Pipeline Insight: Leukemias Underserved Patient Populations Offer Potential For Market Growth
Introduction
Introduction
Despite major advances in treatment in the last decade, a considerable percentage of the leukemia population still has high unmet needs. Some key oncology companies have entered the leukemias market fairly recently while others are pursuing late-phase development in this indication, hoping to exploit the commercial potential of patient subgroups underserved by existing treatment options.
Scope
*Forecast sales of the drugs in late-phase development for leukemia in the seven major markets over the period 2010 to 2019
*In-depth analysis for all leukemia drugs in late-phase development, including trial data, SWOT analysis and clinical and commercial potential
*Segmentation and analysis of the leukemia pipeline by developmental phase, class and indication
*Insight and analysis of leukemia market potential including epidemiology, patient segmentation, unmet needs and target product profiles
Highlights
Despite high cure rates in some forms of leukemia, certain groups of patients still have high unmet needs. Drug developers are targeting increasingly defined subsets of patients with high unmet need in order to establish a market for their products. Examples include elderly patients and patients with certain genetic characteristics.
Chronic lymphocytic leukemia (CLL) offers the greatest potential. Datamonitor forecasts the three drugs in late-phase development to achieve total sales of $938m in 2019. This stems from the large size of the target patient populations and a lack of effective treatment options in these patient subgroups, which will drive high market penetration.
A number of late-phase drugs will have a notable impact on the leukemia market as they go some way towards addressing some of the remaining unmet needs. These agents include Revlimid (lenalidomide; Celgene), RG7159 (obinutuzumab; Glycart/Roche/Genentech/Biogen Idec/Chugai) and bosutinib (PF-5208763; Pfizer).
Reasons to Purchase
*Justify go/no-go decisions on the basis of potential return on investment
*Identifying licensing opportunities based on company portfolio and market needs
*Use product profiles to aid pricing and reimbursement decisions
Table of Contents :
"Overview 1
Catalyst 1
Summary 1
ABOUT HEALTHCARE 2
About the Oncology pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
insight into the disease market 3
Contributing experts 5
Related reports 5
Upcoming related reports 5
Table of Contents 6
1. Pipeline Overview and Dynamics 7
Key findings 7
Pipeline overview 8
Pipeline summary 8
Acute myeloid leukemia is the form of leukemia most targeted by drug developers 9
Targeted therapies account for over half of leukemia drugs in clinical development 11
Comparative forecasts 12
Drugs in late-phase development for leukemias will achieve combined sales of $1.9 billion by 2019 12
Key companies involved in the leukemias pipeline 14
Novartis 14
Roche 15
Key R&D company strategies 16
Drug developers are targeting increasingly defined subsets of patients 16
2. R&D Approach 17
Key findings 17
Clinical trial design in leukemia 17
Patient selection 17
Increasingly significant in the era of targeted treatment 17
Clinical trial duration 18
Sufficient follow-up is necessary to establish true clinical benefit 18
The advent of novel therapies 18
Diversity of targeted therapies will require an evolution in clinical trial design 18
Clinical trial endpoints in leukemia 18
Most oncology clinical trials designate multiple endpoints 18
Survival 19
Quality of life 19
Response rates 19
Toxicity 19
Time to progression 19
3. Acute lymphoblastic leukemia 21
Key findings 21
Disease overview - market potential 22
Definition of acute lymphoblastic leukemia (ALL) 22
ALL is a group of disorders that result from aberrant proliferation and differentiation of lymphoblasts 22
Genetic alterations provide insight into the pathogenesis of ALL 22
Non-specific syndromes are common in ALL 23
Patient segmentation 23
The classification of ALL is still evolving 23
Patients are stratified according to risk 24
Response to therapy: minimal residual disease is a critical prognostic factor 25
Epidemiology 25
Incidence of ALL will reach over 11,000 in the seven major markets by 2019 25
Current treatment options 27
Remission-induction 31
Consolidation treatment 32
Maintenance treatment 32
Current comparator therapies 33
Unmet need in ALL 33
More effective therapies are required for adult ALL, particularly for relapse 33
Philadelphia chromosome-positive patients remain a patient subset with high unmet need despite new therapies 34
More research is needed for elderly ALL patients 34
Prognostic markers are required for risk-adapted therapeutic strategies 35
Target product profiles versus current level of attainment 35
Induction therapy 35
Relapse therapy 36
Pipeline analysis and forecasts 38
Pipeline summary 38
Comparative forecasts 40
Graspa (erythrocyte-encapsulated L-asparaginase; ERYtech) 42
Drug overview 42
Drug profile 42
Key historical events 43
Clinical trial data 43
Phase II data suggest that Graspa is better tolerated than native L-asparaginase, while inducing similar asparagine depletion 44
SWOT analysis 45
Clinical and commercial attractiveness 45
Limited evidence of clinical efficacy makes it difficult to comment on Graspa's clinical potential 45
A favorable toxicity profile alone may not be sufficient for Graspa to capture significant market share 45
Forecasts to 2019 46
Marqibo (liposomal vincristine; Hana Biosciences) 47
Drug overview 47
Drug profile 47
Key historical events 48
Clinical trial data 49
Marqibo shows promising evidence of efficacy in heavily pretreated ALL 50
SWOT analysis 52
drug assessment summary for Marqibo 53
Clinical and commercial attractiveness 53
Marqibo will only partially address the need for more effective salvage regimens in ALL 53
Data from a small single-arm study may be insufficient to support approval and drive uptake of Marqibo 54
Forecasts to 2019 54
Rituxan/MabThera (rituximab; Biogen Idec/Roche/Genentech/Zenyaku Kogyo/Chugai) 55
Drug overview 55
Drug profile 56
Key historical events 57
Clinical trial data 58
Rituxan/MabThera plus HyperCVAD shows promising evidence of efficacy in younger patients with CD20-positive ALL 58
Rituxan/MabThera plus HyperCVAD also shows promising efficacy in Burkitt-type ALL, particularly in elderly patients 59
SWOT analysis 61
drug assessment summary for Rituxan 62
Clinical and commercial attractiveness 62
Phase II data point to Rituxan/MabThera's promising potential in ALL, but provoke several questions 62
The use of Rituxan/MabThera in ALL may remain off-label for the foreseeable future 63
Forecasts to 2019 64
4. Acute myeloid leukemia 65
Key findings 65
Disease overview - market potential 66
Definition of acute myeloid leukemia (AML) 66
AML is a disease of older age 66
Symptoms can vary for AML patients 66
Patient segmentation 66
Two classification systems are used in AML 66
Cytogenetics is the most important prognostic factor 67
Age is a major determinant of survival 68
Secondary AML patients have particularly poor prognosis 69
Epidemiology 69
Incidence of AML will reach over 31,000 in the seven major markets by 2019, driven by population aging 69
Current treatment options 71
Induction treatment 73
Post-induction treatment 73
Consolidation treatment 74
Relapse treatment 74
Current comparator therapies 74
Unmet need in AML 75
More effective and tolerable therapies are required for AML, particularly in older patients 75
HSCT remains an underutilized procedure 76
Molecular markers may help improve risk-adapted therapeutic strategies 76
Target product profiles versus current level of attainment 76
Induction therapy 77
Consolidation therapy 77
Relapse therapy 78
Pipeline analysis and forecasts 80
Pipeline summary 80
Comparative forecasts 81
AS1413 (amonafide; Antisoma) 85
Drug overview 85
Drug profile 85
Key historical events 86
Clinical trial data 87
Antisoma has amended the primary endpoint in AS1413's pivotal Phase III study 87
Phase II study shows encouraging evidence of activity in secondary AML 88
SWOT analysis 89
drug assessment summary for AS1413 90
Clinical and commercial attractiveness 90
AS1413 has the potential to address unmet need in a difficult-to-treat patient population 90
AS1413's potential in the wider AML population is uncertain 91
Forecasts to 2019 91
Clolar/Evoltra (clofarabine; Genzyme) 92
Drug overview 92
Drug profile 93
Key historical events 94
Clinical trial data 95
Phase II data in newly diagnosed elderly AML insufficient to support label extension for Clolar 97
Phase II data show potential of Clolar in combination with low-dose cytarabine 98
SWOT analysis 99
drug assessment summary for Clolar/Evoltra 100
Clinical and commercial attractiveness 100
Clolar's unsuccessful bid for accelerated approval in AML is a double blow to Genzyme 100
Clolar could receive off-label use in the absence of label expansion 101
Forecasts to 2019 102
Dacogen (decitabine; Eisai) 103
Drug overview 103
Drug profile 104
Key historical events 105
Clinical trial data 106
Dacogen has shown promising evidence of efficacy in previously untreated elderly AML patients 107
SWOT analysis 109
drug assessment summary for Dacogen 110
Clinical and commercial attractiveness 110
Dacogen's low toxicity could be a major driver of uptake 110
Vidaza will be Dacogen's principal competitor in the AML market 111
Forecasts to 2019 112
Midostaurin (PKC412; Novartis) 113
Drug overview 113
Drug profile 113
Key historical events 114
Clinical trial data 115
For more information, please visit :
www.aarkstore.com/reports/Pipeline-Insight-Leukemias-Underserved-patient-populations-offer-potential-for-market-growth-45093.html
by: Aarkstore Enterprise
Aarkstore Enterprise--pet Supplies And Pet Care Products Market Research Aggregator The Future Of Payment Card Loyalty - Market Research Reports On Aarkstore Enterprise HTC Wildfire Deals: the wildest handset Available in the market Aarkstore Enterprise - Enzo Biochem Swot Profile - Market Research Anxiety 2 Rest Scam Outsource Your Article Marketing Celebrity Cookie Diet Scam Diabetes Care Devices Market In Brazil, Russia, India & China (bric) Impact Of Tax Amnesties On Offshore Fs - Market Research Reports On Aarkstore Enterprise Aarkstore Enterprise--pet Supplies,pet Care Products,u.s.market, Global Perspective Aarkstore Enterprise - Imugene Limited Swot Profile - Market Research Foreclosure Guide Site Scam Mint money with Marketing Jobs
Pipeline Insight: Leukemias Underserved Patient Populations Offer Potential For Market Growth Anaheim