Commercial Insight: Psoriasis

Intellectual property drives growth

Publication Date	July 2009
Publisher	Datamonitor
Product Type	Report
Pages	204
ISBN Number	not applicable
Product Code	DAT03300

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Summary

The launch of new brands in both biologic and topical treatments in 2009 is shaking up the psoriasis market. Stelara (ustekinumab; Johnson & Johnson) is eagerly anticipated by dermatologists, and Datamonitor forecast strong uptake. However, the threat of biosimilars looms over all biologic therapies.

Scope

Analysis of the current and future market dynamics in psoriasis across the US, France, Germany, Italy, Spain the UK and Japan
Assessment of biologic, vitamin derivative, topical corticosteroid and immunomodulator classes
Psoriasis-specific forecast data for indication scrutiny, but total brand data also included to put sales in context for brand and company
Scenario forecasts for go/no-go on biosimilar legislation and the impact of possible additional cost containment measures

Highlights

The biologics created $1.4 billion in psoriasis sales in 2008 across the seven major markets, contributing 55% of the $2.5billion psoriasis market. However, the economic downturn resulted in a plateau in biologic sales in psoriasis in 2008. Following a double digit CAGR over the last 4 years, it will slow to 3.4% from 2008 to 2018.

Leo Pharma's Dovobet (calcipotriol + betamethasone) brand dominates the topical class, reaching nearly $0.5billion over the next 10 years. Other molecules are attempting to break into this domain. Galderma's Vectical (calcitriol) launched in February 2009 in the US, but intellectual property challenges are predicted to dampen its potential.

The withdrawal of Genentech/Merck Serono's Raptiva (efalizumab) in Q1 2009 is predicted to benefit both Abbott's Humira (adalimumab) and Johnson & Johnson's Stelara (ustekinumab), but safety will be even more key to regulators now. Dermatologists are particularly eager to use Stelara, and peak psoriasis sales reach $600m in the seven major markets.

Reasons to Purchase

Assess the impact of the economic downturn on psoriasis, which is vulnerable to cost-saving behavior compared to other autoimmune disorders
Assess the impact of new brands on the market and consider the value to volume ratio for the key classes
See how psoriasis contributes to total brand sales and company portfolios

Content

ABOUT DATAMONITOR HEALTHCARE

About the Immunology & Inflammation therapy analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Strategic scoping and focus
Datamonitor insight into the disease market
Related reports
Upcoming related reports

CHAPTER 2 MARKET DEFINITION

Market definition for this report
Biologic therapies
Systemic immunomodulators
Topical corticosteroids
Topical vitamin derivatives
Other
Indication split methodology
Diagnosis value based on retail data only
Country coverage

CHAPTER 3 MARKET OVERVIEW

Seven major markets
Current and future market overview
Biologic and topical vitamin derivative launches spurred psoriasis market growth in 2005-08
Seven major psoriasis market will grow from $2.5 billion in 2008 to $3.5 billion in 2018
Volume analysis shows topical therapies create the cornerstone of treatment
US
Current and future market assessment
US sales jumped between 2005 and 2007, but leveled off by 2007-08
US will continue to be the largest of the seven major markets for psoriasis
Opportunities and threats
Opportunities
Threats
Japan
Current and future market assessment
Japanese psoriasis market growth has been slowed by government price cuts
Biologics and vitamin derivatives will drive psoriasis sales in Japan in 2018
Opportunities and threats
Opportunities
Threats
Five major European markets (5EU)
Current and future market assessment
Opportunities and threats
Opportunities
Threats
European trends
Germany, Italy: topical vitamin derivative license expiries loom
UK: NICE guidance slows uptake of biologics for psoriasis
Rest of the world snapshot
Current market assessment

CHAPTER 4 BRAND DYNAMICS

Overview of competitive landscape
Patient acquisition process
Introduction
Patient care path
Points of influence in the patient care path
Initial therapy recommendation is a key point of influence in psoriasis
Topical treatment efficacy depends heavily on patient compliance
Specialists are more likely to initiate systemic therapy for psoriasis
Drivers of brand choice
Disease modification and long-term efficacy drive prescribing
Efficacy and safety are important to all classes
Perceived safety motivates topical vitamin derivative usage
Speed of action governs the prescribing decision for steroids
US pricing and reimbursement status for leading brands
Trends in marketing strategies
Marketing strategy for leading brands
Sponsorship/disease awareness campaigns
Direct-to-consumer advertising
Overview of biologics in psoriasis
The anti-TNF class dominates biological therapy for psoriasis
More data are required to elucidate biologics' long-term safety in psoriasis
Enbrel (etanercept; Amgen, Pfizer/Wyeth, Takeda)
Drug profile
Product positioning
Enbrel leads the market, but cost-driven prescribing may constrain its efficacy
Prescribers perceive Enbrel as a safer option in biological psoriasis therapy
First pediatric psoriasis indication stands to enhance Enbrel's position
In 2005, Enbrel overstepped its labeling in DTC advertising
Breaking news regarding continuous treatment and an autoinjector in Europe
SWOT analysis
Brand forecast to 2018
Humira (adalimumab; Abbott, Eisai)
Drug profile
Product positioning
Humira's efficacy in psoriasis has helped it gain a foothold quickly
Humira appears set to challenge Enbrel's lead in psoriasis
Humira's market share expands with additional country and pediatric approvals
In 2008, a Humira psoriasis journal advertisement hit a wrong note with the FDA
SWOT analysis
Brand forecast to 2018
Remicade (infliximab; Centocor Ortho Biotech, Merck/Schering-Plough and Mitsubishi Tanabe)
Drug profile
Product positioning
Remicade relies on a long history of use in diverse indications
Remicade defends its position at second/third-line
SWOT analysis
Brand forecast to 2018
Raptiva (efalizumab; Genentech, Merck Serono)
Drug profile
The aftermath of Raptiva's withdrawal
Raptiva was condemned on safety grounds
Humira is set to sweep share from Raptiva by virtue of its efficacy and dosing
Stelara (ustekinumab; Centocor Ortho Biotech, Janssen-Cilag)
Drug profile
Product positioning
Compared to Enbrel, Stelara shines in terms of efficacy
Dosing frequency distinguishes Stelara from marketed biologics
SWOT analysis
Brand forecast to 2018
Dovonex (calcipotriol; Leo Pharma, Warner Chilcott, Intendis Torii and Teikoku Medix)
Drug profile
Product positioning
Leo Pharma's response to generic competition has sparked controversy
Licensing agreements complicate Dovonex's market presence in Europe
SWOT analysis
Brand forecast to 2018
Dovobet (calcipotriol/betamethasone; Leo Pharma, Warner Chilcott, Intendis)
Drug profile
Product positioning
Dovobet is a reformulation with lifecycle management implications
SWOT analysis
Brand forecast to 2018
Silkis/Vectical (calcitriol; Galderma)
Drug profile
Product positioning
Silkis/Vectical marketing pushes brand as an "attachment to your regimen" in the US
Silkis US formulation patent will not defend the brand for long
SWOT analysis
Brand forecast to 2018
Additional brands
Olux/Olux-E (clobetasol; Stiefel/GlaxoSmithKline)
Olux brand proposition: patient preference for the VersaFoam vehicle
Olux/Olux-E Complete: competitive strategy in a combination pack
Brand forecast to 2018
Clobex (clobetasol propionate; Galderma)
The Clobex brand value proposition is based on innovation
Combining clobetasol and calcitriol in a novel formulation could drive success
Brand forecast to 2018
Soriatane/Neotigason (acitretin; Roche, Actavis, Stiefel/GlaxoSmithKline)
Patents expired but generics not launched, side effects continue to be limiting
Brand Forecasts to 2018

CHAPTER 5 KEY DEVELOPERS

Strategic overview
Recent strategic partnerships and deals
Pfizer and Wyeth
GlaxoSmithKline and Stiefel
Merck and Schering-Plough
Company strategies in psoriasis
Big Pharma-backed biologics create a competitive atmosphere, but psoriasis is not the top earner
Abbott
Amgen and Wyeth
Johnson & Johnson and Schering-Plough
Topical treatments employ a number of strategies to varying success
Leo Pharma's Dovobet shows profitability of fixed dose combinations
Ointment remains the most used formulation, but foams command a higher price
Prodrugs and molecular variations offer limited innovation

CHAPTER 6 CASE STUDIES

Potential impact of biosimilars in the US
Base case: biosimilar impact from 2014
Scenario A: price cuts to innovative biologics but no biosimilars in the next 10 years
Scenario B: 20% price cut and moratorium on price increases from 2014 with biosimilars launch in 2018
Scenario C: biosimilars launch in 2018, without interim action by US payers

BIBLIOGRAPHY

Journal papers
Others
Conference papers
Websites
Other sources
Datamonitor reports

APPENDIX A

Data definitions, limitations and assumptions
Standard units
Lining out of branded products in the forecast versus 'all others'
Diagnosis values for topical products
Assumptions regarding biosimilars
Derivation of sales forecasts and pricing trends
Forecast methodology

APPENDIX B

Contributing experts
Report methodology
About Datamonitor
About Datamonitor Healthcare
About the Disease analysis team
Disclaimer
Table 1: Dermatologist breakdown by region for IMS Prescribing Insights data, 2008
Table 2: Sales and growth of drug classes and brands for psoriasis in the seven major markets, 2008-2018
Table 3: Key events impacting the psoriasis market, 2009-2018
Table 4: Psoriasis volume and volume growth for the major drug classes for psoriasis in the seven major markets, 2008-2018
Table 5: Sales forecasts for psoriasis in the seven major markets ($m), 2008-2018
Table 6: Sales and growth of drug classes and brands for psoriasis in the US, 2008-2018
Table 7: Sales forecasts for psoriasis in the US ($m), 2008-2018
Table 8: Summary of opportunities and threats in the psoriasis market in the US, 2009
Table 9: Sales and growth of drug classes and brands for psoriasis in Japan, 2008-2018
Table 10: Sales forecasts for psoriasis in Japan ($m), 2008-2018
Table 11: Summary of opportunities and threats in the psoriasis market in Japan, 2009
Table 12: Sales and growth of drug classes and brands for psoriasis in the five major EU markets, 2008-2018
Table 13: Sales forecasts for psoriasis in the five major EU markets ($m), 2008-2018
Table 14: Summary of opportunities and threats for psoriasis in the five major European markets, 2009
Table 15: Comparison of leading branded drug sales ($m) for psoriasis in the seven major markets and the rest of the world (ROW), 2008
Table 16: Leading branded drug sales for psoriasis in the seven major markets, by class ($m), 2008-2018
Table 17: Dermatologists surveyed regarding psoriasis, 2008
Table 18: Comparison of PASI 50, -75 and -90 scores among the biologic brands
Table 19: Comparative importance of factors affecting dermatologists' prescribing decisions for topical vitamin derivatives by country, points out of 100, 2008
Table 20: Representative formulary tier status in the US for leading brands in psoriasis, 2009
Table 21: Marketing strategies employed by the companies behind the top two biologics for psoriasis, 2009
Table 22: Tuberculosis post-marketing data for TNF inhibitors (rheumatoid arthritis), 2008
Table 23: Enbrel - drug profile, 2009
Table 24: Comparative efficacy of Enbrel (etanercept) and Raptiva (efalizumab) in psoriasis, 2004
Table 25: Comparative cost per QALY of Enbrel (etanercept) and Raptiva (efalizumab) in psoriasis in the UK, 2004
Table 26: Humira (adalimumab) - drug profile, 2009
Table 27: Selected recent Humira (adalimumab) trials in psoriasis, 2009
Table 28: Remicade - drug profile, 2009
Table 29: Selected recent Remicade (infliximab) trials in psoriasis, 2009
Table 30: Raptiva (efalizumab) - drug profile, 2009
Table 31: Stelara (ustekinumab) - drug profile, 2009
Table 32: Projected pricing for Stelara (ustekinumab) based on relative pricing of Humira compared to Germany, 2009 ($/SU)
Table 33: Dovonex (calcipotriol) - drug profile, 2008
Table 34: Dovobet (calcipotriol/betamethasone) - drug profile, 2009
Table 35: Silkis/Vectical (calcitriol) - drug profile, 2009
Table 36: Olux (clobetasol) - drug profile, 2009
Table 37: Olux-E/Olux-E Complete (clobetasol) - drug profile, 2009
Table 38: Clobex (clobetasol propionate) - drug profile, 2009
Table 39: Soriatane/Neotigason (acitretin) - drug profile, 2009
Table 40: Leading companies in the seven major market for psoriasis-specific sales, 2008-2018
Table 41: Comparative price ($ per patient year) of topical treatments by formulation, 2008
Table 42: Potential scenarios for US biosimilar entry
Table 43: Base case forecast impact of biosimilars by country
Figure 1: Psoriasis sales by drug class in the seven major markets ($m), 2005-08
Figure 2: Key events impacting the psoriasis market, 2005-09
Figure 3: Psoriasis-specific value ($m) and volume (SU/dose/year) by class, 2008 and 2018
Figure 4: Psoriasis sales by drug class in the US ($m), 2005-08
Figure 5: Psoriasis sales by drug class in Japan ($m), 2005-08
Figure 6: Price per standard unit ($/SU) for Remicade (infliximab) in Japan, Q1 2007-Q2 2008
Figure 7: Psoriasis sales by drug class in the five major EU markets ($m), 2005-08
Figure 8: Effect of expiration of distribution agreement between Schering (now Intendis) and Leo Pharma on the Psorcutan Beta and Dovobet brands of calcipotriol/betamethasone topical combinations for psoriasis in Germany ($m), 2005-2018f
Figure 9: Effect of expiration of distribution agreement between Schering (now Intendis) and Leo Pharma on the Token (Psorcutan Beta) and Dovobet brands of calcipotriol/betamethasone topical combinations for psoriasis in Italy ($m), 2005-2018f
Figure 10: Psoriasis sales ($m) and growth of biologics in the five major EU markets, 2005-08
Figure 11: Global psoriasis sales breakdown, 2008
Figure 12: Annual estimated psoriasis sales outside the seven major markets, 2005-08
Figure 13: Psoriasis patient path
Figure 14: Mean non-pharmacological and pharmacological treatment rates in psoriasis across the seven major markets, 2008
Figure 15: Drivers of brand choice for psoriasis, 2009
Figure 16: Comparative importance of factors affecting dermatologist prescribing decisions by class across the seven major markets, 2008
Figure 17: Screenshot of Humira of patient assistance program targeting all patients
Figure 18: Screenshot of Enbrel patient assistance program targeting all patients
Figure 19: Screenshot of LeAnn Rimes' story, www.stophiding.org
Figure 20: Screenshot of advertising information, www.psoriasis.org
Figure 21: Biologics launch dates, by indication, across the seven major markets, 1998-2009
Figure 22: Enbrel (etanercept) SWOT analysis, 2009
Figure 23: Enbrel (etanercept) psoriasis sales by country across the seven major markets ($m), 2008-2018
Figure 24: Abbott Humira advertisement in American Academy of Dermatology Post-Meeting News, 2008
Figure 25: Humira (adalimumab): SWOT analysis, 2009
Figure 26: Humira (adalimumab) psoriasis sales by country across the seven major markets ($m), 2008-2018
Figure 27: Remicade SWOT analysis, 2009
Figure 28: Remicade (infliximab) psoriasis sales by country across the seven major markets ($m), 2008-2018
Figure 29: Datamonitor estimated biologic market share, 2008 and 2010
Figure 30: Apotheke.de screenshot showing the price of Stelara
Figure 31: Stelara (ustekinumab) SWOT analysis, 2009
Figure 32: Stelara (ustekinumab) psoriasis sales by country, across the seven major markets ($m), 2008-2018
Figure 33: Dovonex (calcipotriol) SWOT analysis
Figure 34: Dovonex (calcipotriol) psoriasis sales by country across the seven major markets ($m), 2008-2018
Figure 35: Dovobet (calcipotriol/betamethasone) SWOT analysis, 2009
Figure 36: Dovobet (calcipotriol/betamethasone) psoriasis sales by country in the US and 5EU ($m), 2008-2018
Figure 37: Vectical brand website with "Choose Vectical" rationale, Galderma US, 2009
Figure 38: Vectical trial comparisons, Vectical brand website, Galderma US, 2009
Figure 39: Splash page, Vectical brand website, Galderma US, 2009
Figure 40: Vectical brand website outlining regime Galderma USA, 2009
Figure 41: Silkis/Vectical (calcitriol) SWOT analysis, 2009
Figure 42: Silkis/Vectical (calcitriol) psoriasis sales in the US and 5EU ($m), 2008-2018
Figure 43: Olux brand website, Stiefel Laboratories, 2009
Figure 44: Olux/Olux-E (clobetasol) psoriasis sales by country, in the US, UK and Italy ($m), 2008-2018
Figure 45: Clobex (clobetasol) psoriasis sales by country in the US and 5EU ($m), 2008-2018
Figure 46: Soriatane/Neotigason (acitretin) psoriasis sales by country in the US and 5EU ($m), 2008-2018
Figure 47: Pfizer and Wyeth's company-reported global prescription sales and Datamonitor forecasts split by therapy area ($m), 2002-2014
Figure 48: Merck and Schering-Plough's company-reported global prescription sales and Datamonitor forecasts split by therapy area ($m),, 2002-2014
Figure 49: Psoriasis-specific sales for key biologic brands, in the seven major markets ($m), 2008-2018
Figure 50: Proportion of total brand sales attributed to psoriasis for key biologic brands in the seven major markets ($m), 2008 and 2018
Figure 51: Importance of Humira within Abbott portfolio, company-reported global sales and Datamonitor forecast, ($ billion), 2008-2014
Figure 52: Importance of Enbrel within the Wyeth and Amgen portfolios, company-reported global sales and Datamonitor forecast, ($ billion), 2008-2014
Figure 53: Importance of Remicade within the Schering-Plough and Johnson & Johnson portfolios, company-reported global sales and Datamonitor forecast, ($ billion), 2009-2014
Figure 54: Psoriasis-specific sales split by delivery method across the seven major markets ($m), 2004-08
Figure 55: Successful uptake of Dovobet showing some switch from Dovonex in the seven major markets ($m), 2005-08
Figure 56: Topical vitamin derivatives and corticosteroids by formulation in the seven major markets ($m), 2005-2018
Figure 57: Vitamin D analog structures
Figure 58: US psoriasis-specific biologic sales ($m), 2008-2018
Figure 59: Remicade price cut and recovery in Japan ($/SU), 2008
Figure 60: Scenario A: US psoriasis-specific sales ($m), 2008-2018
Figure 61: Scenario B: US psoriasis-specific sales ($m), 2008-2018
Figure 62: Scenario C: US psoriasis-specific sales ($m), 2008-2018