Press Release

Nexavar, the Only Approved Targeted Therapy for Advanced Liver Disease, Continues to Dominate as Other Late Stage Trials Fail


January 11th, 2013

Global Information Inc. would like to present a new market research report, "Liver Cancer Therapeutics Market to 2018 - Nexavar, the Only Approved Targeted Therapy for Advanced Disease, Continues to Dominate as Other Late Stage Trials Fail" by GBI Research.

The Liver Cancer Therapeutics Market is Forecast to Grow at a CAGR of 8.1% from 2011 to 2018

The liver cancer therapeutics market in the top seven markets (the US, the UK, Germany, France, Spain, Italy and Japan) was estimated at $374.3m in 2011, having grown at a Compound Annual Growth Rate (CAGR) of 21.7% from 2004. Growth was driven by an increase in the patient volume and the Annual Cost of Therapy (ACT) per patient, which was itself due to the approval of Nexavar (sorafenib) in the US and Europe. The market is forecast to reach $644.3m by 2018 at a CAGR of 8.1% from 2011. The anticipated launch of Eli Lillys ramucirumab (IMC-1121B), a monoclonal Antibody (mAb) in 2014; Celsion Corporations ThermoDox in 2014; and PrevOnco in 2015 will drive market growth.

Newer Techniques are Being Studied for Treating Liver Cancer

Hepatocellular Carcinoma (HCC) is usually detected late as symptoms tend to appear in the advanced stages of the disease. As a result, most patients have a poor prognosis. Poor diagnosis measures also affect the patient volume available for HCC treatment. New treatment options have recently been considered for treating HCC, and doctors are looking at advances in different types of neoadjuvant (before surgery) and adjuvant (after surgery) therapies that might help to increase survival rates. Chemotherapy, ablation, embolization and radiation therapy are examples of important types of neoadjuvant therapy.

New drugs are being developed that work differently from standard chemotherapy drugs, by targeting specific parts of cancer cells or their surrounding environment. Nexavar, which works by hindering new blood vessel and thereby tumor growth, is being studied for use in the early stages of cancer. Additionally, a newer approach to treatment is the use of a virus known as JX-594, the same virus that was used to make the smallpox vaccine, but that has been altered so that it infects mainly cancer cells by causing them to die or make proteins that result in them being attacked by the bodys immune system, leaving normal cells unaffected.

Hepatocellular Carcinoma Pipeline has 80 Molecules in Various Phases of Development

Companies and research institutions are actively pursuing R&D activities for HCC treatment, and activity is expected to remain high during the 2011-2018 period. There are currently 80 molecules in various stages of development, of which the majority are in Phase II (25%) and Preclinical (26%). Late-stage molecules (Phase III and Phase II/III) account for 17%, while Phase I/II and Phase I constitute 29%. Discovery constitutes the remaining 3% of the HCC pipeline.

However, in recent late-stage clinical trials (such as BRISK-FL, PS), one of the most promising molecules, Bristol-Myers Squibbs (BMS) brivanib, was announced to be ineffective at meeting its primary endpoint. Additionally, Pfizer discontinued a Phase III study of Sutent (sunitinib malate) for HCC in 2010 due to a high incidence of serious adverse effects and Sutents inability to prove its superiority over Nexavar.

Weak Competition in the Liver Cancer Therapeutics Market

The competitive landscape in the liver cancer therapeutics market is weak with only Miripla (Japan) and Nexavar (US and Europe) being approved for the treatment of HCC. Prior to Nexavars approval in 2007, doxorubicin, cisplatin, 5-fluorouracil, gemcitabine and their combination regimens were the most commonly used off-label chemotherapeutic agents, despite a low response rate in clinical studies and lack of evidence relating to overall survival impact. Although a number of molecules are in late-stage clinical trials, they are not expected to be approved until 2014 and 2015. Bayer and Dainippon Sumitomo Pharma (DSP) are currently the only companies whose products have received approvals.


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