Table of Contents
Imminent Arrival of 3 Promising Drug Classes Intensifies Competition
•The market for moderate-to-severe psoriasis therapeutics is becoming increasingly competitive with the imminent arrival of a new class of biologic: anti-interleukin–17(IL-17). If approved, Novartis will lead the pack with a potential 2014 launch of first-in-class secukinumab, followed by Eli Lilly’s izekizumab and Amgen/AstraZeneca’s brodalumab.
•The market also looks to benefit from the arrival of xxnovel oral drugs: Pfizer’s Xeljanz, a janus kinase (JAK) inhibitor approved for rheumatoid arthritis (RA) in the United States, and Celgene’s Apremilast, a phosphodiesterase-4 (PDE4) inhibitor.
•The development pipeline for moderate-to-severe psoriasis therapeutics is competitive, with at leastxx investigational biologic and small molecule drugs in various stages of development. Particularly competitive classes include anti-IL-17 with xx candidates in late stage development and anti-interleukin-23 (IL-23) with 5 candidates in various stages of development.
oThere are also xxbiosimilar anti-tumor necrosis factor (TNF) agents in Phase xx trials for psoriasis— biosimilar versions of adalimumab and 1 biosimilar etanercept.
•The pipeline for mild-to-moderate psoriasis includes at least xxinvestigational topical therapies in various stages of development.
•Pivotal clinical trial programs for 6 late-stage candidates comprise xx to xx trials each and include approximatelyxx to xxpatients in total. Most include at least 1 study design that evaluates the effects of treatment withdrawal and retreatment, which is a common practice with psoriasis patients.
•Comparative head-to-head trials have also become a common practice, with most sponsors of late-stage candidates pitting their drugs against Enbrel (etanercept) or Stelara (ustekimumab) in the case of brodalumab. Novartis was the first to show superiority of an anti-IL-17 over an anti-TNF (Enbrel) in a Phasexx trial with recently announced results of FIXTURE.
Methodology and Scope
•This research service focuses on prescription drugs used for the treatment of mild-to-moderate and moderate-to-severe chronic plaque psoriasis (PS). This study does not cover non-pharmaceutical therapies such as phototherapy or treatments for related disorders such as psoriatic arthritis (PsA).
•A product and pipeline assessment is provided for marketed and investigational products for the treatment of chronic PS. Segmentation by disease severity and drug class is provided, along with additional supporting information such as clinical trial timelines and results, projected launch timelines, and epidemiology.
•The information contained in this research service was derived from published sources, including the following: disease organization Web sites; public health organization Web sites; company publications, including annual reports, SEC filings, and press releases; government public sources; and published articles in scientific journals.
Psoriasis is a chronic inflammatory disease of varying severity that manifests primarily as inflammation of the skin in the form of scaling, erythematous, disfiguring plaques that may be associated with pain, itching, and significant quality of life issues. Despite localization of the main symptom to the skin, psoriasis is a systemic autoimmune inflammatory disease. It is often associated with co-morbidities such as PsA, inflammatory bowel diseases, cardiovascular disease, diabetes, and lymphoma; severe cases may increase overall mortality risk. There is currently no cure for psoriasis. The goal of treatment is to reduce the severity and coverage of lesions and to induce and maintain remission for as long as possible.
The market for psoriasis treatments is mainly focused on developing improved therapeutic options for moderate-to-severe cases of psoriasis where there is still a great deal of unmet need. Since the introduction of biologic therapies such as TNF inhibitors for psoriasis and related autoimmune diseases such as RA, treatment of these diseases has greatly improved because of the strong efficacy of these revolutionary therapies. However, available biologics are associated with varying or waning efficacy, along with significant safety issues such as infections.
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