Acute Lymphocytic Leukemia Therapeutics Market (Pipeline Forecast & Market Forecast in G8 Countries) (2010 - 2020)

The incidence of acute lymphocytic leukemia is high in children from 0 to 14 years than the people aged above 14. It is the most common childhood acute lymphocytic leukemia. However, the acute lymphocytic leukemia may also occur in adults. Acute lymphocytic leukemia distribution depends on age. For instance, 30% of is diagnosed before the age of 5 and 55% of ALL age 15.The acute lymphocytic leukemia market is segmented into two types; namely childhood acute lymphocytic leukemia, and adult acute lymphocytic leukemia. The market was dominated by Hyper-CVAD regimen in 2010. However, in 2020, the market is expected to be equally dominated by Hyper-CVAD and Linker regimen.

This report studies the market from 2010 to 2020 covering eight major regimens and single drugs (off-patent and pipeline) for acute lymphocytic leukemia treatment. Growing acute lymphocytic leukemia population is an impetus for the growth of the market. This market is expected to grow at a CAGR of 5.21% from 2015 to 2020. North America was the major contributor to this market; accounting for 58% of the total sales of acute lymphocytic leukemia drugs in 2010; whereas Hyper-CVAD was the major regimen accounting for 39.40% of the total sales of acute lymphocytic leukemia drugs in 2010. Acute lymphocytic leukemia is still an area with high unmet need for early diagnosis and limited treatment options in this area.

The report studies six existing regimens and single drugs for leukemia market. Currently, there are about two major drugs in pipeline for acute lymphocytic leukemia expecting a market launch by 2012. Talon Therapeutics Inc submitted new drug application to FDA for Marqibo in July 2011, leading to its market launch by 2012.

Graspa will be launched in the market in 2012 by ERYtech Pharma (France) on receiving Orphan Drug Designation (ODD) grant from the FDA in 2010. The drug is expected to be priced at $420 for patients who take them annually.

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 the major strategies adopted by the players from January 2008 to September 2011.

Pipeline drugs form a major growth strategy in the acute lymphocytic leukemia therapeutics market in G8 countries; accounting for 40% share in this market between January 2008 and September 2011, followed by agreements and collaborations with a 27% share, and approvals with a 20% share.

GlaxoSmithKline Pharmaceuticals Limited and Genzyme Corporation rule the present market for acute lymphocytic leukemia drugs; whereas ERYtech Pharma & Talon Therapeutic Inc are expected to capture major share of the market by 2020.

Scope of the report

This acute lymphocytic leukemia therapeutics market research report evaluates the leukemia therapeutics market with respect to the current and pipeline drugs and regimens. The report analyzes geography; forecasting revenue, and trends in each of the following submarkets:

• Chemotherapy regimens
  • Hyper-CVAD
  • CALGB 8811 regimen
  • Linker regimen
• Chemotherapy drugs
  • Clolar
  • Nelarabine
  • Oncaspar
• Pipeline drugs
  • Graspa
  • Marqibo

The geographies covered under the report are:

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

Each section provides market data, market drivers, trends and opportunities, key players, and competitive outlook. The report makes provisions for market tables to cover the sub-segments and micro-markets. Additionally, it makes ways for company profiles that cover all the sub-segments. The report has been made by keeping past trends, current happenings and future forecasts in consideration.

TABLE OF CONTENTS    
   
1 INTRODUCTION  
  1.1 KEY TAKE-AWAYS  
  1.2 REPORT DESCRIPTION  
  1.3 MARKETS COVERED  
  1.4 STAKEHOLDERS  
  1.5 RESEARCH METHODOLOGY  
      1.5.1 MARKET SIZE  
      1.5.2 KEY DATA POINTS TAKEN FROM SECONDARY SOURCES  
      1.5.3 ASSUMPTIONS MADE FOR THIS REPORT  
   
2 EXECUTIVE SUMMARY  
  2.1 OVERVIEW OF THE MARKET  
   
3 MARKET OVERVIEW  
  3.1 DEFINING LEUKEMIA  
  3.2 DEFINING ACUTE LYMPHOCYTIC LEUKEMIA  
      3.2.1 RISK FACTORS  
      3.2.2 STAGES/PHASES OF ACUTE LYMPHOCYTIC LEUKEMIA  
            3.2.2.1 Childhood ALL  
                    3.2.2.1.1 Standard (low) risk  
                    3.2.2.1.2 High risk  
                    3.2.2.1.3 Recurrent  
            3.2.2.2 Adult ALL  
                    3.2.2.2.1 Untreated adult ALL  
                    3.2.2.2.2 Adult ALL in remission  
                    3.2.2.2.3 Recurrent adult ALL  
      3.2.3 DIAGNOSIS  
            3.2.3.1 Biopsy and bone marrow aspiration  
            3.2.3.2 Complete blood count (CBC) and differential  
            3.2.3.3 Philadelphia chromosome’s presence  
            3.2.3.4 Spinal tap (lumbar puncture) and cerebrospinal fluid (CSF) analysis  
            3.2.3.5 Immunophenotyping or phenotyping by flow cytometry  
            3.2.3.6 Polymerase chain reaction (PCR)  
      3.2.4 LEUKEMIA PREVALENCE  
      3.2.5 INCIDENCE & MORTALITY  
  3.3 MARKET STRUCTURE  
            3.3.1.1 Key therapies  
                    3.3.1.1.1 Chemotherapy  
                    3.3.1.1.2 Stem cell/bone marrow transplant  
                    3.3.1.1.3 Radiation therapy  
   
4 ACUTE LYMPHOCYTIC LEUKEMIA MARKET DYNAMICS  
  4.1 MARKET OVERVIEW  
  4.2 BURNING ISSUES  
  4.3 WINNING IMPERATIVES  
      4.3.1 STRATEGY OF MARKET EXPANSION BY UTILIZING MULTIPLE THERAPEUTIC APPROACHES  
  4.4 MARKET DYNAMICS  
      4.4.1 MARKET DRIVERS  
            4.4.1.1 Innovative therapies to drive the market for leukemia  
            4.4.1.2 Oncology is the largest therapeutic market with high unmet needs  
      4.4.2 MARKET RESTRAINTS  
            4.4.2.1 Low production capability for efficient drugs  
      4.4.3 MARKET OPPORTUNITIES  
            4.4.3.1 Limited players in the market  
            4.4.3.2 Leukemia’s underserved patient populations offer potential for market growth  
   
5 LEUKEMIA PRODUCT MARKET  
  5.1 MARKET OVERVIEW  
      5.1.1 HYPER-CVAD REGIMEN  
      5.1.2 CALGB 8811 REGIMEN  
      5.1.3 LINKER REGIMEN  
      5.1.4 NUCLEOSIDE METABOLIC INHIBITORS (CLOLAR + ARRANON)  
      5.1.5 ONCASPAR  
   
6 LEUKEMIA DRUG PIPELINE (PHASE III)  
  6.1 PIPELINE DRUGS  
      6.1.1 GRASPA  
      6.1.2 MARQIBO  
   
7 GEOGRAPHIC ANALYSIS  
  7.1 U.S.  
  7.2 CANADA  
  7.3 U.K.  
  7.4 GERMANY  
  7.5 FRANCE  
  7.6 ITALY  
  7.7 SPAIN  
  7.8 JAPAN  
   
8 COMPETITIVE LANDSCAPE  
  8.1 INTRODUCTION  
   
9 COMPANY PROFILES  
  9.1 ARIAD PHARMACEUTICALS INC  
      9.1.1 OVERVIEW  
      9.1.2 FINANCIALS  
      9.1.3 PRODUCTS & SERVICES  
      9.1.4 DEVELOPMENTS  
  9.2 ERYTECH PHARMA  
      9.2.1 OVERVIEW  
      9.2.2 FINANCIALS  
      9.2.3 PRODUCTS & SERVICES  
      9.2.4 STRATEGY  
      9.2.5 DEVELOPMENTS  
  9.3 GENZYME CORPORATION  
      9.3.1 OVERVIEW  
      9.3.2 FINANCIALS  
      9.3.3 PRODUCTS & SERVICES  
      9.3.4 STRATEGY  
      9.3.5 DEVELOPMENTS  
  9.4 TALON THERAPEUTICS INC  
      9.4.1 OVERVIEW  
      9.4.2 FINANCIALS  
      9.4.3 PRODUCTS & SERVICES  
      9.4.4 STRATEGY  
      9.4.5 DEVELOPMENTS  
   
LIST OF TABLES   
   
TABLE 1 YEARLY COST OF DRUGS IN NORTH AMERICA & JAPAN, 2011 ($)  
TABLE 2 YEARLY COST OF DRUGS IN EUROPEAN COUNTRIES, 2011 ($)  
TABLE 3 DOSAGE PATTERN OF DRUGS  
TABLE 4 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS MARKET REVENUE, BY REGIMENS/DRUGS, 2008 - 2020 ($MILLION)   
TABLE 5 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS – PATENT STATUS  
TABLE 6 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS MARKET REVENUE, BY TYPES, 2008 – 2020 ($MILLION)  
TABLE 7 ACUTE LYMPHOCYTIC LEUKEMIA DRUG/REGIMENS MARKET REVENUE, 2008 – 2020 ($MILLION)  
TABLE 8 ACUTE LYMPHOCYTIC LEUKEMIA REGIMEN (HYPER-CVAD) MARKET REVENUE, BY COUNTRY, 2008 – 2020 ($MILLION)  
TABLE 9 ACUTE LYMPHOCYTIC LEUKEMIA REGIMEN (CALGB 8811) MARKET REVENUE, BY COUNTRY, 2008 – 2020 ($MILLION)  
TABLE 10 ACUTE LYMPHOCYITC LEUKEMIA DRUGS (LINKER REGIMEN) MARKET REVENUE, BY COUNTRY, 2008 – 2020 ($MILLION)  
TABLE 11 ACUTE LYMPHOCYTIC LEUKEMIA DRUG CLASS (NUCLEOSIDE METABOLIC INHIBITORS) MARKET REVENUE, BY COUNTRY, 2008 – 2020 ($MILLION)   
TABLE 12 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS (ONCASPAR) MARKET REVENUE, BY COUNTRY, 2008 – 2020 ($MILLION)  
TABLE 13 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS – PIPELINE (GRASPA) MARKET REVENUE, BY COUNTRY, 2015 – 2020 ($MILLION)  
TABLE 14 ACUTE LYMPHOCYTIC LEUKEMIA DRUGS – PIPELINE (MARQIBO) MARKET REVENUE, BY COUNTRY, 2015 – 2020 ($MILLION)  
TABLE 15 SEER STATISTICS FOR LEUKEMIA (ESTIMATED) IN U.S., 2011  
TABLE 16 U.S: ACUTE LYMPHOCYTIC LEUKEMIA DRUGS MARKET REVENUE, BY DRUGS/REGIMENS, 2008 – 2020 ($MILLION)   
TABLE 17 U.S: ACUTE LYMPHOCYTIC LEUKEMIA DRUGS – PIPELINE MARKET REVENUE, BY DRUGS, 2008 – 2020 ($MILLION)  
TABLE 18 CANADA: ACUTE LYMPHOCYTIC LEUKEMIA DRUGS MARKET REVENUE, BY DRUGS/REGIMENS, 2008 – 2020 ($MILLION)  
TABLE 19 CANADA: LEUKEMIA DRUGS – PIPELINE MARKET REVENUE, BY DRUGS, 2015 – 2020 ($MILLION)  
TABLE 20 U.K: INCIDENCE BY GENDER & TYPE OF LEUKEMIA, 2010  
TABLE 21 U.K: LEUKEMIA DRUGS MARKET REVENUE, BY DRUGS/REGIMENS, 2008 – 2020 ($MILLION)   
TABLE 22 U.K: LEUKEMIA DRUGS – PIPELINE MARKET REVENUE, BY DRUGS, 2015 – 2020 ($MILLION)   
TABLE 23 GERMANY: LEUKEMIA DRUGS MARKET REVENUE, BY DRUGS/REGIMENS, 2008 – 2020 ($MILLION)   
TABLE 24 GERMANY: ACUTE LYMPHOCYTIC LEUKEMIA DRUGS – PIPELINE MARKET REVENUE, BY DRUGS, 2015 – 2020 ($MILLION)  
TABLE 25 FRANCE: LEUKEMIA DRUGS MARKET REVENUE, BY DRUGS/REGIMENS, 2008 – 2020 ($MILLION)  
TABLE 26 FRANCE: ACUTE LYMPHOCYTIC LEUKEMIA DRUGS – PIPELINE MARKET REVENUE, BY DRUGS, 2015 – 2020 ($MILLION)  
TABLE 27 ITALY: ACUTE LYMPHOCYTIC LEUKEMIA DRUGS MARKET REVENUE, BY DRUGS/REGIMENS, 2008 – 2020 ($MILLION)   
TABLE 28 ITALY: ACUTE LYMPHOCYTIC LEUKEMIA DRUGS – PIPELINE MARKET REVENUE, BY DRUGS, 2015 – 2020 ($MILLION)  
TABLE 29 SPAIN: ACUTE LYMPHOCYTIC LEUKEMIA DRUGS MARKET REVENUE, BY DRUGS/REGIMENS, 2008 – 2020 ($MILLION)   
TABLE 30 SPAIN: ACUTE LYMPHOCYTIC LEUKEMIA DRUGS – PIPELINE MARKET REVENUE, BY DRUGS, 2008 – 2020 ($MILLION)  
TABLE 31 JAPAN: ACUTE LYMPHOCYTIC LEUKEMIA DRUGS MARKET REVENUE, BY DRUGS/REGIMENS, 2008 – 2020 ($MILLION)   
TABLE 32 JAPAN: ACUTE LYMPHOCYTIC LEUKEMIA DRUGS – PIPELINE MARKET REVENUE, BY DRUGS, 2008 – 2020 ($MILLION)  
TABLE 33 COLLABORATIONS/PARTNERSHIPS/AGREEMENTS/JOINT VENTURES  
TABLE 34 NEW PRODUCTS LAUNCH, 2008 – 2011  
TABLE 35 EXPANSIONS/NEW FACILITY/INVESTMENTS, 2011  
TABLE 36 FDA APPROVALS, 2008 – 2011  
TABLE 37 CLINICAL TRIALS, 2008 – 2011  
TABLE 38 NDA, BLA & MARKETING APPLICATIONS, 2008 – 2011  
TABLE 39 ARIAD PHARMACEUTICALS: TOTAL REVENUE & R&D EXPENSES, 2008 – 2010 ($MILLION)   
TABLE 40 ARIAD PHARMACEUTICALS: PRODUCT PORTFOLIO  
TABLE 41 ERYTECH PHARMA: PRODUCT PIPELINE  
TABLE 42 GENZYME CORPORATION: TOTAL REVENUE AND R&D EXPENSES, 2008 – 2010 ($MILLION)   
TABLE 43 GENZYME CORPORATION: PRODUCT PORTFOLIO  
TABLE 44 TALON THERAPEUTICS INC: TOTAL R&D EXPENSES, 2008 – 2010 ($MILLION)  
TABLE 45 TALON THERAPEUTICS INC: PIPELINE PRODUCT PORTFOLIO   
    
    
LIST OF FIGURES    
   
FIGURE 1 TOTAL ACUTE LYMPHOCYTIC LEUKEMIA MARKET, 2008 – 2020 ($MILLION)  
FIGURE 2 ACUTE LEUKEMIA MARKET REVENUE, BY REGIMENS/DRUGS, 2008 – 2020 ($MILLION)   
FIGURE 3 TYPES OF LEUKEMIA  
FIGURE 4 TOTAL LEUKEMIA POPULATION, BY COUNTRY, 2008-2020  
FIGURE 5 ACUTE LYMPHOCYTIC LEUKEMIA DEVELOPMENT & PROGRESSION RATE, BY AGE  
FIGURE 6 STAGES AND PHASES OF ACUTE LYMPHOCYTIC LEUKEMIA  
FIGURE 7 ACUTE LYMPHOCYTIC LEUKEMIA POPULATION, BY COUNTRY, 2008 – 2020   
FIGURE 8 ACUTE LYMPHOCYTIC LEUKEMIA: MARKET SEGMENTATION, BY REGIMENS/DRUGS   
FIGURE 9 ACUTE LYMPHOCYTIC LEUKEMIA: EXISTING DRUGS MARKET SHARE, 2010 VS 2020  
FIGURE 10 ACUTE LYMPHOCYTIC LEUKEMIA: PIPELINE DRUGS MARKET SHARE, 2015 VS 2020  
FIGURE 11 ACUTE LYMPHOCYTIC LEUKEMIA EXISTING REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2010 VS 2020  
FIGURE 12 ACUTE LYMPHOCYTIC LEUKEMIA PIPELINE REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2015 VS 2020  
FIGURE 13 U.S: EXISTING REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2010 VS 2020 ($MILLION)   
FIGURE 14 U.S: ACUTE LYMPHOCYTIC PIPELINE REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2015 VS 2020  
FIGURE 15 CANADA: EXISTING REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2010 VS 2020  
FIGURE 16 CANADA: PIPELINE REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2015 VS 2020   
FIGURE 17 U.K: EXISTING REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2010 VS 2020   
FIGURE 18 U.K: PIPELINE REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2015 VS 2020   
FIGURE 19 GERMANY: ACUTE LYMPHOCYTIC LEUKEMIA EXISTING REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2010 VS 2020  
FIGURE 20 GERMANY: ACUTE LYMPHOCYTIC LEUKEMIA PIPELINE REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2015 VS 2020  
FIGURE 21 FRANCE: ACUTE LYMPHOCYTIC LEUKEMIA EXISTING REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2010 VS 2020  
FIGURE 22 FRANCE: ACUTE LYMPHOCYTIC LEUKEMIA PIPELINE REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2015 VS 2020  
FIGURE 23 ITALY: ACUTE LYMPHOCYTIC LEUKEMIA EXISTING REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2010 VS 2020  
FIGURE 24 ITALY: ACUTE LYMPHOCYTIC LEUKEMIA PIPELINE REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2015 VS 2020  
FIGURE 25 SPAIN ACUTE LYMPHOCYTIC LEUKEMIA EXISTING REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2010 VS 2020  
FIGURE 26 SPAIN: ACUTE LYMPHOCYTIC LEUKEMIA PIPELINE REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2015 – 2020  
FIGURE 27 JAPAN: ACUTE LYMPHOCYTIC LEUKEMIA EXISTING REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2010 VS 2020  
FIGURE 28 JAPAN: ACUTE LYMPHOCYTIC LEUKEMIA PIPELINE REGIMENS/DRUGS MARKET SHARE, BY TYPES, 2015 VS 2020  
FIGURE 29 KEY GROWTH STRATEGIES (JANUARY 2008 – SEPTEMBER 2011)

In acute lymphocytic leukemia, the body rapidly produces a large number of immature white blood cells, called lymphocytes. These immature white blood cells replace normal cells in the bone marrow. This type of cancer can be sub-categorized into childhood acute lymphocytic leukemia and adult acute lymphocytic leukemia. The childhood acute lymphocytic leukemia can further divided into standard risk group, high risk group, and recurrent childhood ALL. The adult acute lymphocytic leukemia can be further divided into the untreated ALL, adult ALL in remission, and recurrent adult ALL.

Acute Lymphocytic Leukemia Development & Progression Rate, by Age

It is the most common childhood acute leukemia. However, this leukemia may also occur in adults. Acute lymphocytic leukemia accounts for about 20% to 25% of all the childhood cancers. Acute lymphocytic leukemia prevalence is high among one to four year old children and it is almost eight times more than the young adults aged between 20 and 24.

Acute Lymphocytic Leukemia diagnosed population, 2008 - 2020, (Thousands)

Source: Globocan

Acute lymphocytic leukemia is expected to be more prominent in the developed and in higher socioeconomic groups. Radiation exposure is the primary cause of acute lymphocytic leukemia. Global incidence of acute lymphocytic leukemia was 32,558 in 2008 with the developing countries. Total 42,301 new cases were recorded in 2010 with 68,390 and 96,920 as the predicted new cases for 2015 and 2020.

Leukemia is rarely associated with pregnancy, affecting only about 1 in 10,000 pregnant women. How it is handled depends primarily on the type of leukemia. Nearly all leukemias appearing in pregnant women are acute leukemias. Acute leukemias normally require prompt, aggressive treatment, despite significant risks of pregnancy loss and birth defects, especially if chemotherapy is given during the developmentally sensitive first trimester.