Steady growth is expected for the Uveitis market from 2012 to 2017. The report estimates that the Uveitis market across the six major markets (6MM) covered in this report (US, France, Germany, Italy, Spain, and UK) was worth $340m in 2012 and will grow to $464m by 2017. This represents a Compound Annual Growth Rate (CAGR) of 6.5%. The majority of sales will come from the US market, which will have a CAGR of 8.7% during the forecast period from 2012–2017 due to the earlier introduction of pipeline drugs than in the European Union (EU) countries.
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The major drivers of the growth of the Uveitis market over the forecast period are as follows:
- The most significant driver of the growth of the Uveitis market during the forecast period will be the introduction of biologics, with Humira being shifted away from off-label use to a marketed drug, and Xoma 052 being introduced as a novel biologic. This is expected to significantly change the treatment landscape for Uveitis patients, and it might introduce a shift in the treatment regimen for patients with severe forms of Uveitis.
- While corticosteroids have been at the core of Uveitis treatment, the introduction of new routes of administration for these drugs has resulted in new treatment options. Ocular implants like Retisert (fluocinolone acetonide intravitreal implant) and Ozurdex (dexamethasone intravitreal implant) have already introduced this route of administration for corticosteroids, and the pipeline product, Medidur, is expected to make ocular implants more attractive due to an expected better safety profile, long lifetime, and biodegradability. EGP-437 is a corticosteroid product for the treatment of Uveitis with a novel route of administration, and is delivered into the eye using the iontophoresis technology known as the Eyegate II Delivery System (EGDS).
- The pipeline drug, DE-109, is an intravitreal sirolimus injection that promises to offer a non-corticosteroid injection for the treatment of Uveitis, and could potentially replace corticosteroid treatment.
- Uveitis pipeline products frequently gain orphan drug status, such as DE-109 for the treatment of chronic, non-infectious Uveitis, and Xoma 052 for the treatment of Behҫet’s disease, with Uveitis being one of the hallmarks of this disease.
The major barriers to the growth of the Uveitis market are as follows:-
- Uveitis remains an under-researched indication with diverse etiologies, which means that diverse treatment options are required, and also presents a challenge for patient enrollment in clinical trials. The new biologics already target the inflammation more specifically in comparison with corticosteroid treatment, but a cure for Uveitis remains to be found.
- The majority of Uveitis patients receive corticosteroid treatments, which are a very cost-effective treatment option. Some patients receive immunosuppressive drugs, which, depending on the exact drug, are also very economical treatment options. Today, healthcare providers are increasingly focused on the cost-effectiveness of drug treatments, especially in the EU. This might make it difficult for the significantly pricier biologics, Humira and Xoma 052, to gain market approval, or it might lead to very restricted access to these drugs, even if they are approved.
- The recent failure of the previously promising Phase III pipeline product, Luveniq (voclosporin), has restricted the growth of the Uveitis market. Luveniq, which was under development for the treatment of chronic, non-infectious intermediate, posterior, and panUveitis, received orphan drug status in the EU and US in 2007. In June 2011, the Committee for Medicinal Products for Human Use (CHMP) announced a negative opinion for the product, and Lux Biosciences subsequently announced the withdrawal of its European marketing application in October 2011.
Drugs with diverse mechanisms of action and routes of administration are poised to enter the Uveitis market
The diversity of both the etiologies of Uveitis and patients’ needs are reflected in the diversity of the pipeline products for this indication. The two dominant trends are the introduction of biologics (Humira, Xoma 052) for the treatment of Uveitis, and the development of new routes of administration for corticosteroids (EGP-437, Medidur). These are supplemented by an immunosuppressive drug (DE-109), which will offer an alternative to intravitreal corticosteroid injections. The diversity of Uveitis patients as well as the drugs used to treat the condition makes it challenging to compare these drugs with one another in terms of their clinical and commercial characteristics. For this reason, GlobalData compared the pipeline products against the most appropriate drug currently used for the treatment of Uveitis in terms of mechanism of action and route of administration. Humira was used as a comparator for Xoma 052, as it is currently used as an off-label treatment and is also a pipeline product for this indication. EGP-437 was compared with topical corticosteroids, and Medidur was compared with the ocular corticosteroid implant, Retisert. The intravitreal injection, DE-109, was compared with the intravitreal corticosteroid injection, Triesence (triamcinolone acetonide). Corticosteroid treatments (oral, eyedrops, and intravitreal injections like Triesence) will remain at the center of Uveitis treatment, while biologics will offer a welcome addition to the treatment regimen.
A treatment that permanently controls inflammation, with a good short- and long-term safety profile, remains elusive
At the heart of the unmet needs in the Uveitis market is the development of a cure and/or treatment options that are permanently able to control inflammation and prevent a decrease in vision. Corticosteroids, whether administered as a systemic treatment or as ocular-specific therapy, have side effects, which, over time, lead to low compliance, as well as the requirement for corticosteroid-sparing treatment. Biologics are overall well tolerated on a day to day basis, but are associated with potentially severe long-term side effects, such as infection and malignancies.
Therefore, a therapy that has both a good short- and long-term safety profile is still needed. Regarding the route of administration, key opinion leaders (KOLs) interviewed by GlobalData were very split in their preferences, as both systemic and ocular-specific treatments come with a set of complications. Therefore, diversity in the route of administration will remain key for the treatment of Uveitis patients.
Spanning over 199 pages, 59 Tables and 17 Figures, “OpportunityAnalyzer: Uveitis - Opportunity Analysis and Forecasts to 2017” report covering Table of Contents, Introduction, Disease Overview, Epidemiology, Current Treatment Options, Unmet Needs Assessment and Opportunity Analysis, Research and Development Strategies, Pipeline Assessment, Pipeline Valuation Analysis, Appendix.
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