Chronic clinical conditions, such as diabetes, cardiovascular disorders, certain types of neurological disorders, and cancer, are considered to be among the leading causes of death and disability across the world. The Center for Managing Chronic Disease at the University of Michigan recently reported that over 50% of the global population is suffering from some form of chronic disease.
Despite significant advances in drug/therapy development for the treatment of chronic diseases, there are several concerns related to the delivery of such therapeutics. Since most medications are developed for parenteral delivery, dosing errors and accidental needlestick injuries are some of the primary areas of concern. In fact, needle phobia is officially recognized as a medical condition by the American Psychiatric Association in its Diagnostic and Statistical Manual of Mental Disorders and is known to affect nearly 10% of the population.
The Needlestick Safety and Prevention Act, which was signed into law in the US in November 2000, encouraged the development of a variety of needleless syringes/safety syringes, such as needle-free injection systems, microneedle patches and microneedle pens. A sustained focus towards self-injection has also facilitated significant advances in drug development and administration. In fact, the self-injection devices market is characterized by the presence of a myriad of advanced and innovative drug delivery solutions, such as (in alphabetical order) autoinjectors, jet injectors, large volume wearable injectors, microneedles, pen injectors, needleless syringes and prefilled syringes.
The concept of needle free drug delivery is realized using a variety of actuation mechanisms (such as spring- or gas-powered devices) that are capable of facilitating the delivery of therapeutic interventions without the use of needles. On the other hand, microneedles are extremely minute needles (of the order of a few micrometers), which are designed to deliver drugs across the dermis. It is worth highlighting that such delivery systems are primarily based on the subcutaneous/intradermal and transdermal routes.
The field of needleless drug delivery continues to witness significant advances, in terms of innovation in drug/therapy administration (such as dose tracking and real-time updates) and the development of compatible drug formulations. As a result, several stakeholders in the healthcare industry have developed interest in this upcoming field, and have launched product development/commercialization initiatives in the recent past.
Scope of the Report
This report features an extensive study of the current landscape and the likely future opportunities associated with the needle-free injection systems and microneedles market, over the next 10-12 years. Amongst other elements, the report includes:
A detailed review of the overall landscape of the needle-free injection systems market, featuring a comprehensive list of device developers and analysis based on a number of parameters, such as year of establishment, company size, geographical location, current development status of various products (under development and commercialized), details on intellectual property portfolio, route of administration (subcutaneous, intramuscular, intradermal and others), type of load (solid and liquid), usability (disposable and reusable), actuation mechanism (spring-based, gas-powered and others), capacity of the device (in terms of volume of drug delivered) and target disease areas.
An overview of the current market landscape of microneedle devices, featuring a comprehensive list of device developers and analysis based on a number of parameters, such as year of establishment, company size, geographical location, current development status of various products (under development and commercialized), details on intellectual property portfolio, type of microneedle device (hollow, solid and dissolving), route of administration (subcutaneous, transdermal, intradermal and others), microneedle length and target disease areas.
A detailed product competitiveness analysis of both needle-free injection systems and microneedle devices, taking into consideration the supplier power (based on the year of establishment of developer company) and key product specifications. For needle-free injection systems, specifications, such as therapeutic area, route of administration, maximum device volume, usability, size of intellectual property portfolio, and commercial availability, were considered. For microneedles, specifications, such as therapeutic area, route of administration, length of microneedle, and size of intellectual property portfolio, were considered.
A list of marketed drugs/therapies and pipeline candidates that are anticipated to be developed in combination with needle free injectors and microneedles in the near future; the analysis is based on a variety of relevant parameters, such as (in alphabetical order) current status of development, dose concentration, dosing frequency, route of administration, type of dose (standard/weight dependent), expected patent expiry (relevant only for marketed drugs) and information on product sales (relevant only for marketed drugs).
An informed business portfolio analysis based on an attractiveness and competitiveness (AC) framework, highlighting the current worth of different types of needle-free injection systems and microneedle devices.
Elaborate profiles of prominent product developers engaged in this domain. Each profile features a brief overview of the company, its financial information (if available), information on its product portfolio and recent developments.
A case study on the role of contract manufacturing organizations within the medical device industry. It includes a brief description of the various regulatory guidelines for medical devices and highlights the challenges associated with the manufacturing of such products. In addition, it features a list of contract manufacturers that claim to offer services for drug delivery devices and their geographical landscape.
One of the key objectives of the report was to estimate the existing market size and potential future growth opportunities for needle-free injection systems and microneedle devices. Based on various parameters, such as number of marketed/pipeline products, existing price of devices (for commercially available products only) and estimated annual adoption rate, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030.
For needle-free injection systems, the report also features the likely distribution of the current and forecasted opportunity across [A] different types of actuation mechanisms (spring-based, gas powered and others), [B] routes of administration (subcutaneous, intramuscular and intradermal), [C] target disease indication (infectious diseases, diabetes, pain disorders and others), [D] product usability (disposable and re-usable) and [E] key geographical regions (North America, Europe, Asia and Rest of the World).
Similarly, the projected future opportunity for microneedle devices has been analyzed across [A] various types of microneedle devices (hollow, solid and dissolving), [B] target disease indication (infectious diseases, osteoarthritis, pain disorders, cancer, and others), [C] type of intervention (vaccines, therapeutic agent and others), and [D] key geographical regions (North America, Europe, Asia and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.
The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:
Michael Schrader, CEO and Founder, Vaxess Technologies
Patrick Anquetil, CEO, Portal Instruments
Henry King, Market Intelligence and Business Development Manager, Innoture
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
Key Topics Covered
1 PREFACE 1.1. Scope of the Report 1.2. Research Methodology 1.3. Chapter Outlines
2 EXECUTIVE SUMMARY
3 INTRODUCTION 3.1 Chapter Overview 3.2. Conventional Parenteral Drug Delivery 3.2.1. Needlestick Injuries 3.2.2. Incidence and Cost Burden Related to Needlestick Injuries 3.3. Minimally Invasive Drug Delivery 3.3.1. Key Drivers of Minimally Invasive Drug Delivery Systems 220.127.116.11. Rising Burden of Chronic Diseases 18.104.22.168. Healthcare Cost Savings 22.214.171.124. Need for Immediate Treatment in Emergency Situations 126.96.36.199. Growing Injectable Drugs Market 188.8.131.52. Need for Improving Medication Adherence 3.4. Needle-Free Injection Technology 3.4.1. Key Components of Needle-Free Injection Systems 184.108.40.206. Injection Device 220.127.116.11. Nozzle 18.104.22.168. Pressure Source 3.4.2. Operating Mechanism 3.4.3. Classification of Injectors based on Type of Load 22.214.171.124. Powder-based Injectors 126.96.36.199. Liquid-based Injectors 188.8.131.52. Depot Projectile-based Injectors 3.4.4. Injectors based on Different Actuation Mechanisms 184.108.40.206. Spring Loaded Jet Injectors 220.127.116.11. Battery Powdered Jet Injectors 18.104.22.168. Gas Powdered Jet Injectors 22.214.171.124. Laser Powered Injectors 126.96.36.199. Lorentz Force-based Injectors 3.5. Drug Delivery through Microneedle Devices 3.5.1. Types of Microneedle Devices 3.5.2. Advantages of Microneedle Devices 3.5.3. Fabrication of Microneedle Devices 3.5.4. Operating Mechanism of Microneedle Devices 3.6. Needle-Free Injection Systems and Microneedle Devices: Unaddressed Challenges 3.7. Future of Needle-Free Injection Systems and Microneedle Devices
4 NEEDLE-FREE INJECTION SYSTEMS: MARKET OVERVIEW 4.1. Chapter Overview 4.2. Needle-Free Injection Systems: List of Developers 4.2.1. Analysis by Year of Establishment 4.2.2. Analysis by Company Size and Geographical Location 4.3. Needle-Free Injection Systems: List of Available / Under Development Devices 4.3.1. Analysis by Type of Load 4.3.2. Analysis by Route of Administration 4.3.3. Analysis by Actuation Mechanism 4.3.4. Analysis by Status of Development 4.3.5. Analysis by Patent Availability 4.4. Needle-Free Injection Systems: Additional Information 4.4.1. Analysis by Target Disease Area 4.4.2. Analysis by Device Capacity 4.4.3. Analysis by Product Usability 4.5. Needle-Free Injection Systems: Recent Partnerships (2015-2019)
5 MICRONEEDLE DEVICES: MARKET OVERVIEW 5.1. Chapter Overview 5.2. Microneedle Devices: List of Developers 5.2.1. Analysis by Year of Establishment 5.2.2. Analysis by Company Size and Geographical Location 5.3. Microneedle Devices: List of Available / Under Development Devices 5.3.1. Analysis by Type of Microneedle Devices 5.3.2. Analysis by Route of Administration 5.3.3. Analysis by Length of the Needle 5.3.4. Analysis by Target Disease Area 5.3.5. Analysis by Patent Availability
6 PRODUCT COMPETITIVENESS ANALYSIS 6.1. Chapter Overview 6.2. Methodology 6.3. Assumptions and Key Parameters 6.4. Product Competitiveness Analysis: Needle-Free Injection Systems 6.4.1. Spring-based Needle-Free Injection Systems 6.4.2. Gas-powered Needle-Free Injection Systems 6.4.3. Other Needle-Free Injection Systems 6.5. Product Competitiveness Analysis: Microneedle Devices 6.5.1. Hollow Microneedle Devices 6.5.2. Solid Microneedle Devices 6.5.3. Dissolving Microneedle Devices 6.5.4. Other Microneedle Devices
7 COMPANY PROFILES 7.1. Chapter Overview 7.2. Inovio Pharmaceuticals 7.2.1. Company Overview 7.2.2. Product Portfolio 188.8.131.52. Iject 184.108.40.206. Vitajet 220.127.116.11. Serojet 18.104.22.168. ZetaJet 22.214.171.124. Biojector 2000 126.96.36.199. Jupiter Jet 188.8.131.52. ID PEN 7.3. Medical International Technology 7.3.1. Company Overview 7.3.2. Product Portfolio 184.108.40.206. MED-JET MBX 220.127.116.11. MED-JET H4 18.104.22.168. MED-JET H-III 22.214.171.124. Meso-Jet 7.4. D'Antonio Consultants International 7.4.1. Company Overview 7.4.2. Product Portfolio 126.96.36.199. LectraJet HS 188.8.131.52. LectraJet M3 RA 184.108.40.206. LectraJet M4 RA 7.5. Enesi Pharma 7.5.1. Company Overview 7.5.2. Product Portfolio 220.127.116.11. ImplaVax 7.6. PharmaJet 7.6.1. Company Overview 7.6.2. Product Portfolio 18.104.22.168. PharmaJet Stratis 22.214.171.124. Tropis 7.7. Inolife Sciences 7.7.1. Company Overview 7.7.2. Product Portfolio 126.96.36.199. Inojex 30 188.8.131.52. Nanojex 7.8. Valeritas 7.8.1. Company Overview 7.8.2. Product Portfolio 184.108.40.206. V-Go 7.9. NanoPass Technologies 7.9.1. Company Overview 7.9.2. Product Portfolio 220.127.116.11. MicronJet600 18.104.22.168. MicroPyramid 7.10. 3M 7.10.1. Company Overview 7.10.2. Product Portfolio 22.214.171.124. Hollow Microstructured Transdermal System 126.96.36.199. Solid Microstructured Transdermal System 7.11. Micropoint Technologies 7.11.1. Company Overview 7.11.2. Product Portfolio 188.8.131.52. Micropoint Patch 184.108.40.206. Hollow Microneedle Hub 7.12. Nemaura Pharma 7.12.1. Company Overview 7.12.2. Product Portfolio 220.127.116.11. Memspatch 18.104.22.168. Micro-Patch 22.214.171.124. Mycrolator
8 AC MATRIX 8.1. Chapter Overview 8.2. AC Matrix: An Overview 8.2.1. Strong Business Units 8.2.2. Average Business Units 8.2.3. Weak Business Units 8.3. AC Matrix: Analytical Methodology 8.4. AC Matrix: Plotting the Information 8.5. AC Matrix: Analyzing the Data 8.5.1. Strong Business Units 8.5.2. Average Business Units 8.5.3. Weak Business Units 8.6. Concluding Remarks
9 CASE STUDY: DRUG DELIVERY DEVICE CONTRACT MANUFACTURERS 9.1. Chapter Overview 9.2. Challenges Associated with Medical Device Manufacturing 9.3. Role of Contract Manufacturing Organizations in the Device Development Process 9.4. Regulatory Guidelines for Medical Devices 9.5. Drug Delivery Device: List of Contract Manufacturers 9.5.1. Analysis by Year of Establishment 9.5.2. Analysis by Company size 9.5.3. Analysis by Geographical Location 9.6. Geographical Distribution of Device Developers and Contract Service Providers
10 NEEDLE-FREE INJECTION SYSTEMS: LIKELY DRUG CANDIDATES 10.1. Chapter Overview 10.2. Marketed Drugs Candidates 10.2.1. Most Likely Candidates for Delivery via Needle-Free Injection Systems 10.2.2. Likely Candidates for Delivery via Needle-Free Injection Systems 10.2.3. Less Likely Candidates for Delivery via Needle-Free Injection Systems 10.2.4. Unlikely Candidates for Delivery via Needle-Free Injection Systems 10.3. Clinical Drug Candidates (Biologics) 10.4. Clinical Drug Candidates (Small Molecules)
11 MICRONEEDLE DEVICES: LIKELY DRUG CANDIDATES 11.1. Chapter Overview 11.2. Marketed Drugs Candidates 11.2.1. Most Likely Candidates for Delivery via Microneedle Devices 11.2.2. Likely Candidates for Delivery via Microneedle Devices 11.2.3. Less Likely Candidates for Delivery via Microneedle Devices 11.2.4. Unlikely Candidates for Delivery via Microneedle Devices 11.3. Clinical Drug Candidates (Biologics) 11.4. Clinical Drug Candidates (Small Molecules)
12 MARKET SIZING AND OPPORTUNITY ANALYSIS 12.1. Chapter Overview 12.2. Forecast Methodology and Key Assumptions 12.3. Global Needle-Free Injection Systems Market, 2019-2030 12.4. Global Needle-Free Injection Systems Market: Distribution by Actuation Mechanism, 2019-2030 12.5. Global Needle-Free Injection Systems Market: Distribution by Route of Administration, 2019-2030 12.6. Global Needle-Free Injection Systems Market: Distribution by Target Disease Indication, 2019-2030 12.7. Global Needle-Free Injection Systems Market: Distribution by Product Usability, 2019-2030 12.8. Global Needle-Free Injection Systems Market: Distribution by Regions, 2019-2030 12.8.1 Needle-Free Injection Systems Market in North America, 2019-2030 126.96.36.199. Needle-Free Injection Systems Market in North America: Distribution by Actuation Mechanism, 2019-2030 188.8.131.52. Needle-Free Injection Systems Market in North America: Distribution by Route of Administration, 2019-2030 184.108.40.206. Needle-Free Injection Systems Market in North America: Distribution by Target Disease Indication, 2019-2030 220.127.116.11. Needle-Free Injection Systems Market in North America: Distribution by Product Usability, 2019-2030 12.8.2. Needle-Free Injection Systems Market in Europe, 2019-2030 12.8.3. Needle-Free Injection Systems Market in Asia, 2019-2030 12.8.4. Needle-Free Injection Systems Market in Rest of the World, 2019-2030 12.9. Global Microneedle Devices Market, 2019-2030 12.10. Global Microneedle Devices Market: Distribution by Type of Microneedle, 2019-2030 12.11. Global Microneedle Devices Market: Distribution by Target Disease Indication, 2019- 2030 12.12. Global Microneedle Devices Market: Distribution by Type of Intervention, 2019-2030 12.13. Global Microneedle Devices Market: Distribution by Regions, 2019-2030
13 INTERVIEW TRANSCRIPTS 13.1. Chapter Overview 13.2. Vaxess Technologies 13.2.1. Company Snapshot 13.2.2. Interview Transcript: Michael Schrader, CEO and Founder 13.3. Portal Instruments 13.3.1. Company Snapshot 13.3.2. Interview Transcript: Patrick Anquetil, CEO 13.3. Innoture 13.3.1. Company Snapshot 13.3.2. Interview Transcript: Henry King, Market Intelligence and Business Development Manager
14 CONCLUDING REMARKS
15 APPENDIX 1: TABULATED DATA
16 APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
Activa Brand Products
Aijex Pharma International
American Medical Systems
AMETEK Engineered Medical Components
Apex Medical Technologies
Australasian Medical & Scientific
Beijing Dongfang Biotech
Beijing QS Medical Technology
Bioject Medical Technologies
Biomedical Advanced Research and Development Authority
Birla Institute of Technology and Science
CANbridge Life Sciences
Children's Hospital of Eastern Ontario Research Institute