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Report Description
Prefilled syringes are gaining strong acceptance in the market as drug delivery systems for injectable drugs. They have become a preferred device for parenteral administration of drugs, mainly used for treatment of chronic conditions requiring patients to self-administer medication several times a week.
The rising demand for prefilled syringes is driving the manufacturers to introduce improvements in technology related to the material of prefilled syringes, and lubrication technology to reduce leachables and extractables. These developments are primarily to accommodate the increasing number of biologic drugs reaching the market. Additionally, the companies have developed multi-chamber prefilled syringes for use with lyophilised drugs. We look at how these developments and others factors are shaping the market and discuss the factors creating opportunities in the market for prefilled syringes.
While the market is still relatively small, capturing just 25.4% of total injectable drug delivery systems market, it is forecasted to grow strongly over the period 2013-2018 and beyond. The prefilled syringes market faces some significant challenges ahead, but the outlook looks promising.
Scope of the Report
The 'Prefilled Syringe Market' 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, the report talks about needlestick injuries and looks at the safety laws and legislations across major regional markets for prefilled syringe. The report focuses on analysing the existing market size and potential future growth of these drug delivery devices across different regions. We have also discussed the leading prefilled syringe manufacturers in the industry and the likely future developments driven by these companies.
The report also analyses the market size of the most important drug therapeutic classes, which are available in prefilled syringes. This includes analyses of the leading drugs in each class present in prefilled syringes. The report contains a brief overview of biologics and biosimilars market, one of the primary drivers for growth of the market.
A key objective of the report is to enumerate various prefilled syringes systems available in the market, drugs available in prefilled syringes and the market potential of these devices across different geographical regions. The report discusses various historical / likely future trends which have shaped / will shape the US, European, Japanese, Chinese and Rest of the world (RoW) markets including India and Indonesia.
The market forecasts across different segments and regions have been presented till 2023. 2012 is the base year and actual figures have been taken, analysed from publicly available information. Unless otherwise specified, all figures are presented in USD.
The report also provides profiles of leading manufacturers of prefilled syringes, with analyses of their product portfolio and financial performance. Our report provides a comprehensive view on the worldwide presence of prefilled syringe manufacturers, helping understand the gaps and opportunities.
Contents
Chapter 1 is a high level Executive Summary of the key market insights presented in the report.
Chapter 2 provides a general overview of prefilled syringes including their origin, components, types, and manufacturing material. The chapter also talks about needlestick injuries and various preventive laws worldwide have been discussed with focus on safety features in prefilled syringes.
Chapter 3 highlights the global market for injectable drug delivery systems, including prefilled syringes in 2012 and the likely future growth trends till 2023. This chapter analyses the market with respect to the leading prefilled syringe segments and the leading companies. Also included is our analysis of the glass and plastic prefilled syringe systems available in the market, including their advantages and disadvantages are material of choice for syringe barrel.
Chapter 4 analyses the regional markets (the US, Europe, Japan, China and RoW) for prefilled syringes. Within each region, the chapter focuses on the market size and various technological, commercial and regulatory details.
Chapter 5 looks at the market for injectable drugs and biologics in 2012 and market forecast for biologics to 2023. The chapter also highlights the leading therapeutic drug classes available in prefilled syringes. Also provided is a list of top ten drugs in prefilled syringes with three case studies.
Chapter 6 details the technological developments in prefilled syringes market. It discusses the prefilled syringes manufactured for lyophilised drugs, silicone-free syringes and prefilled syringes with integrated safety features.
Chapter 7 provides profiles of the key manufacturers of prefilled syringes. Each company profile includes information on financial performance, geographical presence, marketed devices, role and strategy for manufactured devices and recent developments.
Chapter 8 provides the SWOT analysis of prefilled syringes market giving strategic insights in to 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 9 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 10 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 11 is an appendix, which provides a list of companies and organisations mentioned in this report
1. EXECUTIVE SUMMARY
1.1. Scope of the Report
1.2 Research Methodology
1.3 Chapter Outlines
1.4 Key Highlights
1.4.1. Prefilled Syringes Market is Likely to Grow Strongly During the Period 2013-2023
1.4.2. Currently Dominated by a Few Large Companies
1.4.3. Biologics to Drive Growth of Prefilled Syringes
1.4.4. Prefilled Syringes Market is Full of Opportunities, but Challenges Remain
2. INTRODUCTION TO PREFILLED SYRINGES
2.1. What are Prefilled Syringes?
2.2. History of Prefilled Syringes
2.3. Prefilled Syringe Components
2.4. Classification of Prefilled Syringes
2.4.1. Single-Chamber and Dual-Chamber
2.4.2. Type of Needle
2.4.3. Manufacturing Material of Barrel
2.4.3.1. Limitations of Glass Prefilled Syringes
2.5. Needlestick Injuries
2.5.1. Incidence and Cost Burden
2.5.2. Government Legislation for Needlestick Injury Prevention
2.6. Safety Options in Prefilled Syringes
3. GLOBAL PREFILLED SYRINGES MARKET, 2013-2023
3.1. Chapter Overview
3.2. Injectable Drug Delivery Systems Market in 2012
3.3. Prefilled Syringe Market, 2012
3.3.1. Most Prefilled Syringes are Provided in Ready-to-Fill Formats
3.3.2. Glass Prefilled Syringes Still Dominate the Prefilled Syringes Market
3.3.2.1. Glass: Historical Material of Choice
3.3.2.2. Plastics: An Alternative to Glass
3.3.2.2.1. Slow Adoption of Plastic Prefilled Syringes
3.3.2.2.2. Factors Driving the Use of Plastic Prefilled Syringes
3.4. Most of the Prefilled Syringes are Provided with Pre-attached Needles
3.5. Leading Companies in the Prefilled Syringes Market
3.5.1. Other Companies in the Prefilled Syringes Market
3.6. Prefilled Syringe Systems Available in the Market, 2013
3.6.1. Glass Prefilled Syringes
3.6.2. Plastic Prefilled Syringes
3.7. Convergence of Prefilled Syringes with Autoinjectors
3.7.1. Pen Injectors vs. Autoinjectors
3.8. Injectable Drug Delivery Systems Market, 2013-2023
3.9. Conventional Hypodermic Needle Systems, 2013-2023
3.10. Autoinjectors and Other Self-Injection Devices, 2013-2023
3.11. Prefilled Syringes Market, 2013-2023
3.11.1. Factors Driving the Prefilled Syringe Market
3.11.1.1. Increase in Incidence of Chronic Diseases
3.11.1.2. Use of Prefilled Syringes in Advanced Delivery Devices
3.11.1.3. Innovation in Prefilled Syringes to Address Needlestick Injuries
3.11.1.4. Growth of Biologics and Biosimilars
3.11.1.5. Changing Pharmaceutical Strategies Driving Demand for Prefilled Syringes
4. LEADING REGIONAL MARKETS FOR PREFILLED SYRINGE SYSTEMS, 2013-2023
4.1. The US has Caught up with Europe on Use of Prefilled Syringes
4.2. The US Market for Prefilled Syringes, 2012
4.2.1. Prefilled Syringes are Combination Products
4.2.1.1. Regulation of Combination Products in the US
4.2.1.2. Regulatory Approval of Prefilled Syringes in the US
4.2.2. Trends in the US Prefilled Syringes Market
4.3. European Market for Prefilled Syringes, 2012
4.3.1. Combination Products in Europe
4.3.2. Regulatory Approval of Prefilled Syringes in Europe
4.3.3. Trends in the European Prefilled Syringe Market
4.3.3.1. Europe is the Preferred Destination for Manufacturing Prefilled Syringes
4.3.4. Patient Demographics is Likely to Support Growth of Prefilled Syringes in Europe
4.4. The Chinese Market for Prefilled Syringes, 2012
4.5. Rest of the World Markets for Prefilled Syringes, 2012
4.5.1. The Japanese Market for Prefilled Syringes
4.5.1.1. Regulation of Combination Products in Japan
4.5.1.2. Primary Pharmaceutical Packaging Market in Japan
4.5.1.3. State of the Market: Drugs and Companies, 2012
4.5.2. Indian Market for Prefilled Syringes, 2012
4.5.2.1. Presence of Leading Prefilled Syringe Manufacturers in India
4.5.3. Indonesian Market for Prefilled Syringes, 2012
4.6. Regional Prefilled Syringes Market Forecast, 2013-2023
5. PRODUCTS AVAILABLE IN PREFILLED SYRINGES
5.1. Injectable Drugs Market, 2012
5.2. Biologics Market
5.2.1. Biologics Market Forecast, 2013-2023
5.2.2. Biologics Market Trends
5.3. Drugs Market by Therapeutic Classes, 2012
5.3.1. Anti-rheumatics Market, 2012
5.3.1.1. Anti-rheumatic Drugs in Prefilled Syringes
5.3.1.2. Launch of Biosimilars Post 2014 is Likely to Drive Demand for Prefilled Syringes
5.3.2. Multiple Sclerosis (MS) Therapies Market, 2012
5.3.2.1. MS Therapies in Prefilled Syringes
5.3.3. Anticoagulants Market, 2012
5.3.4. Anti-Diabetes Market, 2012
5.3.4.1. Anti-diabetic Drugs Available in Prefilled Syringes
5.3.5. Vaccines Market, 2012
5.4. Drugs Available in Prefilled Syringes, 2012
5.4.1. Pipeline Products
5.5. Case Studies
5.5.1. Humira (Adalimumab), AbbVie /Eisai
5.5.1.1. Indications and Dosage Forms
5.5.1.2. Humira: Launched in Prefilled Syringe
5.5.2. Enbrel (Etanercept), Amgen/Pfizer/Takeda
5.5.2.1. Indications and Dosage Forms
5.5.2.2. Enbrel: Move from Vial to Syringes
5.5.3. Copaxone (Glatiramer acetate), Teva Pharmaceuticals
5.5.3.1. Copaxone: Move from Vial to Syringes
5.6. Contrast Agents Available in Prefilled Syringes
6. TECHNOLOGICAL DEVELOPMENT IN PREFILLED SYRINGES
6.1. Prefilled Syringes for Lyophilised Drugs
6.1.1. Prefilled Diluent Syringes
6.1.2. Dual/Multi-Chamber Syringes
6.1.3. Lyophilised Drugs Available in Dual/Multi-Chamber Prefilled Syringe
6.2. Silicone-free Syringes
6.2.1. Fluoropolymer Film Coating
6.2.2. XSi Coating
6.3. Prefilled Safety Syringes
6.3.1. Safety Mechanism Used by Prefilled Syringe Manufacturers
6.3.1.1. Unifill Safety Syringes
6.3.1.2. MedPro Prefilled Safety Syringes
6.3.1.3. Becton Dickinson To Strengthen Its Safety Portfolio
7. PROFILES OF LEADING COMPANIES
7.1. Becton Dickinson (BD)
7.1.1. Company Overview
7.1.2. Financial Performance, 2012
7.1.3. Products and Processes
7.1.3.1. BD Hypak Syringe Systems
7.1.3.2. BD Neopak Syringe System
7.1.3.3. BD Sterifill Syringe Systems
7.1.3.4. BD Uniject
7.1.3.5. Other Injectable Delivery Systems
7.1.3.6. Safety Systems: Add-On Devices
7.1.3.7. BD Prefilled Technology Solutions
7.1.4. Recent Developments
7.2. Gerresheimer
7.2.1. Company Overview
7.2.2. Financial Performance, 2012
7.2.3. Products and Processes
7.2.3.1. Glass Syringes (Ready to Fill and Bulk)
7.2.3.2. ClearJect Plastic Syringes
7.2.3.3. Insulin Pens
7.2.3.4. Finishing Processes
7.2.4. Recent Developments
7.2.4.1. Expansion of Manufacturing Capacity for RTF Syringes
7.2.4.2. Medical Plastic Systems Capacity Expansion
7.2.4.3. Growing Interest in the Emerging Economies
7.3. SCHOTT
7.3.1. Company Overview
7.3.2. Financial Performance, 2012
7.3.3. Prefilled Syringe Products
7.3.3.1. Forma 3s Glass Syringes
7.3.3.2. TopPac Polymer Syringes
7.3.3.3. InJentle Syringes
7.3.4. Recent Developments
7.3.4.1. Looking To Grow in the Emerging Markets
7.3.4.2. Production Facility in the US Likely to Provide Advantage
7.4. West Pharmaceutical Services
7.4.1. Company Overview
7.4.2. Financial Performance, 2012
7.4.3. Marketed Products
7.4.3.1. Daikyo Crystal Zenith (CZ) RU System
7.4.3.2. Autoinjectors and Other Systems
7.4.3.3. Prefilled Syringe Components
7.4.4. Recent Developments
7.5. Nuova Ompi
7.5.1. Company Overview
7.5.2. Products
7.5.2.1. EZ-fill Syringes
7.5.3. Recent Developments
7.6. MGlas AG (Now a Part of Nipro Corporation)
7.6.1. Company Overview
7.6.2. Prefilled Glass Syringes
7.6.3. Acquisition by Nipro Corporation
8. SWOT ANALYSIS
8.1. Overview
8.2. Strengths
8.2.1. Ease of Use
8.2.2. Elimination of Medication Errors
8.2.3. High Incidence of Blood-borne Pathogen Transmission
8.2.4. Economic Advantages
8.2.5. Life Cycle Management
8.3. Weaknesses
8.3.1. Manufacturing Complexities
8.3.2. Elevated Packaging Costs
8.3.3. Product Stability
8.3.4. Air Bubbles During Filling
8.4. Opportunities
8.4.1. Increase in Number of Self-injecting Patients
8.4.2. Rich Pipeline of Drugs
8.4.3. Growth of Biologics
8.4.4. Growth of Biosimilars
8.4.5. Geographic Expansion
8.4.6. Useful in Vaccination Programmes
8.5. Threats
8.5.1. Material Compatibility Issues
8.5.2. Recall of Prefilled Syringes
8.5.3. Alternative Drug Delivery Devices
9. CONCLUSIONS
9.1. The Shift from Vials to Prefilled Syringes
9.2. Plastic Syringes to Outperform Glass Syringes
9.3. Current and Future State of the Prefilled Syringes Market
9.4. Key Driving Factors
9.5. Concluding Remarks
10. APPENDIX 1: TABLES
11. APPENDIX 2: LIST OF COMPANIES AND ORGANISATIONS
FIGURE 3.1 Injectable Drug Delivery Systems Market, 2012 - By Leading Segments (USD BN, %)
FIGURE 3.2 Prefilled Syringes Market, 2012 - By Type of Syringe Before Fill/Finish (USD BN, %)
FIGURE 3.3 Prefilled Syringes Market, 2012 - By Material of Barrel (USD MM, %)
FIGURE 3.4 Prefilled Syringes Market, 2012 - By Needle Type (USD BN, %)
FIGURE 3.5 Injectable Drug Delivery Systems Market, Short - Mid Term Forecast, 2012-2018 (USD BN)
FIGURE 3.6 Injectable Drug Delivery Systems Market, Long Term Forecast, 2019-2023 (USD BN)
FIGURE 3.7 Global Prevalence of Diabetes, 2012 - By Countries (MM, %)
FIGURE 4.1 Prefilled Syringes Market, 2012 - By Leading Regions (USD MM, %)
FIGURE 4.2 The US Vaccines Market - By Type of Packaging (%)
FIGURE 4.3 European Vaccines Market - By Type of Packaging (%)
FIGURE 4.4 Domestic Prefilled Syringe Manufacturers in China - Annual Production Capacities, 2012 (MM Units)
FIGURE 4.5 Shandong Weigao - Prefilled Syringes Revenue (RMB MM), 2009-2012
FIGURE 4.6 Japanese Prefilled Syringes Market, 2012 - By Material of Barrel (%)
FIGURE 4.7 Prefilled Syringes Market Forecast – By Leading Regions, Short-Mid Term, 2012 – 2018 (USD BN)
FIGURE 4.8 Prefilled Syringes Market Forecast – By Leading Regions, Long Term, 2018 – 2023 (USD BN)
FIGURE 4.9 Prefilled Syringes Market, 2011-2017 - Shares by Leading Regions (%)
FIGURE 5.1 Injectable Drugs Market Share, 2012 (%)
FIGURE 5.2 Total Drugs Market, 2012 - By Nature of Drug (USD BN, %)
FIGURE 5.3 Drugs Market Forecast, Short - Mid Term Forecast (2012-2018) - Split by Biologics and Pharmaceuticals (USD BN)
FIGURE 5.4 Drugs Market Forecast, Long Term Forecast (2018-2023) - Split by Biologics and Pharmaceuticals (USD BN)
FIGURE 5.5 Biologic Drugs in Development, 2012 - Number by Type of Molecule (%)
FIGURE 5.6 Total Drugs Market, 2012 - by Therapeutic Classes (USD BN, %)
FIGURE 5.7 Anti-rheumatics Drug Market, 2012 - by Leading Drugs (USD MM, %)
FIGURE 5.8 Multiple Sclerosis (MS) Therapies Market, 2012 - By Leading Drugs (USD MM, %)
FIGURE 5.9 Anticoagulants Market, 2012 - By Leading Drugs (USD MM, %)
FIGURE 5.10 Anti-Diabetes Market, 2012 - By Leading Drugs (USD MM, %)
FIGURE 5.11 Vaccines Market, 2012 - by Leading Vaccines (USD MM, %)
FIGURE 5.12 Sales of Some Leading Drugs Available in Prefilled Syringes, 2012 (USD MM)
FIGURE 5.13 Humira Sales, 2003-2012 - Abbott Laboratories (USD MM)
FIGURE 5.14 Enbrel Sales, 2002-2012 - Amgen (USD MM)
FIGURE 5.15 Copaxone Sales, 2001-2012 (USD MM)
FIGURE 5.16 Copaxone Unit Sales, 2000-2008 - By Vials and Prefilled Syringes (MM)
FIGURE 7.1 Becton Dickinson Medical, 2012 - Sales by Business Divisions (USD MM, %)
FIGURE 7.2 Gerresheimer, 2012 - Sales by Business Divisions (USD MM, %)
FIGURE 7.3 West Pharmaceutical Services, 2012 - Sales by Business Divisions (USD MM, %)
FIGURE 7.4 West Pharmaceutical Delivery Systems, 2011 - Sales by Product Line (USD MM, %)
FIGURE 8.1 Common Medication Errors (%)
FIGURE 8.2 Common Sources of Medication Errors (%)
FIGURE 8.3 Number of Biologics Approved by the US FDA, 2009-2012
FIGURE 8.4 Biosimilars in Development, 2011 (%) - by Stage of Development
TABLE 3.1 Pharmaceutical Filling Lines - Process Flow by Type of Prefilled Syringe
TABLE 3.2 Advantages of Glass as Barrel Material
TABLE 3.3 Advantages of Plastic Polymers as Barrel Material
TABLE 3.4 Some Glass Prefilled Syringes Available in the Market, 2013
TABLE 3.5 Some Plastic Prefilled Syringes Available in the Market, 2013
TABLE 3.6 List of Some Autoinjector Systems Using Prefilled Syringes
TABLE 4.1 Seasonal Flu Vaccines in the US, 2012-2013
TABLE 4.2 Population Over 65 in the US and Selected Countries in Europe, 2010, 2015 and 2020 (%)
TABLE 4.3 Some Drugs Approved in Prefilled Syringes Format in Japan, 2007-2012
TABLE 5.1 Anti-rheumatics Drug Market, 2012 - by Leading Drugs (USD MM, %)
TABLE 5.2 Anti-rheumatics Drug Available in Prefilled Syringes, 2012
TABLE 5.3 Anti-rheumatic Drugs - Patent Expiry and Biosimilar Development
TABLE 5.4 Multiple Sclerosis (MS) Therapies Market, 2012 - By Leading Drugs (USD MM, %)
TABLE 5.5 Anticoagulants Market, 2012 - By Leading Drugs (USD MM, %)
TABLE 5.6 Anti-Diabetes Market, 2012 - By Leading Drugs (USD MM, %)
TABLE 5.7 Vaccines Market, 2012 - by Leading Vaccines (USD MM, %)
TABLE 5.8 List of Other Drugs Sold in Prefilled Syringes
TABLE 5.9 List of Some Pipeline Drugs Using Prefilled Syringe Systems
TABLE 5.10 Contrast Agents Available in Prefilled Syringes, 2013
TABLE 6.1 Prefilled Syringes for Lyophilised Drugs
TABLE 8.1 SWOT Analysis of Prefilled Syringes Market
TABLE 8.2 Some Prefilled Syringe Recalls, 2003-2012
TABLE 10.1 Injectable Drug Delivery Devices Market, 2012 (USD BN)
TABLE 10.2 Prefilled Syringes Market, 2012 - By Type of Syringe Before Fill/Finish (USD BN, %)
TABLE 10.3 Prefilled Syringes Market, 2012 - By Material of Barrel (USD MM, %)
TABLE 10.4 Prefilled Syringes Market, 2012 - By Needle Type (USD BN, %)
TABLE 10.5 Injectable Drug Delivery Systems Market, Short - Mid Term Forecast, 2012-2018 (USD BN)
TABLE 10.6 Injectable Drug Delivery Systems Market, Long Term Forecast, 2018-2023 (USD BN)
TABLE 10.7 Global Prevalence of Diabetes, 2012 - By Countries (MM, %)
TABLE 10.8 Prefilled Syringes Market, 2012 - By Leading Regions (USD MM, %)
TABLE 10.9 Domestic Prefilled Syringe Manufacturers in China - Annual Production Capacities, 2012 (MM Units)
TABLE 10.10 Shandong Weigao - Revenue from Prefilled Syringes, 2009-2012
TABLE 10.11 Prefilled Syringes Market Forecast – By Leading Regions, Short-Mid Term, 2012 – 2018 (USD BN)
TABLE 10.12 Prefilled Syringes Market Forecast – By Leading Regions, Long Term, 2018 – 2023 (USD BN)
TABLE 10.13 Prefilled Syringes Market Share Forecast - By Leading Regions, 2012 - 2023 (%)
TABLE 10.14 Total Drugs Market (Prescription and OTC), 2012 - by Mode of Delivery (USD BN)
TABLE 10.15 Total Drugs Market (Prescription and OTC), 2012 - by Nature of Drug (USD BN)
TABLE 10.16 Drugs Market Forecast, Short - Mid Term Forecast (2012-2018) - Split by Biologics and Pharmaceuticals (USD BN)
TABLE 10.17 Drugs Market Forecast, Long Term Forecast (2012-2018) - Split by Biologics and Pharmaceuticals (USD BN)
TABLE 10.18 Biologic Drugs in Development, 2012 - Number by Type of Molecule
TABLE 10.19 Total Drugs Market, 2012 - by Therapeutic Classes (USD BN, %)
TABLE 10.20 List of Some Drugs Sold in Prefilled Syringes, 2012
TABLE 10.21 Humira Sales, 2003-2012 - Abbott Laboratories (USD MM)
TABLE 10.22 Enbrel Sales, 2002-2012 - Amgen (USD MM)
TABLE 10.23 Copaxone Sales, 2001-2012 (USD MM)
TABLE 10.24 Copaxone Unit Sales, 2000-2008 - By Vials and Prefilled Syringes (MM)
TABLE 10.25 Becton Dickinson Medical, 2012 - Sales by Business Divisions (USD MM, %)
TABLE 10.26 Gerresheimer, 2012 - Sales by Business Divisions (USD MM, %)
TABLE 10.27 West Pharmaceutical Services, 2012 - Sales by Business Divisions (USD MM, %)
TABLE 10.28 West Pharmaceutical Delivery Systems, 2011 - Sales by Product Line (USD MM, %)
TABLE 10.29 Biosimilars in Development, 2012 - by Stage of Development
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The following organisations have been mentioned in this report.
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