NEW YORK, June 15, 2016 /PRNewswire/ -- INTRODUCTION
With the rising trend towards self-injection devices and rapidly growing pipeline of the biologics / biosimilars, autoinjectors have recently emerged as an important class of medical devices. Compared to conventional delivery systems, these devices automate the process of delivering drugs through subcutaneous or intramuscular routes. Autoinjectors are primarily spring-driven systems and use fillable / prefilled syringes or cartridges as primary containers. Due to their numerous benefits including easy self-administration, improved patient compliance, reduced anxiety and dosage errors, these devices have gained a lot of popularity from both pharmaceutical companies and end-users. The growing concern about the hazards associated with the needlestick injuries and other safety concerns has given an additional push to the market.
The origin of autoinjectors dates back to 1960s when a self-administered device was developed with a primary motive for use in military purposes to inject the antidote for nerve agents in biological weapons. Subsequently, EpiPen® by Pfizer / Mylan became the first disposable autoinjector to hit the US commercial market and received marketing approval in 1980s for the treatment of anaphylaxis. Following this, several autoinjectors were approved for various therapeutic indications. Anaphylaxis, so far, has continued to dominate the overall market. Autoinjectors for other chronic / emergency indications such as multiple sclerosis, rheumatoid arthritis, migraine, psoriasis and diabetes have also witnessed rising adoption.
It is well-known that pharmaceutical companies have frequently collaborated with device manufacturing companies to develop innovative drug delivery systems for their respective marketed / pipeline drugs. Several drugs have been approved in combination with autoinjectors in the past few years. Examples of such drugs include SIMPONI®, AVONEX®, PLEGRIDY®, EVZIO®, Repatha™, ORENCIA®, Trulicity®, ACTEMRA®, Otrexup™, Cosentyx® and COPAXONE®. In addition, these devices act as a life cycle management tool for drugs for which the patent has already expired or is close to expiry.
The increased interest has driven medical device manufacturers to introduce next generation of autoinjectors with advanced features and innovative designs making drug administration relatively more safe and convenient. Reformulation of first generation biologics, growing prevalence of chronic diseases, urgent treatment required in emergency conditions, needle safety regulations and technological advancements in this area are some of the factors that will drive this market in the near future.
SCOPE OF THE REPORT
The 'Global Autoinjectors Market, 2016-2026' report provides a comprehensive analysis of the current state of autoinjectors market and the likely future evolution of these devices over the next decade. Starting with an overview of self-administration devices, the report elaborates on the origin / history of autoinjectors, their components and advantages offered by different categories of autoinjectors. It also covers information on needlestick injuries and looks at the safety laws and legislations across major regional markets for prefilled syringes that are incorporated as primary drug containers in autoinjectors.
One of the key objectives of the study is to enumerate various autoinjectors available in the market, combination products currently available / being developed and the corresponding market potential across different therapeutic areas. Amongst other elements, the report elaborates on the following key areas:
- The current state of the market with respect to key players, routes of administration, primary drug containers, usability, indications and drugs being targeted.
- 2 X 2 matrices depicting the product competitiveness and supplier power across the growing landscape of disposable and reusable autoinjectors.
- Detailed case studies on the drugs that have been potential targets for autoinjectors.
- List of likely candidates for delivery via autoinjectors based upon their route of administration, targeted indication and dosage regime.
- Detailed company profiles of the key autoinjector manufacturers as well as emerging players that are trying to build a foothold in this industry.
- The future growth opportunities likely to drive the market in the short term and long term.
The study also focuses on analyzing the existing market size and potential future growth of these drug delivery devices across different therapeutic classes, routes of administration and extent of usability. The report provides sales forecast for the overall autoinjectors market for the period 2016 - 2026. It takes into account the price variation that is likely to occur as a result of mass adoption and increased competition. We have provided three market forecast scenarios to add robustness to our model. Accordingly, the conservative, base and optimistic scenarios represent three different tracks of industry's evolution. For the purposes of the study, we interviewed important stakeholders to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. 2015 is the base year; actual figures have been sourced and analyzed from publicly available information. Unless otherwise specified, all figures are presented in USD.
Most of 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 over the coming ten years, 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. The summary offers a high level view on the likely evolution of autoinjectors market.
Chapter 3 provides a general overview of the various self-injection devices and autoinjectors. It covers the historical evolution of autoinjectors, their components, categories and associated manufacturing/packaging processes. In addition, it elaborates on the benefits of autoinjectors that have led to a growing adoption over the last several years. The chapter also highlights the issue of needlestick injuries and various preventive laws worldwide that have put the focus on introducing safety features in these devices.
Chapter 4 includes an introduction on the types of primary drug containers that are utilized in autoinjectors. Broadly, it covers an overview on the current trends coming up in the market of prefilled syringes and cartridges. It also lists the key manufacturers of these primary drug containers.
Chapter 5 provides a comprehensive analysis of the current market of autoinjectors. It lists over 80 autoinjector devices (including variants) that can be used to carry out self-administration for a variety of application areas. For these devices, we have identified the type and volume of the primary drug container used, usability, route of administration, needle size and other technical parameters. The chapter also includes list of combination products that have been approved or are under development with respect to indications being targeted. For both disposable and reusable autoinjectors, we have presented 2 X 2 matrices to compare the relevant product competitiveness and supplier power.
Chapter 6 presents a list of therapeutic drugs that are currently available in autoinjectors. It also provides case studies on the most common drugs / indications targeted. In addition, we have put together a list of potential molecules, based upon the route of administration, indication targeted and dosage regime, which are likely to form the target drugs for delivery via autoinjectors in the future.
Chapter 7 provides detailed profiles of key autoinjector manufacturers highlighting information on the company overview, financial performance, technology overview, product portfolio, collaborations and recent developments. Key players covered in this section include (in alphabetical order) Bespak, DALI Medical Devices, Elcam Medical, Meridian Medical Technologies, Owen Mumford, SHL Group, Union Medico and Ypsomed Delivery Systems.
Chapter 8 discusses profiles of new entrants in the autoinjectors industry. These profiles cover information on their company overview, technology overview, product portfolio and recent developments. Emerging players covered in this section include (in alphabetical order) Amedra Pharmaceuticals, Kaleo Pharma, Nuance Design, Oval Medical Technologies, Xeris Pharmaceuticals and Zion Clinical Pharmacy.
Chapter 9 provides a detailed description of the likely evolution of autoinjectors market. We have adopted a 'top down' approach, backed by robust data and credible inputs from primary research, to identify the likely size of the market, both in terms of value (USD billion) and volume (number of devices).
Chapter 10 highlights the key future growth opportunities likely to increase market share of manufacturers active in this area. These include life cycle management, growing pipeline of biologics and biosimilars, emerging target indications, launch of autoinjectors in other regions and introduction of specific advanced and user friendly features in these devices.
Chapter 11 is a collection of interview transcripts. For the purpose of our study, we contacted number of stakeholders in order to ascertain the key strategic initiatives and future roadmap of the industry. These include Douglas Marenzi (Managing Director, PHC) and Tsachi Shaked (Senior Marketing and BD Director, Injectable Drug Delivery Devices, Elcam Medical). Other participants requested anonymity.
Chapter 12 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.
Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 14 is an appendix, which provides a list of companies and organizations mentioned in this report.
1. During our research, we identified over 80 autoinjectors being developed or commercially available by more than 20 companies. Over 50 drugs as combination products have been commercialized so far; several companies such as Amgen, GSK, Sanofi and Palatin Technologies are testing their late stage pipeline drugs with autoinjectors.
2. Most of the autoinjectors being developed are disposable devices, contributing a share of 62%; reusable / rechargeable / electronic autoinjectors have also emerged providing options for multiple dosing of the drugs.
3. Some of the established pharmaceutical stakeholders working in this domain include BD, Bespak, Changzhou Delfu, Elcam Medical, DALI Medical Devices, Meridian Medical Technologies, Owen Mumford, SHL Group, Union Medico, West Pharmaceutical Services and Ypsomed. Several new / small companies have entered with their innovative technologies and devices. Examples of such innovators include Amedra Pharmaceuticals, ChemProtect SK, Future Injection Technologies, Haselmeier AG, Kaleo Pharma, Nuance, Nemera, Oval Medical Technologies, Unilife and Xeris Pharmaceuticals.
4. Developers are focusing on introducing a variety of advanced features to make these devices more user-friendly. Specific examples include push-on-skin release, one-handed operation, twist & mix mechanism, automatic reconstitution / priming, anti-roll, compact and sleek designs. Smart electronic autoinjectors are being developed featuring bluetooth connectivity, LCD screen and special software to connect the device or part of the device with computer systems to maintain injection records. Some of the devices, such as Safelia™ autoinjector (Nemera) and Syrina™ AR (Bespak), are also capable of delivering drugs with high volume and high viscosity.
5. A variety of novel technologies have emerged for the development of autoinjectors. Examples of such technologies include Breeze™ technology (Nuance Designs), Depot Control technology (Union Medico), VapourSoft™ technology (Bespak), Rotaject™ Pressure Release technology, NIT™ technology, Negasai™ spring technology and Pushclick™ technology (SHL Group).
6. Although autoinjectors have been in the market for over two decades, the market is still evolving. There is widespread optimism that such devices hold significant opportunity for the pharmaceutical companies; the rapidly evolving pipeline of biologics and biosimilars will act as a major driver.
7. We anticipate the global autoinjectors market to grow at an annualized growth rate of over 8% in the next ten years. 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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