Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM
|出版日||ページ情報||英文 105 Pages
|アジア太平洋地域の多形性膠芽腫(GBM)治療薬市場：新規診断／再発患者のアンメットニーズを対象とした、新たな治療アプローチ Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM|
|出版日: 2014年08月20日||ページ情報: 英文 105 Pages||
GBI Research, the leading business intelligence provider, has released its latest research, "Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM", which provides in-depth analysis of the Glioblastoma Multiforme (GBM) therapeutics market within the Asia-Pacific (APAC) region, covering Australia, China, India and Japan. The report provides estimates of market size for 2013, along with market forecasts until 2020. It also covers disease epidemiology, treatment algorithms, treatment patterns, and in-depth analysis of the marketed and pipeline products.
The value of the GBM market in the APAC region amounted to an estimated $49.4m in 2013, and is expected to register a Compound Annual Growth Rate (CAGR) of 11.5%, to reach $105.8m by 2020. The GBM market in India was the smallest of the APAC markets in 2013, but is expected to experience the highest growth rate in the forecast period, at a CAGR of 14.4%, due to having the highest number of promising candidates in the pipeline. Japan currently has the largest share of GBM market in the APAC region, at 48%, and is expected to experience healthy growth during the forecast period at a CAGR of 13.8%.
The existing treatment landscape is bleak for both newly diagnosed and recurrent GBM, with temozolomide alone serving as the standard of care after surgery and radiation. For first-line treatment Rindopepimut, a novel vaccine, is in late-stage development in India and Australia, but it is limited to EGFRvIII patients. There are two strong candidates in the current pipeline for second-line treatment: Avastin and Cotara. Avastin is the first and only targeted therapy for newly diagnosed GBM, is already approved as second-line treatment in Australia and Japan, and is in Phase III development in China and India. Cotara is a single-infusion drug with a novel delivery route, which is in Phase II development in India. The expected launch of these three drugs is the key driver for growth in APAC GBM market. As all are expensive, even a modest uptake will increase the annual cost of therapy, and subsequently the market size.
Glioblastoma Multiforme Therapeutics Market in Asia-Pacific Region to Post High Growth to Reach $105.8m by 2020
The Glioblastoma Multiforme (GBM) therapeutics market in the four Asia-Pacific (APAC) markets of Australia, China, India and Japan was worth $49.4m in 2013, and is expected to grow at a Compound Annual Growth Rate (CAGR) of 11.5% to $105.8m by 2020. Japan was the largest of these markets in 2013, valued at $23.8m, equivalent to a share of 48%, closely followed by China at $19.7m or 40%. This significant expected growth is due to the probable approval and market entries of Rindopepimut (CDX-110), Cotara (TNT-1) and Avastin (bevacizumab) in some of the APAC regions during the forecast period.
India and Australia have more promising candidates for possible approval in the forecast period than China and Japan. The growth forecast for Japan, however, is still high, even though it has just one candidate in late-stage development that could be approved during the forecast period, due to recent approval of Avastin. Japan is expected to post a high CAGR of 13.8%, second only to India among the APAC countries. The GBM market in India is currently the smallest, estimated at $4.6m in 2013, but is expected to post the highest growth, at a CAGR of 14.4% until 2020. There are four promising GBM drugs in the pipeline in India that could have a significant impact on market growth - Rindopepimut and BIOMAb (nimotuzumab) for newly diagnosed GBM; Avastin and Cotara for treatment in the recurrent setting.
The pipeline presents two promising novel therapies - Rindopepimut and Cotara - that could have a significant bearing on the GBM market in the APAC region. Phase II studies of Rindopepimut demonstrated a relatively high median Overall Survival (OS), and a significant survival benefit when compared to historic controls treated with the standard of care. However, the vaccine is limited to the 30% of GBM patients who are Epidermal Growth Factor Receptor (EGFR) variant (v) III-positive. Phase II studies of Cotara showed similar OS to Avastin, with slightly better Progression Free Survival (PFS) improvement in recurrent GBM. As a single-infusion therapy, Cotara is likely to become a good alternative second-line treatment.
Pipeline Boasts High Diversity of Molecular Targets Despite Setbacks
Several targeted therapies have failed in late-stage development or have shown too little efficacy to be viable therapeutic alternatives. Growth Factor Receptors (GFR) are one of the most prevalent molecular targets in the GBM pipeline. Although EGFR gene amplification is the most common mutation seen in GBM patients, several drugs with EGFR as molecular targets have failed to demonstrate significant efficacy. Drugs that target EGFR but that failed to demonstrate significant benefit in improving median OS or PFS include Tarceva (erlotinib), Erbitux (cetuximab), and Iressa (gefitinib). Vascular Endothelial Growth Factor Receptor (VEGFR)-targeting drugs such as Recentin (cediranib) have also experienced some setbacks. Currently, Avastin (bevacizumab) is the only anti-VEGFR agent marketed for GBM. Despite these setbacks, the GBM pipeline consists of a sizeable share of drugs targeting GFRs - 35% - with some of them reaching late-stage development. EGFR inhibitors in the late-stage pipeline include ABT-414, gefitinib, AMG-595, and nimotuzumab. Similarly, 17% of the disclosed pipeline consists of kinases. While the majority of Phosphoinositide 3-Kinase (PI3K) inhibitors are unable to cross the Blood-Brain Barrier (BBB), 22% of the kinases in the GBM pipeline are PI3K inhibitors. PX-866, a PI3K inhibitor developed by Oncothyreon, was discontinued in Phase II development due to low efficacy. BKM-120 (buparlisib hydrochloride) is another PI3K inhibitor currently in Phase II trials for recurrent GBM. The current pipeline consists of a highly diverse set of molecular targets, which may potentially serve as effective treatments in the future.
Promising Future for Glioblastoma Multiforme Therapeutic Landscape
GBM is the most malignant of gliomas, which are an aggressive type of tumor with very poor prognosis, in spite of the improvements seen with the current standard of care temozolomide. There are very limited therapeutic alternatives currently available for newly diagnosed or recurrent GBM. Existing options include three chemotherapeutic agents - temozolomide, Gliadel Wafer (carmustine in polifeprosan) and BiCNU (carmustine); and Avastin, a monoclonal Antibody (mAb), which is the only approved targeted therapy. Extensive heterogeneity and the presence of the BBB are the two key challenges in the development of efficacious therapeutic options. Many of the existing chemotherapy drugs are hydrophilic and their molecular size is too large to penetrate the BBB and hence not suitable in the treatment of GBM.
There are some strong candidates in the current pipeline that promise to be effective agents in overcoming the BBB. Examples include BIOMAb (nimotuzumab) by Biocon, a mAb and an EGFR antagonist that binds preferentially to the cells overexpressing EGFR and holds promise in its capacity to cross the BBB; and Cotara, a targeted mAb developed by Peregrine Pharmaceuticals that uses Convection-Enhanced Delivery (CED) to overcome the BBB and is in Phase II trials for newly diagnosed GBM; and BKM-120 (buparlisib hydrochloride) developed by Novartis, a PI3K inhibitor in Phase II trials for recurrent GBM with proven ability to penetrate the BBB. Although a cure is not expected in the near future, the late-stage pipeline presents some strong candidates that have the potential to expand the therapeutic alternatives available for GBM.