Strong Clinical Pipeline with Several First-in-Class Molecules

Wednesday 18 April 2012, Amsterdam

The “Waldenström’s Macroglobulinemia Therapeutics - Pipeline Assessment and Market Forecasts to 2019” report is an essential source of information and analysis on the global Waldenström’s macroglobulinemia therapeutics market. The report identifies the key trends shaping and driving the global Waldenström’s macroglobulinemia therapeutics market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global Waldenström’s macroglobulinemia therapeutics sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by a team of industry experts.

The Waldenström’s Macroglobulinemia Therapeutics Market is Forecast to Decline Until 2019

The report estimated the global Waldenström’s macroglobulinemia therapeutics market to be worth $201.4m in 2011. From 2006 - 2011, the market grew at a Compound Annual Growth Rate (CAGR) of 4.3%, from $163.3m in 2006 to $201.4m in 2011. However, the Waldenström’s macroglobulinemia therapeutics market is forecast to decline at a CAGR of 2.4% for the next eight years to reach $165.6m by 2019. Key factors likely to impact the market in the future include:

• Lack of molecules in Phase III of development in the pipeline.
• The patents of currently used off-label therapeutic agents such as rituximab are set to expire in 2015 in the US and 2014 in the EU. Similarly, bortezomib will lose its patent in 2017 in the US and 2019 in the EU and thalidomide will lose its patent in 2019 in the EU.

However, Perifosine, a Phase II molecule is expected to be launched in the US in 2019, which could offset the impact of patent expiries in the US.

The Waldenström’s Macroglobulinemia Therapeutics Market has Significant Unmet Need which Offers Scope for New Entrants

At present, the treatment for Waldenström’s macroglobulinemia is dominated by off-label and generic drugs. There is currently no approved agent/regimen for the treatment of Waldenström’s macroglobulinemia. Choice of therapy therefore depends on mode of administration, toxicity and cost to the individual patient. Therefore, single-agent alkylating agents such as cyclophosphamide and chlorambucil, nucleoside analogs such as fludarabine and cladribine, anti CD20 monoclonal antibodies such as rituximab and proteasome inhibitors such as bortezomib are standard choices for primary therapy. These agents have moderate to high efficacy and low safety profiles, which is a significant unmet need for Waldenström’s macroglobulinemia patients. The Waldenström’s macroglobulinemia therapeutics market therefore has high potential for new approved drugs or therapies, as patients are underserved by the existing therapies.

Strong Clinical Pipeline with Several First-in-Class Molecules

This analysis found that the Waldenström’s macroglobulinemia pipeline is strong, with 23 molecules in the different stages of clinical development. The pipeline is dominated by first-in-class molecules with novel mechanisms of action and the promise of distinct advantages over the currently marketed products. These molecules are expected to offer better efficacy and safety profiles.

However, there are no molecules in Phase III of the pipeline, and therefore the market is unlikely to be impacted during the forecast period. The Phase II pipeline comprises promising molecules such as Perfosine (KRX-0401) from AEterna Zentaris Inc. and Panabinostat from Novartis. It is estimated that Perifosine could be launched in the US in around 2019.