Epigenetics Therapeutics to 2017 – High Market Potential for Epigenetics Drugs in Acute Myeloid Leukemia, Multiple Myeloma and Cutaneous T-Cell Lymphoma

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Epigenetics Therapeutics to 2017 – High Market Potential for Epigenetics Drugs in Acute Myeloid Leukemia, Multiple Myeloma and Cutaneous T-Cell Lymphoma Powered By Docstoc
					  Epigenetics Therapeutics to 2017 – High Market Potential for
    Epigenetics Drugs in Acute Myeloid Leukemia, Multiple
          Myeloma and Cutaneous T-Cell Lymphoma
 Reference Code: GBIHC039MR                                                                                                      Publication Date: SEP 2010


                                      Four Epigenetics Drugs Generated Revenues Worth $517m In 2009
Vidaza, Dacogen, Zolinza              Vidaza, Dacogen, Zolinza and Istodax are the four currently approved epigenetic drugs in the
and Istodax are the four              market. The sales of these drugs amounted to $517m in 2009. Vidaza and Dacogen are approved
currently approved                    for the indication Myelodysplastic Syndrome (MDS) and Zolinza and Istodax are approved for the
epigenetic drugs in the               indication Cutaneous T-cell lymphoma (CTCL). Of all the drugs, Vidaza had the largest market
market. The sales of these            share in 2009, followed by Dacogen.
drugs amounted to $517m
in 2009                                 Epigenetic Therapeutics Market, Global, Revenue Forecast ($m) 2009–2017

                                                             1,000
                                                                     CAGR(2009 to 2017): 7.6%
                                                              900


                                                              800


                                                              700


                                                              600
                                              Revenue ($m)




                                                              500


                                                              400


                                                              300


                                                              200


                                                              100


                                                                0
                                                                     2009      2010       2011     2012     2013      2014      2015     2016      2017


                                        Source: GBI Research, Merck & Co, Celgene and Eisai annual reports




                                      Vidaza and Dacogen Belong to a Class of Drugs called DNA Methyltransferase Inhibitors
                                      that Dominate the Epigenetics Market
                                      Vidaza and Dacogen belong to a new class of drugs called DNA Methyltransferase inhibitors.
                                      These drugs cause the removal of the methyl group from the cytosine residue in the DNA and
                                      cause the repression of tumor genes. Of all the drugs, Vidaza and Dacogen are the most
                                      commonly used drugs for the treatment of MDS. They are currently employed by physicians as a
                                      second or third line of therapy.
                                      The Epigenetic Therapies are Currently Only Approved for Blood Cancer
                                      Epigenetic drugs are currently approved to treat MDS and CTCL, which are cancers of the blood
                                      cells. MDS is a type of blood cancer that affects the stem cells secreted in the bone marrow. CTCL
                                      affects the lymphocytes that secrete T-cells. The accumulation of the proliferated T-lymphocytes in
                                      the subcutaneous regions causes a rash-like appearance and progresses to become metastasis.
                                      Vidaza’s Uptake is Projected to Grow. The Drug is Forecast to Reach $600m by 2017



Epigenetics Therapeutics to 2017 – High Market Potential for                                                                 GBIHC039MR / Published SEP 2010
Epigenetics Drugs in Acute Myeloid Leukemia, Multiple
Myeloma and Cutaneous T-Cell Lymphoma                                                                                                                     Page 1
                                                                                          © GBI Research. This is a licensed product and is not to be photocopied
                                      Vidaza by Celgene is one of the therapies commonly employed to treat MDS. Vidaza’s uptake in
                                      the top seven markets will be driven by epidemiological factors and an escalation in Vidaza price.
                                      The annual cost of therapy ranges from $45,135 to $49,886. Thus, it is estimated to reach
                                      revenues of $604m by the year 2017.
                                      Vidaza is in Phase III Clinical Trails for AML Treatment and it is Estimated to Have High
                                      Market Potential
                                      Vidaza is in the late stage of clinical trials for the treatment of Acute Myeloid Leukemia (AML). AML
                                      is a rare disease that affects the blood cells. As Vidaza is approved for MDS, which is a precursor
                                      to AML, it is expected to be widely accepted after being approved for AML. Vidaza is estimated to
                                      achieve peak sales of $312m for AML by the year 2012 in the top seven markets.
                                      Dacogen, Indicated for the Treatment of MDS, is Forecast to Reach $283m in Sales by 2017
                                      Dacogen by Eisai is similar to Vidaza in terms of its mechanism of action and is indicated for the
                                      treatment of MDS. The annual cost of Dacogen treatment for MDS is $61,938, which is higher than
                                      Vidaza’s cost. Dacogen is employed as an alternative to Vidaza therapy in many cases, which
                                      leads to lower uptake. Thus, Dacogen is forecast to reach revenues of $283m by 2017, which is
                                      much lower than the estimates for Vidaza.
                                      Zolinza, Indicated for the Treatment of CTCL, Will Reach $42m By 2017
                                      Zolinza is indicated for the treatment CTCL which is a rare disease. The market for Zolinza as a
                                      CTCL therapy is expected to be steady throughout the forecast period. The annual cost of
                                      treatment ranges from $25,743 to $31,464 depending on the treatment period. The increase in the
                                      incidence and prevalence of the disease will drive the market from $21m in 2009 to $42m in 2017
                                      at a Compound Annual Growth Rate (CAGR) of 10.7%.
                                      Zolinza is Being Studied in More Than 61 Clinical Trails and is in Phase III for the Treatment
                                      of Multiple Myeloma
                                      Zolinza is in Phase III clinical trials for the treatment of Multiple Myeloma (MM). The study is being
                                      conducted by Merck & Co. MM is a type of blood disorder The acceptance and uptake of Zolinza is
                                      expected to remain low as the growth in the acceptance and uptake of the drug is expected to be
                                      slow over the forecast period. Thus, the drug will achieve peak sales of $197m by 2017 for the MM
                                      market.
                                      Istodax is Indicated for the Treatment of CTCL and is Estimated to Achieve Sales of $108m
                                      by 2017
                                      Istodax by Celgene is indicated for the treatment of CTCL. The drug was approved in 2009. The
                                      average annual cost of therapy for the treatment of CTCL ranges from $36,777 to $44,950
                                      depending on the treatment period. The drug is estimated to reach sales of $108m by 2017 at a
                                      CAGR of 16% for the period from 2010 to 2017. Certain epidemiological factors will support the
                                      growth of this market.




Epigenetics Therapeutics to 2017 – High Market Potential for                                               GBIHC039MR / Published SEP 2010
Epigenetics Drugs in Acute Myeloid Leukemia, Multiple
Myeloma and Cutaneous T-Cell Lymphoma                                                                                                   Page 2
                                                                         © GBI Research. This is a licensed product and is not to be photocopied
                                      1           Table of Contents
                                      1   Table of Contents ........................................................................................................................ 3
                                          1.1    List of Tables..................................................................................................................... 5
                                          1.2    List of Figures ................................................................................................................... 6
                                      2   Introduction.................................................................................................................................. 7
                                          2.1    GBI Research Report Guidance ....................................................................................... 7
                                      3   Market Characterization: Global Epigenetics Market................................................................... 8
                                          3.1    Disease Overview ............................................................................................................. 8
                                             3.1.1    Myelodysplastic Syndrome ........................................................................................ 8
                                             3.1.2    Cutaneous T-cell Lymphoma..................................................................................... 8
                                          3.2    Epigenetic Drugs...............................................................................................................9
                                          3.3    The US............................................................................................................................ 11
                                          3.4    Top Five European Markets............................................................................................ 12
                                          3.5    Japan .............................................................................................................................. 14
                                      4   In-Depth Analysis ...................................................................................................................... 16
                                          4.1    Introduction ..................................................................................................................... 16
                                          4.2    Vidaza (Azacitidine) ........................................................................................................ 16
                                             4.2.1    Indication ................................................................................................................. 16
                                             4.2.2    Mechanism of Action ............................................................................................... 16
                                             4.2.3    Revenue Forecast ................................................................................................... 16
                                             4.2.4    Key Takeaway ......................................................................................................... 23
                                             4.2.5    Market Potential....................................................................................................... 23
                                             4.2.6    Pipeline Analysis ..................................................................................................... 29
                                             4.2.7    Drug Profile.............................................................................................................. 32
                                          4.3    Dacogen (Decitabine) ..................................................................................................... 33
                                             4.3.1    Indication ................................................................................................................. 33
                                             4.3.2    Mechanism of action................................................................................................ 33
                                             4.3.3    Revenue Forecast ................................................................................................... 34
                                             4.3.4    Key Takeaway ......................................................................................................... 39
                                             4.3.5    Market Potential....................................................................................................... 39
                                             4.3.6    Pipeline Analysis ..................................................................................................... 45
                                             4.3.7    Drug Profile.............................................................................................................. 48
                                          4.4    Zolinza (Vorinostat)......................................................................................................... 49
                                             4.4.1    Indication ................................................................................................................. 49
                                             4.4.2    Mechanism of Action ............................................................................................... 49
                                             4.4.3    Revenue Forecast ................................................................................................... 49
                                             4.4.4    Disease Overview.................................................................................................... 55
                                             4.4.5    Market Potential....................................................................................................... 55
                                             4.4.6    Pipeline Analysis ..................................................................................................... 61
                                             4.4.7    Drug Profile.............................................................................................................. 63
                                          4.5    Istodax (Romidepsin) ...................................................................................................... 64
                                             4.5.1    Indication ................................................................................................................. 64
                                             4.5.2    Disease Overview.................................................................................................... 64
                                             4.5.3    Mechanism of Action ............................................................................................... 65
                                             4.5.4    Market Potential....................................................................................................... 65
                                             4.5.5    Pipeline Analysis ..................................................................................................... 71
                                             4.5.6    Clinical Studies by Phases ...................................................................................... 71
                                             4.5.7    Clinical Studies by Indication ................................................................................... 72
                                             4.5.8    Drug Profile.............................................................................................................. 73
                                      5   Competitive Landscape ............................................................................................................. 75
                                          5.1    Merck & Co. .................................................................................................................... 75
                                             5.1.1    Company Overview ................................................................................................. 75
                                             5.1.2    Business Description ............................................................................................... 75
                                             5.1.3    SWOT...................................................................................................................... 77


Epigenetics Therapeutics to 2017 – High Market Potential for                                                                            GBIHC039MR / Published SEP 2010
Epigenetics Drugs in Acute Myeloid Leukemia, Multiple
Myeloma and Cutaneous T-Cell Lymphoma                                                                                                                                           Page 3
                                                                                         © GBI Research. This is a licensed product and is not to be photocopied
                                        5.2    Celgene Corporation....................................................................................................... 77
                                           5.2.1    Company Overview ................................................................................................. 77
                                           5.2.2    Business Description ............................................................................................... 78
                                           5.2.3    SWOT...................................................................................................................... 79
                                        5.3    EISAI............................................................................................................................... 80
                                           5.3.1    Company Overview ................................................................................................. 80
                                           5.3.2    Business Description ............................................................................................... 80
                                           5.3.3    SWOT...................................................................................................................... 82
                                      6 Epigenetic Therapeutics: Appendix ........................................................................................... 83
                                        6.1    Market Definitions ........................................................................................................... 83
                                        6.2    Abbreviations .................................................................................................................. 83
                                        6.3    Research Methodology ................................................................................................... 84
                                           6.3.1    Coverage ................................................................................................................. 85
                                           6.3.2    Secondary Research ............................................................................................... 85
                                           6.3.3    Primary Research.................................................................................................... 85
                                           6.3.4    Forecasts................................................................................................................. 86
                                           6.3.5    Expert Panel Validation ........................................................................................... 88
                                        6.4    Contact Us ...................................................................................................................... 88
                                        6.5    Disclaimer ....................................................................................................................... 88
                                        6.6    Sources........................................................................................................................... 88




Epigenetics Therapeutics to 2017 – High Market Potential for                                                                         GBIHC039MR / Published SEP 2010
Epigenetics Drugs in Acute Myeloid Leukemia, Multiple
Myeloma and Cutaneous T-Cell Lymphoma                                                                                                                                       Page 4
                                                                                        © GBI Research. This is a licensed product and is not to be photocopied
                                      1.1       List of Tables
                                      Table 1:    List of Approved Epigenetic Drugs, 2010 ......................................................................... 8
                                      Table 2:    Epigenetic Therapeutics Market, Global, Revenue Forecast ($m) 2009–2017 ................ 9
                                      Table 3:    Epigenetic Therapeutics Market, by Geography, Revenue Forecast ($m) 2009–2017 10
                                      Table 4:    Epigenetic therapeutics Market, The US, Revenue Forecast ($m) 2009 - 2017 ............ 12
                                      Table 5:    Epigenetic Therapeutics Market, Europe, Revenue Forecast ($m), 2009- 2017............ 13
                                      Table 6:    Epigenetic Therapeutics Market, Japan, Revenue Forecast ($m), 2009–2017.............. 15
                                      Table 7:    Vidaza – Snapshot, 2010 ............................................................................................... 16
                                      Table 8:    Vidaza, Global, Revenue Forecast ($m) 2009–2017 ..................................................... 17
                                      Table 9:    Vidaza, By Geography, Revenue Forecast ($m )2009 - 2017........................................ 18
                                      Table 10:   Vidaza, The US, Revenue Forecast ($m) 2009–2017.................................................... 19
                                      Table 11:   Vidaza, Europe, Revenue Forecast ($m), 2009–2017 ................................................... 21
                                      Table 12:   Vidaza, Japan, Revenue Forecast ($m), 2009–2017 ..................................................... 22
                                      Table 13:   Vidaza Market Potential, Global, Revenue Forecast ($m) 2012–2017........................... 24
                                      Table 14:   Vidaza Market Potential, By Geography, Revenue Forecast ($m), 2012–2017 ............. 25
                                      Table 15:   Vidaza Market Potential, The US, Revenue Forecast ($m), 2012–2017........................ 26
                                      Table 16:   Vidaza Market Potential, Europe, Revenue Forecast ($m), 2012–2017 ........................ 27
                                      Table 17:   Vidaza Market Potential, Japan, Revenue Forecast ($m), 2012–2017 .......................... 28
                                      Table 18:   Efficacy of Vidaza in MDS Patients, 2010 ...................................................................
				
DOCUMENT INFO
Description: Epigenetics Therapeutics to 2017 – High Market Potential for Epigenetics Drugs in Acute Myeloid Leukemia, Multiple Myeloma and Cutaneous T-Cell Lymphoma Summary GBI Research’s report, “Epigenetics Therapeutics to 2017 – High Market Potential for Epigenetics Drugs in Acute Myeloid Leukemia, Multiple Myeloma and Cutaneous T-Cell Lymphoma”, provides in-depth analysis of trends, issues and challenges in this industry. The report analyzes the technology that shape the industry dynamics for the key geographies: the US, the top five countries in Europe (the UK, Germany, France, Italy and Spain) and Japan. Further, the report provides competitive benchmarking for the leading companies and analyzes the licensing agreements that shape the global markets. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts. Scope The scope of this report includes: - Annualized market data from 2001 to 2009, forecast forward to 2016. - Analysis of the leading technology in this space - Market characterization - Key drivers and barriers that have a significant impact on the market. - Competitive benchmarking of leading companies. Reasons to buy The report will enhance your decision making capability. It will allow you to - Align your product portfolio to the markets with high growth potential. - Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth. - Reinforce R&D pipelines - Develop key strategic initiatives by understanding the key focus areas of leading companies. - Exploit in-licensing and out-licensing opportunities by identifying products that could fill portfolio gaps.
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