Top Needle Free Injection Device Manufacturers 2014-2024

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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

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Top Needle Free Injection Device Manufacturers 2014-2024

  1. 1. Medical Device Leader Series: Top Needle-Free Injection Device Manufacturers 2014-2024 ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.
  2. 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 www.visiongain.com
  3. 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 www.visiongain.com
  4. 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 www.visiongain.com
  5. 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 www.visiongain.com
  6. 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 www.visiongain.com
  7. 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 www.visiongain.com
  8. 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 www.visiongain.com
  9. 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 www.visiongain.com
  10. 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 ($m) and Revenue Share (%), by Product Line, 2010 Table 4.7 Bioject: Summary of Technologies Table 4.8 Zogenix: Key Facts, 2013 www.visiongain.com
  11. 11. Contents Table 4.9 Zogenix: Summary of Technology Table 4.10 Zogenix: Revenue ($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 www.visiongain.com
  12. 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 www.visiongain.com
  13. 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 www.visiongain.com
  14. 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 www.visiongain.com
  15. 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 www.visiongain.com
  16. 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. www.visiongain.com Page 102
  17. 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. www.visiongain.com Page 103

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