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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 [email protected], 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
Improvements in Administration and Efficacy Drive Growth
NC77–52
December 2013
2 NC67-52
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
Contents
Source: Frost & Sullivan
3 NC77-52
• 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.
Methodology
Source: Frost & Sullivan
4 NC77-52
Scope and Segmentation
• 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.
Geographic Coverage US
Study Period 2009–2017
Base Year 2012
Forecast Period 2013–2017
Monetary Unit US Dollars
Source: Frost & Sullivan
5 NC77-52
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
6 NC77-52
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.
DME
Total Retinal Therapeutics Market
RVO
Total Retinal Therapeutics Market: Market Segmentation, US, 2012
AMD
Market Segmentation
Source: Frost & Sullivan
7 NC77-52
New Market Opportunities
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.
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.
Source: Frost & Sullivan
8 NC77-52
Marketed
Pre-
registration
Phase 2
Phase 1
Phase 3 AMD DME
RVO
Competitive Landscape
Total Retinal Therapeutics Market: Competitive Landscape, US, 2013
Eylea
(Regeneron)
Lucentis
(Genentech)
Macugen
(Valeant Pharmaceuticals/
Pfizer)
Lucentis
(Genentech)
Lucentis
(Genentech) Ozurdex
(Allergan)
Eylea
(Regeneron)
Fovista
(Archemix, Ophthotech)
Sirolimus
(MacuSight)
Sonepcizumab
(Lpath)
Squalamine
(Ohr Pharmaceutical)
Ruboxistaurin
(Eli Lilly)
Triamcinolone
(Allergan)
Eylea
(Regeneron)
Macugen
(Valeant Pharmaceuticals/
Pfizer)
Sirolimus
(MacuSight)
CNTO 2476
(Janssen)
Danazol
(Ampio)
Danazol
(Ampio)
Eculizumab
(Alexion)
Emixustat
(Acucela)
ESBA 1008
(Alcon)
ICO-007
(Isis)
Mecamylamine
(CoMentis)
Mecamylamine
(CoMentis)
MP 0112
(Molecular Partners)
MP 0112
(Allergan/Molecular
Partners)
Pazopanib
(GSK)
AAV2sFLT 01
(Genzyme / AGTC)
ACU 3223
(Acucela)
AKB 9778
(Aerpio
Therapeutics)
NOVA63035
(Novagali)
hI-con1
(Iconic
Therapeutic)
LD22-4
(Advanced Refractive
Technologies)
P 529
(Paloma)
Triamcinolone
(Icon Bioscience)
Triamcinolone
(Icon Bioscience) Volociximab
(Ophthotech)
X 82
(Tyrogenex)
Intravitreal Injection
Oral
Topical
ARC1905
(Ophthotech)
Source: Frost & Sullivan
9 NC77-52
Marketed Product Analysis
Product Company Class Indication
US
Launch
Patent
Expiry Administration
Eylea
(aflibercept) Regeneron VEGFR1
AMD,
RVO 2011 2020
Intravitreal Injection/Bi-
monthly
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
Total Retinal Therapeutics Market: Marketed Product Analysis, US, 2013
Source: Frost & Sullivan
10 NC77-52
Pipeline Analysis
Total Retinal Therapeutics Market: Pipeline Analysis, US, 2013
Product Company Class Phase Indication Administration
Fovista
(E 10030) Archemix, Ophthotech PDGF-B 3 AMD Intravitreal Injection
Ruboxistaurin Eli Lilly PKC beta 3 DME Oral
Triamcinolone 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
11 NC77-52
Pipeline Analysis (continued)
Source: Frost & Sullivan
Product Company MOA/Class Phase Indication Dose/Administration
CNTO 2476 Janssen Unknown 2 AMD Intravitreal Injection
Danazol Ampio Pharmaceuticals Antiangiogenic 2 AMD, DME Oral
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 (AGN-
150998)
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
12 NC77-52
Pipeline Analysis (continued)
Product Company MOA/Class Phase Indication Dose/Administration
ACU 3223 Acucela Vitamin A derivative 1 AMD Oral
AKB 9778 Aerpio Therapeutics
HPTPβ
inhibitor/Tie-2
activator
1 DME Oral
NOVA63035 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
13 NC77-52
Timeline of Key Events
2017 2016 2015 2014 2013 2012 2009 2010 2011
Fovista Approval
(Ophthotec)
Iluvien Approval
(Alimera)
RVO DME AMD
Total Retinal Therapeutics Market: Timeline of Key Events, US, 2009–2017
Source: Frost & Sullivan
Key Takeaway: Ophthotech’s Fovista has the potential to become an add-on therapy to VEGF
treatment in 2017.
Eylea Approval
(Regeneron)
Ozurdex Approval
(Allergan)
Lucentis Approval
(Genentech)
Eylea Approval
(Regeneron)
Eylea Approval
(Regeneron)
Lucentis Approval
(Genentech)
14 NC77-52
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
Learn More—Next Steps
Source: Frost & Sullivan
15 NC77-52
For More Information
Jennifer Carson Corporate Communications
(+1) 210.247.2450
16 NC77-52
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
17 NC77-52
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
18 NC77-52
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
19 NC77-52
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