Oncology Market in India to 2017 - Limited Patient Affordability for High Priced Biologics Lowers Market Potential by GBIResearch

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									            Oncology Market in India to 2017 - Limited Patient
           Affordability for High Priced Biologics Lowers Market
                                  Potential
 Reference Code: GBIHC058MR                                                                                               Publication Date: December 2010

  Oncology market in india
  is mainly driven by larger            High Growth Rate and Increasing Use of Biologics Has Made the Oncology Market Attractive
  population base and high              The overall market for five indications – breast cancer, colorectal cancer, prostate cancer, lung
  spending on clinical trials.          cancer, and Non-Hodgkin’s Lymphoma (NHL) – is at $153.4m in 2009. This is expected to grow at
  It is expected to grow at             a CAGR (Compound Annual Growth Rate) of 11.3% for the next eight years and will reach
  the CAGR of more than                 $361.9m.
  11%
                                         Oncology Market, India, $m, 2002-2017

                                                           400



                                                           350
                                                                                                                   CAGR(2009-2017) : 11.3%

                                                           300



                                                           250
                                            Revenue ($m)




                                                           200

                                                                     CAGR(2002-2009) : 11.2%
                                                           150



                                                           100



                                                           50



                                                             0
                                                                 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017


                                         Source: GBI Research




                                        Major drivers of the market are large population base and increasing incidence rate, along with
                                        government support. However the number of restraints is much higher than the drivers. The major
                                        restraint is pricing and patent issues. This has created a lot of issues in the past. Tarceva and
                                        Glivec are two famous cases which are still pending in the court.
                                        Along with these major restraints, reimbursement is also a large factor. There are very few health
                                        policies which cover for cancer diseases. Companies which provide such coverage either charge
                                        very high premiums or their conditions are very restrictive. Thus the Indian population is not able to
                                        fully utilize the benefits of newly developed drugs.




Oncology Market in India to 2017 - Limited Patient Affordability                                                            GBIHC058MR / Published DEC 2010
for High Priced Biologics Lowers Market Potential
                                                                                                                                                         Page 1
                                                                                          © GBI Research. This is a licensed product and is not to be photocopied
                                        Strong Pipeline and the Entry of New Players Will Intensify the Competition
                                        The global oncology market has a strong pipeline base that will support the growth of this market,
                                        thereby attracting many pharmaceutical and biotechnological companies. Major molecules are in
                                        Phase II and Phase III, so a high chance of intense competition can be predicted.

                                         Oncology Market, Global Pipeline by Phase of Development, %, 2010

                                                                                        Discovery
                                                                                           1% Preclinical
                                                                   Phase III                      6%
                                                                     19%

                                                                                                                   Phase I
                                                                                                                    17%




                                                                                 Phase II
                                                                                  57%

                                         Source: GBI Research




                                        Major pharmaceutical companies such as Pfizer, Astrazeneca, Sanofi-aventis, Merck, Roche and
                                        Novartis are active in the pipeline for oncology. The rapid entry of new players and the highly active
                                        pipeline will intensify the competition.




Oncology Market in India to 2017 - Limited Patient Affordability                                                 GBIHC058MR / Published DEC 2010
for High Priced Biologics Lowers Market Potential
                                                                                                                                              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..................................................................................................................... 6
                                          1.2    List of Figures ................................................................................................................... 8
                                        2 Oncology Market in India: Introduction ...................................................................................... 10
                                          2.1    GBI Research Report Guidance ..................................................................................... 11
                                        3 Oncology Market in India: Market Characterization ................................................................... 12
                                          3.1    Market Size ..................................................................................................................... 12
                                          3.2    Annual Cost of Treatment ............................................................................................... 13
                                          3.3    Treatment Usage Pattern ................................................................................................ 14
                                             3.3.1    Diseased Population................................................................................................ 15
                                             3.3.2    Treated Population .................................................................................................. 16
                                          3.4    Drivers ............................................................................................................................ 17
                                             3.4.1    High Spending By Big Pharmaceutical Companies for Drug Trials ......................... 17
                                             3.4.2    Larger Population Base ........................................................................................... 17
                                             3.4.3    High Government Support and Initiatives ................................................................ 18
                                          3.5    Barriers ........................................................................................................................... 19
                                             3.5.1    Counterfeit Medical Products................................................................................... 19
                                             3.5.2    Unfavorable Patent Law for Bigger Companies ....................................................... 19
                                             3.5.3    Restrictive Pricing and Reimbursement Policies Causing Serious Problems in the
                                                      Cancer Market Growth ............................................................................................ 19
                                             3.5.4    Poor Infrastructure and Insufficient Trained Manpower ........................................... 20
                                             3.5.5    More than 80 Molecules to be launched Over the Next Seven Years, Leading to
                                                      More Competition .................................................................................................... 20
                                          3.6    Case Studies................................................................................................................... 21
                                             3.6.1    Unfavorable Patent Law for Bigger Foreign Companies, Roche versus Cipla......... 21
                                             3.6.2    Unfavorable Patent Law for Bigger Foreign Companies, Novartis – Glivec ............. 23
                                        4 Oncology Market in India: Therapeutic Landscape.................................................................... 25
                                          4.1    Introduction ..................................................................................................................... 25
                                          4.2    Breast Cancer ................................................................................................................. 25
                                             4.2.1    Market Size.............................................................................................................. 25
                                             4.2.2    Average Annual Cost of Treatment ......................................................................... 26
                                             4.2.3    Treatment Usage Pattern ........................................................................................ 27
                                             4.2.4    Drivers ..................................................................................................................... 29
                                             4.2.5    Restraints ................................................................................................................ 30
                                          4.3    Colorectal Cancer ........................................................................................................... 31
                                             4.3.1    Market Size.............................................................................................................. 31
                                             4.3.2    Annual Cost of Treatment........................................................................................ 32
                                             4.3.3    Treatment Usage Pattern ........................................................................................ 33
                                             4.3.4    Drivers ..................................................................................................................... 35
                                             4.3.5    Restraints ................................................................................................................ 36
                                          4.4    Prostate Cancer .............................................................................................................. 37
                                             4.4.1    Market Size.............................................................................................................. 37
                                             4.4.2    Annual Cost of Treatment........................................................................................ 38
                                             4.4.3    Drivers ..................................................................................................................... 39
                                             4.4.4    Restraints ................................................................................................................ 39
                                             4.4.5    Treatment Usage Pattern ........................................................................................ 39
                                          4.5    Lung Cancer ................................................................................................................... 42
                                             4.5.1    Market Size.............................................................................................................. 42
                                             4.5.2    Annual Cost of Treatment........................................................................................ 43
                                             4.5.3    Drivers ..................................................................................................................... 44
                                             4.5.4    Restraints ................................................................................................................ 44
                                             4.5.5    Treatment Usage Pattern ........................................................................................ 45
                                          4.6    Non-Hodgkin’s Lymphoma .............................................................................................. 48


Oncology Market in India to 2017 - Limited Patient Affordability                                                                       GBIHC058MR / Published DEC 2010
for High Priced Biologics Lowers Market Potential
                                                                                                                                                                              Page 3
                                                                                          © GBI Research. This is a licensed product and is not to be photocopied
                                               4.6.1   Market Size.............................................................................................................. 48
                                               4.6.2   Annual Cost of Treatment........................................................................................ 49
                                               4.6.3   Drivers ..................................................................................................................... 50
                                               4.6.4   Restraints ................................................................................................................ 50
                                               4.6.5   Treatment Usage Pattern ........................................................................................ 51
                                        5   Oncology in India: Regulatory Landscape ................................................................................. 54
                                            5.1    Major Regulatory Bodies in India .................................................................................... 54
                                               5.1.1   The Central Drugs Standard Control Organization (CDSCO) .................................. 54
                                               5.1.2   State Drug Regulatory Authority (SDRA) ................................................................. 55
                                            5.2    IPR Protection in India .................................................................................................... 56
                                               5.2.1   Effect of Patent Laws on Pharmaceutical Production in India ................................. 58
                                               5.2.2   Key Impact of Newer Patent Laws on India ............................................................. 58
                                            5.3    Key Regulations for Conducting Oncology Research in India ......................................... 59
                                            5.4    Government Initiatives to Support Oncology Research in India ...................................... 60
                                               5.4.1   Focus Areas ............................................................................................................ 61
                                            5.5    Oncology in India: Pricing and Reimbursements ............................................................ 62
                                               5.5.1   Pricing of Oncology Drugs in India .......................................................................... 62
                                               5.5.2   Reimbursement of Oncology Drugs in India ............................................................ 65
                                        6   Oncology in India: Pipeline Analysis .......................................................................................... 67
                                            6.1    Key Area Focus for R&D in India .................................................................................... 67
                                            6.2    Pipeline Segmentation by Clinical Phase of Development.............................................. 67
                                            6.3    Pipeline Segmentation by Indication ............................................................................... 68
                                               6.3.1   Lung Cancer ............................................................................................................ 69
                                               6.3.2   Breast Cancer.......................................................................................................... 70
                                               6.3.3   Colorectal Cancer .................................................................................................... 71
                                               6.3.4   Non-Hodgkin’s Lymphoma ...................................................................................... 72
                                               6.3.5   Prostate Cancer....................................................................................................... 73
                                            6.4    Key Late Stage Pipeline Drugs ....................................................................................... 74
                                               6.4.1   Lung Cancer ............................................................................................................ 74
                                               6.4.2   Breast Cancer.......................................................................................................... 75
                                               6.4.3   Colorectal Cancer .................................................................................................... 77
                                               6.4.4   Non-Hodgkin’s Lymphoma ...................................................................................... 81
                                               6.4.5   Prostate Cancer....................................................................................................... 84
                                        7   Oncology in India: Competitive Landscape ............................................................................... 88
                                            7.1    Key Indian Players in the Indian Oncology Market.......................................................... 88
                                               7.1.1   Dr. Reddy’s Lab ....................................................................................................... 88
                                               7.1.2   Piramal Healthcare .................................................................................................. 91
                                               7.1.3   Biocon Limited ......................................................................................................... 95
                                               7.1.4   Cipla Ltd. ................................................................................................................. 97
                                            7.2    Key Foreign Players in the Indian Oncology Market ..................................................... 100
                                               7.2.1   Sanofi-Aventis ....................................................................................................... 100
                                               7.2.2   F. Hoffmann-La Roche Ltd/Genentech, Inc. .......................................................... 104
                                               7.2.3   AstraZeneca .......................................................................................................... 107
                                               7.2.4   GlaxoSmithKline .................................................................................................... 109
                                        8   Deals Landscape ..................................................................................................................... 112
                                            8.1    Mergers and Acquisitions .............................................................................................. 112
                                               8.1.1   Deals by Year ........................................................................................................ 112
                                               8.1.2   Deals by Type........................................................................................................ 113
                                               8.1.3   Deal by Value ........................................................................................................ 114
                                               8.1.4   Top 10 M&A Deals ................................................................................................ 115
                                            8.2    Licensing Agreements .................................................................................................. 118
                                               8.2.1   Deals by Year ........................................................................................................ 118
                                               8.2.2   Deals by Value ...................................................................................................... 119
                                               8.2.3   Key Takeaway ....................................................................................................... 120
                                               8.2.4   Top 10 Licensing Deals ......................................................................................... 120

Oncology Market in India to 2017 - Limited Patient Affordability                                                                      GBIHC058MR / Published DEC 2010
for High Priced Biologics Lowers Market Potential
                                                                                                                                                                             Page 4
                                                                                         © GBI Research. This is a licensed product and is not to be photocopied
                                        9   Appendix ................................................................................................................................. 123
                                            9.1    Market Definitions ......................................................................................................... 123
                                            9.2    Abbreviations ................................................................................................................ 123
                                            9.3    Research Methodology ................................................................................................. 124
                                               9.3.1    Coverage ............................................................................................................... 124
                                               9.3.2    Secondary Research ............................................................................................. 124
                                               9.3.3    Primary Research .................................................................................................. 125
                                               9.3.4    Expert Panel Validation ......................................................................................... 125
                                            9.4    Contact Us .................................................................................................................... 125
                                            9.5    Disclaimer ..................................................................................................................... 125
                                            9.6    Sources ......................................................................................................................... 126




Oncology Market in India to 2017 - Limited Patient Affordability                                                                        GBIHC058MR / Published DEC 2010
for High Priced Biologics Lowers Market Potential
                                                                                                                                                                                Page 5
                                                                                          © GBI Research. This is a licensed product and is not to be photocopied
                                        1.1     List of Tables
                                        Table 1:    Oncology Market, India, $m, 2002–2009 ....................................................................... 12
                                        Table 2:    Oncology Market, India, $m, 2009-2017 ........................................................................ 12
                                        Table 3:    Oncology Market, India, Annual Cost of Treatment, $, 2002–2009 ................................ 13
                                        Table 4:    Oncology Market, India, Annual Cost of Treatment, $, 2009–2017 ................................ 13
                                        Table 5:    Oncology Market, India, Treatment Usage Patterns, 2002–2009 .................................. 14
                                        Table 6:    Oncology Market, India, Treatment Usage Patterns, 2009–2017 .................................. 14
                                        Table 7:    Oncology Market, India, Breast Cancer, Market Size, ($m), 2002–2009 ....................... 25
                                        Table 8:    Oncology Market, India, Breast Cancer, Market Size, ($m), 2009-2017 ........................ 25
                                        Table 9:    Oncology Market, India, Breast Cancer, Average Annual Cost of Treatment, 2002-2009
                                                    ....................................................................................................................................... 26
                                        Table 10:   Oncology Market, India, Breast Cancer, Average Annual Cost of Treatment, 2009-2017
                                                    ....................................................................................................................................... 26
                                        Table 11:   Oncology Market, India, Breast Cancer, Treatment Usage Patterns, 2002–2009 .......... 27
                                        Table 12:   Oncology Market, India, Breast Cancer, Treatment Usage Patterns, 2009-2017 .......... 27
                                        Table 13:   Oncology Market, Colorectal Cancer, India, Market Size, ($m), 2002–2009.................. 31
                                        Table 14:   Oncology Market, Colorectal Cancer, India, Market Size, ($m), 2009–2017.................. 31
                                        Table 15:   Oncology Market, Colorectal Cancer, India, Annual Cost of Treatment, ($), 2002–2009
                                                    ....................................................................................................................................... 32
                                        Table 16:   Oncology Market, Colorectal Cancer, India, Annual Cost of Treatment, ($), 2009–2017
                                                    ....................................................................................................................................... 32
                                        Table 17:   Oncology Market, India, Colorectal Cancer, Treatment Usage Pattern, 2002-2009....... 33
                                        Table 18:   Oncology Market, India, Colorectal Cancer, Treatment Usage Pattern, 2009-2017....... 33
                                        Table 19:   Oncology Market, India, Prostate Cancer, Market Size, ($m), 2002–2009 .................... 37
                                        Table 20:   Oncology Market, India, Prostate Cancer, Market Size, ($m), 2009–2017 .................... 37
                                        Table 21:   Oncology Market, India, Prostate Cancer, Annual Cost of Treatment, ($), 2002–2009. 38
                                        Table 22:   Oncology Market, India, Prostate Cancer, Annual Cost of Treatment, ($), 2009–2017. 38
                                        Table 23:   Oncology Market, India, Prostate Cancer, Treatment Usage Pattern, 2002–2009 ........ 40
                                        Table 24:   Oncology Market, India, Prostate Cancer, Treatment Usage Pattern, 2009–2017 ........ 40
                                        Table 25:   Oncology Market, India, Lung Cancer, Market Size, ($m), 2002–2009 .......................... 42
                                        Table 26:   Oncology Market, India, Lung Cancer, Market Size, ($m), 2009–2017 .......................... 42
                                        Table 27:   Oncology Market, India, Lung Cancer, Average Annual Cost of Treatment, ($), 2002–
                                                    2009 ............................................................................................................................... 43
                                        Table 28:   Oncology Market, India, Lung Cancer, Average Annual Cost of Treatment, ($), 2009–
                                                    2017 ............................................................................................................................... 43
                                        Table 29:   Oncology Market, India, Lung Cancer, Treatment Usage Pattern, 2002–2009 .............. 45
                                        Table 30:   Oncology Market, India, Lung Cancer, Treatment Usage Pattern, 2009–2017 .............. 45
                                        Table 31:   Oncology Market, India, Non-Hodgkin’s Lymphoma, Market Size, ($m), 2002-2009 ..... 48
                                        Table 32:   Oncology Market, India, Non-Hodgkin’s Lymphoma, Market Size, ($m), 2009-2017 ..... 48
                                        Table 33:   Oncology Market, India, Non-Hodgkin’s Lymphoma, Average Annual Cost of Treatment,
                                                    2002-2009 ...................................................................................................................... 49
                                        Table 34:   Oncology Market, India, Non-Hodgkin’s Lymphoma, Average Annual Cost of Treatment,
                                                    2009-2017 ...................................................................................................................... 49
                                        Table 35:   Oncology Market, India, Non-Hodgkin’s Lymphoma, Treatment Usage Pattern, 2002-
                                                    2009 ............................................................................................................................... 51
                                        Table 36:   Oncology Market, India, Non-Hodgkin’s Lymphoma, Treatment Usage Pattern, 2009-
                                                    2017 ............................................................................................................................... 51
                                        Table 37:   Oncology Market, India, Competitive Landscape, Dr. Reddy’s, Marketed Products, 2009
                                                    ....................................................................................................................................... 90
                                        Table 38:   Oncology Market, India, Competitive Landscape, Dr. Reddy’s, Product Pipeline, 2009 90
                                        Table 39:   Oncology Market, India, Competitive Landscape, Dr. Reddy’s, M&A , Licensing Deals,
                                                    2009-2010 ...................................................................................................................... 91
                                        Table 40:   Oncology Market, India, Competitive Landscape, Piramal Life Sciences, Product
                                                    Pipeline, 2009 ................................................................................................................ 93
                                        Table 41:   Oncology Market, India, Competitive Landscape, Piramal Life Sciences, M&A Deals,
                                                    2009-2010 ...................................................................................................................... 94
                                        Table 42:   Oncology Market, India, Competitive Landscape, Biocon Limited, Marketed Products,
                                                    2009 ............................................................................................................................... 96
                                        Table 43:   Oncology Market, India, Competitive Landscape, Biocon Limited, Product Pipeline, 2009
                                                    ....................................................................................................................................... 96
                                        Table 44:   Oncology Market, India, Competitive Landscape, Cipla Ltd., M&A Deals, 2009-2010 ... 99


Oncology Market in India to 2017 - Limited Patient Affordability                                                                         GBIHC058MR / Published DEC 2010
for High Priced Biologics Lowers Market Potential
                                                                                                                                                                                   Page 6
                                                                                         © GBI Research. This is a licensed product and is not to be photocopied
                                        Table 45: Oncology Market, India, Competitive Landscape, Key Foreign Players, Sanofi-Aventis,
                                                  Major Marketed Products, 2009 ................................................................................... 102
                                        Table 46: Oncology Market, India, Competitive Landscape, Key Foreign Players, Sanofi-Aventis,
                                                  Major Pipeline Products, 2009 ..................................................................................... 103
                                        Table 47: Oncology Market, India, Competitive Landscape, Key Foreign Players, F. Hoffmann-La
                                                  Roche Ltd., Major Marketed Products, 2009 ................................................................ 106
                                        Table 48: Oncology Market, India, Competitive Landscape, Key Foreign Players, F. Hoffmann-La
                                                  Roche Ltd., Major Pipeline Products, 2009 .................................................................. 106
                                        Table 49: Oncology Market, India, Competitive Landscape, Key Foreign Players, AstraZeneca,
                                                  Marketed Products, 2009 ............................................................................................. 108
                                        Table 50: Oncology Market, India, Competitive Landscape, Key Foreign Players, AstraZeneca,
                                                  Oncology Pipeline, 2009 .............................................................................................. 109
                                        Table 51: Oncology Market, India, Competitive Landscape, Key Foreign Players, GlaxoSmithKline
                                                  Pharmaceuticals Ltd, Marketed Products, 2009 ........................................................... 111
                                        Table 52: Oncology Market, India, Competitive Landscape, Key Foreign Players, GlaxoSmithKline
                                                  Pharmaceuticals Ltd, Pipeline Products, 2009 ............................................................. 111
                                        Table 53: Oncology Market, India, Deals Landscape, M&A Deals, 2004-2010 ............................ 115




Oncology Market in India to 2017 - Limited Patient Affordability                                                               GBIHC058MR / Published DEC 2010
for High Priced Biologics Lowers Market Potential
                                                                                                                                                                   Page 7
                                                                                      © GBI Research. This is a licensed product and is not to be photocopied
                                        1.2       List of Figures
                                        Figure 1: Oncology Market, India, $m, 2002-2017 ........................................................................ 12
                                        Figure 2: Oncology Market, India, Annual Cost of Treatment, $, 2002-2017................................. 13
                                        Figure 3: Oncology Market, India, Treatment Usage Patterns, 2002-2017 ................................... 14
                                        Figure 4: Oncology Market, India, Total Diseased Population, 2002-2017 ................................... 15
                                        Figure 5: Oncology Market, India, Total Treated Population, 2002-2017 ...................................... 16
                                        Figure 6: Oncology Market, India, Drivers and Restraints, 2009 ................................................... 18
                                        Figure 7: Oncology Market, India, Case Studies, Roche versus Cipla, 2006-2010 ....................... 21
                                        Figure 8: Oncology Market, India, Case Studies, Novartis, 1993-2010 .
								
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