Datamonitor expects Novartis's Gilenia (fingolimod) to launch at the end of 2010 as a first-line therapy, while Merck Serono's oral cladribine is anticipated to launch at the start of 2011.

Dallas, TX -- (SBWire) -- 08/09/2010 -- ReportsandReports announce it will carry Commercial Insight: Multiple Sclerosis - Next generation therapies signal the start of a new era Market Research Report in its Store.

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With FDA advisory board support for Gilenia (fingolimod), Novartis will move ahead of Merck Serono's oral cladribine in the race to become the first oral multiple sclerosis therapy. Although growth will be stifled by biosimilars, these new product launches will see the multiple sclerosis market grow at a compound annual growth rate (CAGR) of 2.3% over the next 10 years (20092019).

Scope

• In-depth analysis of the current and future multiple sclerosis therapies across the US, Japan, France, Germany, Italy, Spain and the UK.
• Country-specific total brand sales forecasts for key products, biosimilars and pipeline agents across the seven major markets to 2019.
• Assessment of the commercial opportunities and threats present in the multiple sclerosis market, with analysis of trends in emerging markets.
• Evaluation of the strategies of leading players in the multiple sclerosis disease market.

Highlights

Datamonitor expects Novartis's Gilenia (fingolimod) to launch at the end of 2010 as a first-line therapy, while Merck Serono's oral cladribine is anticipated to launch at the start of 2011. These drugs offer improved efficacy and a less invasive method of administration than current treatments.

Datamonitor expects entry of biosimilar drugs from 2014. The introduction of cost competition will force current market players to cease raising the price of their drugs above the norm; a strategy that has helped them to substantially increase revenues in recent years.

Novartis is set to usurp Biogen Idec and become the market leading player by the end of the forecast period in 2019. In addition to Gilenia and Extavia (interferon beta 1b), Novartis is developing two multiple sclerosis candidates; PI-230 (Phase I) and BAF312 (Phase II), illustrating its commitment to growing its presence in the marketplace

Reasons to Purchase

• Quantify the current and future size of the multiple sclerosis drug class market and understand the main commercial opportunities and threats
• Assess key marketed and pipeline drugs, including new oral agents, Acorda's Ampyra (dalfampridine) and GW Pharmaceuticals' Sativex (nabiximols).
• Understand the country-specific impact of key events in the multiple sclerosis market during the forecast period 2010 to 2019.

Table Of contents

OVERVIEW 1
Catalyst 1
Summary 1
ABOUT DATAMONITOR HEALTHCARE 2
About the central nervous system pharmaceutical analysis team 2
EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the multiple sclerosis market 3
Related reports 4
Table of Contents 5

1. MARKET DEFINITION
Market definition for this report 6

2. MARKET OVERVIEW
Seven major markets 7
Current market assessment 7
Notable historical growth in multiple sclerosis sales exceeds volume growth from 2005 to 2009
The interferons contributed over half of all sales in the multiple sclerosis disease-modifying market in 2009 10
Copaxone outstrips Avonex to become market leader 11
Approved Tysabri continues strong year-on-year growth 12
Future market assessment 13
Key multiple sclerosis brands will undergo strong competition 13
Market value will continue to grow until generic incursion in 2014 13
Pipeline oral disease modifiers will offset generic incursion 14
Opportunities and threats 17
Opportunities 1: efficacious treatment for progressive multiple sclerosis remains a key unmet need 17
Opportunities 2: identifying patients before symptoms emerge 19
Opportunities 3: development of biomarkers will lead to a earlier treatment approach 20
Opportunities 4: targeting symptomatic treatment opens up large patient population 21
Threat 1: biosimilar competition 24
Threat 2: active cost containment set to dampen growth 27
Threat 3: increasing evidence of lack of efficacy for disease-modifying therapies 28
US 28
Current and future market assessment 28
The US multiple sclerosis market captured the largest share of the seven major markets in 2009 28
The US will continue to be the largest of the seven major markets for multiple sclerosis 29
Opportunities and threats 33
Opportunity 1: first oral drugs awarded Fast Track status 33
Opportunity 2: healthcare reform to open up the market for multiple sclerosis developers 34
Threat 1: drug rebates and discounts offset sales growth 35
Threat 2: further tightening of Pharma marketing practices 35
Japan 36
Current and future market assessment 36
Japan is the smallest of the seven major multiple sclerosis markets 36
Launch of Avonex leads to strong growth in 2007-09 37
Approval of Tysabri and Gilenia will boost market growth 37
Opportunities and threats 40
Opportunity 1: Japanese market has considerable scope for development 40
Opportunity 2: raising awareness of multiple sclerosis will grow market 40
Opportunity 3: elimination of lengthy approval process provides faster approval times 41
Threat 1: biennial price cuts by the Japanese government 41
Five major EU markets (5EU) 41
Current and future market assessment 41
European multiple sclerosis market sales represent strongest growth of the seven major markets 41
Rebif was the Number 1 European multiple sclerosis brand in 2009 42
Pipeline oral drugs to become multiple sclerosis market leaders 43
Opportunities and threats 46
Opportunity 1: innovative drug development encouraged by price premium and high-level reimbursement 46
Opportunity 2: UK market provides scope for considerable growth 46
Opportunity 3: more extensive UK training of neurologists and better awareness will promote access to therapies 48
Threat 1: Europe's biosimilar pathway is the most advanced in the seven major markets 48
Threat 2: increase in parallel importation threatens drug prices 49
France 51
Current and future market assessment 51
Historical growth driven by Copaxone and Tysabri 51
France to maintain market value 52
Germany 56
Current and future market assessment 56
German multiple sclerosis market is the strongest growing and largest European country 56
German multiple sclerosis market set to remain the largest and most attractive European country 57
Italy 60
Current and future market assessment 60
Italy showed the lowest CAGR of all the major markets from 2005 to 2009 60
Biosimilars will make less impact in Italy than the rest of the European markets 60
Spain
Current and future market assessment 64
Multiple sclerosis market in Spain generated $300m in 2009 64
Strong market growth projected to continue 64
UK
Current and future market assessment 68
Despite rapid growth, the UK multiple sclerosis market remains the smallest European market
Securing NICE approval remains critical to success of pipeline drugs 69
Rest of the world snapshot 73
Current market assessment 73
Rest of world exhibited stronger CAGR than the US 73
Rest of World growth is slower than the seven major markets 73
Rest of the world only represents 17% of global multiple sclerosis sales 75
Despite its small market size, the BRIC countries demonstrated the strongest growth 76
Copaxone is the leading global drug and demonstrates the strongest growth 77
Opportunities and threats 78
Opportunity 1: increasing awareness and treatment of multiple sclerosis in developing countries 78
Threat 1: cost of premium priced multiple sclerosis therapies will restrict growth 78

3. BRAND DYNAMICS
Overview of competitive landscape 79
Oral therapies set to outstrip traditional market leaders 79
Patient acquisition process 80
Introduction 80
Patient care path 80
Points of influence in the patient care path 81
Trigger point 1: assessment of the multiple sclerosis activity severity 81
Trigger point 2: disease duration and activity will influence use of biologics 82
Trigger point 3: location of impairments influences type of rehabilitation 84
Drivers of brand choice 84
Disease-modifying efficacy and safety are the most influential factors in prescription 84
Number one influential factor is disease-modifying efficacy 85
Side effects are second major attribute driving brand choice 85
Compliance dependant on efficacy and side effects 86
Disease modifying therapy cost is high 86
US formulary tier status for leading brands 87
Disease modifying multiple sclerosis drugs are in the highest co-payment tiers 88
Trends in marketing strategies 88
Marketing strategy for leading brands 89
Sponsorship/disease awareness campaigns 90
Marketed brands overview - disease-modifying drugs 91
Avonex (interferon beta-1a; Biogen Idec and Genzyme) - the gold standard 92
Drug profile 92
Datamonitor continues to view Avonex as the gold standard 92
Product positioning 93
Avonex is currently the preferred first choice interferon in multiple sclerosis 93
SWOT analysis 94
Brand forecast to 2019 95
Betaseron (interferon beta-1b; Bayer Schering) 97
Drug profile 97
The first multiple sclerosis disease modifier 97
Product positioning 98
Betaseron benefits from historical experience 98
SWOT analysis 98
Brand forecast to 2019 99
Rebif (interferon beta-1a; Merck Serono and Pfizer) 101
Drug profile 101
Product positioning 101
Rebif has superior efficacy compared to Avonex 101
SWOT analysis 103
Brand forecast to 2019 104
Extavia (interferon beta-1a; Novartis) 106
Drug profile 106
Novartis's branded version of interferon beta-1b 106
Product positioning 106
Extavia will establish the ground for Novartis's multiple sclerosis portfolio 106
SWOT analysis 107
Brand forecast to 2019 108
Copaxone (glatiramer acetate; Teva and Sanofi-Aventis) 110
Drug profile 110
Copaxone is biggest selling multiple sclerosis drug 110
Product positioning 111
First-line therapy in competition against interferons 111
SWOT analysis 112
Brand forecast to 2019 113
Tysabri (natalizumab; Biogen Idec and Elan) 115
Drug profile 115
Sale growth continues despite increase in PML cases 115
Product positioning 116
PML risk hinders Tysabri's movement up the treatment algorithm 116
SWOT analysis 117
Brand forecast to 2019 118
Novantrone (mitoxantrone, Merck Serono); 119
Pipeline brands overview 121
Gilenia (fingolimod, Novartis & Mitsubishi Tanabe Pharma) 122
Drug profile 122
First oral drug expected to enter the multiple sclerosis market 122
Development overview 123
Robust clinical trial program strengthens Gilenia's potential 123
Success will depend on risk-benefit ratio of Gilenia 124
Product positioning 126
Gilenia will compete to become first-line therapy 126
SWOT analysis 126
Drug forecast to 2019 127
Oral cladribine (Merck Serono) 128
Drug profile 128
Refusal to file setback delays launch 128
Development overview 129
Favorable annualized relapse reduction rates compared to interferons 129
Phase III trials show impressive efficacy data 130
Product positioning 131
SWOT analysis 131
Drug forecast to 2019 132
Marketed brands overview - key multiple sclerosis-specific symptomatic drugs 134
Ampyra (dalfampridine; Acorda therapeutics) 135
Drug profile 135
First drug approved to help multiple sclerosis patients walk 135
Product positioning 136
Ampyra would be a useful drug for multiple sclerosis, but payers likely to restrict sales 136
Seizure risk necessitates REMS program 137
SWOT analysis 138
Drug forecast to 2019 138
Sativex (nabiximols; GW Pharmaceuticals) 139
Drug profile 139
Development overview 140
Drug evaluation 142
Drug forecast to 2019 142

4. KEY DEVELOPERS
Strategic overview 144
Trends in corporate strategy 145
Licensing deals represent an essential tactic to bolster pipeline agents 145
Recent strategic partnerships and deals 146
Abbott acquire Facet Biotech 146
Novartis 147
Corporate strategy 147
Novartis to become the leading multiple sclerosis developer through Gilenia launch 147
Multiple sclerosis portfolio assessment 147
Biogen Idec 148
Corporate strategy 148
Biogen Idec's will remain a leading multiple sclerosis developer through reformulations and novel candidates 148
Multiple sclerosis portfolio assessment 148
Merck Serono 149
Corporate strategy 149
Multiple sclerosis portfolio assessment 149
Teva 150
Corporate strategy 150
Multiple sclerosis portfolio assessment 150
Portfolio assessment of other leading companies 151
Bayer Schering 151

5. CASE STUDIES
Introduction 152
Case study 152
Price increases higher than for other autoimmune disorders 152
Price increases in US the highest across the seven major markets 154
BIBLIOGRAPHY 158
Journal papers 158
Websites 159
Other sources 164
Datamonitor reports 164

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