Ophthalmology Drug Futures

Date: April 22, 2011
Pages: 118
Price:
US$ 2,265.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: O727DF11E94EN
Leaflet:

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Ophthalmology Drug Futures
A complete and practical analysis of Ophthalmology Drugs packed with facts, figures and forecasts for launched and late-stage products

The US$14 billion global ophthalmology sector faces both commercial challenge and clinical opportunity, and this report answers key questions:

  • Why are we interested in chronic eye diseases?
  • Driven by ageing populations, which markets are expected to see the highest growth in the 65+ age groups?
  • Which sectors of the market are anticipated to contract by value over the next five years?
  • What new products will be launched over the next 5 years and what impact will they have on the market?
  • Which companies are set to improve their market share?
  • What novel products are in development for Wet Age-related Macular Degeneration (AMD)?
  • Dry AMD – large unmet clinical need, but what is the potential?
  • What potential benefits does Bayer’s VEGF TrapEye Regeneron have over existing treatments?
  • Merck’s NDA for Saflutan was submitted to FDA in March 2011 – what impact on the market could this product have?
  • Why are new treatments needed for dry eye?

Sight preservation in chronic eye disease is a high yielding, valuable and expanding sector in developed and emerging markets

AGE-RELATED MACULAR DEGENERATION

The market for drugs used to treat wet age-related macular degeneration (AMD) is estimated to be worth US$3.3 billion. There are relatively few players and an increasing patient pool; continued growth is expected over the medium term.

The current standard of care for wet AMD is Lucentis (ranibizumab), marketed by Roche in the US and Novartis elsewhere. Growth has been impressive since its launch in 2006; global sales amounted to US$3 billion in 2010. The cost of treatment is high, however, and there is some competition from off-label use of Roche’s Avastin (bevacizumab), which is significantly cheaper. In the US, the National Eye Institute is conducting a major Phase III comparative study of Avastin and Lucentis for the treatment of AMD.

But there is new competition expected on the market. The most advanced developmental treatment for AMD is Bayer and Regeneron’s VEGF Trap-Eye. Following positive top-line results from Phase III trials, regulatory filings have been planned in the US and EU in 2011. If approved, it is expected that this product will be quickly taken up in the market-place. It appears to have similar efficacy to Lucentis with less frequent dosing, which is likely to prove popular among patients and healthcare providers alike.

The report covers

Market analysis
What is macular degeneration?
How is it treated?
Photodynamic Therapy
Anti-VEGF
Why are new treatments needed?
What is in development?
AMD prevalence
Launched products
Lucentis (ranibizumab)
Macugen (pegaptanib)
Visudyne (verteporfin)
Phase III
VEGF Trap-Eye
Phase II
ACU-4429
PF-4523655

GLAUCOMA

Glaucoma affects around 65-70 million people worldwide and is the second leading cause of blindness, after cataracts. The WHO estimates that glaucoma was responsible for around 12.3% of world blindness in 2002, affecting around five million people.

Undoubtedly, generic companies will claim a significant share of the US$4.9 billion glaucoma market over the next few years. Pfizer’s US patent for the market leader, Xalatan (latanoprost) expired in March 2011 and the first generics have been approved.

Others in this segment are also set to lose exclusivity over the next few years. Dependent on the outcome of patent litigation, Alcon’s Travatan Z (travoprost) could face generic competition in the US as early as December 2011. Allergan’s US patents for Lumigan (bimatoprost) will expire in 2012 and 2014, while the European patents are set to expire in various markets between 2013 and 2017.

In the short term, there may be new competition in the US if Merck & Co is successful in gaining approval for Saflutan (tafluprost). Merck & Co has a licensing agreement for the product with Santen Pharmaceutical who market it in some Asian/European markets. Beyond new formulations and combination products in Phase III, the most advanced novel agents have yet to progress beyond Phase II.

The report covers

Market analysis
What is glaucoma?
How is it treated?
Why are new treatments needed?
What is in development?
Glaucoma prevalence
Launched products
Alphagan (brimonidine)
Trusopt (dorzolamide)
Azopt (brinzolamide)
Xalatan (latanoprost)
Lumigan (bimatoprost)
Travatan (travoprost)
Saflutan (tafluprost)
Phase II
BOL-303259-X
AR-12286
Phase I/II
INO-8875

DRY EYE SYNDROME

Alongside glaucoma and AMD, dry eye is a growing problem and one that also increases with age. While this condition is widely treated with artificial tear products that are available over the counter, the prescription market is currently worth around US$1.5 billion.

There are relatively few prescription pharmaceuticals to treat more severe cases; in the US, Allergan’s Restasis (ciclosporin) ophthalmic emulsion is currently the only product approved to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation. Competition may be on the horizon, however, from ISTA Pharmaceuticals’ Remura (bromfenac), which is in Phase III for the condition.

The report covers

Market analysis
What is dry eye syndrome?
How is it treated?
Why are new treatments needed?
What is in development?
Dry eye prevalence
Launched products
Restasis (ciclosporin)
Hyalein (sodium hyaluronate)
Diquas (diquafosol)
New formulations in development
Remura (bromfenac)
Mucosta (rebamipide)
Phase II/III
CF101
Phase II
Tofacitinib

About the Author

The report has been researched and written by Espicom’s Senior Analyst, Karen Holmes. Karen has over 15 years pharmaceutical and healthcare market analysis experience. Her recent studies include:
  • Injectable Generic Drugs: Prospects and Opportunities,
  • Emerging Opportunities in Inhalation and Nasal Spray Generic Drugs
  • Multiple Sclerosis: what the future holds
  • The Indian Pharmaceutical Industry
FOREWORD

EXECUTIVE SUMMARY

MARKET OVERVIEW

RESEARCH & DEVELOPMENT SUMMARY
COMPETITOR RATIO ANALYSIS
BACKGROUND INFORMATION
  Eye Disease in an Ageing Population

AGE-RELATED MACULAR DEGENERATION

MARKET ANALYSIS
WHAT IS MACULAR DEGENERATION?
HOW IS IT TREATED?
  Photodynamic Therapy
  Anti-VEGF
WHY ARE NEW TREATMENTS NEEDED?
WHAT IS IN DEVELOPMENT?
AMD PREVALENCE
ESTABLISHED PRODUCTS
  Lucentis (ranibizumab)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Sales Forecast
    Clinical Trial Results
  Macugen (pegaptanib)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Clinical Trial Results
  Visudyne (verteporfin)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Clinical Trial Results
PHASE III
  VEGF Trap-Eye
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Sales Forecast
    Clinical Trial Results
PHASE II
  ACU-4429
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
PF-4523655
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis

GLAUCOMA

MARKET ANALYSIS
WHAT IS GLAUCOMA?
HOW IS IT TREATED?
  Open-Angle Glaucoma and Ocular Hypertension
    Pharmacological Treatments
    Laser Treatment/Surgery
  Angle-Closure Glaucoma
    Pharmacological Intervention
    Laser Treatment/Surgery
WHY ARE NEW TREATMENTS NEEDED?
WHAT IS IN DEVELOPMENT?
GLAUCOMA PREVALENCE
ESTABLISHED PRODUCTS
  Alphagan (brimonidine)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Sales Forecast
  Trusopt (dorzolamide)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Sales Forecast
  Azopt (brinzolamide)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Sales Forecast
  Xalatan (latanoprost)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Sales Forecast
  Lumigan (bimatoprost)
    Mechanism of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Clinical Trial Results
    Competitor Ratio Analysis
    Sales Forecast
  Travatan (travoprost)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Sales Forecast
  Saflutan (tafluprost)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Sales Forecast
PHASE II
  Taprenepag
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Clinical Trial Results
  BOL-303259-X
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
  AR-12286
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition with the Market
    Competitor Ratio Analysis
    Clinical Trial Results
PHASE I/II
  INO-8875
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis

DRY EYE SYNDROME

MARKET ANALYSIS
WHAT IS DRY EYE SYNDROME?
HOW IS IT TREATED?
WHY ARE NEW TREATMENTS NEEDED?
WHAT IS IN DEVELOPMENT?
DRY EYE PREVALENCE
LAUNCHED PRODUCTS
  Restasis (ciclosporin)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Sales Forecast
  Hyalein (sodium hyaluronate)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Sales Forecast
  Diquas (diquafosol)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
NEW FORMULATIONS IN DEVELOPMENT
  Remura (bromfenac)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition with the Market
    Competitor Ratio Analysis
    Clinical Trial Results
  Mucosta (rebamipide)
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
PHASE II/III
  CF101
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis
    Clinical Trial Results
PHASE II
  Tofacitinib
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market
    Competitor Ratio Analysis

METHODOLOGY

    Competitor Ratio Analysis Criteria
Drug     Sales Forecasting

SOURCES

LIST OF TABLES

Company Overview
Drugs in Clinical Development
Competitor Ratio Analysis Summary
Sales of Leading Eye Care Pharmaceuticals, 2009-2016 (US$ Million)
Male Life Expectancy at Birth (Years), 2005-2009
Female Life Expectancy at Birth (Years), 2005-2009
Leading AMD Drug Sales, 2005-2010 (US$ Million)
AMD Market Share by Company, 2010 (%)
Drugs in Clinical Development for Age-related Macular Degeneration
Lucentis Sales by Company, 2009-2016 (US$ Million)
Final RADICAL outcomes (24 months)
Leading Glaucoma Drug Sales, 2005-2010 (US$ Million)
Drugs in Clinical Development for Glaucoma
Alphagan/Combigan Sales, 2009-2016 (US$ Million)
Trusopt/Cosopt Sales, 2009-2016 (US$ Million)
Xalatan/Xalacom Sales, 2009-2016 (US$ Million)
Lumigan Sales, 2009-2016 (US$ Million)
Leading Dry Eye Prescription Drug Sales, 2005-2010 (US$ Million)
Drugs in Clinical Development for Dry Eye Syndrome
Restasis Sales, 2009-2016 (US$ Million)
Hyalein Sales, 2009-2016 (US$ Million)

LIST OF FIGURES

Ophthalmology Market Sectors, 2010 (%)
Market Share by Company, 2010 (%)
Ophthalmology Market Sectors, 2016 (%)
Market Share by Company, 2016 (%)
Life Expectancy at Birth, 2008
Population Aged 65+ by Country, 2005 and 2020 (%)
Population Aged 65+, 2005-2020 (Millions)
Market Share of Leading AMD Drugs, 2010 (%)
How AMD Affects the Eye
Lucentis Sales, 2007-2016 (US$ Million)
VEGF Trap-Eye Sales, 2012-2016 (US$ Million)
Market Share of Leading Glaucoma Drugs, 2010 (%)
Glaucoma Market Share by Company, 2010 (%)
Diagram of a Healthy Eye
How Glaucoma Affects the Eye
Alphagan/Combigan Sales, 2007-2016 (US$ Million)
Trusopt/Cosopt Sales, 2007-2016 (US$ Million)
Azopt/Azarga Sales, 2009-2016 (US$ Million)
Xalatan/Xalacom Sales, 2007-2016 (US$ Million)
Lumigan Sales, 2007-2016 (US$ Million)
Travatan/Travatan Z Sales, 2009-2016 (US$ Million)
Saflutan/Tapros Sales, 2008-2016 (US$ Million)
Market Share of Leading Dry Eye Prescription Drugs, 2010 (%)
Dry Eye Market Share by Company, 2010 (%)
Restasis Sales, 2007-2016 (US$ Million)
Hyalein Sales, 2007-2016 (US$ Million)
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