Needle Free Delivery Technology Market Forecast 2015-2025

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Needle-Free Delivery Technology Market Forecast 2015-2025

Opportunities for Leading Companies

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Contents 1. Report Overview 1.1 Global Needle-Free Delivery Technology Market Overview

1.2 Overview of Findings

1.3 Structure of the Report

1.4 Global Needle-Free Delivery Technology Market Segmentation

1.5 Why You Should Read This Report

1.6 How This Report Delivers

1.7 Key Questions Answered by This Analytical Report

1.8 Who is This Report For?

1.9 Methodology

1.10 Frequently Asked Questions (FAQ)

1.11 Associated Visiongain Reports

1.12 About Visiongain

2. Introduction to Needle-Free Delivery Technology 2.1 What is Needle-Free Delivery Technology?

2.1.1 Needlestick Injury

2.1.1.1 Blood-Borne Pathogens and Needlestick Injury

2.1.1.2 Accidental Needlestick Injury: A Serious Healthcare Problem

2.2 The Needle-Free Delivery Technology Market

2.3 Jet Injectors

2.3.1 Concerns about Multi-use Nozzle Jet injectors (MUNJIs)

2.3.2 Strengths and Weaknesses of Jet Injectors

2.4 Competing Needle-Free Technologies

2.4.1 Novel Needle Technology

2.4.1.1 Pen Needles

2.4.1.2 Microneedles

2.4.1.3 Hollow Microneedles

2.4.1.4 Solid Coated Microneedles

2.4.1.5 Solid Biodegradable Microneedles

2.4.1.6 Solid Uncoated Microneedles

2.4.1.7 Selection of Microneedles

2.4.2 Inhaler Technology

2.4.3 Transdermal Patch Technology

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

2.5.1 Pain Management

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Contents 2.5.1.1 Using Needle-Free Injection Devices to Administer Lidocaine

2.5.2 Vaccine Delivery: Improving Immune Response

2.5.2.1 Needle-Free Vaccine Delivery

2.5.2.2 Mass Immunisation

2.5.3 Insulin Delivery for Diabetics

2.5.4 Paediatric Injections

2.5.5 Other Uses for Needle-Free Injection Technology

2.6 Regulation of the Needle-Free Delivery Technology 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. Needle-Free Delivery Technology: World Market 2015-2025 3.1 The Needle-Free Delivery Technology Market: Overview

3.2 Needle-Free Delivery Technology Market Segmentation, 2014

3.3 The Needle-Free Delivery Technology Market Forecast, 2015-2025

3.4 How Will Segmental Market Shares Change to 2025?

3.5 Needle-Free Delivery Technology: Market Trends, 2015-2025

3.6 Needle-Free Delivery Technology: Drivers and Restraints 2015-2025

4. Jet Injectors Technology Market, 2015-2025 4.1 The Jet Injectors Market Overview

4.2 Jet Injectors: Market Forecast 2015-2025

4.3 Jet Injector Devices on the Market

4.3.1 Biojector 2000 (Bioject Medical Technologies)

4.3.2 ZetaJet (Bioject Medical Technologies)

4.3.3 Vision (Antares Pharma)

4.3.4 Vibex (Antares Pharma)

4.3.5 Sumavel DosePro (Endo International)

4.3.6 Stratis (PharmaJet)

4.3.7 LectraJet (D’Antonio Consultants International)

4.3.8 AdvantaJet and GentleJet (Activa Brand Products)

4.3.9 Vitajet (Bioject Medical Technologies)

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Contents 4.3.10 Med-Jet (Medical International Technologies)

4.3.11 J-Tip (National Medical Products)

4.3.12 Injex30 (Injex Pharma)

4.3.13 SQ-Pen, SQ-X and MHP-1 (Bespak)

4.3.14 E-Jet 100 (Eurojet Medical)

4.3.15 Penjet (Penjet Corporation)

4.4 Jet Injectors Development Pipeline

4.4.1 Glide SDI (Glide Pharmaceutical Technologies)

4.4.2 Zeneo (Crossject)

4.4.3 Relday (Zogenix)

4.4.4 Magnetic Injection (Massachusetts Institute of Technology)

4.4.5 Intradermal (ID) Pen (Bioject Medical Technologies)

4.4.6 Iject and Iject R (Bioject Medical Technologies)

4.4.7 Jupiter Jet (Bioject Medical Technologies)

5. Competing Needle-Free Technology Market, 2015-2025 5.1 The Competing Needle-Free Technology Overview

5.2 The Competing Technology: Market Forecast 2015-2025

5.3 How Will Segmental Market Shares Change to 2025?

5.4 Novel Needle Technology Overview

5.5 Novel Needle Technology: Market Forecast, 2015-2025

5.5.1 Leading Novel Needle Technologies

5.5.1.1 Soluvia Microinjection System (BD)

5.5.1.2 Ultra-Fine Nano 4mm Pen Needle (BD)

5.5.1.3 AutoShield Duo Pen Needle (BD)

5.5.1.4 Microstructured Transdermal Systems (3M)

5.5.1.5 ZP Patch Technology (Zosano)

5.5.2 Novel Needle Technology Development Pipeline

5.5.2.1 Microneedle Patch (Georgia Institute of Technology)

5.5.2.2 Micronjet (NanoPass)

5.5.2.3 DebioJect (Debiotech)

5.5.2.4 AdminPen (nanoBioSciences)

5.5.2.5 PKA SoftTouch (PKA SoftTouch Corp)

5.5.2.6 DrugMat and VaxMat (TheraJect)

5.5.2.7 MicroCor (Corium International)

5.5.2.8 Nanopatch (Vaxxas)

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Contents 5.5.2.9 Nanotopography Enhanced Microneedle Delivery (University of California-San

Francisco, Georgia Institute of Technology and Kimberly-Clark)

5.5.2.10 Memspatch and Micro-Patch (Nemaura)

5.5.2.11 Microneedle Patch for Lidocaine Delivering (National University of Singapore)

5.6 Inhaler Technology Overview

5.7 Inhaler Technology: Market Forecast, 2015-2025

5.7.1 Inhaler Products in the Asthma Market

5.7.1.1 Preventer Inhalers

5.7.1.2 Reliever Inhalers

5.7.2 Inhaler Products in the Insulin Market

5.7.2.1 Afrezza (MannKind)

5.7.3 Inhaler Products in the Vaccine Market

5.7.3.1 FluMist Quadrivalent (MedImmune)

5.7.4 Vaccine Inhaler Pipeline

5.8 Transdermal Patch Technology Overview

5.9 Transdermal Patch Technology: Market Forecast, 2015-2025

5.9.1 Selected Transdermal Patch Products

5.9.1.1 Duragesic (Fentanyl, Janssen Pharmaceuticals)

5.9.1.2 Nicoderm CQ (Nicotine, GlaxoSmithKline)

5.9.1.3 Exelon Patch (Rivastigmine, Novartis)

5.9.1.4 Zecuity (Sumatriptan, Teva)

5.9.2 Transdermal Patch Technology Development Pipeline

5.9.2.1 Electronic Transdermal Patch (Rhenovia Pharma)

5.9.2.2 Electroporation-Mediated DNA Drug Delivery (TriGrid, Ichor Medical Systems)

5.9.2.3 Ultrasonic Waveforms (U-Strip, Transdermal Specialties)

5.9.2.4 Prelude SkinPrep System (Echo Therapeutics)

5.10 Other Competing Needle-free delivery Technology in development

5.10.1 Microbubbles Injection (Shibaura Institute of Technology)

5.10.2 Laser Injection (Seoul National University)

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

5.10.4 Nanotechnology Syringes (Gwangju Institute of Science and Technology, South Korea)

6. Leading National Markets 2015-2025 6.1 National Breakdown of the World Needle-Free Technology Market

6.2 World Needle-Free Delivery Technology Market: Regional Forecast 2015-2025

6.2.1 How Will Regional Market Shares Change to 2025?

6.3 The US Needle-Free Delivery Technology Market 2015-2025

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Contents 6.3.1 US Needle-Free Delivery Technology Market Forecast 2015-2025

6.3.2 FDA Guideline for Combination Products

6.3.3 Needle-Free Delivery and the US Flu Vaccination Market

6.3.4 Measles Outbreak in the US

6.4 The EU5 Needle-Free Delivery Technology Market 2015-2025

6.4.1 EU5 Needle-Free Delivery Technology Market Forecast 2015-2025

6.4.2 The German Needle-Free Delivery Technology Market Forecast, 2015-2025

6.4.3 The French Needle-Free Delivery Technology Market Forecast, 2015-2025

6.4.4 The UK Needle-Free Delivery Technology Market Forecast, 2015-2025

6.4.5 The Italian Needle-Free Delivery Technology Market Forecast, 2015-2025

6.4.6 The Spanish Needle-Free Delivery Technology Market Forecast, 2015-2025

6.5 The Japanese Needle-Free Delivery Technology Market 2015-2025

6.5.1 Japanese Needle-Free Delivery Technology Market Forecast 2015-2025

6.6 The Chinese Needle-Free Delivery Technology Market 2015-2025

6.6.1 Chinese Needle-Free Delivery Technology Market Forecast 2015-2025

6.7 The Indian Needle-Free Delivery Technology Market 2015-2025

6.7.1 Indian Needle-Free Delivery Technology Market Forecast 2015-2025

6.7.2 Needles and Syringes Being reused in Indian Hospitals

7. Leading Companies in the Needle-Free Delivery Technology Market 7.1 Leading Needle-Free Delivery Technology Manufacturers in 2014

7.2 Antares Pharma

7.2.1 Antares Pharma: Needle-Free Delivery Technology Product Portfolio

7.2.2 Antares Pharma: Financial Overview

7.2.3 Antares Pharma: Products in Development

7.2.4 Settlement of Patent Infringement Case between Antares Pharma and Medac Pharma

7.3 Zogenix

7.3.1 Zogenix: Product Portfolio

7.3.2 Zogenix: Current Pipeline

7.3.3 Zogenix: Financial Overview

7.4 3M

7.4.1 3M: Needle-Free Delivery Technology Product Portfolio

7.4.1.1 3M: Metered Dose Inhaler

7.4.1.2 3M: Transdermal patch

7.4.1.3 3M: Microneedle

7.4.2 3M: Financial Overview

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Contents 7.5 BD

7.5.1 BD: Needle-Free Delivery Technology Product Portfolio

7.5.2 BD: Financial Overview

7.5.3 Recall of BD Needles in HongKong

7.6 PharmaJet

7.6.1 PharmaJet: Needle-Free Delivery Technology Product Portfolio

7.6.2 First FDA Approved Jet Injector for Flu Shot in the US

7.6.3 PharmaJet: Collaborations and Needle-Free Delivery Technology Pipeline

7.6.4 Preference for PharmaJet over Needle and Syringe

7.7 Bioject Medical Technologies

7.7.1 Bioject Medical Technologies: Needle-Free Delivery Technology Product Portfolio and

Pipeline

7.7.2 Bioject Medical Technologies: Financial Overview

7.7.3 Focusing on Developing Countries

8. Qualitative Analysis of the Needle-Free Delivery Technology Market

2015-2025 8.1 SWOT Analysis of the Needle-Free Delivery Technology Market

8.2 Strengths

8.2.1 Strong Growth in the Biologic Drug Market

8.2.2 Increasing Development in Transdermal Delivery

8.2.3 No Specialist Training Required and No Needlestick Injuries

8.2.4 Eliminating the Cold Chain Problem

8.3 Weaknesses

8.3.1 Healthcare Practitioners are not Familiar with Novel Delivery Systems

8.3.2 Greater Regulatory Scrutiny

8.3.3 Inefficient Manufacturing Processes

8.4 Opportunities

8.4.1 Emerging Economies Offer Significant Growth Opportunities

8.4.2 Mass Immunisation Programmes 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

8.5.2 Needle and Syringes with Anti Needlestick Injury Technology

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Contents 8.5.3 Limited Clinical Data

8.5.4 Medical Device Excise Tax

9. Research Interviews 9.1 Interview with Mark Logomasini, Director of Business Development, Bioject Medical

Technologies

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

9.1.2 Other Competing Needle-Free Delivery Platforms

9.1.3 Regulations Determine Jet Injector Market

9.1.4 Small Needle Free Delivery Companies Requires Large External Capital

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 Interview with Chris Cappello, CTO, PharmaJet

9.3.1 On Current Collaborations

9.3.2 On potential Competitors and the restraint in the market

9.3.3 The Application of Microneedles and transdermal patches is still limited

9.3.4 On Future Growth of the Jet Injector 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

9.5 Interview with Dr D F Chowdhury, CEO, Nemaura

9.5.1 Current Development of Nemaura

9.5.2 Patented Skin Delivery Platforms

9.5.3 Greatest Restraint: Regulatory Barriers

9.5.4 Advantages over Other Technologies

9.5.5 On Future Trends for the Patch and Microneedle Market

9.6 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

9.6.1 Aktiv-Dry's PuffHaler

9.6.2 The Benefits of Inhaler Technology

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Contents 9.6.3 The Competitive Landscape for Measles Inhaler Vaccines

9.6.4 ACTIV DRY’S Collaborations

9.6.5 The Challenges to Introduction Novel Inhaler Technology

10. Conclusions 10.1 The World Needle-Free Technology Market in 2014 and 2015

10.1.1 Current Leading Needle-Free Technology Segments

10.1.2 Notable Needle-Free Technology Companies

10.1.3 Leading Regional Markets

10.2 World Needle-Free Technology Market Forecast 2015-2025

10.3 The Future of the Needle-Free Technology Market?

10.3.1 Biosimilars are a Major Driver of the Needle Free Delivery Market

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

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Needle-Free Delivery Technology Market Forecast

2015-2025: Opportunities for Leading Companies

On the other hand, needle-free delivery methods are still more costly than needles and syringes.

The high cost associated with this technology is one of the major drawbacks. Due to the high start-

up and maintenance costs, the initial adoption of needle-free systems was slow. Nevertheless, the

development costs is expected to be reduced, resulting in the manufacture of more needle-free

injection devices, indicated for a wide variety of administrations including vaccines, hormones and

anaesthetics.

Authorities have started to require manufacturers to combine their technologies with a particular

drug before the device can be approved. Furthermore, failure to educate health professionals with

new technologies can be devastating for the marketing of the device, which is best illustrated by

Pfizer’s Exubera.

Figure 3.5 Needle-Free Delivery Technology: Drivers and Restraints 2015-2025

Source: visiongain 2015

• Increased safety compared to conventional needles and syringes

• Alleviate needle phobia and pain

• The advent of biologics and biotechnology-based compounds

• Help prolong the pharmaceutical product life cycle

• Trend toward self-administration of injectable drugs

• Faster to get approved utilising existing drugs

Drivers Restraints

• More expensive than traditional methods

• More stringent regulatory environment

• Health professionals are not likely to adopt a new technology immediately




4.3.14 E-Jet 100 (Eurojet Medical)

The E-Jet 100 device can subcutaneously deliver a wide range of injectables, such as vitamins,

hormones, anticoagulants, vaccines etc. Using a special pre-filled dual chamber cartridge for the

E-Jet 100, one can inject wet-and-dry drugs such as interferons. The device is capable of

operating in the temperature range of 0°C to 50°C. The injector is activated by a push button.

The E-Jet 100 can be used to deliver drugs into the intradermal, subcutaneous and intramuscular

layers. According to Eurojet Medical, the key advantages of E-Jet 100 device include an easy-to-

use design and no specialist or previous training is required to operate the device. The device is

highly accurate, reliable and is available at an affordable price (€75).

4.3.15 Penjet (Penjet Corporation)

Penjet is a disposable needle-free jet injector that is powered by a self-contained, compressed

inert gas and provides subcutaneous, intradermal and intramuscular injections. Owing to its low

cost and easy to use design, the Penjet is indicated for use in mass immunisation programmes and

individual patient home use. The device was available either pre-filled with a drug or may be filled

prior to injection by the patient.

While most needle-free jet injectors use carbon dioxide as the gas of choice to propel the

medication through the skin, the Penjet’s gas canisters are powered by nitrogen. Unlike carbon

dioxide, nitrogen has a wide functional temperature range and can be kept refrigerated prior to

injection. The gas is also located in a patented metal canister which helps to eliminate leakage

caused by an incomplete injection, as seen with plastic gas canisters. The company estimates that

the Penjet, when produced in large quantities, will cost about a dollar. The injector, however, is no

longer in production.

4.4 Jet Injectors Development Pipeline

4.4.1 Glide SDI (Glide Pharmaceutical Technologies)

The Glide System is an injection system for the injection of drugs and vaccines in solid doses. The

Glide System uses a solid (powder) form of drug. This differs from the more traditional and widely

used liquid injectors. By using a solid form of the drug pharmaceutical firms can reformulate off

patent drugs. Many drugs in early development are discarded as they are not water soluble. The

Glide SDI offers pharmaceutical firms an alternative method of delivery for non water soluble




Figure 6.11 EU5 Needle-Free Delivery Technology Market: Market Shares (%) by National Market, 2025

6.4.2 The German Needle-Free Delivery Technology Market Forecast,

2015-2025

Germany is Europe’s most populous country and is currently the fourth largest needle-free delivery

device market in the world. It houses some leading organisations in the needle-free industry. One

notable example would be Injex, based in Berlin, which is one of the few jet injector companies

with an international presence. The German market was the largest single European needle-free

delivery technology market in 2014, with a market worth $78m.

Germany is one of the most attractive medical device markets in the EU due to the underlying

strength of the German economy. Austerity measures did not hit the German medical device

industry too hard compared to drugs. Although price pressures do have an effect, an €1.1bn

additional financial support for hospitals during 2013 and 2014 has been a positive development.

The German needle-free market will show healthy growth during the forecast period with a CAGR

of 10.7% between 2014-2025 (table 6.5, figure 6.12). The prevalence of diabetes in Germany

(surveyed at January 2012) stands at 7.4 million. This number will steadily increase during the

forecast period and this will drive the needle-free delivery technology market. Around 500,000

Germany 35.3%

France 26.8%

UK 18.2%

Italy 10.1%

Spain 9.6%

Source: visiongain 2015




7.7 Bioject Medical Technologies

Table 7.16 Bioject Medical Technologies: Overview, 2015

Company Bioject Medical TechnologiesNotable Subsidiaries -Business Areas Drug Delivery

Headquarters Tigard, Oregon, USEstablished 1985Leading Products ZetaJet, Biojector 2000

FY 2013 Revenue ($m) 1.5FY 2014 Revenue ($m) 1.8

Founded in 1985, Bioject Medical Technologies is a drug delivery company specialising in the

needle-free injection of liquid medications including pharmaceuticals, vaccines and biologics. The

company currently boasts a broad technology platform for delivering many different types of

medications and vaccines. Bioject is also developing inexpensive, pre-filled, disposable injection

systems. Bioject and its partners have a large number of published studies using the needle-free

injection technology. The company is based in Oregon, US, although a large proportion of their

sales are overseas.

7.7.1 Bioject Medical Technologies: Needle-Free Delivery Technology

Product Portfolio and Pipeline

Bioject has developed a portfolio of injection systems based on its core technology, which involves

forcing liquid medication at high speed through a small orifice held against the skin. This creates

an ultra-fine stream of fluid that penetrates the skin, delivering medication in a fraction of a second.

The company claims their technology is unique as it allows delivery of drugs to a number of

injection depths - intramuscular, subcutaneous and intradermal. Furthermore, Bioject’s products

allow the medication to be dispersed in the tissue, while a needle-syringe system usually deposits

the medication as a bolus. This improves the distribution of the drug, and ultimately facilitates a

more rapid and effective absorption.

Bioject Medical Technologies’ current product portfolio includes:

Source: Bioject Medical Technologies 2015, visiongain 2015




9. Research Interviews

9.1 Interview with Mark Logomasini, Director of Business Development,

Bioject Medical Technologies

Mark Logomasini is the Director of Business Development of Bioject Medical Technologies, a

Oregon, US-based drug delivery company specialising in the needle-free injection of liquid

medications. We discussed topics ranging from the different types of jet injector devices to the

regulatory outlook for the needle-free delivery market.

9.1.1 The Spring-Powered, Gas-Powered and Battery Powered Jet

Injector Markets

visiongain: Your jet injector products use a range of different power sources, from spring-powered

Vitajet and Zetajet to gas-powered Biojector® 2000, what is the differentiation between each

technology? What are the benefits and drawbacks of each?

ML: Gas powered jet injectors were the original technology that came out of the military back in the

50s,60s, 70s and used all the through the 90s.That is what our Biojector®-2000 (“B2000”)device is

based on. In the 1990’s, spring-powered devices were developed including the Vitajet™ and then

later the ZetaJet™. The, the most apparent difference between the two technologies is obviously

the driving force. One uses gas power; in the case of the B2000, CO2 gas. The other devices,

which apply to most of the jet injectors on the market are spring-powered. A spring drives the

plunger that injects the medication.

The major operational difference is that you do not get as much driving force out of a spring as you

do with gas. With a gas powered injector, you can inject up to 1ml of medication. With a spring

powered injector you can inject up 0.5 mls of medication, I do not know any company that has

gone beyond this due to the mechanical limitations of the spring. With a spring powered device

there is also the limitation associated with spring wear. You do not get as many injections as a gas

powered device before the device needs servicing. A rough estimate is that spring powered

devices deliver about 10% of the injections ahead of servicing. We have gas powered devices out

there that have given more than 100,000 injections.

The benefit to spring powered device is that it has a self contained driving force, so you don’t need

an external power source as you do with a gas powered device. With spring powered devices, you