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Large Volume Wearable Injectors (2nd Edition), 2014 - 2025

  • September 2014
  • 242 pages
  • Roots Analysis Private Ltd.
Report ID: 2404392

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INTRODUCTION

The injectable drug delivery market holds significant potential for the future. From the conventional syringes with vials and painful needles to the modern-day pre-filled syringes, pen-injectors, needle free injectors and auto-injectors, the market has come a long way. The rising prevalence of chronic diseases is one of the key factors driving the companies to develop systems that allow patients to self-administer drugs. Taking the concept of self-injectors to a new stratum, ‘Large volume Wearable Injectors’ have surfaced recently. Also known as bolus injectors and non-insulin patch pumps, these devices not only offer a range of benefits to the end users but also provide a number of additional benefits to other stakeholders in the industry.

One of the main drivers for the perceived growth of these injectors is the large number of biologics currently under development. A majority of these molecules are highly viscous and are required to be delivered in volumes of greater than 1 ml. The absence of devices which can safely administer these drugs is currently a big unmet need in the market. However, the early signs are encouraging. Despite the uncertainties related to the device development and approval, many companies are investing time, money and resources to develop novel devices. Some customized drug-device combinations are currently being developed for specific drugs such as Herceptin, AMG-145 and Furosemide. In addition, pharma companies have many undisclosed programs which are likely to provide the necessary growth impetus in the near future.

This development is being led jointly by established firms such as Becton Dickinson, West Pharmaceuticals and emerging players such as Unilife, SteadyMed Therapeutics, Ratio Drug Delivery, Sensile Medical, Enable Injections and scPharmaceuticals. It is widely anticipated that, once ready, such devices which will allow self-administration of high viscosity, large volume biologics and be readily adopted in the industry.

SCOPE OF THE REPORT

The ‘Large Volume Wearable Injectors’ market report provides a comprehensive analysis of the current state of the market and the likely future evolution over the next ten years. Starting with the basic introduction to these injectors, the report lays emphasis on the current unmet needs of the market. As all the large volume wearable injectors are currently only available for investigational use, the investment being done in this area is geared towards tapping the significant future potential of this market. In fact, one of the primary objectives of this report is to estimate the size of this future promise offered by such injectors.

A large number of biologics are currently under development and a majority of these molecules are highly viscous and require to be delivered in volumes of greater than 1 ml. It is widely anticipated that devices which will allow self-administration of these molecules will be readily adopted by all stakeholders in the industry. For the purposes of our analysis, we followed a top-down approach to estimate the size of this market. This included:
- Conducting an extensive research to identify high viscosity and large volume biologics which are either currently under development or are already marketed.
- Based on the standard dosage regime and the likely injection frequency, shortlisting the highly likely candidates for delivery via bolus injectors.
- For these molecules under development, estimating the likely timeline by when they will be ready for subcutaneous administration.
- Estimating the proportion of these molecules which will be available for subcutaneous delivery via large volume wearable injectors for around 14 disease classes.
- Estimating the sales potential (both in terms of value and volume) of these injectors for each drug-disease combination over the next ten years.

Where possible, we have added robustness to our forecasting model by conducting extensive primary research interviews with senior stakeholders in the industry. Owing to the uncertain nature of the market, we have provided three scenarios for our market forecast. The conservative, base and optimistic scenarios are considered for the forecasting of each of the analysed drug-disease combinations and represent three different tracks of industry evolution.

EXAMPLE HIGHLIGHTS

1. In total, 17 large volume wearable drug delivery devices (including variants) currently under development have been identified during our research.
2. Approximately 53% of these devices operate electronically. Other modes of operation include mechanical, hydrogel and hydraulic. Many of these injectors have additional features such as an audio / visual panel making their usage very easy for the end users.
3. The range of volume these devices can cater to is as high as 30 ml. The first commercial launch is anticipated to take place in 2015/2016. In our research, we have profiled five drugs which are currently undergoing trials for delivery via large volume injectors.
4. Pharma companies also have many undisclosed research programs. We have identified about 30 biologics which are likely to be immediate targets for preparation of subcutaneous formulation and delivery via large volume wearable injectors. In addition to these highly likely candidates, there are more than 100 other drug-disease combinations which are expected to draw interest in the short-mid term.
5. The manufacturer’s landscape is still evolving. In addition the established firms such as Becton Dickinson and West Pharma, many start-ups including Unilife, Sensile Medical, SteadyMed Therapeutics and Enable Injections are heading towards the pole position
6. The growth in biologics will be one of the key drivers for the emergence of large volume wearable injectors. Around 50% of the top 100 selling drugs are expected to be biologics by 2016; biologics are estimated to contribute 27% of the total drugs market by 2020.
7. Other key reasons for the growth of bolus injectors include their potential to act as life cycle management tool, increasing trend towards drug self-administration and the overall drive towards cheaper healthcare costs.

RESEARCH METHODOLOGY

Most of the data presented in this report has been gathered by secondary research. We have also conducted 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 shape up across different regions and drug 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
- Other analysts’ opinion reports

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and 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. The summary offers a high level view on the likely evolution of the bolus injectors market.

Chapter 3 provides a general introduction to the market and the historical evolution of self-administration injection devices. The chapter also talks about needlestick injuries and the growing preference towards safe and easy-to-use devices.

Chapter 4 provides a detailed overview on wearable injectors and the various unmet needs which are fuelling the rise of these injectors. It not only provides a detailed introduction to large volume wearable injectors but also highlights their key features and categorises the various large volume wearable injectors (currently under development) by mode of operation, device usage and volume.

Chapter 5 highlights the various molecules which are likely to form the target market of large volume wearable injectors. It also looks at the likely growth of biologics market over the next ten years; this is expected to be a significant driver for the large volume wearable injectors which are likely to become the preferred device for delivery of high viscous, large volume biologics.

Chapter 6 provides detailed case studies on five drugs being targeted to deliver through bolus injectors/patch pumps.

Chapter 7 includes detailed profiles of various large volume wearable injectors, their applications, usage mechanism and current state of development.

Chapter 8 looks at the future state of large volume wearable injectors market till 2025. It highlights the leading disease classes which will drive this growth and the relative market size of large volume wearable injectors within each disease class, both in terms of the number of units and the value of the market.

Chapter 9 provides the SWOT analysis of large volume wearable injectors market giving strategic insights to the major factors that are likely to contribute to the growth while also highlighting the weakness and threats that can negatively impact the growth.

Chapter 10 includes profiles of the key companies in the large volume wearable injectors market. Each company profile includes information such as financial performance, marketed / pipeline products, recent developments and future growth plans.

Chapter 11 is a collection of transcripts of some of the interviews which were conducted while preparing this report.

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 the previous chapters.

Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures presented in the report.

Chapter 14 is an appendix, which provides a list of companies and organisations mentioned in this report.

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