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“Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus on the US (2011-2020)”
 

“Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus on the US (2011-2020)”

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With sales worth US$ 57 Million in 2010, biosimilars are still far from their billion dollar sales potential that most analysts believe they will generate. This market, however, unlike small molecule ...

With sales worth US$ 57 Million in 2010, biosimilars are still far from their billion dollar sales potential that most analysts believe they will generate. This market, however, unlike small molecule generics, is expected to be more akin to a marathon than a sprint. IMARC Group, one of the world‘s leading research and advisory firms, in its new report “Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus on the US (2011-2020)” finds that biosimilars in the US will soon represent a multi-billion dollar market as they would be posing stiff competition to as many as twenty biological molecules during 2011-2020.

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    “Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus on the US (2011-2020)” “Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus on the US (2011-2020)” Document Transcript

    • Report Description & HighlightsWith sales worth US$ 57 Million in 2010, biosimilars are still far from their billion dollar sales potentialthat most analysts believe they will generate. This market, however, unlike small molecule generics, isexpected to be more akin to a marathon than a sprint. IMARC Group, one of the world‘s leadingresearch and advisory firms, in its new report “Biosimilar/Follow-on Biologics Market Report &Forecast: A Focus on the US (2011-2020)” finds that biosimilars in the US will soon represent a multi-billion dollar market as they would be posing stiff competition to as many as twenty biologicalmolecules during 2011-2020.Findings from the report suggest that the historical performance of Omnitrope cannot be taken as abenchmark to gauge the potential of pipeline biosimilars as market acceptance for each biosimilar classis expected to vary significantly from one another. The report expects that the competition betweenbranded biological drugs and their biosimilar counterparts would be more of a brand-brand competitionthan a brand-generic competition. The high costs involved in the development and launch of biosimilarsare expected to limit the number of players in this market. As a result, erosions in price and volumecaused by biosimilars are likely to be lower compared to those created by small molecule generics.IMARC‘s new report entitled “Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus onthe US (2011-2020)” provides an analytical and statistical insight into the US biosimilar market. Thestudy, that has been undertaken using desk-based as well as qualitative primary research, provides anddraws upon analysis of six aspects of the US biosimilar market.Key Aspects Analyzed:Evaluating the Current Market Landscape of Biosimilars: Identification of currently marketed biosimilars and their historical performance Identifying the reasons for the slow uptake of currently marketed biosimilars Analyzing historical data to formulate conclusions on the future growth and market trends of biosimilarsEvaluating the Extent of Price, Sales and Volume Erosions Caused by Biosimilars: Analyzing historical time series data on price, volume and sales erosion in the US & Europe Analyzing previous models and assumptions on price and volume erosion caused by biosimilars Evaluating and comparing price and volume erosion created by biosimilars vis-a-vis by small molecule generics Evaluating and comparing price, volume and sales erosion by biosimilars across various biological classesimarc©
    • Evaluating the Market Potential of Biosimilars Across Various Molecules:Molecules Covered: Somatropin (Genotropin/Humatrope/Other HGH), Epoetin Alfa (Epogen/Eprex),Filgrastim (Neupogen), Pegfilgrastim (Neulasta), Insulin Lispro (Humalog), Insulin Glargine (Lantus),Insulin Detemir (Levemir), Interferon Beta-1A (Avonex), Interferon Beta-1A (Rebif), Interferon Beta-1B(Betaferon), Bevacizumab (Avastin), Trastuzumab (Herceptin), Rituximab (Mabthera/Rituxan),Cetuximab (Erbitux), Etanercept (Enbrel), Infliximab (Remicade), Adalimumab (Humira), Ranibizumab(Lucentis), Omalizumab (Xolair) and Natalizumab (Tysabri).Focus of the Analysis for Each Molecule: Historical background and overview Historical brand sales Patent position Competing products Biosimilars in pipeline Brand and biosimilar sales forecastsEvaluating the Sales of Biosimilars across Various Indications:Indications Covered: Immunology & Inflammation, Diabetes, Oncology, Blood Disorders and GrowthDeficiencyFocus of the Analysis for Each Indication: Historical brand sales Brand and biosimilar sales forecasts Indication wise breakup of moleculesEvaluating the Biosimilar Competitive Landscape: Identifying branded biological manufacturers that expect the highest amount of erosion from biosimilars Identifying biosimilar manufacturers and their pipelinesUnderstanding the Current Legislation on Biosimilars: An insight into the Biologics Price Competition and Innovation Act An insight into the key biosimilar issues that still remain unaddressed Interchangeability and Substitutability Data Exclusivity Statutory provisions for dealing with patent litigationsimarc©
    • Table of Contents1 Market Definitions & Research Methodology ............................................................................................... 132 Executive Summary ........................................................................................................................................ 153 The US Biosimilar Market Landscape ........................................................................................................... 214 US Biosimilar Market: Current Experience ................................................................................................... 24 4.1 The Performance of Growth Hormone Biosimilars Has Been Dismal So Far ............................................. 24 4.2 Pediatrics Represent the Prime Customer Base for Growth Hormones ..................................................... 25 4.3 Omnitrope Was Launched with an Inconvenient Delivery Device ............................................................... 25 4.4 Prescribing Patterns for Omnitrope ............................................................................................................ 26 4.5 Uptake is Likely to Increase with the Accumulation of Post-Market Safety Data ........................................ 265 US Biosimlar Market: How Much Price, Volume & Sales Erosion will Result ............................................ 28 5.1 Omnitrope Cannot be Taken as a Benchmark to Gauge the Performance of Other Biosimilars ................ 28 5.2 The European Uptake of ESA & GCSF Biosimilars Give Us a Very Positive Outlook for the US ............... 29 5.3 Models for Biosimilar Volume Erosion Across Various Biological Classes ................................................. 32 5.4 Models for Biosimilar Price Erosion Across Various Biological Classes ..................................................... 36 5.5 Models for Biosimilar Sales Erosion Across Various Biological Classes .................................................... 406 US Biosimilar Market: Current Trends & Forecast by Drug ........................................................................ 41 6.1 Growth Hormones ...................................................................................................................................... 44 6.1.1 Somatropin (Genotropin/Humatrope/Other HGH) .............................................................................. 44 6.1.1.1 Drug Overview ............................................................................................................................... 44 6.1.1.2 Current Brand & Biosimilar Sales .................................................................................................. 45 6.1.1.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 47 6.2 Erythropoiesis Stimulating Agents .............................................................................................................. 49 6.2.1 Epoetin Alfa (Epogen/Eprex) ............................................................................................................. 49 6.2.1.1 Drug Overview ............................................................................................................................... 49 6.2.1.2 Historical Brand Sales ................................................................................................................... 50 6.2.1.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 51 6.3 Granulocyte Colony Stimulating Factor ...................................................................................................... 54 6.3.1 Filgrastim (Neupogen) ....................................................................................................................... 54 6.3.1.1 Drug Overview ............................................................................................................................... 54 6.3.1.2 Historical Brand Sales ................................................................................................................... 55 6.3.1.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 55 6.3.2 Pegfilgrastim (Neulasta) ..................................................................................................................... 57 6.3.2.1 Drug Overview ............................................................................................................................... 57 6.3.2.2 Historical Brand Sales ................................................................................................................... 57 6.3.2.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 58 6.4 Insulin ......................................................................................................................................................... 60 6.4.1 Insulin Lispro (Humalog) .................................................................................................................... 60 6.4.1.1 Drug Overview ............................................................................................................................... 60 6.4.1.2 Historical Brand Sales ................................................................................................................... 60 6.4.1.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 61 6.4.2 Insulin Glargine (Lantus) .................................................................................................................... 63 6.4.2.1 Drug Overview ............................................................................................................................... 63 6.4.2.2 Historical Brand Sales ................................................................................................................... 64 6.4.2.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 64 6.4.3 Insulin Detemir (Levemir) ................................................................................................................... 66 6.4.3.1 Drug Overview ............................................................................................................................... 66 6.4.3.2 Historical Brand Sales ................................................................................................................... 66imarc©
    • 6.4.3.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 67 6.5 Interferons .................................................................................................................................................. 69 6.5.1 Interferon Beta-1A (Avonex) .............................................................................................................. 69 6.5.1.1 Drug Overview ............................................................................................................................... 69 6.5.1.2 Historical Brand Sales ................................................................................................................... 69 6.5.1.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 70 6.5.2 Interferon Beta-1A (Rebif) .................................................................................................................. 72 6.5.2.1 Drug Overview ............................................................................................................................... 72 6.5.2.2 Historical Biosimilar Sales ............................................................................................................. 72 6.5.2.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 73 6.5.3 Interferon Beta-1B (Betaferon/Betaseron) ......................................................................................... 75 6.5.3.1 Drug Overview ............................................................................................................................... 75 6.5.3.2 Historical Brand Sales ................................................................................................................... 75 6.5.3.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 76 6.6 TNF Alpha & Monoclonal Antibodies (Immunology & Inflammation) .......................................................... 78 6.6.1 Etanercept (Enbrel) ............................................................................................................................ 78 6.6.1.1 Drug Overview ............................................................................................................................... 78 6.6.1.2 Historical Brand Sales ................................................................................................................... 79 6.6.1.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 80 6.6.2 Infliximab (Remicade) ........................................................................................................................ 82 6.6.2.1 Drug Overview ............................................................................................................................... 82 6.6.2.2 Historical Brand Sales ................................................................................................................... 83 6.6.2.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 83 6.6.3 Adalimumab (Humira) ........................................................................................................................ 85 6.6.3.1 Drug Overview ............................................................................................................................... 85 6.6.3.2 Historical Brand Sales ................................................................................................................... 85 6.6.3.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 86 6.6.4 Ranibizumab (Lucentis) ..................................................................................................................... 88 6.6.4.1 Drug Overview ............................................................................................................................... 88 6.6.4.2 Historical Brand Sales ................................................................................................................... 88 6.6.4.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 89 6.6.5 Omalizumab (Xolair) .......................................................................................................................... 92 6.6.5.1 Drug Overview ............................................................................................................................... 92 6.6.5.2 Historical Brand Sales ................................................................................................................... 93 6.6.5.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 93 6.6.6 Natalizumab (Tysabri) ........................................................................................................................ 95 6.6.6.1 Drug Overview ............................................................................................................................... 95 6.6.6.2 Historical Brand Sales ................................................................................................................... 96 6.6.6.3 Brand & Biosimilar Forecast (2011-2020)...................................................................................... 97 6.7 Monoclonal Antibodies (Oncology) ........................................................................................................... 100 6.7.1 Bevacizumab (Avastin) .................................................................................................................... 100 6.7.1.1 Drug Overview ............................................................................................................................. 100 6.7.1.2 Historical Brand Sales ................................................................................................................. 101 6.7.1.3 Brand & Biosimilar Forecast (2011-2020).................................................................................... 102 6.7.2 Trastuzumab (Herceptin) ................................................................................................................. 104 6.7.2.1 Drug Overview ............................................................................................................................. 104 6.7.2.2 Historical Biosimilar Sales ........................................................................................................... 104 6.7.2.3 Brand & Biosimilar Forecast (2011-2020).................................................................................... 105 6.7.3 Rituximab (Mabthera) ...................................................................................................................... 107 6.7.3.1 Drug Overview ............................................................................................................................. 107 6.7.3.2 Historical Biosimilar Sales ........................................................................................................... 107 6.7.3.3 Brand & Biosimilar Forecast (2011-2020).................................................................................... 108 6.7.4 Cetuximab (Erbitux) ......................................................................................................................... 110 6.7.4.1 Drug Overview ............................................................................................................................. 110 6.7.4.2 Historical Brand Sales ................................................................................................................. 111 6.7.4.3 Brand & Biosimilar Forecast (2011-2020).................................................................................... 1117 US Biosimilar Market: Current Trends & Forecast by Indication .............................................................. 113 7.1 Immunology & Inflammation ..................................................................................................................... 116 7.1.1 Current Trends & Forecast .............................................................................................................. 116imarc©
    • 7.1.2 Biosimilar Sales Breakup by Molecule ............................................................................................. 117 7.2 Diabetes ................................................................................................................................................... 119 7.2.1 Current Trends & Forecast .............................................................................................................. 119 7.2.2 Biosimilar Sales Breakup by Molecule ............................................................................................. 120 7.3 Oncology .................................................................................................................................................. 121 7.3.1 Current Trends & Forecast .............................................................................................................. 121 7.3.2 Biosimilar Sales Breakup by Molecule ............................................................................................. 122 7.4 Blood Disorders ........................................................................................................................................ 124 7.4.1 Current Trends & Forecast .............................................................................................................. 124 7.4.2 Biosimilar Sales Breakup by Molecule ............................................................................................. 125 7.5 Growth Deficiency .................................................................................................................................... 127 7.5.1 Current Trends & Forecast .............................................................................................................. 127 7.5.2 Biosimilar Sales Breakup by Molecule ............................................................................................. 1288 Competitive Landscape ................................................................................................................................ 129 8.1 Branded Manufacturers: Companies Facing the Highest Amount of Biosimilar Erosion .......................... 129 8.2 Biosimilar Manufacturers: Companies Gaining the Most From Biosimilar Launches ................................ 1329 Biosimilar Legislation in the US................................................................................................................... 136 9.1 The Biologics Price Competition and Innovation Act: An Insight .............................................................. 136 9.2 Biosimilar Issues that Still Remain Unaddressed ..................................................................................... 139 9.3 Major Issues Impacting the Business Strategies of Biological Companies ............................................... 140 9.3.1 Interchangeability & Substitutability ................................................................................................. 140 9.3.2 Data Exclusivity................................................................................................................................ 141 9.3.3 Patent Litigation ............................................................................................................................... 14310 Key Company Profiles .................................................................................................................................. 145 10.1 Teva Pharmaceutical Industries Ltd.......................................................................................................... 145 10.2 Sandoz, Inc............................................................................................................................................... 146 10.3 Hospira, Inc. ............................................................................................................................................. 147 10.4 STADA Arzneimittel AG ............................................................................................................................ 148 10.5 Dr. Reddys Laboratories Ltd. ................................................................................................................... 149 10.6 Celltrion, Inc.............................................................................................................................................. 150 10.7 Bioexpress Therapeutics SA .................................................................................................................... 151imarc©
    • List of FiguresFigure 1-1: Model Used to Forecast Brand and Biosimilar Sales ................................................................................. 14Figure 2-1: US: Executive Summary: Biosimilar Timeline: 2011-2020 ......................................................................... 15Figure 3-1: US: Biosimilar Market (in Million US$), 2007-2010 .................................................................................... 21Figure 3-2: US: Biosimilar Timeline: 2011-2020 ........................................................................................................... 22Figure 3-3: US: Biosimilar Market Forecast (in Million US$), 2011-2020 ..................................................................... 23Figure 4-1: US: Human Growth Hormone Market: Sales Share of Different Brands & Biosimilars (in %), 2007-2010 . 24Figure 4-2: US: Human Growth Hormone Market: Brand & Biosimilar Patient Share (in %), 2007-2020 ..................... 27Figure 5-1: US, Germany, France, Italy, Spain & UK: Somatropin Biosimilars: Patient Share (in %), 2007-2010 ...... 29Figure 5-2: Germany, France, Italy, Spain & UK: Epoetin Alfa Biosimilars: Patient Share (in %), 2007-2010 ............ 30Figure 5-3: US: Percentage of Physicians Expected to Prescribe ESA Biosimilars After They Have Been Launched,(in %), 2010 .................................................................................................................................................................. 31Figure 5-4: Germany, France, Italy, Spain & UK: Filgrastim Biosimilars: Patient Share (in %), 2008-2010 ................ 31Figure 5-5: Average Generic Volume Erosion of Molecules Based-on Complex Drug Characteristics, (in %) ............. 33Figure 5-6: Average Generic Volume Erosion Across Various Countries From Time Since First Generic Entry, (in %)..................................................................................................................................................................................... 35Figure 5-7: Average Generic Price Erosion of Molecules Based Upon Complex Drug Characteristics, (in %) ............ 38Figure 5-8: Average Generic Price Erosion Across Various Countries From Time Since First Generic Entry ............. 38Figure 5-9: Average Brand Price Erosion Across Various Countries From Time Since First Generic Entry ................ 39Figure 6-1: US: Somatropin (Genotropin/Humatrope/Other HGH) Market: Brand & Biosimilar Sales Share (in %),2007-2010 .................................................................................................................................................................... 46Figure 6-2: US: Somatropin (Genotropin/Humatrope/Other HGH) Market: Share of Marketed Brands & Biosimilars (in%), 2007-2010.............................................................................................................................................................. 47Figure 6-3: US: Somatropin (Genotropin/Humatrope/Other HGH) Market Forecast: Brand & Biosimilar Sales Share (in%), 2011-2020.............................................................................................................................................................. 48Figure 6-4: US: Epoetin Alfa (Epogen/Eprex) Market: Share of Marketed Brands (in %), 2007-2010.......................... 51Figure 6-5: US: Epoetin Alfa (Epogen/Eprex) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 . 53Figure 6-6: US: Filgrastim (Neupogen) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ........... 56Figure 6-7: US: Pegfilgrastim (Neulasta) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ......... 59Figure 6-8: US: Insulin Lispro (Humalog) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ......... 62Figure 6-9: US: Insulin Glargine (Lantus) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ......... 65Figure 6-10: US: Insulin Detemir (Levemir) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ...... 68Figure 6-11: US: Interferon Beta-1A (Avonex) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 . 71Figure 6-12: US: Interferon Beta-1A (Rebif) Market: Brand & Biosimilar Sales Share (in %), 2011-2020 ................... 74Figure 6-13: US: Interferon Beta-1B (Betaferon/Betaseron) Market Forecast: Brand & Biosimilar Sales Share (in %),2011-2020 .................................................................................................................................................................... 77Figure 6-14: US: Etanercept (Enbrel) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 .............. 81Figure 6-15: US: Infliximab (Remicade) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ........... 84Figure 6-16: US: Adalimumab (Humira) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 .......... 87Figure 6-17: US: Ranibizumab (Lucentis) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ....... 91Figure 6-18 : US: Omalizumab (Xolair) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ........... 94imarc©
    • Figure 6-19: US: Natalizumab (Tysabri) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 .......... 99Figure 6-20: US: Bevacizumab (Avastin) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ...... 103Figure 6-21: US: Trastuzumab (Herceptin) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ... 106Figure 6-22 : US: Rituximab (Mabthera) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ........ 109Figure 6-23: US: Cetuximab (Erbitux) Market Forecast: Brand & Biosimilar Sales Share (in %), 2011-2020 ........... 112Figure 7-1: US: Biosimilar Market Forecast: Share by Indication (in %), 2011-2020.................................................. 115Figure 7-2: US: Immunology & Inflammation Market Forecast: Brand & Biosimilar Share (in %), 2011-2020 .......... 117Figure 7-3: US: Immunology & Inflammation Market Forecast: Biosimilar Sales Breakup by Molecule (in %), 2011-2020 ........................................................................................................................................................................... 118Figure 7-4: US: Diabetes Market forecast: Brand & Biosimilar Share (in %), 2011-2020 ........................................... 119Figure 7-5: US: Diabetes Market Forecast: Biosimilar Sales Breakup by Molecule (in %), 2011-2020 ..................... 120Figure 7-6: US: Oncology Market Forecast: Brand & Biosimilar Share (in %), 2011-2020......................................... 122Figure 7-7: US: Oncology Market Forecast: Biosimilar Sales Breakup by Molecule (in %), 2011-2020 .................... 123Figure 7-8: US: Blood Disorder Market Forecast: Brand & Biosimilar Share (in %), 2011-2020 ................................ 125Figure 7-9: US: Blood Disorder Biosimilar Market Forecast: Anemia & Neutropenia Sales (in %), 2011-2020.......... 125Figure 7-10: US: Blood Disorder Market Forecast: Biosimilar Sales Breakup by Molecule (in %), 2011-2020 ......... 126Figure 7-11: US: Growth Deficiency Market: Brand & Biosimilar Share (in %), 2007-2010........................................ 127Figure 7-12: US: Growth Deficiency Market Forecast: Brand & Biosimilar Share (in %), 2011-2020 ......................... 128Figure 8-1: US: Innovator Company Brand Sales That Face Biosimilar Sales Erosion (in Million US$), 2010 & 2020................................................................................................................................................................................... 131imarc©
    • List of TablesTable 1-1: US Biosimilar/Follow-On Biologics Market: Market Definition & Overview .................................................. 13Table 2-1: US: Executive Summary: Major Biosimilar Launches ................................................................................. 16Table 2-2: US: Executive Summary: Biosimilar Sales Forecast by Molecule (in Million US$), 2011-2020................... 18Table 2-3: US: Executive Summary: Biosimilar Sales Forecast by Indication (in Million US$), 2011-2020.................. 19Table 3-1: US: Patent Expiries and Biosimilar Launch ................................................................................................. 22Table 5-1: Biosimilar Vulnerability of Various Biopharmaceutical Classes ................................................................... 28Table 5-2: Germany, France, Italy, Spain & UK: Epoetin Alfa Biosimilars: Patient Share (in %), 2007-2010............... 30Table 5-3: Germany, France, Italy, Spain & UK: Filgrastim Biosimilars: Patient Share (in %), 2008-2010 ................. 32Table 5-4: US: Various Studies & Assumptions for Biosimilar Volume Erosion ........................................................... 33Table 5-5: US, Germany and UK: Biosimilar Volume Penetration by Molecule After 3 years from Launch (in %) ....... 36Table 5-6: Various Studies & Assumptions for Biosimilar Price Erosion ...................................................................... 37Table 5-7: US, Germany and UK: Biosimilar Sales Penetration by Molecule After 3 years from Launch (in %) .......... 40Table 6-1: US: Biosimilar Sales by Molecule (in Million US$), 2007-2010 ................................................................... 41Table 6-2: US: Biosimilar Sales Forecast by Molecule (in Million US$), 2011-2020 .................................................... 42Table 6-3: US: Biosimilar Share Forecast by Molecule (in %), 2011-2020................................................................... 43Table 6-4: US: Somatropin: Brand & Biosimilar Market Overview ............................................................................... 45Table 6-5: US: Somatropin (Genotropin/Humatrope/Other HGH) Market: Brand & Biosimilar Sales/Patient Share,2007-2010 .................................................................................................................................................................... 46Table 6-6: US: Somatropin (Genotropin/Humatrope/Other HGH) Market: Sales of Marketed Brands & Biosimilars (inMillion US$), 2007-2010............................................................................................................................................... 46Table 6-7: US: Somatropin (Genotropin/Humatrope/Other HGH) Market Forecast: Brand & Biosimilar Sales/PatientShare, 2011-2020 ........................................................................................................................................................ 48Table 6-8: US: Epoetin Alfa: Brand & Biosimilar Market Overview............................................................................... 49Table 6-9: US: Epoetin Alfa (Epogen/Eprex) Market: Brand Sales (in Millions US$), 2007-2010 ................................ 50Table 6-10: US: Epoetin Alfa (Epogen/Eprex) Market: Sales of Marketed Brands (in Million US$), 2007-2010 .......... 50Table 6-11: US: Epoetin Alfa (Epogen/Eprex) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020..................................................................................................................................................................................... 52Table 6-12: US: Filgrastim: Brand & Biosimilar Market Overview ................................................................................ 54Table 6-13: US: Filgrastim (Neupogen) Market: Brand Sales (in Millions US$), 2007-2010 ........................................ 55Table 6-14: US: Filgrastim (Neupogen) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ......... 56Table 6-15: US: Pegfilgrastim: Brand & Biosimilar Market Overview ........................................................................... 57Table 6-16: US: Pegfilgrastim (Neulasta) Market: Brand Sales (in Millions US$), 2007-2010 ..................................... 58Table 6-17: US: Pegfilgrastim (Neulasta) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ....... 58Table 6-18: US: Insulin Lispro: Brand & Biosimilar Market Overview ........................................................................... 60Table 6-19: US: Insulin Lispro (Humalog) Market: Brand Sales (in Millions US$), 2007-2010 ..................................... 61Table 6-20: US: Insulin Lispro (Humalog) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ...... 62Table 6-21: US: Insulin Glargine: Brand & Biosimilar Market Overview ....................................................................... 63Table 6-22: US: Insulin Glargine (Lantus) Market: Brand Sales (in Millions US$), 2007-2010..................................... 64Table 6-23: US: Insulin Glargine (Lantus) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ..... 65imarc©
    • Table 6-24: US: Insulin Detemir: Brand & Biosimilar Market Overview ........................................................................ 66Table 6-25: US: Insulin Detemir (Levemir) Market: Brand Sales (in Millions US$), 2007-2010 ................................... 67Table 6-26: US: Insulin Detemir (Levemir) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 .... 68Table 6-27: US: Interferon Beta-1A (Avonex): Brand & Biosimilar Market Overview ................................................... 69Table 6-28: US: Interferon Beta-1A (Avonex) Market: Brand Sales (in Millions US$), 2007-2010 .............................. 70Table 6-29: US: Interferon Beta-1A (Avonex) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 . 71Table 6-30: US: Interferon Beta-1A (Rebif): Brand & Biosimilar Market Overview ....................................................... 72Table 6-31: US: Interferon Beta-1A (Rebif) Market: Brand Sales (in Millions US$), 2007-2010 ................................... 73Table 6-32: US: Interferon Beta-1A (Rebif) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 .... 73Table 6-33: US: Interferon Beta-1B: Brand & Biosimilar Market Overview ................................................................... 75Table 6-34: US: Interferon Beta-1B (Betaferon/Betaseron) Market: Brand Sales (in Millions US$), 2007-2010 ......... 76Table 6-35: US: Interferon Beta-1B (Betaferon/Betaseron) Market Forecast: Brand & Biosimilar Sales/Patient Share,2011-2020 .................................................................................................................................................................... 76Table 6-36: US: Etanercept: Brand & Biosimilar Market Overview............................................................................... 79Table 6-37: US: Etanercept (Enbrel) Market: Brand Sales (in Millions US$), 2007-2010............................................. 79Table 6-38: US: Etanercept (Enbrel) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ............. 80Table 6-39: US: Infliximab: Brand & Biosimilar Market Overview ................................................................................ 82Table 6-40: US: Infliximab (Remicade) Market: Brand Sales (in Millions US$), 2007-2010 ......................................... 83Table 6-41: US: Infliximab (Remicade) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020........... 84Table 6-42: US: Adalimumab: Brand & Biosimilar Market Overview ............................................................................ 85Table 6-43: US: Adalimumab (Humira) Market: Brand Sales (in Millions US$), 2007-2010 ........................................ 86Table 6-44: US: Adalimumab (Humira) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 .......... 87Table 6-45: US: Ranibizumab: Brand & Biosimilar Market Overview ........................................................................... 88Table 6-46: US: Ranibizumab (Lucentis) Market: Brand Sales (in Million US$), 2007-2010 ........................................ 89Table 6-47: US: Ranibizumab (Lucentis) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020....... 90Table 6-48: US: Omalizumab: Brand & Biosimilar Market Overview ............................................................................ 92Table 6-49: US: Omalizumab (Xolair) Market: Brand Sales (in Millions US$), 2007-2010 ........................................... 93Table 6-50: US: Omalizumab (Xolair) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ............ 94Table 6-51: US: Natalizumab: Brand & Biosimilar Market Overview ............................................................................ 95Table 6-52: US: Natalizumab (Tysabri) Market: Brand Sales (in Millions US$), 2007-2010......................................... 96Table 6-53: US: Natalizumab (Tysabri) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ......... 98Table 6-54: US: Bevacizumab: Brand & Biosimilar Market Overview ........................................................................ 100Table 6-55: US: Bevacizumab (Avastin) Market: Brand Sales (in Millions US$), 2007-2010 .................................... 101Table 6-56: US: Bevacizumab (Avastin) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020....... 102Table 6-57: US: Trastuzumab: Brand & Biosimilar Market Overview ......................................................................... 104Table 6-58: US: Trastuzumab (Herceptin) Market: Brand Sales (in Millions US$), 2007-2010 ................................. 105Table 6-59: US: Trastuzumab (Herceptin) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 .... 106Table 6-60: US: Rituximab: Brand & Biosimilar Market Overview ............................................................................. 107Table 6-61: US: Rituximab (Mabthera) Market: Brand Sales (in Millions US$), 2007-2010 ....................................... 108Table 6-62: US: Rituximab (Mabthera) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ........ 109Table 6-63: US: Cetuximab: Brand & Biosimilar Market Overview ............................................................................. 110Table 6-64: US: Cetuximab (Erbitux) Market: Brand Sales (in Millions US$), 2007-2010 .......................................... 111imarc©
    • Table 6-65: US: Cetuximab (Erbitux) Market Forecast: Brand & Biosimilar Sales/Patient Share, 2011-2020 ........... 112Table 7-1: US: Biosimilars Market: Indications Assigned for Various Molecules ........................................................ 113Table 7-2: US: Biosimilars Market: Sales by Indication (in Million US$), 2007-2010.................................................. 114Table 7-3: US: Biosimilar Market Forecast: Sales by Indication (in Million US$), 2011-2020 ................................... 114Table 7-4: US: Immunology & Inflammation Market: Brand Sales (in Million US$), 2007-2010 ................................. 116Table 7-5: US: Immunology & Inflammation Market Forecast: Brand & Biosimilar Sales (in Million US$), 2011-2020................................................................................................................................................................................... 116Table 7-6: US: Immunology & Inflammation Market Forecast: Biosimilar Sales Breakup by Molecule (in Million US$),2011-2020 .................................................................................................................................................................. 118Table 7-7: US: Diabetes Market: Brand Sales (in Million US$), 2007-2010 ............................................................... 119Table 7-8: US: Diabetes Market Forecast: Brand & Biosimilar Sales (in Million US$), 2011-2020 ............................ 119Table 7-9: US: Diabetes Market Forecast: Biosimilar Sales Breakup by Molecule (in Million US$), 2011-2020 ....... 120Table 7-10: US: Oncology Market: Brand Sales (in Million US$), 2007-2010 ............................................................ 121Table 7-11: US: Oncology Market Forecast: Brand & Biosimilar Sales (in Million US$), 2011-2020 ......................... 121Table 7-12: US: Oncology Market Forecast: Biosimilar Sales Breakup by Molecule (in Million US$), 2011-2020 .... 122Table 7-13 : US: Blood Disorder Market: Brand Sales (in Million US$), 2007-2010 ................................................... 124Table 7-14 : US: Blood Disorder Market Forecast: Brand & Biosimilar Sales (in Million US$), 2011-2020 ................ 124Table 7-15 : US: Blood Disorder Market Forecast: Biosimilar Sales Breakup by Molecule (in Million US$), 2011-2020................................................................................................................................................................................... 126Table 7-16 : US: Growth Deficiency Market: Brand & Biosimilar Sales (in Million US$), 2007-2010.......................... 127Table 7-17 : US: Growth Deficiency Market Forecast: Brand & Biosimilar Sales (in Million US$), 2011-2020........... 127Table 8-1: US: Innovator Companies Facing the Highest Amount of Biosimilar Sales Erosion (in Million US$), 2010,2013, 2016 & 2020 ..................................................................................................................................................... 130Table 8-2: Companies Developing Herceptin (Trastuzumab) Biosimilars .................................................................. 132Table 8-3: Companies Developing Enbrel (Etanercept) Biosimilars ........................................................................... 133Table 8-4: Companies Developing Remicade (Infliximab) Biosimilars ....................................................................... 133Table 8-5: Companies Developing Mabthera (Rituximab) Biosimilars ....................................................................... 134Table 8-6: Companies Developing Humira (Trastuzumab) Biosimilars ...................................................................... 134Table 8-7: Companies Developing Other Biosimilars ................................................................................................. 135Table 9-1: US: Overview of Biosimilar Legislations .................................................................................................... 136Table 9-2: Comparison of Patent Protection and Data Exclusivity ............................................................................. 143imarc©
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