LONDON, May 18, 2016 /PRNewswire/ -- INTRODUCTION
Injectable drug delivery systems have traversed a long way from conventional syringes with vials to prefilled syringes, auto-injectors, pen injectors and needle free systems. These modern devices have become preferred devices for parenteral administration of drugs, mainly used for treatment of chronic conditions requiring patients to self-administer medication several times a week.
The origins of prefilled syringes can be traced back to early 1980s when Sanofi and Rhone Poulenc-Rorer (Sanofi-Aventis) introduced syringes as drug delivery devices for heparins in Europe. These have been around for more than three decades and are used in all major therapeutic classes for injectable drug formulations. Owing to their numerous benefits over conventional delivery systems and the growing application areas, prefilled syringes have now become indispensable in the medical fraternity. This is evident from our research during which we identified a large number of instances where prefilled syringes are being used to administer vaccines, anticoagulants, multiple sclerosis drugs, anti-arthritic drugs, anti-anaemic drugs and drugs from several other classes. Further, these syringes are also being used as primary drug containers in pen and auto-injectors. In addition, prefilled diluent syringes and flush syringes are also increasingly finding wider adoption. With pharma companies viewing prefilled syringes as a potent life cycle management tool, the pipeline is rich and growing rapidly.
The rising demand has also driven the manufacturers to introduce improvements in technology related to the material of prefilled syringes and lubrication (to reduce leachables and extractables). These developments will aid an increasing number of biologic drugs to reach the market. Additionally, the companies have developed multi-chamber prefilled syringes for use with lyophilised drugs. In our research, we have looked at how these developments and other factors are shaping the market and discussed the factors creating opportunities for various stakeholders in the market.
SCOPE OF THE REPORT
The 'Prefilled Syringes Market (3rd Edition)' report provides a comprehensive analysis of the state of prefilled syringes market. Starting with the basic introduction to prefilled syringes, their origin, components and manufacturing material, this report talks about needlestick injuries and looks at the safety laws and legislations across major regional markets for prefilled syringes. A key objective of the report is to enumerate various prefilled syringe systems available in the market, drugs available in these syringes and the corresponding market potential across different geographical regions. We have discussed various historical/likely future trends which have shaped/will shape the US, European, Japanese, Chinese, Indian and rest of the world markets. We have also included a detailed overview of biologics and biosimilars, one of the primary growth drivers of this market.
The study focuses on analysing the existing market size and potential future growth of these drug delivery devices across different drug therapeutic classes and regions. The forecast, over the next ten years, has been presented both in terms of volume (number of units) and value (USD billion). It takes into account the likely price variation which will occur as a result of mass adoption and increased competition. Owing to uncertainty surrounding the adoption of prefilled syringes in newer drug classes (which are currently in pipeline); we have also done a multi-variate sensitivity analysis to understand the various market growth scenarios.
In an effort to identify existing gaps and future opportunities, we have discussed the leading global prefilled syringe manufacturers in the industry, analysed their product portfolio and the likely future developments driven by these companies. We have put special emphasis and provided details on local manufacturers which are very well positioned to take advantage of the emerging big home consumer markets. In addition, we have profiled some important prefilled syringe component manufacturers as well as manufacturers of self-injection systems that use prefilled syringes as primary drug container.
The market forecasts across different segments and regions have been presented till 2025. 2014 is the base year; actual figures have been sourced and analysed 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 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.
The sales/revenue data are actual sales as reported in the company annual reports and represent full year sales for respective fiscal years.
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 prefilled syringes market.
Chapter 3 provides a general overview of prefilled syringes including their origin, components, types and manufacturing material. We have listed the major prefilled syringes currently available and presented a detailed market landscape. The chapter also discusses the technological advancements that have led to the evolution of the industry over the last several years.
Chapter 4 highlights the issue of needlestick injuries and various preventive laws worldwide which have put the focus on safety features in prefilled syringes. The chapter also discusses various manufacturers of safety systems including add-on devices and integrated safety prefilled syringes.
Chapter 5 highlights the key growth drivers of prefilled syringes market. These include the growing trend of self-injection, rise in chronic diseases, changing patient demographics and growth of biologics.
Chapter 6 highlights the leading therapeutic drug classes available in prefilled syringes. It also provides a list of top nine drugs in prefilled syringes with detailed case studies on Humira, Enbrel and Copaxone. For each therapeutic class, we have identified the drugs available in prefilled syringes and estimated patent expiry; we have also looked at the biosimilars currently in development.
Chapter 7 details the recent technological developments and their applications in prefilled syringes market focusing on syringes being manufactured for lyophilised drugs in dual / multi chambered system for drug reconstitution.
Chapter 8 provides profiles of the key manufacturers of prefilled syringes. Each company profile includes information on financial performance, geographical presence, marketed devices, recent developments and an informed future outlook. Key players covered in this section include (in alphabetical order) Aguettant, Becton Dickinson, Gerresheimer, Nipro Corporation, Nuova Ompi, SCHOTT, Unilife, Vetter Pharma and West Pharmaceuticals.
Chapter 9 highlights various prefilled syringe component manufacturers and their product portfolio. Key players covered in this section include Aptar Stelmi, Datwyler and West Pharmaceuticals.
Chapter 10 discusses detailed profiles of major pen and auto-injector manufacturers which use prefilled syringes as primary drug container providing information on their financial performance, product portfolio and recent developments. Key players covered in this section include (in alphabetical order) Becton Dickinson, Bespak, DALI Medical, Future Injection Technologies, Owen Mumford, SHL Group, Unilife, West Pharmaceuticals and Ypsomed.
Chapter 11 provides the SWOT analysis of prefilled syringes market giving strategic insights on the major factors that have contributed to the growth of the market, while highlighting the weaknesses and threats that can negatively impact the growth.
Chapter 12 analyses the regional markets (the US, Europe, China, Japan, India and RoW) for prefilled syringes. For each region, the chapter focuses on the market size and various technological, commercial and regulatory details; in addition to the global players which have been profiled in earlier sections, this chapter includes profiles of the key regional players in Chinese, Japanese and Indian markets.
Chapter 13 provides a detailed description of the likely evolution of prefilled syringes market. We have adopted a detailed '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 volume (number of units) and value (in USD billion).
Chapter 14 is a collection of interview transcripts. For the purposes of our study, we contacted a number of stakeholders in order 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 provided in the report.
Chapter 17 is an appendix, which provides a list of companies and organisations mentioned in this report.
1. Over 65 drugs and vaccines are already available in prefilled syringes across different therapeutic classes. In addition, there are several more in clinical pipeline which are being tested in prefilled syringes.
2. Vaccines and anti-coagulants are examples of well-established applications. The emergence of biologics will be a major growth driver; growth in the long-term will be fuelled by pipeline drugs and the rising adoption in developing markets.
3. Increasing number of suppliers now provide ready to fill/ sterile prefilled syringes, which make up more than 80% of the prefilled syringes market. The integration of prefilled syringes with advanced delivery systems such as pen and autoinjectors will aid in gaining wider adoption.
4. Companies are constantly innovating technology for improving the compatibility of syringes with biologics to provide better extractables and leachables profiles. In addition, improved ergonomic designs now offer comfortable administration of drugs.
5. The market is highly consolidated and is currently dominated by key global players such as Becton Dickinson, Gerresheimer, MGlas AG, SCHOTT and Nuova Ompi. Other companies, which are relatively new entrants (e.g. West Pharmaceutical Services, Unilife, Vetter Pharma and Aguettant), are likely to foster more innovation. Apart from these companies, companies such as Datwyler and Aptar Stelmi are well-known suppliers of various components of prefilled syringes.
6. The global prefilled syringes market is likely to grow at a compounded annual growth rate (CAGR) of 4.3% between 2014 to 2025. Developed markets of the US and EU currently account for 80% of the market. With increasing adoption in Asia Pacific and rest of the world markets, this domination is likely to gradually decline.
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