Needle-Free Delivery Technology 2014-2024

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Needle-Free Delivery: Technology and Market Forecast 2014-2024 & Prospects for Leading Companies

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Contents

1.1 Sector Highlights

1.2 Aim, Scope and Format of This Report

1.3 Chapter Outline

1.4 Research and Analysis Methods

1.5 Glossary of Terms Relating to the Report

2.1 What is Needle-Free Technology?

2.1.1 History of Needle-Free Injections (NFI)

2.2 Why the Need For Needle-Free Delivery Technology?

2.2.1 Needle Stick Injury

2.2.1.1 Blood-Borne Pathogens and Needle Stick Injury

2.2.1.2 Accidental Needle Stick Injury: A Serious Healthcare Problem

2.3 Clinical Settings Where Needle-Free Delivery Technology Will Be Beneficial

2.3.1 Pain Management

2.3.1.1 Pain Management: Using NFI Devices to Administer Lidocaine

2.3.2 Vaccine Delivery: Improving Immune Response

2.3.2.1 The Global Vaccine Market, 2014-2024

2.3.2.2 Needle-Free Vaccine Delivery

2.3.2.3 Mass Immunisation

2.3.3 Insulin Delivery For Diabetics

2.3.4 Paediatric Injections

2.3.5 Other Uses For Needle-Free Injection Technology

2.4 Advantages and Disadvantages of Needle-Free Injections

2.5 The Needle-Free Delivery Market

2.5.1 Jet Injectors

1. Executive Summary

2. Introduction to Needle-Free Delivery of Drugs/Vaccines

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Contents 2.5.1.1 Concerns About Multi-use Nozzle Jet injectors (MUNJIs)

2.5.1.2 Strengths and Weaknesses of Jet Injectors

2.5.2 Competing Needle-Free Technologies

2.5.2.1 Novel Needle Technology

2.5.2.1.1 Pen Needles

2.5.2.1.2 Microneedles

2.5.2.1.3 Hollow Microneedles

2.5.2.1.4 Solid Coated Microneedles

2.5.2.1.5 Solid Biodegradable Microneedles

2.5.2.1.6 Solid Uncoated Microneedles

2.5.2.1.7 Selection of Microneedles

2.5.2.2 Inhaler Technology

2.5.2.3 Transdermal Patch Technology

2.6 Regulation of the Needle-Free Delivery Market

2.6.1 The US Regulation System

2.6.1.1 Combination Products

2.6.1.2 FDA Statement Clamps Down On Delivery of Medications in

Non-approved Needle-Free Devices

2.6.2 The European Regulation System

2.6.2.1 Post Marketing Surveillance in the EU

3.1 The Needle-Free Delivery Technology Market: Overview

3.2 The Needle-Free Delivery Technology Market by Segments, 2012-2013

3.3 The Needle-Free Delivery Market Forecast, 2014-2024

3.4 Needle-Free Delivery Technology: Market Trends, 2014-2024

3. The Global Needle-Free Injection Device Market, 2014-2024

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Contents

4.1 The Jet Injectors Market, 2012-2013

4.2 The Jet Injectors Market Forecast, 2014-2024

4.3 Leading Devices in the Jet Injectors Market, 2014

4.3.1 Biojector 2000 (Bioject Medical Technologies)

4.3.2 SUMAVEL DosePro (Zogenix)

4.3.3 E-Jet 100 (Eurojet Medical)

4.3.4 STRATIS (Pharmajet)

4.3.5 ZetaJet (Bioject Medical Technologies)

4.3.6 LectraJet (D’Antonio Consultants International)

4.3.7 Med-Jet (Medical International Technologies)

4.3.8 Vision (Antares Pharma)

4.3.9 Glide System (Glide Pharmaceutical Technologies)

4.3.10 AdvantaJet (Activa Brand Products)

4.3.11 J-Tip (National Medical Products)

4.3.12 SQ-Pen (Diabetes Management International)

4.3.13 Vitajet3 (Bioject Medical Technologies)

4.3.14 Penjet (Penjet Corporation)

4.3.15 INJEX30 (Injex)

4.4 Jet Injectors Development Pipeline, 2014

4.4.1 Zeneo (Crossject Medical Technologies)

4.4.2 Jupiter Jet (Bioject Medical Technologies)

4.4.3 Iject (Bioject Medical Technologies)

4.4.3.1 Iject R (Bioject Medical Technologies)

4.4.4 Relday (Zogenix)

4.5 Concluding Remarks

4. The Jet Injectors Technology Market, 2014-2024

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Contents

5.1 Competing Needle-Free Technologies: Overview

5.2 Competing Needle-Free Technology Market, 2012-2013

5.3 Competing Needle Free Technologies Market Forecast by Segments, 2014-2024

5.4 Novel Needle Technology Market, 2013

5.4.1 Novel Needle Technology Market Forecast, 2014-2024

5.4.2 Leading Products in the Microneedle Technology Market, 2014

5.4.3 Microneedle Patches for Vaccine Delivery, 2014

5.4.3.1 Microneedle Patch for the Polio Vaccine (Georgia Tech’s School of

Chemical and Biomolecular Engineering)

5.4.3.2 AdminPen (nanoBioSciences)

5.4.3.3 PKA SoftTouch (PKA SoftTouch Corp)

5.4.3.4 DrugMAT (TheraJect)

5.4.3.5 MicroCor (Corium International)

5.4.3.6 Nanopatch (Vaxxas)

5.4.3.7 ZP Patch Technology (Zosana)

5.5 Inhaler Technology Market, 2013

5.5.1 Inhaler Technology Market Forecast, 2014-2024

5.5.2 Inhalers in the Asthma Market, 2014

5.5.3 Inhalers in the Insulin Market, 2014

5.5.4 Inhalers in the Vaccine Market, 2014

5.6 The Patch Technology Market, 2013

5.6.1 The Patch Technology Market Forecast, 2014-2024

5.6.2 Drug Patches in the Market, 2014

5.7 Other Competing Needle-free delivery Technology in development

5.7.1 Magnetic Injection

5.7.2 Laser Injection

5.7.3 Vaccine Delivery Using Micro-Shock Waves (Indian Institute of Science, Bangalore)

5. Competing Needle-Free Technology Market, 2014-2024

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Contents 5.7.4 Nanotechnology Syringes (Gwangju Institute of Science and Technology, South

Korea)

5.7.5 Nanotechnology Implant (University of California, San Francisco)

6.1 Leading National Breakdown of the Needle-Free Delivery Market, 2012-2013

6.2 The Leading National Needle-Free Delivery Market Forecast, 2014-2024

6.3 The US Needle-Free Delivery Market Forecast, 2014-2024

6.4 The European Needle-Free Delivery Market, 2013

6.4.1 The European Needle-Free Delivery Market Forecast, 2014-2024

6.4.1.1 The German Needle-Free Delivery Market Forecast, 2014-2024

6.4.1.2 The French Needle-Free Delivery Market Forecast, 2014-2024

6.4.1.3 The Italian Needle-Free Delivery Market Forecast, 2014-2024

6.4.1.4 The Spanish Needle-Free Delivery Market Forecast, 2014-2024

6.4.1.5 The UK Needle-Free Delivery Market Forecast, 2014-2024

6.5 The Japanese Needle-Free Delivery Market Forecast, 2014-2024

6.6 The Chinese Needle-Free Delivery Market Forecast, 2014-2024

6.7 The Indian Needle-Free Delivery Market Forecast, 2014-2024

7.1 Antares Pharma7.1.1 Sales and Performance Analysis, 2010-2012

7.1 Antares Pharma

7.1.1 Sales and Performance Analysis

7.1.2 Product Sales, 2012

7.1.3 Revenue by Region, 2012

7.1.4 Revenue by Major Customers, 2011-2012

7.1.5 Sales and Performance Analysis, 3Q 2013

7.1.6 Technology of Antares Pharma

6. Leading National Needle-Free Delivery Markets, 2014-2024

7. Leading Companies in the Needle-Free Delivery Market 2014

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Contents 7.1.6.1 Pressure Assisted Injection Devices

7.1.6.2 Transdermal Gel System

7.1.7 Marketed Products, 2014

7.1.8 Pipeline Products, 2014

7.2 Zogenix


7.2.2 Sales by Segment, 2013

7.2.3 Needle-Free Products

7.2.3.1 Marketed Products, 2014

7.2.3.1.1 Sumavel® DosePro®: Rapid Acting Migraine Relief

7.2.3.1.2 Zohydro™ ER (hydrocodone bitartrate) Extended-

Release Capsules

7.2.3.1.3 Zohydro™ ER Approval: Cause for Controversy?

7.2.3.1.4 Pipeline Products, 2014

7.2.4 Collaborations

7.2.4.1 Co-promotion of Migranal Nasal Spray with Valeant

7.2.5 Manufacturing

7.3 Bioject Medical Technologies


7.3.2 Sales Performance Analysis by Products

7.3.3 Sales and Performance Analysis, 3Q 2012-2013

7.3.4 Bioject’s Sales Revenue Setbacks

7.3.5 Collaborations

7.3.5.1 Navy Malaria Study: Utilises Bioject’s B2000 Technology

7.3.5.2 Cyto Pulse Sciences: Clinical Trials for an HIV/DNA vaccine

7.3.5.3 CDA intradermal influenza study

7.3.5.4 MPI Research: Seeking Drug/Device Combinations

7.3.5.5 World Health Organisation (WHO): The Push to Eradicate Infectious

Disease in Developing Countries


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Contents 7.3.6.1 Biojector® 2000: Adaptable Power Source Allows Use in Home

and Mass Vaccination Setting

7.3.6.2 Vitajet™: Low-cost Insulin Delivery System

7.3.6.3 ZetaJet™: Auto-disable Feature Improves User Safety

7.3.7 Needle-Free Injection Device Pipeline

7.3.7.1 Intradermal Pen Injector: Targeted Drug Delivery

7.3.7.2 Iject®: Providing Tailored Depth of Penetration

7.3.7.3 Jupiter Jet: Multi Dosing With Single Loaded Syringe

7.4 3M


7.4.2 3M Drug Delivery Systems

7.4.2.1 Inhalation

7.4.2.2 Transdermal patch

7.4.2.3 Microneedles

7.5 Medical International Technology (MIT)


7.5.2 Increased Product Awareness Through Globalisation

7.5.2.1 Further Expansion in China

7.5.3 Products

7.5.3.1 Med Jet

7.6 D’Antonio Consultants International (DCI)


7.6.1.1 LectraJet®: Lightweight Device Reduces User Fatigue

7.6.2 Needle-Free Injection Device Pipeline

7.6.2.1 Low Workload Jet Injector: Single-shot Manual System

7.6.2.2 Multi Channel Jet Injector: For Simultaneous Vaccine Delivery

7.7 PharmaJet


7.7.1.1 STRATIS®: Drug Delivery in Less Than a Second

7.7.1.2 Applications

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Contents 7.7.2 Collaborations: Pursuing a Drug/Device Combination for Vaccine Administration

7.8 Akra Dermojet


7.8.1.1 DERMOJET® “HR”: User-Friendly Design Allows Use in High

Intensive Applications

7.8.1.2 DERMOJET Polymedical®: Interchangeable Injection Tips Reduces

Risk of Contamination

7.8.1.3 Automatic DERMOJET®

7.9 Injex Pharma

7.9.1 Injex 30

7.9.1.1 Injex 30’s Applications

7.9.2 Injex’s Worldwide Distribution

7.9.2.1 Exclusive Distributor Agreement with Russia’s Medici Ltd.

7.9.2.2 Chinese SFDA approval

7.9.2.3 NHS’s Withdrawal of Injex30

7.10 Glide Pharma

7.10.1 Applications

7.10.1.1 Glide SDI system’s Advantages

7.10.2 Injecting Solid Formulations

7.10.3 Pharmaceutical Companies

7.10.4 Collaboration with Pfenex Inc. to Aid Delivery of Solid Dose Vaccine

8.1 SWOT Analysis of the Needle-Free Delivery Market, 2014-2024

8.2 Strengths

8.2.1 Strong Growth in the Biologic Drug Market

8.2.2 Increasing Development in Transdermal Delivery

8. Qualitative Analysis of the Needle-Free Delivery Market, 2014-

2024

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Contents 8.2.3 No Specialist Training Required for Drug/Vaccine Delivery

8.2.4 Eliminating the Cold Chain Problem

8.2.5 Reduction in Needle Stick Injuries

8.3 Weaknesses

8.3.1 Healthcare Practitioners are not Familiar with Novel Delivery Systems

8.3.2 Current Inefficient Manufacturing Processes Lead to Costly Needle-Free

Technology

8.3.3 Current Technology is Very Expensive

8.4 Opportunities

8.4.1 Emerging Economies Offer Significant Growth Opportunities

8.4.2 Mass Immunisation Programs Around the World

8.4.3 Increasing Global Diabetes Population

8.4.4 Shift Towards Home Administration Setting

8.4.5 Extending Life Cycle of Drugs

8.5 Threats

8.5.1 Traditional Needles and Syringes are Very Cheap to Mass Produce

8.5.1.1 Needle and Syringes with Anti Needle-Stick Injury Technology

8.5.2 Greater Regulatory Scrutiny

8.5.3 Limited Clinical Data

8.5.4 Medical Device Excise Tax

9.1 Interview with Robert E. Sievers, CEO and President, Aktiv-Dry LLC, and Professor,

Department of Chemistry and Biochemistry Center for Pharmaceutical Biotechnology,

University of Colorado, Boulder

9.1.1 Aktiv-Dry's PuffHaler

9.1.2 The Benefits of Inhaler Technology

9.1.3 The Competitive Landscape for Measles Inhaler Vaccines

9.1.4 ACTIV DRY’S Collaborations

9. Expert Opinion

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Contents 9.1.5 The Challenges to Introduction Novel Inhaler Technology

9.2 Interview with David Hoey, CEO, Vaxxas

9.2.1 Vaxxas’s Nanopatch™ technology

9.2.2 The Advantages of Using Nanopatch Technology in Developed and Developing

Markets

9.2.3 The Challenges of Manufacturing Patch Technology

` 9.2.4 The Future for the Nanopatch Technology

9.3 Professor Mark Kendall, Inventor of the Nanopatch and Co-founder of Vaxxas

9.3.1 Microneedles: Proof of Concept to Commerical Product

9.3.2 Needle Delivery Market is Still Strong

9.3.3 The Microneedle Market

9.4 Interview with John Turanin, Vice President and General Manager, Zogenix Technologies

9.4.1 The Use of Gas Power in Jet Injectors

9.4.2 The Incentives for Drug Companies in Adopting Needle-Free Delivery

9.4.3 Regulating the Needle-Free Delivery Technology Market

9.4.4 Regional Market Forecasts for Jet Injectors

9.4.5 Jet Injectors: Competitive Space and Restraints on the Market

9.4.6 Regional Market Forecasts for Jet Injectors

9.4.7 Jet Injectors: Competitive Space and Restraints on the Market

9.5 Interview with Mark Logomasini, President and CEO, Bioject Medical Technologies

9.5.1 The Spring-Powered, Gas-Powered and Battery Powered Jet Injector Markets

9.5.2 Other Competing Needle-Free Delivery Platforms

9.5.3 Regulations Determine Jet Injector Market

9.5.4 Small Needle Free Delivery Companies Requires Large External Capital

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Contents

10.1 The Needle-Free Delivery Market, 2014-2024

10.1 The Needle-Free Delivery Market, 2014-2024

10.2 Transdermal Delivery For Vaccine Delivery

10.3 Biologic Drugs are a Major Driver of the Needle Free Delivery Market

10.4 Strong Pipeline Will Drive the Competing Needle-Free Injection Technology Market

10.5 Concluding Remarks

10. Conclusions

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Table 4.4 lists some of the current jet injector devices in development.

Table 4.4 The Jet Injector Development Pipeline, 2014 Device Manufacturer SectionZeneo Crossject 4.4.1

Jupiter JetBioject Medical Technologies 4.4.2

IjectBioject Medical Technologies 4.4.3

Relday Zogenix 4.4.4

4.4.1 Zeneo (Crossject Medical Technologies) Zeneo is the name for a family of disposable needle-free injectors being developed by the French

based Crossject Medical Technology. They are expected to be introduced into the market by 2015.

Unlike other technologies, the zeneo crossject injector generates gas at the time of injection in a

controlled manner, producing the right amount of pressure to allow the medicine to penetrate the

skin tissue and distribute in a few milliseconds. Currently, there are three zeneo devices in

development and these are classified by the depth of injection. The devices are able to penetrate

to the intradermal (ID), subcutaneous (SC) or intramuscular (IM) layers. The zeneo devices are

currently being tested for clinical validation and efficacy. Crossject are also developing a zeneo

device that can be used on animals. Table 4.5 lists the different zeneo devices along with their

development status.

Table 4.5 Crossject: Zeneo Development Pipeline, 2014 Product Development StatusSC 0,5ml Clinical efficacySC 0,8ml Clinical validation of injectionSC high viscosity Preclinical validationIM 0,5ml Clinical validation of injectionID animal Clinical efficacyID human Clinical validation of injection

Source: visiongain 2014

Source: visiongain 2014, Crossject Medical Technology 2014

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becomes stable, people will consider using new technologies like needle-free injections. Patient

demographics will drive the growth of this market during the forecast period.

Table 6.8 The Italian Needle-Free Delivery Market Forecast: Revenue ($m), AGR (%), CAGR (%), 2012-2024

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024Italy ($m) 33.24 34.67 36.40 38.59 42.06 46.26 50.89 55.98 62.14 70.21 79.34 90.45 103.11AGR (%) 4 5 6 9 10 10 10 11 13 13 14 14CAGR (%) 2013-2018CAGR (%) 2013-2024

8 2018-2024 1210

Figure 6.9 The Italian Needle-Free Delivery Market Forecast: Revenue ($m), AGR (%), 2012-2024

6.4.1.4 The Spanish Needle-Free Delivery Market Forecast, 2014-2024 The Spanish needle- free delivery market was worth $31.84m in 2013, contributing 10.9% of the

European market and 2.8% of the global needle-free delivery market. Visiongain predicts this

market will reach $79.49m in 2024 with a CAGR of 9% between the period 2013-2024 (figure

6.10). Spain has been following severe austerity measures following the European economic crisis.

Its public healthcare expenditure is approximately 7% of GDP in 2013 as compared with the

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unfavourable market conditions in 2013. The company's major source of revenue is from product

sales.

Table 7.14 MIT: Revenue ($m), AGR (%), 2009-2013

2009 2010 2011 2012 2013Revenue ($m) 0.66 0.64 0.44 1.00 0.85

AGR (%) -2.3 -31.8 127.9 -15.0

Figure 7.13 MIT: Revenue ($m), AGR (%), 2009-2013

7.5.2 Increased Product Awareness Through Globalisation In recent years, the MED-JET needle-free injector has gained considerable worldwide awareness

through increased product approvals, namely in Russia and China. In the case with Russia, MIT

has established a new close working relationship with a Russian distributor to cover marketing and

sales of the MED-JET device in Russia. This follows news of MIT receiving official certification to

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Source: MIT 2014, Visiongain 2014

Source: MIT 2014, Visiongain 2014

Needle-Free Delivery Technology 2014-2024

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