Published on April 3, 2014
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www.visiongain.com 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 126.96.36.199 Blood-Borne Pathogens and Needle Stick Injury 188.8.131.52 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 184.108.40.206 Pain Management: Using NFI Devices to Administer Lidocaine 2.3.2 Vaccine Delivery: Improving Immune Response 220.127.116.11 The Global Vaccine Market, 2014-2024 18.104.22.168 Needle-Free Vaccine Delivery 22.214.171.124 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
www.visiongain.com Contents 126.96.36.199 Concerns About Multi-use Nozzle Jet injectors (MUNJIs) 188.8.131.52 Strengths and Weaknesses of Jet Injectors 2.5.2 Competing Needle-Free Technologies 184.108.40.206 Novel Needle Technology 220.127.116.11.1 Pen Needles 18.104.22.168.2 Microneedles 22.214.171.124.3 Hollow Microneedles 126.96.36.199.4 Solid Coated Microneedles 188.8.131.52.5 Solid Biodegradable Microneedles 184.108.40.206.6 Solid Uncoated Microneedles 220.127.116.11.7 Selection of Microneedles 18.104.22.168 Inhaler Technology 22.214.171.124 Transdermal Patch Technology 2.6 Regulation of the Needle-Free Delivery Market 2.6.1 The US Regulation System 126.96.36.199 Combination Products 188.8.131.52 FDA Statement Clamps Down On Delivery of Medications in Non-approved Needle-Free Devices 2.6.2 The European Regulation System 184.108.40.206 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
www.visiongain.com 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) 220.127.116.11 Iject R (Bioject Medical Technologies) 4.4.4 Relday (Zogenix) 4.5 Concluding Remarks 4. The Jet Injectors Technology Market, 2014-2024
www.visiongain.com 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 18.104.22.168 Microneedle Patch for the Polio Vaccine (Georgia Tech’s School of Chemical and Biomolecular Engineering) 22.214.171.124 AdminPen (nanoBioSciences) 126.96.36.199 PKA SoftTouch (PKA SoftTouch Corp) 188.8.131.52 DrugMAT (TheraJect) 184.108.40.206 MicroCor (Corium International) 220.127.116.11 Nanopatch (Vaxxas) 18.104.22.168 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
www.visiongain.com 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 22.214.171.124 The German Needle-Free Delivery Market Forecast, 2014-2024 126.96.36.199 The French Needle-Free Delivery Market Forecast, 2014-2024 188.8.131.52 The Italian Needle-Free Delivery Market Forecast, 2014-2024 184.108.40.206 The Spanish Needle-Free Delivery Market Forecast, 2014-2024 220.127.116.11 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
www.visiongain.com Contents 18.104.22.168 Pressure Assisted Injection Devices 22.214.171.124 Transdermal Gel System 7.1.7 Marketed Products, 2014 7.1.8 Pipeline Products, 2014 7.2 Zogenix 7.2.1 Sales and Performance Analysis 7.2.2 Sales by Segment, 2013 7.2.3 Needle-Free Products 126.96.36.199 Marketed Products, 2014 188.8.131.52.1 Sumavel® DosePro®: Rapid Acting Migraine Relief 184.108.40.206.2 Zohydro™ ER (hydrocodone bitartrate) Extended- Release Capsules 220.127.116.11.3 Zohydro™ ER Approval: Cause for Controversy? 18.104.22.168.4 Pipeline Products, 2014 7.2.4 Collaborations 22.214.171.124 Co-promotion of Migranal Nasal Spray with Valeant 7.2.5 Manufacturing 7.3 Bioject Medical Technologies 7.3.1 Sales and Performance Analysis 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 126.96.36.199 Navy Malaria Study: Utilises Bioject’s B2000 Technology 188.8.131.52 Cyto Pulse Sciences: Clinical Trials for an HIV/DNA vaccine 184.108.40.206 CDA intradermal influenza study 220.127.116.11 MPI Research: Seeking Drug/Device Combinations 18.104.22.168 World Health Organisation (WHO): The Push to Eradicate Infectious Disease in Developing Countries 7.3.6 Needle-Free Products
www.visiongain.com Contents 22.214.171.124 Biojector® 2000: Adaptable Power Source Allows Use in Home and Mass Vaccination Setting 126.96.36.199 Vitajet™: Low-cost Insulin Delivery System 188.8.131.52 ZetaJet™: Auto-disable Feature Improves User Safety 7.3.7 Needle-Free Injection Device Pipeline 184.108.40.206 Intradermal Pen Injector: Targeted Drug Delivery 220.127.116.11 Iject®: Providing Tailored Depth of Penetration 18.104.22.168 Jupiter Jet: Multi Dosing With Single Loaded Syringe 7.4 3M 7.4.1 Sales and Performance Analysis 7.4.2 3M Drug Delivery Systems 22.214.171.124 Inhalation 126.96.36.199 Transdermal patch 188.8.131.52 Microneedles 7.5 Medical International Technology (MIT) 7.5.1 Sales and Performance Analysis 7.5.2 Increased Product Awareness Through Globalisation 184.108.40.206 Further Expansion in China 7.5.3 Products 220.127.116.11 Med Jet 7.6 D’Antonio Consultants International (DCI) 7.6.1 Needle-Free Products 18.104.22.168 LectraJet®: Lightweight Device Reduces User Fatigue 7.6.2 Needle-Free Injection Device Pipeline 22.214.171.124 Low Workload Jet Injector: Single-shot Manual System 126.96.36.199 Multi Channel Jet Injector: For Simultaneous Vaccine Delivery 7.7 PharmaJet 7.7.1 Needle-Free Products 188.8.131.52 STRATIS®: Drug Delivery in Less Than a Second 184.108.40.206 Applications
www.visiongain.com Contents 7.7.2 Collaborations: Pursuing a Drug/Device Combination for Vaccine Administration 7.8 Akra Dermojet 7.8.1 Needle-Free Products 220.127.116.11 DERMOJET® “HR”: User-Friendly Design Allows Use in High Intensive Applications 18.104.22.168 DERMOJET Polymedical®: Interchangeable Injection Tips Reduces Risk of Contamination 22.214.171.124 Automatic DERMOJET® 7.9 Injex Pharma 7.9.1 Injex 30 126.96.36.199 Injex 30’s Applications 7.9.2 Injex’s Worldwide Distribution 188.8.131.52 Exclusive Distributor Agreement with Russia’s Medici Ltd. 184.108.40.206 Chinese SFDA approval 220.127.116.11 NHS’s Withdrawal of Injex30 7.10 Glide Pharma 7.10.1 Applications 18.104.22.168 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
www.visiongain.com 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 22.214.171.124 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
www.visiongain.com 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
www.visiongain.com 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
Page 65www.visiongain.com Needle-Free Delivery: Technology and Market Forecast 2014-2024 & Prospects for Leading Companies Table 4.4 lists some of the current jet injector devices in development. Table 4.4 The Jet Injector Development Pipeline, 2014 Device Manufacturer Section Zeneo Crossject 4.4.1 Jupiter Jet Bioject Medical Technologies 4.4.2 Iject Bioject 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 Status SC 0,5ml Clinical efficacy SC 0,8ml Clinical validation of injection SC high viscosity Preclinical validation IM 0,5ml Clinical validation of injection ID animal Clinical efficacy ID human Clinical validation of injection Source: visiongain 2014 Source: visiongain 2014, Crossject Medical Technology 2014
Page 96www.visiongain.com Needle-Free Delivery: Technology and Market Forecast 2014-2024 & Prospects for Leading Companies 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 ($m), AGR (%), CAGR (%), 2012-2024 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Italy ($m) 33.24 34.67 36.40 38.59 42.06 46.26 50.89 55.98 62.14 70.21 79.34 90.45 103.11 AGR (%) 4 5 6 9 10 10 10 11 13 13 14 14 CAGR (%) 2013-2018 CAGR (%) 2013-2024 8 2018-2024 12 10 Figure 6.9 The Italian Needle-Free Delivery Market Forecast: Revenue ($m), AGR (%), 2012-2024 126.96.36.199 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 $79.49m in 2024 with a CAGR of 9% between the period 2013-2024 (figure 6.10). Spain has been following severe austerity measures following the European economic crisis. Its public healthcare expenditure is approximately 7% of GDP in 2013 as compared with the 0 2 4 6 8 10 12 14 16 0 20 40 60 80 100 120 AGR(%) Revenue($m) Year Source: visiongain 2014 Source: visiongain 2014
Page 129www.visiongain.com Needle-Free Delivery: Technology and Market Forecast 2014-2024 & Prospects for Leading Companies unfavourable market conditions in 2013. The company's major source of revenue is from product sales. Table 7.14 MIT: Revenue ($m), AGR (%), 2009-2013 2009 2010 2011 2012 2013 Revenue ($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 ($m), AGR (%), 2009-2013 7.5.2 Increased Product Awareness Through Globalisation In recent years, the MED-JET needle-free injector has gained considerable worldwide awareness through increased product approvals, namely in Russia and China. In the case with Russia, MIT has established a new close working relationship with a Russian distributor to cover marketing and sales of the MED-JET device in Russia. This follows news of MIT receiving official certification to -2.3 -31.8 127.9 -15.0 -40 -20 0 20 40 60 80 100 120 140 0.00 0.20 0.40 0.60 0.80 1.00 1.20 AGR(%) Revenue($m) Year Revenue ($m) AGR (%) Source: MIT 2014, Visiongain 2014 Source: MIT 2014, Visiongain 2014
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