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  5. > Acute Lymphocytic/Lymphoblastic Leukemia Therapeutics Market – (Pipeline Forecast & Market Forecast in G8 Countries) (2011 – 2020)

The acute lymphocytic/lymphoblastic leukemia therapeutics market has growth potential as the incidence rate of the disease is increasing all over the globe. The incidence of acute lymphocytic/lymphoblastic leukemia is higher in children from 0 to 14 years than in those aged 15 years and above. However, acute lymphocytic/lymphoblastic leukemia may also occur in adults. The acute lymphocytic/lymphoblastic leukemia market is segmented into two types—childhood acute lymphocytic/lymphoblastic leukemia and adult acute lymphocytic/lymphoblastic leukemia.

The acute lymphocytic/lymphoblastic leukemia therapeutics market primarily covers regimens and drugs (patented, off-patent, and pipeline). The growing acute lymphocytic/lymphoblastic leukemia population is an impetus for the growth of the market. This market is expected to grow at a CAGR of 4.0% from 2015 to 2020. In 2012, the overall ALL therapeutics market was dominated by Linker regimen, Hyper-CVAD regimen, and Nucleoside metabolic inhibitors treatments. However, by 2020, the overall share of these drugs and regimens will be largely impacted by the launch of Graspa (ERYtechPharma), an innovative form of L-Asparaginase, followed by Marqibo (Talon Therapeutics) and Inotuzumab Ozogamicin (Pfizer, Inc.).

In contrast to the growth of the market, the cost of the therapies is majorly restraining the acute lymphocytic/lymphoblastic leukemia therapeutics market. In addition, patent expirations of some of the existing drugs in the market are also expected to limit the market growth during 2013 to 2020.

Market players are implementing various growth strategies in the market to gain a competitive edge. New product launches, product pipelines, agreements and collaborations, clinical trials, and acquisitions were some of the major strategies adopted by the players from January 2008 to November 2013.

Scope of the report:

This research report categorizes the acute lymphocytic/lymphoblastic leukemia market in G8 countries into the following segments:

Acute Lymphocytic/Lymphoblastic Leukemia Market, by Drug

Existing Regimens/Drugs
Hyper-CVAD Regimen
CALGB 8811 Regimen
Linker Regimen
Nucleoside Metabolic Inhibitors (Clolar and Nelarabine)
Oncaspar
Pipeline Drugs (Phase III)
Graspa
Marqibo
Inotuzumab Ozogamicin

Acute Lymphocytic/Lymphoblastic Leukemia Market, by Geography

North America
U.S.
Canada
Europe
Germany
France
Italy
Spain
U.K.
Japan

Table Of Contents

Acute Lymphocytic/Lymphoblastic Leukemia Therapeutics Market - (Pipeline Forecast and Market Forecast in G8 Countries) (2011 - 2020)
1 INTRODUCTION 16

1.1 OBJECTIVES OF THE STUDY 16
1.2 REPORT DESCRIPTION 17
1.3 MARKETS COVERED 18
1.4 STAKEHOLDERS 19
1.5 RESEARCH METHODOLOGY 19
1.5.1 MARKET SIZE ESTIMATION AND DATA TRIANGULATION 20
1.5.2 MARKET ESTIMATION MODEL 23
1.5.3 KEY DATA POINTS TAKEN FROM SECONDARY SOURCES 23
1.5.4 ASSUMPTIONS MADE FOR THIS REPORT 24

2 EXECUTIVE SUMMARY 31

3 MARKET OVERVIEW 36

3.1 DEFINING LEUKEMIA 37
3.2 ACUTE LYMPHOCYTIC LEUKEMIA 39
3.2.1 RISK FACTORS 40
3.2.2 STAGES/RISK GROUPS OF ACUTE LYMPHOCYTIC LEUKEMIA 40
3.2.2.1 Childhood ALL 41
3.2.2.1.1 Standard (low) risk 41
3.2.2.1.2 High risk 42
3.2.2.1.3 Recurrent 42
3.2.2.2 Adult ALL 42
3.2.2.2.1 Untreated adult ALL 42
3.2.2.2.2 Adult ALL in remission 42
3.2.2.2.3 Recurrent adult ALL 42
3.2.3 DIAGNOSIS 43
3.2.3.1 Biopsy and Bone Marrow Aspiration 43
3.2.3.2 Complete Blood Count (CBC) and Differential 44
3.2.3.3 Presence of Philadelphia Chromosome 44
3.2.3.4 Spinal Tap (Lumbar Puncture) and Cerebrospinal Fluid (CSF) Analysis 45
3.2.3.5 Immunophenotyping or Phenotyping by Flow Cytometry 45
3.2.3.6 Polymerase Chain Reaction (PCR) 45
3.2.4 LEUKEMIA PREVALENCE 46
3.2.5 INCIDENCE and MORTALITY 46
3.3 MARKET STRUCTURE 47
3.3.1 KEY THERAPIES 47
3.3.1.1 Chemotherapy 47
3.3.1.2 Stem Cell/Bone Marrow Transplant 48
3.3.1.3 Radiation Therapy 48

4 ACUTE LYMPHOCYTIC LEUKEMIA MARKET DYNAMICS 49

4.1 MARKET OVERVIEW 50
4.2 MARKET DYNAMICS 52
4.2.1 MARKET DRIVERS 52
4.2.1.1 Innovative Therapies to Drive the Market for Acute Lymphocytic Leukemia 52
4.2.1.2 Oncology is the Largest Therapeutic Market with High Unmet Needs 52
4.2.2 MARKET RESTRAINTS 54
4.2.2.1 Costs Associated with the Treatment 54
4.2.2.2 Adverse Events of Treatment 54
4.2.2.3 Low Production Capability of Drugs 55
4.2.2.4 Genericiazation of the Major Drugs 55
4.2.3 MARKET OPPORTUNITIES 56
4.2.3.1 Limited Players in the Market 56
4.2.3.2 Leukemia's Underserved Patient Populations offer Potential for Market Growth 56
4.3 BURNING ISSUES 56
4.4 WINNING IMPERATIVES 57
4.4.1 MARKET EXPANSION THROUGH MULTIPLE THERAPEUTIC APPROACHES 57

5 LEUKEMIA PRODUCT MARKET 59

5.1 MARKET OVERVIEW 60
5.1.1 HYPER-CVAD REGIMEN 63
5.1.2 CALGB 8811 REGIMEN 65
5.1.3 LINKER REGIMEN 66
5.1.4 NUCLEOSIDE METABOLIC INHIBITORS
(CLOLAR + ARRANON) 68
5.1.5 ONCASPAR 71

6 ACUTE LYMPHOCYTIC LEUKEMIA PIPELINE MOLECULES
(PHASE III) 73

6.1 INTRODUCTION 74
6.1.1 GRASPA 74
6.1.2 MARQIBO 77
6.1.3 INOTUZUMAB OZOGAMICIN 79

7 GEOGRAPHIC ANALYSIS 81

7.1 INTRODUCTION 82
7.2 U.S. 83
7.3 CANADA 88
7.4 U.K. 94
7.5 GERMANY 99
7.6 France 104
7.7 ITALY 109
7.8 SPAIN 114
7.9 JAPAN 120

8 COMPANY PROFILES 126
(Overview, Financials, Products Portfolio, Growth Strategy, and Developments)*

8.1 ERYTECH PHARMA 126
8.2 GENZYME CORPORATION 131
8.3 TALON THERAPEUTICS, INC.
(SPECTRUM PHARMACEUTICALS, INC.) 134
8.4 SIGMA-TAU PHARMACEUTICALS, INC. 138
8.5 PFIZER INC 142
8.6 GLAXOSMITHKLINE PLC 145
*Details on Financials, Products Portfolio, Growth Strategy, and Developments might not
be captured in case of unlisted companies.
COMPETETIVE DEVELOPMENTS (2008 - 2013) 148
ACQUISITIONS/COLLABORATIONS/PARTNERSHIPS/ AGREEMENTS/JOINT VENTURES, 2008 - 2013 148
NEW PRODUCT LAUNCHES, 2008 - 2013 151
EXPANSIONS/NEW FACILITIES/INVESTMENTS,
2008 - 2013 152
APPROVALS, 2008 - 2013 152
DEVELOPMENTS RELATED TO CLINICAL TRIALS,
2008 - 2013 154
OTHER DEVELOPMENTS, 2008 - 2013 156

LIST OF TABLES

TABLE 1 YEARLY COST OF DRUGS IN NORTH AMERICA and JAPAN, 2013 ($) 26
TABLE 2 YEARLY COST OF DRUGS IN EUROPEAN COUNTRIES, 2013 ($) 27
TABLE 3 DOSAGE PATTERN OF ALL DRUGS 28
TABLE 4 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS: PATENT STATUS 50
TABLE 5 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS: MARKET REVENUE, BY TYPE, 2011 - 2020 ($MILLION) 51
TABLE 6 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS/REGIMENS MARKET REVENUE, 2011 - 2020 ($MILLION) 61
TABLE 7 ACUTE LYMPHOCYTIC LEUKEMIA REGIMEN (HYPER-CVAD) MARKET REVENUE, BY COUNTRY, 2011 - 2020 ($MILLION) 64
TABLE 8 ACUTE LYMPHOCYTIC LEUKEMIA REGIMEN (CALGB 8811) MARKET REVENUE, BY COUNTRY, 2011 - 2020 ($MILLION) 66
TABLE 9 ACUTE LYMPHOCYITC LEUKEMIA DRUGS (LINKER REGIMEN) MARKET REVENUE, BY COUNTRY, 2011 - 2020 ($MILLION) 67
TABLE 10 ACUTE LYMPHOCYTIC LEUKEMIA DRUG CLASS (NUCLEOSIDE METABOLIC INHIBITORS) MARKET REVENUE, BY COUNTRY,
2011 - 2020 ($MILLION) 70
TABLE 11 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS (ONCASPAR) MARKET REVENUE, BY COUNTRY, 2011 - 2020 ($MILLION) 72
TABLE 12 PRODUCT PIPELINE MOLECULES: PHASE III FOR ACUTE LYMPHOCYTIC LEUKEMIA 74
TABLE 13 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS - PIPELINE (GRASPA): MARKET REVENUE, BY COUNTRY, 2015 - 2020 ($MILLION) 76
TABLE 14 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS - PIPELINE (MARQIBO): MARKET REVENUE, BY COUNTRY, 2013 - 2020 ($MILLION) 78
TABLE 15 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS - PIPELINE (INOTUZUMAB OZOGAMICIN): MARKET REVENUE, BY COUNTRY,
2015 - 2020 ($MILLION) 80
TABLE 16 ACUTE LYMPHOCYTIC LEUKEMIA MARKET IN G8 COUNTRIES,
BY GEOGRAPHY, 2011 - 2020 ($MILLION) 82
TABLE 17 U.S.: ACUTE LYMPHOCYTIC LEUKEMIA EPIDEMIOLOGY, 2011 - 2020 83
TABLE 18 U.S.: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/DRUGS MARKET REVENUE, 2011 - 2020 ($MILLION) 84
TABLE 19 U.S.: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET REVENUE, 2012 - 2020 ($MILLION) 86
TABLE 20 CANADA: ACUTE LYMPHOCYTIC LEUKEMIA EPIDEMIOLOGY,
2011 - 2020 89
TABLE 21 CANADA: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/DRUGS MARKET REVENUE, 2011 - 2020 ($MILLION) 90
TABLE 22 CANADA: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET REVENUE, 2012 - 2020 ($MILLION) 92
TABLE 23 U.K.: ACUTE LYMPHOCYTIC LEUKEMIA EPIDEMIOLOGY, 2011 - 2020 94
TABLE 24 U.K.: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/DRUGS MARKET REVENUE, 2011 - 2020 ($MILLION) 95
TABLE 25 U.K.: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET REVENUE, 2012 - 2020 ($MILLION) 97
TABLE 26 GERMANY: ACUTE LYMPHOCYTIC LEUKEMIA EPIDEMIOLOGY,
2011 - 2020 99
TABLE 27 GERMANY: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/ DRUGS MARKET REVENUE, 2011 - 2020 ($MILLION) 100
TABLE 28 GERMANY: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET REVENUE, 2012 - 2020 ($MILLION) 102
TABLE 29 France: ACUTE LYMPHOCYTIC LEUKEMIA EPIDEMIOLOGY, 2011 - 2020 104
TABLE 30 France: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMEN/ DRUGS MARKET REVENUE, 2011 - 2020 ($MILLION) 105
TABLE 31 France: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET REVENUE, 2012 - 2020 ($MILLION) 107
TABLE 32 ITALY: ACUTE LYMPHOCYTIC LEUKEMIA EPIDEMIOLOGY, 2011 - 2020 109
TABLE 33 ITALY: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/DRUGS MARKET REVENUE, 2011 - 2020 ($MILLION) 110
TABLE 34 ITALY: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET REVENUE, 2011 - 2020 ($MILLION) 112
TABLE 35 ITALY: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET SHARE, 2015 VS. 2020 113
TABLE 36 SPAIN: ACUTE LYMPHOCYTIC LEUKEMIA EPIDEMIOLOGY, 2011 - 2020 115
TABLE 37 SPAIN: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/ DRUGS MARKET REVENUE, 2011 - 2020 ($MILLION) 116
TABLE 38 SPAIN: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET REVENUE, 2012 - 2020 ($MILLION) 118
TABLE 39 JAPAN: ACUTE LYMPHOCYTIC LEUKEMIA EPIDEMIOLOGY, 2011 - 2020 121
TABLE 40 JAPAN: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/ DRUGS MARKET REVENUE, 2011 - 2020 ($MILLION) 122
TABLE 41 JAPAN: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET REVENUE, 2011 - 2020 ($MILLION) 124
TABLE 42 ERYTECH PHARMA: PRODUCT PIPELINE 127
TABLE 43 ERYTECH: TOTAL OPERATING REVENUE AND RandD EXPENDITURE,
2010 - 2012 ($MILLION) 128
TABLE 44 GENZYME CORPORATION: PRODUCT PORTFOLIO 132
TABLE 45 GENZYME CORPORATION: TOTAL REVENUE AND RandD EXPENDITURE, 2008 - 2010 ($MILLION) 132
TABLE 46 TALON THERAPEUTICS, INC.: PIPELINE PRODUCT PORTFOLIO 135
TABLE 47 TALON THERAPEUTICS, INC.: TOTAL RandD EXPENDITURE,
2008 - 2012 ($MILLION) 136
TABLE 48 SIGMA - TAU GROUP: TOTAL REVENUE, 2008 - 2012 ($MILLION) 139
TABLE 49 PFIZER, INC.: TOTAL REVENUE AND RandD EXPENDITURE,
2008 - 2012 ($MILLION) 143
TABLE 50 GALXOSMITHKLINE PLC: TOTAL REVENUE and RandD EXPENSES,
2008 - 2012 ($MILLION) 146

LIST OF FIGURES

FIGURE 1 ACUTE LYMPHOCYTIC LEUKEMIA MARKET IN G8 COUNTRIES,
BY EXISTING REGIMENS/DRUGS ($MILLION) 32
FIGURE 2 ACUTE LYMPHOCYTIC LEUKEMIA MARKET IN G8 COUNTRIES,
BY PRODUCT PIPELINE ($MILLION) 33
FIGURE 3 STATUS OF ACUTE LYMPHOCYTIC LEUKEMIA PRODUCT PIPELINE 34
FIGURE 4 ACUTE LYMPHOCYTIC LEUKEMIA MARKET, BY COUNTRY 35
FIGURE 5 MOST COMMON TYPES OF LEUKEMIA 37
FIGURE 6 TOTAL LEUKEMIA POPULATION, BY COUNTRY, 2008 - 2020 38
FIGURE 7 ACUTE LYMPHOCYTIC LEUKEMIA: AGE AT DIAGNOSIS 39
FIGURE 8 STAGES AND PHASES OF ACUTE LYMPHOCYTIC LEUKEMIA 41
FIGURE 9 ACUTE LYMPHOCYTIC LEUKEMIA: POPULATION, BY COUNTRY,
2008 - 2020 43
FIGURE 10 MARKET REVENUE, BY TOP 10 THERAPEUTIC CLASS ($BILLION) 53
FIGURE 11 ERYTECH AND TALON: PRODUCT PIPELINE 57
FIGURE 12 ACUTE LYMPHOCYTIC LEUKEMIA EXISTING REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2013 VS 2015 VS 2020 62
FIGURE 13 ACUTE LYMPHOCYTIC LEUKEMIA PIPELINE REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2015 VS 2020 63
FIGURE 14 U.S.: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/DRUGS MARKET SHARE, 2013 VS. 2015 VS. 2020 ($MILLION) 85
FIGURE 15 U.S: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET SHARE, 2015 VS. 2020 87
FIGURE 16 CANADA: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/ DRUGS MARKET SHARE, 2013 VS. 2015 VS. 2020 91
FIGURE 17 CANADA: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET SHARE, 2015 VS. 2020 93
FIGURE 18 U.K.: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/ DRUGS MARKET SHARE, 2013 VS. 2015 VS. 2020 96
FIGURE 19 U.K.: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET SHARE, 2015 VS. 2020 98
FIGURE 20 GERMANY: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/DRUGS MARKET SHARE, 2013 VS. 2015 VS. 2020 101
FIGURE 21 GERMANY: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET SHARE, 2015 VS. 2020 103
FIGURE 22 France: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/DRUGS MARKET SHARE, 2013 VS. 2015 VS. 2020 106
FIGURE 23 France: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET SHARE, 2015 VS. 2020 108
FIGURE 24 ITALY: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/ DRUGS MARKET SHARE, 2013 VS. 2015 VS. 2020 111
FIGURE 25 SPAIN: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/ DRUGS MARKET SHARE, 2013 VS. 2015 VS. 2020 117
FIGURE 26 SPAIN: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET SHARE, 2015 VS. 2020 119
FIGURE 27 JAPAN: ACUTE LYMPHOCYTIC LEUKEMIA - EXISTING REGIMENS/DRUGS MARKET SHARE, 2013 VS. 2015 VS. 2020 123
FIGURE 28 JAPAN: ACUTE LYMPHOCYTIC LEUKEMIA - PIPELINE DRUGS MARKET SHARE, 2015 VS. 2020 125

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