Significant Market Growth Driven by Personalized Vaccine DCVax-L
The Glioblastoma Multiforme (GBM) market is forecast to grow rapidly from $305m in 2012 to $583m in 2019 at a Compound Annual Growth Rate (CAGR) of 9.7%. This significant growth comes despite the upcoming patent expiration of Temodar and is primarily contributed to by the market entry of DCVax-L. DCVax-L a dendritic cell-based therapeutic vaccine that demonstrated an Overall Survival (OS) that was around 2.3 times longer that observed with the standard of care in newly diagnosed patients during clinical trials. Currently, surgery, radiotherapy and chemotherapy with Temodar (temozolomide) is the standard initial treatment, but the OS resulting from these treatments does not exceed 15 months. DCVax-L, which will be marketed as an add-on to the standard treatment for newly diagnosed patients followed by surgery, is expected to demand a premium price and bear high market potential, given that its efficacy has translated into larger Phase III trials. The vaccine is anticipated to be approved in 2015 in the US and in 2016 in EU. The cancer vaccine Rindopepimut (CDX-110) and targeted therapy Cotara will also enter the GBM market in 2017 and 2016 respectively, but will drive growth to a lesser extent. Despite its high potency in prolonging OS in newly diagnosed patients, the uptake of Rindopepimut is likely to be lower due to its lower efficacy in comparison with DCVax-L. Cotara, developed for treating recurrent GBM, will have limited market uptake due to less favorable cost-effectiveness compared to its competitor Avastin (bevacizumab).
Challenging Clinical Trial Landscape Poses Barrier to Market Entrants
Analysis indicates that GBM clinical trials are of an exceptionally long average duration and have a high attrition rate. These trends pose a huge challenge for the development of new products for the GBM market. These findings indicate that investment in the market is high-risk, and explain the small total of players that are currently active in the market landscape. The clinical trial landscape is characterized by limited efficacy of developmental products due to the limitations in drug delivery techniques and the heterogenous nature of the disease. This is further exacerbated by low prevalence rates, making trial recruitment difficult, resulting in low patient accrual rate, and above-industry average trial durations, leading to a very high cost of drug development. However, attractive opportunities can be found in the market as huge unmet needs remain. This is particularly relevant to recurrent GBM, as the market entrants are not expected to address the unmet needs in this patient segment over the forecast period. Therapies that exhibit high potency against chemotherapy-resistant tumors will remain in high demand, given the limited OS benefits demonstrated by current treatment options.
Significant Presence of Targeted Therapies from Phase II to Phase III of the Pipeline
Targeted therapies and personalized treatments have a significant presence in the late-stages of the pipeline, however, drugs targeting DNA represent only 4% of the total developmental pipeline. This is in contrast to the current market landscape which is dominated by DNA-targeting drugs. This reflects a shift toward treatment strategies with higher tumor specificity and multiple molecular targets. These new treatments can potentially translate into more profound survival improvements with fewer systemic side effects, one of the limitations of Avastin.
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