Abstract
Overview
Introduction
Systemic Lupus Erythematosus is a chronic, life-long and potentially fatal
autoimmune disease characterized by multiple system distress and unpredictable
flares. High unmet need makes this an attractive market but dispute over
patient numbers and clinical trial difficulties are significant hurdles for
new entrants to overcome.
Scope
- Assessment of patient size across the seven major markets (US, Japan,
France, Germany, Italy, Spain, UK), including split by age and gender
- Qualitative interviews with key opinion leaders including treating
physicians, patient advocates and research scientists
- Investigation of the current unmet needs from a range of professionals
involved in SLE treatment and research
- Current treatment controversies and novel therapies in the developmental
pipeline
Report Highlights
The main obstacle to approval of a new treatment for SLE is ambiguity in the
requirements for randomized clinical trials. Recruitment is becoming a
particular issue as a large number of late-Phase trials are being carried out
at present. Datamonitor recommends e-recruitment, patient advocacy group
collaboration and liaison with regulatory agencies.
Awareness among primary care physicians is low, but once a treatment reaches
the market, companies are expected implement large marketing initiatives. This
will to improve physician knowledge of the condition and available treatments,
aiding the challenge of correct diagnosis of this disease, and enlarging the
market.
New drugs entering the market have a number of opportunities which can be
exploited by the developing company. Orphan drug status is a key advantage of
the SLE market. However, improved SLE survival rates have emphasized
co-morbidities, resulting in the threat of an increased risk of thrombotic
events.
Reasons to Purchase
- Identify the challenges in clinical trial design including assessment tool
selection and renal verses non-renal designs
- Understand the key issues for potential treatments for heterogeneous SLE
patients
- Gain insight into opinion leaders' thoughts on the challenges facing the
SLE market
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