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Global Autoinjectors Market by Type of Autoinjector, Route of Administration, Type of Molecule, Therapeutic Indication and Geography : Industry Trends and Global Forecasts, 2021-2035

Global Autoinjectors Market by Type of Autoinjector, Route of Administration, Type of Molecule, Therapeutic Indication and Geography : Industry Trends and Global Forecasts, 2021-2035

  • October 2021
  • 610 pages
  • ID: 6189679
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
According to the National Health Interview Survey (NHIS), nearly 52% of the adult population in the US is diagnosed with at least one chronic condition, such as asthma, diabetes, and hypertension. The annual cost burden associated with chronic disorders in the US is around USD 3.7 trillion; this accounts for nearly 20% of the country’s GDP share. A major share of expenses incurred by patients living with a chronic disorder is driven by the frequent need to medicate, which may require repeated visits to hospitals / out-patient clinics. In addition, patient compliance and adherence to the treatment regimen prove to be a challenge. In order to mitigate this challenge, a wide variety of self-administering injectable drugs have been developed, which impart greater independence and psychological benefits to the patients, as compared to drug administration by healthcare professionals. Amongst the various self-injection devices, autoinjectors have steadily gained prominence, especially for the treatment of emergency and chronic conditions, such as anaphylactic shock and rheumatoid arthritis. The additional features of autoinjectors, such as integrated needle safety, Bluetooth connectivity, and monitoring injection dose history, enable them to resolve several injection-related compliance issues faced by the patients.

Given the inherent benefits of autoinjectors, a number of players have launched their proprietary products in combination with autoinjectors for use across a wide array of disease indications. One of the most widely recognized autoinjector in the market is EpiPen® (Mylan), which is a prefilled epinephrine autoinjector. The generic version of EpiPen received the FDA approval in 2018. Notable examples of other autoinjector-based combination products include Fasenra® Pen (AstraZeneca), Gvoke® Hypopen (Xeris Pharmaceuticals), NUCALA Autoinjector (GlaxoSmithKline), and Vyleesi™ Autoinjector (AMAG Pharmaceuticals® / Palatin Technologies). Apart from being a patient-friendly alternative to conventional drug delivery methods, autoinjectors also serve as potential life cycle management tools; several pharmaceutical players have reformulated their proprietary drugs as autoinjector combination products to expand market exclusivity period. For instance, Amgen reformulated lyophilized Enbrel® for delivery via the SureClick® autoinjector to extend the patent protection of the drug by almost 11 years. Further, it is worth mentioning that several autoinjector developers have made significant efforts in developing novel autoinjector technologies, paving the way for new generation of autoinjector devices. The field is presently witnessing several innovations, such as LED / LCD-based visualization, Bluetooth connectivity, dosage recording, safety lock, visual / audible drug delivery confirmation notifications, and automatic drug reconstitution. In this context, it is worth highlighting that nearly 5,000 patents have been filed / granted, since 2015, for autoinjectors and affiliated products / technologies. We believe that such efforts are likely to drive growth in this market over the coming years.

SCOPE OF THE REPORT
The “Global Autoinjectors Market (4th Edition) by Type of Autoinjector (Disposable and Reusable), Route of Administration (Subcutaneous and Intramuscular), Type of Molecule (Monoclonal Antibody, Peptide, Protein, and Small Molecule), Therapeutic Indication (Anaphylaxis, Multiple Sclerosis, Rheumatoid Arthritis, Migraine, Diabetes, and Others) and Geography (North America, Europe, Asia-Pacific, and Rest of the World): Industry Trends and Global Forecasts, 2021-2035” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of autoinjectors till 2035. The report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. In addition to other elements, the study includes:
An overview of the current market landscape of autoinjectors that are either marketed / being developed by various stakeholders, providing information on the usability (disposable and reusable), type of primary drug container (cartridge, syringe and vial), volume of container, type of dose (fixed and variable), route of administration (intradermal, intracavernosal, intramuscular and subcutaneous), actuation mechanism (automatic and manual) and feedback mechanism integrated in the device. It also provides details on the developers, highlighting their year of establishment, company size (small, mid-sized, large and very large), and location of headquarters.
A competitiveness analysis of various disposable and reusable autoinjectors, taking into consideration supplier power of their developers (based on year of establishment and company size) and key product specifications, such as route of administration, primary drug container used, injector actuation mechanism, type of dose and user friendliness of the product.
A detailed brand positioning analysis of leading industry players (shortlisted on the basis of strength of product portfolio), highlighting the current perceptions regarding their proprietary brands by taking into consideration several relevant aspects, such as strength and diversity of product portfolio, route of administration, actuation mechanism, geographical presence / reach and supplier power of each company.
An in-depth analysis of the patents that have been filed / granted for autoinjectors, highlighting trends across key parameters, such as type of patent, publication year, issuing authority, CPC classification, emerging focus areas and leading industry players (on the basis of number of patents). It also includes a detailed patent benchmarking and an insightful valuation analysis.
A review of autoinjectors being developed in combination with drugs, featuring details on initial year of approval (for marketed products), phase of development, usability of the device, route of administration (intracavernous, intramuscular and subcutaneous), type of drug molecule (antibody, peptide, protein and small molecule), dose strength, therapeutic area and other approved dosage forms (for marketed products). In addition, the chapter provides details on the developers, including year of establishment, company size and location of headquarters.
Detailed case studies on the most commonly targeted indications, covering history of development and detailed description of the approved autoinjector products, along with their respective mechanisms of action and historical sales records. The study also includes a list of the drugs that are currently being delivered via autoinjectors.
A list of marketed drugs / therapies and pipeline candidates that are likely to be developed in combination with autoinjectors in the near future, shortlisted on the basis of an in-depth analysis that takes into consideration various relevant parameters, such as route of administration, type of drug molecule, target indications, other available dosage forms (for approved drugs) and historical annual sales information (for approved drugs).
Elaborate profiles of autoinjector manufacturers that have more than three devices in their respective product portfolios; each profile features an overview of the company, its financial information (if available), information on its product portfolio, autoinjector device specifications, collaborations, recent developments and an informed future outlook. Additionally, the report includes brief profiles of emerging players that have been established in the past decade.
A list of key opinion leaders (KOLs) within this domain who were short-listed based on their contributions (such as involvement in clinical trials and research publications); it features a schematic world map representation, highlighting the geographical locations of eminent scientists / researchers engaged in this domain.
An analysis of the recent collaborations (since 2016) focused on the development of autoinjectors. It includes partnerships inked by various stakeholders in this domain, covering licensing agreements (specific to technology platforms and product candidates), product development and commercialization agreements, mergers and acquisitions, and other relevant agreements.
A SWOT analysis capturing the key parameters and trends that are likely to influence the future of autoinjectors market.
A case study on the role of CMOs offering services for drug delivery devices; it features a list of service providers, highlighting the various types of services offered for different types of drug-delivery devices.
An overview of the current market landscape of companies engaged in manufacturing prefilled syringes, providing information on year of establishment, company size, geographical location of the headquarters and manufacturing facilities, type of material used (glass and plastic), number of barrel chambers (single chamber and dual chamber), type of needle system (fixed needle system, luer lock and luer cone) and syringe volume.

One of the key objectives of the report was to estimate the existing market size and assess potential future growth opportunities for autoinjector devices. Based on parameters, such as number of commercialized combination products, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market over the period 2021-2035. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] usability (disposable and reusable), [B] route of administration (subcutaneous and intramuscular), [C] type of molecule (monoclonal antibody, peptide, protein and small molecule) [D] therapeutic indication (anaphylaxis, multiple sclerosis, rheumatoid arthritis, migraine, diabetes and other indications), and [E] key geographies (North America, Europe, Asia-Pacific and rest of the World).

The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. The opinions and insights presented in the report were influenced by discussions held with several players in this industry. The study includes detailed transcripts of discussions held with the following individuals:
David Daily (CEO and Co-founder, DALI Medical Devices)
Barbara Lead (Chief Executive Officer, Oval Medical Technologies)
William G. Fortina (Business Development Director-Drug Delivery Systems, Duoject Medical Systems)
Douglas Marenzi (Managing Director, PHC Injection Technologies)
Tsachi Shaked (Senior Marketing and BD Director, Injectable Drug Delivery Devices, Elcam Medical)
Jesse Fourt (Design Director, IDEO)
Dennis Lee (Senior Program Officer in CMC, Bill & Melinda Gates Foundation)

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 QUESTIONS ANSWERED
• Who are the leading autoinjector device developers?
• For which disease indications are autoinjector-based combination products available?
• Which partnership models are commonly adopted by stakeholders developing autoinjectors?
• Which drug candidates are likely to be considered for administration via autoinjectors?
• How has the intellectual property landscape of autoinjectors evolved over the years?
• Who are the Key Opinion Leaders across different regions of the world?
• Who are the leading contract manufacturing organizations providing services for autoinjector devices?
• What is the share of autoinjector devices, in terms of revenue generation potential, across different disease markets?
• How is the current and future opportunity likely to be distributed across key market segments?

RESEARCH METHODOLOGY
The data presented in this report has been primarily gathered via primary and secondary 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 2035, 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 likely evolution of the autoinjectors market in the short-mid term and long term.

Chapter 3 provides a general overview of various devices that enable self-administration of drugs, specifically focusing on autoinjectors. The chapter features a discussion on the historical evolution of autoinjectors, along with details related to their individual components, device categories and associated manufacturing / packaging processes. In addition, it elaborates on the benefits of autoinjectors that have led to their growing adoption over the last several years. The chapter also highlights the existing concerns related to needlestick injuries and the various preventive laws that have been passed worldwide, for addressing the pressing need for introducing advanced safety features in such devices.

Chapter 4 is an overview of the various types of primary drug containers that are utilized in autoinjectors. It features information on current trends related to the use of prefilled syringes and cartridges. In addition, it lists the diverse types of primary drug containers that are available in the market, along with details on companies that are involved in the production of such containers.

Chapter 5 provides information on close to 100 autoinjectors that have already been developed or are under development, and a detailed analysis of these devices based on various relevant parameters, such as primary drug container used (cartridge, prefilled syringe and vial), volume, device usability (disposable and reusable), route of administration (intramuscular, intradermal and subcutaneous) and other technical parameters. In addition, the chapter provides information on manufacturers, along with information on year of establishment, location of headquarters and strength of employee base.

Chapter 6 presents an insightful competitiveness analysis of disposable and reusable autoinjectors (separately) based on the supplier power of the developers and key product specifications, such as route of administration, primary drug container used, mechanism of operation, dosage type and user friendliness.

Chapter 7 provides an elaborate brand positioning analysis of the leading device developers / manufacturers, highlighting the current perceptions regarding their proprietary brands across different device types. The analysis takes into consideration several aspects, such as strength and diversity of product portfolio, routes of administration, actuation mechanism, geographical presence / reach and supplier power of each player.

Chapter 8 provides an in-depth patent analysis, presenting an overview of how the industry is evolving from the R&D perspective. For this analysis, we looked at the patents that have been published by various players since 2015. The analysis highlights the key information associated with these patents, including patent type, publication year, geographical location, CPC classification, emerging areas, leading industry players, patent benchmarking and valuation analysis.

Chapter 9 provides details on the various pipeline and approved products that are being tested or available in autoinjectors. It features a detailed analysis of these drugs, based on the various parameters, such as the target disease indication(s), phase of development, type of drug molecule, route of administration(s), approval year (in case of marketed products), dosage (in case of marketed products) and other approved dosage forms (in case of marketed products). In addition, the chapter provides information on drug developers, year of their establishment, location of headquarters and strength of employee base.

Chapter 10 provides detailed case studies on the most commonly targeted indications covering history of development and detailed description of the approved autoinjector products, along with mechanism of action and historical sales of the drugs.

Chapter 11 presents a list of marketed and pipeline molecules that are likely to be considered for delivery via autoinjectors in the future. It is worth highlighting that this list has been compiled based on various parameters, such as route of administration, target therapeutic indication(s), other available dosage forms (in case of marketed drugs), type of drug molecule and drug sales of the approved 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). Additionally, we reviewed over 1,500 clinical trials and compiled a list of pipeline molecules that are being investigated for delivery via the aforementioned routes. The likelihood of delivery via an autoinjector in the future was estimated using the weighted average method.

Chapter 12 includes detailed profiles of key autoinjector manufacturers. Each profile features an overview of the company, its financial information (if available), information on its product portfolio, autoinjector device specifications, collaborations, recent developments and an informed future outlook.

Chapter 13 includes brief profiles of some of the emerging players in the autoinjectors industry. Each profile features an overview of the company, technology, information on its product portfolio, autoinjector device specifications and recent developments.

Chapter 14 provides an analysis of KOLs in the field of drug-delivery devices, including autoinjectors. It features a comprehensive list of principal investigators / study directors of different clinical trials and patent assignees, along with the information related to the affiliated organizations. The chapter features a schematic representation on a world map, highlighting the geographical locations of eminent scientists / researchers who are engaged in this domain. It highlights the notable KOLs who have relatively more experience in this domain. The chapter also provides details on different parameters of the KOLs (wherever available), including number of publications, number of citations, number of clinical trials / patents, number of affiliations and extent of professional network.

Chapter 15 features an elaborate discussion and analysis of the various partnerships and collaborations that have been inked between various stakeholder in the industry, since 2016. Further, the partnership activity in this domain has been analyzed on the basis of year of agreement / partnership, the type of partnership model, licensing agreements (specific to technology platforms and product candidates), product development and commercialization agreements, mergers and acquisitions, and others, companies involved, and regional distribution of the collaborations.

Chapter 16 presents a detailed analysis capturing the key parameters and trends that are likely to influence the future of autoinjectors market, under a comprehensive SWOT framework.

Chapter 17 is a case study focused on the role of medical device CMOs in the manufacturing and assembly of drug-delivery devices, including autoinjectors. It provides a list of service providers with details on their scale of operation and types of services provided for production of devices.

Chapter 18 provides an overview of around 80 prefilled syringes that are available in the market and provides details on the companies that manufacture such products. It features analyses of the prefilled syringes, based on various parameters, such as type of material (glass and plastic), number of barrel chambers (dual chamber and single chamber), type of needle system (fixed needle system and luer system) and syringe volume. In addition, the chapter provides information on manufacturers, along with information on year of establishment, location of headquarters and manufacturing facilities, and strength of employee base. The chapter also includes a discussion on the technological advances of prefilled syringes that have taken place in the recent past.

Chapter 19 presents an insightful market forecast analysis, highlighting the future potential of the autoinjectors market till the year 2035. We have segregated the opportunity of the market on the basis of [A] usability (disposable and reusable), [B] route of administration (subcutaneous and intramuscular), [C] type of molecule (monoclonal antibody, peptide, protein and small molecule) [D] therapeutic indication (anaphylaxis, multiple sclerosis, rheumatoid arthritis, migraine, diabetes and other indications), and [E] key geographies (North America, Europe, Asia-Pacific and rest of the World). The likely size of the market has been estimated both in terms of value (USD billion) and volume (number of devices).

Chapter 20 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 our conversations with David Daily (CEO and Co-founder, DALI Medical Devices), Barbara Lead (Chief Executive Officer, Oval Medical Technologies), William G. Fortina (Business Development Director - Drug Delivery Systems, Duoject Medical Systems), Douglas Marenzi (Managing Director, PHC Injection Technologies), Tsachi Shaked (Senior Marketing and BD Director, Injectable Drug Delivery Devices, Elcam Medical), Jesse Fourt (Design Director, IDEO) and Dennis Lee (Senior Program Officer in CMC, Bill & Melinda Gates Foundation)

Chapter 21 summarizes the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 22 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 23 is an appendix, which provides a list of companies and organizations mentioned in this report.

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