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Medical Device Leader Series:
Top Needle-Free Injection Device Developers,
Manufacturers and Marketers in 2016
Market Analysis Including Antares Pharma, PharmaJet, Mylan and Other Firms in
North America, Europe, Israel and Asia Pacific, Covering Jet Injectors, Transdermal
Patches, Microneedles, Pen Injectors and Other Drug Delivery Systems

2. www.visiongain.com
Contents
1. Report Overview
1.1 Overview of the Top Needle-Free Injection Device Manufacturers
1.2 Why You Should Read This Report
1.3 How This Report Delivers Research and Analysis
1.4 Main Questions Answered by This Analytical Study
1.5 Who is This Report For?
1.6 Methodology
1.7 Frequently Asked Questions (FAQ)
1.8 Associated Visiongain Reports
1.9 About Visiongain
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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Contents
3. The Global Needle-Free Injection Device Market, 2016-2026
3.1 The Global Needle-Free Injection Device Market, 2016
3.2 The Global Needle-Free Injection Device Market: Revenue Forecast, 2016-2026
3.3 What Will Drive The Global Needle-Free Injection Device Market Between 2016 and 2026?
3.4 What Factors are Likely to Restrain the Global Needle-Free Injection Device Market Between
2016 and 2026?
3.5 The Global Jet Injector Device Market, 2016
3.5.1 The Global Jet Injector Device Market: Industry Trends, 2016-2026
3.6 The Global Competing Technologies Market, 2016
3.6.1 The Global Competing Technologies Market: Industry Trends, 2016-2026
3.6.1.1 Transdermal Patches: Attractive and Cheap Option
3.6.1.2 Microneedle Technology: Huge Potential for Mass Vaccinations
3.6.1.3 Metered Dose Inhalers: Change in Device Propellant to Drive Adoption
3.7 Needle-Free Delivery Technology: Market Trends, 2016-2026
3.8 Needle-Free Delivery Technology: Drivers and Restraints, 2016-2026
4. The Leading North American Needle-Free Injection Device
Manufacturers, 2016
4.1 Antares Pharma
4.1.1 Antares Pharma: Financial Overview
4.1.2 Needle-Free Products
4.1.2.1 ZOMAJET™: Delivering Liquid Insulin or Human Growth Hormone
4.1.2.2 Vibex™: Hidden Needle to Alleviate Patient Fear
4.1.2.3 OTREXUP™: Combining Vibex MTX and Methotrexate
4.1.2.4 Vibex™ MTX: Targeting Growing Population of RA Sufferers
4.1.2.5 T-JET™
4.1.3 Needle-Free Injection Device Pipeline
4.1.3.1 Vibex™ QS (QuickShot): Modified Vibex to Offer Improved Function

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Contents
4.1.3.2 Pen Injector: Devices Being Used Clinical Testing
4.1.3.3 VIBEX® QS T
4.1.3.4 VIBEX® QS M
4.2 Mylan Inc.
4.2.1 Mylan: Financial Overview
4.2.2 Needle-Free Products
4.2.2.1 EpiPen® Auto-Injector
4.2.2.2 EpiPen Jr® Auto-Injector
4.3 Bioject Medical Technologies
4.3.1 Bioject Medical Technologies: Financial Overview
4.3.2 Needle-Free Products
4.3.2.1 Biojector® 2000: Adaptable Power Source Allows Use in Home and Mass Vaccination
Setting
4.3.2.2 Vitajet™: Low-Cost Insulin Delivery System
4.3.2.3 Bioject® ZetaJet™: Auto-Disable Feature Improves User Safety
4.3.2.4 Bioject® Drug Reconstitution System
4.3.2.5 Bioject® Needle-Free Vial Adapter
4.3.3 Needle-Free Injection Device Pipeline
4.3.3.1 Intradermal Pen Injector: Targeted Drug Delivery
4.3.3.2 Iject®: Providing Tailored Depth of Penetration
4.3.3.3 Iject® R: The Reusable Version
4.3.3.4 Jupiter Jet: Multi Dosing With Single Loaded Syringe
4.3.3.5 Mega Jet: The New Design
4.3.4 Collaborations
4.3.4.1 MPI Research: Seeking Drug/Device Combinations
4.3.4.2 World Health Organisation (WHO): The Push to Eradicate Infectious Disease in
Developing Countries
4.4 Activa Brand Products, Inc.
4.4.1 Technology: The Activa Family for Diabetics
4.4.2 Needle-Free Products

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Contents
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 Increased Awareness Through Globalisation
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

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Contents
4.10.1.2 V-Go®: Click and Go Technology to Simplify Insulin Drug Delivery
4.10.1.3 Micro-Trans™:
4.10.1.4 h-Patch™: Controlled Delivery Patch
4.11 3M (MMM)
4.11.1 Needle-Free Products
4.11.1.1 3M: Metered Dose Inhaler
4.11.1.2 3M: Transdermal Patch
4.11.1.3 3M: Microneedle
4.12 Zogenix
4.12.1 Needle-Free Products
4.12.2 Needle-Free Injection Pipeline
4.13 BD - Becton, Dickinson and Company
4.13.1 Needle-Free Products
4.13.1.1 BD SmartSite
4.13.1.2 Soluvia
4.13.1.3 BD Ultra-Fine Nano Pen Needle
4.13.1.4 AutoShield Duo Pen Needle (BD)
4.13.1.5 BD Accuspray SCF Nasal Spray System
4.14 Portal Instruments
4.14.1 Needle-Free Products
4.14.1.1 Portal’s Needle-Free Jet Injector
4.14.1.2 Partnering
5. The Leading European Needle-Free Injection Device Manufacturers,
2016
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
5.1.1.2 DERMOJET Polymedical®: Interchangeable Injection Tips Reduces Risk of Contamination

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Contents
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 Glide Pharma
5.3.1 Needle-Free Products
5.3.1.1 Glide SDI®
5.3.1.2 Applications
5.3.2 Advantages
5.3.2.1 Injecting Solid Formulations
5.3.2.2 Pharmaceutical Companies
5.3.3 Collaboration With Pfenex Inc. to Aid Delivery of Solid Dose Vaccine
5.4 Merck KGaA
5.4.1 Needle-Free Products
5.4.1.1 Cool.click® and Cool.click2®
5.4.1.2 Click.easy®
5.4.1.3 SeroJet™
5.5 Spirit Healthcare
5.5.1 Spirit Healthcare Needle-Free Products
5.5.1.1 InsuJet™
5.6 AstraZeneca
5.6.1 AstraZeneca’s Needle-Free Product
6. The Leading Emerging-Market Needle-Free Device Manufacturers,
2016
6.1 Injex Pharma AG
6.1.1 Needle-Free Products
6.1.1.1 INJEX30®: First Multiple Application Needle-Free Device?

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Contents
6.2 Romsons Scientific & Surgical Pvt. Ltd.
6.2.1 Needle-Free Products
6.2.1.1 Safesite™
6.2.1.2 Exteena™ Uno
6.2.1.3 Exteena™ Duo
6.2.1.4 Exteena™ Trio
6.3 Binny’s Health Care Ltd
6.3.1 Needle-Free Products
6.3.1.1 Binny’s Needle-Free IV Injection
7. Leading Needle-Free Injection Companies in the Rest of the World,
2016
7.1 Mika Medical Co.
7.1.1 Needle-Free Products
7.1.1.1 Comfort-in™
7.2 JMS Singapore Pte Ltd
7.2.1 Needle-Free Products
7.2.1.1 Planecta™
7.3 B. Braun Singapore Pte Ltd.
7.3.1 Needle-Free Products
7.3.1.1 CARESITE® Luer Access Device (LAD)
7.3.1.2 SAFELINE® Split Septum Needleless Connector
7.3.1.3 ULTRASITE® Luer Access Device
7.4 NanoPass Technologies
7.4.1 Nanopass Drug Delivery Products
7.4.1.1 Micronjet Needle
7.4.1.2 Anti-Aging Microdermabrasion
7.5 Vaxxas
7.5.1 Needle-Free Products

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Contents
7.5.1.1 The Nanopatch™
8. Qualitative Analysis of the Global Needle-Free Injection Device
Market, 2016-2026
8.1 SWOT Analysis of the Global Needle-Free Injection Device Market, 2016-2026
8.1.1 Strengths
8.1.1.1 A Less Painful Alternative to Needle-Based Injections
8.1.1.2 No Specialist Training Required for Delivery
8.1.1.3 Strong Growth in the Biologic Drug Market
8.1.1.4 Increasing Development in Transdermal Delivery
8.1.1.5 Reduced Transport Costs and Eliminating the Cold Chain Problem
8.1.2 Weaknesses
8.1.2.1 Expensive Technology
8.1.3 Healthcare Practitioners Are Not Familiar with Novel Delivery Systems
8.1.3.1 Inefficient Manufacturing Process
8.1.4 Greater Regulatory Scrutiny
8.1.4.1 Off Patent/Generics Require Reformulating Prior to Use in Needle-Free Delivery Systems
8.1.5 Opportunities
8.1.5.1 Emerging Economies
8.1.5.2 Mass Immunisation Programmes
8.1.5.3 Shift Towards Home Administration Setting
8.1.5.4 Potential Delivery of Vaccines
8.1.5.5 Increasing Global Diabetes Population
8.1.5.6 Extending Life Cycle of Drugs
8.1.6 Threats
8.1.6.1 Traditional Needles and Syringes are Cheap to Mass Produce
8.1.6.2 Limited Clinical Data
8.1.6.3 Increased Scrutiny from Regulatory Bodies
8.1.6.4 Needle and Syringes with Anti Needlestick Injury Technology

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Contents
8.2 STEP Analysis of the Global Needle-Free Injection Device Market, 2016-2026
8.2.1 Social Factors
8.2.2 Technological Developments
8.2.3 Economic Pressures
8.2.4 Political Issues
9. Research Interview
9.1 Mr David Hoey, CEO, Vaxxas
9.1.1 Vaxxas Overview
9.1.2 Introducing the Nanopatch™
9.1.3 Vaxxas’ Leading Strategy: Competition & Collaboration
9.1.4 Future Directions for Vaxxas and the Industry
10. Conclusions
10.1 The Global Needle-Free Injection Device Market, 2015-2026
10.2 Antares Pharma Dominates the Global Needle-Free Injection Device Market in 2016
10.3 Strong Pipeline Will Drive the Competing Needle-Free Injection Technology Market
10.4 The Future of the Needle-Free Technology Market?
10.5 Biosimilars are a Major Driver of the Needle Free Drug Delivery Market
10.6 Concluding Remarks

11. www.visiongain.com Page 55
Medical Device Leader Series: Top Needle-Free Injection Device
Developers, Manufacturers and Marketers in 2016
Market Analysis Including Antares Pharma, PharmaJet, Mylan and Other Firms in North
America, Europe, Israel and Asia Pacific, Covering Jet Injectors, Transdermal Patches,
Microneedles, Pen Injectors and Other Drug Delivery Systems
Table 3.5 Vaccine Inhalers in Development, 2016
Name Target Manufacturer(s) Description
Conix One General
Cambridge Consultants
(Licensed to 3M in December
2008)
Disposable, multi-dose inhaler developed
for mass vaccination, asthma and seasonal
allergies.
Utilises reverse-cyclone technology to
increase delivery effectiveness
Inhaled TB Vaccine
Tuberculosis
(TB)
Harvard University & North
Carolina University
Aerosol vaccine delivered as fine mist
directly to the lung
Inhaled Measles
Vaccine
Measles University of Colorado
Dry powder inhaler. Work has also begun
to develop oral and sublingual formulations
FluMist H1N1 Infuenza MedImmune
Attenuated live vaccine sprayed into the
nose
3.7 Needle-Free Delivery Technology: Market Trends, 2016-2026
The needle-free delivery technology market is in a phase of transition. While hypodermic needles
are still the primary mode of drug delivery, visiongain predicts the needle-free technology market
will achieve strong growth during the forecast period.
Although jet injectors have been a longer established market, the competing needle-free device
technologies market will show stronger growth in the forecast period as it has greater number of
development dollars invested into the industry and better patient adoption rates. Pen needles and
microneedles will show substantial growth owing to the widening diabetes global population, many
of whom seek more comfortable mechanisms to administer insulin.
The push to develop needle-free technology has largely arisen from strong demand from patient
groups seeking alternatives to needle-based systems. An increasing number of diabetic patients
wishing to use needle-free alternatives will drive growth in the needle-free market. Paediatric
injection and pain management will become increasingly important markets for needle-free delivery
devices.
Source: visiongain 2016

12. www.visiongain.com Page 147
Medical Device Leader Series: Top Needle-Free Injection Device
Developers, Manufacturers and Marketers in 2016
Market Analysis Including Antares Pharma, PharmaJet, Mylan and Other Firms in North
America, Europe, Israel and Asia Pacific, Covering Jet Injectors, Transdermal Patches,
Microneedles, Pen Injectors and Other Drug Delivery Systems
maintain vaccine immunogenicity. Whilst this may be a minor issue in developed countries, the
costs and associated logistic issues with transporting vaccines are common in the emerging
markets, particularly in remote rural areas. The advantage of needle free delivery methods is that
many offer the ability to get rid of the cold chain. Vaccine delivered with microneedles and patches
are produced in such a way that they do not need the cold chain. Patches have the drug imbedded
in them. Therefore, the patches can be stored at room temperature and do not require any
refrigeration.
Figure 8.1 shows a typical transport process that any vaccine undergoes. The delivery of such
vaccines - especially to regions such as sub-Saharan Africa where they are needed most and
across high temperature climates - is an ongoing challenge for manufacturers. Vaccines need to
be kept below a certain temperature in order to remain effective. This generally means that they
must be refrigerated during transport. Maintaining or even purchasing refrigeration units to ensure
the vaccine is kept at the correct temperature is costly, especially for developing nations during
mass immunisation programmes. Consequently, the overall expense increases as transport costs
are included.
Figure 8.1 The Transport Process for a Vaccine
Source: visiongain 2016

13. www.visiongain.com Page 161
Medical Device Leader Series: Top Needle-Free Injection Device
Developers, Manufacturers and Marketers in 2016
Market Analysis Including Antares Pharma, PharmaJet, Mylan and Other Firms in North
America, Europe, Israel and Asia Pacific, Covering Jet Injectors, Transdermal Patches,
Microneedles, Pen Injectors and Other Drug Delivery Systems
animal models, using as little as 1/10 of a normal dose of vaccine, the Nanopatch™ has been
shown to produce an immune response equivalent to a full dose delivered by needle and syringe.
Because its projections are very short, we believe the Nanopatch™ has the potential to be safer for
health-workers and patients by avoiding the risk of needle-stick injuries. And studies have shown
that vaccine coated on the Nanopatch™ can be stable for extended periods at room temperature.
This not only eliminates the cost and logistics burden normally needed for refrigeration during
transportation and storage, but can also extend the reach of vaccines to remote regions and the
developing world.
visiongain: What are the challenges and restraints associated with developing the Nanopatch™?
How did you overcome them?
Mr Hoey: Large molecules like vaccines don’t tend to survive terminal sterilization processes like
gamma irradiation. To ensure patient safety, it is therefore essential to establish a validated
aseptic process to manufacture vaccine-coated devices like the Nanopatch™. This is a huge
undertaking for small companies. Over the past two years we’ve put in place the operational
infrastructure and quality systems and now have this capability.
9.1.3 Vaxxas’ Leading Strategy: Competition & Collaboration
visiongain: Could highlight the distinctive features of the Nanopatch™ that give it the competitive
advantage over other technologies currently in the market?
Mr Hoey: We’re excited to be entering clinical development and to have the team, infrastructure
and capabilities to support this work. Needle and syringe effectively has 100% market share – a
very entrenched and tough competitor. Against this competitor we’re focused on making the
Nanopatch™ compelling to all segments of the market-chain; economically compelling for vaccine
companies and health insurance payers; compelling in logistics, ease-of-use, and safety for health
workers; and of course, compelling in consumer experience.
visiongain: Vaxxas has made successful collaborations with prominent firms and organizations
such as Merck & Co. and the WHO for the commercialisation of the Nanopatch™ technology. Are
you able to tell us about any future partnerships or funding opportunities?
Mr Hoey: Vaxxas is working with a number of pharmaceutical companies and is performing
programmes that target clinical development for aid organizations. The company is also working in