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Non-Hodgkin Lymphoma Therapeutics in Major Developed Markets to 2020

  • ID: 3030120
  • Report
  • Region: Global
  • 109 Pages
  • GBI Research
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New Entrants and Promising Pipeline Widen Targeted and Immunotherapeutic Treatment Options
Summary:

This report provides in-depth insight into the indication. It provides estimates of market size for 2013 along with forecasts until 2020 for the eight major developed markets, which comprises the US, UK, France, Germany, Italy, Spain, Japan and Canada. It also covers disease epidemiology, treatment algorithms, treatment patterns, in-depth analysis of clinical trials including failure rates and pipeline analysis, and analysis of deals relevant to Non-Hodgkin Lymphoma (NHL).

The value of the NHL market is expected to reach $9.2 billion by 2020 from $5.6 billion in 2013 at a modest Compound Annual Growth Rate (CAGR) of 7.4%. The expected launch of promising drugs, including novel small molecule inhibitors and next-generation monoclonal antibodies, as well as the continued use of the current blockbuster, Rituxan/Mabthera (rituximab), will be the key growth drivers. The launch of a premium-priced novel glycol-engineered antibody; obinutuzumab; the personalized vaccine dasiprotimut-T, mTOR inhibitor everolimus, and several kinase inhibitors including idelalisib and ibrutinib (which already gained FDA approval) are expected to have a significant impact on the market size. Additionally, the extension of indications of several already marketed drugs such as Revlimid as a maintenance therapy for DLBCL, Velcade as a front-line therapy for MCL and Adcetris as front-line therapy for CD30 T-cell lymphoma, will fuel the growth during the forecast period.

The emerging treatment challenges in the current treatment landscape (which include, treatment of refractory/relapsed disease and increasing rituximab resistance) are expected to be addressed by the promising NHL pipeline. In spite of a slew of expected approvals the market is set to increase a modest pace due to the patent expiry of the gold-standard therapy during the forecast period.

Scope:

The report analyzes treatment usage patterns, market characterization, the pipeline, and key licensing and co-development deals in the eight major developed markets of the US, UK, France, Germany, Italy, Spain, Japan and Canada. It includes -
- A brief introduction to NHL, including the disease’s pathogenesis, etiology, diagnosis and treatment algorithms
- In-depth analysis of currently marketed drugs for NHL, examining their safety, efficacy, treatment patterns and strengths/weaknesses and including a heat map that compares the drugs in terms of safety and efficacy
- A comprehensive review of the pipeline for NHL, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period; the pipeline is analyzed on the basis of Phase distribution, molecule type, program type, mechanism of action and molecular target
- Additional in-depth analysis of pipeline drug clinical trials by Phase, trial size, trial duration and program failure rate for each molecule type
- Multi-scenario forecast data of the market to 2020, taking into account how the market may be affected by the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets
Discussion of the drivers of and barriers to market growth
- In-depth analysis of all licensing and co-development deals that have occurred in the NHL market since 2006

Reasons to Purchase:

The report will enhance your decision-making capability by allowing you to -
- Understand the NHL pipeline and the factors that indicate that it is becoming more innovative
- Examine detailed profiles of promising pipeline products and gain an insight into how they are likely to compete in the market and who their main competitors will be
- Follow the trends in NHL clinical trial size and duration in relation to industry averages and assess the potential risk of future developmental programs according to mechanism of action by considering the recorded clinical trial failure rates
- Observe the potential growth patterns expected for the NHL market over the forecast period, identify which countries are expected to make the biggest contribution to this growth, and devise a more effective country strategy through an understanding of key drivers and barriers in the NHL market
- Accelerate and strengthen your market position by identifying key companies for strategic partnerships
Note: Product cover images may vary from those shown
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1.1 List of Tables
1.2 List of Figures

2 Introduction
2.1 Symptoms
2.2 Etiology
2.3 Pathophysiology
2.4 Diagnosis
2.4.1 Biopsy
2.4.2 Laboratory molecular tests
2.4.3 Imaging tests
2.5 Classification
2.5.1 B-Cell Lymphomas
2.5.2 T-Cell Lymphoma
2.6 Epidemiology
2.7 Prognosis and Disease Staging
2.7.1 Staging
2.8 Treatment Options
2.8.1 Surgery and Radiation Therapy
2.8.2 Stem Cell Transplantation
2.8.3 Pharmacological
2.8.4 Treatment Algorithms and Prescribing Habits

3 Marketed Products
3.1 Therapeutic Landscape
3.2 Targeted/Immunotherapies
3.2.1 Rituxan/Mabthera (rituximab) – Roche
3.2.2 Adcetris (Brentuximab vedotin) – Seattle Genetics/Millennium
3.2.3 Zevalin (ibritumomab tiuxetan) – Spectrum Pharmaceuticals
3.2.4 Revlimid (lenalidomide) – Celgene
3.2.5 Velcade (bortezomib) – Millennium/Johnson-Johnson
3.2.6 Istodax (romidepsin) – Celgene
3.2.7 Zolinza (vorinostat) – Merck
3.2.8 Zydelig (idelalisib/GS-1101) – Gilead Sciences
3.2.9 Imbruvica (ibrutinib) – Pharmacyclics/Janssen Biotech
3.2.10 Beleodaq (belinostat) – Spectrum Pharmaceuticals
3.2.11 Poteligeo (mogamulizumab) – Kyowa Hakko Kirin
3.3 Chemotherapies/Regimens
3.3.1 Pixuvri (pixantrone dimaleate) – CTI BioPharma
3.3.2 Treanda (bendamustine) + Rituxan (rituximab)
3.3.3 CHOP/R-CHOP
3.3.4 CVP/R-CVP
3.4 Comparative Efficacy and Safety (Marketed Products)

4 Pipeline Products
4.1 Overall Pipeline
4.2 Pipeline Analysis by Molecule Type
4.3 Pipeline Analysis by Mechanism of Action
4.4 Clinical Trials
4.4.1 Failure Rate
4.4.2 Patient Enrollment and Clinical Trial Size
4.4.3 Duration
4.5 Promising Drug Candidates in the Pipeline
4.5.1 BiovaxID (dasiprotimut T) – Biovest International
4.5.2 Alisertib (MLN8237) – Millennium Pharmaceuticals
4.5.3 Arzerra (ofatumumab) – Genmab/GlaxoSmithKline
4.5.4 Gazyva (obinutuzumab) – Roche
4.5.5 Afinitor (everolimus) – Novartis
4.6 Heat Map of Safety and Efficacy and Product Competitiveness Framework for Non-Hodgkin Lymphoma Pipeline

5 Market Forecast to 2020
5.1 Geographical Markets
5.1.1 Global Market
5.1.2 North America
5.1.3 Top Five EU Countries
5.1.4 Japan
5.2 Drivers and Barriers for the Disease Market
5.2.1 Drivers
5.2.2 Barriers

6 Deals and Strategic Consolidations
6.1 Major Co-development Deals
6.1.1 Roche Signs an Agreement with GlycArt and Genentech
6.1.2 Cell Therapeutics Enters Agreement with Bayer
6.1.3 Chugai Enters Co-development Agreement with Nippon Shinyaku for GA101
6.1.4 GlaxoSmithKline Enters Co-development Agreement with Genmab
6.1.5 Biogen Idec Enters Co-development Agreement with Genentech
6.1.6 Seattle Genetics Enters Co-development Agreement with Millennium
6.2 Major Licensing Deals
6.2.1 Spectrum Enters Licensing Agreement with Bayer for Zevalin
6.2.2 Janssen Biotech Enters Licensing Agreement with Pharmacyclics for PCI-32765
6.2.3 Lundbeck Enters Licensing Agreement with Cephalon
6.2.4 TG Therapeutics Enters Licensing Agreement with Ildong for Ublituximab
6.2.5 Provenance Enters Licensing Agreement with Merck Serono
6.2.6 Cephalon Enters Licensing Agreement with SymBio
6.2.7 Genentech Enters Licensing Agreement with Seattle Genetics

7 Appendix
7.1 Market Definitions
7.2 Abbreviations
7.3 Bibliography
7.4 Pipeline Tables
7.4.1 Discovery
7.4.2 Preclinical
7.4.3 Investigational New Drug-Filed
7.4.4 Phase I
7.4.5 Phase II
7.4.6 Phase III
7.5 Market Forecasts to 2020
7.5.1 Global
7.5.2 US
7.5.3 UK
7.5.4 France
7.5.5 Germany
7.5.6 Italy
7.5.7 Spain
7.5.8 Canada
7.5.9 Japan
7.6 Research Methodology
7.6.1 Coverage
7.6.2 Secondary Research
7.6.3 Primary Research
7.6.4 Therapeutic Landscape
7.6.5 Geographical Landscape
7.6.6 Pipeline Analysis
7.7 Expert Panel Validation
7.8 Contact Us
7.9 Disclaimer

1.1 List of Tables
Table 1: Non-Hodgkin Lymphoma Therapeutics, Most Common Chromosomal Aberrations Associated With NHL
Table 2: Non-Hodgkin Lymphoma Therapeutics, International Working Formulation Classification of Lymphoproliferative Diseases, 1981
Table 3: Non-Hodgkin Lymphoma Market, Classification of Non-Hodgkin Lymphoma
Table 4: Non-Hodgkin Lymphoma Market, Top Five European Countries, Incidence rates (per 100,000), 2012
Table 5: Non-Hodgkin Lymphoma Market, International Prognostic Index Good and Poor Prognostic Factors
Table 6: Non-Hodgkin Lymphoma Market, Ann Arbor Staging System for Lymphoma, 2013
Table 7: Non-Hodgkin Lymphoma Market, Commonly Used Chemo-Regimens
Table 8: Non-Hodgkin Lymphoma Market, Dosing Regime of Rituxan for Multiple Sub-types
Table 9: Non-Hodgkin Lymphoma Market, Endpoints of Various Chemotherapeutic Regimens (%), 1993
Table 10: Non-Hodgkin Lymphoma Market, Efficacy Comparison of R-CHOP vs. CHOP
Table 11: Non-Hodgkin Lymphoma Market, Efficacy Comparison of CVP vs. R-CVP, 2005
Table 12: Non-Hodgkin Lymphoma Market, Global, Average Clinical Trial Duration (Months)
Table 13: Non-Hodgkin Lymphoma Market, Top Five EU Countries, 5-Year Survival Rates (%), 2000–2007
Table 14: Non-Hodgkin Lymphoma Market, Global, Deals and Strategic Consolidations, 2006–2014
Table 15: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (Discovery), 2014
Table 16: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (Preclinical), 2014
Table 17: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (IND-filed), 2014
Table 18: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (Phase I), 2014
Table 19: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (Phase II), 2014
Table 20: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (Phase III), 2014
Table 21: Non-Hodgkin Lymphoma Market, Global, Market Forecast, 2013–2020
Table 22: Non-Hodgkin Lymphoma Market, US, Market Forecast, 2013–2020
Table 23: Non-Hodgkin Lymphoma Market, UK, Market Forecast, 2013–2020
Table 24: Non-Hodgkin Lymphoma Market, Germany, Market Forecast, 2013–2020
Table 25: Non-Hodgkin Lymphoma Market, Germany, Market Forecast, 2013–2020
Table 26: Non-Hodgkin Lymphoma Market, Italy, Market Forecast, 2013–2020
Table 27: Non-Hodgkin Lymphoma Market, Spain, Market Forecast, 2013–2020
Table 28: Non-Hodgkin Lymphoma Market, Canada, Market Forecast, 2013–2020
Table 29: Non-Hodgkin Lymphoma Market, Japan, Market Forecast, 2013–2020

1.2 List of Figures
Figure 1: Non-Hodgkin Lymphoma Market, Global, Distribution of Prevalence Population (‘000), 2013–2020
Figure 2: Non-Hodgkin Lymphoma Market, Treatment Algorithm for Indolent Non-Hodgkin Lymphoma, 2014
Figure 3: Non-Hodgkin Lymphoma Market, Treatment Algorithm for Aggressive Non-Hodgkin Lymphoma, 2014
Figure 4: Non-Hodgkin Lymphoma Market, Global, Rituxan, Annual Sales ($bn), 2006–2013
Figure 5: Non-Hodgkin Lymphoma Market, Global, Adcetris, Annual Sales ($m), 2011–2013
Figure 6: Non-Hodgkin Lymphoma Market, Global, Velcade, Annual Sales ($bn), 2007–2013
Figure 7: Non-Hodgkin Lymphoma Market, Global, Istodax, Annual Sales ($m), 2010–2013
Figure 8: Non-Hodgkin Lymphoma Market, Global, Comparative Safety and Efficacy of Marketed Products (Heat Map), 2014
Figure 9: Non-Hodgkin Lymphoma Market, Global, Pipeline by Stage of Development, Program Type and Route of Administration, 2014
Figure 10: Non-Hodgkin Lymphoma Market, Global, Pipeline by Molecule Type and Stage of Development, 2014
Figure 11: Non-Hodgkin Lymphoma Market, Global, Pipeline by Mechanism of Action, 2014
Figure 12: Non-Hodgkin Lymphoma, Global, Pipeline by Mechanism of Action, Molecule Type and Stage of Development (Number), 2014
Figure 13: Non-Hodgkin Lymphoma Market, Global, Clinical Trial Failure Rate (%), 2014
Figure 14: Non-Hodgkin Lymphoma Market, Global, Clinical Trial Size (Participants), 2014
Figure 15: Non-Hodgkin Lymphoma Market, Global, Pipeline Clinical Trial Duration (Months), 2014
Figure 16: Non-Hodgkin Lymphoma Market, Global, Comparative Safety and Efficacy of Pipeline Products (Heat Map), 2014
Figure 17: Non-Hodgkin Lymphoma Market, Global, Treatment Use Pattern and Market Size, 2013–2020
Figure 18: Non-Hodgkin Lymphoma Market, North America, Treatment Use Pattern (‘000), 2013–2020
Figure 19: Non-Hodgkin Lymphoma Market, North America, Annual Cost of Therapy ($), 2013–2020
Figure 20: Non-Hodgkin Lymphoma Market, North America, Market Size ($m), 2013–2020
Figure 21: Non-Hodgkin Lymphoma Market, Top Five EU Countries, Treatment Use Pattern (‘000), 2013–2020
Figure 22: Non-Hodgkin Lymphoma Market, Top Five EU Countries, Annual Cost of Therapy ($‘000), 2013–2020
Figure 23: Non-Hodgkin Lymphoma Market, Top Five EU Countries, Market Size ($m), 2013–2020
Figure 24: Non-Hodgkin Lymphoma Market, Japan, Treatment Use Pattern (‘000), 2013–2020
Figure 25: Non-Hodgkin Lymphoma Market, Japan, Annual Cost of Therapy ($‘000), 2013–2020
Figure 26: Non-Hodgkin Lymphoma Market, Japan, Market Size ($m), 2013–2020
Figure 27: Non-Hodgkin Lymphoma Market, Global Deals by Value, Year and Stage of Development, 2006–2014
Figure 28: Non-Hodgkin Lymphoma Market, Global, Deals by Phase, Molecule Type and Mechanism of Action, 2006–2014
Figure 29: Non-Hodgkin Lymphoma Market, Global, Co-development Deals by Geography, 2006–2014
Figure 30: Non-Hodgkin Lymphoma Market, Global, Licensing Deals by Geography, 2006–2014
Figure 31: Market Forecasting Model (Example)
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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.
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