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Therapeutic Clinical Intelligence - Rheumatoid ArthritisPublished by: Austin Research Group Published: Dec. 1, 2007 Table of Contents
AbstractThe world-wide market for Rheumatoid Arthritis (RA) therapeutics has undergone significant change over the past 5-10 years with the introduction of biologics. These biologic products, specifically, the anti-TNF-alpha monoclonal antibodies—Enbrel, Humira, and Remicade—are dominating the moderate-to-severe RA therapeutic market, with newcomers Rituxan and Orencia garner single digit market share.The biologics due have the potential to shift the treatment paradigm by increasing utilization anti-TNFs in earlier lines of therapy. However, the competitive intensity within the RA segment is on the rise as companies are aggressively developing both novel and second-generation compounds that have the potential to challenge the competitive position of these market leaders in the future. Potential threats on the horizon include novel biologic therapies such as Actemra, Cimzia, Golimumab, Ocrelizumab, and TRU-015. Additionally, the development landscape for targeted small molecules could produce therapeutic alternatives that would directly compete with the anti-TNFs and other biologics in earlier lines of therapy. Novel compounds including CP-690,550 and Prinaberel have a convenience and cost advantage over the biologics due to their oral formulation and potential attractiveness to managed care organizations and pharmacy benefit managers (payers). However it is yet to be seen if any of these agents will be able to consistently demonstrate superior efficacy over the current market leaders for. The Rheumatoid Arthritis Therapeutic Clinical Intelligence report provides an in-depth assessment of the R&D competitive landscape for Rheumatoid Arthritis (RA) therapeutics from a product-level and clinical perspective. We profile the supporting clinical data for 37 compounds in phase 2 of development and beyond—including key in-line products. Specifically, our analysis concentrates on the clinical study protocol design and efficacy and safety data for these products, which we believe, have the potential to alter the market dynamics in RA over the next 3-7 years. This methodological approach is intended to provide insight into the market opportunities and challenges, as well as the clinical hurdles facing RA drug developers. Reports contain synthesized information and analysis of clinical development activities for key marketed and pipeline products within multiple therapeutic categories and generally include the following data points: Product Overview: Mechanism of Action, Developing Companies, Indications and Phase of Development. Clinical Trial Assessments: Detailed evaluations of completed and ongoing competitor studies that capture key elements of the study protocol including:
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