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

Summary

GBI Research, a leading business intelligence provider, has released its latest research report, “Non-Hodgkin Lymphoma Therapeutics in Major Developed Markets to 2020 - New Entrants and Promising Pipeline Widen Targeted and Immunotherapeutic Treatment Options”, which 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 buy

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

Table Of Contents

Non-Hodgkin Lymphoma Therapeutics in Major Developed Markets to 2020 - New Entrants and Promising Pipeline Widen Targeted and Immunotherapeutic Treatment Options
1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 8
1.2 List of Figures 9
2 Introduction 10
2.1 Symptoms 10
2.2 Etiology 11
2.3 Pathophysiology 11
2.4 Diagnosis 12
2.4.1 Biopsy 12
2.4.2 Laboratory molecular tests 12
2.4.3 Imaging tests 13
2.5 Classification 13
2.5.1 B-Cell Lymphomas 14
2.5.2 T-Cell Lymphoma 16
2.6 Epidemiology 17
2.7 Prognosis and Disease Staging 18
2.7.1 Staging 19
2.8 Treatment Options 20
2.8.1 Surgery and Radiation Therapy 20
2.8.2 Stem Cell Transplantation 20
2.8.3 Pharmacological 21
2.8.4 Treatment Algorithms and Prescribing Habits 22
3 Marketed Products 25
3.1 Therapeutic Landscape 25
3.2 Targeted/Immunotherapies 25
3.2.1 Rituxan/Mabthera (rituximab) - Roche 25
3.2.2 Adcetris (Brentuximab vedotin) - Seattle Genetics/Millennium 27
3.2.3 Zevalin (ibritumomab tiuxetan) - Spectrum Pharmaceuticals 29
3.2.4 Revlimid (lenalidomide) - Celgene 29
3.2.5 Velcade (bortezomib) - Millennium/Johnson-Johnson 30
3.2.6 Istodax (romidepsin) - Celgene 32
3.2.7 Zolinza (vorinostat) - Merck 33
3.2.8 Zydelig (idelalisib/GS-1101) - Gilead Sciences 33
3.2.9 Imbruvica (ibrutinib) - Pharmacyclics/Janssen Biotech 34
3.2.10 Beleodaq (belinostat) - Spectrum Pharmaceuticals 35
3.2.11 Poteligeo (mogamulizumab) - Kyowa Hakko Kirin 35
3.3 Chemotherapies/Regimens 36
3.3.1 Pixuvri (pixantrone dimaleate) - CTI BioPharma 36
3.3.2 Treanda (bendamustine) + Rituxan (rituximab) 37
3.3.3 CHOP/R-CHOP 38
3.3.4 CVP/R-CVP 39
3.4 Comparative Efficacy and Safety (Marketed Products) 39
4 Pipeline Products 42
4.1 Overall Pipeline 42
4.2 Pipeline Analysis by Molecule Type 43
4.3 Pipeline Analysis by Mechanism of Action 45
4.4 Clinical Trials 47
4.4.1 Failure Rate 47
4.4.2 Patient Enrollment and Clinical Trial Size 48
4.4.3 Duration 50
4.5 Promising Drug Candidates in the Pipeline 52
4.5.1 BiovaxID (dasiprotimut T) - Biovest International 52
4.5.2 Alisertib (MLN8237) - Millennium Pharmaceuticals 52
4.5.3 Arzerra (ofatumumab) - Genmab/GlaxoSmithKline 53
4.5.4 Gazyva (obinutuzumab) - Roche 54
4.5.5 Afinitor (everolimus) - Novartis 54
4.6 Heat Map of Safety and Efficacy and Product Competitiveness Framework for Non-Hodgkin Lymphoma Pipeline 55
5 Market Forecast to 2020 58
5.1 Geographical Markets 58
5.1.1 Global Market 58
5.1.2 North America 59
5.1.3 Top Five EU Countries 63
5.1.4 Japan 67
5.2 Drivers and Barriers for the Disease Market 70
5.2.1 Drivers 70
5.2.2 Barriers 71
6 Deals and Strategic Consolidations 72
6.1 Major Co-development Deals 75
6.1.1 Roche Signs an Agreement with GlycArt and Genentech 76
6.1.2 Cell Therapeutics Enters Agreement with Bayer 76
6.1.3 Chugai Enters Co-development Agreement with Nippon Shinyaku for GA101 76
6.1.4 GlaxoSmithKline Enters Co-development Agreement with Genmab 76
6.1.5 Biogen Idec Enters Co-development Agreement with Genentech 76
6.1.6 Seattle Genetics Enters Co-development Agreement with Millennium 77
6.2 Major Licensing Deals 77
6.2.1 Spectrum Enters Licensing Agreement with Bayer for Zevalin 78
6.2.2 Janssen Biotech Enters Licensing Agreement with Pharmacyclics for PCI-32765 79
6.2.3 Lundbeck Enters Licensing Agreement with Cephalon 79
6.2.4 TG Therapeutics Enters Licensing Agreement with Ildong for Ublituximab 79
6.2.5 Provenance Enters Licensing Agreement with Merck Serono 79
6.2.6 Cephalon Enters Licensing Agreement with SymBio 79
6.2.7 Genentech Enters Licensing Agreement with Seattle Genetics 80
7 Appendix 81
7.1 Market Definitions 81
7.2 Abbreviations 81
7.3 Bibliography 84
7.4 Pipeline Tables 89
7.4.1 Discovery 89
7.4.2 Preclinical 90
7.4.3 Investigational New Drug-Filed 92
7.4.4 Phase I 93
7.4.5 Phase II 96
7.4.6 Phase III 99
7.5 Market Forecasts to 2020 101
7.5.1 Global 101
7.5.2 US 101
7.5.3 UK 102
7.5.4 France 102
7.5.5 Germany 103
7.5.6 Italy 103
7.5.7 Spain 104
7.5.8 Canada 104
7.5.9 Japan 105
7.6 Research Methodology 105
7.6.1 Coverage 105
7.6.2 Secondary Research 106
7.6.3 Primary Research 106
7.6.4 Therapeutic Landscape 106
7.6.5 Geographical Landscape 108
7.6.6 Pipeline Analysis 109
7.7 Expert Panel Validation 109
7.8 Contact Us 109
7.9 Disclaimer 109

1.1 List of Tables

Table 1: Non-Hodgkin Lymphoma Therapeutics, Most Common Chromosomal Aberrations Associated With NHL 12
Table 2: Non-Hodgkin Lymphoma Therapeutics, International Working Formulation Classification of Lymphoproliferative Diseases, 1981 14
Table 3: Non-Hodgkin Lymphoma Market, Classification of Non-Hodgkin Lymphoma 17
Table 4: Non-Hodgkin Lymphoma Market, Top Five European Countries, Incidence rates (per 100,000), 2012 18
Table 5: Non-Hodgkin Lymphoma Market, International Prognostic Index Good and Poor Prognostic Factors 19
Table 6: Non-Hodgkin Lymphoma Market, Ann Arbor Staging System for Lymphoma, 2013 19
Table 7: Non-Hodgkin Lymphoma Market, Commonly Used Chemo-Regimens 21
Table 8: Non-Hodgkin Lymphoma Market, Dosing Regime of Rituxan for Multiple Sub-types 27
Table 9: Non-Hodgkin Lymphoma Market, Endpoints of Various Chemotherapeutic Regimens (%), 1993 38
Table 10: Non-Hodgkin Lymphoma Market, Efficacy Comparison of R-CHOP vs. CHOP 38
Table 11: Non-Hodgkin Lymphoma Market, Efficacy Comparison of CVP vs. R-CVP, 2005 39
Table 12: Non-Hodgkin Lymphoma Market, Global, Average Clinical Trial Duration (Months) 50
Table 13: Non-Hodgkin Lymphoma Market, Top Five EU Countries, 5-Year Survival Rates (%), 2000-2007 63
Table 14: Non-Hodgkin Lymphoma Market, Global, Deals and Strategic Consolidations, 2006-2014 72
Table 15: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (Discovery), 2014 89
Table 16: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (Preclinical), 2014 90
Table 17: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (IND-filed), 2014 92
Table 18: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (Phase I), 2014 93
Table 19: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (Phase II), 2014 96
Table 20: Non-Hodgkin Lymphoma Market, Global, Pharmaceutical Pipeline (Phase III), 2014 99
Table 21: Non-Hodgkin Lymphoma Market, Global, Market Forecast, 2013-2020 101
Table 22: Non-Hodgkin Lymphoma Market, US, Market Forecast, 2013-2020 101
Table 23: Non-Hodgkin Lymphoma Market, UK, Market Forecast, 2013-2020 102
Table 24: Non-Hodgkin Lymphoma Market, Germany, Market Forecast, 2013-2020 102
Table 25: Non-Hodgkin Lymphoma Market, Germany, Market Forecast, 2013-2020 103
Table 26: Non-Hodgkin Lymphoma Market, Italy, Market Forecast, 2013-2020 103
Table 27: Non-Hodgkin Lymphoma Market, Spain, Market Forecast, 2013-2020 104
Table 28: Non-Hodgkin Lymphoma Market, Canada, Market Forecast, 2013-2020 104
Table 29: Non-Hodgkin Lymphoma Market, Japan, Market Forecast, 2013-2020 105

1.2 List of Figures

Figure 1: Non-Hodgkin Lymphoma Market, Global, Distribution of Prevalence Population (‘000), 2013-2020 18
Figure 2: Non-Hodgkin Lymphoma Market, Treatment Algorithm for Indolent Non-Hodgkin Lymphoma, 2014 23
Figure 3: Non-Hodgkin Lymphoma Market, Treatment Algorithm for Aggressive Non-Hodgkin Lymphoma, 2014 24
Figure 4: Non-Hodgkin Lymphoma Market, Global, Rituxan, Annual Sales ($bn), 2006-2013 26
Figure 5: Non-Hodgkin Lymphoma Market, Global, Adcetris, Annual Sales ($m), 2011-2013 28
Figure 6: Non-Hodgkin Lymphoma Market, Global, Velcade, Annual Sales ($bn), 2007-2013 31
Figure 7: Non-Hodgkin Lymphoma Market, Global, Istodax, Annual Sales ($m), 2010-2013 32
Figure 8: Non-Hodgkin Lymphoma Market, Global, Comparative Safety and Efficacy of Marketed Products (Heat Map), 2014 41
Figure 9: Non-Hodgkin Lymphoma Market, Global, Pipeline by Stage of Development, Program Type and Route of Administration, 2014 43
Figure 10: Non-Hodgkin Lymphoma Market, Global, Pipeline by Molecule Type and Stage of Development, 2014 44
Figure 11: Non-Hodgkin Lymphoma Market, Global, Pipeline by Mechanism of Action, 2014 46
Figure 12: Non-Hodgkin Lymphoma, Global, Pipeline by Mechanism of Action, Molecule Type and Stage of Development (Number), 2014 47
Figure 13: Non-Hodgkin Lymphoma Market, Global, Clinical Trial Failure Rate (%), 2014 48
Figure 14: Non-Hodgkin Lymphoma Market, Global, Clinical Trial Size (Participants), 2014 49
Figure 15: Non-Hodgkin Lymphoma Market, Global, Pipeline Clinical Trial Duration (Months), 2014 51
Figure 16: Non-Hodgkin Lymphoma Market, Global, Comparative Safety and Efficacy of Pipeline Products (Heat Map), 2014 57
Figure 17: Non-Hodgkin Lymphoma Market, Global, Treatment Use Pattern and Market Size, 2013-2020 59
Figure 18: Non-Hodgkin Lymphoma Market, North America, Treatment Use Pattern (‘000), 2013-2020 60
Figure 19: Non-Hodgkin Lymphoma Market, North America, Annual Cost of Therapy ($), 2013-2020 61
Figure 20: Non-Hodgkin Lymphoma Market, North America, Market Size ($m), 2013-2020 63
Figure 21: Non-Hodgkin Lymphoma Market, Top Five EU Countries, Treatment Use Pattern (‘000), 2013-2020 64
Figure 22: Non-Hodgkin Lymphoma Market, Top Five EU Countries, Annual Cost of Therapy ($‘000), 2013-2020 65
Figure 23: Non-Hodgkin Lymphoma Market, Top Five EU Countries, Market Size ($m), 2013-2020 67
Figure 24: Non-Hodgkin Lymphoma Market, Japan, Treatment Use Pattern (‘000), 2013-2020 68
Figure 25: Non-Hodgkin Lymphoma Market, Japan, Annual Cost of Therapy ($‘000), 2013-2020 69
Figure 26: Non-Hodgkin Lymphoma Market, Japan, Market Size ($m), 2013-2020 70
Figure 27: Non-Hodgkin Lymphoma Market, Global Deals by Value, Year and Stage of Development, 2006-2014 73
Figure 28: Non-Hodgkin Lymphoma Market, Global, Deals by Phase, Molecule Type and Mechanism of Action, 2006-2014 74
Figure 29: Non-Hodgkin Lymphoma Market, Global, Co-development Deals by Geography, 2006-2014 75
Figure 30: Non-Hodgkin Lymphoma Market, Global, Licensing Deals by Geography, 2006-2014 78
Figure 31: GBI Research Market Forecasting Model (Example) 108

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