Summary
INTRODUCTION
Chronic diseases, such as diabetes, cardiovascular disorders, neurological disorders, autoimmune disorders and various types of cancer, are known to be the leading causes of death and disability across the world. The clinical conditions associated with these diseases affect patients’ overall quality of life. In fact, according to the World Health Organization (WHO), over 50% of the global population is currently estimated to be suffering from at least one chronic disease. The past few years have witnessed introduction of several innovative pharmaceutical interventions for the treatment of a number of such diseases. However, majority of the available treatment options require parenteral administration of the drug, frequent dosing, and involve repeated hospital visits. Treatment administration via the parenteral route is also associated with various concerns, such as dosing errors, risk of microbial contamination and needlestick injuries. These are known to be the primary factors affecting medication adherence and, thereby, have a significant impact on therapeutic outcomes. Over the past few years, a number of companies have developed advanced therapeutic delivery solutions (such as autoinjectors, pen injectors, prefilled syringes) to overcome the challenges associated with the administration of both conventional and novel drug / therapy molecules. In fact, these drug delivery devices can prove to be potential vehicles for drug administration in disease outbreaks / pandemics (such as the one being faced due to the novel corona virus / COVID-19). Amongst modern drug delivery practices, the concept of self-injection has facilitated the administration of medications outside the clinical setting. Such practices also allow reductions in healthcare costs and enable the optimal usage of healthcare resources.
Specifically, large volume wearable injectors used for subcutaneous drug delivery, 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 biologics) in large volumes (more than 1 mL), offering numerous dosing options (basal, bolus or continuous), integrated safety mechanisms, and an almost negligible risk of needlestick injuries. Such devices have captured the interest of several stakeholders in this industry and are being used for the administration of both insulin and non-insulin drugs. The field is presently witnessing a lot of innovation, such as the development of integrated mobile applications with smart health monitoring, artificial intelligence algorithms and other interesting features (including 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. We believe that such efforts are likely to drive growth in this market over the coming years.
SCOPE OF THE REPORT
The “Large Volume Wearable Injectors Market (5th Edition), 2020-2030: Focus on Bolus , Basal and Continuous Delivery Devices” report features an extensive study of the current market landscape and the likely future evolution of these self-injection devices, over the next ten 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:
- An overview of current market landscape of the large volume wearable injectors available for delivery of insulin and non-insulin drugs, providing information on status of development and device specifications, such as type of device (patch pump / injector and infusion pump / injector), type of dose administered (basal, bolus and others), route of administration (subcutaneous and others), mode of injection (needle, needle / cannula and needle / catheter), storage capacity of the device, actuation mechanism (electromechanical, rotary pump, cell / expanded battery, pressurized gas, osmotic pressure and others), usability (disposable and reusable), availability of prefilled drug reservoir and availability of device connectivity. The report also features additional information on availability of prefilled insulin cartridges, availability of continuous glucose monitoring / blood glucose monitoring (CGM / BGM) systems, availability of Automated Insulin Delivery feature and type of remote control features (control within device / personal diabetes manager (PDM) / smartphone) in the insulin delivery devices.
- A detailed competitiveness analysis of large volume wearable injectors based on various relevant parameters, such as supplier power (based on the experience / expertise of the developer) and product specifications (type of device, type of dose, storage capacity of the device, usability, route of administration, connectivity and availability of a continuous glucose monitoring / blood glucose monitoring (CGM / BGM) systems (in case of insulin devices).
- Elaborate profiles of the prominent companies that develop large volume wearable injectors. Each company profile features a brief overview of the company, its financial information (if available), information on its product portfolio, recent developments and an informed future outlook. Additionally, the report includes tabulated profiles of wearable drug device combination products.
- An analysis of the partnerships that have been inked by the stakeholders in this domain, during the period between 2015 and 2020, covering acquisitions, product development agreements, product integration agreements, technology integration agreements, distribution and supply agreements, commercialization agreements, clinical trial agreements, licensing agreements, manufacturing agreements, service agreements, and other relevant types of deals.
- A detailed analysis on acquisition targets, taking into consideration the historical trend of the activity of the companies that have acquired other firms since 2000, and offering a means for other industry stakeholders to identify potential acquisition targets.
- An in-depth analysis of the various patents that have been submitted / filed related to large volume wearable injectors over the last three decades. It also highlights the key parameters associated with the patents, including information on patent type, issuing authority / patent offices involved, Cooperative Patent Classification (CPC) symbols, emerging areas (in terms of number of patents filed / granted), company type and leading industry, non-industry and individual patent assignees (in terms of size of intellectual property portfolio).
- 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, identified on the basis of 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).
- 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 in the last few years.
- A detailed analysis of completed, ongoing and planned clinical trials of various large volume wearable injector products based on the various relevant parameters, such as trial registration year, current trial phase, trial status, study design, study focus, targeted therapeutic area 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 information on the services provided by contract service providers for manufacturing of various device components (primary containers), infusion sets, adhesives, closures and injection moldings.
- An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval across North America (the US, Canada and Mexico), Europe (the UK, France, Germany, Italy, Spain and rest of Europe), Asia-Pacific and rest of the world (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.
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 2020-2030. The report also features sales forecasts for the overall large volume wearable injectors market with a detailed market segmentation on the [A] type of device (patch pump, injector and infusion pump and injector), [B] usability (reusable and disposable), [C] therapeutic area (neurological disorders, cardiovascular disorders, infectious disease, oncological disorders and others) and [D] key geographies (North America, Europe, Asia Pacific 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 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:
- Mark Banister (CEO, Medipacs / RxActuator)
- Michael Hooven (CEO, Enable Injections)
- Jesper Roested (CEO, Subcuject)
- Pieter Muntendam (former President and CEO, scPharmaceuticals)
- Menachem Zucker (VP and Chief Scientist, Elcam Medical)
- Graham Reynolds (VP and GM, Biologics, West Pharmaceutical Services)
- Mindy Katz (Director of Product, Sorrel Medical)
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.
KEY QUESTIONS ANSWERED
- Who are the leading large volume wearable device developers?
- What are the prevalent trends within competitive landscape of large volume wearable injectors for delivery of non-insulin drugs?
- What are the prevalent trends within competitive landscape of large volume wearable injectors for delivery of insulin?
- What are the types of drug candidates that are suited for delivery via large volume wearable injectors?
- Who are the key contract service providers involved in this domain?
- What are medical device regulations across different regions?
- How is the current and future market opportunity likely to be distributed across key market segments?
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. Additionally, 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 information on the large volume wearable injectors that are capable of delivering drugs and drug device combinations designed for delivery of specific drugs. In addition, the chapter includes a detailed analysis of these injector devices based on the status of development, type of device (patch pump / injector and infusion pump / injector), type of dose administered (basal, bolus and others), route of administration (subcutaneous and others), mode of injection (needle, needle / cannula and needle / catheter), storage capacity of the device, actuation mechanism (electromechanical, rotary pump, cell / expanded battery, pressurized gas, osmotic pressure and others), usability (disposable and reusable), availability of prefilled drug reservoir and availability of device connectivity. In addition, the chapter provides a list of the large volume wearable injectors for delivery of insulin, along with the information on the aforementioned parameters and availability of prefilled insulin cartridges, availability of CGM / BGM systems, availability of Automated Insulin Delivery Feature and type of remote control features (control within device / PDM / smartphone).
Chapter 5 presents a detailed competitiveness analysis of 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 the key players that develop large volume wearable injectors. Each profile presents a brief overview of the company, financial information (if available), product portfolio, recent developments and an informed future outlook.
Chapter 7 provides tabulated profiles of drug device combination products. Each profile includes drug specifications, mechanism of action, current status of development, dosage and sales information.
Chapter 8 features an in-depth analysis and discussion on the various partnerships inked between the players in this market in the time period between 2015 and 2020, covering acquisitions, product development agreements, product integration agreements, technology integration agreements, distribution and supply agreements, commercialization agreements, clinical trial agreements, licensing agreements, manufacturing agreements, service agreements, and other relevant types of deals.
Chapter 9 provides a detailed acquisition target analysis, taking into consideration the historical trend of the activity of the companies that have acquired other firms since 2015, and offering a means for other industry stakeholders to identify potential acquisition targets.
Chapter 10 provides an in-depth patent analysis, presenting an overview of 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 over the last three decades. The analysis highlights the key information and trends associated with these patents, including patent type (granted patents, patent applications and others), patent publication year, issuing authority / patent offices involved, CPC symbols, emerging focus areas, type of players (industry and non-industry players) and the leading industry players, non-industry players and individual patent assignees. The chapter also includes a patent benchmarking analysis and patent valuation analysis.
Chapter 11 presents a list of marketed and pipeline molecules that are likely to be considered for delivery via large volume wearable injectors in the future, identified on the basis of an analysis of the potential candidates, taking into consideration the various parameters, such as stage of development, dosage, dose concentration, route of administration, type of dose and drug sales (in case of 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 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 12 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 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 13 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 based on the various parameters, such as trial registration year, current trial phase, current trial status, study design, study focus, targeted therapeutic area and clinical endpoints.
Chapter 14 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 information on the services provided by such organizations for manufacturing of device components (primary containers), infusion sets, adhesives, closures and injection moldings. In addition, it includes a schematic world map representation highlighting the location of the CMOs and their device manufacturing service portfolio.
Chapter 15 features a discussion on the various guidelines established by major regulatory bodies for medical device approvals across North America (the US, Canada and Mexico), Europe (the UK, France, Germany, Italy, Spain and rest of Europe), Asia-Pacific and rest of the world (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.
Chapter 16 presents an insightful market forecast analysis, highlighting the future potential of large volume wearable injectors (for delivery of non-insulin drugs) till the year 2030. We have segregated the opportunity on the basis of the type of device (patch pump, injector and infusion pump and injector), usability (reusable and disposable), key therapeutic areas (neurological disorders, cardiovascular disorders, infectious disease, oncological disorders and others) and key geographies (North America, Europe, Asia Pacific and rest of the world). In addition, the chapter presents an opportunity analysis of the market for large volume wearable injectors for delivery of insulin, till the year 2030.
Chapter 17 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 detailed SWOT framework.
Chapter 18 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 Mark Banister (CEO, Medipacs), Michael Hooven (CEO, Enable Injections), Jesper Roested (CEO, Subcuject), Pieter Muntendam (former President and CEO, scPharmaceuticals), Menachem Zucker (VP and Chief Scientist, Elcam Medical), Graham Reynolds (VP and GM, Biologics, West Pharmaceutical Services) and Mindy Katz (Director of Product, Sorrel Medical)
Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures included in the report.
Chapter 20 is an appendix, which contains a list of companies and organizations mentioned in this report.
