Non-Hodgkin Lymphoma Therapeutics in Major Developed Markets to 2020 - New Entrants and Promising Pipeline Widen Targeted and Immunotherapeutic Treatment Options, New Report Launched

Non-Hodgkin Lymphoma Therapeutics Market to Witness Modest Growth over Forecast Period

The approval of Rituxan (rituximab) has caused the size of the Non-Hodgkin Lymphoma (NHL) market to increase dramatically over the last two decades. This growth is expected to continue at a moderate pace during the forecast period, from $5.6 billion in 2013 culminating in revenues of $9.2 billion by 2020, at a Compound Annual Growth Rate (CAGR) of 7.4%, in the major developed markets. In 2013, the major share of the global NHL market was attributed to by the US, representing 53% of the overall NHL market and this dominance is expected to be retained throughout the forecast period.

The increasing uptake of new targeted therapies, especially novel small molecule inhibitors in the relapsed and refractory setting, along with the dominant usage of Rituxan is expected to fuel market growth in all the major developed markets. The expected launches of premium-priced novel antibodies and small molecule inhibitors, especially protein kinase inhibitors, targeting both indolent and aggressive sub-types of NHLs will widen the treatment population eligible for novel targeted and immunotherapies. The anticipated approval of promising pipeline drug candidates, Roche’s obinutuzumab, Novartis’ Afinitor (everolimus), Takeda’s alisertib and Biovest’s BiovaxID (dasiprotimut T) and GlaxoSmithKline’s Arzerra (ofatumumab) for various NHL subtypes is a key driver for the steady increase in NHL market size. Despite of a flurry of expected launches, the growth in market is not anticipated to grow rapidly, particularly due to loss of patent exclusivity of Rituxan during the forecast period.

Recently Launched Targeted and Immunotherapies has Widened Treatment Alternatives for Specific Sub-types

Over the past two decades, significant progress has been made in the development of new therapies for NHL. Perhaps the most important milestone is the addition of Rituxan, approved by the US Food and Drug Administration (FDA) for relapsed or refractory Cluster of Differentiation (CD) 20-positive B-cell lymphoma in 1997. Following the approval of Rituxan in 1997, the US FDA approved five other monoclonal Antibodies (mAbs): Campath (alemtuzumab) in 2001, Bexxar (tositumomab) in 2003, Zevalin (ibritumomab tiuxetan) in 2002, Arzerra in 2009, and Adcetris (brentuximab vedotin) in 2011. Another novel mAb, mogamulizumab, which is still in Phase III clinical trials in the US, has already gained approval in Japan. The majority of these drugs are approved for the treatment of specific NHL sub-types.

As the availability of safe and effective mAbs has markedly altered treatment strategies for patients with NHL and specific modifications to these have led to the development of highly effective drugs, including radioimmunotherapies such as Bexxar and Zevalin, which provide the dual benefit of radiation and targeted immunotherapy. Another interesting modification is the development of Antibody-Drug Conjugates (ADC), which include Adcetris, a mAb that is linked to an anti-cancer drug.

Significant improvement has also occurred in the development of small molecule targeted therapies, which act by inhibiting or modulating specific receptors, proteins or deregulated pathways that are related to tumors. These include a range of categories, including Histone Deacetylase (HDAC) inhibitors, proteasome inhibitors, novel Bruton's Tyrosine Kinase (BTK) inhibitors and Phosphoinositide 3-Kinase (PI3K) inhibitors, to name a few.

The launch of these targeted and highly effective immunotherapies has altered the treatment choices for patients with NHL sub-types to a significant extent. The NHL sub-type Mantle Cell Lymphoma (MCL), which was generally treated only with traditional chemo-regimens, with or without Rituxan, can now be treated with Revlimid (lenalidomide), Velcade (bortezomib) and Zevalin as treatment alternatives, while Adcetris has been approved for systemic Anaplastic Large Cell Lymphoma (sALCL), and Istodax (romidepsin), Zolinza (vorinostat), Campath (alemtuzumab) and Poteligeo (mogamulizumab) have been approved for treating Cutaneous T-Cell Lymphoma CTCL. Similarly the new chemo entrant Pixuvri (pixantrone) is a novel option for aggressive B-cell NHL patients that have relapsed after multiple rounds of previous chemotherapy or are not responding to other treatments. Despite these advances, relapsed and refractory NHL and increasing Rituxan resistance are still major treatment challenges for NHL.

Robust Pipeline with Promising Late-Stage Molecules to Cater for Unmet Need

Despite the significant improvements to the NHL treatment landscape, a substantial unmet need for new therapies still exists, especially for patients with relapsed NHL, which represent a large part of the diseased population that is currently under-served. Rituxan resistance is a growing concern for patients that rely on this treatment. The highly active NHL pipeline has the potential to satisfy the unmet needs in this segment to a considerable extent.

The pipeline for NHL is very strong, with a total of 339 active pipeline molecules in development, as either monotherapies or combination therapies. The majority of these pipeline candidates are for the treatment of advanced stage disease, either as front-line therapies or for relapsed or refractory NHLs. Only a few of these promising pipeline molecules are likely to gain a market share, and only a few have the potential to increase the treatment population.

The pipeline drug candidates are diverse and include novel mAbs (including next-generation anti-CD20 mAbs and non-anti-CD20 mAbs), ADCs, radioimmunotherapies, small-molecule inhibitors that target cell survival and growth pathways, mammalian Target Of Rapamycin (mTOR) inhibitors, and HDAC inhibitors. Many of these therapies have shown considerable promise, providing significant response rates in NHL patients.

Spanning over 109 pages, “Non-Hodgkin Lymphoma Therapeutics in Major Developed Markets to 2020 - New Entrants and Promising Pipeline Widen Targeted and Immunotherapeutic Treatment Options” report covering the Introduction, Marketed Products, Pipeline Products, Market Forecast to 2020, Deals and Strategic Consolidations, Appendix.

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