, US, 2013 Phase 1 AMD LD22-4 (Advanced Refractive Technologies) MP 0112 (Molecular Partners) Sirolimus (MacuSight) Sonepcizumab Fovista (Lpath) (Archemix, Ophthotech) AAV2sFLT 01 (Genzyme / AGTC) Squalamine (Ohr Pharmaceutical) X 82 (Tyrogenex) Mecamylamine (CoMentis) Phase 2 ACU 3223 (Acucela) hI-con1 (Iconic Therapeutic) Triamcinolone (Icon Bioscience) ARC1905 (Ophthotech) ESBA 1008 (Alcon) Danazol (Ampio) Emixustat (Acucela) Oral Topical NC77-52 Sirolimus (MacuSight) Marketed Triamcinolone (Allergan) Lucentis (Genentech) Lucentis (Genentech) Macugen (Valeant Pharmaceuticals/ Ozurdex Pfizer) (Allergan) Eylea (Regeneron) Lucentis (Genentech) Eylea (Regeneron) Pazopanib (GSK) Triamcinolone (Icon Bioscience) Volociximab (Ophthotech) Intravitreal Injection Ruboxistaurin (Eli Lilly) Eylea (Regeneron) CNTO 2476 (Janssen) Eculizumab (Alexion) DME Phase 3 Preregistration Macugen (Valeant Pharmaceuticals/ Pfizer) Danazol (Ampio) ICO-007 (Isis) AKB 9778 (Aerpio Therapeutics) Mecamylamine (CoMentis) MP 0112 (Allergan/Molecular Partners) NOVA63035 (Novagali) P 529 (Paloma) RVO Source: Frost & Sullivan 8
  9. 9. Marketed Product Analysis Total Retinal Therapeutics Market: Marketed Product Analysis, US, 2013 US Launch Patent Expiry Product Company Class Indication Administration Eylea (aflibercept) Regeneron VEGFR1 AMD, RVO 2011 2020 Intravitreal Injection/Bimonthly Ozurdex (dexamethasone) Allergan Steroid RVO 2009 2020–2024 Intravitreal Injection/Monthly Macugen (pegaptanib) Valeant Pharmaceuticals/ Pfizer VEGF-A AMD 2004 2017 Intravitreal Injection Lucentis (ranibizumab) Genentech VEGFR1, VEGFR2 AMD, DME, RVO 2006 2017, 2019 Intravitreal Injection/Monthly Source: Frost & Sullivan NC77-52 9
  10. 10. Pipeline Analysis Total Retinal Therapeutics Market: Pipeline Analysis, US, 2013 Product Company Class Fovista (E 10030) Archemix, Ophthotech PDGF-B Ruboxistaurin Eli Lilly Triamcinolone Phase Indication Administration 3 AMD Intravitreal Injection PKC beta 3 DME Oral Allergan Steroid 3 DME Intravitreal Injection Eylea (aflibercept) Regeneron VEGFR1 3 DME Intravitreal Injection Macugen (pegaptanib) Valeant Pharmaceuticals / Pfizer VEGF-A 3 DME Intravitreal Injection Sirolimus MacuSight mTOR 2 AMD, DME Intravitreal Injection Sonepcizumab Lpath S1P 2 AMD Intravitreal Injection Squalamine Ohr Pharmaceutical Angiogenic 2 AMD Topical Source: Frost & Sullivan NC77-52 10
  11. 11. Pipeline Analysis (continued) Product Company MOA/Class Phase Indication CNTO 2476 Janssen Danazol Dose/Administration Unknown 2 AMD Ampio Pharmaceuticals Antiangiogenic 2 AMD, DME Eculizumab Alexion C5 2 AMD Intravitreal Injection Emixustat Acucela REP65 2 AMD Oral ESBA1008 Alcon (Novartis) VEGF 2 AMD Intravitreal Injection ICO 007 Isis/iCo Therapeutics c-Raf 2 DME Intravitreal Injection Mecamylamine (ATG 003) CoMentis Nicotinic acetylcholine /Antiangiogenic 2 AMD, DME Topical MP 0112 (AGN150998) Allergan/Molecular Partners VEGF-A 2 AMD, DME Intravitreal Injection Pazopanib GlaxoSmithKline VEGFR2, PDGFR, c-kit 2 AMD Intravitreal Injection AAV2sFLT 01 Genzyme/AGTC Gene therapy 1 AMD Intravitreal Injection Intravitreal Injection Oral Source: Frost & Sullivan NC77-52 11
  12. 12. Pipeline Analysis (continued) Product Company MOA/Class ACU 3223 Acucela Vitamin A derivative AKB 9778 Aerpio Therapeutics NOVA63035 Phase Indication Dose/Administration 1 AMD Oral HPTPβ inhibitor/Tie-2 activator 1 DME Oral Novagali Steroid 1 DME Intravitreal Injection hI-con1 Iconic Therapeutics hI-con1 1 AMD Intravitreal Injection LD22-4 Advanced Refractive Technologies Antiangiogenic 1 AMD Intravitreal Injection P 529 Paloma Pharmaceuticals Dual TORC1/2 inhibitor 1 AMD Intravitreal Injection Triamcinolone Icon Bioscience Steroid 1 AMD, RVO Intravitreal Injection Volociximab Ophthotech Anti-α5β1 1 AMD Intravitreal Injection ARC1905 Ophthotech Anti-C5 aptamer 1 AMD Intravitreal Injection X 82 Tyrogenex VEGF 1 AMD Intravitreal Injection Source: Frost & Sullivan NC77-52 12
  13. 13. Timeline of Key Events Key Takeaway: Ophthotech’s Fovista has the potential to become an add-on therapy to VEGF treatment in 2017. Total Retinal Therapeutics Market: Timeline of Key Events, US, 2009–2017 Lucentis Approval (Genentech) 2009 2010 Lucentis Approval (Genentech) 2011 Eylea Approval (Regeneron) 2012 Ozurdex Approval (Allergan) 2013 Eylea Approval (Regeneron) Iluvien Approval (Alimera) 2014 2015 2016 Eylea Approval (Regeneron) AMD 2017 Fovista Approval (Ophthotec) DME RVO Source: Frost & Sullivan NC77-52 13
  14. 14. Learn More—Next Steps Included below please find the detailed Table of Contents for Analysis of the US Retinal Therapeutics Market: Improvements in Administration and Efficacy Drive Growth For more information, please refer to the following slide for contact details. Additional Sources of Information on Ophthalmic Disorders • U.S. Retinal Therapeutics Market • Analysis of the United States Glaucoma Pharmaceuticals Market • Breakthroughs in Ophthalmic Devices and Drug Delivery Technologies (Technical Insights) Additional Frost & Sullivan offerings: • Talk to an analyst • Take our DNA Survey • Arrange a Growth Workshop • Explore the Growth Excellence Matrix 2.0 • Attend a relevant live or virtual event • Explore Healthcare Growth Consulting opportunities Source: Frost & Sullivan NC77-52 14
  15. 15. For More Information Jennifer Carson Corporate Communications (+1) 210.247.2450 jennifer.carson@frost.com NC77-52 15
  16. 16. Contents Section Slide Number Executive Summary 8 Market Overview 18 Competitive Playbook 21 Total Retinal Therapeutics Market – • Drivers and Restraints 24 • Forecasts and Trends 27 Competitive Environment 36 AMD Segment Breakdown 50 DME Segment Breakdown 58 RVO Segment Breakdown 66 Key Companies to Watch 74 The Last Word 79 Appendix 85 NC77-52 16
  17. 17. List of Exhibits Exhibit Slide Number Total Retinal Therapeutics Market: Market Engineering Measurements, US, 2012 13 Total Retinal Therapeutics Market: Market Segmentation, US, 2012 19 Total Retinal Therapeutics Market: Game-changing Strategies, US, 2013 23 Total Retinal Therapeutics Market: Key Market Drivers, US, 2012–2017 25 Total Retinal Therapeutics Market: Key Market Restraints, US, 2012–2017 26 Total Retinal Therapeutics Market: Market Engineering Measurements, US, 2012 28 Total Retinal Therapeutics Market: Revenue Forecast, US, 2009–2017 32 Total Retinal Therapeutics Market: Average Wholesale Price per Injection, US, 2009–2017 34 Total Retinal Therapeutics Market: Competitive Landscape, US, 2013 37 Total Retinal Therapeutics Market: Marketed Product Analysis, US, 2013 38 Total Retinal Therapeutics Market: Pipeline Analysis, US, 2013 39 Total Retinal Therapeutics Market: Absolute Market Share Trend by Revenue US, 2012 and 2017 43 NC77-52 17
  18. 18. List of Exhibits (continued) Exhibit Slide Number Total Retinal Therapeutics Market: Company Market Share Analysis of Top 4 Participants, US, 2012 44 Total Retinal Therapeutics Market: SWOT Analysis, US, 2013 44 Total Retinal Therapeutics Market: Timeline of Key Events, US, 2009–2017 46 Total Retinal Therapeutics Market: Patent Expirations, US, 2000–2030 47 Total Retinal Therapeutics Market, AMD Segment: Comparative Best Corrected Visual Acuity from Baseline for Select Marketed Drugs, US, 2012 48 AMD Segment: Market Engineering Measurements, US, 2012 49 AMD Segment: Revenue Forecast, US, 2009–2017 52 AMD Segment: Prevalence and Treated Patient Forecast, US, 2009–2017 54 AMD Segment: Penetration Analysis, US, 2009–2017 56 DME Segment: Market Engineering Measurements, US, 2012 59 DME Segment: Revenue Forecast, US, 2009–2017 60 DME Segment: Prevalence and Treated Patient Forecast, US, 2009–2017 62 NC77-52 18
  19. 19. List of Exhibits (continued) Exhibit Slide Number DME Segment: Penetration Analysis, US, 2009–2017 64 RVO Segment: Market Engineering Measurements, US, 2012 67 RVO Segment: Revenue Forecast, US, 2009–2017 68 RVO Segment: Prevalence and Treated Patient Forecast, US, 2009–2017 70 RVO Segment: Penetration Analysis, US, 2009–2017 72 NC77-52 19

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