Table of Contents
In today’s pharmaceutical market, many drugs are supplied in powdered formulation because of their lower shelf life in liquid formulation. The drugs are formulated into powdered form by various processes such as lyophilisation or spray drying; these drugs are then reformulated into liquid form by mixing with a suitable diluent at the time of administration. The overall market of drug reconstitution systems is characterised by the presence of around 50 devices (both conventional and novel). The primary goal of these systems is to provide a hassle free reconstitution process in minimal number of steps. In addition, these systems also aim to provide an optimal protection from needlestick injuries to both the patients and healthcare providers.
Conventional drug reconstitution systems, including Vial Adaptors, Vial to Vial Systems, Direct Connection to Vial Systems and a few others, currently dominate the market. Some of these systems were developed nearly two decades ago and have gained a significant share of the market overtime. In addition, the use of traditional hypodermic needles for reconstituting the drug using a diluent vial is still widespread, especially in the developing countries. However, with new needlestick injuries prevention laws being implemented, along with rising approvals for biologic drugs, novel reconstitution systems such as Dual Chamber Systems are expected to be more popular and preferred option. A number of these novel systems make the process as easy as the push of a button in a much more safer and accurate manner.
Though the market for such novel devices is currently at nascent stage, there are several devices available for investigational use. The technology used in novel systems is likely to play an important part in enhancing the safety, patient compliance and ease of use. When ready, these devices are likely to have a significant impact on the overall market landscape.
SCOPE OF THE REPORT
The ‘Novel Drug Reconstitution Systems, 2014-2024 Market’ report provides a comprehensive study of the growing market of drug reconstitution systems. As mentioned earlier, this includes not only the conventional systems such as Vial Adaptors, Vial to Vial Systems but also novel systems such as Dual Chamber Systems. Due to an increasing number of biologics and the growing trend towards self-administration of drugs, novel drug reconstitution devices are becoming a key focus area for medical device manufacturers. The focus of this study is primarily to understand the governing trends and the likely future evolution of these devices over the next decade.
The report covers various aspects such as market developments, recent partnerships and our opinion on the likely drivers which will influence the industry’s evolution. In addition, we have provided a holistic view of the market landscape including detailed profiles of leading devices, key features and their comparative position vis-à-vis other devices. Innovations in design and advanced safety mechanisms will continue to present encouraging prospects to device manufacturers in the years ahead.
In addition to the key benefits and the likely market drivers, this study also highlights some of the challenges associated with the use and implementation of these devices. Regular modifications in design and incorporation of safety features present operational challenges to the manufacturers. Cost is another factor that can significantly restrain the market, especially in the case of novel reconstitution systems. However, with the entrance of more devices in the market, prices are expected to come down; this, in turn, will result in a higher uptake of such systems.
The report also includes a special case study on drugs and vaccines requiring reconstitution prior to administration. We have looked at the specific indications, therapeutic areas and mode of administration of these powdered formulations.
The study provides short-midterm and long term market forecasts for the period 2014 - 2019 and 2019 - 2024, respectively. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research.
1. We expect that the overall market for drug reconstitution systems is likely to grow at an annualised rate of 7.3% over the coming decade. Novel reconstitution systems will continue to gain ground; by 2024, we expect them to contribute a significant share (27%) to the overall market.
2. Increased venture capital interest is expected to drive additional resources to fund future development. Other drivers include the growing presence of lyophilised drugs, focus on self-administration, convenient disposal, applicability to mass immunisation / vaccination programmes and customisation options as per end-user requirements.
3. Specific pockets of growth include ‘closed systems’, which are expected to rise significantly as more number of chemotherapeutics receive approval in the near future.
4. The market is characterised by the presence of various established players such as West Pharmaceutical Services, Becton Dickinsonalong with emerging firms such as Unilife Corporation, Sensile Medical, Integrity Bio, Mystic Pharmaceuticals. Emergence of small companies is expected to foster ongoing innovation in the area.
5. The increasing number of partnerships is evident of the fact that the leading companies actively look up to these smaller companies for licensing the technology and use their own global presence to make the technology widely available.
Most of the data presented in this report has been gathered via secondary 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 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 an executive summary of major highlights captured in the report. It offers a high level view on the likely future of drug reconstitution systems market.
Chapter 3 provides a general introduction to the drug reconstitution process. It covers the advantages of advanced reconstitution systems over conventional systems including likely benefits to both the patients and the manufacturers.
Chapter 4 provides a comprehensive analysis of the current market of drug reconstitution systems. It lists 50 devices that can be used to carry out reconstitution of powdered drugs, categorising them into the various sub-types (Vial Adaptors, Vial to Vial Systems, Direct Connection to Vial Systems, Dual Chamber Systems, Closed Systems and Needle Free Systems), mode of delivery and the nature of the device (disposable / reusable).
Chapter 5 provides detailed analysis on Dual Chamber Systems that are used for reconstitution of lyophilised drugs. We have presented a 2 X 2 matrix to compare the product competitiveness and supplier power of several devices belonging to this category. The chapter also provides detailed profiles of a number of Dual Chamber Systems which are currently available either commercially or for investigational use.
Chapter 6 focuses on other novel drug reconstitution systems. As in the last chapter, we have provided detailed profiles and highlighted key features of some of the upcoming devices in this category.
Chapter 7 focuses on Needle Free Reconstitution Systems. Most of these systems are used for infusion purposes. In addition to the detailed profiles of such systems, we have also included a special case study on ZetaJetTM, an advanced spring powered system that is designed to deliver vaccines and injectable medication either subcutaneously or intramuscularly.
Chapter 8 focuses on 24 conventional reconstitution systems which were identified during the course of this study. For these Vial Adaptors, Direct Connection to Vial Systems and Closed Systems, we have done a 2 X 2 matrix to compare the product competitiveness with respective supplier power. As in the earlier chapters, we have also profiled a number of these devices.
Chapter 9 highlights the likely future evolution of drug reconstitution systems market over the next ten years. We have done separate analysis for both conventional and novel reconstitution systems till the year 2024.
Chapter 10 provides information on FDA approved drugs and vaccines which are supplied in powdered formulation. We have analysed the product landscape highlighting the popular therapeutic areas and the mode of drug administration.
Chapter 11 includes the detailed profiles of some of the major players in the drug reconstitution systems market. For each company, we have covered details on financial performance, product portfolio, recent developments and future growth plans.
Chapter 12 captures the recent developments which have influenced the drug reconstitution systems market. It includes the agreements / partnerships that have been inked between different stakeholders. We have also provided a technology evolution roadmap clearly depicting the key milestones which have shaped the industry thus far.
Chapter 13 provides the SWOT analysis of drug reconstitution systems market giving strategic insights to the major factors that have contributed to the growth of this market. It also highlights the weaknesses and threats that can negatively impact the growth.
Chapter 14 is a collection of interview transcripts; for the purposes of this study, we held discussions with several experts to ascertain the key strategic initiatives and future roadmap of the industry.
Chapter 15 summarises 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 16 is an appendix, which provides tabulated data and numbers for all the figures presented in the report.
Chapter 17 is an appendix, which provides a list of companies and organisations mentioned in this report.
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