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Prefilled Syringes Market (4th Edition), 2016 - 2026

  • December 2016
  • 533 pages
  • Roots Analysis Private Ltd.
Report ID: 2243611

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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. Specifically, the demand for prefilled syringes has been rising strongly over the past several years. A growing number of healthcare facilities are now adopting this format for delivering drugs. The popularity of prefilled syringes is not limited to healthcare settings; self-injecting patients looking for easier and safer methods also prefer using prefilled syringes for drug administration in home settings. The rise in parenteral drugs, especially biologics for the treatment of diseases and chronic conditions, such as multiple sclerosis and rheumatoid arthritis, has forced drug and packaging manufacturers to seek more sophisticated container closure and drug delivery systems. Responding to this increasing preference, pharmaceutical companies are now packaging a number of their injectable drugs and vaccines in prefilled syringe format. Over 100 injectable drug products are available in prefilled syringes and a rising number of pipeline drugs are targeted to be delivered by this method.

The origins of prefilled syringes can be traced back to the early 1980s when Sanofi and Rhone Poulenc-Rorer (Sanofi-Aventis) introduced them as drug delivery devices for heparins in Europe. They have been around for more than three decades now and are used for administration of all major classes of therapeutics, including vaccines, anticoagulants, anti-arthritic drugs and anti-anemic drugs. Prefilled syringes have improved significantly over the years. Manufacturers have recently developed multi-chamber syringes for use with lyophilized drugs. Such syringes are also being integrated with advanced injection devices, such as autoinjectors and pen injectors. In addition, prefilled diluent syringes and flush syringes are already quite popular. With more than 60% of candidate drugs / therapies in the clinical pipeline being biologics that usually require parenteral administration, the adoption of prefilled syringes is anticipated to further increase in the mid-long term.

SCOPE OF THE REPORT
The ‘Prefilled Syringes Market (4th edition), 2016-2026’ report provides a comprehensive analysis of the current state of prefilled syringes market and the likely future evolution of these devices over the next decade. Starting with an overview on prefilled syringes, the report elaborates on the development and manufacturing of prefilled syringes. It also includes information on needlestick injuries and provides an overview of the safety laws and legislations related to prefilled syringes across the major markets in the world.

Some of the key objectives of the report were to enumerate the various prefilled syringe systems that are available in the market, identify the drugs that are available in such dosage forms and estimate their corresponding market potential across different geographical regions. Specifically, the report includes insights on:

- The current state of the market with respect to key players, targeted disease indications and the therapeutic classes of drugs that are available in the form of prefilled syringes, including a brief overview of biologics and biosimilars that are considered to be one of the primary growth drivers of this market.
- The key drugs that are available in prefilled syringes; this has been presented in the form of detailed case studies.
- The regulatory landscape in different countries, including the guidelines related to the grant of a marketing authorization for drugs in prefilled syringes.
- The candidates that are likely to be tried for delivery via prefilled syringes in the future. It is worth highlighting that the candidates were chosen based on various parameters, such as their current route of administration, targeted indication and dosage frequency.
- The key prefilled syringe and component manufacturers based in different geographies.
- Product competitiveness and supplier power (in the form of 2 X 2 matrices) across the growing landscape of glass and plastic prefilled syringes.
- Specialty syringes, which include prefilled flush syringes, prefilled diluent systems and contrast agents in prefilled syringes.
- The contract manufacturing organizations providing fill / finish services related to prefilled syringes.
- Future growth opportunities that are likely to drive the market in the short and long terms.

The study also features a detailed analysis of the existing market size and the potential future growth opportunities of these drug delivery devices across different classes of therapeutics. The analysis includes volumetric (number of units of prefilled syringes) and financial (future market size) projections of the market’s evolution over the next ten years (2016-2026). We have provided insights on the regional evolution of the prefilled syringes market covering North America, Europe (UK, France, Italy, Spain, Germany and the rest of Europe), Latin America (Brazil, Mexico, Argentina and the rest of Latin America), Asia Pacific (Japan, China, India, South Korea and the rest of Asia Pacific), and the Middle East and Africa (Saudi Arabia, UAE, Africa and the rest of the Middle East). In addition, we have provided the likely evolution distributed by the type of material (glass and plastic), and nature of molecules (vaccines, biosynthetic insulins, synthetic pentasaccharides, monoclonal antibodies, small molecules). The forecast takes into account the impending price variations that are likely to emerge in the mid-long term as a result of growing adoption and increased competition. In order to account for the uncertainties associated with drug development and production, we have forecasted three different market scenarios, depicting conservative, base and optimistic tracks of the industry’s evolution.

The opinions and insights presented in this study were influenced by discussions conducted with experts in this field. These included contributions from Kevin Cancelliere and Tibor Hlobik (Marketing Directors, West Pharmaceutical Services), Kirti Maheshwari (Chief Technical Officer, Intas Pharmaceuticals), Matthew Young (Founder and Chief Technology Officer, Oval Medical Technologies), and Rondald Wheet (Chief Executive Officer, Revolutions Medical). All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

1.1. RESEARCH METHODOLOGY
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 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.

1.2. CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research and offers a high level view on where the market for prefilled syringes is headed in the mid-long term.

Chapter 3 provides a general overview of prefilled syringes, including details on their origin, required components (barrel, lock adapter, lubricant, needle, needle shield, plunger rod / piston, plunger stopper and tip cap) and manufacturing material (glass and plastic) . The chapter outlines the various types of prefilled syringe systems that are available in the market and provides details on the companies that manufacture such products. It also includes a discussion on the technological advances that have taken place in the recent past.

Chapter 4 highlights the growing concerns associated with needlestick injuries and the various legislative steps that have been taken to prevent them. These include installing various safety features in modern versions of prefilled syringes. In addition, the chapter provides information on some of the safety systems, including both add-on devices and device integrated features, and the companies involved in developing and manufacturing such solutions.

Chapter 5 presents information on the regulatory environment related to the grant of marketing authorizations for combination products across different countries. It highlights the role of regulatory bodies in the approval of prefilled syringes in North America, Europe, Latin America, Asia Pacific and the Middle East.

Chapter 6 features a detailed discussion on the key growth drivers of the prefilled syringes market. It also describes the rise in the number of chronic diseases, the growing trend of self-injection, changing patient demographics, and the emergence of biologics / biosimilars.

Chapter 7 provides details of the various products available in the form of prefilled syringes, primarily focusing on injectable drugs and vaccines. The chapter includes case studies of some of the marketed drugs available as prefilled syringes, such as Humira®, Enbrel®, Copaxone®, Lovenox® and Abilify Maintena®. We have also captured details on the molecules that are under clinical development as prefilled syringes. The chapter features a grid analysis, representing the distribution of pipeline drugs across different therapeutic areas and different stages of clinical development. Additionally, the chapter outlines major therapeutic drug classes that are available as prefilled syringes. For each therapeutic class, we have identified the drugs that are already available in prefilled syringes, their estimated patent expiry dates and corresponding generics / biosimilars that are under development.

Chapter 8 presents a list of drug candidates (marketed / pipeline) that are likely to be tried for delivery via prefilled syringes in the future. This list is based on insights gathered on the respective routes of administration of these candidates, the nature of the indication they are prescribed for, dosage frequency and annual sales (in case of marketed drugs).

Chapter 9 provides detailed profiles of some of the key manufacturers of prefilled syringes based in different geographies. Each profile includes a brief overview of the company, its financial information, product portfolio, technology platforms, recent facility expansions and / or acquisitions, and a comprehensive future outlook. The companies that have been included in this section include Aguettant, Becton Dickinson, Gerresheimer, Nipro Corporation, Nuova Ompi, SCHOTT, Terumo Corporation, Unilife, Vetter Pharma, Weigao Group Pharmaceutical Packaging Products Company and West Pharmaceutical Services. In addition, we have included brief profiles of some of the key prefilled syringe manufacturers that are based in emerging markets. The chapter also presents 2 X 2 matrix representations, comparing product competitiveness and supplier power of both glass and plastic prefilled syringes.

Chapter 10 provides insights on the various prefilled syringe component manufacturers along with details of their respective product portfolios. The key players covered in this section include Aptar Stelmi, Datwyler and West Pharmaceutical Services.

Chapter 11 provides information on fill and finish activities and the processes and technologies associated with them. The chapter highlights the importance of aseptic fill and finish operations, and features a discussion on future trends in this segment. It also includes detailed profiles of the global players that are engaged in this segment of the industry.

Chapter 12 features information on specialty syringes, namely prefilled flush syringes, prefilled diluent systems and contrast agents that are supplied in prefilled syringes. For each type of specialty syringe, we have provided a brief overview and presented details such as the different products that are available in the market and their advantages.

Chapter 13 offers a comprehensive perspective on how the prefilled syringe market is likely to evolve over the next ten years. Based on data collected through secondary research and insights from primary research, we adopted a top-down approach in order to estimate the future size of the market, both in terms of volume (number of units) and value (in USD billion). We have projected the market’s evolution North America, Europe (UK, France, Italy, Spain, Germany and the rest of Europe), Latin America (Brazil, Mexico, Argentina and the rest of Latin America), Asia Pacific (Japan, China, India, South Korea and the rest of Asia Pacific), and the Middle East and Africa (Saudi Arabia, UAE, Africa and the rest of the Middle East). In addition, we have looked at the market’s evolution by the type of material (glass and plastic) used and the nature of the product contained within the syringe (vaccines, biosynthetic insulins, synthetic pentasaccharides, monoclonal antibodies, small molecules and others). The analysis presents insightful 2 X 2 matrices based on Market Share and Market Attractiveness derived from the current and likely future state of the market.

Chapter 14 presents a list of autoinjectors that utilize prefilled syringes as their primary containers. In this chapter, we have included profiles of manufacturers of such autoinjectors, featuring an overview of the company and respective product portfolios. The key players that have been covered in this section include Bespak, DALI Medical Devices, Elcam Medical, Nuance Owen Mumford, SHL Group, Union Medico and Ypsomed Delivery Systems.

Chapter 15 discusses the recent technological developments in this domain and their applications. The chapter provides details on the advances in design technology and manufacturing of prefilled syringes that have enabled pharmaceutical companies to market lyophilized drugs in dual / multi chambered systems. The chapter highlights the advances related to novel lubrication and sterilization technologies as well.

Chapter 16 provides a comprehensive SWOT analysis of the prefilled syringes market. The chapter presents strategic insights on major factors that have contributed to the growth of the market, while highlighting the weaknesses and threats that are likely to have an impact on its future.

Chapter 17 summarizes the overall report. In this chapter, we have provided a recap of the key takeaways and expressed our independent opinion, based on the research and analysis described in previous chapters, on how the market is likely to fare in the shot and long terms.

Chapter 18 is a collection of interview transcripts of our discussions with some of the key players in this industry. In this chapter, we have presented the details of our conversations with Kevin Cancelliere and Tibor Hlobik (Marketing Directors, West Pharmaceutical Services), Kirti Maheshwari (Chief Technical Officer, Intas Pharmaceuticals), Matthew Young (Founder and Chief Technology Officer, Oval Medical Technologies), and Rondald Wheet (Chief Executive Officer, Revolutions Medical).

Chapters 19 and 20 are appendices, which provide tabulated data of all the charts and the list of companies that are mentioned in the report.

EXAMPLE HIGHLIGHTS
1. Currently, more than 100 drugs and vaccines are available in prefilled syringes across different therapeutic classes. Humira®, Enbrel®, Copaxone®, Lovenox®, Rebif® and Pegasys® are examples of blockbuster drugs that are being extensively administered via prefilled syringes. In addition, over 65 drugs in prefilled syringe format are in clinical development for the treatment of number of indications such as rheumatoid arthritis and multiple sclerosis.
2. The rise of biologics has emerged as a major growth driver. Additionally, a number of biologics are getting off patent in the coming few years. Biosimilar developers will be competing for the same drug and, in such situations, use of prefilled syringes as a mode of administration can act as a key differentiator. The market’s evolution in the long-term will be fueled by pipeline drugs, technological advances and the rising adoption in developing markets. Moreover, integration of prefilled syringes with advanced delivery systems such as pen and autoinjectors will aid in gaining wider adoption.
3. The development and launch of dual / multi-chambered syringes and prefilled diluent syringes has enabled easier and faster delivery of lyophilized drugs. Novel lubrication technologies such as TriboFilm Research’s TriboGlide® and Becton Dickinson’s XSi™ coating technologies have been introduced to overcome the problems associated with the use of silicone oil. Additionally, the design and availability of silicone-free and tungsten-free syringes is making them more suitable for use with sensitive drugs such as biologics.
4. The current market is highly consolidated and is dominated by a handful of key manufacturers such as Becton Dickinson, Gerresheimer, SCHOTT, and Nuova Ompi. Other key players include West Pharmaceutical Services and Vetter Pharma; these players have already driven some novel devices and technologies in the market and are likely to foster more innovation.
5. Many regional players have recently surfaced. Specifically in China, which has a large home consumer market, domestic players have an installed annual production capacity of as high as 150 million units; Shandong Weigao Group Medical Polymer Company, Shandong Zibo Minkang Pharmaceutical Packing, and Shandong Pharmaceutical Glass are well-known players. In Japan, Arte Corporation, Nipro Corporation, Taisei Kako and Terumo Corporation are known manufacturers of prefilled syringes; similarly, Roselabs Group, an India based manufacturer has invested heavily in this area.
6. Aseptic filling of sterile drugs into prefilled syringes is one of the most crucial steps in pharmaceutical production. During the course of our study, we identified more than 45 contract manufacturing organizations, which provide fill and finish services for prefilled syringes. Majority (~70%) of the fill and finish service providers are based in North America and Europe. Prominent players in these regions include Biopharma Solutions, Catalent, Pfizer CentreOne, Rovi CM and Boehringer Ingelheim BioXcellence. Some well-known fill and finish service providers based in emerging markets include Cipla BioTec, DM Bio, Genovior Biotech and The Birgi Mefar Group.
7. We anticipate the global prefilled syringe market to grow at an annualized rate of 3.9% between 2016 and 2026. The majority share of the prefilled syringes market is currently divided between North America (35%) and the EU (45%). We believe that the prefilled syringes markets in Asia, Latin America, the Middle East and Africa are likely to grow at faster rate than those of the more developed regions.

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