For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website http://www.visiongain.com/Report/1151/Medical-Device-Leader-Series-Top-Needle-Free-Injection-Device-Manufacturers-2014-2024

1. Medical Device Leader Series:
Top Needle-Free Injection Device
Manufacturers 2014-2024
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2. Contents
1. Executive Summary
1.1 Leading NFI Device Manufacturers: Overview of Findings
1.2 Chapters in the Report
1.3 Research and Analysis Methods
1.4 Aims, Scope and Format of the Report
1.5 Glossary of Terms
2. Introduction to Needle-Free Injection
2.1 What is Needle-Free Drug Delivery?
2.1.1 History of Needle-Free Injections: From Military to Clinic
2.1.2 Modern Needle-Free Devices: Concept of High Pressure Fluid Jet
2.2 What is the Rationale for Needle-Free Injections?
2.3 Applications of Needle-Free Drug Delivery
2.3.1 Pain Management: Using NFI Devices to Administer Lidocaine
2.3.2 Vaccine Delivery: Improving Immune Response
2.3.3 Insulin Delivery: Jet Injection Enhances Drug Distribution
2.3.4 Paediatrics: Alleviating Childhood Anxiety and Phobia
2.4 Regulation of Needle-Free Delivery Devices
2.4.1 The US Regulation System: Prolonged Approval Process
2.4.2 The European Regulation System: Manufacturers Seeking EU Approval First?
2.5 Advantages and Disadvantages of Needle-Free Systems
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3. Contents
3. The Global Needle-Free Injection Device Market, 2013-2024
3.1 The Global Needle-Free Injection Device Market, 2012
3.2 The Global Needle-Free Injection Device Market: Revenue Forecast, 2013-2024
3.3 How Will the Market Shares of Leading Sectors Change From 2013-2024?
3.4 What Will Drive The Global Needle-Free Injection Device Market Between 2014 and 2024?
3.5 What Factors are Likely to Restrain The Global Needle-Free Injection Device Market Between
2014 and 2024?
3.6 The Global Jet Injector Device Market, 2012
3.6.1 The Global Jet Injector Device Market: Revenue Forecast, 2013-2024
3.6.2 The Global Jet Injector Device Market: Industry Trends, 2013-2024
3.7 The Global Competing Technologies Market, 2012
3.7.1 The Global Competing Technologies Market: Revenue Forecast, 2013-2024
3.7.2 The Global Competing Technologies Market: Industry Trends, 2013-2024
3.7.2.1 Transdermal Patches: Attractive and Cheap Option
3.7.2.2 Microneedle Technology: Huge Potential for Mass Vaccinations
3.7.2.3 Metered Dose Inhalers: Change in Device Propellant to Drive Adoption
4. The Leading North American Needle-Free Injection Device
Manufacturers, 2013
4.1 Antares Pharma
4.1.1 Needle-Free Products
4.1.1.1 Vision™: Delivering Liquid Insulin or Human Growth Hormone
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4. Contents
4.1.1.2 Vibex™: Hidden Needle to Alleviate Patient Fear
4.1.1.3 Pen Injector: Devices Being Used Clinical Testing
4.1.2 Sales Performance, 2012
4.1.3 Needle-Free Injection Device Pipeline
4.1.3.1 Vibex™ MTX: Targeting Growing Population of RA Sufferers
4.1.3.2 Vibex™ QS (QuickShot): Modified Vibex to Offer Improved Function
4.1.3.3 OTREXUP™: Combining Vibex MTX and Methotrexate
4.2 Bioject Medical Technologies
4.2.1 Needle-Free Products
4.2.1.1 Biojector® 2000: Adaptable Power Source Allows Use in Home and Mass
Vaccination Setting
4.2.1.2 Vitajet™: Low-cost Insulin Delivery System
4.2.1.3 ZetaJet™: Auto-disable Feature Improves User Safety
4.2.2 Sales Performance
4.2.3 Needle-Free Injection Device Pipeline
4.2.3.1 Intradermal Pen Injector: Targeted Drug Delivery
4.2.3.2 Iject®: Providing Tailored Depth of Penetration
4.2.3.3 Jupiter Jet: Multi Dosing With Single Loaded Syringe
4.2.4 Collaborations
4.2.4.1 MPI Research: Seeking Drug/Device Combinations
4.2.4.2 World Health Organisation (WHO): The Push to Eradicate Infectious Disease in
Developing Countries
4.3 Zogenix
4.3.1 Needle-Free Products
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5. Contents
4.3.1.1 Sumavel® DosePro®: Rapid Acting Migraine Relief
4.3.2 Sales Performance, 2012
4.3.3 Needle-Free Injection Device Pipeline
4.3.3.1 Relday™: Needle-based Alterative for Improved Drug Distribution
4.3.4 Collaborations
4.3.5 Manufacturing
4.4 Activa Brand Products, Inc.
4.4.1 Technology: The Activa Family for Diabetics
4.4.2 Needle-Free Products
4.4.2.1 Product Advantages
4.5 D’Antonio Consultants International Inc. (DCI)
4.5.1 Needle-Free Products
4.5.1.1 LectraJet®: Lightweight Device Reduces User Fatigue
4.5.2 Needle-Free Injection Device Pipeline
4.5.2.1 Low Workload Jet Injector: Single-shot Manuel System
4.5.2.2 Multi Channel Jet Injector: For Simultaneous Vaccine Delivery
4.6 National Medical Products, Inc.
4.6.1 Needle-Free Products
4.6.1.1 J-Tip®: Offering Needle-free Administration of Anaesthesia
4.7 Medical International Technologies
4.7.1 Needle-Free Products
4.7.1.1 MED-JET®: Extremely Thin Orifice Offers Improved Drug Absorption
4.7.2 Sales Performance, 2012
4.7.3 Increased Awareness Through Globalisation
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6. Contents
4.8 Penjet Corporation
4.8.1 Needle-Free Products
4.8.1.1 Penjet®: Nitrogen-powered Device Allows Efficient Storage
4.8.2 Applications
4.8.2.1 Multi-Component Drugs
4.8.2.2 Lyophilised Drug Delivery
4.8.2.3 Small Pox Vaccination
4.9 PharmaJet
4.9.1 Needle-Free Products
4.9.1.1 STRATIS®: Drug Delivery in Less Than a Second
4.9.2 Applications
4.9.3 Collaborations: Pursuing a Drug/Device Combination for Vaccine Administration
4.10 Valeritas
4.10.1 Needle-Free Products
4.10.1.1 Mini-Ject™: Potential Delivery of Lyophilised Drugs May Open Huge
Opportunities for Valeritas
5. The Leading European Needle-Free Injection Device
Manufacturers, 2013
5.1 Akra Dermojet
5.1.1 Needle-Free Products
5.1.1.1 Dermojet® “HR”: User-Friendly Design Allows Use in High Intensive
Applications
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7. Contents
5.1.1.2 DERMOJET Polymedical®: Interchangeable Injection Tips Reduces Risk of
Contamination
5.1.1.3 Automatic DERMOJET®
5.2 Crossject Medical Technology
5.2.1 Technology: Highly Customisable Device Allows Tailoring to Specific Drugs
5.2.2 Needle-Free Products
5.2.2.1 Zeneo®: Gas Propellant Generated Upon Injection
5.3 Injex Pharma AG
5.3.1 Needle-Free Products
5.3.1.1 INJEX30®: First Multiple Application Needle-Free Device?
5.4 Glide Pharma
5.4.1 Needle-Free Products
5.4.1.1 Glide SDI®
5.4.1.2 Applications
5.4.2 Advantages
5.4.2.1 Injecting Solid Formulations
5.4.2.2 Pharmaceutical Companies
5.4.3 Collaboration with Pfenex Inc. to Aid Delivery of Solid Dose Vaccine
6. Qualitative Analysis of the Global Needle-Free Injection Device
Market, 2013-2024
6.1 SWOT Analysis of The Global Needle-Free Injection Device Market, 2013-2024
6.1.1 Strengths
6.1.1.1 A Less Painful Alternative to Needle-Based Injections
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8. Contents
6.1.1.2 No Specialist Training Required for Delivery
6.1.1.3 Reduced Transport Costs
6.1.2 Weaknesses
6.1.2.1 Expensive Technology
6.1.2.2 Inefficient Manufacturing Process
6.1.2.3 Off Patent/Generics Require Reformulating Prior to Use in Needle-Free Delivery
Systems
6.1.3 Opportunities
6.1.3.1 Emerging Economies
6.1.3.2 Mass Immunisation Programmes
6.1.3.3 Potential Delivery of Vaccines
6.1.3.4 Patent Expiry of Leading Drugs will Increase Competition
6.1.4 Threats
6.1.4.1 Traditional Needles and Syringes are Cheap to Mass Produce
6.1.4.2 Limited Clinical Data
6.1.4.3 Increased Scrutiny from Regulatory Bodies
6.1.4.4 Medical Device Excise Tax
6.2 STEP Analysis of The Global Needle-Free Injection Device Market, 2013-2024
6.2.1 Social Factors
6.2.2 Technological Developments
6.2.3 Economical Pressures
6.2.4 Political Issues
7. Opinions from Our Industry Survey
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9. Contents
7.1 Interview with Zogenix Technologies
7.1.1 Recent Technological Developments in Needle-Free Systems
7.1.2 Competing Technologies and Market Opportunities
7.1.3 Market Restraints and Future Directions
7.2 Interview with Bioject Medical Technologies
7.2.1 Finding a Competitive Edge over Market Rivals
7.2.2 Market Dynamics and Company Collaborations
7.2.3 Potential of Emerging Markets and Regulatory Concerns
7.3 Interview with Team Consulting
7.3.1 Historical Development of the Needle-Free Market
7.3.2 Company Activities and Overcoming the Skin Barrier
7.3.3 Challenges and Limits to Market Growth
7.3.4 Prospects for the Needle-Free Market
8. Conclusions
8.1 The Global Needle-Free Injection Device Market, 2013-2024
8.2 Zogenix Dominated The Global Needle-Free Injection Device Market in 2012
8.3 Strong Company Pipeline Will Help Drive the Market
8.4 Concluding Remarks
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10. Contents
List of Tables
Table 1.1 Currency Exchange Rates
Table 2.1 Examples of Needle-Free Vaccine Delivery Systems, 2013
Table 2.2 Examples of Needle-Free Insulin Delivery Systems, 2013
Table 2.3 Advantages and Disadvantages of Needle-Free Injection, 2013
Table 3.1 The Global Needle Free Injection Device Market: Revenue ($m) and Market Share (%)
by Technology, 2012
Table 3.2 The Global Needle-Free Injection Device Market: Revenue Forecast ($m, AGR %,
CAGR %) by Technology, 2013-2024
Table 3.3 The Global Needle-Free Injection Device Market: Market Share (%) by Technology,
2013-2024
Table 3.4 The Global Needle-Free Injection Device Market: Drivers and Restraints, 2013-2024
Table 3.5 Patent Expiries For Leading Drugs, 2014-2016
Table 3.6 Classification of Jet Injector Devices, 2013
Table 3.7 The Global Jet Injection Device Market: Revenue Forecast ($m, AGR %, CAGR %),
2013-2024
Table 3.8 The Global Competing Needle-Free Technologies Market: Revenue Forecast ($m, AGR
%, CAGR %), 2013-2024
Table 3.9 Insulin Inhalation Systems in Development, 2013
Table 3.10 Vaccine Inhalers in Development, 2013
Table 4.1 Antares Pharma: Key Facts, 2013
Table 4.2 Antares Pharma Licensing Partnerships, 2013
Table 4.3 Antares Pharma: Revenue ($m) & Revenue Share (%) by Business Segment, 2012
Table 4.4 Antares Pharma: Product Revenue ($m, CAGR %) by Category, 2010-2012
Table 4.5 Bioject Medical Technologies: Key Facts, 2013
Table 4.6 Bioject: Revenue ($m) and Revenue Share (%), by Product Line, 2010
Table 4.7 Bioject: Summary of Technologies
Table 4.8 Zogenix: Key Facts, 2013
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11. Contents
Table 4.9 Zogenix: Summary of Technology
Table 4.10 Zogenix: Revenue ($m) and Revenue Share (%) by Business Segment, 2012
Table 4.11 Activa Brand Products: Key Facts, 2013
Table 4.12 D’Antonio Consultants: Key Facts, 2013
Table 4.13 National Medical Products: Key Facts, 2013
Table 4.14 Medical International Technologies: Key Facts, 2013
Table 4.15 Medical International Technologies: Revenue ($m, CAGR %), 2009-2012
Table 4.16 PenJet Corporation : Key Facts, 2013
Table 4.17 PharmaJet: Key Facts, 2013
Table 4.18 Valeritas: Key Facts, 2013
Table 5.1 Akra Dermojet: Key Facts, 2013
Table 5.2 Akra Dermojet: Summary of Technology
Table 5.3 Crossject Medical Technology: Key Facts, 2013
Table 5.4 Injex Pharma AG: Key Facts, 2013
Table 5.5 Glide Pharma: Key Facts, 2013
Table 6.1 SWOT Analysis of The Global Needle-Free Injection Device Market, 2013-2024
Table 6.2 Average Price for Needle-Free Drug/Vaccine Delivery Technology, 2013
Table 6.3 Patent Expiries for Leading Drugs, 2014-2016
Table 6.4 The Global Needle-Free Injection Market: STEP Analysis, 2013-2024
Table 8.1 The Global Needle-Free Injection Device Market: Revenue Forecast ($m, AGR %,
CAGR %) and Market Share (%) by Technology, 2012, 2015, 2018, 2021 and 2024
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12. Contents
List of Figures
Figure 3.1 The Global Needle Free Injection Device Market: Share (%) by Technology, 2012
Figure 3.2 The Global Needle Free Injection Device Market: Revenue ($m) by Technology, 2012
Figure 3.3 The Global Needle-Free Injection Device Market: Revenue Forecast ($m), 2013-2024
Figure 3.4 The Global Needle-Free Injection Device Market: Share (%) by Technology, 2018
Figure 3.5 The Global Needle-Free Injection Device Market: Share (%) by Technology, 2024
Figure 3.6 The Global Jet Injection Device Market: Revenue Forecast ($m), 2013-2024
Figure 3.7 The Global Competing Needle-Free Technologies Market: Revenue Forecast ($m),
2013-2024
Figure 4.1 Antares Pharma: Revenue Share (%) by Business Segment, 2012
Figure 4.2 Antares Pharma: Product Revenue ($m) by Category, 2010-2012
Figure 4.3 Bioject: Revenue Share (%) by Product Line, 2010
Figure 4.4 Bioject: Revenue ($m), 2010-2012
Figure 4.5 Zogenix: Revenue Share (%) by Business Segment, 2012
Figure 4.6 Zogenix: Revenue ($m) by Business Segment, 2010-2012
Figure 4.7 Medical International Technologies: Revenue ($m), 2009-2012
Figure 6.1 The Transport Process for A Vaccine
Figure 8.1 The Global Needle-Free Injection Device Market: Revenue Forecast ($m) by
Technology, 2012, 2015, 2018, 2021 and 2024
Figure 8.2 The Global Needle-Free Injection Device Market: Leading Companies by Revenue
($m), 2012
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13. Contents
Organisations Mentioned in This Report
3M
Actavis
Activa Brand Products
Aerogen
Akra Dermojet
ALZA Pharmaceuticals
Ankara University
Antares Pharma
Aradigm Corporation
Astellas Pharma
AstraZeneca
Battelle
Bill and Melinda Gates Foundation
Bioject Medical Technologies
BioValve Technologies
Bristol-Myers Squibb
Cambridge Consultants
CDC Measles Eradication Committee
Centre for Devices and Radiological Health (CDRH)
Centre for Disease Control and Prevention (CDC)
China State Food and Drug Administration (SFDA)
Covidien
Crossject Medical Technology
CSL Behring
CSL Limited
Daewoong Pharmaceuticals
Dance Pharmaceuticals
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14. Contents
D'Antonio Consultants International
Diabetes Management International
Dr. Reddy’s Laboratories
Durect Corporation
Echo Therapeutics
Eli Lilly
Eurojet Medical
European Union
Ferndale Pharma Group
Ferring Pharmaceuticals
Food and Drug Administration (FDA)
Georgia Tech University
GlaxoSmithKline (GSK)
Glide Pharma
Harvard University
Injex Pharma AG
JCR Pharmaceuticals
Jiangsu Hualan Medical International Technologies
Johnson & Johnson
Mallinckrodt Pharmaceuticals
MannKind
Meda Pharmaceuticals
Medical International Technologies
MedImmune
Merck & Co.
Merck Serono
MGlas AG
Minnesota Rubber and Plastics (MRP)
MPI Research
Mylan
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15. Contents
National Medical Products
Nektar Therapeutics
North Carolina University
Novartis
Novo Nordisk
Nypro Limited
Patheon
Penjet Corporation
Pfenex Inc.
Pfizer
PharmaJet
Philips Medical
Sanofi-Aventis
Sanofi-Pasteur
Takeda
Team Consulting
Teva Pharmaceuticals
UCB
University of Colorado
US Army Medical Research Institute of Infectious Disease (USAMRIID)
Valeritas
Vaxxas
Weston Medical
World Health Organization (WHO)
Zogenix
Zomajet
Zosano Pharma
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16. Medical Device Leader Series: Top Needle-Free
Injection Device Manufacturers 2014-2024
Table 6.4 The Global Needle-Free Injection Market: STEP Analysis, 2013-2024
Social Factors
Technological Developments
Possible stigma of being dependant on others
for needle-based injections
New devices offer improved drug diffusion rates
and more reliable penetration depths
Patients may feel their Injection is a burden
associated with their disease, leading to soclai
exclusion and self-isolation
Introduction of devices with improved
engineering, design and warm colours to
increase patient adoption
Economic Pressures
Political Issues
Needle-stick injuries (and associated
complications) can costs upwards of $4000 to
treat
Regulatory agencies remain sceptical towards
the use of needle-free delivery systems
Use of needle-free systems reduces the
economic burden by eliminating risk of needlestick injuries
New legislations coming into effect in developed
markets that recommends the use of needle-free
systems ahead of needle-based injections
Source: visiongain 2013
6.2.1 Social Factors
The use of injectable therapies to treat conditions where oral administration is not as effective or
even available is one of, if not the biggest, barrier to patient compliance. This is simply because the
most patients dislike injections, and they begin to feel dependent on others to administer their
treatment. Specifically, patients begin to consider the injection to be a burden associated with their
disease, rather than the way to best manage their disease. Furthermore, the emotional burden can
lead to the patient engaging in self-isolating behaviours to minimise secondary stigma. Also, as
stigma is socially constructed, it varies substantially by clinical presentation of the disease. For
example, some chronic conditions are visible while others, such as diabetes, are invisible. This a
key factor in whether patients feel that their condition makes them “different” from the general
population, which subjects them to possible stigmatisation by those who do not have the illness.
Needle-free devices decrease the social stigma associated with injectable chronic treatments, and
affords the patient maximum independence over their treatment and reduces the risk of misplaced
injections due to unreliable injection assistance. This allows for broader patient acceptance,
particularly for those patients who self-inject their medication (for example, diabetics).
Going forward, there needs to be a greater understanding - from the view of nurses and other
healthcare professionals - of how patients cope with stigmatising conditions, as this is essential in
order to provide optimal, comprehensive and individualised patient care.
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17. Medical Device Leader Series: Top Needle-Free
Injection Device Manufacturers 2014-2024
6.2.2 Technological Developments
There have been significant advances in the needle-free space in recent years, which aims to
increase the adoption of self-injectable therapies. Previously, such devices were used solely for
mass vaccination and insulin delivery applications; however these systems increased the risk of
disease transmission and required disinfection prior to use. Next generation devices included
integrated, hand-held systems but these remained unspecific with regards to different depths of
injection, for example intramuscular and subcutaneous drug delivery and the patient experience
was far from optimal as pain and injection site tolerability was not always equal to or better than
using a traditional needle and syringe. Consequently these devices were rarely used in drug/device
combinations.
The goal of modern needle-free injection is to increase the prescribing and adoption of important
drugs that require self-injection, such as biologics. Innovators in needle-free injection technologies
aim to achieve this by improving drug diffusion rates and to offer a more reliable depth of drug
penetration. Also, modern needle-free systems offer only mild discomfort in pain and studies have
shown these devices to be at least as effective as traditional needle and syringes in terms of
volume of drug delivered. In addition, newer needle-free injection systems also have the potential
to deliver highly viscous drug products that cannot be delivered by traditional needle and syringe,
adding to the utility of the technology. Furthermore, the market has witnessed the introduction of
new device models that incorporate design enhancements and improved engineering. These new
generation devices are lighter, have a sleek profile, and employ warm colours to encourage patient
adoption.
Visiongain predicts technological advancements in this field will continue, especially as drug
delivery companies are facing pressures to remain competitive and to ensure that their device is
chosen as the preferred delivery system for new and sophisticated drugs being launched on the
market by big pharma (more than half of which cannot be taken orally). Indeed, injection devices
were once considered as an afterthought but now in some product categories they are becoming
an entry ticket for pharma companies; an essential part of the drug’s presentation to the market,
without which they would fail to attract patients. As a result, pharmaceutical companies are
developing injectors in parallel with their new drugs, in the knowledge that a device will be needed
at product launch. It is therefore critical that, now more than ever, needle-free systems approved
for use in drug-device combinations are more patient-friendly and easier-to-use to encourage
further treatment compliance, especially when taking into account the elderly patients population
who may have compromised dexterity.
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