NEW YORK, April 21, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
http://www.reportlinker.com/p0484753/Ophthalmology-DrugFutures .html
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 Trap?Eye 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
Table of Contents
FOREWORD ....... 1
EXECUTIVE SUMMARY .. 3
MARKET OVERVIEW ...... 5
RESEARCH & DEVELOPMENT SUMMARY ......... 10
COMPETITOR RATIO ANALYSIS .. 12
BACKGROUND INFORMATION ... 14
Eye Disease in an Ageing Population ........ 14
AGE-RELATED MACULAR DEGENERATION ... 18
MARKET ANALYSIS . 18
WHAT IS MACULAR DEGENERATION? .. 20
HOW IS IT TREATED?.......... 21
Photodynamic Therapy ...... 21
Anti-VEGF ........ 21
WHY ARE NEW TREATMENTS NEEDED? ........... 22
WHAT IS IN DEVELOPMENT? ....... 22
AMD PREVALENCE . 24
ESTABLISHED PRODUCTS 25
Lucentis (ranibizumab) .......... 25
Mode of Action .......... 25
Current Status 25
Proof of Concept/Clinical Data .... 25
Development Risks .. 27
Company Expertise .. 27
Competition within the Market .. 27
Competitor Ratio Analysis . 28
Sales Forecast 28
Clinical Trial Results . 29
Macugen (pegaptanib) .......... 35
Mode of Action .......... 35
Current Status 35
Proof of Concept/Clinical Data .... 35
Development Risks .. 37
Company Expertise .. 37
Competition within the Market .. 37
Competitor Ratio Analysis . 38
Clinical Trial Results . 38
Visudyne (verteporfin) ........... 40
Mode of Action ......... 40
Current Status ........... 40
Proof of Concept/Clinical Data.... 40
Development Risks .. 41
Company Expertise . 41
Competition within the Market .. 41
Competitor Ratio Analysis 41
Clinical Trial Results . 41
PHASE III ........ 45
VEGF Trap-Eye .. 45
Mode of Action ......... 45
Current Status ........... 45
Proof of Concept/Clinical Data.... 45
Development Risks .. 46
Company Expertise . 46
Competition within the Market .. 46
Competitor Ratio Analysis 46
Sales Forecast 47
Clinical Trial Results . 47
PHASE II ......... 51
ACU-4429 ........... 51
Mode of Action ......... 51
Current Status ........... 51
Proof of Concept/Clinical Data.... 51
Development Risks .. 51
Company Expertise . 52
Competition within the Market .. 52
Competitor Ratio Analysis 52
PF-4523655 ........ 53
Mode of Action ......... 53
Current Status ........... 53
Proof of Concept/Clinical Data.... 53
Development Risks .. 53
Company Expertise . 53
Competition within the Market .. 54
Competitor Ratio Analysis 54
GLAUCOMA ..... 55
MARKET ANALYSIS . 55
WHAT IS GLAUCOMA? ...... 56
HOW IS IT TREATED? ......... 58
Open-Angle Glaucoma and Ocular Hypertension ........ 58
Pharmacological Treatments ....... 58
Laser Treatment/Surgery ... 59
Angle-Closure Glaucoma ...... 59
Pharmacological Intervention ..... 59
Laser Treatment/Surgery ... 59
WHY ARE NEW TREATMENTS NEEDED? ........... 60
WHAT IS IN DEVELOPMENT? ....... 60
GLAUCOMA PREVALENCE ........... 62
ESTABLISHED PRODUCTS 63
Alphagan (brimonidine) ........ 63
Mode of Action .......... 63
Current Status 63
Proof of Concept/Clinical Data .... 63
Development Risks .. 64
Company Expertise .. 64
Competition within the Market .. 64
Competitor Ratio Analysis . 65
Sales Forecast 65
Trusopt (dorzolamide) ........... 67
Mode of Action .......... 67
Current Status 67
Proof of Concept/Clinical Data .... 67
Development Risks .. 67
Company Expertise .. 68
Competition within the Market .. 68
Competitor Ratio Analysis . 68
Sales Forecast 69
Azopt (brinzolamide) . 70
Mode of Action .......... 70
Current Status 70
Proof of Concept/Clinical Data .... 70
Development Risks .. 71
Company Expertise .. 71
Competition within the Market .. 71
Competitor Ratio Analysis . 71
Sales Forecast 72
Xalatan (latanoprost) .. 73
Mode of Action .......... 73
Current Status 73
Proof of Concept/Clinical Data .... 74
Development Risks .. 74
Company Expertise . 74
Competition within the Market .. 74
Competitor Ratio Analysis 75
Sales Forecast 75
Lumigan (bimatoprost) ......... 77
Mechanism of Action .......... 77
Current Status ........... 77
Proof of Concept/Clinical Data.... 77
Development Risks .. 78
Company Expertise . 78
Competition within the Market .. 78
Clinical Trial Results . 79
Competitor Ratio Analysis 80
Sales Forecast 81
Travatan (travoprost) . 82
Mode of Action ......... 82
Current Status ........... 82
Proof of Concept/Clinical Data.... 83
Development Risks .. 83
Company Expertise . 83
Competition within the Market .. 83
Competitor Ratio Analysis 84
Sales Forecast 85
Saflutan (tafluprost) .... 86
Mode of Action ......... 86
Current Status ........... 86
Proof of Concept/Clinical Data.... 86
Development Risks .. 87
Company Expertise . 87
Competition within the Market .. 87
Competitor Ratio Analysis 88
Sales Forecast 88
PHASE II ......... 89
Taprenepag ....... 89
Mode of Action ......... 89
Current Status ........... 89
Proof of Concept/Clinical Data.... 89
Development Risks .. 89
Company Expertise . 89
Competition within the Market .. 89
Competitor Ratio Analysis 90
Clinical Trial Results . 90
BOL-303259-X ... 92
Mode of Action .......... 92
Current Status 92
Proof of Concept/Clinical Data .... 92
Development Risks .. 92
Company Expertise .. 92
Competition within the Market .. 93
Competitor Ratio Analysis . 93
AR-12286 94
Mode of Action .......... 94
Current Status 94
Proof of Concept/Clinical Data .... 94
Development Risks .. 94
Company Expertise .. 94
Competition with the Market ...... 94
Competitor Ratio Analysis . 95
Clinical Trial Results . 95
PHASE I/II ....... 96
INO-8875 96
Mode of Action .......... 96
Current Status 96
Proof of Concept/Clinical Data .... 96
Development Risks .. 96
Company Expertise .. 96
Competition within the Market .. 96
Competitor Ratio Analysis . 97
DRY EYE SYNDROME ... 98
MARKET ANALYSIS . 98
WHAT IS DRY EYE SYNDROME? . 99
HOW IS IT TREATED?........ 100
WHY ARE NEW TREATMENTS NEEDED? ......... 100
WHAT IS IN DEVELOPMENT? ..... 100
DRY EYE PREVALENCE..... 101
LAUNCHED PRODUCTS .. 102
Restasis (ciclosporin) 102
Mode of Action ....... 102
Current Status ......... 102
Proof of Concept/Clinical Data . 102
Development Risks ........... 102
Company Expertise ........... 103
Competition within the Market 103
Competitor Ratio Analysis .......... 103
Sales Forecast .......... 104
Hyalein (sodium hyaluronate) ....... 105
Mode of Action ....... 105
Current Status ......... 105
Proof of Concept/Clinical Data.. 105
Development Risks 105
Company Expertise ........... 105
Competition within the Market 105
Competitor Ratio Analysis .......... 106
Sales Forecast .......... 106
Diquas (diquafosol) .. 107
Mode of Action ....... 107
Current Status ......... 107
Proof of Concept/Clinical Data.. 107
Development Risks 107
Company Expertise ........... 108
Competition within the Market 108
Competitor Ratio Analysis .......... 108
NEW FORMULATIONS IN DEVELOPMENT ..... 109
Remura (bromfenac) 109
Mode of Action ....... 109
Current Status ......... 109
Proof of Concept/Clinical Data.. 109
Development Risks 109
Company Expertise ........... 110
Competition with the Market .... 110
Competitor Ratio Analysis .......... 110
Clinical Trial Results ........... 110
Mucosta (rebamipide) ......... 111
Mode of Action ....... 111
Current Status ......... 111
Proof of Concept/Clinical Data.. 111
Development Risks 111
Company Expertise ........... 111
Competition within the Market 112
Competitor Ratio Analysis .......... 112
PHASE II/III .. 113
CF101 ..... 113
Mode of Action ....... 113
Current Status ......... 113
Proof of Concept/Clinical Data . 113
Development Risks ........... 113
Company Expertise ........... 113
Competition within the Market ........... 113
Competitor Ratio Analysis .......... 114
Clinical Trial Results .......... 114
PHASE II ....... 115
Tofacitinib ........ 115
Mode of Action ....... 115
Current Status ......... 115
Proof of Concept/Clinical Data . 115
Development Risks ........... 115
Company Expertise ........... 115
Competition within the Market ........... 115
Competitor Ratio Analysis .......... 116
METHODOLOGY ....... 117
Competitor Ratio Analysis Criteria ...... 117
Drug Sales Forecasting .... 117
SOURCES ....... 118
List of Tables
Company Overview .. 8
Drugs in Clinical Development .. 10
Competitor Ratio Analysis Summary .... 12
Sales of Leading Eye Care Pharmaceuticals, 2009-2016 (US$ Million) .. 13
Male Life Expectancy at Birth (Years), 2005-2009 ..... 15
Female Life Expectancy at Birth (Years), 2005-2009 15
Leading AMD Drug Sales, 2005-2010 (US$ Million) . 18
AMD Market Share by Company, 2010 (%) .... 19
Drugs in Clinical Development for Age-related Macular Degeneration .......... 23
Lucentis Sales by Company, 2009-2016 (US$ Million) ........ 28
Final RADICAL outcomes (24 months) . 43
Leading Glaucoma Drug Sales, 2005-2010 (US$ Million) .. 55
Drugs in Clinical Development for Glaucoma ........... 61
Alphagan/Combigan Sales, 2009-2016 (US$ Million) ......... 65
Trusopt/Cosopt Sales, 2009-2016 (US$ Million) ....... 69
Xalatan/Xalacom Sales, 2009-2016 (US$ Million) ..... 75
Lumigan Sales, 2009-2016 (US$ Million) ......... 81
Leading Dry Eye Prescription Drug Sales, 2005-2010 (US$ Million) ....... 98
Drugs in Clinical Development for Dry Eye Syndrome ..... 101
Restasis Sales, 2009-2016 (US$ Million) ......... 104
Hyalein Sales, 2009-2016 (US$ Million) .......... 106
List of Figures
Ophthalmology Market Sectors, 2010 (%) ......... 5
Market Share by Company, 2010 (%) ...... 6
Ophthalmology Market Sectors, 2016 (%) ......... 7
Market Share by Company, 2016 (%) ...... 7
Life Expectancy at Birth, 2008 .... 14
Population Aged 65+ by Country, 2005 and 2020 (%) ....... 16
Population Aged 65+, 2005-2020 (Millions) ... 17
Market Share of Leading AMD Drugs, 2010 (%) ........ 19
How AMD Affects the Eye 20
Lucentis Sales, 2007-2016 (US$ Million) .......... 29
VEGF Trap-Eye Sales, 2012-2016 (US$ Million) .......... 47
Market Share of Leading Glaucoma Drugs, 2010 (%) ......... 55
Glaucoma Market Share by Company, 2010 (%) ...... 56
Diagram of a Healthy Eye 57
How Glaucoma Affects the Eye . 57
Alphagan/Combigan Sales, 2007-2016 (US$ Million) ......... 66
Trusopt/Cosopt Sales, 2007-2016 (US$ Million) ........ 69
Azopt/Azarga Sales, 2009-2016 (US$ Million) ........... 72
Xalatan/Xalacom Sales, 2007-2016 (US$ Million) ..... 76
Lumigan Sales, 2007-2016 (US$ Million) ......... 81
Travatan/Travatan Z Sales, 2009-2016 (US$ Million) ........... 85
Saflutan/Tapros Sales, 2008-2016 (US$ Million) ....... 88
Market Share of Leading Dry Eye Prescription Drugs, 2010 (%) .. 98
Dry Eye Market Share by Company, 2010 (%) ........... 99
Restasis Sales, 2007-2016 (US$ Million) ......... 104
Hyalein Sales, 2007-2016 (US$ Million) .......... 106
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