NEW YORK, Nov. 3, 2010 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Multiple Sclerosis Drug Discoveries: what the future holds
http://www.reportlinker.com/p0323695/Multiple-Sclerosis-Drug-Discoveries-what-the-future-holds.html
EXTENSIVE ANALYSIS OF THE GLOBAL
MULTIPLE SCLEROSIS MARKET AND ASSESSMENT OF ALL SIGNIFICANT CURRENT AND FUTURE PRODUCTS
The recent approval in the US of Novartis' orally administered Gilenya (fingolimod) heralds a new phase in the treatment of Multiple Sclerosis (MS).
Over the last few years, the MS market has been driven by five disease-modifying agents: Teva's Copaxone (glatiramer acetate), Biogen Idec's Avonex (interferon beta-1a) and Tysabri (natalizumab), Merck KGaA's Rebif (interferon beta-1a) and Bayer's Betaferon (interferon beta-1b). From 2009, interferon beta-1b has also been available from Novartis as Extavia; this is the same formulation as Betaferon.
In addition to these, Amgen's Novantrone (mitoxantrone) has been available to treat MS. Generic mitoxantrone is also available. Avonex, Betaferon/Extavia, Rebif and Copaxone are all used in first-line therapy for RRMS. They are generally well accepted and have accumulated comprehensive safety and clinical trial data supporting their use in modifying the course of the disease. Tysabri and mitoxantrone are generally used in second-line therapy in RRMS. Mitoxantrone is also approved to treat SPMS and PRMS. Both of these agents are associated with serious side-effects.
The arrival of oral treatments brings big clinical advantages
The development of oral therapies for MS has attracted significant investment from pharmaceutical companies and the first of these have begun to receive marketing approvals, signaling another major change in the way MS is treated. In September 2010, Novartis won the race to gain the first oral approval in the US with its sphingosine-1-phosphate (S1P) receptor agonist, Gilenya. The product was also approved in Russia in the same month. Merck's oral product, Movectro (cladribine) was approved in Russia in July 2010 and in Australia in September 2010 for the treatment of RRMS for a maximum duration of two years. However, the European Medicine Agency's CHMP issued a negative opinion for Movectro for the treatment of RRMS.
Espicom estimates the current MS market value is in the region of US$12.6 billion with strong growth going forward
Background to the disease
Multiple Sclerosis is a chronic autoimmune neurological disease affecting up to 2.5 million people worldwide, the majority of whom live in North America and Europe. It is a complex disorder that affects people in different ways. Around 85% of patients are initially diagnosed with relapsing remitting MS (RRMS). Up to half of these will go on to develop secondary-progressive MS (SPMS).
The other main types identified are primary progressive MS (PPMS), which affects around 10% of patients at onset, and progressive-relapsing MS (PRMS) which affects up to 5% of patients. There is currently no cure for MS and treatment is aimed at its symptoms and slowing disease progression. The launch of interferons during the 1990s transformed the treatment of MS but there is still a large unmet clinical need in reducing disease progression.
Shape of the industry in 2010...
At the forefront of the MS market is Biogen Idec, with a market share of 27% due to sales of Avonex and Tysabri. Following closely are Teva and sanofi-aventis who currently market Copaxone, giving them a combined share of the market by sales value of around 30%. With the third biggest seller, Rebif, Merck Serono has been attributed with a market share of 19%; Bayer Schering takes 15% of the market with Betaferon sales; while Elan's share of Tysabri sales provide the company with around 4%.
...and in 2016
By 2016, a number of new agents will be available to treat MS, and their contribution to revenues will enhance Biogen Idec's leading position. In addition, Teva's Copaxone will lose patent protection in the US in May 2014. If approved, generic versions of Copaxone would undoubtedly put pricing pressures on both the branded version and related therapies. The combined effect of an influx of new therapies and generic competition for the market leader is likely to cause a ripple through the entire MS therapy market. Consequently, the current market leaders will all have their share of the US$15.3 billion market reduced as competition increases. Over US$4 billion of the MS market will be generated by recently approved or developmental products that will be launched in the near term.
Key company, market and product questions answered such as...
What are the four main types of MS?
Research into MS vaccines has stalled. What is the current situation and are there still opportunities in this area?
How might the asthma treatment salbutamol (albuterol) help control MS?
Which countries have the highest prevalence of patients per 100,000 population?
MS is a geographically specific condition – what are the theories as to why this is so?
Despite having patent protection until 2014, generic companies are already making a play for Teva's Copaxone. Who's involved and what is the current status?
What are the expected sales in 2016 of Novartis' novel oral MS treatment Gilenya?
What are the patient safety concerns with Biogen Idec's Ampyra (dalfampridine), the first in class treatment for treating MS symptoms?
How many Phase III products are in the pipeline and when are they expected to launch?
What positive clinical trial results did sanofi-aventis report for its oral MS drug teriflunomide?
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, Diabetes Drug Discoveries: what the future holds
The Indian Pharmaceutical Industry: New strategies in a changing world.
More Information...
Unique market share and 5-year sales forecasts for leading products, pipeline prospects and companies
A comprehensive examination of the multiple sclerosis market and disease prevalence
Critical competitive evaluation and scoring of current and future products
This report delivers real insights to MS drugs, prospects and companies…
Evaluate the current clinical understanding of multiple sclerosis
Know the disease prevalence trends in major markets
Contrast and compare the competitive landscape in 2010 and 2016
Profile product potential with original 5-year sales forecasts for current products
Compare and review up and coming Phase II/III products with 5-year forecasts from year of launch for significant late-stage candidates
Benefit from Espicom's unique product assessment and scoring
CONTENTS
FOREWORD 1
EXECUTIVE SUMMARY . 3
MARKET ANALYSIS . 5
CURRENT MARKET . 7
FUTURE MARKET 9
What's in the Pipeline? 12
MS Vaccines in Limbo? . 13
Asthma medication may benefit MS patients 13
BACKGROUND INFORMATION 14
What is MS? 14
Why are New Treatments Needed? 15
Patient Statistics 16
PRODUCT ANALYSIS 20
ESTABLISHED PRODUCTS . 20
Copaxone (glatiramer acetate) . 20
Mode of Action . 20
Current Status 20
Approvals/Filings . 20
Development . 21
Proof of Concept/Clinical Data . 21
Development Risks 22
Company Expertise . 22
Competition within the Market-place . 22
Patents and Exclusivity 22
Generic Competition 23
Competitor Ratio Analysis 24
Forecast 24
Clinical Trial Results . 25
Avonex (interferon beta-1a) . 30
Mode of Action . 30
Current Status 30
Approvals/Filings . 30
Development . 30
Proof of Concept/Clinical Data . 31
Development Risks 31
Company Expertise . 31
Competition within the Market-place . 31
Patents 31
Competitor Ratio Analysis 32
Forecast 32
Clinical Trial Results . 33
Betaferon/Betaseron & Extavia (interferon beta-1b) . 34
Mode of Action . 34
Current Status 34
Approvals/Filings . 34
Development . 35
Proof of Concept/Clinical Data . 35
Development Risks 35
Company Expertise . 35
Competition within the Market-place . 36
Patents 36
Competitor Ratio Analysis 36
Forecast 36
Clinical Trial Results . 37
Rebif (interferon beta-1a) 39
Mode of Action . 39
Current Status 39
Approvals/Filings . 39
Development . 40
Proof of Concept/Clinical Data . 40
Development Risks 41
Company Expertise . 41
Competition within the Market-place . 41
Competitor Ratio Analysis 41
Forecast 41
Clinical Trial Results . 42
Novantrone (mitoxantrone) . 44
Mode of Action . 44
Current Status 44
Approvals/Filings . 44
Proof of Concept/Clinical Data . 45
Development Risks 45
Company Expertise . 46
Competition within the Market-place . 46
Generic Competition 46
Competitor Ratio Analysis 47
Clinical Trial Results . 47
Tysabri (natalizumab) 48
Mode of Action . 48
Current Status 48
Approvals/Filings . 48
Development . 49
Proof of Concept/Clinical Data . 49
Development Risks 49
Company Expertise . 49
Competition within the Market-place . 50
Patents 50
Competitor Ratio Analysis 50
Forecast 50
Clinical Trial Results . 51
NEW APPROVALS/FILED PRODUCTS 52
Gilenya (fingolimod) 52
Mode of Action . 52
Current Status 52
Approvals/Filings . 52
Development . 53
Proof of Concept/Clinical Data . 53
Development Risks 53
Company Expertise . 54
Competition within the Market-place . 54
Competitor Ratio Analysis 54
Forecast 54
Clinical Trial Results . 55
Movectro (cladribine) 58
Mode of Action . 58
Current Status 58
Approvals/Filings . 58
Development . 58
Proof of Concept/Clinical Data . 59
Development Risks 59
Company Expertise . 59
Competition within the Market-place . 60
Competitor Ratio Analysis 60
Forecast 60
Clinical Trial Results . 61
Ampyra (dalfampridine) . 63
Mode of Action . 63
Current Status 63
Approvals/Filings . 63
Proof of Concept/Clinical Data . 63
Development Risks 64
Company Expertise . 64
Competition within the Market-place . 64
Competitor Ratio Analysis 64
Forecast 65
Clinical Trial Results . 66
PHASE III . 67
Alemtuzumab . 67
Mode of Action . 67
Current Status 67
Approvals/Filings . 67
Development . 67
Proof of Concept/Clinical Data . 68
Development Risks 68
Company Expertise . 68
Competition within the Market-place . 68
Competitor Ratio Analysis 69
Forecast 69
Clinical Trial Results . 70
MS Phase II . 70
BG-12 72
Mode of Action . 72
Current Status 72
Proof of Concept/Clinical Data . 72
Development Risks 72
Company Expertise . 73
Competition within the Market-place . 73
Competitor Ratio Analysis 73
Forecast 73
Clinical Trial Results . 74
Daclizumab 76
Mode of Action . 76
Current Status 76
Approvals/Filings . 76
Development . 76
Proof of Concept/Clinical Data . 77
Development Risks 77
Company Expertise . 77
Competition within the Market-place . 77
Competitor Ratio Analysis 77
Forecast 78
Clinical Trial Results . 79
Laquinimod . 80
Mode of Action . 80
Current Status 80
Proof of Concept/Clinical Data . 80
Development Risks 80
Company Expertise . 81
Competition within the Market-place . 81
Competitor Ratio Analysis 81
Forecast 81
Clinical Trial Results . 82
Teriflunomide . 84
Mode of Action . 84
Current Status 84
Proof of Concept/Clinical Data . 84
Development Risks 85
Company Expertise . 85
Competition within the Market-place . 85
Competitor Ratio Analysis 85
Forecast 85
Clinical Trial Results . 86
PHASE II 88
ACT-128800 . 88
Mode of Action . 88
Current Status 88
Proof of Concept/Clinical Data . 88
Development Risks 88
Company Expertise . 88
Competition within the Market-place . 89
Competitor Ratio Analysis 89
BAF312 . 90
Mode of Action . 90
Current Status 90
Proof of Concept/Clinical Data . 90
Development Risks 90
Company Expertise . 90
Competition within the Market-place . 90
Competitor Ratio Analysis 91
Firategrast 92
Mode of Action . 92
Current Status 92
Proof of Concept/Clinical Data . 92
Development Risks 92
Company Expertise . 92
Competition within the Market-place . 93
Competitor Ratio Analysis 93
Ocrelizumab 94
Mode of Action . 94
Current Status 94
Proof of Concept/Clinical Data . 94
Development Risks 94
Company Expertise . 95
Competition within the Market-place . 95
Competitor Ratio Analysis 95
Clinical Trial Results . 95
Ofatumumab . 96
Mode of Action . 96
Current Status 96
Approvals/Filings . 96
Development . 96
Proof of Concept/Clinical Data 97
Development Risks 97
Company Expertise . 97
Competition within the Market-place . 97
Competitor Ratio Analysis 97
Clinical Trial Results . 98
Perampanel 99
Mode of Action . 99
Current Status 99
Proof of Concept/Clinical Data . 99
Development Risks 99
Company Expertise . 99
Competition within the Market-place 100
Competitor Ratio Analysis . 100
METHODOLOGY . 101
Competitor Ratio Analysis Criteria . 101
Drug Sales Forecasting . 101
LIST OF TABLES
Competitor Ratio Analysis Summary 6
Global MS Drug Sales, 2009-2016 (US$ Millions) 7
Drugs in Clinical Development for MS . 12
People with MS by Country and Region, 2010-2015 . 17
Prevalence of MS per 100,000 Population by Country & Region, 2010 . 18
Data Exclusivity . 22
Patent Expiry 23
Copaxone Sales by Company (2008-2016) 24
Patent Expiry 31
Avonex Sales (2008-2016) 32
Interferon Beta-1b Sales by Company (2008-2016) 36
Rebif Sales (2008-2016) 42
Patent Expiry 46
FDA ANDA Approvals for Mitoxantrone . 47
Tysabri Sales by Company (2008-2016) . 50
Gilenya Sales (2011-2016) . 54
Movectro/Mylinax Sales (2011-2016) 60
Data Exclusivity . 64
Patent Expiry 64
Ampyra Sales (2010-2016) 65
Patent Expiry 69
Campath Sales by Indication (2008-2016) 69
BG-12 Sales (2012-2016) 73
Daclizumab Sales in MS (2012-2016) . 78
Laquinimod Sales (2012-2016) . 81
Teriflunommide Sales (2012-2016) . 85
LIST OF FIGURES
Leading MS Products by Sales Value, 2009 (%) . 8
MS Market by Company, 2009 (%) . 8
Leading MS Products by Sales Value, 2016 (%) 10
MS Market by Company, 2016 (%) 11
Total Number of People with MS, 2007 . 16
Mean Age of Onset of MS, 2007 . 17
Geographic Spread of People with MS, 2010 (%) 18
Geographic Prevalence of MS per 100,000 Population, 2010 19
Copaxone Sales by Company (2008-2016) . 25
Avonex Sales (2008-2016) . 32
Interferon Beta-1b Sales by Company (2008-2016) 37
Rebif Sales (2008-2016) 42
Tysabri Sales by Company (2008-2016) . 51
Gilenya Sales (2011-2016) . 55
Movectro/Mylinax Sales (2010-2016) . 61
Ampyra Sales (2008-2016) 65
Campath Sales by Indication (2008-2016) 70
BG-12 Sales (2012-2016) 74
Daclizumab Sales in MS (2011-2016) . 78
Laquinimod Sales (2012-2016) . 82
Teriflunomide Sales (2012-2016) . 86
To order this report:
Drug Discovery and Development Industry: Multiple Sclerosis Drug Discoveries: what the future holds
Drug Discovery and Development Business News
Check our Company Profile, SWOT and Revenue Analysis!
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