Look Towards A New Future

Aug 9, 2010

Commercial Insight: Multiple Sclerosis - Next generation therapies signal the start of a new era now available at ReportsandReports

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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).


  • 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.


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


Catalyst 1

Summary 1


About the central nervous system pharmaceutical analysis team 2


Strategic scoping and focus 3

Datamonitor insight into the multiple sclerosis market 3

Related reports 4

Table of Contents 5


Market definition for this report 6


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


Current and future market assessment 64

Multiple sclerosis market in Spain generated $300m in 2009 64

Strong market growth projected to continue 64


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


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


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


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


Journal papers 158

Websites 159

Other sources 164

Datamonitor reports 164

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