Global Autoinjectors Market (2nd Edition), 2018-2030

LONDON, June 26, 2018 /PRNewswire/ -- INTRODUCTION
Over the years, the self-injection devices market has grown into a promising segment of the pharmaceutical industry. The domain is presently characterized by the presence of advanced technology platforms and innovative devices, offering a variety of user-friendly drug delivery solutions. One of the major driving forces behind the growth in this field is the rising incidence of chronic clinical conditions, such as rheumatoid arthritis, multiple sclerosis and diabetes.

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Although various pharmacological interventions are available for the treatment of these conditions, they require parenteral administration, frequent hospital visits, and are associated with multiple concerns, such as dosing and medication errors, risk of microbial contamination and needlestick injuries. However, therapies developed in combination with self-administration enabling devices have witnessed high adoption rates and have actually resulted in marked improvements in adherence to prescribed therapeutic regimens. In addition, such devices have been widely utilized in the treatment of emergency conditions such as anaphylaxis and other allergic disorders.

Since the introduction of the first autoinjector device in 1980s, their numerous benefits, such as ease-of-use, reduced chances of dosing errors, integrated safety mechanisms, and almost negligible risk of needlestick injuries, have been widely recognized among consumers and healthcare service providers. Autoinjectors are also considered to be potential life cycle management tool. Drugs nearing patent expiry can be developed for delivery using an autoinjector and retain market exclusivity as a combination product. Lyophilized Enbrel® is a well-known example; it was reformulated for delivery as a liquid formulation in the Sureclick™ autoinjector, extending its patent age by almost 11 years.

It is worth highlighting that such devices have captured the interest of several stakeholders in the industry. Various initiatives are underway to further improve safety, add better features (such as controlled-release capabilities) and make these devices more patient-friendly. In fact, between January 2013 and December 2017, close to 3,800 patents were filed in this domain, indicating the rapid pace at which research is being carried out. We believe that such efforts are likely to boost the overall growth of this market in the coming years.

SCOPE OF THE REPORT
The 'Global Autoinjectors Market (2nd Edition), 2018-2030' report provides a comprehensive analysis of the current state of the autoinjectors market and the likely future evolution of these devices over the next decade. The study presents an in-depth analysis of a diverse set of companies that are engaged in this domain across different regions of the globe. Amongst other elements, the report includes:
• A review of the overall landscape of the autoinjectors market, highlighting the contributions of industry players and the key device specifications, including the primary drug container used, its volume, usability of the device, route of administration, indication and targeted drugs.
• An in-depth patent analysis to provide an overview on how the industry has evolved from the R&D perspective. For this analysis, we looked at the patents that have been published since 2013. The analysis also highlights key information associated with these patents, such as patent type, regional distribution, CPC classification, IP litigations, emerging areas and leading industry players.
• A comprehensive product competitiveness analysis of disposable and reusable autoinjectors taking into consideration the supplier power (based on size of employee base) and product specifications, such as route of administration, primary drug container used, mechanism of operation, dosage type and user friendliness.
• Comprehensive 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 a comprehensive future outlook. Additionally, the report includes brief profiles of emerging players that have been established in the past decade.
• 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. In addition, we have listed all the drugs that are currently being delivered through autoinjectors.
• A list of marketed and pipeline candidates that are likely to be developed in combination with autoinjectors in the near future; the candidate drugs / therapies were selected based on various parameters, such as their current route of administration, target therapeutic indication and dosage. 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 900 clinical trials and compiled a list of pipeline molecules that are being investigated for delivery via the aforementioned routes. The likelihood of delivery via autoinjector device in the future was estimated by assigning a specific score (weight) to each parameter.
• A SWOT analysis capturing the key parameters and trends that are likely to influence the future of autoinjectors market.

One of the key objectives of the report was to estimate the existing market size and potential future growth opportunities for autoinjector devices. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market over the period 2018-2030. The report provides sales forecasts for the overall autoinjectors market with detailed market segmentation on the basis of indication (anaphylaxis / multiple sclerosis / rheumatoid arthritis / migraine / diabetes / other indications), route of administration (subcutaneous / intramuscular), usability (disposable / reusable) and the geographical distribution of the market (North America / Europe / Asia Pacific / rest of the World). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios namely the conservative, base and optimistic scenarios, which represent three 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 David Daily (CEO and Co-founder, DALI Medical Devices), Tsachi Shaked (Senior Marketing and BD Director, Injectable Drug Delivery Devices, Elcam Medical) and Douglas Marenzi (Managing Director, PHC). 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.

1.1. 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 the various devices that enable self-injection of parenteral drugs, specifically focusing on autoinjectors. It 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 safety features in such devices.

Chapter 4 is an introduction to the various types of primary drug containers that are utilized in autoinjectors. It features an overview of 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 key manufacturers that are involved in the production of such containers.

Chapter 5 provides information on more than 85 autoinjectors that have already been developed or are under development. It features a comprehensive analysis of these devices based on different parameters, such as primary drug container used, volume, device usability, route of administration and other technical parameters. The chapter also includes a list of combination products that have been approved or are under development for various indications. For both disposable and reusable autoinjectors, we have presented detailed 2 X 2 matrices to compare product competitiveness, based on the supplier power (based on size of employee base) and product specifications, such as route of administration, primary drug container used, mechanism of operation, dosage type and user friendliness.

Chapter 6 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 2013. The analysis highlights the key information associated with these patents, including patent type, regional distribution, CPC classification, IP litigations, emerging areas and the leading industry players.

Chapter 7 presents a list of therapeutic drugs that are currently available for delivery via autoinjectors. It also 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 8 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 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). Additionally, we reviewed over 900 clinical trials and compiled a list of pipeline molecules that are being investigated for delivery via the aforementioned routes. The likelihood of delivery via autoinjector device in the future was estimated by assigning a specific score (weight) to each parameter.

Chapter 9 provides detailed profiles of key autoinjector manufacturers. Each profile includes an overview of the company, its financial information (if available), overview of the autoinjector technology used, information on its product portfolio, specifications of autoinjectors devices, collaborations, recent developments and a comprehensive future outlook.

Chapter 10 provides brief profiles of certain emerging players in the autoinjectors industry. Each profile features an overview of the company, technology overview, information on product portfolio, details on the respective autoinjector devices and recent developments.

Chapter 11 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 12 presents a comprehensive market forecast analysis, highlighting the future potential of autoinjectors, till the year 2030. We have segregated the opportunity on the basis of indication (anaphylaxis / multiple sclerosis / rheumatoid arthritis / migraine / diabetes / other indications), route of administration (subcutaneous / intramuscular), usability (disposable / reusable) and the geographical distribution of the market (North America, Europe, Asia Pacific and rest of the World). Future sales and growth opportunity were estimated based on the likely adoption rates and the anticipated price of products. We have adopted a top down approach, backed by robust data and credible inputs from primary research, to estimates the likely size of the market, both in terms of value (USD billion) and volume (number of devices).

Chapter 13 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 14 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 (in alphabetical order of company name) David Daily (CEO and Co-founder, DALI Medical Devices, Tsachi Shaked (Senior Marketing and BD Director, Injectable Drug Delivery Devices, Elcam Medical) and Douglas Marenzi (Managing Director, PHC).

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

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

EXAMPLE HIGHLIGHTS
1. Over 85 autoinjector devices (33% reusable / 67% disposable), including variants of individual products, are presently being manufactured by close to 20 companies. 22% of these devices are designed to deliver a variable dose of drug.
2. 75 drug-autoinjector combination products are commercially available; amongst these, 30% received marketing approval between 2015 and 2017. Over 30 devices have been approved to cater to the rising demand for convenient delivery options for the treatment of chronic clinical conditions, such as multiple sclerosis and rheumatoid arthritis / psoriasis. These are followed by devices that are used to administer drugs for the treatment of anaphylaxis, organophosphate poisoning, migraine, growth hormone deficiency and diabetes. In addition, products are also approved for multiple other indications, such as cardiac arrhythmias, anxiety disorders, opioid overdose and systemic lupus erythematosus.
3. Notable examples of such combination products include (no selection criteria) Auvi-Q® (Kaléo Pharma), Avonex Pen® (Biogen Idec), BYDUREON BCise (AstraZeneca), EpiPen® (Mylan / Meridian Medical Technologies), Imitrex STATdose Pen® (GlaxoSmithKline) ORENCIA® ClickJect™ (Bristol-Myers Squibb), PRALUENT® (Sanofi), TRIPLEPEN HAD (ChemProtect SK), Trulicity® (Eli Lilly / Sumitomo Dainippon Pharma) and VIBEX® Sumatriptan (Antares Pharma / Teva Pharmaceutical).
4. A number of novel technology platforms are presently being utilized for the development of autoinjectors with advanced features, such as integrated sharps handling and controlled rate of injection. Examples of such technologies (no selection criteria) include Breeze™ technology (Nuance Designs), Depot Control technology (Union Medico), VapourSoft™ and ASI® technology (Bespak), and Rotaject™ Pressure Release technology, NIT™ technology and Pushclick™ technology (SHL Group).
5. As a result of the widening research interest, close to 3,800 patents have been filed recently. A detailed analysis of these patents indicates that automated self-injection devices, with advanced features, are gradually becoming mainstream. Some of these features include push-on-skin release, one-handed operation, twist and mix mechanism, automatic reconstitution / priming, anti-roll, compact and sleek design, LCD screens, and Bluetooth and other connectivity platforms. Examples of autoinjectors that have been designed to be connected to smart devices include (in alphabetical order) GROWJECTOR®2 (JCR Pharmaceuticals), Flexi-eMU (Elcam Medical), RebiSmart™ (EMD Serono) and YpsoMate® Smart (Ypsomed).
6. A comprehensive analysis of several marketed / pipeline products suggests that over 100 drugs (not currently available in autoinjectors) are suited for delivery via autoinjectors. Most of these drugs target chronic conditions, require frequent dosing and are available for delivery via subcutaneous / intramuscular routes. We believe that these clinical candidates, if evaluated with autoinjectors, are likely to contribute substantially to the market's evolution in the mid-long term.
7. As more drug-device combination products get approved for a diverse range of indications, we expect the market to steadily evolve over the next decade. North America (primarily the US) and Europe currently capture the largest share (close to 75%) of the market. Launch in emerging regions, such as India and China, availability of such devices for other chronic (in addition to multiple sclerosis and rheumatoid arthritis) and emergency indications (in addition to anaphylaxis), introduction of life cycle management projects for drugs nearing patent expiry are some of the opportunity areas wherein the companies are likely to focus on.

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