Pulmonary Drug Delivery Systems: Technologies and Global Markets

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Pulmonary Drug Delivery Systems: Technologies and Global
Markets
Published on January 2012

Report Summary

REPORT SCOPE

INTRODUCTION

STUDY GOALS AND OBJECTIVES

This BCC market research report, Pulmonary Drug Delivery Systems: Technologies and Global Markets, provides a detailed overview
and thorough analysis of the present and future global market for pulmonary drug delivery technologies. This report analyzes in detail
the pulmonary drug delivery technologies that are available and currently used and their markets. This report includes products in this
market and detailed analyses of the markets and competitive environments. It also analyzes current and future market prospects.
The report provides a comprehensive review of emerging pulmonary drug delivery technologies, particularly with regard to inhaled
drug delivery systems. The analysis reviews technological developments, product innovations, and recent strategic industry activities
of major players across different product categories. It reviews their strengths and weaknesses, opportunities, and the threats facing
various devices and drugs in this market space. The report also reviews developments already on the market, major issues involved
in the research and development (R&D) of more effective devices for drug delivery to the lungs, and new products in development.

REASONS FOR DOING THE STUDY

Pulmonary drug delivery has emerged as a more relevant alternative for delivering drugs. Respiratory conditions such as asthma,
chronic obstructive pulmonary, and emphysema disease are therapeutic areas of the pulmonary sector. However, recent
technological advancements have applied the application of pulmonary devices to the treatment of nonrespiratory conditions such
diabetes and migraines. Advancements in formulating technology are expected to push sales of dry powder inhalers, replacing
metered-dose inhalers to a large extent. Pulmonary delivery of drugs for the treatment of respiratory diseases stems from the fact
that topical drug deposition to the infected lung gives a fast therapeutic effect and reduces side effects associated with key drugs.
There is a need to understand the trends in this market, currently available devices and their problems, and the latest developments
for drug delivery to the lungs.

SCOPE AND FORMAT

The report reviews global markets for drug delivery technologies and new developments, and forecasts trends for use of current
devices for drug delivery and for safety and toxicology through 2016. The report presents important devices, technologies, and the
latest developments, market share by device and disease type, current products on the market, market share by company or product,
and statistical information for types of respiratory diseases prevalent worldwide, with special emphasis on the U.S. market. The
report also includes current issues and trends affecting the industry including costs, and factors influencing demand will be discussed.
The report covers products in development, new technologies, trends, alliances, patents, and mergers. The report offers market data
with respect to segments and geography. It also provides market trends with respect to drivers, restraints, and opportunities.

INTENDED AUDIENCE

Pulmonary Drug Delivery Systems: Technologies and Global Markets (From Slideshare) Page 1/12


This report is an exhaustive study of the worldwide drug delivery market, giving crucial statistics and analysis on existing
technologies, the latest trends, market structure, market size, key drug segments, important trends in technology development, major
opportunities, and market shares of key players and drugs. This report may prove crucial for drug development companies in drug
delivery space, potential investors in the concerned sector. This report shows devices currently being used for drug delivery to the
lungs, new developments, spending trends, and revenue prospects for these technologies. The report provides market data for 2010
to 2016 and also covers commercial prospects for pulmonary devices and current inhalers in use and their future.

METHODOLOGY

Both primary and secondary research methodologies were used in preparing this report. Secondary sources include books,
newspapers, trade journals, white papers, industry portals, government agencies, trade associations, industry news, and
developments and access to paid databases. The base year of the report is 2010, with forecast data provided through 2016.
Historical, base year, and forecast data are provided for each market segment of this report. The report provides a comprehensive
review of emerging drug delivery technologies, particularly with regard to inhaled drug delivery systems. The new analysis reviews
technological developments, product innovations/introductions, and recent strategic industry activities of major players across various
product categories. Growth rates are determined through a compilation of data, including past trends, future trends, demographics,
incidence, mortality, products in R&D, and current product growth.

Table of Content

Table of Contents

CHAPTER ONE: INTRODUCTION 1
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
SCOPE AND FORMAT 1
INTENDED AUDIENCE 2
METHODOLOGY 2
RELATED BCC STUDIES 2
ANALYST CREDENTIALS 3
BCC ON-LINE SERVICES 3
DISCLAIMER 3
CHAPTER TWO: SUMMARY 4
SUMMARY 4
SUMMARY (CONTINUED) 5
SUMMARY TABLE GLOBAL MARKET FOR PULMONARY DRUG
DELIVERY TECHNOLOGIES, THROUGH 2016 ($ MILLIONS) 6
SUMMARY FIGURE GLOBAL MARKET FOR PULMONARY DRUG
DELIVERY TECHNOLOGIES, 2010'2016 ($ MILLIONS) 6
CHAPTER THREE: OVERVIEW 7
TECHNOLOGY TRENDS 7
PULMONARY DRUG DELIVERY 8
PULMONARY CONDITIONS AND THERAPIES 8
RESPIRATORY SYSTEM 9
Respiratory System (Continued) 10



Lung 11
Particle Size, Toxicity and Drug Deposition 11
SYSTEMIC AND LOCAL THERAPY 12
Pulmonary Drug Delivery-Devices 13
Device Characteristics 13
Device Characteristics (Continued) 14
Pulmonary Drug Delivery ' the Future 19
Inhaler Devices 19
TABLE 1 INHALER DEVICES AND CHARACTERISTICS 19
TABLE 2 DOSAGE FORMS-INHALERS 20
Available Products 20
TABLE 3 METERED DOSE INHALERS 20
Available Products (Continued) 21
TABLE 4 DRY POWDER INHALERS 22
INHALER-DRUG PROFILES 22
Aerosol Aztreonam (Cayston) 22
Dulera (mometasone furoate/formoterol fumarate
dihydrate) 23
Amikacin 24
SYSTEMIC PULMONARY DELIVERY 25
Development of Exubera 25
Lung Cancer Concerns 26
Aerogen and Dance Pharmaceuticals 27
Safety Concerns 27
Future 27
Insulin -Exubera 28
MannKind's 'Afrezza 29
Summary 30
Key Players 30
Pulmonary Drug Delivery-In a New Light 30
ASTHMA AND COPD ' MAJOR RESPIRATORY DISEASE
CONDITIONS 31
Asthma: Primary Respiratory Syndrome 31
Asthma: Primary Respiratory ' (Continued) 32
Asthma and Obesity 33
TABLE 5 ASTHMA AND BIOMARKERS 34
Monitoring of Asthma 35
TABLE 6 INHALED STEROIDS (ASTHMA INHALERS) 36
TABLE 7 SYSTEMIC STEROIDS FOR ASTHMA TREATMENT 37
Delivery Methods 37
Delivery Methods (Continued) 38
Delivery Methods (Continued) 39
Chronic Obstructive Pulmonary Disease (COPD) 40
What is COPD' 40



COPD and Causative Factors 41
TABLE 8 COPD AND LUNG DAMAGE 42
COPD and ' (Continued) 43
Diagnosis of COPD 44
COPD and Treatment 45
Methods of Drug Delivery 46
METHODS OF DRUG DELIVERY 47
Aerosols 47
TABLE 9 COPD DRUGS ON THE MARKET 48
Formulations 49
INHALATION MARKET 49
Asthma Prevalence and Statistics 49
COPD and Incidence 50
Disease and Epidemiology 51
TABLE 10 INHALED DRUGS AND MARKET OPPORTUNITIES:
CURRENT MARKET FOR INHALED DRUGS (% MARKET SHARE) 52
CHAPTER FOUR: PULMONARY DRUG DELIVERY SYSTEM 53
BENEFITS OF PULMONARY DRUG DELIVERY SYSTEMS 53
INHALER DEVICES 53
TABLE 11 INHALER DEVICES 54
Pulmonary Drug Delivery Technologies 54
Technology Descriptions 54
Wide Array of Applications 54
TABLE 12 DRUGS AND THERAPEUTIC AGENTS ADMINISTERED BY
INHALATION 55
Types of Inhalation Devices 55
Inhalers 55
Metered-dose Inhalers 56
MDIs-How Does It Work' 56
History 57
MDIs and Drug Delivery 57
Advantages and Challenges for MDIs 58
MDIs and Corticosteroids 58
TABLE 13 BRAND NAME METERED DOSE INHALERS
(CORTICOSTEROIDS) 59
Bronchodilators 59
TABLE 14 BRAND NAME METERED DOSE INHALERS
(BRONCHODILATORS) 59
Combination Inhalers 59
Nonsteroidal Inhalers 60
Problems with MDI Use and Spacers 60
Problems with '(Continued) 61
Propellants and MDI Development 62
TABLE 15 LIST OF METERED DOSE INHALERS AND INGREDIENTS 63
Fluticascone 63
Fluticasone and Salmeterol 64
Flunisolide 64
Beclomethasone 64



Transition to HFA propellants 65
Chlorofluorocarbons (CFCs) 65
TABLE 16 THE SEVEN CFC INHALERS 66
Analgesic Inhalers 66
Dry Powder Inhaler (DPI) 67
Dry Powder ' (Continued) 68
TABLE 17 TYPES OF DPI DEVICES 69
Types of DPI Devices 69
TABLE 18 DPIS CURRENTLY ON THE MARKET 70
TABLE 18 (CONTINUED) 71
TABLE 19 DPI: ADVANTAGES VERSUS DISADVANTAGES 72
TABLE 20 TYPES OF DRY POWDER INHALERS (DPI) 72
DPIs for Children 72
Nebulizers 73
How Do They Work' 73
Use 74
TABLE 21 NEBULIZERS AND DRUGS 74
Use (Continued) 75
TABLE 22 NEBULIZERS: ADVANTAGES AND DISADVANTAGES 76
Ultrasonic Nebulizers 76
TABLE 23 VIBRATING MESH NEBULIZERS 77
Factors Influencing Clinical Effectiveness of Inhalation
Devices 78
CONCLUSIONS 79
CHAPTER FIVE: PULMONARY DRUG DELIVERY: DRUGS IN USE 80
CURRENT INHALATION DRUGS AND MARKET 80
AEROSOL AZTREONAM (CAYSTON) 80
DULERA (MOMETASONE FUROATE/FORMOTEROL
FUMARATE DIHYDRATE) 81
AMIKACIN 82
PULMONARY DELIVERY OF SYSTEMIC DRUGS 83
Antibiotics 83
Analgesics 83
Anti-emetics 83
TABLE 24 THERAPEUTIC AGENTS ADMINISTERED BY
INHALATION 84
Pulmonary Specific Vasodilators 84
Nicotine 85
Nebulizers for Pediatric Care 85
Vaccines 85
Obesity 85
Drugs and Inhalers: How do they Work' 85
TABLE 25 SHORT-ACTING BRONCHODILATOR INHALERS 86
TABLE 26 LONG-ACTING BRONCHODILATOR INHALERS 86
Steroid Inhalers 87
TABLE 27 INHALED STEROID MEDICATIONS 87
TABLE 28 COMBINATION INHALERS 87
Breath-Activated Inhalers 88



Nebulizers 88
Pulmonary Delivery 89
Controlled Release 89
Controlled Release (Continued) 90
Controlled Release (Continued) 91
Formulations 92
Lactose Carrier Systems 92
Liposomes 93
Liposomes (Continued) 94
PulmoSpheres 95
Biodegradable Polymers 96
CHAPTER SIX: GLOBAL MARKET FOR PULMONARY DRUG
DELIVERY TECHNOLOGIES 97
GLOBAL RESPIRATORY MARKET 97
DRUG DELIVERY MARKET 98
Drug Delivery Technologies and Market 98
GLOBAL PHARMACEUTICAL MARKET 99
TABLE 29 GLOBAL PHARMACEUTICAL SALES, THROUGH 2016 ($
BILLIONS) 100
FIGURE 1 GLOBAL PHARMACEUTICAL SALES, 2010'2016 ($
BILLIONS) 100
Pharmaceutical Growth Rates 101
A Shift to Generics as Patents Expire 101
Growth in New Drugs 101
Recent Mergers and Acquisitions (M&A Deals) 102
Emerging Markets 103
United States Pharmaceutical Industry 104
Top 20 Pharmaceutical Companies 105
TABLE 30 TOP 20 PHARMACEUTICAL COMPANIES IN 2011 ($
MILLIONS) 106
TABLE 31 TOP 20 PHARMACEUTICAL COMPANIES IN 2010 ($
MILLIONS) 107
TABLE 32 TWELVE LARGEST PHARMACEUTICAL COMPANIES IN
2010 ($ MILLIONS) 108
India and the Pharmaceutical Market 109
DRUG DELIVERY MARKET 109
Global Market 109
TABLE 33 TOTAL GLOBAL DRUG DELIVERY TECHNOLOGIES
MARKET, THROUGH 2016 ($ MILLIONS) 110
FIGURE 2 TOTAL GLOBAL DRUG DELIVERY TECHNOLOGIES
MARKET, 2010'2016 ($ MILLIONS) 111
TABLE 34 GLOBAL DRUG DELIVERY TECHNOLOGIES MARKET,
THROUGH 2016 ($ MILLIONS) 111
FIGURE 3 GLOBAL DRUG DELIVERY TECHNOLOGIES MARKET,
2010'2016 ($ MILLIONS) 112
Oral Drug Delivery 112



TABLE 35 GLOBAL ORAL DRUG DELIVERY TECHNOLOGIES
FIGURE 4 GLOBAL ORAL DRUG DELIVERY TECHNOLOGIES
Implantable and Injectable Drug Delivery 114
TABLE 36 GLOBAL IMPLANTABLE/INJECTABLE DRUG DELIVERY
FIGURE 5 GLOBAL IMPLANTABLE/INJECTABLE DRUG DELIVERY
Transdermal Drug Delivery 116
TABLE 37 GLOBAL TRANSDERMAL DRUG DELIVERY
TECHNOLOGIES MARKET, THROUGH 2016 ($ MILLIONS) 116
FIGURE 6 GLOBAL TRANSDERMAL DRUG DELIVERY
TECHNOLOGIES MARKET, 2010'2016 ($ MILLIONS) 117
Drug Delivery Market in the US 117
TABLE 38 US DRUG DELIVERY TECHNOLOGIES MARKET,
THROUGH 2015 ($ MILLIONS) 117
FIGURE 7 US DRUG DELIVERY TECHNOLOGIES MARKET, 2010'
2016 ($ MILLIONS) 118
Pulmonary Drug Delivery 118
TABLE 39 TYPES OF INHALER UNITS SOLD WORLDWIDE, 2007 (%) 119
TABLE 40 GLOBAL PULMONARY DELIVERY TECHNOLOGIES
FIGURE 8 GLOBAL PULMONARY DELIVERY TECHNOLOGIES
TABLE 41 PULMONARY DELIVERY TECHNOLOGIES MARKET IN
THE US AND EUROPE, THROUGH 2016 ($ MILLIONS) 120
FIGURE 9 PULMONARY DRUG DELIVERY TECHNOLOGIES
MARKET IN THE US AND EUROPE, 2010'2016 ($ MILLIONS) 121
PULMONARY DRUG DELIVERY SYSTEMS 122
Metered Dose Inhalers (MDIs) 122
Leading Inhalation Prescription Drugs across All
Segments 123
TABLE 42 MARKET FOR MDI TECHNOLOGIES, THROUGH 2016 ($
MILLIONS) 124
FIGURE 10 MARKET FOR MDI TECHNOLOGIES, 2010'2016 ($
MILLIONS) 125
Dry Powder Inhalation (DPI) 125
TABLE 43 MARKET FOR DPI TECHNOLOGIES, THROUGH 2016 ($
MILLIONS) 126
FIGURE 11 MARKET FOR DPI TECHNOLOGIES, 2010'2016 ($
MILLIONS) 126
The Attractiveness of Inhalers 127
Phase-out of CFC inhalers and Future Developments 127
Phase-out of CFC '(Continued) 128
Phase-out of CFC '(Continued) 129
TABLE 44 SALES OF INHALED STEROIDS AND AEROSOL BETA
AGONISTS JANUARY TO JUNE 2007 ($ MILLIONS/%) 130



Dry Powder Inhalation: A Promising Technology 130
Dry Powder Inhalers 131
TABLE 45 DPI DEVICES (BRAND NAME/MANUFACTURER) 131
Growth for DPIs 132
TABLE 46 GROWTH AREAS FOR INHALERS 132
TOP SELLING INHALED DRUGS 132
Fluticasone/Salmeterol 133
Fluticasone/Salmeterol (Continued) 134
TABLE 47 TOP SELLING INHALERS, 2010 ($ MILLIONS) 135
Tiotropium Bromide 135
Tiotropium Bromide (Continued) 136
Tiotropium Bromide (Continued) 137
Other Drugs 138
MAJOR PLAYERS 138
GlaxoSmithKline 138
TABLE 48 TOP SELLING DRUGS IN 2010 (MILLIONS) 138
Nebulizers: Displaying Promising Growth 139
TABLE 49 GLOBAL RESPIRATORY DEVICE MARKET, THROUGH
2016 ($ MILLIONS) 139
FIGURE 12 GLOBAL RESPIRATORY DEVICE MARKET, 2010'2016 ($
MILLIONS) 139
Nebulizers: Displaying '(Continued) 140
TABLE 50 US RESPIRATORY DEVICE MARKET, THROUGH 2016 ($
MILLIONS) 141
FIGURE 13 US RESPIRATORY DEVICES MARKET, 2010'2016 ($
MILLIONS) 142
TABLE 51 GLOBAL MARKET FOR NEBULIZERS, THROUGH 2016 ($
MILLIONS) 142
FIGURE 14 GLOBAL MARKET FOR NEBULIZERS, 2010'2016 ($
MILLIONS) 143
Nebulizers on the Market 143
GLOBAL TRENDS AND INHALER MARKET 144
Asia 144
Asia (Continued) 145
Asia (Continued) 146
CHAPTER SEVEN: GLOBAL MARKET TRENDS 147
GLOBAL MARKET TRENDS 147
REGULATORY CHANGES 'PULMONARY DRUG DELIVERY
HURDLES 148
INCREASED RESEARCH AND DEVELOPMENT EFFORTS 148
AEROSOL DELIVERY MARKET 149
Distribution Channels 149
GROWTH AND NEW DEVELOPMENTS 150
Pulmonary Disease Drug Market 151
Market Trends in Asia 151
Market Segmentation 152
Patient Involvement 153
Pulmonary Insulin 154



Exubera 155
Afrezza 155
Inhaled Small Molecule Therapeutics 156
TABLE 52 APPROVED PULMONARY DRUGS IN RECENT YEARS 156
SELECTED PROFILES OF NEW DRUGS ON THE MARKET 157
Dulera 157
Dulera (Continued) 158
Arcapta (indacaterol maleate inhalation powder) 159
Daliresp 160
Daliresp (Continued) 161
CHAPTER EIGHT: KEY COMPANIES 162
KEY COMPANIES 162
3M 163
AKELA PHARMA INC (CANADA) 163
ALEXZA PHARMACEUTICALS 164
ALKERMES 164
ALPHARX INC 165
AOP ORPHAN PHARMACEUTICLS 165
APT PHARMACEUTICALS, INC 166
ARADIGM CORPORATION (USA) 166
ASTRAZENECA PLC (UK) 167
AXENTIS PHARMA 167
CONSORT MEDICAL PLC (UK) 168
DAIICHI SANKYO 168
DEY LP (USA) 169
GILEAD SCIENCES 169
GLAXOSMITHKLINE PLC (UK) 169
GRACEWAY PHARMACEUTICALS, LLC (USA) 170
HOVIONE 170
INSPIRE PHARMACEUTICALS, INC 171
MANNKIND 171
MAP PHARMACEUTICALS 172
MERCK & CO 173
MICRODOSE THERAPEUTX 173
MPEX PHARMACEUTICALS 173
NEKTAR THERAPEUTICS 174
NEXT SAFETY 175
NOVARTIS INTERNATIONAL AG 175
ORIEL THERAPEUTICS, INC 175
PEARL THERAPEUTICS 176
PHARMAXIS 176
PULMATRIX 177
RESPIRICS 177
SAVARA 178
SKYEPHARMA PLC (UK) 178
SUNOVION PHARMACEUTICALS INC 179
SYNAIRGEN RESEARCH LTD 179



TEVA NORTH AMERICA 180
THERAVANCE 180
UNITED THERAPEUTICS 181
VECTURA GROUP PLC (UK) 181
CHAPTER NINE: DEVELOPMENTS AND COLLABORATIONS 182
CURRENT AND FUTURE DEVELOPMENTS 182
BAYER SCHERING PHARMA AG, GERMANY 182
CIVITAS THERAPEUTICS 183
DR REDDY'S LABORATORIES 184
MANNKIND'S INHALED INSULIN DRUG AFREZZA 184
MannKind's Inhaled ' (Continued) 185
PEARL THERAPEUTICS 186
PULMATRIX 187
RESPIRA THERAPEUTICS 187
SANDOZ 188
SUNPHARMA 189
TEVA 190
Teva (Continued) 191
THERAVANCE AND GLAXOSMITHKLINE 192
UNITED THERAPEUTICS CORPORATION 193
PRODUCTS IN CLINICAL DEVELOPMENT 194
FENTANYL TAIFUN 194
Fentanyl Taifun (Continued) 195
SPIRIVA RESPIMAT MIST INHALER 196
THERAVANCE PHASE III WITH RELOVAIR 197
Theravance Phase III with Relovair (Continued) 198
CHAPTER TEN: PATENT ANALYSIS 199
PATENT LANDSCAPE 199
REGULATORY ISSUES 200
NEW PATENT FILINGS 201
COMPETITIVE LANDSCAPE 202
TABLE 53 AREAS FOR DRUG DELIVERY IMPROVEMENTS 202
KEY PATENTS 202
Advair and Patent Issues 202
TABLE 54 PULMONARY DRUG DELIVERY TECHNOLOGIES AND
KEY PATENTS 203
Advair and Patent Issues (Continued) 204
Proventil HFA 205
REFERENCES 206
REFERENCES 206
REFERENCES (CONTINUED) 207


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