Activery The amorphization specialist
Activery believes that amorphous drugs provide new and innovative routes to final dosage forms with differentiated pharmacokinetics
| Reformulated combination corticosteroid/anti-infective brands will continue be integral to the treatment of psoriasis and dermatitis |
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BUSINESS INSIGHTS
“The • Increased safety concerns will restrict future growth for topical immunosuppressants such as Novartis’ Elidel and Astellas’ Protopic. Both these products have a declining market presence due to the FDA’s black box label warning in 2005 for potential cancer risk. • Major branded oral acne treatments including Roaccutane will face growing generic competition over the 2008-2013 period. Leading brands in the topical acne treatment market are only expected to achieve marginal growth, while the total market for acne treatments is expected to amass $3b of revenue in 2013. • The market for psoriasis treatments is forecast to register strong growth between 2008-2013, driven by the performances of key drugs such as Raptiva, Taclonex, Soriatane. • The corticosteroid market is estimated to value $3.7b by 2013. Reformulated combination corticosteroid/anti-infective brands will continue be integral to the treatment of psoriasis and dermatitis and will continue to be the primary growth drivers within the area. • Leo Pharma is believed to feature the strongest R&D pipeline in the dermatology market, with five projects currently in the mid to late stages of development. However, most leading companies have sparsely populated pipelines. The dermatology market remains highly competitive, with developers ranging from Big Pharma to biotechnology and specialty pharmaceutical firms. In recent years levels of innovation in the area have dwindled, allowing generic competition to erode the market share of several leading brands across major drug classes. As leading players continue to lose ground to smaller, specialised players, opportunities are being created for companies that can implement effective lifecycle management and identify lucrative niches. “The dermatology market is dominated by sales of original brands and "other branded products" sold under an alternative brand. Collectively, the two categories represented 64% of the market in 2007. Overall, the strongest growth was derived from the "other brands" segment, which registered 14% growth over 2006, with sales of $3.7b...“ • Assess the epidemiology and forecast prevalence of major dermatological disorders including acne, psoriasis, dermatitis, rosacea across key geographies including the • Evaluate the performances and strategies of major dermatology developers by examining the sales focus by drug class, currently marketed products and R&D portfolios of Bayer Schering, Galderma, GSK, Leo Pharma, Novartis, J&J, Roche, Sanofi-Aventis, Schering-Plough and Stiefel Labs. • Generics threaten branded oral acne treatments. The majority of anti-acne brands, excluding Roaccutane and Diane, are based on generic molecules and formulations. This is expected to cause a shift in developmental focus to topical acne treatments and lead to a collapse in the value of the branded oral acne market. • The future of corticosteroids. Triple combination products and reformulations are continuing to revive the sales of corticosteroid brands following poor performance in 2006. However, widespread genericization is threatening to stifle future growth in this class. • Competition intensifies for psoriasis treatments. New molecular entities are largely focused upon psoriasis indications. The market is likely to witness strong growth in the forecast period as anti-TNF therapies such as Enbrel and Humira maintain strong performances. Chapter 3: Global market analysis Corticosteroids: Market analysis by drug class The global corticosteroid market grew by 9.7% over the period 2006–07, accounting for $1.4bn in sales. Topical plain corticosteroids, which contain dermatological products with one or more corticosteroids and no other active ingredients, form the major share of the market at 75.5%. This class of corticosteroids also grew at a higher rate of 11%, compared to the second class of corticosteroids which have an anti-infective agent in combination. The latter class recorded a growth of 6.1% over its 2006 sales of $336m. Olux—Stiefel Labs’ drug for scalp psoriasis—was the leading corticosteroid drug in 2007, while Nestlé's Clob X had the second highest market share at 19.8%. Schering-Plough’s Diprogenta, indicated for corticosteroid responsive dermatoses, had the highest market share in the second category of corticosteroid formulations, at 10.4%. Key brands analysis: Olux Olux foam is a super-potent topical corticosteroid indicated for the short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp, as well as the short-term topical treatment of mild to moderate plaque-type psoriasis of nonscalp regions (excluding the face and intertriginous areas). In March 2007, Stiefel Labs launched Olux in DERMATOLOGICAL DISORDERS • Introduction • Acne - Overview - Epidemiology - Forecast epidemiology • Psoriasis - Overview - Epidemiology - Forecast epidemiology • Dermatitis - Overview - Epidemiology - Forecast epidemiology • Rosacea - Overview - Epidemiology - Forecast epidemiology • Infectious diseases of the skin - Overview - Viral infections of the skin - Bacterial infections of the skin - Fungal infections of the skin - Epidemiology - Viral infections of the skin - Bacterial infections of the skin - Fungal infections of the skin - Forecast epidemiology - Viral infections of the skin - Bacterial infections of the skin - Fungal infections of the skin CHAPTER 3: GLOBAL MARKET ANALYSIS • Introduction • Market analysis by country • Licensing trends • Market analysis by drug class • Leading brands dynamics • Dermatology sales forecast to 2013 • Key events in the dermatology market - Biologics expected to drive growth in the psoriasis market - FDA requires class labeling and strengthened warnings for all four leading anti-TNF therapies - Topical acne market moving towards combination products - Black box warning for Elidel and Protopic to adversely impact growth - Roche’s Roaccutane plagued by side-effect concerns and limited risk management programs • Acne treatments - Market analysis by drug class - Leading acne treatment brands by drug class - Key brands analysis - Differine - Roaccutane - Acne treatment sales forecast to 2013 • Psoriasis treatments - Market analysis by drug class - Leading psoriasis treatment brands by drug class - Key brands analysis - Raptiva - Soriatane - Psoriasis treatment sales forecast to 2013 • Corticosteroid treatments - Market analysis by drug class - Leading corticosteroid treatment brands by drug class - Key brands analysis - Olux - Corticosteroid treatment sales forecast to 2013 • Anti-infective treatments - Market analysis by drug class - Leading anti-infective treatment brands by drug class - Key brands analysis - Lamisil - Bactroban - Aldara - Zovirax - Anti-infective treatments sales forecast to 2013 • Non steroidal products - Market analysis by drug class - Non steroidal brands by drug class - Key brands analysis - Elidel - Protopic - Non steroidal treatments sales forecast to 2013 CHAPTER 4: PIPELINE ANALYSIS • Introduction • Key trends in R&D - Celgene’s apremilast may be an alternative to current anti-TNF therapies - Intense competition in psoriasis, but voclosporin could compete on better side-effect profile and cost - Collagenex (Galderma) licenses becocalcidol from QuatRx - Reformulation products gaining traction • Dermatology pipeline • Leading drugs in development • Profiles of key pipeline products • Recently marketed drugs - Altabax - Desonate (desonide hydrogel) - Humira Table of Contents (contd.) - Ziana - Oracea - Taclonex • Drugs in registration - Ustekinumab (CNTO–1275) - Panaclar/BG-12 • Drugs in Phase III clinical studies - Voclosporin (ISA-237) - ABT-874 (formerly J-695) • Drugs in Phase II clinical studies - Apremilast (CC-10004) - COL-118 • Pipeline forecast CHAPTER 5: COMPETITIVE LANDSCAPE • Introduction - Sales performance of leading players • Detailed analysis of leading dermatology players • Stiefel Labs - Overview - Sales focus by drug class - Marketed product portfolio - R&D pipeline analysis - Strategic and growth analysis • Johnson & Johnson (J&J) - Overview - Sales focus by drug class - R&D pipeline analysis • Sanofi-Aventis - Overview - Sales focus by drug class - Marketed product portfolio - R&D pipeline analysis - Strategic and growth analysis • Novartis - Overview - Sales focus by drug class - Marketed product portfolio - R&D pipeline analysis - Strategic and growth analysis • GlaxoSmithKline (GSK) - Overview - Sales focus by drug class - Marketed product portfolio - R&D pipeline analysis - Strategic and growth analysis • Galderma - Overview - Sales focus by drug class - Marketed product portfolio - R&D pipeline analysis - Strategic and growth analysis • Leo Pharma - Overview - Sales focus by drug class - Marketed product portfolio - R&D pipeline analysis - Strategic and growth analysis • Bayer-Schering Pharma - Overview - Sales focus by drug class - Marketed product portfolio - R&D pipeline analysis - Strategic and growth analysis • Schering-Plough - Overview - Sales focus by drug class - Marketed product portfolio - R&D pipeline analysis - Strategic and growth analysis • Roche - Overview - Sales focus by drug class - Marketed product portfolio - R&D pipeline analysis - Strategic and growth analysis LIST OF FIGURES • Mechanism of acne formation • Disease progression and symptoms of acne • Common forms of psoriasis • Types of dermatitis • Types of contact dermatitis • Subtypes of rosacea • Types of viral infections • Types of bacterial infections • Types of fungal infections • Global dermatology market share by geography, 2007, US$m • Sales of types of dermatology brands, 2006–07 • Prevailing R&D approaches, 2008 • Leading recently launched products and late-stage R&D in the dermatology market, 2008 • Market share of key players by sales value, 2007 • Projected market share of key players by sales value, 2013 • Market share and ranking of leading players in the global dermatology market, 2007–13 For the following companies: • Dermatology sales by drug class, 2007 - Stiefel Labs - J&J - Sanofi-Aventis - Novartis - GSK - Galderma - Leo Pharma - Bayer Schering - Schering Plough LIST OF TABLES • Estimated prevalence of dermatological conditions across the seven major markets, 2007 ...SAVE £300/€435/$575 as a special pre-publication offer when you order by Friday 31st October 2008... Table of Contents For the following disorders: • Estimated prevalence across the seven major markets, 2007 • Forecast epidemiology across the seven major markets, 2007–13 - Acne - Psoriasis - Dermatitis - Rosacea - Viral infections of the skin - Fungal infections - Bacterial infections • The global dermatology market by drug class 2006–07 • Leading brands in the global dermatology market, 2006–07 • Dermatology market sales forecast by drug class 2007–13 • The global acne market by drug class, 2006–07 • Leading acne treatments in the global dermatology market, • Anti-acne products sales forecast, 2007–13 • The global psoriasis market by drug class, 2006–07 • Leading psoriasis treatments in the global dermatology market, 2006–07 • Anti-psoriasis sales forecast, 2007–13 • The global corticosteroid market by drug class, 2006–07 • Leading corticosteroid treatments in the global dermatology market, 2006–07 • Corticosteroid treatments sales forecast, 2007–13 • The global anti-infectives market by drug class, 2006–07 • Leading anti-infective treatments in the global dermatology market, 2006–07 • Anti-infective treatments sales forecast, 2007–13 • Non steroidal treatments by drug class, 2006–07 • Non steroidal treatments in the global dermatology market, • Other leading dermatology treatments sales forecast, 2007–13 • Dermatology pipeline by indication and stage of development, 1H2008 • Product Overviews - Altabax - Desonate - Humira REVEAL data - Humira versus placebo - Ziana - Oracea - Taclonex - Ustekinumab - Panaclar - Voclosporin (ISA-237) - ABT-874 - Apremilast - COL-118 • Dermatology disorders pipeline forecast, 2008–13 ($m) • Leading Players in the global dermatology market, 2007–13 ($m) For the following companies: • Leading dermatology product portfolio, 2006–07 • Dermatology R&D product pipeline, 2007 (where appropriate) - Stiefel Labs - J&J - Sanofi-Aventis - Novartis - GSK - Galderma - Leo Pharma - Bayer Schering - Schering Plough - Roche |
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