Abstract
The 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:
- Trial design
- Start and end dates
- Study size and patient type
- Number of participating sites
- Dosing regimen
- Endpoints
- Safety and efficacy results
Clients utilize the report as a critical resource used to support key
strategic decisions including:
- Analyzing the overall depth and breadth of the competitive landscape
within a therapeutic area
- Assessing target product profiles of key current and future competitors
- Benchmarking competitor clinical trial designs and results
- Developing clinical analogues to support go-no-go decisions
- Identifying clinical hurdles posed by competitors
- Designing clinical trials more effectively to maximize a product' s
penetration
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