Table of Contents
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. Taking the concept of self-injectors to a new stratum, ‘Bolus Injectors’ have surfaced recently. Also known as 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 bolus 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.
This development is being led jointly by established firms such as Becton Dickinson, West Pharmaceuticals and emerging players such as Unilife, Ratio Drug Delivery and Sensile Medical, amongst others. 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 “Bolus Injectors” report provides a comprehensive analysis of the current state of this market and the likely future evolution over the next ten years. Starting with the basic introduction to bolus injectors, their components, the report explains the advantages, usage mechanism and the current status of development of each of these devices. As these 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 bolus injectors.
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 have already been marketed.
- For the molecules under development, estimating the likely timeline by when they will be ready for intravenous infusion formulation.
- Estimating the likely proportion of these molecules which will be available for subcutaneous delivery via bolus injectors for 15 disease classes.
- Estimating the sales of bolus injectors (both in terms of unit sales and market value) 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 provide 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.
1. Approximately 67% of bolus injectors being developed operate electronically. Other modes of operation include mechanical, hydrogel and hydraulic. Many injectors have an audio / visual panel which facilitate the device usage by patients.
2. The range of these devices can cater to drug volume of as high as 30 ml, though majority of these devices are being designed to handle less than 5 ml of volume.
3. We anticipate the first commercial launch to take place in 2014/2015. There are a variety of biologics which are currently available for intravenous infusion delivery and are likely to be first targets for preparation of subcutaneous formulation and delivery via bolus injectors.
4. Cancer will be the most researched area for bolus injectors. We expect cancer and related conditions to account for approx. 50% of the devices to be sold annually when the market matures. Other prominent target disease conditions are likely to be autoimmune diseases (approx. 11% share in 2024), blood disorders (approx. 7.9% share in 2024) and genetic disorders (approx. 7.8% share in 2024).
5. The growth in biologics will be one of the key drivers for the emergence of bolus injectors. According to our estimates, biologics are expected to be worth USD 215 billion by 2018, rising to USD 900 billion by 2024.
6. 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.
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 2 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 3 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 bolus injectors but also highlights their key features and categorises the various bolus injectors (currently under development) by mode of operation, device usage and volume.
Chapter 4 highlights the various molecules which are likely to form the target market of bolus 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 bolus injectors which are likely to become the preferred device for delivery of high viscous, large volume biologics.
Chapter 5 includes detailed profiles of various bolus injectors, their applications, usage mechanism and current state of development.
Chapter 6 looks at the future state of bolus injectors market till 2024. It highlights the leading disease classes which will drive this growth and the relative market size of bolus injectors within each disease class, both in terms of the number of units and the value of the market.
Chapter 7 provides the SWOT analysis of bolus 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 8 includes profiles of the key companies in the bolus injectors market. Each company profile includes information such as financial performance, marketed / pipeline products, recent developments and future growth plans.
Chapter 9 is a collection of transcripts of some of the interviews which were conducted while preparing this report.
Chapter 10 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 11 is an appendix, which provides tabulated data and numbers for all the figures presented in the report.
Chapter 12 is an appendix, which provides a list of companies and organisations mentioned in this report.
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