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.
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.
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
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.