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Medical Device Leader Series: Top Needle-Free Injection Device

Manufacturers 2014-2024

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Contents

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

2.1 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

1. Executive Summary

2. Introduction to Needle-Free Injection

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Contents

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

4.1 Antares Pharma

4.1.1 Needle-Free Products

4.1.1.1 Vision™: Delivering Liquid Insulin or Human Growth Hormone

3. The Global Needle-Free Injection Device Market, 2013-2024

4. The Leading North American Needle-Free Injection Device

Manufacturers, 2013

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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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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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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

5.1 Akra Dermojet

5.1.1 Needle-Free Products

5.1.1.1 Dermojet® “HR”: User-Friendly Design Allows Use in High Intensive

Applications

5. The Leading European Needle-Free Injection Device

Manufacturers, 2013

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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

6.1 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

6. Qualitative Analysis of the Global Needle-Free Injection Device

Market, 2013-2024

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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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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

8.1 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

8. Conclusions

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Contents

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

List of Tables

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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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Contents

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

List of Figures

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Contents

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

Organisations Mentioned in This Report

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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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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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Medical Device Leader Series: Top Needle-Free Injection Device Manufacturers 2014-2024

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.

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 needle-

stick 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

Table 6.4 The Global Needle-Free Injection Market: STEP Analysis, 2013-2024

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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.