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Microneedles for Transdermal and Intradermal Drug Delivery, 2014-2030

  • October 2014
  • -
  • Roots Analysis Private Ltd.
  • -
  • 210 pages

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INTRODUCTION
Transdermal delivery via microneedles is increasingly gaining traction as one of the more promising drug delivery technologies. Microneedles are of a few hundred microns in size, capable of creating transient pores across the skin by penetrating the stratum corneum layer to deliver molecules. These needles are not big enough to reach the nerve-rich regions of the skin; as a result, the drug delivery is perceived as completely painless and devoid of bleeding. Drugs, vaccines, proteins, peptides and other biomolecules are suitable for delivery using the microneedle technology.

The market is still in its infancy. So far, only one microneedle based delivery device, Soluvia prefilled microinjection system, has reached the market. The vaccine-device combination product was FDA approved in May 2011 for intradermal delivery of Fluzone influenza vaccine. We have identified more than 25 companies, with proprietary microneedle technology, actively working towards the development of microneedle-based drug or vaccine products. Clearside Biomedical, NanoPass Technologies, Corium International, Circassia, Radius Health and Zosano Pharma are examples of companies which are evaluating microneedle based drug/vaccine – device combination products (referred to as products hereafter) in clinical trials.

During the course of our research, we came across 22 products currently in different stages of development. We expect around ten products to be launched by the end of this decade, providing the much needed push to this market. Technological advancements will ensure the development of microneedle systems with improved safety and efficacy profile. As more products move from pipeline to the market, we expect to see an increase in the investment in this area from various quarters.

SCOPE OF THE REPORT
The ‘Microneedles for Transdermal and Intradermal Drug Delivery, 2014-2030’ report provides an extensive study in the field of microneedle based delivery systems for therapeutic use. The report covers various aspects, such as, benefits of microneedle assisted drug delivery over conventional needle-syringe system, key industry stakeholders, manufacturing challenges and upcoming opportunities.

One of the key objectives of this report is to understand the current and future state of the microneedles market. This is done by analysing
- Products currently available in the market and those under development (both clinical / pre-clinical)
- Recent partnerships which have taken place over the last few years covering product co-development and technology licensing
- Spin-off companies from academic institutions carrying forward the research work to develop end-user products
- Competitive landscape and inherent threats to growth in the short and long term
- Development and sales potential based on target consumer segments, likely adoption rate and expected pricing

The base year for the report is 2013. The study provides short-mid term and long term market forecasts for the period 2014 - 2022 and 2022 - 2030, respectively. The research, analysis and insights presented in this report include potential sales of microneedle based delivery devices based on the adoption of 13 marketed and pipeline products; this analysis is backed by a deep understanding of key drivers behind the growth.

Owing to niche nature of the market, with most products in the pipeline, we have provided three market forecast scenarios to add robustness to our model. The conservative, base and optimistic scenarios represent three different tracks of industry evolution.

For the scope of our report, we have only considered the microneedle products intended for medicinal use and excluded the microneedle-based products which are directed towards cosmetic applications. All actual figures have been sourced and analysed from publicly available information. The figures mentioned in this report are in USD, unless otherwise specified.

EXAMPLE HIGHLIGHTS
1. Microneedles can deliver a plethora of drugs and vaccines; the technology is not limited to any specific class of drugs. More than 70% of the products in development are patches incorporating solid or dissolvable needles, rest are hollow microneedle arrays which employ the use of a syringe.
2. About 12 products based on microneedle technology are currently in clinical development, more than half of which are in phase II or a higher stage of development. In addition, there are a number of other products currently in preclinical trials.
3. Amongst the various firms involved in developing microneedle products, almost 50% are start-ups, which have received financial support from various investors.
4. Many academic institutions are also exploring the use of microneedles for diagnostics, gene delivery and continuous drug monitoring purposes. Majority of these research projects are focused in developing microneedle products as easy-to-use wearable patches.
5. With several new microneedle based therapeutic product launches by the end of this decade, we expect the overall market for microneedle based delivery devices to reach annual sales of 485 million units by 2030.

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 presents an executive summary of the report. It offers a high level view on where the microneedles market is headed in the mid-long term.

Chapter 3 provides a general introduction to microneedles for transdermal drug delivery. In this section we have discussed, in detail, the concept of microneedles, their historical evolution, mechanism of action and advantages over traditional needle syringes.

Chapter 4 provides an overview of the market landscape. This chapter includes comprehensive information on various technology providers, types of microneedle products, associated materials and manufacturing processes. Information regarding the partnerships that have taken place in the past few years has also been included in this chapter.

Chapter 5 focuses on the key technology providers which have proprietary microneedle technology, with special reference to companies which have microneedle based products under clinical stage of development. In addition to providing detailed profiles of five leading players in the industry, we have also looked at 13 other players which are currently focused in this market.

Chapter 6 discusses the notable microneedle based research work currently underway in academia. It includes comprehensive information on various universities, along with their projects, which have taken a keen interest in this emerging research area.

Chapter 7 provides insights on all the products that are currently marketed or being developed based on the microneedle technology. All these drugs / vaccines have been profiled in this chapter. Amongst other things, these profiles include information related to drug specifications, current stage of development, clinical trials details etc.

Chapter 8 includes case studies of two additional products that are based on microneedle technology but employ a different mode of administration. In addition, we have also profiled a contract manufacturer which manufactures microneedle using its proprietary micro molding technology.

Chapter 9 identifies the forecasted future opportunity presented by the microneedle market. It includes our sales estimates on individual products that are currently marketed or are likely to be available in the near future. We have provided three different growth scenarios for the time period 2014 - 2030.

Chapter 10 provides our analysis of the strengths, weaknesses, opportunities and threats influencing the overall market, capturing the key elements likely to determine future growth.

Chapter 11 is a collection of interview transcripts; these discussions have helped us in forming a better understanding of the key market dynamics, competitive landscape and the likely future trends.

Chapter 12 summarises the overall report. In this chapter, we have provided 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 presented in the report.

Chapter 14 is an appendix, which lists down all the companies and organisations referenced in the report.

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