The Future of the U.S. Biologics and Biosimilars Treatment Market for Psoriasis

"The new report from MP Advisors titled “The Future of the U.S. Biologics and Biosimilars Treatment Market for Psoriasis” examines in detail the current treatment landscape and the outlook through 2021 of psoriasis treatment market facing the U.S. Biologics and the Biosimilars. The report offers strong strategic market insights and expert analyses supported by a robust market and epidemiology model. The report is authored by a seasoned Analyst with experience of over 15 years in Healthcare Strategy Consulting and Market Research.

Quick Psoriasis Market View

Psoriasis is a chronic auto-immune disease characterized by skin lesions. Psoriasis causes abnormal proliferation of skin cells that result in the formation of layers of raised inflamed skin covered by flaky silvery scales. There are several clinical types of psoriasis that include

(1) plaque psoriasis,
(2) guttate psoriasis,
(3) inverse psoriasis,
(4) pustular psoriasis and
(5) erythrodermic psoriasis. Plaque psoriasis represents 80% of the cases with the remaining 20% having a moderate or severe form of the disease.

Focus Areas

Psoriasis disease deep dive, in-depth epidemiology, treatment guidelines, and assessment tools
Revenue analyses by drug class and the leading brands
Current and forecast market sales of Biologics and Biosimilars
Leading Players Analyses, Company Strategy and Outlook
Detailed Late-stage pipeline intelligence and the projected peak sales contribution
Market & R&D Trends, Drivers, challenges and the opportunities facing the sector


Major Takeaways

The U.S. psoriasis treatment market for Biologics and Biosimilars was estimated at $6.6bn in 2016 is projected to almost double during the forecast period to reach $12.9bn in 2021 driven by safety and efficacy improvements of the new generation biologics.

The psoriasis treatment market is dominated by topical agents and photo therapy for the non-severe forms (mainly corticosteroids), but mild to severe forms are treated with systemic agents. The psoriasis treatment market is dominated by topical agents and photo therapy for the non-severe forms (mainly corticosteroids), but mild to severe forms are treated with systemic agents.

Driven by improved efficacy, the first group of anti TNF treatments led by Enbrel, Humira and Remicade made strong penetration into the psoriasis market. However the emergence of the IL-17 inhibitor class driven by Novartis’ Cosentyx and Eli Lilly’s Talz have set a new benchmark for efficacy in moderate to severe psoriasis treatment with potential for safety improvement in comparison to the anti TNF drugs given their greater specificity in immune Suppression. MP Advisors expect the TNF class of drugs to lose share to the newer brands with improved clinical profiles in Psoriasis.

The market growth in psoriasis is driven by an upsurge in demand from new therapies in moderate to severe patient population which overshadows reduced pricing of branded TNF-α inhibitor and recent biosimilar launches. The psoriasis treatment market is facing increasing competitive pressure from a wave of biosimilar launches such as biosimilars of Janssen’s Remicade, and Amgen’s Enbrel with the impact of the headwinds expected to be more pronounced in the next few years.

Stelara has been an important growth driver of Janssen’s immunology franchise in recent years, with overall global sales doubling from $1.5bn in 2013 to more than $3.2bn in 2016. However Stelara has started to face steeper competition from the IL-17 drug class. A new head-to-head study report IL-17 products to demonstrate superior efficacy to Stelara for psoriasis.

The Future of the U.S. Biologics and Biosimilars Treatment Market for Psoriasis” from MP Advisor aims to answer the following questions:

• Who are the top players dominating the psoriasis market currently and how do their current product portfolio look like
• Who will be the leading players in 2021
• How will the treatment landscape set to evolve
• How is competitive dynamics playing out and what are the key milestones to watch out for
• Which are the new targets, Mechanism of Action (MoA), and the emerging R&D trends
• Which are the key pipeline assets and the disruptive late-stage products under development
• How is the partnership and alliances space shaping up
• Who will be the frontier companies and what are their winning strategies

Executive Summary 4
List of Figures 7
List of Tables 8
1. Psoriasis Market Overview 9
1.1. Disease background 9
1.2. Types of psoriasis 10
1.2.1. Plaque psoriasis 11
1.2.2. Guttate psoriasis 11
1.2.3. Inverse (flexural) psoriasis 11
1.2.4. Pustular psoriasis 11
1.2.5. Erythrodermic psoriasis 12
1.3. Pathophysiology 12
1.4. Etiology 12
1.4.1. Environmental factors 12
1.4.2. Genetic factors 12
1.4.3. Immunologic factors 14
1.5. Risk factors and co-morbidities 16
1.6. Epidemiology 16
1.7. Treatment options 17
1.7.1. Phototherapy 18
1.7.2. Topical treatments 18
1.7.3. Conventional systemic agents 18
1.7.4. Other systemic drugs 18
1.7.5. Biologics 18
1.8. Treatment Guidelines 19
1.8.1. Mild to moderate Psoriasis 22
1.8.2. Moderate Psoriasis 22
1.8.3. Moderate –to–severe psoriasis 22
1.8.4. Severe psoriasis 22
2. Psoriasis Treatment Market for Biologics 23
2.1. Introduction and Market Overview 23
2.2. Revenue Analysis for Biologics in the U.S. 30
2.3. Key marketed products for psoriasis treatment 33
2.3.1. Remicade (infliximab; Janssen) 38
2.3.2. Humira (adalimumab; AbbVie) 42
2.3.3. Stelara (ustekinumab; Janssen) 46
2.3.4. Cosentyx (secukinumab; Novartis) 50
2.3.5. Taltz (ixekizumab; Lilly) 55
2.3.6. Siliq (brodalumab; Valeant) 59
2.3.7. Tremfya (guselkumab; Janssen) 62
2.4. Key pipeline products for psoriasis treatment 65
2.4.1. Tildrakizumab; Merck / Sun Pharma 66
2.4.2. Cimzia (certolizumab pegol; UCB/Dermira Pharmaceuticals) 68
2.4.3. Risankizumab; AbbVie/Boehringer Ingelheim 70
2.5. Growth Drivers and Resistors for Biologics 71
2.5.1. Growth Drivers: 71
2.5.2. Resistors 73
2.6. Competitive Landscape Approved Products 75
2.7. Competitive Landscape Pipeline Products 77
3. Psoriasis Market for Biosimilars 79
3.1. Introduction and Market Overview 79
3.2. Approved biosimilars 79
3.2.1. Approved biosimilars in the U.S. 79
3.2.2. Revenue Analysis for Biosimilars in U.S. 81
3.2.3. Approved biosimilars in the EU 81
3.3. Pipeline Analysis 83
3.3.1. Clinical development Humira (adalimumab) biosimilars 84
3.3.2. Clinical development Enbrel (etanercept) biosimilars 84
3.3.3. Clinical development Remicade (infliximab) biosimilars 85
3.4. Biosimilars deals and partnerships 86
3.5. Growth Drivers and Resistors for Biosimilars 87
3.5.1. Growth Drivers 87
3.5.2. Resistors 90
3.6. Competitive Landscape Approved Biosimilars in the U.S. and EU 94
3.7. Competitive Landscape – TNF α Inhibitors Biosimilars Pipeline 96
References: 98


List Of Tables

Table 1: Common sub-types of psoriasis
Table 2: Genes associated with psoriasis sU.S.ceptibility
Table 3: Psoriasis types of treatments’
Table 4: Psoriasis treatment options
Table 5: Psoriasis global assessment
Table 6: Approved biologics for psoriasis
Table 7: Enbrel – Drug profile
Table 8: Plaque psoriasis clinical studies – Enbrel
Table 9: Meta-analyses comparison of TNF-α inhibitors and ustekinumab
Table 10: Remicade – drug profile
Table 11: Plaque psoriasis clinical studies – Remicade
Table 12: Humira – drug profile
Table 13: Plaque psoriasis clinical studies – Humira
Table 14: Stelara – drug profile
Table 15: Plaque psoriasis clinical studies – Stelara
Table 16: Cosentyx – drug profile
Table 17: Plaque psoriasis clinical studies – Cosentyx
Table 18: Taltz – drug profile
Table 19: Plaque psoriasis clinical studies – Taltz
Table 20: Siliq – drug profile
Table 21: Plaque psoriasis clinical studies – Siliq
Table 22: Tremfya – drug profile
Table 23: Plaque psoriasis clinical studies – Tremfya
Table 24: Key pipeline products for psoriasis
Table 25: Plaque psoriasis clinical studies – Tildrakizumab
Table 26: Plaque psoriasis clinical studies – Cimzia
Table 27: Phase-II comparator trial - risankizumab vs. ustekinumab
Table 28: Growth drivers and resistors for biologics for psoriasis
Table 29: Annual per patient expenditure on biologics for psoriasis
Table 30: Competitive landscape of approved biologics for psoriasis
Table 31: Competitive landscape of pipeline biologics for psoriasis
Table 32: Approved biosimilars for psoriasis in the U.S., 2017
Table 33: Approved biosimilars for psoriasis in the EU, 2017
Table 34: Adalimumab biosimilars pipeline for psoriasis, 2017
Table 35: Etanercept biosimilars pipeline for psoriasis, 2017
Table 36: Infliximab biosimilars pipeline for psoriasis, 2017
Table 37: Key biosimilars for psoriasis – Partnerships and Deals
Table 38: Growth drivers and resistors for biosimilars for psoriasis
Table 39: EMA and U.S. FDA - biosimilars approval guidance comparison
Table 40: Competitive landscape – Approved biosimilars in the U.S.
Table 41: Competitive landscape – Approved biosimilars in EU
Table 42: Competitive landscape – TNF-α inhibitors biosimilars pipeline


List Of Figures

Figure 1: Common areas of distribution of psoriasis
Figure 2: Psoriasis coverage and distribution
Figure 3: Proposed schema of the evolution of a psoriatic lesion
Figure 4: Comorbidities associated with psoriasis
Figure 5: Burden of psoriasis by countries
Figure 6: Psoriasis management algorithm
Figure 7: Therapeutic targets for biologics in psoriasis
Figure 8: Biological effects of TNF- α
Figure 9: Schematic configuration of dominant TNF- α inhibitors
Figure 10: The structure and function of the cytokines IL-12 and IL-23
Figure 11: IL-17-induced signaling pathways
Figure 12: IL- 17 and IL 23 in the pathogenesis of psoriasis
Figure 13: Sales estimates for biologics in psoriasis in U.S., 2016-21
Figure 14: Sales estimates forTNF-α inhibitor biologics in psoriasis in U.S., 2016-21
Figure 15: Sales estimates forIL-inhibitor biologics in psoriasis in U.S., 2016-21
Figure 16: SWOT analysis Enbrel
Figure 17: Overall sales analysis Enbrel
Figure 18: SWOT analysis Remicade
Figure 19: Overall sales analysis Remicade
Figure 20: SWOT analysis Humira
Figure 21: Overall sales analysis Humira
Figure 22: SWOT analysis Stelara
Figure 23: Overall sales analysis Stelara
Figure 24: SWOT analysis Cosentyx
Figure 25: Overall sales analysis Cosentyx
Figure 26: SWOT analysis Taltz
Figure 27: Overall sales analysis Taltz
Figure 28: SWOT analysis Siliq
Figure 29: SWOT analysis Tremfya
Figure 30: Sales estimates for biosimilars in psoriasis in U.S., 2016-21
Figure 31: Projected Savings from biosimilars in the US


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