subject: Pipeline Insight: Leukemias Underserved Patient Populations Offer Potential For Market Growth [print this page] 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
