GLOBAL MARKETS FOR EMERGING INSULIN DRUG AND DELIVERY TECHNOLOGIES - FOCUS ON INSULIN PENS. HLC157A August Shalini Shahani Dewan Project Analyst

Transcription

1 GLOBAL MARKETS FOR EMERGING INSULIN DRUG AND DELIVERY TECHNOLOGIES - FOCUS ON INSULIN PENS HLC157A August 2013 Shalini Shahani Dewan Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA , Custom Reports: carol.laverty@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY OBJECTIVES 2 REASONS FOR DOING THIS STUDY 2 CONTRIBUTIONS OF THE STUDY AND FOR WHOM 2 SCOPE OF THE STUDY 3 METHODOLOGY 3 INFORMATION SOURCES 3 ABOUT THE AUTHOR 3 RELATED BCC RESEARCH REPORTS 4 BCC ONLINE SERVICES 4 DISCLAIMER 4 CHAPTER 2 SUMMARY 6 SUMMARY TABLE GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET, SUMMARY FIGURE GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET, 7 8 CHAPTER 3 OVERVIEW 10 DIABETES OVERVIEW 10 DIABETES CLASSIFICATION 10 TABLE 1 DISTINGUISHING FEATURES OF TYPE 1 AND TYPE 2 DIABETES 11 EPIDEMIOLOGY 13 TABLE 2 ESTIMATED DIABETES CASES IN 2030 AND POPULATION CHANGES WITH RESPECT TO 2000 TYPE 1 DIABETES MELLITUS MANAGEMENT 14 INSULIN 15 HISTORY OF INSULIN ISOLATION AND THE DEVELOPMENT OF ITS ANALOGS 15 TABLE 3 HISTORY OF INSULIN ISOLATION AND DEVELOPMENT 15 STRUCTURE OF INSULIN 16 INSULIN BIOSYNTHESIS 16 INSULIN TYPES 17 TABLE 4 CHARACTERISTIC PROPERTIES OF VARIOUS INSULIN FORMULATIONS 19 TREATMENT PROTOCOL 20 Multiple Daily Injections 20 TABLE 5 ADVANTAGES AND DISADVANTAGES OF SYRINGES 21 Continuous Subcutaneous Insulin Infusion and Insulin Pump Therapy 21 TABLE 6 INSULIN PUMPS CURRENTLY ON THE MARKET 22 TABLE 7 COMPARATIVE DEPICTION OF RISK VERSUS BENEFIT FEATURES FOR VARIOUS INSULIN DELIVERY SYSTEMS TABLE 8 INSULIN PENS CURRENTLY ON THE MARKET 25 ADMINISTRATION ROUTES 26 TABLE 9 INSULIN ADMINISTRATION ROUTES CHAPTER 4 REGULATORY ASPECTS 29 APPROVALS FOR INSULIN DRUGS 29

3 TABLE 10 INSULIN DRUG APPROVALS, 2009-MARCH APPROVALS GRANTED FOR INSULIN DEVICES 30 TABLE 11 PREMARKET APPROVAL SUPPLEMENTAL APPROVALS FOR INSULIN DEVICES, 2009 MARCH 2013 PREMARKET NOTIFICATION OR 510(K) CLEARANCE 32 TABLE 12 PREMARKET NOTIFICATION OR 510 (K) CLEARANCES FOR INSULIN DEVICES, 2009 MARCH 2013 SAFETY ALERTS AND RECALLS 34 TABLE 13 SAFETY ALERTS FOR INSULIN DRUGS AND DEVICES, 2009 APRIL TABLE 14 DRUG RECALLS FOR INSULIN DRUGS AND DEVICES, 2009 APRIL CHAPTER 5 NEW DEVELOPMENTS 41 NEW TECHNOLOGIES FOR INSULIN DELIVERY 42 INSULIN INHALERS 42 INSULIN SPRAY 42 IMPLANTABLE INSULIN PUMPS 42 TRANSDERMAL PATCH 42 PRODUCT DEVELOPMENT 43 TABLE 15 NEW DEVELOPMENTS FOR INSULIN DRUGS AND DELIVERY DEVICES 43 MERGERS AND ACQUISITIONS 45 TABLE 16 INSULIN DRUG AND DELIVERY DEVICE COMPANY MERGERS AND ACQUISITIONS LICENSING, PARTNERSHIPS, AND AGREEMENTS 47 TABLE 17 LICENSING, PARTNERSHIPS, AND AGREEMENTS FOR INSULIN DRUGS AND DELIVERY DEVICES PIPELINE PRODUCTS 51 TABLE 18 INSULIN DRUG AND DELIVERY DEVICE PIPELINE PRODUCTS CHAPTER 6 GLOBAL MARKETS 56 MARKET BY TYPE 57 MARKET OVERVIEW 57 MARKET REVENUE 58 TABLE 19 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY TYPE, FIGURE 1 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY TYPE, MARKET SHARE 59 TABLE 20 INSULIN DRUG AND DELIVERY DEVICE MARKET SHARES BY TYPE, 2012 (%) FIGURE 2 INSULIN DRUG AND DEVICE MARKET SHARES BY TYPE, 2012 (%) 60 MARKET BY REGION 60 MARKET OVERVIEW 61 MARKET REVENUE 62 TABLE 21 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY REGION, FIGURE 3 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY REGION, MARKET SHARE

4 TABLE 22 INSULIN DRUG AND DELIVERY DEVICE MARKET SHARE BY REGION, 2012 (%) FIGURE 4 INSULIN DRUG AND DEVICE MARKET SHARE BY REGION, 2012 (%) 63 INSULIN SYRINGES AND VIALS 64 Market Overview 64 Market Revenue 64 TABLE 23 GLOBAL INSULIN SYRINGE AND VIAL MARKET BY REGION, THROUGH 2018 ($ MILLIONS) FIGURE 5 GLOBAL INSULIN SYRINGE AND VIAL MARKET BY REGION, ($ MILLIONS) Market Share 65 TABLE 24 INSULIN SYRINGE AND VIAL MARKET SHARES BY REGION, 2012 (%) 66 FIGURE 6 INSULIN SYRINGE AND VIAL MARKET SHARES BY REGION, 2012 (%) 66 INSULIN PENS 66 Market Overview 67 Market Revenue 67 TABLE 25 GLOBAL INSULIN PEN MARKET BY REGION, 68 FIGURE 7 GLOBAL INSULIN PEN MARKET BY REGION, 68 Market Share 68 TABLE 26 INSULIN PEN MARKET SHARES BY REGION, 2012 (%) 69 FIGURE 8 INSULIN PEN MARKET SHARES BY REGION, 2012 (%) 69 INSULIN PUMPS 69 Market Overview 70 Market Revenue 71 TABLE 27 GLOBAL INSULIN PUMP MARKET BY REGION, THROUGH 2018 ($ MILLIONS) FIGURE 9 GLOBAL INSULIN PUMP MARKET BY REGION, THROUGH 2018 ($ MILLIONS) Market Share 72 TABLE 28 INSULIN PUMP MARKET SHARES BY REGION, 2012 (%) 72 FIGURE 10 INSULIN PUMP MARKET SHARES BY REGION, 2012 (%) 72 MARKET BY APPLICATIONS 73 TYPE 1 DIABETES 73 TYPE 2 DIABETES 74 GESTATIONAL DIABETES 75 MARKET OVERVIEW 75 MARKET REVENUE 76 TABLE 29 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY APPLICATION, FIGURE 11 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY APPLICATION, MARKET SHARE 77 TABLE 30 INSULIN DRUG AND DELIVERY DEVICE MARKET SHARES BY APPLICATION, 2012 (%) FIGURE 12 INSULIN DRUG AND DELIVERY DEVICE MARKET SHARES BY APPLICATION, 2012 (%) CHAPTER 7 INSULIN PEN MARKET ANALYSIS 80 MARKET BY TYPE 80

5 MARKET OVERVIEW 81 MARKET REVENUE 81 TABLE 31 GLOBAL INSULIN PEN MARKET BY TYPE, 81 FIGURE 13 GLOBAL INSULIN PEN MARKET BY TYPE, 81 MARKET SHARE 82 TABLE 32 INSULIN PEN MARKET SHARES BY TYPE, 2012 (%) 82 FIGURE 14 INSULIN PEN MARKET SHARES BY TYPE, 2012 (%) 82 MARKET BY REGION 83 MARKET OVERVIEW 83 MARKET REVENUE 84 TABLE 33 GLOBAL INSULIN PEN MARKET BY REGION, 84 FIGURE 15 GLOBAL INSULIN PEN MARKET BY REGION, 85 DURABLE OR REUSABLE INSULIN PENS 85 Market Overview 85 Market Revenue 86 TABLE 34 GLOBAL DURABLE OR REUSABLE INSULIN PEN MARKET BY REGION, FIGURE 16 GLOBAL DURABLE OR REUSABLE INSULIN PEN MARKET BY REGION, DISPOSABLE INSULIN PENS 87 Market Overview 87 Market Revenue 88 TABLE 35 GLOBAL DISPOSABLE INSULIN PEN MARKET BY REGION, THROUGH 2018 ($ MILLIONS) FIGURE 17 GLOBAL DISPOSABLE INSULIN PEN MARKET BY REGION, THROUGH 2018 ($ MILLIONS) MARKET SHARE 89 TABLE 36 INSULIN PEN MARKET SHARES BY REGION, 2012 (%) 89 FIGURE 18 INSULIN PEN MARKET SHARES BY REGION, 2012 (%) 89 MARKET BY APPLICATIONS 90 TYPE 1 DIABETES 90 TYPE 2 DIABETES 91 GESTATIONAL DIABETES 91 MARKET OVERVIEW 91 MARKET REVENUE 92 TABLE 37 INSULIN PEN MARKET BY APPLICATION, 92 FIGURE 19 INSULIN PEN MARKET BY APPLICATION, 92 MARKET SHARE 93 TABLE 38 INSULIN PEN MARKET SHARES BY APPLICATION, 2012 (%) 93 FIGURE 20 INSULIN PEN MARKET SHARES BY APPLICATION, 2012 (%) 93 INDUSTRY STRUCTURE 93 MARKET LEADERS 94 TABLE 39 LEADING INSULIN PEN MANUFACTURERS AND SUPPLIERS 94 MARKET SHARES 95 TABLE 40 INSULIN PEN MANUFACTURER MARKET SHARES, 2012 (%) 95 FIGURE 21 INSULIN PEN MANUFACTURER MARKET SHARES, 2012 (%) CHAPTER 8 PATENT ANALYSIS 98

6 PATENTS BY YEAR 98 TABLE 41 U.S. PATENTS, JANUARY 2009 MARCH 2013 (%) 98 FIGURE 22 U.S. PATENTS, JANUARY 2009-MARCH 2013 (%) 98 PATENTS BY TYPE 99 TABLE 42 U.S. INSULIN PATENTS BY TYPE, JANUARY 2009-MARCH FIGURE 23 U.S. INSULIN PATENTS BY TYPE, JANUARY 2009-MARCH PATENTS BY COMPANY 100 TABLE 43 U.S. PATENTS BY COMPANY, JANUARY 2009-MARCH PATENTS BY COUNTRY 102 TABLE 44 U.S. PATENTS BY COUNTRY, JANUARY 2009-MARCH FIGURE 24 U.S. PATENTS BY COUNTRY, JANUARY 2009-MARCH PATENTS BY ASSIGNEE 103 TABLE 45 U.S. PATENTS BY ASSIGNEE, JANUARY 2009-MARCH FIGURE 25 U.S. PATENTS BY ASSIGNEE, JANUARY 2009-MARCH CHAPTER 9 CURRENT SITUATION 106 MARKET TRENDS 107 INSULIN PUMPS 107 Artificial Pancreas 107 Closed-Loop Insulin Pump 107 INSULIN PENS 108 INSULIN SYRINGES 108 MODERN INSULIN AND ALTERNATIVE DELIVERY METHODS 108 ORAL INSULIN 108 NASAL INSULIN SPRAY 109 BIOSIMILAR INSULIN 109 OVERALL MARKET DRIVERS FOR INSULIN DELIVERY DEVICE MARKET 109 FACTORS GOVERNING THE INSULIN DELIVERY DEVICE MARKET 110 COLLABORATIONS, MERGERS AND AQUISITIONS 110 CHAPTER 10 COMPANY PROFILES 114 ADOCIA 114 ANIMAS CORPORATION 114 ANTRIABIO 115 BECTON, DICKINSON AND COMPANY 116 BIOCON LIMITED 116 BIODEL INC. 117 DEBIOTECH 118 ELI LILLY 118 ETERNITY HEALTHCARE 119 F. HOFFMANN-LA ROCHE LTD. (DISETRONIC MEDICAL SYSTEMS AG) 120 GENEREX BIOTECHNOLOGY CORPORATION 120 HALOZYME THERAPEUTICS INC. 121 INSULINE MEDICAL 121 INSULUTION ABM 122 LIFESCAN 122 MANNKIND 123

7 MARINA BIOTECH INC. 124 MEDTRONIC INC. 125 MICROPORT SCIENTIFIC CORPORATION 125 MIDASOL THERAPEUTICS (JOINT VENTURE OF MIDATECH LTD. AND MONOSOL RX) NOVO NORDISK 126 ORAMED PHARMACEUTICALS INC. 127 PHOSPHAGENICS LIMITED 128 SANOFI 128 SENSILE MEDICAL AG 129 THERMALIN DIABETES INC. 130 XERIS PHARMACEUTICALS 131 YPSOMED HOLDING AG

8 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET, TABLE 1 DISTINGUISHING FEATURES OF TYPE 1 AND TYPE 2 DIABETES 11 TABLE 2 ESTIMATED DIABETES CASES IN 2030 AND POPULATION CHANGES WITH RESPECT TO 2000 TABLE 3 HISTORY OF INSULIN ISOLATION AND DEVELOPMENT 15 TABLE 4 CHARACTERISTIC PROPERTIES OF VARIOUS INSULIN FORMULATIONS 19 TABLE 5 ADVANTAGES AND DISADVANTAGES OF SYRINGES 21 TABLE 6 INSULIN PUMPS CURRENTLY ON THE MARKET 22 TABLE 7 COMPARATIVE DEPICTION OF RISK VERSUS BENEFIT FEATURES FOR VARIOUS INSULIN DELIVERY SYSTEMS TABLE 8 INSULIN PENS CURRENTLY ON THE MARKET 25 TABLE 9 INSULIN ADMINISTRATION ROUTES 26 TABLE 10 INSULIN DRUG APPROVALS, 2009-MARCH TABLE 11 PREMARKET APPROVAL SUPPLEMENTAL APPROVALS FOR INSULIN DEVICES, 2009 MARCH 2013 TABLE 12 PREMARKET NOTIFICATION OR 510 (K) CLEARANCES FOR INSULIN DEVICES, 2009 MARCH 2013 TABLE 13 SAFETY ALERTS FOR INSULIN DRUGS AND DEVICES, 2009 APRIL TABLE 14 DRUG RECALLS FOR INSULIN DRUGS AND DEVICES, 2009 APRIL TABLE 15 NEW DEVELOPMENTS FOR INSULIN DRUGS AND DELIVERY DEVICES 43 TABLE 16 INSULIN DRUG AND DELIVERY DEVICE COMPANY MERGERS AND ACQUISITIONS TABLE 17 LICENSING, PARTNERSHIPS, AND AGREEMENTS FOR INSULIN DRUGS AND DELIVERY DEVICES TABLE 18 INSULIN DRUG AND DELIVERY DEVICE PIPELINE PRODUCTS 51 TABLE 19 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY TYPE, TABLE 20 INSULIN DRUG AND DELIVERY DEVICE MARKET SHARES BY TYPE, 2012 (%) 59 TABLE 21 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY REGION, TABLE 22 INSULIN DRUG AND DELIVERY DEVICE MARKET SHARE BY REGION, 2012 (%) TABLE 23 GLOBAL INSULIN SYRINGE AND VIAL MARKET BY REGION, THROUGH 2018 ($ MILLIONS) TABLE 24 INSULIN SYRINGE AND VIAL MARKET SHARES BY REGION, 2012 (%) 66 TABLE 25 GLOBAL INSULIN PEN MARKET BY REGION, 68 TABLE 26 INSULIN PEN MARKET SHARES BY REGION, 2012 (%) 69 TABLE 27 GLOBAL INSULIN PUMP MARKET BY REGION, 71 TABLE 28 INSULIN PUMP MARKET SHARES BY REGION, 2012 (%) 72 TABLE 29 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY APPLICATION, TABLE 30 INSULIN DRUG AND DELIVERY DEVICE MARKET SHARES BY APPLICATION, 2012 (%) TABLE 31 GLOBAL INSULIN PEN MARKET BY TYPE, 81 TABLE 32 INSULIN PEN MARKET SHARES BY TYPE, 2012 (%) 82 TABLE 33 GLOBAL INSULIN PEN MARKET BY REGION, 84 TABLE 34 GLOBAL DURABLE OR REUSABLE INSULIN PEN MARKET BY REGION,

9 TABLE HEADING TABLE 35 GLOBAL DISPOSABLE INSULIN PEN MARKET BY REGION, THROUGH 2018 ($ MILLIONS) TABLE 36 INSULIN PEN MARKET SHARES BY REGION, 2012 (%) 89 TABLE 37 INSULIN PEN MARKET BY APPLICATION, 92 TABLE 38 INSULIN PEN MARKET SHARES BY APPLICATION, 2012 (%) 93 TABLE 39 LEADING INSULIN PEN MANUFACTURERS AND SUPPLIERS 94 TABLE 40 INSULIN PEN MANUFACTURER MARKET SHARES, 2012 (%) 95 TABLE 41 U.S. PATENTS, JANUARY 2009 MARCH 2013 (%) 98 TABLE 42 U.S. INSULIN PATENTS BY TYPE, JANUARY 2009-MARCH TABLE 43 U.S. PATENTS BY COMPANY, JANUARY 2009-MARCH TABLE 44 U.S. PATENTS BY COUNTRY, JANUARY 2009-MARCH TABLE 45 U.S. PATENTS BY ASSIGNEE, JANUARY 2009-MARCH

10 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET, FIGURE 1 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY TYPE, FIGURE 2 INSULIN DRUG AND DEVICE MARKET SHARES BY TYPE, 2012 (%) 60 FIGURE 3 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY REGION, FIGURE 4 INSULIN DRUG AND DEVICE MARKET SHARE BY REGION, 2012 (%) 63 FIGURE 5 GLOBAL INSULIN SYRINGE AND VIAL MARKET BY REGION, ($ MILLIONS) FIGURE 6 INSULIN SYRINGE AND VIAL MARKET SHARES BY REGION, 2012 (%) 66 FIGURE 7 GLOBAL INSULIN PEN MARKET BY REGION, 68 FIGURE 8 INSULIN PEN MARKET SHARES BY REGION, 2012 (%) 69 FIGURE 9 GLOBAL INSULIN PUMP MARKET BY REGION, 72 FIGURE 10 INSULIN PUMP MARKET SHARES BY REGION, 2012 (%) 72 FIGURE 11 GLOBAL INSULIN DRUG AND DELIVERY DEVICE MARKET BY APPLICATION, FIGURE 12 INSULIN DRUG AND DELIVERY DEVICE MARKET SHARES BY APPLICATION, 2012 (%) FIGURE 13 GLOBAL INSULIN PEN MARKET BY TYPE, 81 FIGURE 14 INSULIN PEN MARKET SHARES BY TYPE, 2012 (%) 82 FIGURE 15 GLOBAL INSULIN PEN MARKET BY REGION, 85 FIGURE 16 GLOBAL DURABLE OR REUSABLE INSULIN PEN MARKET BY REGION, FIGURE 17 GLOBAL DISPOSABLE INSULIN PEN MARKET BY REGION, THROUGH 2018 ($ MILLIONS) FIGURE 18 INSULIN PEN MARKET SHARES BY REGION, 2012 (%) 89 FIGURE 19 INSULIN PEN MARKET BY APPLICATION, 92 FIGURE 20 INSULIN PEN MARKET SHARES BY APPLICATION, 2012 (%) 93 FIGURE 21 INSULIN PEN MANUFACTURER MARKET SHARES, 2012 (%) 96 FIGURE 22 U.S. PATENTS, JANUARY 2009-MARCH 2013 (%) 98 FIGURE 23 U.S. INSULIN PATENTS BY TYPE, JANUARY 2009-MARCH FIGURE 24 U.S. PATENTS BY COUNTRY, JANUARY 2009-MARCH FIGURE 25 U.S. PATENTS BY ASSIGNEE, JANUARY 2009-MARCH