Microneedles and Needle-Free Injection Systems / Jet Injectors (Devices based on Spring, Gas and Other Mechanisms) Market, 2019-2030

Despite Significant Advances in Drug / Therapy Development for the Treatment of Chronic Diseases, There are Several Concerns Related to the Delivery of Such Therapeutics

Overview

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

The “Microneedles and Needle-Free Injection Systems/Jet Injectors (Devices based on Spring, Gas and Other Mechanisms) Market, 2019-2030” 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.

Contents

Chapter Outlines

Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the current scenario within the needle-free injection systems and microneedle devices market and describes its evolution in the short-mid term and long term.

Chapter 3 provides a general introduction to needle-free injection systems and microneedles, highlighting the growing demand for devices that enable painless administration of medication in the homecare setting. The chapter emphasizes the need for such devices, specifically in terms of the rising incidence and prevalence of chronic diseases. Subsequently, it provides an overview of the different types of needle free injectors and microneedles, listing their specifications and varied mechanisms of action. It also features a brief discussion on the challenges related to the R&D efforts associated with such healthcare, offering insights on anticipated future trends.

Chapter 4 provides a detailed overview of the overall landscape of needle-free injection systems that are developed/being developed for administration of various drug products. It features an in-depth analysis of the devices, based on a number of parameters, such as details on intellectual property portfolio, current status of development, route of administration (subcutaneous/intradermal/intramuscular), actuation mechanism (spring-based, gas-powered and others), type of load (liquid and solid), usability (single use and multiple use), capacity of the device (in terms of drug volume) and target disease areas. In addition, the chapter provides information on drug developer(s), highlighting year of establishment, location of headquarters and strength of employee base.

Chapter 5 provides a detailed overview of the overall landscape of microneedle devices that are developed/being developed for administration of various drugs. It features an in-depth analysis of the devices, based on a number of parameters, such as 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. In addition, the chapter provides information on drug developer(s), highlighting year of establishment, location of headquarters and strength of employee base.

Chapter 6 features a product competitiveness analysis of needle-free injection systems and microneedles, based on the supplier power and product specifications. The analysis was designed to enable stakeholder companies to compare their existing capabilities within and beyond their respective peer groups and identify opportunities to achieve a competitive edge in the industry.

Chapter 7 provides detailed profiles of key needle-free injection systems and microneedle device developers. Each profile presents a brief overview of the company, financial information (if available), product portfolio and recent developments.

Chapter 8 features a detailed analysis of needle-free injection systems and microneedles based on the AC (attractiveness versus competitiveness) matrix framework. It also includes a discussion on the relative market attractiveness and competitive strength of these devices. The purpose of the analysis is to enable companies to analyze their respective technical expertise, develop informed growth strategies (with respect to technical strength), and also make decisions related to acquiring new technologies or divesting the outdated ones.

Chapter 9 includes a brief case study on the role of contract manufacturing organizations that offer services for medical devices with emphasis on drug delivery devices. The chapter also features a discussion of the various challenges associated with medical device manufacturing and regulatory guidelines for medical devices. In addition, the chapter presents a region-wise mapping of the developers of the needle-free injection systems and microneedles with the availability of medical device contract manufacturers.

Chapter 10 presents a list of marketed and pipeline molecules that are likely to be considered for delivery via needle-free injection systems in the future. The list was compiled considering various 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 product sales (relevant only for marketed drugs). For the purpose of this analysis, we collated a list of over 100 top-selling marketed drugs, which were initially screened on the basis of route of administration (subcutaneous/intramuscular/intravenous). Additionally, we reviewed over 1,400 clinical trials and compiled a list of pipeline molecules that are being investigated for delivery via the aforementioned routes. The likelihood of delivery via needle free injectors and microneedles in the future was estimated using the weighted average of the aforementioned parameters.

Chapter 11 presents a list of marketed and pipeline molecules that are likely to be considered for delivery via microneedle devices in the future. The list was compiled considering various 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 product sales (relevant only for marketed drugs). For the purpose of this analysis, we collated a list of over 100 top-selling marketed drugs, which were initially screened on the basis of route of administration (subcutaneous/intramuscular/intravenous). Additionally, we reviewed over 1,400 clinical trials and compiled a list of pipeline molecules that are being investigated for delivery via the aforementioned routes. The likelihood of delivery via needle free injectors and microneedles in the future was estimated using the weighted average of the aforementioned parameters.

Chapter 12 presents an insightful market forecast analysis, highlighting the future potential of needle free injectors and microneedles, till the year 2030. We have segregated the opportunity of needle-free injection systems on the basis of different types of actuation mechanisms (spring-based, gas powered and others), routes of administration (subcutaneous, intramuscular and intradermal), target disease indication (infectious diseases, diabetes, pain disorders and others), product usability (disposable and re-usable) and key geographical regions (North America, Europe, Asia and Rest of the World). Similarly, the projected future opportunity for microneedle devices has been analyzed across various types of microneedle devices (hollow, solid and dissolving), target disease indication (infectious diseases, osteoarthritis, pain disorders, cancer, and others), type of intervention (vaccines, therapeutic agent and others), and key geographical regions (North America, Europe, Asia and Rest of the World).

Chapter 13 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of interviews held with Michael Schrader (CEO and Founder, Vaxess Technologies), Patrick Anquetil (CEO, Portal Instruments) and Henry King (Market Intelligence and Business Development Manager, Innoture).

Chapter 14 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the drug delivery devices industry.

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 16 is an appendix, which contains a list of companies and organizations mentioned in this report.