STUDY OBJECTIVES

A drug delivery system is one of the very important aspects in today’s growth in the pharmaceutical industry. BCC Research’s goal in steering this study is to provide an overview of the current and future characteristics of the market for these drug delivery systems. The key objective is to present a comprehensive analysis and future direction of these drug delivery systems as an important tool in improving the efficacy and safety of the release of drugs in the body.
This report explores the present and future strategies within the drug delivery market, which includes sustained release drug delivery, prodrug, implants and intrauterine devices (IUDs), targeted drug delivery, polymeric drug delivery, transdermal drug delivery, and transmucosal drug delivery systems. The improvisation of the market and the setbacks and the needs of the market are discussed in this report. The classifications, comparisons and usage of these types of drug delivery systems are also portrayed in this report.
A detailed analysis of drug delivery industry structure has been conducted. Revenues are broken down by region. Sales figures are estimated for the five-year period from 2013 through 2018.
Applications for drug delivery systems are also discussed in the report, with emphasis on the usage of these systems in various therapeutic categories and various disease sectors. The report also covers significant patents and their allotments in each category.

REASONS FOR DOING THIS STUDY

Extensive research in the field of various drug delivery systems has revealed their specific functionality in improving the transportation of a pharmaceutical compound in the body as desired to safely achieve its anticipated therapeutic effect. Modern industries have now begun to explore the advantages of these drug delivery systems in their productions and processes. This has led to the steady market for those drug delivery systems.
R&D spending, along with increasing competition, patent expiries and new technologies, are directing this in a new direction. The new advancements and new product launches have influenced the market to grow in the foreseeable future. This study looks at almost all the systems affected by these factors.
Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strengths and weaknesses of each type/technology in light of the new technologies, growing competition and changing customer needs.

INTENDED AUDIENCE

This study contributes to the areas of market growth in various drug delivery systems manufacturers and users. Pharmaceutical biotechnical companies and research institutes will find this study to be of interest.

SCOPE OF THE STUDY

The scope of this study encompasses drug delivery systems in pharmaceutical and biotechnology markets. BCC Research analyzes each market by its type, region and its applications, regulatory environment, technology, market projections and market share. Technological issues include the latest trends and developments. The emerging markets for drug delivery systems include countries such as India, China, Japan, Korea, Taiwan, Canada, Africa, Australia, New Zealand and so forth.

METHODOLOGY

Both primary and secondary research methodologies were used in preparing this study. BCC Research conducted a comprehensive literature search, which included technical newsletters and journals, and many other sources. Data were collected through interviews and correspondence with manufacturers of drug delivery systems and technical experts. Projections were based on estimates such as the current number of end users, potential end users, mergers and acquisitions, new developments and market trends.

INFORMATION SOURCES

Many companies were surveyed to obtain data for this study. Included were manufacturers and end users of drug delivery systems in therapeutic categories and various disease sectors industries. Data were gathered from various industry sources. BCC Research spoke with officials within the industry, consulted newsletters, company literature, product literature, and a host of technical articles, journals, indexes and abstracts. Exhaustive investigations of databases by key terminology were completed. In addition, data were compiled from current financial, trade and government sources.

ABOUT THE AUTHOR

A team of professionals in the biotechnology industry carried out this study. The project manager is Shalini S. Dewan, who holds a master’s degree in pharmaceutical chemistry and has over 14 years’ of industry experience. Among the research topics she has covered are studies on compounds of potential pharmaceutical interest from ibuprofen and 2-naphthyl acetic acid. Shalini was awarded a Gold Medal by the Prime Minister of India for her work and has worked with top companies in India and in the U.S. Some of her other reports with BCC Research are:Reagents for Chromatography; Spectroscopy: An Enduring Market; Advanced Drug Delivery Systems: Technologies and Global Markets; Orthopedic Drugs, Implants and Devices; Medical Imaging Reagents and Analysis Equipment; Pharmaceutical Regulatory Industry; The Dynamic Media, Sera and Reagent Market in Biotechnology; Contract Pharmaceutical Manufacturing, Research and Packaging: Global Markets; Chiral Technology: Global Markets; Autacoids and Related Drugs: Technologies and Global Markets; Contraceptives: Technologies and Global Markets; Liver Disease Treatments: The Global Market; Hormone Replacement Therapies and Other Hormone Therapies: Global Markets; Cardiovascular Medicine: Diagnostics, Drugs and Devices; and Cancer Therapies: Technologies and Global Markets.

REPORT HIGHLIGHTS

The global revenue for advanced drug delivery systems is estimated to be $181.9 billion in 2013. In 2018, revenues are estimated to reach nearly $212.8 billion, demonstrating a compound annual growth rate (CAGR) of 3.2%.
This report provides:
• An overview of the global market for drug delivery systems, with a focus on routes of administration.
• Analyses of market trends, with data from 2012, estimates for 2013, and projections of CAGRs through 2018.
• Discussion of the current state, setbacks, innovations, and the future needs of the market.
• Analyses of the regulatory environment and the technology involved, including the latest developments.

Table Of Contents

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2

STUDY OBJECTIVES 2
REASONS FOR DOING THIS STUDY 2
INTENDED AUDIENCE 3
SCOPE OF THE STUDY 3
METHODOLOGY 3
INFORMATION SOURCES 3
ABOUT THE AUTHOR 3
RELATED BCC RESEARCH REPORTS 4
BCC RESEARCH ONLINE SERVICES 4
DISCLAIMER 4

CHAPTER 2 SUMMARY 6

SUMMARY TABLE GLOBAL REVENUE OF ADVANCED DRUG DELIVERY SYSTEMS,BY
REGION, THROUGH 2018 ($ MILLIONS) 7
SUMMARY FIGURE GLOBAL REVENUE OF ADVANCED DRUG DELIVERY SYSTEMS,BY
REGION, 2011-2018 ($ MILLIONS) 7

CHAPTER 3 OVERVIEW 9

NEED FOR THE DOSAGE FORMS 9
TABLE 1 HISTORIC EVENTS IN DRUG DELIVERY 10
CLASSIFICATION OF DRUG DELIVERY ACCORDING TO TECHNOLOGY 11
SUSTAINED RELEASE DRUG DELIVERY 11
Oral Sustained Release Drug Delivery 11
Intramuscular (IM) Injections or Microsyringes 12
TABLE 2 ADVANTAGES AND DISADVANTAGES OF SUSTAINED RELEASE DRUG
DELIVERY 12
PRODRUGS 13
Subtypes of Prodrugs 14
TABLE 3 CLASSIFICATION OF PRODRUGS 14
Need for Prodrugs 15
TABLE 4 ADVANTAGES AND DISADVANTAGES OF PRODRUGS 15
IMPLANTS AND INTRAUTERINE DEVICES (IUDS) 16
Copper-based Devices 16
Hormonal-based Devices 16
Mechanism 17
TABLE 5 ADVANTAGES AND DISADVANTAGES OF IMPLANTS AND IUDS 17
TARGETED DRUG DELIVERY 18
Delivery Vehicles 18
Liposomes 18
TABLE 6 ADVANTAGES AND DISADVANTAGES OF LIPOSOMES 19
Micelles and Dendrimers 19
Mechanisms of Drug Delivery 19
Advantages of Dendrimers 20
Biodegradable Particles 20
Artificial DNA Nanostructures 20
Monoclonal Antibodies 21
Applications 21
TABLE 7 ADVANTAGES AND DISADVANTAGES OF MONOCLONAL ANTIBODIES 22
POLYMERIC DRUG DELIVERY 22
Applications of Polymers in Drug Delivery 22
TABLE 8 ADVANTAGES AND DISADVANTAGES OF POLYMERS 23
Pegylation 23
TABLE 9 ADVANTAGES AND DISADVANTAGES OF PEGYLATION 24
Future Perspectives 24
CLASSIFICATION OF DRUG DELIVERY BY ROUTE OF ADMINISTRATION 24
ORAL DRUG DELIVERY 24
TABLE 10 ADVANTAGES AND DISADVANTAGES OF ORAL DRUG DELIVERY 25
INJECTABLE OR PARENTERAL DRUG DELIVERY 25
TABLE 11 ADVANTAGES AND DISADVANTAGES OF PARENTRAL DRUG DELIVERY 25
PULMONARY DRUG DELIVERY 26
TABLE 12 ADVANTAGES AND DISADVANTAGES OF PULMONARY DRUG DELIVERY 26
NASAL DRUG DELIVERY 27
TABLE 13 ADVANTAGES AND DISADVANTAGES OF NASAL DRUG DELIVERY 27
ORAL MUCOSAL DRUG DELIVERY 27
TABLE 14 ADVANTAGES AND DISADVANTAGES OF ORAL MUCOSAL DRUG
DELIVERY 28
RECTAL DRUG DELIVERY 28
TABLE 15 ADVANTAGES AND DISADVANTAGES OF RECTAL DRUG DELIVERY 28
OCULAR DRUG DELIVERY 29
TABLE 16 ADVANTAGES AND DISADVANTAGES OF OCULAR DRUG DELIVERY 29
TRANSDERMAL DRUG DELIVERY 29
TABLE 17 ADVANTAGES AND DISADVANTAGES OF TRANSDERMAL DRUG DELIVERY 29

CHAPTER 4 REGULATORY ASPECTS 32

NEW PRODUCTS APPROVED IN 2009-2013 32
TABLE 18 FDA-APPROVED NEW PRODUCTS, 2009-JULY 2013 32
FDA RECALLS AND SAFETY ALERTS 35
TABLE 19 PRODUCT RECALLS: DRUG DELIVERY, 2009-JUNE 2013 35
TABLE 20 SAFETY ALERTS, 2009 TO JUNE 2013 37

CHAPTER 5 NEW DEVELOPMENTS 40

NEW PARTNERSHIPS, MERGERS AND ACQUISITION 40
TABLE 21 NEW PARTNERSHIPS, MERGERS AND ACQUISITIONS, 2009-JUNE 2013 41
NEW PRODUCTS 42
TABLE 22 NEW INNOVATIONS IN DRUG DELIVERY, 2009-JUNE 2013 43
PIPELINE PRODUCTS 44
TABLE 23 PIPELINE PRODUCTS FOR DRUG DELIVERY MARKET 44

CHAPTER 6 GLOBAL MARKETS 47

MARKET BY TYPE 47
MARKET OVERVIEW 47
MARKET REVENUE 50
TABLE 24 GLOBAL REVENUE OF DRUG DELIVERY SYSTEMS BY TYPE, THROUGH
2018 ($ MILLIONS) 50
FIGURE 1 GLOBAL REVENUE OF DRUG DELIVERY SYSTEMS BY TYPE, 2011-2018 ($
MILLIONS) 50
MARKET SHARE 51
TABLE 25 MARKET SHARE OF DRUG DELIVERY SYSTEMS BY TYPE, 2012 (%) 51
FIGURE 2 MARKET SHARE OF DRUG DELIVERY SYSTEMS BY TYPE, 2012 (%) 52
MARKET BY REGION 52
SUSTAINED RELEASE DRUG DELIVERY SYSTEM 52
Market Overview 53
Market Revenue 54
TABLE 26 GLOBAL REVENUE OF SUSTAINED RELEASE DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 54
FIGURE 3 GLOBAL REVENUE OF SUSTAINED RELEASE DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 54
Market Share 55
TABLE 27 MARKET SHARE OF SUSTAINED RELEASE DRUG DELIVERY BY REGION,
FOR 2012 (%) 55
FIGURE 4 MARKET SHARE OF SUSTAINED RELEASE DRUG DELIVERY BY REGION,
FOR 2012 (%) 55
PRODRUGS 55
Market Overview 56
Market Revenue 56
TABLE 28 GLOBAL REVENUE OF PRODRUGS DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 56
FIGURE 5 GLOBAL REVENUE OF PRODRUGS DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 56
Market Share 57
TABLE 29 MARKET SHARE OF PRODRUGS DRUG DELIVERY, BY REGION, 2012 (%) 57
FIGURE 6 MARKET SHARE OF PRODRUGS DRUG DELIVERY BY REGION, 2012 (%) 57
IMPLANTS AND IUDS 58
Market Overview 58
Market Revenue 58
TABLE 30 GLOBAL REVENUE OF IMPLANTS AND IUDS BY REGION, THROUGH 2018
($ MILLIONS) 59
FIGURE 7 GLOBAL REVENUE OF IMPLANTS AND IUDS BY REGION, 2011-2018 ($
MILLIONS) 59
Market Share 59
TABLE 31 MARKET SHARE OF IMPLANTS AND IUDS BY REGION, 2012 (%) 60
FIGURE 8 MARKET SHARE OF IMPLANTS AND IUDS BY REGION, 2012 (%) 60
TRANSMUCOSAL DELIVERY SYSTEMS 60
Market Overview 61
Market Revenue 63
TABLE 32 GLOBAL REVENUE OF TRANSMUCOSAL DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 63
FIGURE 9 GLOBAL REVENUE OF TRANSMUCOSAL DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 63
Market Share 64
TABLE 33 MARKET SHARE OF TRANSMUCOSAL DRUG DELIVERY BY REGION, 2012
(%) 64
FIGURE 10 MARKET SHARE OF TRANSMUCOSAL DRUG DELIVERY BY REGION, 2012
(%) 64
TARGETED DRUG DELIVERY 64
Market Overview 65
Market Revenue 66
TABLE 34 GLOBAL REVENUE OF TARGETED DRUG DELIVERY BY REGION, THROUGH
2018 ($ MILLIONS) 66
FIGURE 11 GLOBAL REVENUE OF TARGETED DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 66
Market Share 67
TABLE 35 MARKET SHARE OF TARGETED DRUG DELIVERY BY REGION, 2012 (%) 67
FIGURE 12 MARKET SHARE OF TARGETED DRUG DELIVERY BY REGION, 2012 (%) 67
TRANSDERMAL DRUG DELIVERY SYSTEM 67
Market Overview 68
Market Revenue 68
TABLE 36 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 68
FIGURE 13 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 69
Market Share 69
TABLE 37 MARKET SHARE OF TRANSDERMAL DRUG DELIVERY SYSTEM BY REGION,
2012 ($ MILLIONS) 69
FIGURE 14 MARKET SHARE OF TRANSDERMAL DRUG DELIVERY SYSTEMS BY
REGION, 2012 (%) 69
POLYMERIC DRUG DELIVERY 70
Market Overview 70
Market Revenue 71
TABLE 38 GLOBAL REVENUE OF POLYMERIC DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 71
FIGURE 15 GLOBAL REVENUE OF POLYMERIC DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 71
Market Share 72
TABLE 39 MARKET SHARE OF POLYMERIC DRUG DELIVERY BY REGION, 2012 (%) 72
FIGURE 16 MARKET SHARE OF POLYMERIC DRUG DELIVERY BY REGION, 2012 (%) 72
MARKET BY END USERS 72
MARKET OVERVIEW 73
MARKET REVENUE 77
TABLE 40 GLOBAL MARKET FOR DRUG DELIVERY DOSAGE FORMS BY
APPLICATIONS, THROUGH 2018 ($ MILLIONS) 78
FIGURE 17 GLOBAL MARKET FOR DRUG DELIVERY DOSAGE FORMS BY
APPLICATIONS, 2011-2018 ($ MILLIONS) 78
MARKET SHARE 79
TABLE 41 MARKET SHARE OF DRUG DELIVERY DOSAGE FORMS BY APPLICATIONS,
2012 (%) 80
FIGURE 18 MARKET SHARE OF DRUG DELIVERY DOSAGE FORMS BY APPLICATIONS,
2012 (%) 80

CHAPTER 7 MARKET ANALYSIS FOR ADVANCED DRUG DELIVERY SYSTEMS BY ROUTE OF ADMINISTRATION 82

TABLE 42 GLOBAL REVENUE OF ADVANCED DRUG DELIVERY SYSTEMS BY ROUTE
OF ADMINISTRATION, THROUGH 2018 ($ MILLIONS) 83
FIGURE 19 GLOBAL REVENUE OF ADVANCED DRUG DELIVERY SYSTEMS BY ROUTE
OF ADMINISTRATION, 2011-2018 ($ MILLIONS) 83
MARKET BY TYPE 84
ORAL, TOPICAL AND INJECTABLE DRUG DELIVERIES 84
Market Overview 85
Market Revenue 86
TABLE 43 GLOBAL REVENUE OF ORAL, TOPICAL AND INJECTABLE DRUG DELIVERY
BY TYPE, THROUGH 2018 ($ MILLIONS) 86
FIGURE 20 GLOBAL REVENUE OF ORAL, TOPICAL AND INJECTABLE DRUG DELIVERY
BY TYPE, 2011-2018 ($ MILLIONS) 87
TRANSMUCOSAL DELIVERY SYSTEMS 87
Market Overview 88
Market Revenue 90
TABLE 44 GLOBAL REVENUE OF TRANSMUCOSAL DELIVERY SYSTEMS BY TYPE,
THROUGH 2018 ($ MILLIONS) 91
FIGURE 21 GLOBAL REVENUE OF TRANSMUCOSAL DELIVERY SYSTEMS BY TYPE,
2011-2018 ($ MILLIONS) 91
TRANSDERMAL DRUG DELIVERY SYSTEM 92
Market Overview 93
Market Revenue 93
TABLE 45 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY SYSTEMS,
THROUGH 2018 ($ MILLIONS) 93
FIGURE 22 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY SYSTEMS,
2011-2018 ($ MILLIONS) 93
MARKET BY REGION 94
MARKET OVERVIEW 94
MARKET REVENUE 95
Oral, Topical, Injectables 96
TABLE 46 GLOBAL REVENUE OF ORAL, TOPICAL AND INJECTABLE DRUG DELIVERY
BY REGION, THROUGH 2018 ($ MILLIONS) 96
FIGURE 23 GLOBAL REVENUE OF ORAL, TOPICAL AND INJECTABLE DRUG DELIVERY
BY REGION, 2011-2018 ($ MILLIONS) 96
Transmucosal Drug Delivery 97
TABLE 47 GLOBAL REVENUE OF TRANSMUCOSAL DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 97
FIGURE 24 GLOBAL REVENUE OF TRANSMUCOSAL DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 97
Transdermal Drug Delivery 98
TABLE 48 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 98
FIGURE 25 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 98
INDUSTRY STRUCTURE 99
ORAL, INJECTABLE AND TOPICAL DRUG DELIVERY 99
Market Leaders 99
TABLE 49 MAJOR MANUFACTURERS IN ORAL, INJECTABLE AND TOPICAL DRUG
DELIVERY, 2012 99
Market Share of Oral Drug Delivery 100
TABLE 50 MARKET SHARE FOR MANUFACTURERS OF ORAL DOSAGE FORMS, 2012
(%) 101
FIGURE 26 MARKET SHARE FOR MANUFACTURERS OF ORAL DOSAGE FORMS, 2012
(%) 101
Market Share of Injectable Drug Delivery 101
TABLE 51 MARKET SHARE FOR MANUFACTURERS OF INJECTABLE DOSAGE FORMS,
2012 (%) 102
FIGURE 27 MARKET SHARE FOR MANUFACTURERS OF INJECTABLE DOSAGE FORMS,
2012 (%) 102
Market Share of Topical Drug Delivery 102
TABLE 52 MARKET SHARE FOR MANUFACTURERS OF TOPICAL DOSAGE FORMS,
2012 (%) 103
FIGURE 28 MARKET SHARE FOR MANUFACTURERS OF TOPICAL DOSAGE FORMS,
2012 (%) 103
TRANSMUCOSAL DRUG DELIVERY 104
Market Leaders 104
TABLE 53 MAJOR MANUFACTURERS IN TRANSMUCOSAL DRUG DELIVERY 104
Market Share of Nasal Drug Delivery 105
TABLE 54 MARKET SHARE OF THE MANUFACTURERS IN PULMONARY AND NASAL
DRUG DELIVERY, 2012 (%) 105
FIGURE 29 MARKET SHARE OF THE MANUFACTURERS IN PULMONARY AND NASAL
DRUG DELIVERY, 2012 (%) 106
Market Share of Oral Mucosal/Buccal Drug Delivery 106
TABLE 55 MARKET SHARE OF THE MANUFACTURERS IN BUCCAL DRUG DELIVERY,
2012 (%) 106
FIGURE 30 MARKET SHARE OF THE MANUFACTURERS IN BUCCAL DRUG DELIVERY,
2012 (%) 106
Market Share of Rectal Drug Delivery 107
TABLE 56 MARKET SHARE OF THE MANUFACTURERS IN RECTAL DRUG DELIVERY,
2012 (%) 107
FIGURE 31 MARKET SHARE OF THE MANUFACTURERS IN RECTAL DRUG DELIVERY,
2012 (%) 107
Market Share of Ocular Drug Delivery 108
TABLE 57 MARKET SHARE OF THE MANUFACTURERS IN OCULAR DRUG DELIVERY,
2012 (%) 108
FIGURE 32 MARKET SHARE OF THE MANUFACTURERS IN OCULAR DRUG DELIVERY,
2012 (%) 108
Market Share of Vaginal Drug Delivery 109
TABLE 58 MARKET SHARE OF THE MANUFACTURERS IN VAGINAL DRUG DELIVERY,
2012 (%) 109
FIGURE 33 MARKET SHARE OF THE MANUFACTURERS IN VAGINAL DRUG DELIVERY,
2012 (%) 110
TRANSDERMAL DRUG DELIVERY 110
Market Leaders 110
TABLE 59 MAJOR MANUFACTURERS IN TRANSDERMAL DRUG DELIVERY, 2012 110
Market Share 111
TABLE 60 MARKET SHARE OF THE MANUFACTURERS IN TRANSDERMAL DRUG
DELIVERY, 2012 (%) 111
FIGURE 34 MARKET SHARE OF THE MANUFACTURERS IN TRANSDERMAL DRUG
DELIVERY, 2012 (%) 111

CHAPTER 8 PATENT ANALYSIS 113

PATENTS BY YEAR 113
TABLE 61 NUMBER OF U.S. PATENTS BY YEAR, JANUARY 2009-JULY 2013 113
FIGURE 35 NUMBER OF U.S. PATENTS BY YEAR, JANUARY 2009-JULY 2013 113
PATENTS BY CATEGORY 114
TABLE 62 NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2009-JULY 2013 114
FIGURE 36 NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2009-JULY 2013 115
PATENTS BY TYPE 115
TABLE 63 NUMBER OF U.S. PATENTS BY TYPE, JANUARY 2009-JULY 2013 115
PATENTS BY COMPANY 116
TABLE 64 NUMBER OF U.S. PATENTS BY COMPANY, JANUARY 2009-JULY 2013 116
PATENTS BY COUNTRY 118
TABLE 65 NUMBER OF U.S. PATENTS BY COUNTRY, JANUARY 2009-JULY 2013 118
PATENTS BY ASSIGNEE 119
TABLE 66 NUMBER OF U.S. PATENTS BY ASSIGNEE, JANUARY 2009-JULY 2013 119
FIGURE 37 NUMBER OF U.S. PATENTS BY ASSIGNEE, JANUARY 2009-JULY 2013 119

CHAPTER 9 CURRENT SITUATION 121

CHAPTER 10 COMPANY PROFILES 125

3M COMPANY 125
ABBOTT LABORATORIES 125
ACTAVIS INC. 126
AKELA PHARMA INC. 126
AKORN, INC. 127
ALCON INC. 127
ALEXION PHARMACEUTICALS, INC. 128
ALKERMES 128
ALLERGAN INC. 128
AMGEN INC. 129
A.P. PHARMA 130
APTALIS PHARMA INC. 130
ASTELLAS PHARMA INC. 131
ASTRAZENECA PLC 131
ATON PHARMA 132
BAUSCH and LOMB 132
BAXTER INTERNATIONAL INC. 132
BAYER HEALTHCARE PHARMACEUTICALS 133
BIOGEN IDEC 133
BIOSANTE PHARMACEUTICALS, INC. 134
BOEHRINGER INGELHEIM 134
BOSTON SCIENTIFIC 135
BRISTOL MYERS SQUIBB 135
CELGENE CORPORATION 136
CEPHALON, INC. 136
COLUMBIA LABORATORIES, INC. 137
EISAI CO., LTD 137
ELAN DRUG TECHNOLOGIES 138
ENZON PHARMACEUTICALS 138
GENENTECH INC. 139
GENEREX BIOTECHNOLOGY CORPORATION 139
GENZYME CORPORATION 140
GILEAD SCIENCES, INC. 141
GLAXOSMITHKLINE PLC 141
HISAMITSU PHARMACEUTICAL CO., INC. 142
IMCLONE SYSTEMS INC. 142
JANSSEN BIOTECH, INC. 143
JOHNSON and JOHNSON 143
KEMPHARM, INC. 144
K.V. PHARMACEUTICAL CO. 144
LAVIPHARM CORPORATION 145
MANNKIND CORPORATION 145
MERCK and CO. 146
MYLAN LABORATORIES INC. 146
NEKTAR THERAPEUTICS 147
NEUROGESX INC. 147
NEWGEN BIOPHARMA 148
NOVARTIS AG 148
NOVAVAX, INC. 149
NOVEN PHARMACEUTICALS, INC. 149
NYCOMED US INC. 150
OSI PHARMACEUTICALS, INC. 150
PAR PHARMACEUTICAL COMPANIES, INC. 151
PDL BIOPHARMA, INC. 151
PFIZER INC. 152
QLT INC. 152
ROCHE HOLDING AG 153
SANOFI SA 153
TEVA PHARMACEUTICAL INDUSTRIES LTD. 154
THERAJECT, INC. 155
UMEWORLD LTD. 155
VALEANT PHARMACEUTICALS INTERNATIONAL, INC. 156
XEL PHARMACEUTICALS, INC. 156

CHAPTER 11 APPENDIX I 158



LIST OF TABLES

SUMMARY TABLE GLOBAL REVENUE OF ADVANCED DRUG DELIVERY SYSTEMS,BY
REGION, THROUGH 2018 ($ MILLIONS) 7
TABLE 1 HISTORIC EVENTS IN DRUG DELIVERY 10
TABLE 2 ADVANTAGES AND DISADVANTAGES OF SUSTAINED RELEASE DRUG
DELIVERY 12
TABLE 3 CLASSIFICATION OF PRODRUGS 14
TABLE 4 ADVANTAGES AND DISADVANTAGES OF PRODRUGS 15
TABLE 5 ADVANTAGES AND DISADVANTAGES OF IMPLANTS AND IUDS 17
TABLE 6 ADVANTAGES AND DISADVANTAGES OF LIPOSOMES 19
TABLE 7 ADVANTAGES AND DISADVANTAGES OF MONOCLONAL ANTIBODIES 22
TABLE 8 ADVANTAGES AND DISADVANTAGES OF POLYMERS 23
TABLE 9 ADVANTAGES AND DISADVANTAGES OF PEGYLATION 24
TABLE 10 ADVANTAGES AND DISADVANTAGES OF ORAL DRUG DELIVERY 25
TABLE 11 ADVANTAGES AND DISADVANTAGES OF PARENTRAL DRUG DELIVERY 25
TABLE 12 ADVANTAGES AND DISADVANTAGES OF PULMONARY DRUG DELIVERY 26
TABLE 13 ADVANTAGES AND DISADVANTAGES OF NASAL DRUG DELIVERY 27
TABLE 14 ADVANTAGES AND DISADVANTAGES OF ORAL MUCOSAL DRUG DELIVERY 28
TABLE 15 ADVANTAGES AND DISADVANTAGES OF RECTAL DRUG DELIVERY 28
TABLE 16 ADVANTAGES AND DISADVANTAGES OF OCULAR DRUG DELIVERY 29
TABLE 17 ADVANTAGES AND DISADVANTAGES OF TRANSDERMAL DRUG DELIVERY 29
TABLE 18 FDA-APPROVED NEW PRODUCTS, 2009-JULY 2013 32
TABLE 19 PRODUCT RECALLS: DRUG DELIVERY, 2009-JUNE 2013 35
TABLE 20 SAFETY ALERTS, 2009 TO JUNE 2013 37
TABLE 21 NEW PARTNERSHIPS, MERGERS AND ACQUISITIONS, 2009-JUNE 2013 41
TABLE 22 NEW INNOVATIONS IN DRUG DELIVERY, 2009-JUNE 2013 43
TABLE 23 PIPELINE PRODUCTS FOR DRUG DELIVERY MARKET 44
TABLE 24 GLOBAL REVENUE OF DRUG DELIVERY SYSTEMS BY TYPE, THROUGH 2018
($ MILLIONS) 50
TABLE 25 MARKET SHARE OF DRUG DELIVERY SYSTEMS BY TYPE, 2012 (%) 51
TABLE 26 GLOBAL REVENUE OF SUSTAINED RELEASE DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 54
TABLE 27 MARKET SHARE OF SUSTAINED RELEASE DRUG DELIVERY BY REGION,
FOR 2012 (%) 55
TABLE 28 GLOBAL REVENUE OF PRODRUGS DRUG DELIVERY BY REGION, THROUGH
2018 ($ MILLIONS) 56
TABLE 29 MARKET SHARE OF PRODRUGS DRUG DELIVERY, BY REGION, 2012 (%) 57
TABLE 30 GLOBAL REVENUE OF IMPLANTS AND IUDS BY REGION, THROUGH 2018 ($
MILLIONS) 59
TABLE 31 MARKET SHARE OF IMPLANTS AND IUDS BY REGION, 2012 (%) 60
TABLE 32 GLOBAL REVENUE OF TRANSMUCOSAL DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 63
TABLE 33 MARKET SHARE OF TRANSMUCOSAL DRUG DELIVERY BY REGION, 2012 (%) 64
TABLE 34 GLOBAL REVENUE OF TARGETED DRUG DELIVERY BY REGION, THROUGH
2018 ($ MILLIONS) 66
TABLE 35 MARKET SHARE OF TARGETED DRUG DELIVERY BY REGION, 2012 (%) 67
TABLE 36 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 68
TABLE 37 MARKET SHARE OF TRANSDERMAL DRUG DELIVERY SYSTEM BY REGION,
2012 ($ MILLIONS) 69
TABLE 38 GLOBAL REVENUE OF POLYMERIC DRUG DELIVERY BY REGION, THROUGH
2018 ($ MILLIONS) 71
TABLE 39 MARKET SHARE OF POLYMERIC DRUG DELIVERY BY REGION, 2012 (%) 72
TABLE 40 GLOBAL MARKET FOR DRUG DELIVERY DOSAGE FORMS BY APPLICATIONS,
THROUGH 2018 ($ MILLIONS) 78
TABLE 41 MARKET SHARE OF DRUG DELIVERY DOSAGE FORMS BY APPLICATIONS,
2012 (%) 80
TABLE 42 GLOBAL REVENUE OF ADVANCED DRUG DELIVERY SYSTEMS BY ROUTE OF
ADMINISTRATION, THROUGH 2018 ($ MILLIONS) 83
TABLE 43 GLOBAL REVENUE OF ORAL, TOPICAL AND INJECTABLE DRUG DELIVERY
BY TYPE, THROUGH 2018 ($ MILLIONS) 86
TABLE 44 GLOBAL REVENUE OF TRANSMUCOSAL DELIVERY SYSTEMS BY TYPE,
THROUGH 2018 ($ MILLIONS) 91
TABLE 45 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY SYSTEMS,
THROUGH 2018 ($ MILLIONS) 93
TABLE 46 GLOBAL REVENUE OF ORAL, TOPICAL AND INJECTABLE DRUG DELIVERY
BY REGION, THROUGH 2018 ($ MILLIONS) 96
TABLE 47 GLOBAL REVENUE OF TRANSMUCOSAL DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 97
TABLE 48 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY BY REGION,
THROUGH 2018 ($ MILLIONS) 98
TABLE 49 MAJOR MANUFACTURERS IN ORAL, INJECTABLE AND TOPICAL DRUG
DELIVERY, 2012 99
TABLE 50 MARKET SHARE FOR MANUFACTURERS OF ORAL DOSAGE FORMS, 2012
(%) 101
TABLE 51 MARKET SHARE FOR MANUFACTURERS OF INJECTABLE DOSAGE FORMS,
2012 (%) 102
TABLE 52 MARKET SHARE FOR MANUFACTURERS OF TOPICAL DOSAGE FORMS,
2012 (%) 103
TABLE 53 MAJOR MANUFACTURERS IN TRANSMUCOSAL DRUG DELIVERY 104
TABLE 54 MARKET SHARE OF THE MANUFACTURERS IN PULMONARY AND NASAL
DRUG DELIVERY, 2012 (%) 105
TABLE 55 MARKET SHARE OF THE MANUFACTURERS IN BUCCAL DRUG DELIVERY,
2012 (%) 106
TABLE 56 MARKET SHARE OF THE MANUFACTURERS IN RECTAL DRUG DELIVERY,
2012 (%) 107
TABLE 57 MARKET SHARE OF THE MANUFACTURERS IN OCULAR DRUG DELIVERY,
2012 (%) 108
TABLE 58 MARKET SHARE OF THE MANUFACTURERS IN VAGINAL DRUG DELIVERY,
2012 (%) 109
TABLE 59 MAJOR MANUFACTURERS IN TRANSDERMAL DRUG DELIVERY, 2012 110
TABLE 60 MARKET SHARE OF THE MANUFACTURERS IN TRANSDERMAL DRUG
DELIVERY, 2012 (%) 111
TABLE 61 NUMBER OF U.S. PATENTS BY YEAR, JANUARY 2009-JULY 2013 113
TABLE 62 NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2009-JULY 2013 114
TABLE 63 NUMBER OF U.S. PATENTS BY TYPE, JANUARY 2009-JULY 2013 115
TABLE 64 NUMBER OF U.S. PATENTS BY COMPANY, JANUARY 2009-JULY 2013 116
TABLE 65 NUMBER OF U.S. PATENTS BY COUNTRY, JANUARY 2009-JULY 2013 118
TABLE 66 NUMBER OF U.S. PATENTS BY ASSIGNEE, JANUARY 2009-JULY 2013 119



LIST OF FIGURES

SUMMARY FIGURE GLOBAL REVENUE OF ADVANCED DRUG DELIVERY SYSTEMS,BY
REGION, 2011-2018 ($ MILLIONS) 7
FIGURE 1 GLOBAL REVENUE OF DRUG DELIVERY SYSTEMS BY TYPE, 2011-2018 ($
MILLIONS) 50
FIGURE 2 MARKET SHARE OF DRUG DELIVERY SYSTEMS BY TYPE, 2012 (%) 52
FIGURE 3 GLOBAL REVENUE OF SUSTAINED RELEASE DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 54
FIGURE 4 MARKET SHARE OF SUSTAINED RELEASE DRUG DELIVERY BY REGION, FOR
2012 (%) 55
FIGURE 5 GLOBAL REVENUE OF PRODRUGS DRUG DELIVERY BY REGION, 2011-2018
($ MILLIONS) 56
FIGURE 6 MARKET SHARE OF PRODRUGS DRUG DELIVERY BY REGION, 2012 (%) 57
FIGURE 7 GLOBAL REVENUE OF IMPLANTS AND IUDS BY REGION, 2011-2018 ($
MILLIONS) 59
FIGURE 8 MARKET SHARE OF IMPLANTS AND IUDS BY REGION, 2012 (%) 60
FIGURE 9 GLOBAL REVENUE OF TRANSMUCOSAL DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 63
FIGURE 10 MARKET SHARE OF TRANSMUCOSAL DRUG DELIVERY BY REGION, 2012
(%) 64
FIGURE 11 GLOBAL REVENUE OF TARGETED DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 66
FIGURE 12 MARKET SHARE OF TARGETED DRUG DELIVERY BY REGION, 2012 (%) 67
FIGURE 13 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 69
FIGURE 14 MARKET SHARE OF TRANSDERMAL DRUG DELIVERY SYSTEMS BY REGION,
2012 (%) 69
FIGURE 15 GLOBAL REVENUE OF POLYMERIC DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 71
FIGURE 16 MARKET SHARE OF POLYMERIC DRUG DELIVERY BY REGION, 2012 (%) 72
FIGURE 17 GLOBAL MARKET FOR DRUG DELIVERY DOSAGE FORMS BY
APPLICATIONS, 2011-2018 ($ MILLIONS) 78
FIGURE 18 MARKET SHARE OF DRUG DELIVERY DOSAGE FORMS BY APPLICATIONS,
2012 (%) 80
FIGURE 19 GLOBAL REVENUE OF ADVANCED DRUG DELIVERY SYSTEMS BY ROUTE
OF ADMINISTRATION, 2011-2018 ($ MILLIONS) 83
FIGURE 20 GLOBAL REVENUE OF ORAL, TOPICAL AND INJECTABLE DRUG DELIVERY
BY TYPE, 2011-2018 ($ MILLIONS) 87
FIGURE 21 GLOBAL REVENUE OF TRANSMUCOSAL DELIVERY SYSTEMS BY TYPE,
2011-2018 ($ MILLIONS) 91
FIGURE 22 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY SYSTEMS,
2011-2018 ($ MILLIONS) 93
FIGURE 23 GLOBAL REVENUE OF ORAL, TOPICAL AND INJECTABLE DRUG DELIVERY
BY REGION, 2011-2018 ($ MILLIONS) 96
FIGURE 24 GLOBAL REVENUE OF TRANSMUCOSAL DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 97
FIGURE 25 GLOBAL REVENUE OF TRANSDERMAL DRUG DELIVERY BY REGION,
2011-2018 ($ MILLIONS) 98
FIGURE 26 MARKET SHARE FOR MANUFACTURERS OF ORAL DOSAGE FORMS, 2012
(%) 101
FIGURE 27 MARKET SHARE FOR MANUFACTURERS OF INJECTABLE DOSAGE FORMS,
2012 (%) 102
FIGURE 28 MARKET SHARE FOR MANUFACTURERS OF TOPICAL DOSAGE FORMS,
2012 (%) 103
FIGURE 29 MARKET SHARE OF THE MANUFACTURERS IN PULMONARY AND NASAL
DRUG DELIVERY, 2012 (%) 106
FIGURE 30 MARKET SHARE OF THE MANUFACTURERS IN BUCCAL DRUG DELIVERY,
2012 (%) 106
FIGURE 31 MARKET SHARE OF THE MANUFACTURERS IN RECTAL DRUG DELIVERY,
2012 (%) 107
FIGURE 32 MARKET SHARE OF THE MANUFACTURERS IN OCULAR DRUG DELIVERY,
2012 (%) 108
FIGURE 33 MARKET SHARE OF THE MANUFACTURERS IN VAGINAL DRUG DELIVERY,
2012 (%) 110
FIGURE 34 MARKET SHARE OF THE MANUFACTURERS IN TRANSDERMAL DRUG
DELIVERY, 2012 (%) 111
FIGURE 35 NUMBER OF U.S. PATENTS BY YEAR, JANUARY 2009-JULY 2013 113
FIGURE 36 NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2009-JULY 2013 115
FIGURE 37 NUMBER OF U.S. PATENTS BY ASSIGNEE, JANUARY 2009-JULY 2013 119

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