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Needle-Free Devices, Technologies and Global Markets

  • January 2015
  • -
  • BCC Research
  • -
  • 204 pages

This BCC Research report covers the needle-free devices and technologies market, key growth areas, market strategy, product scope and quantitative market projections for technologies and devices. Market projections are provided through 2019.

Use this report to:
Estimate the market for needle-free devices and technologies, excluding the drug sales combined with these devices.

Receive information on needle-free injectors, Inhaler and transdermal patch technologies.

Identify promising new devices, materials and technologies still in the development and testing stage, and assess the probability that they will be commercialized successfully in the next five years.

Identify and evaluate the impact of demographic, economic and other factors that will drive future demand for needle-free devices and technologies market.

Highlights

The global market for needle free technologies reached $963.6 million in 2013. This market is expected to grow to $1.1 billion in 2014 and $2.1 billion in 2019, with a compound annual growth rate (CAGR) of 14.3%.

The U.S. market reached $531.6 million in 2013. This market is expected to grow to $607.4 million 2014 and $1.2 billion in 2019, with a CAGR of 14.8%.

The European market is expected to grow to $379.7 million in 2014 and $724.4 billion in 2019, with a CAGR of 13.8%.

INTRODUCTION

NEEDLE-FREE DEVICES

In recent years there has been a growing concern regarding needle-based drug delivery devices due to needle phobia, increasing cases of needlestick injuries and the transmission of blood-borne diseases. Needle-free drug delivery devices are considered as an effective alternative and novel technique to introduce drugs into a patient’s body without invading the skin with a needle. It is growing in popularity and has received considerable attention during the past few years primarily due to painless, effective and safe drug delivery methods. Needle-free drug delivery devices typically include needle-free injectors, inhalers, transdermal patches and other devices based on novel needle technologies (e.g., microneedles and advanced pen needles).

According to BCC Research estimates, the global market for needle-free drug delivery technologies (excluding drug sales) is estimated to be approximately $1 billion, whereas the market for pharmaceutical products combined with needle-free technology is estimated to be more than $25 billion. The needle-free injector segment is considered one of the fastest growing segments within the needle-free device and technology market. Key players within the market for needle-free drug delivery technologies include 3M, Consort Medical, PharmaJet, Ypsomed Holding, Zogenix, Antares Pharma and Bioject Medical Technologies.

STUDY BACKGROUND

Delivery of medicine and drugs to patients is typically done through pills, tablets or even in liquid form, either orally or using injection. Drug delivery is administered by injection (intravenously) when the drug must reach the systemic circulation quicker, or when the drug has a shorter half-life, often seen during emergencies. In addition, there are a large number of therapies, particularly protein, gene and vaccine-based medications, that cannot be delivered orally and require intravenous delivery.

The goal of modern needle-free drug delivery techniques is to increase the prescribing and adoption of important drugs that require self-injection, such as biologics.
Continuous innovation and availability of newer needle-free drug delivery systems have the potential to be enabling for highly viscous drug products that cannot be delivered by the traditional needle and syringe, adding to the utility of the technology.
As more companies begin to recognize the benefits, needle-free injection technology will continue to grow in popularity, both among patients and physicians, and ultimately increase adoption of injectable drug therapies.

This report is the first edition of in-depth report to cover the needle-free devices and technologies market, key growth areas, market strategy, product scope and quantitative market projections for technologies and devices. This report includes detailed market size and analysis of needle-free drug delivery devices, including needle-free jet injectors, inhalers, transdermal patch and other novel needle technologies (e.g., microneedles and advanced pen needles). In addition, it includes qualitative and quantitative factors that are driving the global needle-free devices and technologies market. This study attempts to give the reader the information and analysis they need to deal with these challenges.

STUDY GOALS AND OBJECTIVES

During the past several decades, tremendous progress has been made toward the development of safe, effective and convenient means of drug administration. Advances have been possible, at least in part, because of increasing awareness about health concerns associated with traditional needle-based drug delivery devices and
technological innovations to meet the current challenges.

This study, Needle-Free Devices, Technologies and Global Markets, provides an overview of products included in this market and detailed analyses of markets and competitive environments.

This report focuses on some key developments in the field of drug delivery, especially those that deal with the development of painless, patient-friendly alternatives to injections for the delivery of macromolecules. This area covers a wide variety of products that help in safe and effective drug delivery. The study includes information
about significant products, players, issues and trends, and other information affecting the needle-free drug delivery industry.

Our study meets these needs by analyzing global markets for needle-free devices and technologies (see the section “Scope” for a definition of these) in light of the most recently available information. In addition to looking at current and future markets, the study will analyze technological, demographic and economic developments that may have a long-term impact on the size and structure of the needle-free devices and
technologies market. The future of needle-free technology will also be discussed with the market forecasts.

More specific objectives are to:

Identify and segment the needle-free drug delivery market by technology and applications.
Estimate the market for needle-free devices and technologies, excluding the drug sales combined with these devices.
Analyze the type of needle-free drug delivery devices and technologies by geographic markets.
Identify and evaluate the impact of demographic, economic and other factors that will drive future demand for needle-free devices and technologies market.
Forecast the various needle-free technologies that are used for various drug delivery applications.
Identify promising new devices, materials and technologies still in the development and testing stage, and assess the probability that they will be commercialized successfully in the next five years.
Forecast the potential market based on the pipeline, taking into account the estimated probability that they will be commercialized.
Identify leading device manufacturers, technology suppliers and pharmaceutical partners to analyze the structure of the needle-free devices and technologies market within drug delivery industry (e.g., market shares, concentration, and recent merger and acquisition activity)
Assess the long-term outlook for the needle-free drug delivery devices and technologies market, taking into account market opportunities, as well as technological, financial and economic factors.
This study will provide the reader with the knowledge to adequately view and assess the market for needle-free drug delivery devices and technologies while gaining insight into the market’s potential.

Table Of Contents

Needle-Free Devices, Technologies and Global Markets
NEEDLE-FREE DEVICES, TECHNOLOGIES AND GLOBAL MARKETS
HLC178A
January 2015
ww.bccresearch.com
CHAPTER 1 INTRODUCTION 2
NEEDLE-FREE DEVICES 2
STUDY BACKGROUND 2
STUDY GOALS AND OBJECTIVES 3
INTENDED AUDIENCE 4
SCOPE OF THE REPORT 4
METHODOLOGY AND INFORMATION SOURCES 5
ANALYST'S CREDENTIALS 5
RELATED BCC RESEARCH REPORTS 5
BCC RESEARCH WEBSITE 6
DISCLAIMER 6
CHAPTER 2 SUMMARY 8
EXECUTIVE SUMMARY 8
SUMMARY TABLE GLOBAL MARKET FOR NEEDLE-FREE TECHNOLOGIES, THROUGH
2019 ($ MILLIONS) 8
SUMMARY FIGURE GLOBAL MARKET FOR NEEDLE-FREE TECHNOLOGIES,
2013-2019 ($ MILLIONS) 8
CHAPTER 3 DRUG DELIVERY DEVICES 12
STRUCTURE OF HUMAN SKIN 12
EPIDERMIS 12
DERMIS 12
HYPODERMIS 12
OVERVIEW OF DRUG DELIVERY SYSTEMS AND TECHNOLOGIES 13
CLASSIFICATION OF DRUG DELIVERY ACCORDING TO TECHNOLOGY 14
SUSTAINED RELEASE DRUG DELIVERY 14
PRODRUGS 14
IMPLANTS AND INTRAUTERINE DEVICES 15
TARGETED DRUG DELIVERY 15
POLYMERIC DRUG DELIVERY 15
CLASSIFICATION OF DRUG DELIVERY BY ROUTE OF ADMINISTRATION 16
ORAL DRUG DELIVERY 16
Proteins and Peptides 17
Enzyme Inhibitors 17
Mucoadhesives 17
Encapsulation Technologies 18
TABLE 1 ADVANTAGES AND DISADVANTAGES OF ORAL DRUG DELIVERY 18
INJECTABLE OR PARENTERAL DRUG DELIVERY 19
Needle/Syringe Injections 19
Safety Syringes/Needle-Free Injectors 19
TABLE 2 ADVANTAGES AND DISADVANTAGES OF INJECTABLE DRUG DELIVERY 20
PULMONARY DRUG DELIVERY 20
TABLE 3 ADVANTAGES AND DISADVANTAGES OF PULMONARY DRUG DELIVERY 21
NASAL DRUG DELIVERY 21
TABLE 4 ADVANTAGES AND DISADVANTAGES OF NASAL DRUG DELIVERY 21
ORAL MUCOSAL DRUG DELIVERY 22
TABLE 5 ADVANTAGES AND DISADVANTAGES OF ORAL MUCOSAL DELIVERY 22
RECTAL DRUG DELIVERY 22
TABLE 6 ADVANTAGES AND DISADVANTAGES OF RECTAL DRUG DELIVERY 23
OCULAR DRUG DELIVERY 23
TABLE 7 ADVANTAGES AND DISADVANTAGES OF OCULAR DRUG DELIVERY 23
TRANSDERMAL DRUG DELIVERY 24
Passive Methods 24
Active Methods 24
Combined Technologies 25
TABLE 8 ADVANTAGES AND DISADVANTAGES OF TRANSDERMAL DRUG DELIVERY 25
NEED FOR BETTER METHODS OF DRUG DELIVERY 25
AREAS OF ONGOING RESEARCH 26
CHAPTER 4 NEEDLE-FREE TECHNOLOGY AND DRUG DELIVERY DEVICES 29
NEEDLE-FREE DRUG DELIVERY DEVICES AND TYPES 29
HISTORY OF NEEDLE-FREE DEVICES 29
MARKET NEED FOR NEEDLE-FREE DEVICES 30
NEEDLE PHOBIA 31
Vasovagal 31
Associative 31
Resistive 31
Hyperalgesic 32
Vicarious 32
NEEDLESTICK INJURY 32
Overview of Needlestick Injury 32
Incidence of Needlestick Injuries 33
TABLE 9 INCIDENCE OF NEEDLESTICK INJURIES BY GEOGRAPHY, 2013 (NO.) 33
FIGURE 1 INCIDENCE OF NEEDLESTICK INJURIES BY GEOGRAPHY, 2013 `(% OF
TOTAL) 33
Causes of Sharps Injuries 34
Cost of Needlestick Injuries 34
Needlestick Injury Prevention 35
ADVANTAGES OF NEEDLE-FREE TECHNOLOGY 36
CHAPTER 5 NEEDLE-FREE DEVICE APPLICATIONS 38
APPLICATION OF NEEDLE-FREE DEVICES 38
TABLE 10 GLOBAL NEEDLE-FREE TECHNOLOGIES MARKET BY SEGMENT, THROUGH
2019 ($ MILLIONS) 38
FIGURE 2 GLOBAL NEEDLE-FREE TECHNOLOGIES MARKET BY SEGMENT,
2013-2019 ($ MILLIONS) 39
PAIN MANAGEMENT 40
Latest Developments in Needle-Free Pain Management 40
VACCINE DELIVERY 41
Latest Developments in Needle-Free Vaccine Delivery 42
Future Developments in Needle-Free Vaccine Delivery 42
INSULIN DELIVERY 42
Diabetes Overview 42
FIGURE 3 DISTRIBUTION OF DIABETES TYPES GLOBALLY, 2013 (% OF TOTAL
DIABETES) 43
Epidemiology and Economic Burden 44
TABLE 11 PREVALENCE OF DIABETES BY GEOGRAPHY, 2013 ($ MILLIONS) 44
FIGURE 4 PREVALENCE OF DIABETES BY GEOGRAPHY, 2013` (% OF TOTAL) 44
Traditional Insulin Delivery Systems 45
Needle-Free Insulin Delivery Systems 46
Insulin Jet Injectors 46
Inhalable Insulin Devices 47
Insulin Spray Systems 47
Insulin Micropump 47
Insulin Port 48
Transdermal Insulin Patches 48
Insulin Nanopump 48
TABLE 12 COMPARISON BETWEEN PAINFUL AND PAINLESS NEEDLE-FREE INSULIN
DRUG DELIVERY SYSTEMS 49
Future Prospective for Needle-Free Insulin Delivery Systems 49
PEDIATRIC DRUG DELIVERY 50
Needle-Free Injectors 50
Low Workload Jet Injectors for Routine Immunizations 50
Multi-Channel Jet Injectors for Simultaneous Vaccine Delivery 50
Transdermal Methods and Microneedle Technologies for Various Drug
Delivery Applications 50
CHAPTER 6 NEEDLE-FREE INJECTORS 52
INTRODUCTION 52
HISTORICAL BACKGROUND OF NEEDLE-FREE INJECTOR 52
CLINICAL NEED FOR NEEDLE-FREE INJECTORS 53
NEEDLE-FREE INJECTOR TYPES 53
NEEDLE-FREE INJECTORS TYPES BY MEDICATION 53
Liquid-Based Needle-Free Injectors 53
Powder-Based Needle-Free Injectors 54
Depot or Projectile Needle-Free injectors 55
NEEDLE-FREE INJECTOR TYPES BY DRUG DELIVERY 55
Intramuscular Injections 55
Subcutaneous Injections 55
Intradermal Injections 55
NEEDLE-FREE INJECTOR TYPES BY SOURCE OF POWER 55
Spring Powered 55
Compressed Gas Powered 55
NEEDLE-FREE INJECTORS BY USAGE TYPE 56
Single-Use Injectors 56
Disposable Injectors 56
Reusable Injectors 56
COMPONENTS OF NEEDLE-FREE INJECTORS 56
INJECTOR DEVICE AND DRUG RESERVOIR 56
NOZZLE 56
PRESSURE SOURCE 57
MECHANISM OF OPERATION 57
RAW MATERIALS AND KEY NEEDLE-FREE INJECTOR DESIGNS 57
RAW MATERIALS 57
KEY NEEDLE-FREE INJECTOR DESIGNS 58
Jet Injectors 58
Jet Injector Gun 58
Hypodermal Jet Injectors without a Needle 58
Low Workload Jet Injector 59
Multi-Channel Jet Injector 59
Biojector 59
Microjets 59
Intraject Technology 59
Mini-Ject Technology 60
Needle-Free, Auto and Pen Injectors 60
MadaJet 60
INJEX Needle-Free Injectors for Infiltration Anesthesia 60
NEEDLE-FREE INJECTOR APPLICATIONS 60
ADVANTAGES AND DISADVANTAGES OF NEEDLE-FREE INJECTORS 61
EFFICIENT DRUG DISTRIBUTION AND IMPROVED EFFICACY 61
GREATER PATIENT ACCEPTANCE AND COMPLIANCE 61
TABLE 13 ADVANTAGES AND DISADVANTAGES OF NEEDLE-FREE INJECTORS 61
SUPERIOR SAFETY 62
RELIABILITY AND REPEATABILITY 62
FASTER INJECTION TIME 62
ELIMINATES SHARPS WASTE 62
CLINICAL CHALLENGES AND UNMET NEEDS 63
FUTURE DEVELOPMENTS 63
CHAPTER 7 INHALER TECHNOLOGIES 65
PULMONARY DRUG DELIVERY 65
TABLE 14 IDEAL CHARACTERISTICS OF THERAPEUTIC AEROSOLS 65
TABLE 15 ADVANTAGES AND DISADVANTAGES OF PULMONARY DRUG DELIVERY 66
INHALER TECHNOLOGY 66
TABLE 16 ADVANTAGES AND DISADVANTAGES OF INHALER TECHNOLOGIES 66
HISTORICAL BACKGROUND 67
CLINICAL NEED FOR INHALER TECHNOLOGY 67
Epidemiology of Asthma 67
TABLE 17 PREVALENCE OF ASTHMA BY GEOGRAPHY, 2013 (MILLIONS) 68
FIGURE 5 PREVALENCE OF ASTHMA BY GEOGRAPHY, 2013 (% OF TOTAL) 68
Economic Burden of Asthma 69
TYPES OF INHALERS 69
MDI 69
TABLE 18 ADVANTAGES AND DISADVANTAGES OF METERED DOSE INHALERS 70
New Developments in MDI Technology 70
Advanced MDI and Use Enantiomer Preparations of Inhaled
Drugs 70
Generic MDIs 70
Improved Patient Inhalation Coordination with Advanced MDI 70
Flow Gate Valve Technology in Spacers 71
Adaptive Aerosol Delivery Technology 71
Autohaler (Modified Form of pMDI) 71
TABLE 19 ADVANTAGES AND DISADVANTAGES OF F STANDARD PRESS AND
BREATHE METERED DOSE INHALERS 71
DPI 71
New Developments in DPI Technology 72
Air Classifier Technology in Devices 72
Multiple Air Classifier Technology 72
Spiros Inhaler Technology 72
TABLE 20 ADVANTAGES AND DISADVANTAGES OF DRY POWDER INHALERS 73
MDI. vs DPI (Uniformity vs. Diversity) 73
TABLE 21 COMPARISON OF INHALERS: MDI VS. DPI 74
ADVANCES IN PULMONARY DRUG DELIVERY 74
Particle Engineering 74
Agglomerated Vesicle Technology 75
FUTURE DEVELOPMENTS 75
CHAPTER 8 TRANSDERMAL PATCH TECHNOLOGIES 77
TRANSDERMAL DRUG DELIVERY 77
TABLE 22 PARAMETERS AFFECTING SELECTION OF DRUGS IN TRANSDERMAL
DRUG DELIVERY SYSTEMS 77
TRANSDERMAL PATCH TECHNOLOGY 77
TABLE 23 IDEAL PROPERTIES OF TRANSDERMAL DRUG DELIVERY SYSTEMS 78
CLINICAL NEED 79
HISTORICAL BACKGROUND 79
TYPES OF TRANSDERMAL PATCHES 79
Single-Layer Drug-in-Adhesive 79
Multilayer Drug-in-Adhesive 80
Reservoir 80
Matrix 80
Drug-in-Adhesive System 80
Matrix Dispersion System 80
Micro Reservoir System 81
Vapor Patch 81
TABLE 24 ADVANTAGES AND DISADVANTAGES OF TRANSDERMAL PATCHES 81
COMPONENTS OF A TRANSDERMAL PATCH 81
Polymer Matrix 82
Drug 82
Permeation Enhancers 82
Adhesive 82
Backing Laminates 82
Release Liner 82
Other Excipients 83
BENEFITS OF TRANSDERMAL PATCHES OVER OTHER DOSAGE FORMS 83
NEW INNOVATIONS IN TRANSDERMAL PATCHES 83
Dispenser for Transdermal Patches 83
Magnetophoresis Combined with Chemical Enhancers 83
LIMITATIONS OF TRANSDERMAL PATCHES 83
CLINICAL ISSUES OF TRANSDERMAL DELIVERY 83
FUTURE DEVELOPMENTS 84
CHAPTER 9 OTHER NOVEL NEEDLE TECHNOLOGIES 86
MICRONEEDLES 86
HISTORICAL BACKGROUND 86
TYPES OF MICRONEEDLES 86
Solid Microneedles 87
Fabrication of Solid Microneedles 87
Silicon Microneedles 87
Metal Microneedles 87
Polymer Microneedles 87
Ceramic Microneedles 87
Microneedle Rollers 88
Coated Microneedles 88
Dissolving Microneedles 88
Hollow Microneedles 88
APPLICATION OF MICRONEEDLES 88
Blood Glucose Measurements 88
Transdermal Drug Delivery 89
Immunobiologicals 89
Bioactive Macromolecules (Biopharmaceuticals) 89
Drug Delivery 89
Diagnosis 89
Cosmetic Products 89
ADVANTAGES AND DISADVANTAGES OF MICRONEEDLES 90
TABLE 25 ADVANTAGES AND DISADVANTAGES OF MICRONEEDLES 90
ADVANCES IN DRUG DELIVERY BY MICRONEEDLES 91
CURRENT AND FUTURE DEVELOPMENTS 91
PEN NEEDLES 91
CONSTRUCTION AND DESIGN OF PEN NEEDLES 92
TABLE 26 ADVANTAGES AND DISADVANTAGES OF MICRONEEDLES 92
CURRENT AND FUTURE DEVELOPMENTS 92
CHAPTER 10 NEEDLE-FREE DEVICE MARKET ASSESSMENT 94
DRUG DELIVERY DEVICES 94
GLOBAL NEEDLE-FREE TECHNOLOGIES MARKET 94
GLOBAL MARKET BY GEOGRAPHIC REGION 94
TABLE 27 GLOBAL MARKET FOR NEEDLE-FREE TECHNOLOGIES BY REGION,
THROUGH 2019 ($ MILLIONS) 94
FIGURE 6 GLOBAL MARKET FOR NEEDLE-FREE TECHNOLOGIES BY REGION,
2013-2019 ($ MILLIONS) 95
GLOBAL MARKET BY SEGMENT 96
TABLE 28 GLOBAL NEEDLE-FREE TECHNOLOGIES MARKET BY SEGMENT, THROUGH
2019 ($ MILLIONS) 96
FIGURE 7 GLOBAL NEEDLE-FREE TECHNOLOGIES MARKET BY SEGMENT,
2013-2019 ($ MILLIONS) 96
FIGURE 8 NEEDLE-FREE DRUG DELIVERY TECHNOLOGY MARKET BY SEGMENT,
2013 (% OF TOTAL MARKET) 97
GLOBAL MARKET BY APPLICATION 98
TABLE 29 GLOBAL NEEDLE-FREE TECHNOLOGY MARKET BY APPLICATION,
THROUGH 2019 ($ MILLIONS) 98
FIGURE 9 NEEDLE-FREE TECHNOLOGY MARKET BY APPLICATION, 2013 (% OF
TOTAL MARKET) 99
MARKET GROWTH DRIVERS AND RESTRAINTS 99
Growth Drivers 99
Increase in Disease Population Worldwide. 99
Needle Phobia and Increasing Awareness about the Risk of
Needlestick Injuries 99
Increasing Demand for Painless Drug Delivery Technologies 100
Growing Demand for Minimally Invasive Delivery Methods 100
Demand for More Sophisticated Delivery Systems for Effective
Treatment 100
Growing Demand for Drug-Device Combinations 100
Limitations of Oral Drug Delivery 100
Limitations of Hypodermic Needles 101
Growing Demand for Needle-Free Technologies for Chronic Pain
Management 101
Increasing Awareness about the Safety and Efficacy of Drug
Delivery Technologies 101
Rising Prevalence of Diabetes 101
Increasing Awareness about Pediatric Vaccinations 101
Increasing Use of Needle-Free Injections in Anesthesia Delivery 102
Booming Global Vaccine Market 102
Mass Immunization Programs 102
Cost-Efficient Drug Delivery 102
Growth of Biologics and Entry of Biosimilars in Leading
Pharmaceutical Markets 102
Development of Home-Care and Self-Medication Devices 103
Growing Market for Injectable Medications 103
Growing Market for Injectable HGH 103
Growth Restraints 103
High Cost of Needle-Free Technology 103
Increasing Regulatory Scrutiny and Inefficient Manufacturing
Processes 103
Downward Pricing Pressure, Increasing Material Cost and
Inefficient Manufacturing Processes 103
Increasing Competition and Decreasing Profit Margins 104
Increasing Research and Development Cost 104
Shorter Product Life Cycles 104
Risks and Complications 104
COMPETITIVE LANDSCAPE 104
TABLE 30 GLOBAL NEEDLE-FREE DEVICE MARKET REVENUE SHARES, 2013 ($
MILLIONS/%) 105
FIGURE 10 GLOBAL NEEDLE-FREE DEVICE MARKET LEADERS, 2013 (% OF TOTAL
MARKET) 105
CHAPTER 11 MARKET STRATEGY 108
NEEDLE-FREE DEVICES MARKET STRATEGY 108
KEY STRATEGIC EVENTS DURING THE LAST FEW YEARS 108
TABLE 31 NEEDLE-FREE DEVICE MARKET, KEY MERGERS/ACQUISITIONS 109
Key Mergers and Acquisitions 109
OPKO Health's Acquisition of Inspiro Medical 109
Endo International's Acquisition of Zogenix' DosePro Migraine
Therapy Business 110
North Coast Medical's Acquisition of ActivaTek 110
Teva Pharmaceutical's Acquisition of NuPathe 110
Teva Pharmaceutical's Acquisition of MicroDose Therapeutx 110
Becton Dickinson's Acquisition of Safety Syringes 111
Medical Marketing Berlin/Paketeria AG's Acquisition of INJEX
Pharma 111
Key Product and Technology Developments 111
NxStage Announces FDA Clearance of a Single Needle
Technology 111
Vaxxas' Nanopatch Garners WHO Support for Polio Vaccine
Delivery 111
FDA Approves Use of bioCSL's Afluria Influenza Vaccine with
PharmaJet Needle-Free Injector 112
Bioject Inc. Expands its Global Distribution Network 112
Glide Pharma Completed the Successful Proof-of-Concept Study
with Octreotide 112
Crossject Launched Bioequivalence Clinical Study with Zeneo
(Methotrexate) 112
Bioject Enters Into Agreement with Fondaco 113
Antares Pharma's Otrexup Injection Approved by the FDA 113
Zogenix Received FDA Approval for 4 mg Sumavel DosePro
(Sumatriptan Injection) 113
3M Co. Licensed Fentanyl Transdermal Patch Technology to
Stada Arzneimittel 113
Adamis Pharmaceuticals Acquired Dry Powder Inhaler
Technology from 3M Co. 113
Bioject Medical Technologies Featured on Bloomberg
International 113
PharmaJet's Stratis Needle-Free Injector Achieved WHO PQS
Certification 114
Glide Pharma Completed Design Optimization Agreement with
Nypro Healthcare 114
Antares Pharma Obtained U.S. Patent for Vibex Technology 114
Zogenix Signs Co-promotion Deal for Needle-Free Migraine
Treatment 114
INJEX Pharma Received FDA Clearance for the INJEX 30 114
Medical International Technology Gains Chinese SFDA
Certification for Med-Jet 114
Bioject Medical Technologies to Supply ID Pens 115
Zogenix and Durect Signed Development and License
Agreement 115
CHAPTER 12 MARKETED AND PIPELINE PRODUCTS 117
KEY MARKETED PRODUCTS 117
NEEDLE-FREE INJECTORS 117
Antares Pharma 117
Medi-Jector Vision Needle-Free Injector 117
Vibex Pressure Assisted Auto Injection System 117
Pen Injector 118
Otrexup 118
Bioject Medical Technologies 118
Biojector 2000 Needle-Free Injection System 118
Vitajet Insulin Delivery System 119
Cool.click Needle-Free Injection System 119
SeroJet Needle-Free Injection System 119
ZetaJet Auto-Disable Needle-Free Delivery System 119
Endo International 120
Sumavel DosePro Needle-Free Delivery System 120
Activa Brand Products Inc. 120
AdvantaJet 120
D'Antonio Consultants International 120
LectraJet Disposable Syringe Jet Injector System 120
National Medical Products 120
J-Tip Needle-Free System 120
Medical International Technologies 121
Med-Jet Needle-Free System 121
PenJet Corp. 121
PenJet Needle-Free System 121
PharmaJet 122
Stratis Needle-Free System 122
Valeritas 122
Mini-Ject Needle-Free System 122
h-Patch 122
Micro-Trans 122
Akra Dermojet 123
Dermojet HR 123
Dermojet Polymedical with Interchangeable Injection Tips 123
Automatic Dermojet 123
Felton International 123
HSI-500 Needle-Free Injector 123
INJEX Pharma 124
INJEX 30 Multiple Application Needle-Free Device 124
Jet Syringe/Rojex Disposable, Single-Use Devices 124
INJEX 50 Needle-Free Injection 124
Keystone Industries 124
Syrijet Mark II 124
Glide Pharma 124
Glide SDI Drug Delivery System 124
The Medical House PLC (Subsidiary of Consort Medical) 125
mhi-500 Novel Needle-free Insulin Delivery System 125
Spring-Powered SQ-PEN 125
Bespak Drug Delivery Solutions 125
Shreya Life Sciences 125
Recojet Needle-Free Insulin Delivery Device 125
Merck Serono 126
SeroJet 126
Pfizer 126
PowderMed 126
Key Device Approvals by the FDA 126
TABLE 32 NEEDLE-FREE INJECTORS: KEY DEVICE APPROVALS BY THE FDA,
2005-2014 126
INHALERS 127
Short-Acting Bronchodilators 127
Corticosteroids 127
Combination Drugs 128
Key Marketed MDI Devices 128
TABLE 33 KEY METERED DOSE INHALERS ON THE MARKET 128
TRANSDERMAL PATCH 129
TABLE 34 TRANSDERMAL PATCH: KEY MARKETED DEVICES 129
OTHER NOVEL NEEDLE TECHNOLOGIES 130
TABLE 35 "OTHER" NOVEL NEEDLE TECHNOLOGY-BASED DEVICES ON THE
MARKET 131
KEY PIPELINE PRODUCTS 132
NEEDLE-FREE INJECTORS 132
Antares Pharma 132
Vibex MTX 132
Vibex QS (QuickShot) 132
Bioject Medical Technologies 132
ID Pen Injector 132
Iject Needle-Free Injection 133
Jupiter Jet 133
Zogenix 133
Relday 133
Pulse NeedleFree Systems 133
Needle-Free Systems 133
Echo Therapeutics 133
Prelude SkinPrep System 133
American Medical Systems 134
JetTouch Needle-Free Injection System 134
Crossject Medical Technology 134
Zeneo Disposable, Prefilled, Needle-Free, Automatic Injection
System 134
TABLE 36 KEY NEEDLE-FREE DEVICES IN THE PIPELINE 134
METERED DOSE INHALERS 135
Teva Pharmaceutical 135
Albuterol HFA MDI 135
Beclomethasone Dipropionate MDI 135
Sunovion 135
Levalbuterol HFA MDI 135
Solvay Pharmaceuticals and Nektar Therapeutics 135
Dronabinol MDI 135
GlaxoSmithKline 136
FP/SLM HFA MDI 50/25 mcg 136
TABLE 37 KEY METERED DOSE INHALERS IN THE PIPELINE 136
TRANSDERMAL PATCHES 136
Amnio Technology 136
PalinGen (Amniotic Membrane Patch) 136
ICURE Pharmaceutical Inc. 137
Donepezil Patch 137
Formoterol Patch 137
Oxybutynin Patch 137
Merz Pharmaceuticals GmbH 137
Overnight Intensive Patch 137
Mundipharma Research Ltd. 137
Buprenorphine Patch (Extended Release) 137
Tyndall National Institute 137
ImmuPatch 137
TABLE 38 KEY TRANSDERMAL PATCHES IN THE PIPELINE 138
OTHER NOVEL TECHNOLOGIES 139
Seagull Technology 139
SonoEye 139
CHAPTER 13 REGULATORY STRUCTURE 141
REGIONAL REGULATORY STRUCTURES 141
UNITED STATES 141
EUROPEAN UNION 143
TABLE 39 DIFFERENCES IN REGULATORY APPROVAL IN THE U.S. VS. EUROPE 145
JAPAN 145
OTHER ASIA 146
China 146
Hong Kong 147
Korea 147
Taiwan 147
India 147
FDA TECHNICAL CONSIDERATIONS 148
FDA RECALLS AND SAFETY ALERTS 149
OCCUPATIONAL HEALTH AND SAFETY LAWS 149
UNITED STATES 149
Needlestick Safety and Prevention Act/Blood-Borne Pathogens
Standard 149
EUROPEAN UNION 150
CHAPTER 14 PRICING AND REIMBURSEMENT 152
REGIONAL REIMBURSEMENT STRUCTURES 152
UNITED STATES 152
Healthcare Common Procedure Coding System Code 153
TABLE 40 HCPCS 2014 CODE A4210: NEEDLE-FREE INJECTION DEVICE, EACH 154
Insurance and Reimbursement 154
EUROPE 155
JAPAN 156
OTHER ASIA 156
MEDICAL DEVICE PRICING TRENDS 156
CHAPTER 15 CONCLUSIONS AND OUTLOOK FOR NEEDLE-FREE DEVICES 159
MAJOR MARKET INFLUENCES 159
SOCIAL FACTORS 159
TECHNOLOGICAL DEVELOPMENTS 159
Breath-Actuated Metered-Dose Inhalers 160
Novel Formulation Approaches and Technologies for Transdermal
Patches 160
Innovations to Create Autoinjector Syringes to Prevent Unnecessary
Contamination 160
Laser-Powered Needle-Free Injections 160
Other Advanced Transdermal Drug Delivery Technologies 161
Next-Generation Needle-Free Drug Injector 161
Next-Generation Stamp-Sized Nanopatch 161
DEMOGRAPHIC AND ECONOMIC TRENDS 161
Increasing Aging Population 162
TABLE 41 ESTIMATED WORLD POPULATION AND ANNUAL GROWTH BY SELECTED
AGE GROUP AND SELECTED YEARS, THROUGH 2030 (MILLIONS) 162
FIGURE 11 ESTIMATED WORLD POPULATION BY SELECTED AGE GROUP AND
SELECTED YEARS, 2000-2030 ($ MILLIONS) 162
TABLE 42 WORLD POPULATION BY SELECTED GEOGRAPHIC REGION, THROUGH
2030 (MILLIONS) 163
FIGURE 12 WORLD POPULATION BY SELECTED COUNTRy, 2000-2030 ($ MILLIONS) 163
U.S. Demographics 164
TABLE 43 U.S. POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
THROUGH 2030 (MILLIONS) 164
FIGURE 13 U.S. POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
2000-2030 (MILLIONS) 165
U.S. Gender, Age and Life Expectancy 165
TABLE 44 ESTIMATES OF ANTICIPATED U.S. LIFE EXPECTANCY AT BIRTH AND
PROJECTIONS BY GENDER, 2005-2020 (YEARS) 166
FIGURE 14 ESTIMATES OF ANTICIPATED U.S. LIFE EXPECTANCY AT BIRTH AND
PROJECTIONS BY GENDER, 2005-2020 (YEARS) 166
European Demographics 166
TABLE 45 EUROPEAN POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
THROUGH 2030 (MILLIONS) 167
FIGURE 15 EUROPEAN POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
2000-2030 (MILLIONS) 167
Japanese Demographics 167
TABLE 46 JAPANESE POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
THROUGH 2030 (MILLIONS) 168
FIGURE 16 JAPANESE POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
2000-2030 (MILLIONS) 168
Increasing Prevalence of Diabetes 168
TABLE 47 GLOBAL DIABETES PREVALENCE, 2013 AND 2030 169
Income Growth in Developing Markets 169
TABLE 48 PROJECTED TRENDS IN PER CAPITA REAL GDP GROWTH BY REGION,
2012-2015 (ANNUAL AVERAGE PERCENTAGE CHANGE) 169
CHANGING STRUCTURE OF THE HEALTHCARE INDUSTRY 170
Development of Home-Care and Self Medication Devices 170
Developments in Health Insurance and Reimbursement 170
FUTURE OUTLOOK 170
CHAPTER 16 APPENDIX A: ABBREVIATION(S) 174
CHAPTER 17 APPENDIX B: VENDOR PROFILES 177
ACTIVA BRAND PRODUCTS INC. 177
AKRA DERMOJET 177
ALKERMES PLC 178
ALZA CORP. 178
AMNIO TECHNOLOGY LLC. 179
ANTARES PHARMA INC. 179
ARADIGM CORP. 180
ASTELLAS PHARMA INC. 181
ASTRAZENECA PLC 181
BATTELLE 182
BESPAK EUROPE LTD. 182
BIOJECT MEDICAL TECHNOLOGIES 183
BRISTOL-MYERS SQUIBB 184
CAMBRIDGE CONSULTANTS LTD. 184
CLEARSIDE BIOMEDICAL INC. 185
CORIUM INTERNATIONAL INC. 185
COVIDIEN 186
CROSSJECT 186
CYDEX PHARMACEUTICALS INC. 187
D'ANTONIO CONSULTANTS INTERNATIONAL 187
DR. REDDY'S LABORATORIES LTD. 187
DUOJECT MEDICAL SYSTEMS INC. 188
DURECT CORP. 188
ECHO THERAPEUTICS 189
ELI LILLY and CO. 190
ENDO INTERNATIONAL 190
EUROJET MEDICAL INC. 191
FERNDALE PHARMA GROUP INC. 191
FERRING PHARMACEUTICALS INC. 192
GERRESHEIMER AG 192
GLAXOSMITHKLINE PLC 192
GLIDE PHARMACEUTICALS TECHNOLOGIES LTD. 193
HASELMEIER GMBH 194
INJEX PHARMA AG 194
INTERCELL AG 195
JCR PHARMACEUTICALS CO. LTD. 195
KEYSTONE INDUSTRIES 195
LINEAGE THERAPEUTICS INC. 196
LOHMANN THERAPIE-SYSTEME AG 196
MALLINCKRODT PLC 196
MEDICAL INTERNATIONAL TECHNOLOGIES 197
MEDI-PATCH CLINIC 197
MERCK SERONO S.A. 197
MINNESOTA RUBBER and PLASTICS 198
MPI RESEARCH 198
MYLAN INC. 198
NANOPASS TECHNOLOGIES LTD. 199
NATIONAL MEDICAL PRODUCTS INC. 199
NEKTAR THERAPEUTICS 200
NOVARTIS 200
NOVEN PHARMACEUTICALS 201
NOVO NORDISK A/S 201
NYPRO INC. 202
OWEN MUMFORD LTD. 202
PACIRA PHARMACEUTICALS INC. 203
PATHEON 203
PENJET CORP. 204
PFIZER INC. 204
PHARMAJET INC. 204
PSIVIDA CORP. 205
PULSE NEEDLE-FREE SYSTEMS INC. 205
QLT INC. 206
RETRACTABLE TECHNOLOGIES INC. 206
SANOFI-PASTEUR 206
SHL GROUP AB 207
TAKEDA 208
TAPEMARK 208
TEAM CONSULTING LTD. 209
TEVA PHARMACEUTICALS INDUSTRIES LTD. 209
THERAJECT INC. 211
TRANSPHARMA MEDICAL LTD. 211
VALERITAS INC. 211
VAXXAS PTY LTD. 212
YPSOMED HOLDING AG 213
ZOGENIX 213
CHAPTER 18 APPENDIX C: INDUSTRY AND PROFESSIONAL ORGANIZATIONS 216
AMERICAN ASSOCIATION FOR RESPIRATORY CARE 216
ASSOCIATION OF NEEDLE-FREE INJECTION MANUFACTURERS 216
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH 216
CENTERS FOR MEDICARE and MEDICAID SERVICES 217
DEPARTMENT OF HEALTH AND HUMAN SERVICES 217
EUDAMED 217
FOOD AND DRUG ADMINISTRATION 218
IFPMA 218
INTERNATIONAL DIABETES FEDERATION 218
INTERNATIONAL ASSOCIATION FOR THE STUDY OF OBESITY 219
ISIPS 219
NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION 219
NATIONAL INSTITUTE ON AGING 220
OECD 220
OPTICAL SOCIETY 220
PATH 220
PMDA 221
USAMRIID 221
WORLD HEALTH ORGANIZATION 222

LIST OF TABLES

SUMMARY TABLE GLOBAL MARKET FOR NEEDLE-FREE TECHNOLOGIES, THROUGH
2019 ($ MILLIONS) 8
TABLE 1 ADVANTAGES AND DISADVANTAGES OF ORAL DRUG DELIVERY 18
TABLE 2 ADVANTAGES AND DISADVANTAGES OF INJECTABLE DRUG DELIVERY 20
TABLE 3 ADVANTAGES AND DISADVANTAGES OF PULMONARY DRUG DELIVERY 21
TABLE 4 ADVANTAGES AND DISADVANTAGES OF NASAL DRUG DELIVERY 21
TABLE 5 ADVANTAGES AND DISADVANTAGES OF ORAL MUCOSAL DELIVERY 22
TABLE 6 ADVANTAGES AND DISADVANTAGES OF RECTAL DRUG DELIVERY 23
TABLE 7 ADVANTAGES AND DISADVANTAGES OF OCULAR DRUG DELIVERY 23
TABLE 8 ADVANTAGES AND DISADVANTAGES OF TRANSDERMAL DRUG DELIVERY 25
TABLE 9 INCIDENCE OF NEEDLESTICK INJURIES BY GEOGRAPHY, 2013 (NO.) 33
TABLE 10 GLOBAL NEEDLE-FREE TECHNOLOGIES MARKET BY SEGMENT, THROUGH
2019 ($ MILLIONS) 38
TABLE 11 PREVALENCE OF DIABETES BY GEOGRAPHY, 2013 ($ MILLIONS) 44
TABLE 12 COMPARISON BETWEEN PAINFUL AND PAINLESS NEEDLE-FREE INSULIN
DRUG DELIVERY SYSTEMS 49
TABLE 13 ADVANTAGES AND DISADVANTAGES OF NEEDLE-FREE INJECTORS 61
TABLE 14 IDEAL CHARACTERISTICS OF THERAPEUTIC AEROSOLS 65
TABLE 15 ADVANTAGES AND DISADVANTAGES OF PULMONARY DRUG DELIVERY 66
TABLE 16 ADVANTAGES AND DISADVANTAGES OF INHALER TECHNOLOGIES 66
TABLE 17 PREVALENCE OF ASTHMA BY GEOGRAPHY, 2013 (MILLIONS) 68
TABLE 18 ADVANTAGES AND DISADVANTAGES OF METERED DOSE INHALERS 70
TABLE 19 ADVANTAGES AND DISADVANTAGES OF F STANDARD PRESS AND
BREATHE METERED DOSE INHALERS 71
TABLE 20 ADVANTAGES AND DISADVANTAGES OF DRY POWDER INHALERS 73
TABLE 21 COMPARISON OF INHALERS: MDI VS. DPI 74
TABLE 22 PARAMETERS AFFECTING SELECTION OF DRUGS IN TRANSDERMAL DRUG
DELIVERY SYSTEMS 77
TABLE 23 IDEAL PROPERTIES OF TRANSDERMAL DRUG DELIVERY SYSTEMS 78
TABLE 24 ADVANTAGES AND DISADVANTAGES OF TRANSDERMAL PATCHES 81
TABLE 25 ADVANTAGES AND DISADVANTAGES OF MICRONEEDLES 90
TABLE 26 ADVANTAGES AND DISADVANTAGES OF MICRONEEDLES 92
TABLE 27 GLOBAL MARKET FOR NEEDLE-FREE TECHNOLOGIES BY REGION,
THROUGH 2019 ($ MILLIONS) 94
TABLE 28 GLOBAL NEEDLE-FREE TECHNOLOGIES MARKET BY SEGMENT, THROUGH
2019 ($ MILLIONS) 96
TABLE 29 GLOBAL NEEDLE-FREE TECHNOLOGY MARKET BY APPLICATION, THROUGH
2019 ($ MILLIONS) 98
TABLE 30 GLOBAL NEEDLE-FREE DEVICE MARKET REVENUE SHARES, 2013 ($
MILLIONS/%) 105
TABLE 31 NEEDLE-FREE DEVICE MARKET, KEY MERGERS/ACQUISITIONS 109
TABLE 32 NEEDLE-FREE INJECTORS: KEY DEVICE APPROVALS BY THE FDA,
2005-2014 126
TABLE 33 KEY METERED DOSE INHALERS ON THE MARKET 128
TABLE 34 TRANSDERMAL PATCH: KEY MARKETED DEVICES 129
TABLE 35 "OTHER" NOVEL NEEDLE TECHNOLOGY-BASED DEVICES ON THE MARKET 131
TABLE 36 KEY NEEDLE-FREE DEVICES IN THE PIPELINE 134
TABLE 37 KEY METERED DOSE INHALERS IN THE PIPELINE 136
TABLE 38 KEY TRANSDERMAL PATCHES IN THE PIPELINE 138
TABLE 39 DIFFERENCES IN REGULATORY APPROVAL IN THE U.S. VS. EUROPE 145
TABLE 40 HCPCS 2014 CODE A4210: NEEDLE-FREE INJECTION DEVICE, EACH 154
TABLE 41 ESTIMATED WORLD POPULATION AND ANNUAL GROWTH BY SELECTED
AGE GROUP AND SELECTED YEARS, THROUGH 2030 (MILLIONS) 162
TABLE 42 WORLD POPULATION BY SELECTED GEOGRAPHIC REGION, THROUGH
2030 (MILLIONS) 163
TABLE 43 U.S. POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
THROUGH 2030 (MILLIONS) 164
TABLE 44 ESTIMATES OF ANTICIPATED U.S. LIFE EXPECTANCY AT BIRTH AND
PROJECTIONS BY GENDER, 2005-2020 (YEARS) 166
TABLE 45 EUROPEAN POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
THROUGH 2030 (MILLIONS) 167
TABLE 46 JAPANESE POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
THROUGH 2030 (MILLIONS) 168
TABLE 47 GLOBAL DIABETES PREVALENCE, 2013 AND 2030 169
TABLE 48 PROJECTED TRENDS IN PER CAPITA REAL GDP GROWTH BY REGION,
2012-2015 (ANNUAL AVERAGE PERCENTAGE CHANGE) 169

LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET FOR NEEDLE-FREE TECHNOLOGIES, 2013-2019
($ MILLIONS) 8
FIGURE 1 INCIDENCE OF NEEDLESTICK INJURIES BY GEOGRAPHY, 2013 `(% OF
TOTAL) 33
FIGURE 2 GLOBAL NEEDLE-FREE TECHNOLOGIES MARKET BY SEGMENT, 2013-2019
($ MILLIONS) 39
FIGURE 3 DISTRIBUTION OF DIABETES TYPES GLOBALLY, 2013 (% OF TOTAL
DIABETES) 43
FIGURE 4 PREVALENCE OF DIABETES BY GEOGRAPHY, 2013` (% OF TOTAL) 44
FIGURE 5 PREVALENCE OF ASTHMA BY GEOGRAPHY, 2013 (% OF TOTAL) 68
FIGURE 6 GLOBAL MARKET FOR NEEDLE-FREE TECHNOLOGIES BY REGION,
2013-2019 ($ MILLIONS) 95
FIGURE 7 GLOBAL NEEDLE-FREE TECHNOLOGIES MARKET BY SEGMENT, 2013-2019
($ MILLIONS) 96
FIGURE 8 NEEDLE-FREE DRUG DELIVERY TECHNOLOGY MARKET BY SEGMENT, 2013
(% OF TOTAL MARKET) 97
FIGURE 9 NEEDLE-FREE TECHNOLOGY MARKET BY APPLICATION, 2013 (% OF TOTAL
MARKET) 99
FIGURE 10 GLOBAL NEEDLE-FREE DEVICE MARKET LEADERS, 2013 (% OF TOTAL
MARKET) 105
FIGURE 11 ESTIMATED WORLD POPULATION BY SELECTED AGE GROUP AND
SELECTED YEARS, 2000-2030 ($ MILLIONS) 162
FIGURE 12 WORLD POPULATION BY SELECTED COUNTRY, 2000-2030 ($ MILLIONS) 163
FIGURE 13 U.S. POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
2000-2030 (MILLIONS) 165
FIGURE 14 ESTIMATES OF ANTICIPATED U.S. LIFE EXPECTANCY AT BIRTH AND
PROJECTIONS BY GENDER, 2005-2020 (YEARS) 166
FIGURE 15 EUROPEAN POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
2000-2030 (MILLIONS) 167
FIGURE 16 JAPANESE POPULATION ESTIMATES AND PROJECTIONS BY AGE GROUP,
2000-2030 (MILLIONS) 168

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