Large Volume Wearable Injectors Market (4th Edition), 2018-2030

NEW YORK, Jan. 24, 2019 /PRNewswire/ --

INTRODUCTION
Chronic clinical conditions, such as diabetes, cardiovascular disorders, neurological disorders, autoimmune disorders and various types of cancer, are considered to be among the leading causes of death and disability across the world. Recently, the Center for Managing Chronic Disease at the University of Michigan reported that over 50% of the global population is currently suffering from some form of chronic disease. The past few years have witnessed ground breaking advances in the process of drug development and introduction of several innovative pharmaceutical interventions for the treatment of a number of chronic diseases. However, majority of the available treatment options require parenteral administration, frequent dosing, involve repeated hospital visits and are associated with multiple other concerns, such as dosing and medication errors, risk of microbial contamination and needlestick injuries. These challenges represent a substantial threat to medication adherence and, thereby, are likely to significantly impact therapeutic outcomes. Over the past few years, a number of companies have developed advanced therapeutic delivery solutions to alleviate the pressing concerns associated with the administration of both conventional and novel drug / therapy molecules. Amongst modern drug delivery practices, the concept of self-injection has facilitated advanced medications to be administered beyond the clinical setting. This has also served to reduce healthcare costs, improve therapy adherence and optimize the utilization of healthcare resources per treatment.

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The self-injection devices market is currently characterized by the presence of a myriad of advanced and innovative drug delivery solutions, equipped with a variety of user-friendly features. Notable examples of such products include prefilled syringes, reusable and disposable pen injectors, autoinjectors and large volume wearable injectors. Large volume wearable injectors are capable of drug delivery primarily via the subcutaneous route and have become a preferred choice for administration of drugs in the home-care setting. Variants of these wearable devices have been designed to administer highly viscous drugs (such as most biologics) in large volumes (more than 1 ml), offering numerous benefits, such as ease-of-use, reduced chances of dosing-related errors, integrated safety mechanisms, and an almost negligible risk of needlestick injuries. It is worth highlighting that such devices have captured the interest of several stakeholders in this industry to deliver various insulin and non-insulin drugs. Moreover, the field is witnessing emergence of other technological advancements, such as integrated mobile applications with smart health monitoring and other interesting features (such as provisions for reminders, and the ability to connect to web-based portals for sharing medical data with the concerned healthcare providers), visual / audible drug delivery confirmation notifications, automatic drug reconstitution, and error alerts.

SCOPE OF THE REPORT
The "Large Volume Wearable Injectors Market (4th Edition), 2018-2030" report features an extensive study of the current market landscape and the likely future evolution of self-injection devices, over the next twelve years. It specifically lays emphasis on the emergence of patient-centric, convenient, cost-effective and user-friendly wearable drug delivery solutions that are capable of administering large volumes of a drug subcutaneously, in the home-care setting. Amongst other elements, the report includes:
• A detailed review of the overall landscape of the large volume wearable injectors market, highlighting the contributions of industry players related to the delivery of both insulin and non-insulin drugs, along with key device specifications. It features information on current development status of various products (under development and commercialized), type of device (patch pump / injector and infusion pump / injector), type of dose administered (continuous and bolus), route of administration (subcutaneous and others), usability (disposable and reusable), mechanism of action (driving force), mode of injection (needle, needle / cannula and needle / catheter), maximum volume of the device and availability of connected mobile application.
• A comprehensive product competitiveness analysis of all large volume wearable injectors that we came across, taking into consideration the supplier power (based on the year of establishment) and product specifications, such as type of device, type of dose, maximum volume of the device, usability, allowed route of administration, connectivity with the mobile application and availability of an integrated continuous glucose monitoring / blood glucose monitoring (CGM / BGM) system in case of insulin devices.
• Elaborate profiles of prominent product developers engaged in this domain, featuring a brief overview of the company, its financial information (if available), information on its product portfolio, recent developments and a comprehensive future outlook. Additionally, the report includes tabulated profiles of wearable drug device combination products.
• An in-depth analysis of the various patents that have been submitted / filed related to large volume wearable injectors, since 1984. It also highlights the key parameters associated with the patents, including information on patent type, patent offices, CPC classification, emerging areas (in terms of number of patents filed / granted) and leading industry players (in terms of size of intellectual property portfolio).
• A social media analysis depicting prevalent and emerging trends, and the popularity of large volume wearable injectors, as observed on the social media platform, Twitter. The analysis was based on tweets posted on the platform from 2013 to 2018 (till September).
• A comprehensive clinical trial analysis of completed, ongoing and planned studies of various large volume wearable injector products. For the purpose of this analysis, we considered the clinical studies that started in 2010, and analyzed them on the basis of various parameters, such as trial start year, current trail status, current trial phase, study design, targeted therapeutic area, study focus and clinical outcomes.
• A case study on the role of contract manufacturing organizations in the overall manufacturing process / supply chain of wearable injectors. It includes short descriptions of the manufacturing services provided by contract service providers in the making of various device components (primary containers), infusion sets, adhesives, closures and injection moldings.
• A list of marketed drugs / therapies and pipeline candidates that are likely to be developed in combination with large volume wearable injectors in the near future, based on an in-depth analysis of potential candidates, taking into consideration multiple parameters, such as stage of development, dosage, dose concentration, route of administration, type of dose and drug sales (in case of marketed drugs).

One of the key objectives of the report was to estimate the existing market size and potential future growth opportunities for large volume wearable injectors. Based on parameters, such as the number of commercialized devices, number of devices under development, price of the device and the annual adoption rate, we have provided an informed estimate on the likely evolution of the market over the period 2018-2030. The report also features sales forecasts for the overall large volume wearable injectors market with a detailed market segmentation on the therapeutic area, geographical distribution of the market (North America / Europe / Asia Pacific / RoW), type of device (patch pump / injector and infusion pump / injector) and usability (reusable / disposable). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios namely the conservative, base and optimistic scenarios, which represent different tracks of the industry's evolution.

The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (alphabetical order of companies):
• Menachem Zucker (VP and Chief Scientist, Elcam Medical)
• Michael Hooven (CEO, Enable Injections)
• Mark Banister (CEO, Medipacs)
• Pieter Muntendam (President and CEO, scPharmaceuticals)
• Mindy Katz (Director of Product, Sorrel Medical)
• Jesper Roested (CEO, Subcuject)
• Graham Reynolds (VP and GM, Biologics, West Pharmaceutical Services)
• Tiffany H. Burke (Director, Global Communications, West Pharmaceutical Services)

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.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts' views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the current state of the large volume wearable injectors market in the short-mid term and long term.

Chapter 3 provides a general introduction to large volume wearable injectors, highlighting the growing demand for medical devices that enable self-administration. The chapter lays emphasis on the need for such devices, in terms of the rising incidence and prevalence of chronic diseases. Subsequently, it provides an overview of the different types of self-injection devices available in the market, listing their various advantages. It also features a brief discussion on the concerns related to the use of such devices.

Chapter 4 presents separate lists, highlighting large volume wearable injectors capable of delivering any suitable drug and drug device combinations designed for delivery of specific drugs, respectively. In addition, the chapter includes a detailed analysis of these lists based on the products' status of development, type of device, type of dose, route of administration, usability, mechanism of action, mode of injection, maximum volume of the device and availability of connected mobile application. In addition, the chapter lists the large volume wearable injectors for delivery of insulin, highlighting the aforementioned parameters for each of them and information on provision of CGM \ BGM systems.

Chapter 5 presents a product competitiveness analysis of all large volume wearable injectors based on the supplier power and key 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 6 provides detailed profiles of key large volume wearable injectors manufacturers. Each profile presents a brief overview of the company, financial information (if available), product portfolio, recent developments and a comprehensive future outlook.

Chapter 7 provides tabulated profiles of drug device combination products and each profile include drug specifications, mechanism of action, development history, current status of development, and dosage and sales information.

Chapter 8 provides an in-depth patent analysis, presenting an overview on the filed / granted patents related to wearable injectors for the delivery of drugs in large volumes. For this analysis, we looked at the patents that have been published by various players since 1984. The analysis highlights the key information and trends associated with these patents, including patent type (granted patents, patent applications and others), patent publication year, patent offices (USPTO, WIPO, APO, EPO and others), CPC classification, emerging areas and the leading industry players. The chapter also includes a patent benchmarking analysis and patent valuation analysis.

Chapter 9 provides insights on the popularity of large volume wearable injectors on the social media platform, Twitter. The chapter highlights the yearly distribution of tweets posted on the platform in the period between January 2013 and September 2018, and the most significant events responsible for increase in the volume of tweets each year. Additionally, the chapter showcases the most frequently mentioned keywords / phrases and social media activity of the most popular players with the comparison of the tweets associated with their product. It also presents a bubble analysis of the most influential authors related to large volume wearable injectors on Twitter.

Chapter 10 presents a comprehensive clinical trial analysis of the complete and active studies being conducted to evaluate the combinations of drugs and large volume wearable injectors. For the purpose of this analysis, we looked at the clinical studies for these devices which started in 2010, and analyzed them on the basis of various parameters, such as trial start year, current trail status, current trial phase, study design, targeted therapeutic area, study focus and clinical outcomes.

Chapter 11 includes a brief case study on the role of contract manufacturing organizations in the overall manufacturing process / supply chain of a wearable injector. It includes a short description of the manufacturing services provided by these organizations in the making of device components (primary containers), infusion sets, adhesives, closures and injection moldings. In addition, it presents a world map highlighting the location of the CMOs and their device manufacturing service portfolio.

Chapter 12 presents a list of marketed and pipeline molecules that are likely to be considered for delivery via large volume wearable injectors in the future. It is worth highlighting that this list was compiled based on various parameters, such as route of administration, target therapeutic indication and the current dosage regimen of the aforementioned product candidates. 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 a large volume wearable injector in the future was estimated using the weighted average method.

Chapter 13 presents a comprehensive market forecast analysis, highlighting the future potential of large volume wearable injectors, till the year 2030. We have segregated the opportunity on the basis of the therapeutic area, geographical distribution of the market (North America / Europe / Asia Pacific / RoW), type of device (patch pump / injector and infusion pump / injector) and usability (reusable / disposable). In addition, the chapter features an opportunity analysis of the of the large volume wearable injectors for delivery of insulin.

Chapter 14 presents a detailed discussion on the future opportunities of wearable injectors for large volume drug delivery. It also highlights the key parameters and trends that are likely to influence the future of this market, under a comprehensive SWOT framework.

Chapter 15 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 (in alphabetical order of company name) Menachem Zucker (VP and Chief Scientist, Elcam Medical), Michael Hooven (CEO, Enable Injections), Mark Banister (CEO, Medipacs), Pieter Muntendam (President and CEO, scPharmaceuticals), Mindy Katz (Director of Product, Sorrel Medical), Jesper Roested (CEO, Subcuject), Graham Reynolds (VP and GM, Biologics, West Pharmaceutical Services) and Tiffany H. Burke (Director, Global Communications, West Pharmaceutical Services).

Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 17 is an appendix, which contains a list of companies and organizations mentioned in this report.

EXAMPLE HIGHLIGHTS
1. Over 50 large volume wearable injectors are either commercialized and / or are under development for delivery of a variety of drugs. Devices designed for administration of non-insulin drugs have a high storage capacity and are being developed for delivery of high viscosity formulations. In fact, around 17% of such devices have the capability to hold 10-15ml of drug while 23% of the devices have a maximum storage capacity of more than 15 ml. Such devices are designed either for bolus dosing (40%), or continuous dosing (40%); there are certain products that have been designed to administer both continuous and bolus doses of drugs (20%).
2. More than 10 drug device combinations are currently developed / being evaluated for delivery of non-insulin drugs; of these, two drug device combinations are already approved by the USFDA; these are Neulasta® (pegfilgrastim) OnPro™ Kit (Amgen / Insulet) and Pushtronex™ System (Amgen / West Pharmaceuticals). In addition, there are several other drug-device combinations that are being evaluated in clinical studies; examples include (in alphabetical order, no selection criteria) ND0701 (Neuroderm), scWear Infusor (SteadyMed Therapeutics) and Herceptin SC® Injector (Roche).
3. Specifically for insulin delivery, close to 30 devices are being developed / approved. Of these, over 60% of the devices are already marketed. Examples include (in alphabetical order, no selection criteria) ACCU-CHEK® Combo System (Roche), MiniMed™ 630G Insulin Pump System (Medtronic), PAQ®, 3-Day Basal and Bolus Delivery (CeQur)and t:slim X2™ Insulin Pump (Tandem Diabetes Care). It is worth noting that specifically for the delivery of insulin, the market for large volume wearable injectors is anticipated to reach over USD 1.5 billion by 2030, representing a CAGR of close to 5%.
4. The innovation in the field is primarily being driven by start-ups / small companies. Of all the companies developing large volume wearable injectors for non-insulin drugs, 50% are based in North America, primarily in the US. Examples of firms based in this region include (in alphabetical order, no selection criteria) Enable Injections, Medipacs, SteadyMed Therapeutics, scPharmaceuticals and West Pharmaceutical Services. Examples of start-ups based in different geographical regions that have undertaken initiatives in this domain include (in alphabetical order, no selection criteria) Debiotech, Subcuject, ViCentra, Weibel CDS and Eoflow. In addition, a number of established companies are also making substantial contributions in this field; prominent players include (in alphabetical order, no selection criteria) 3M, Becton Dickinson, Insulet, West Pharmaceutical Services and Ypsomed.
5. The development process of high-volume drug injector devices is complex due to the involvement of multiple components, which include both electrical and mechanical modules. Therefore, several device developers have opted to recruit the services of CMOs for manufacturing their proprietary drug delivery devices. Examples of companies that claim to provide manufacturing services to large volume drug delivery device developers include (in alphabetical order, no selection criteria) Baril Corporation, Daikyo Seiko, Flex International, Haselmeier, Phillips-Medisize, Vetter Pharma and Zollner.
6. Close to 2,000 patents pertaining to the abovementioned devices have been filed till 2018. An analysis of these patents revealed that automated self-injection devices, with advanced features, are gradually gaining traction amongst patients with chronic disorders. Some of the advanced features integrated with the delivery devices include automatic reconstitution / priming mechanisms, provisions for audio and visual indications, error alerts and remote monitoring capability through connected devices. Examples of large volume wearable injectors that have been designed to be connected to smart devices include (in alphabetical order, no selection criteria) BD Libertas™ Wearable Injector (Becton Dickinson), Omnipod (Insulet), SmartDose® Generation I (West Pharmaceutical Services) and Subcuject Wearable Bolus Injection (Subcuject).
7. An analysis of clinical studies that are being / have been conducted to evaluate the combinations of drugs and large volume wearable injectors reveal that close to 50% trials assessed the potential of using large volume wearable injectors for delivery of drugs intended for the treatment of neurological disorders. This is followed by the trials conducted to evaluate the effect of large volume wearable injectors in patients suffering from cardiovascular disorders (23%) and cancer (13%).
8. Out of various marketed / under development drug molecules, close to 80 drugs demonstrated a relatively higher potential to be delivered via large volume wearable injectors and are most likely to be evaluated in different drug-device combinations in the near future. Of these, 90% are biologics and 10% are small molecules. These drugs (full list available in the main report) are designed for treatment of chronic conditions, which require frequent dosing, and are not currently available in suitable self-administration systems.
9. The market for large volume wearable devices for delivery of non-insulin drugs is expected to grow at an annualized rate of close to 40% between 2018 and 2030. It is worth noting that disposable injectors are anticipated to capture over 50% of the market share due to the safety concerns reported by the use of reusable injectors. Further, over 60% share of revenues is anticipated to be distributed between North America and Europe. However, we believe that certain counties in Asia Pacific are likely to grow at a faster rate as compared to other regions over the coming decade; this can be attributed to the increasing incidence of chronic disorders in these regions and a relatively less stringent regulatory environment. Specifically, neurological and oncological disorders are anticipated to capture a significantly higher market share in the future.

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