Dallas, Texas (PRWEB) September 01, 2014
The B-cell non-Hodgkin’s Lymphoma (NHL) treatment market value will experience moderate growth across six major markets (the US, France, Italy, Germany, Spain and the UK), from $4.59 billion in 2013 to $5.41 billion by 2018.
The competitive landscape in the B-cell NHL markets in the US, France, Italy, Germany, Spain and the UK is poised to undergo a dramatic shift during the forecast period. Disease management of the four largest B-cell NHL indications, which includes Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL), currently revolves around multiple rounds of Rituxan-based chemotherapy. Although patients can achieve durable remissions to induction therapy, those patients who relapse after primary treatment have poor prognosis and high unmet needs. Several promising pipeline agents are set to have a dramatic impact on treatment of these relapsed/refractory patients over the forecast period: Pharmacyclics’/Janssen’s Imbruvica, which was approved for relapsed/refractory MCL patients in November 2013, Gilead’s Zydelig, which was approved for relapsed/refractory FL patients in July 2014, and Roche’s Gazyva, which will launch in 2015.
Key Questions Answered
- How will the launch of Imbruvica and Zydelig impact the treatment landscape of relapsed/refractory MCL and FL patients?
- How will the launch of Gazyva and the subcutaneous formulation of MabThera help Roche protect their hematology franchise from biosimilar rituximab competition in the 5EU?
- The new agents will launch first in one B-cell indication before seeking label expansion into broader NHL patient populations. How will companies expand their hematology candidates beyond their initial approvals?
- Pharmacyclics has set a high pricing bar with a high ACOT for Imbruvica. How will this pricing strategy affect pricing of other pipeline agents, and will this be a barrier to entry in cost-conscious EU markets?
- The new agents address significant unmet needs in the relapsed/refractory NHL population. What remaining opportunity will remain after their launch?
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List of Companies mention in this report:
- Spectrum Pharmaceuticals
- Seattle Genetics
- Imbruvica will gain significant patient share in the relapsed/refractory MCL market before expanding into the r/r FL setting. However, Zydelig’s time-to-market advantage as well as potentially superior clinical profile in FL patients will result in Zydelig maintaining the market lead in these patients.
- There is significant opportunity for the new agents Imbruvica and Zydelig, which are delivered orally and would greatly increase patient convenience in addition to providing superior clinical benefit over chemoimmunotherapy regimens.
- Physicians in the US and 5EU are eager to eventually transition their patients onto chemo-free combination regimens, and the new oral agents in combination with Rituxan or Gazyva have the potential to address this need in the first line.
- The loss of patent protection in 2013 for the gold-standard CD20 antibody MabThera (Rituxan) will have a significant impact on market growth in the 5EU, as biosimilar competition is expected beginning in 2018. By launching the second-generation CD20 antibody Gazyva, as well as a subcutaneous formulation of MabThera that greatly increases patient convenience, Roche will effectively maintain significant NHL patient share over biosimilar competitors in 2018.
- Many relapsed/refractory NHL patients seek treatment in clinical trials, due to the low clinical efficacy conferred by available chemoimmunotherapy regimens after failure of first-line treatment. As the pipeline agents gain approval and enter the market, GlobalData anticipates that trial registration will decrease, contributing to overall market growth in the US and 5EU as more patients opt to receive treatment outside of the clinical trial setting.
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- Overview of B-cell NHL, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines for DLBCL, FL, MZL and MCL.
- Annualized B-cell NHL (including DLBCL. FL. MZL and MCL) therapeutics market revenue, annual cost of therapy and patient share in the first-line and relapsed/refractory setting (as well as consolidation/maintenance for FL patients) forecast from 2013 to 2018.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the B-cell NHL therapeutics market
- Pipeline analysis: The B-cell NHL pipeline is relatively small, but dominated by high profile novel therapies with the potential to be significant game changers.
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