OPHTHALMIC THERAPEUTIC DRUGS: TECHNOLOGIES AND GLOBAL MARKETS

Transcription

1 OPHTHALMIC THERAPEUTIC DRUGS: TECHNOLOGIES AND GLOBAL MARKETS PHM031D July 2015 Dr. Cheryl Lee Barton Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1) information@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY GOALS AND OBJECTIVES 2 REASONS FOR DOING THE REPORT 2 SCOPE OF REPORT 2 INTENDED AUDIENCE 3 METHODOLOGY AND INFORMATION SOURCES 3 ANALYST'S CREDENTIALS 3 RELATED REPORTS 3 BCC RESEARCH WEBSITE 4 DISCLAIMER 4 CHAPTER 2 SUMMARY 6 SUMMARY TABLE GLOBAL OPHTHALMIC THERAPEUTIC DRUG MARKET BY SEGMENT, THROUGH 2019 ($ SUMMARY FIGURE GLOBAL OPHTHALMIC THERAPEUTIC DRUG MARKET BY SEGMENT, ($ 7 8 CHAPTER 3 RETINAL DISEASES: AGE-RELATED MACULAR DEGENERATION 10 RETINAL DISEASE 10 FIGURE 1 STRUCTURE OF THE EYE 10 AGE-RELATED MACULAR DEGENERATION (AMD) 11 FIGURE 2 AMD ADDRESSABLE PATIENT POPULATION (NUMBERS) 11 DISEASE SUBTYPES 12 Early AMD 12 Intermediate AMD 12 Late-Stage AMD 12 Dry AMD 12 Wet AMD 13 FIGURE 3 PHYSIOLOGICAL CHANGES IN WET AND DRY AMD 13 DIAGNOSIS RATE 14 CURRENT TREATMENT 14 TABLE 1 PRODUCTS APPROVED TO TREAT WET AMD 15 CURRENT MARKET SIZE 15 TABLE 2 GLOBAL AMD SALES OF APPROVED PRODUCTS BY DRUG, THROUGH 2019 ($ TABLE 3 GLOBAL AMD SALES OF APPROVED PRODUCTS BY DRUG CLASS, THROUGH 2019 ($ TABLE 4 GLOBAL AMD SALES OF APPROVED PRODUCTS BY COMPANY, THROUGH 2019 ($ FIGURE 4 GLOBAL MARKET SHARE OF AMD APPROVED PRODUCTS BY COMPANY, MARKET DRIVERS 17 AREAS OF UNMET CLINICAL NEED 18 TABLE 5 AREAS OF UNMET CLINICAL NEED IN AMD TREATMENT 18 NEW THERAPIES FOR WET AMD 18 CONBERCEPT (CHENGDU KANGHONG PHARMACEUTICAL GROUP) 19 LAMPALIZUMAB (GENENTECH) 19 15

3 BROLUCIZUMAB (ALCON) 20 FOVISTA + ANTI-VEGF COMBINATION (ALCON/OPHTHOTECH) 20 TABLE 6 PRODUCTS IN DEVELOPMENT FOR WET AMD PHASE III 21 TABLE 7 PRODUCTS IN DEVELOPMENT FOR WET AMD - PHASE II 21 TABLE 8 PRODUCTS IN DEVELOPMENT FOR WET AMD - PHASE I 23 NEW TREATMENTS FOR DRY AMD 23 TABLE 9 PRODUCTS IN DEVELOPMENT FOR DRY AMD - PHASE III 23 TABLE 10 PRODUCTS IN DEVELOPMENT FOR DRY AMD - PHASE II 24 NEW THERAPIES 24 Emixustat Hydrochloride (Acucela/Otsuka) 24 FIGURE 5 MECHANISM OF ACTION OF ACUCLEA'S VCMS 25 GSK-9337 (GSK) 25 FUTURE MARKET SIZE 25 TABLE 11 GLOBAL AMD SALES OF PIPELINE PRODUCTS, THROUGH 2019 ($ TABLE 12 GLOBAL AMD SALES OF APPROVED AND PIPELINE PRODUCTS, THROUGH 2019 ($ SUMMARY CHAPTER 4 GLAUCOMA 30 FIGURE 6 GLAUCOMA ADDRESSABLE PATIENT POPULATION (NUMBERS) 30 DISEASE SUBTYPES 31 PRIMARY OPEN-ANGLE GLAUCOMA 31 PRIMARY ANGLE-CLOSURE GLAUCOMA 31 FIGURE 7 SCHEMATIC OF OPEN AND CLOSED ANGLE GLAUCOMA 31 DIAGNOSIS RATE 32 CURRENT TREATMENT 33 TABLE 13 APPROVED GLAUCOMA DRUG CHARACTERISTICS 33 MONOTHERAPY 34 TABLE 14 PRODUCTS APPROVED TO TREAT GLAUCOMA - MONOTHERAPY 34 FIXED DOSE COMBINATIONS 35 TABLE 15 PRODUCTS APPROVED TO TREAT GLAUCOMA - FIXED DOSE COMBINATIONS Prescription Patterns 35 FIGURE 8 PRESCRIPTION DRUG CLASSES IN THE U.S., 2013 (%) 35 FIGURE 9 PRESCRIPTION DRUG CLASSES IN EUROPE, 2013 (%) 36 FIGURE 10 PRESCRIPTION DRUG CLASSES IN JAPAN, 2010 (%) 37 CURRENT MARKET SIZE 38 TABLE GLOBAL GLAUCOMA SALES OF APPROVED PRODUCTS, THROUGH 2019 ($ TABLE 17 GLOBAL GLAUCOMA SALES OF APPROVED PRODUCTS BY DRUG CLASS, THROUGH 2019 ($ FIGURE 11 GLOBAL MARKET SHARE OF GLAUCOMA APPROVED PRODUCTS BY DRUG CLASS, TABLE 18 GLOBAL GLAUCOMA SALES OF APPROVED PRODUCTS BY COMPANY, THROUGH 2019 ($ FIGURE 12 GLOBAL MARKET SHARE OF GLAUCOMA APPROVED PRODUCTS BY COMPANY, MARKET DRIVERS

4 AREAS OF UNMET CLINICAL NEED 43 TABLE 19 AREAS OF UNMET CLINICAL NEED IN GLAUCOMA TREATMENT 44 NEW DELIVERY APPROACHES AND FORMULATIONS 44 TABLE 20 PRODUCTS IN DEVELOPMENT TO TREAT GLAUCOMA - PHASE III 45 TABLE 21 PRODUCTS IN DEVELOPMENT TO TREAT GLAUCOMA - PHASE II 46 TABLE 22 PRODUCTS IN DEVELOPMENT TO TREAT GLAUCOMA - PHASE I 47 NEW THERAPIES 47 RHO KINASE (ROCK) INHIBITORS 48 GLANATEC (KOWA) 48 RHOPRESSA AND ROCLATAN (AERIE PHARMACEUTICALS) 48 FIGURE 13 QUADRUPLE MODE OF ACTION OF AERIE PHARMACEUTICALS' RHOPRESSA TABLE 23 ROCK INHIBITORS IN DEVELOPMENT 50 GENE SILENCING AGENTS 50 TABLE 24 GENE SILENCING AGENTS IN DEVELOPMENT 50 BAMOSIRAN (SYLENTIS SA) 50 IST-0036 (ISARNA THERAPEUTICS GMBH) 51 QPI-1007 (QUARK PHARMACEUTICALS) 51 EARLY-STAGE DRUG DEVELOPMENT 52 ANTI-AMYLOID BETA AGENTS 52 CANNABINOIDS 52 TRANSIENT RECEPTOR POTENTIAL VANILLOID ISOFORM 4 (TRPV4) 52 FUTURE MARKET SIZE 53 TABLE 25 GLOBAL GLAUCOMA SALES OF PIPELINE PRODUCTS, THROUGH 2019 ($ TABLE 26 GLOBAL GLAUCOMA SALES OF APPROVED AND PIPELINE PRODUCTS, THROUGH 2019 ($ SUMMARY CHAPTER 5 DRY EYE SYNDROME 58 FIGURE 14 DRY EYE SYNDROME ADDRESSABLE PATIENT POPULATION (NUMBERS) 58 DIAGNOSIS RATE 59 CURRENT TREATMENT 59 TABLE 27 PRODUCTS APPROVED TO TREAT DES 60 CURRENT MARKET SIZE 60 TABLE 28 GLOBAL DES SALES OF APPROVED PRODUCTS, THROUGH 2019 ($ TABLE 29 GLOBAL DES SALES OF APPROVED PRODUCTS BY DRUG CLASS, THROUGH 2019 ($ FIGURE 15 GLOBAL MARKET SHARE OF DES APPROVED PRODUCTS BY DRUG CLASS, TABLE 30 GLOBAL DES SALES OF APPROVED PRODUCTS BY COMPANY, THROUGH 2019 ($ FIGURE GLOBAL MARKET SHARE OF DES APPROVED PRODUCTS BY COMPANY, MARKET DRIVERS 65 AREAS OF UNMET CLINICAL NEED 65 TABLE 31 AREAS OF UNMET CLINICAL NEED IN DES TREATMENT 66 NEW THERAPIES

5 CYCLOKAT/IKERVIS (SANTEN PHARMACEUTICAL) 66 LIFITEGRAST (SHIRE) 66 REFRESH (ACTAVIS) 67 EBI-005 (ELEVEN BIOTHERAPEUTICS) 67 EGP-435 (EYEGATE PHARMA/VALEANT PHARMACEUTICALS) 67 MIM-D3 (MIMETOGEN) 67 TABLE 32 PRODUCTS IN DEVELOPMENT TO TREAT DES - PHASE III 68 TABLE 33 PRODUCTS IN DEVELOPMENT TO TREAT DES - PHASE II 68 NEW FORMULATIONS 69 EARLY-STAGE DRUG DEVELOPMENT 69 FUTURE MARKET SIZE 69 TABLE 34 GLOBAL DES SALES OF PIPELINE PRODUCTS, THROUGH 2019 ($ TABLE 35 GLOBAL DES SALES OF APPROVED AND PIPELINE PRODUCTS, THROUGH 2019 ($ SUMMARY CHAPTER 6 UVEITIS 73 FIGURE 17 UVEITIS ADDRESSABLE PATIENT POPULATION (NUMBERS) 73 DIAGNOSIS RATE 74 CURRENT TREATMENT 75 TABLE 36 PRODUCTS APPROVED TO TREAT UVEITIS 75 CURRENT MARKET SIZE 75 TABLE 37 GLOBAL UVEITIS SALES OF APPROVED PRODUCTS, THROUGH 2019 ($ TABLE 38 GLOBAL UVEITIS SALES OF APPROVED PRODUCTS BY DRUG CLASS, THROUGH 2019 ($ FIGURE 18 GLOBAL MARKET SHARE OF UVEITIS APPROVED PRODUCTS BY DRUG CLASS, TABLE 39 GLOBAL UVEITIS SALES OF APPROVED PRODUCTS BY COMPANY, THROUGH 2019 ($ FIGURE 19 GLOBAL MARKET SHARE OF UVEITIS APPROVED PRODUCTS BY COMPANY, MARKET DRIVERS 79 AREAS OF UNMET CLINICAL NEED 79 TABLE 40 AREAS OF UNMET CLINICAL NEED IN UVEITIS TREATMENT 79 NEW THERAPIES 80 GEVOKIZUMAB (XOMA) 80 SIROLIMUS (SANTEN PHARMACEUTICAL) 80 TABLE 41 PRODUCTS IN DEVELOPMENT TO TREAT UVEITIS - PHASE III 81 TABLE 42 PRODUCTS IN DEVELOPMENT TO TREAT UVEITIS - PHASE II 81 TABLE 43 PRODUCTS IN DEVELOPMENT TO TREAT UVEITIS - PHASE I 82 NEW FORMULATIONS 82 EGP-437 (EYEGATE PHARMA/ VALENAT PHARMACUETICALS) 82 EARLY-STAGE DRUG DEVELOPMENT 83 FUTURE MARKET SIZE 83 TABLE 44 GLOBAL UVEITIS SALES OF PIPELINE PRODUCTS, THROUGH 2019 ($

6 TABLE 45 GLOBAL UVEITIS SALES OF APPROVED AND PIPELINE PRODUCTS, THROUGH 2019 ($ SUMMARY CHAPTER 7 RECENT MARKET ACTIVITY 87 ALLIANCES AND LICENSING DEALS 87 FIGURE 20 OPHTHALMIC ALLIANCE AND LICENSING DEALS BY YEAR, (NO. OF DEALS) FIGURE 21 OPHTHALMIC ALLIANCE AND LICENSING DEALS BY TERRITORY, (NO. OF DEALS) TABLE 46 LEADING OPHTHALMIC DEALS IN THE U.S. BASED ON VALUE, 2007-JULY 2015 ($ TABLE 47 LEADING OPHTHALMIC DEALS IN ASIA BASED ON VALUE, ($ TABLE 48 LEADING OPHTHALMIC DEALS IN EUROPE BASED ON VALUE, ($ ALLIANCES AND LICENSING DEALS BY THERAPEUTIC CATEGORY 91 FIGURE 22 OPHTHALMIC ALLIANCES AND LICENSING DEALS BY THERAPEUTIC CATEGORY, (NO. OF DEALS) TABLE 49 LEADING OPHTHALMIC DEALS IN AMD BASED ON VALUE, ($ TABLE 50 LEADING OPHTHALMIC DEALS IN RETINOPATHY BASED ON VALUE, ($ TABLE 51 LEADING OPHTHALMIC DEALS IN GLAUCOMA BASED ON VALUE, ($ MERGERS AND ACQUISITIONS 96 FIGURE 23 OPHTHALMIC MERGERS AND ACQUISITIONS BY YEAR, (NUMBER) TABLE 52 RECENT ACQUISITIONS IN THE OPHTHALMIC ARENA BASED ON VALUE, JULY 2015 ($ CHAPTER 8 COMPANY PROFILES 101 LEADING PHARMACEUTICALS COMPANIES 101 ACTAVIS (FORMERLY ALLERGAN) 101 ALCON 101 F. HOFFMANN-LA ROCHE 102 MERCK & CO. 103 SHIRE PLC 104 SUMITOMO DAINIPPON PHARMA 104 VALEANT PHARMACEUTICALS 105 LEADING SPECIALIST PHARMA COMPANIES 106 ACUCELA 106 AERIE PHARMACEUTICALS 106 INOTEK PHARMACEUTICALS 107 LUX BIOSCIENCES 107 MOLECULAR PARTNERS AG 108 OPTHERION PHARMACEUTICALS 108 PSIVIDA CORPORATION 109 REGENERON PHARMACEUTICALS 109 RESOLVYX PHARMACEUTICALS 110

7 SANTEN PHARMACEUTICAL CO. LTD 110 SYLENTIS S.A. 111 LEADING GENERIC AND BIOSIMILAR MANUFACTURER 111 AKORN INC. 111 CHAPTER 9 APPENDIX I: ACRONYMS 113 ACRONYMS 113 CHAPTER 10 APPENDIX II: REFERENCES 115 AMD REFERENCES 115 GLAUCOMA REFERENCES 1 DRY EYE SYNDROME REFERENCES 119 UVEITIS REFERENCES 120 WEBSITES 120 WEBLINKS 121

8 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL OPHTHALMIC THERAPEUTIC DRUG MARKET BY SEGMENT, THROUGH 2019 ($ TABLE 1 PRODUCTS APPROVED TO TREAT WET AMD 15 TABLE 2 GLOBAL AMD SALES OF APPROVED PRODUCTS BY DRUG, THROUGH 2019 ($ TABLE 3 GLOBAL AMD SALES OF APPROVED PRODUCTS BY DRUG CLASS, THROUGH 2019 ($ TABLE 4 GLOBAL AMD SALES OF APPROVED PRODUCTS BY COMPANY, THROUGH 2019 ($ TABLE 5 AREAS OF UNMET CLINICAL NEED IN AMD TREATMENT 18 TABLE 6 PRODUCTS IN DEVELOPMENT FOR WET AMD PHASE III 21 TABLE 7 PRODUCTS IN DEVELOPMENT FOR WET AMD - PHASE II 21 TABLE 8 PRODUCTS IN DEVELOPMENT FOR WET AMD - PHASE I 23 TABLE 9 PRODUCTS IN DEVELOPMENT FOR DRY AMD - PHASE III 23 TABLE 10 PRODUCTS IN DEVELOPMENT FOR DRY AMD - PHASE II 24 TABLE 11 GLOBAL AMD SALES OF PIPELINE PRODUCTS, THROUGH 2019 ($ 25 TABLE 12 GLOBAL AMD SALES OF APPROVED AND PIPELINE PRODUCTS, THROUGH 2019 ($ TABLE 13 APPROVED GLAUCOMA DRUG CHARACTERISTICS 33 TABLE 14 PRODUCTS APPROVED TO TREAT GLAUCOMA - MONOTHERAPY 34 TABLE 15 PRODUCTS APPROVED TO TREAT GLAUCOMA - FIXED DOSE COMBINATIONS TABLE GLOBAL GLAUCOMA SALES OF APPROVED PRODUCTS, THROUGH 2019 ($ TABLE 17 GLOBAL GLAUCOMA SALES OF APPROVED PRODUCTS BY DRUG CLASS, THROUGH 2019 ($ TABLE 18 GLOBAL GLAUCOMA SALES OF APPROVED PRODUCTS BY COMPANY, THROUGH 2019 ($ TABLE 19 AREAS OF UNMET CLINICAL NEED IN GLAUCOMA TREATMENT 44 TABLE 20 PRODUCTS IN DEVELOPMENT TO TREAT GLAUCOMA - PHASE III 45 TABLE 21 PRODUCTS IN DEVELOPMENT TO TREAT GLAUCOMA - PHASE II 46 TABLE 22 PRODUCTS IN DEVELOPMENT TO TREAT GLAUCOMA - PHASE I 47 TABLE 23 ROCK INHIBITORS IN DEVELOPMENT 50 TABLE 24 GENE SILENCING AGENTS IN DEVELOPMENT 50 TABLE 25 GLOBAL GLAUCOMA SALES OF PIPELINE PRODUCTS, THROUGH 2019 ($ TABLE 26 GLOBAL GLAUCOMA SALES OF APPROVED AND PIPELINE PRODUCTS, THROUGH 2019 ($ TABLE 27 PRODUCTS APPROVED TO TREAT DES 60 TABLE 28 GLOBAL DES SALES OF APPROVED PRODUCTS, THROUGH 2019 ($ TABLE 29 GLOBAL DES SALES OF APPROVED PRODUCTS BY DRUG CLASS, THROUGH 2019 ($ TABLE 30 GLOBAL DES SALES OF APPROVED PRODUCTS BY COMPANY, THROUGH 2019 ($ TABLE 31 AREAS OF UNMET CLINICAL NEED IN DES TREATMENT 66 TABLE 32 PRODUCTS IN DEVELOPMENT TO TREAT DES - PHASE III 68 TABLE 33 PRODUCTS IN DEVELOPMENT TO TREAT DES - PHASE II 68 TABLE 34 GLOBAL DES SALES OF PIPELINE PRODUCTS, THROUGH 2019 ($

9 TABLE HEADING TABLE 35 GLOBAL DES SALES OF APPROVED AND PIPELINE PRODUCTS, THROUGH 2019 ($ TABLE 36 PRODUCTS APPROVED TO TREAT UVEITIS 75 TABLE 37 GLOBAL UVEITIS SALES OF APPROVED PRODUCTS, THROUGH 2019 ($ TABLE 38 GLOBAL UVEITIS SALES OF APPROVED PRODUCTS BY DRUG CLASS, THROUGH 2019 ($ TABLE 39 GLOBAL UVEITIS SALES OF APPROVED PRODUCTS BY COMPANY, THROUGH 2019 ($ TABLE 40 AREAS OF UNMET CLINICAL NEED IN UVEITIS TREATMENT 79 TABLE 41 PRODUCTS IN DEVELOPMENT TO TREAT UVEITIS - PHASE III 81 TABLE 42 PRODUCTS IN DEVELOPMENT TO TREAT UVEITIS - PHASE II 81 TABLE 43 PRODUCTS IN DEVELOPMENT TO TREAT UVEITIS - PHASE I 82 TABLE 44 GLOBAL UVEITIS SALES OF PIPELINE PRODUCTS, THROUGH 2019 ($ TABLE 45 GLOBAL UVEITIS SALES OF APPROVED AND PIPELINE PRODUCTS, THROUGH 2019 ($ TABLE 46 LEADING OPHTHALMIC DEALS IN THE U.S. BASED ON VALUE, 2007-JULY 2015 ($ TABLE 47 LEADING OPHTHALMIC DEALS IN ASIA BASED ON VALUE, ($ TABLE 48 LEADING OPHTHALMIC DEALS IN EUROPE BASED ON VALUE, ($ TABLE 49 LEADING OPHTHALMIC DEALS IN AMD BASED ON VALUE, ($ TABLE 50 LEADING OPHTHALMIC DEALS IN RETINOPATHY BASED ON VALUE, ($ TABLE 51 LEADING OPHTHALMIC DEALS IN GLAUCOMA BASED ON VALUE, ($ TABLE 52 RECENT ACQUISITIONS IN THE OPHTHALMIC ARENA BASED ON VALUE, JULY 2015 ($

10 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL OPHTHALMIC THERAPEUTIC DRUG MARKET BY SEGMENT, ($ FIGURE 1 STRUCTURE OF THE EYE 10 FIGURE 2 AMD ADDRESSABLE PATIENT POPULATION (NUMBERS) 11 FIGURE 3 PHYSIOLOGICAL CHANGES IN WET AND DRY AMD 13 FIGURE 4 GLOBAL MARKET SHARE OF AMD APPROVED PRODUCTS BY COMPANY, FIGURE 5 MECHANISM OF ACTION OF ACUCLEA'S VCMS 25 FIGURE 6 GLAUCOMA ADDRESSABLE PATIENT POPULATION (NUMBERS) 30 FIGURE 7 SCHEMATIC OF OPEN AND CLOSED ANGLE GLAUCOMA 31 FIGURE 8 PRESCRIPTION DRUG CLASSES IN THE U.S., 2013 (%) 35 FIGURE 9 PRESCRIPTION DRUG CLASSES IN EUROPE, 2013 (%) 36 FIGURE 10 PRESCRIPTION DRUG CLASSES IN JAPAN, 2010 (%) 37 FIGURE 11 GLOBAL MARKET SHARE OF GLAUCOMA APPROVED PRODUCTS BY DRUG CLASS, FIGURE 12 GLOBAL MARKET SHARE OF GLAUCOMA APPROVED PRODUCTS BY COMPANY, FIGURE 13 QUADRUPLE MODE OF ACTION OF AERIE PHARMACEUTICALS' RHOPRESSA FIGURE 14 DRY EYE SYNDROME ADDRESSABLE PATIENT POPULATION (NUMBERS) 58 FIGURE 15 GLOBAL MARKET SHARE OF DES APPROVED PRODUCTS BY DRUG CLASS, FIGURE GLOBAL MARKET SHARE OF DES APPROVED PRODUCTS BY COMPANY, FIGURE 17 UVEITIS ADDRESSABLE PATIENT POPULATION (NUMBERS) 73 FIGURE 18 GLOBAL MARKET SHARE OF UVEITIS APPROVED PRODUCTS BY DRUG CLASS, FIGURE 19 GLOBAL MARKET SHARE OF UVEITIS APPROVED PRODUCTS BY COMPANY, FIGURE 20 OPHTHALMIC ALLIANCE AND LICENSING DEALS BY YEAR, (NO. OF DEALS) FIGURE 21 OPHTHALMIC ALLIANCE AND LICENSING DEALS BY TERRITORY, (NO. OF DEALS) FIGURE 22 OPHTHALMIC ALLIANCES AND LICENSING DEALS BY THERAPEUTIC CATEGORY, (NO. OF DEALS) FIGURE 23 OPHTHALMIC MERGERS AND ACQUISITIONS BY YEAR, (NUMBER)