Pre-Filled Syringes: World Industry and Market Prospects 2014-2024

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1. Executive Summary
1.1 Pre-Filled Syringes: World Market Outlook 2014-2024 1.2 Report Contents 1.2.1 Benefits of this Report 1.3 Report Methodology 1.3.1 Who is this Report for? 1.3.2 Defining the Pre-Filled Syringe Market

2. An Introduction to the Pre-Filled Syringe Market

2.1 A Brief History of Pre-Filled Syringes 2.2 Design and Manufacture of Pre-Filled Syringes 2.2.1 Glass and Plastic Syringes 2.2.2 Safety and the Pre-Filled Syringe Market 2.2.2.1 Concerns over Needlestick Injuries 2.3 An Introduction to Pen Injectors and Autoinjectors 2.3.1 Pen Injectors and Autoinjectors Offer Advantages in Self-Administration 2.3.2 What Determines Injection Device Choice? 2.4 Future Directions for Pre-Filled Syringes

3. Pre-Filled Syringes: World Market Outlook and Forecast 2014-2024

3.1 The World Pre-Filled Syringe Market 2012-2013 3.1.1 Rapid Growth in Demand and Revenues in the Last Decade 3.1.2 Pre-Filled Syringes as a Share of the Global Drug Delivery Market 3.1.3 Pre-Filled Syringe Market Breakdown by Device 2012 3.2 Growth in the Pre-Filled Syringe Market 2014-2024 3.2.1 Pre-Filled Syringe Market Forecast 2014-2024

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3.2.2 Pre-Filled Syringe Unit Sales Forecast 2014-2024 3.2.3 Biologics and Other Market Drivers for this Decade 3.2.3.1 Market Genericisation and Pre-Filled Syringes 3.2.3.2 The Injectable Drug Pipeline is Long 3.2.4 What Will Restrain Market Growth to 2024? 3.2.5 Leading Submarket Revenue Shares 2014-2024 3.3 The Glass Pre-Filled Syringe Submarket 2014-2024 3.3.1 Steady Growth for the Glass Pre-Filled Syringe Submarket 2014-2024 3.3.2 New Manufacturing Processes to Drive Submarket Growth to 2024 3.4 The Plastic Pre-Filled Syringe Submarket 2014-2024 3.4.1 Rapid Growth Forecast for the Plastic Pre-Filled Syringe Submarket to 2024 3.4.2 Plastic Pre-Filled Syringe Submarket Drivers and Restraints 2014-2024 3.5 The Pen Injector and Autoinjector Submarket 2014-2024 3.5.1 Growth in the Pen Injector and Autoinjector Submarket to 2024 3.5.2 High Demand for Simplified Self-Administration Devices 3.5.3 Insulin and Other Biologics to Lead Market Growth

4. Leading National Markets for Pre-Filled Syringes 2014-2024

4.1 Leading National Markets for Pre-Filled Syringes 2012-2013 4.2 National Pre-Filled Syringe Market Forecasts 2014-2024 4.2.1 How Will National Market Shares Change to 2024? 4.3 The US Pre-Filled Syringe Market Forecast 2014-2024 4.3.1 New Drug and Device Launches to Drive Growth to 2024 4.4 Leading EU Nations: National Pre-Filled Syringe Submarket Forecasts 2014-2024 4.4.1 Biosimilars and Growth in the EU Pre-Filled Syringe Submarket 2014-2024 4.5 Pre-Filled Syringes in Japan: Market Outlook and Forecast 2014-2024 4.6 Pre-Filled Syringes in Emerging Markets 2014-2024 4.6.1 Pre-Filled Syringe Manufacturers Are Investing in Emerging Markets 4.6.2 China: The Leading Emerging Pre-Filled Syringe Submarket 2014-2024

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4.6.3 India: Double-Digit Growth Forecast 2014-2024 4.6.4 Brazil: Biologics Growth to Lead to Higher Demand for Pre-Filled Syringes 2014-2024 4.6.5 Russia: Submarket Forecast 2014-2024

5. Outlook for Leading Therapeutic Sectors for Pre-Filled Syringes 2014-2024

5.1 Leading Therapeutic Sectors for Pre-Filled Syringes and Other Injection Devices 2012-2013 5.1.1 Vaccines and Heparins Are Major Market Sectors 2012-2013 5.1.2 Rising Demand in Chronic Conditions: Autoimmune Diseases and Diabetes 5.1.3 Growth for Key Market Sectors 2014-2024 5.2 Pre-Filled Syringes and Pen Injectors for Diabetes 2014-2024 5.2.1 Insulin Market Forecast 2014-2024 5.2.2 High Rates of Pen Injector Use in the EU and Japan 5.2.3 Insulin Pumps: A Technology to Challenge Pen Injectors to 2024? 5.2.4 The Prospects for Biosimilar Insulin in Developed and Emerging Markets 5.2.4.1 Injection Devices for Biosimilar Insulin Products 5.3 Rheumatoid Arthritis: Leading Biologics Dominate the Market 2013 5.3.1 Rheumatoid Arthritis Market Forecast 2014-2024 5.3.2 All Major Injectable Therapies Are Marketed in Proprietary Devices 5.3.3 Novel Injection Systems for RA: Meeting the Needs of Patients 5.3.4 The Threat from Oral Therapies to 2024 5.4 Self-Injection for Multiple Sclerosis: Outlook 2014-2024 5.4.1 Multiple Sclerosis Market Forecast 2014-2024 5.4.2 Reusable Autoinjectors for Interferon Beta Therapy 5.4.3 Oral Therapies to Drive MS Market Growth in this Decade 5.5 Growth Hormones Market Outlook and Forecast 2014-2024 5.5.1 Growth Hormone Market Forecast 2014-2024 5.5.2 Biosimilar Growth Hormones and Pen Injectors 5.5.3 Uptake of Needle-Free Injectors for Growth Hormone Administration

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5.6 Pre-Filled Heparin Syringes 2014-2024 5.6.1 One Brand Leads the Heparin Market, 2012-2013 5.6.2 Pre-Filled Syringes for LMWHs 5.6.3 Heparin Market Forecast 2014-2024 5.6.4 Follow-On Heparins: Biosimilars or Generics? 5.7 The Vaccine Market Outlook 2014-2024 5.7.1 Vaccine Market Forecast 2014-2024 5.7.2 Single-Use Devices for Vaccine Delivery 5.7.2.1 BD Uniject: A Private-Public Collaboration 5.7.3 Needle-Free Injectors for Vaccines

6. Leading Pre-Filled Device Therapies 2014-2024

6.1 Leading Insulin Therapies Using Pen Injectors 2014-2024 6.1.1 Lantus: The Worlds Bestselling Insulin Analogue 6.1.1.1 SoloSTAR, ClikSTAR and AllSTAR: Three Pen Injectors for Lantus 6.1.1.2 Outlook for Lantus 2014-2024 6.1.2 NovoLog: The Leading Fast-Acting Insulin 6.1.2.1 NovoLog FlexPen: Room Temperature Storage for Patient Convenience 6.1.2.2 Faster-Acting Insulin in Development 6.1.3 Humalog 6.1.3.1 Humalog: HumaPen and KwikPen 6.1.3.2 Humalog Revenue Forecast 2014-2024 6.2 Top Biologics for Rheumatoid Arthritis: Device Outlook to 2024 6.2.1 Humira: The Biggest Selling Drug in 2012 6.2.1.1 The Humira Pen Is an Innovative Delivery Device 6.2.1.2 Steady Revenue Growth for Humira to 2017 6.2.2 Enbrel 6.2.2.1 Pre-Filled Injection Devices Available for Enbrel 2013 6.2.2.2 Protected from Biosimilars for this Decade?

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6.3 Multiple Sclerosis: Leading Injectable Therapies 2014-2024 6.3.1 Copaxone: An Injectable Non-Interferon Therapy 6.3.1.1 Copaxone Uses the Autoject 2 Autoinjector from Owen Mumford 6.3.1.2 Next-Generation Copaxone and Generics Expected in 2014 6.3.2 Avonex 6.3.2.1 Biogen Idec Launches the Avonex Pen 2011 6.3.2.2 Outlook for Avonex 2014-2024 6.3.3 Rebif 6.3.3.1 Self-Injection Options for Rebif: Rebiject II, RebiSmart and RebiDose 6.3.3.2 Rebif: A Similar Outlook to Avonex to 2024? 6.4 Two Growth Hormones Dominate the Market 2013 6.4.1 Norditropin: Outlook 2014-2024 6.4.2 Genotropin: Outlook and Revenue Forecast 2014-2024 6.5 Outlook for Leading Heparin Products 2014-2024 6.5.1 Lovenox: Generic Competition in the US Since 2010 6.5.1.1 Lovenox: Revenue Forecast 2014-2024 6.5.2 Arixtra and Fragmin

7. Pre-Filled Syringes: Industry Trends 2014-2024

7.1 Pre-Filled Syringes Market: Strengths and Weaknesses 2012-2013 7.1.1 Pre-Filled Syringes Offer Many Benefits Over Other injection Technologies 7.2 Pre-Filled Syringes Market: Opportunities and Threats 2014-2024 7.2.1 Pre-Filled Syringes Face Challenges from Other Technologies 7.3 Pre-Filled Syringes Market: STEP Analysis 2014-2024 7.3.1 Social Factors: Rising Disease Incidence and Demand for At-Home Care 7.3.2 Technological Developments: Improved Safety and Administration 7.3.3 Economic Pressures: Pre-Filled Syringes Are Cost Efficient 7.3.3.1 High Barriers to Market Entry Exist 7.3.4 Political Issues: Regulatory Developments for Pre-Filled Syringes

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7.4 Regulatory and Safety Outlook for Pre-Filled Syringes 2014-2024 7.4.1 Needlestick Safety and Prevention 7.4.2 International Regulations for Needlestick Prevention 7.4.2.1 The US: The First Country to Introduce Needlestick Legislation 7.4.2.2 The EU: New Rules from 2013 Onwards 7.4.2.3 Needlestick Safety in Japan 2014-2024 7.4.2.4 Legislation for Needlestick Safety in Emerging Markets 7.4.3 Manufacturers Will Continue to Develop New Devices for Needlestick Prevention 7.4.3.1 Ancillary versus Integrated Safety Devices 7.4.4 Extractables and Leachables 7.4.4.1 Companies Will Reduce Sources of Extractables and Leachables 7.4.5 Products that Minimise Extractables and Leachables 7.4.5.1 Protein Aggregation: The Challenge of Biological Drugs 7.4.5.2 Regulatory Requirements for Extractables and Leachables 2013 7.5 Biologics and the Pre-Filled Syringes Market 2014-2024 7.5.1 Manufacturing Pre-Filled Syringes for Biologics: Glass versus Plastic 7.5.2 Biologics Provide New Challenges for Device Manufacturers 7.5.2.1 Lyophilised Drugs and Dual-Chamber Devices 7.5.3 Delivery Opportunities for High Viscosity Drugs 7.5.4 Are Biosimilars an Opportunity for Pre-Filled Syringe Manufacturers? 7.6 The Role of Patients in Pre-Filled Syringe Industry Development and Growth 7.6.1 Chronic Disease Incidence 2014-2024 7.6.2 The Rise in At-Home Care 7.6.3 Improving Patient Adherence 7.6.4 Injection Devices Must be Developed for Patient Convenience: Human Factor Engineering 7.7 Technological Developments in Pre-Filled Syringes to 2024 7.7.1 Product Differentiation Will be Vital in Crowded Treatment Markets 7.7.1.1 Product Customisation: Adapting Injection Devices 7.7.2 Trends in Manufacturing Materials for Pre-Filled Syringes

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7.7.3 Competing Technologies Will Challenge Pre-Filled Syringes 7.7.3.1 Will Needle-Free Devices Become a Significant Competing Technology? 7.7.3.2 Patients Prefer Oral Drug Delivery 7.8 Outsourcing in the Pre-Filled Syringe Industry 7.8.1 Contract Medical Device Manufacturing 7.8.2 Contract Filling of Pre-Filled Syringes

8. Leading Pre-Filled Syringe and Related Technology Manufacturers 2013

8.1 Leading Pre-Filled Syringe Manufacturers 2013 8.1.1 BD Is the Clear Market Leader 8.1.1.1 New Product Launches 2013 8.1.1.2 Outlook for BDs Pre-Filled Syringes 2014-2024 8.1.2 Gerresheimer: Glass and Plastic Syringes and Pen Injectors 8.1.2.1 Gerresheimer: Recent Performance and Outlook 8.1.3 Schott 8.1.3.1 Schott Reports Rising Demand for Plastic Syringes 8.1.4 Nipro Is a Market Leader through its MGlas Acquisition 8.1.5 Nuova Ompi 8.1.5.1 Expansion Planned to 2016 8.1.6 Emerging Market Players 8.1.6.1 Weigao: Pre-Filled Syringes for China and Beyond 8.1.6.2 Unilife: Pre-Filled Safety Syringes 8.1.6.3 Roselabs Entered the Market in 2012 8.2 Leading Pen Injector and Autoinjector Manufacturers 2013 8.2.1 SHL Group 8.2.1.1 Growth for SHL Group 2014-2024 8.2.2 Ypsomed 8.2.2.1 Pen Injector Revenue Returning to Growth in 2014

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8.2.3 Haselmeier 8.2.3.1 Haselmeier Is Looking to Expand Globally 8.2.4 Owen Mumford 8.2.4.1 Outlook for Owen Mumford 2014-2024 8.2.5 Other Leading and Emerging Autoinjector Manufacturers 8.3 Leading Pre-Filled Syringe Component Manufacturers 2013 8.3.1 Datwyler 8.3.1.1 Datwyler: Growth Prospects 2014-2024 8.3.2 West Pharmaceutical Services 8.3.2.1 Expanding Manufacturing in Emerging Markets

9. Expert Opinion
9.1 Richard Harrison, Business Development Manager, Injectables, Bespak Europe 9.1.1 Bespak 9.1.2 Unmet Needs and Future Directions for Autoinjectors 9.1.3 Challenges in Developing Autoinjectors 9.1.4 Trends from Drug Development Impacting Device Manufacturers 9.2 David Daily, Director R&D and BD, Injectable Delivery Devices, Elcam Medical and CEO, DALI Medical Devices 9.2.1 Elcam Medical 9.2.2 Key Unmet Needs and Challenges for Pre-Filled Syringes and Autoinjectors 9.2.3 Advantages of Pre-Filled Syringes over Other Modes of Drug Delivery 9.2.4 Growth in the Pre-Filled Syringe Market to 2024 9.3 West Pharmaceutical Services 9.3.1 Changes in Demand for Pre-Filled Syringes 9.3.2 Future Expectations for the Pre-Filled Syringe Market 9.3.3 The Role of Emerging Markets in Pre-Filled Syringe Growth 9.3.4 Drug Development Trends Impacting Device Manufacturers to 2024

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10. Conclusions from our Study
10.1 Pre-Filled Syringe Market Overview 2012-2013 10.1.1 Glass Syringes Dominate in 2013 10.2 Pre-Filled Syringe Market Growth 2014-2024 10.2.1 Commercial Drivers for Pre-Filled Syringes 10.3 The Future of Pre-Filled Injection Devices

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List of Tables
Table 1.1 Currency Exchange Rates Table 3.1 Pre-Filled Syringe Market: Revenue ($bn) and Units (bn), 2012-2013 Table 3.2 Pre-Filled Syringe Market by Sector: Revenue ($bn) and Units (bn), 2012 Table 3.3 Pre-Filled Syringe Market: Overall Market and Revenue Forecasts ($bn) by Sector, 2012-2024 Table 3.4 Pre-Filled Syringe Market: Overall Market Unit Forecasts (bn) by Sector, 2012-2024 Table 3.5 Pre-Filled Syringe Market Revenue: Submarket Shares (%), 2012-2024 Table 3.6 Glass Pre-Filled Syringe Submarket: Revenue Forecast ($bn), 2012-2024 Table 3.7 Selected Proprietary Polymers for Plastic Pre-Filled Syringes, 2013 Table 3.8 Plastic Pre-Filled Syringe Submarket: Revenue Forecast ($bn), 2012-2024 Table 3.9 Pen Injector and Autoinjector Submarket: Revenue Forecast ($bn), 2012-2024 Table 4.1 Pre-Filled Syringe Market: Revenues ($bn) by Country, 2012-2013 Table 4.2 Pre-Filled Syringe Market: Regional and National Submarket Revenue Forecasts ($bn), 2012-2024 Table 4.3 Pre-Filled Syringe Market: National Submarket Shares (%) Table 4.4 US Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024 Table 4.5 European Pre-Filled Syringe Market: Leading National Submarket Revenue Forecasts ($bn), 2012-2024 Table 4.6 Japanese Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024 Table 4.7 Chinese Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024 Table 4.8 Indian Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024 Table 4.9 Brazilian Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024 Table 4.10 Russian Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024 Table 5.1 Pen Manufacturing Agreements for Leading Insulin Brand Manufacturers, 2013 Table 5.2 Selected Biosimilar Insulin Pen Injectors, 2013 Table 5.3 Insulin Market: Revenue Forecast ($bn), 2012-2024 Table 5.4 Rheumatoid Arthritis Market: Revenue Forecast ($bn), 2012-2024

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Table 5.5 Interferon Beta Therapies for MS, 2013 Table 5.6 Oral Therapies Launched for MS, 2010-2013 Table 5.7 Multiple Sclerosis Market: Revenue Forecast ($bn), 2012-2024 Table 5.8 Growth Hormone Market: Revenue Forecast ($bn), 2012-2024 Table 5.9 Selected Emerging Market Biosimilar Growth Hormones, 2013 Table 5.10 Heparin Market: Revenue Forecast ($bn), 2012-2024 Table 5.11 Vaccine Market by Company: Revenues ($bn), 2012 Table 5.12 Vaccines Market: Revenue Forecast ($bn), 2012-2024 Table 6.1 Leading Pre-Filled Insulin Therapies: Revenues ($bn), 2008-2012 Table 6.2 Lantus: Revenue Forecast ($bn), 2012-2024 Table 6.3 NovoLog: Revenue Forecast ($bn), 2012-2024 Table 6.4 Humalog: Revenue Forecast ($bn), 2012-2024 Table 6.5 Leading Pre-Filled Rheumatoid Arthritis Therapies: Revenues ($bn), 2010-2012 Table 6.6 Humira: Revenue Forecast ($bn), 2012-2024 Table 6.7 Enbrel: Revenue Forecast ($bn), 2012-2024 Table 6.8 Leading Pre-Filled Multiple Sclerosis Therapies: Revenues ($bn), 2008-2012 Table 6.9 Copaxone: Revenue Forecast ($bn), 2012-2024 Table 6.10 Avonex: Revenue Forecast ($bn), 2012-2024 Table 6.11 Rebif: Revenue Forecast ($bn), 2012-2024 Table 6.12 Leading Pre-Filled Growth Hormone Therapies: Revenues ($bn), 2010-2012 Table 6.13 Norditropin: Revenue Forecast ($bn), 2012-2024 Table 6.14 Genotropin: Revenue Forecast ($bn), 2012-2024 Table 6.15 Leading Pre-Filled Heparins: Revenues ($bn), 2010-2012 Table 6.16 Lovenox: Revenue Forecast ($bn), 2012-2024 Table 7.1 Pre-Filled Syringe Market: Strengths and Weaknesses, 2012-2013 Table 7.2 Benefits and Weaknesses to Pre-Filled Syringes as an Injectable Delivery Device, 2013 Table 7.3 Pre-Filled Syringe Market: Opportunities and Threats, 2014-2024 Table 7.4 Pre-Filled Syringe Market: STEP Analysis, 2014-2024 Table 7.5 Leading Market Participants: Broad Product Portfolios, 2013 Table 7.6 Hepatitis B and C: Prevalence by Country, 2013

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Table 7.7 Selected Safety Products for Pre-Filled Syringes, 2013 Table 7.8 Selected Pre-Filled Injection Devices for Lyophilised Drugs, 2013 Table 7.9 Leading Blockbuster Biologic Patent Expiries in the US and EU, 2013-2028 Table 7.10 Pre-Filled Syringe Manufacturers: Alternative Injectable Technologies, 2013 Table 7.11 Selected Insulin Pumps Available, 2013 Table 7.12 Oral Drug Competitors for Leading Pre-Filled Syringe Therapeutic Sectors, 2014-2024 Table 7.13 Selected Leading CMOs: Pre-Filled Syringe Filling Capabilities, 2013 Table 8.1 BD: Pre-Filled Injection Systems, 2013 Table 8.2 BD Medical - Pharmaceutical Systems: Revenue ($bn), 2008-2012 Table 8.3 Gerresheimer: Revenue ($bn) by Division, 2010-2012 Table 8.4 Schott: Revenue ($bn), 2011-2012 Table 8.5 Weigao: Pre-Filled Syringe Revenue ($m) and Production Volume, 2010-2012 Table 8.6 Unilife: Pre-Filled Syringe Product Portfolio, 2013 Table 8.7 Unilife: Revenue ($m), 2008-2013 Table 8.8 SHL Group: Pen Injector and Autoinjector Portfolio, 2013 Table 8.9 Ypsomed: Pen Injector and Autoinjector Portfolio, 2013 Table 8.10 Ypsomed Delivery Devices: Revenue ($bn), 2009-2013 Table 8.11 Haselmeier: Pen Injector and Autoinjector Portfolio, 2013 Table 8.12 Owen Mumford: Pen Injector and Autoinjector Portfolio, 2013 Table 8.13 Owen Mumford: Revenue ($bn), 2009-2012 Table 8.14 Datwyler Pharma Packaging: Revenue ($bn), 2007-2012 Table 8.15 West Pharmaceutical Services: Revenue ($bn) by Division, 2009-2012 Table 9.1 Bespak: Needle-Free Injectors, 2013 Table 10.1 Pre-Filled Syringe Market: Revenue Forecasts ($bn) and Market Shares (%) by Sector, 2012-2024 Table 10.2 Pre-Filled Syringe Market: Revenue Forecasts ($bn) and Market Shares (%) by Region, 2012-2024

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List of Figures
Figure 2.1 Key Events in the Pre-Filled Syringe Market History, 1954-2000 Figure 2.2 Major Trends for Pre-Filled Syringe Market Growth, 2014-2024 Figure 3.1 Pre-Filled Syringe Market: Revenue ($bn) and Units (bn), 2012-2013 Figure 3.2 Pre-Filled Syringe Market: Revenue Share (%) by Sector, 2012 Figure 3.3 Pre-Filled Syringe Market: Unit Share (%) by Sector, 2012 Figure 3.4 Pre-Filled Syringe Market Forecast ($bn), 2012-2024 Figure 3.5 Pre-Filled Syringe Market Unit Forecast (bn), 2012-2024 Figure 3.6 Pre-Filled Syringe Unit Share (%) by Sector, 2012-2024 Figure 3.7 Pre-Filled Syringes Market: Drivers, 2014-2024 Figure 3.8 Pre-Filled Syringes Market: Restraints, 2014-2024 Figure 3.9 Pre-Filled Syringe Market Revenue: Submarket Shares (%), 2018 Figure 3.10 Pre-Filled Syringe Market Revenue: Submarket Shares (%), 2024 Figure 3.11 Glass Pre-Filled Syringe Submarket: Revenue Forecast ($bn), 2012-2024 Figure 3.12 Glass Pre-Filled Syringe Submarket: Drivers and Restraints, 2014-2024 Figure 3.13 Plastic Pre-Filled Syringe Submarket: Revenue Forecast ($bn), 2012-2024 Figure 3.14 Plastic Pre-Filled Syringe Submarket: Drivers and Restraints, 2014-2024 Figure 3.15 Pen Injector and Autoinjector Submarket: Revenue Forecast ($bn), 2012-2024 Figure 3.16 Pen Injector and Autoinjector Submarket: Drivers and Restraints, 2014-2024 Figure 4.1 Pre-Filled Syringe Market: Revenues ($bn) by Region, 2012-2013 Figure 4.2 Pre-Filled Syringe Market: National Submarket Shares (%), 2018 Figure 4.3 Pre-Filled Syringe Market: National Submarket Shares (%), 2024 Figure 4.4 US Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024 Figure 4.5 French and German Pre-Filled Syringe Submarket Forecasts ($bn), 2012-2024 Figure 4.6 Italian, UK and Spanish Pre-Filled Syringe Submarket Forecasts ($bn), 2012-2024 Figure 4.7 Japanese Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024 Figure 4.8 Chinese Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024 Figure 4.9 Indian Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024

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Figure 4.10 Brazilian Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024 Figure 4.11 Russian Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024 Figure 5.1 Insulin Market: Revenue Forecast ($bn), 2012-2024 Figure 5.2 Rheumatoid Arthritis Market: Revenue Forecast ($bn), 2012-2024 Figure 5.3 Multiple Sclerosis Market: Revenue Forecast ($bn), 2012-2024 Figure 5.4 Growth Hormone Market: Revenue Forecast ($bn), 2012-2024 Figure 5.5 Heparin Market: Revenue Forecast ($bn), 2012-2024 Figure 5.6 Vaccines Market: Revenue Forecast ($bn), 2012-2024 Figure 6.1 Lantus: Revenue Forecast ($bn), 2012-2024 Figure 6.2 NovoLog: Revenue Forecast ($bn), 2012-2024 Figure 6.3 Humalog: Revenue Forecast ($bn), 2012-2024 Figure 6.4 Humira: Revenue Forecast ($bn), 2012-2024 Figure 6.5 Enbrel: Revenue Forecast ($bn), 2012-2024 Figure 6.6 Copaxone: Revenue Forecast ($bn), 2012-2024 Figure 6.7 Avonex: Revenue Forecast ($bn), 2012-2024 Figure 6.8 Rebif: Revenue Forecast ($bn), 2012-2024 Figure 6.9 Norditropin: Revenue Forecast ($bn), 2012-2024 Figure 6.10 Genotropin: Revenue Forecast ($bn), 2012-2024 Figure 6.11 Lovenox: Revenue Forecast ($bn), 2012-2024 Figure 7.1 Hepatitis B and C: Prevalence by Country, 2013 Figure 7.2 World Biologics Market: Revenue Forecast ($bn), 2012-2024 Figure 7.3 World Biosimilars Market: Revenue Forecast ($bn), 2012-2024 Figure 8.1 BD Medical - Pharmaceutical Systems: Revenue ($bn), 2008-2012 Figure 8.2 Gerresheimer: Revenue ($bn) by Division, 2010-2012 Figure 8.3 Schott: Revenue ($bn), 2011-2012 Figure 8.4 Weigao: Pre-Filled Syringe Revenue ($m) and Production Volume, 2010-2012 Figure 8.5 Unilife: Revenue ($m), 2008-2013 Figure 8.6 Ypsomed Delivery Devices: Revenue ($bn), 2009-2013 Figure 8.7 Owen Mumford: Revenue ($bn), 2009-2012 Figure 8.8 Datwyler Pharma Packaging: Revenue ($bn), 2007-2012

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Figure 8.9 West Pharmaceutical Services: Revenue ($bn) by Division, 2009-2012 Figure 10.1 Pre-Filled Syringe Market: Revenue Forecast ($bn) by Sector, 2012-2024 Figure 10.2 Pre-Filled Syringe Market: Revenue Forecast ($bn) by Region, 2012-2024

Companies and Other Organisations Mentioned in this Report

AbbVie Accu-Chek (part of Roche) Ach Aesica Pharmaceuticals AI Biosciences Albany Molecular Research Inc (AMRI) Althea Technologies Amega Biotech Amgen Animas Antares Pharma Aptar Pharma (part of AptarGroup) Aptar Stelmi (part of AptarGroup) AptarGroup Batelle Baxter BioPharma Solutions Bayer Becton, Dickinson & Co. (BD) Berlin-Chemie (part of Menarini Group) Bespak Biocon BioConnection Biodel

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Biogen Idec Bioject Medical Technologies Biosidus Boehringer Ingelheim Boehringer Ingelheim BioXcellence (part of Boehringer Ingelheim) Bristol-Myers Squibb Cambridge Consultants Carl Zeiss Foundation Catalent Pharma Solutions Centers for Disease Control and Prevention (CDC) China Food and Drug Administration (CFDA) Cipla Consort Medical Cosmo Pharmaceuticals Crossject Daikyo Seiko DALI Medical Devices Datwyler Disetronic Group (part of Roche) Dong-A Pharmaceutical Dr. Reddys Laboratories Drug Controller General of India (DCGI) Duoject Medical Systems Eisai Elcam Medical Eli Lilly Emisphere European Medicines Agency (EMA) FDA Office of Device Evaluation [US] Ferring Pharmaceuticals

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Future Injection Technologies (FIT) Gan & Lee Pharmaceuticals GAVI Alliance Genentech (part of Roche) GeneScience Pharmaceuticals (GenSci) Gerresheimer GSK Haselmeier Haselmeier Inc. (part of Haselmeier) Hospira Hospira One2One (part of Hospira) Hyaluron Contract Manufacturing (HCM, part of AMRI) Incepta Pharmaceuticals Insulet J&J Jabil Circuit Janssen Biotech (part of J&J) Johns Hopkins University LG Life Sciences Marvel Life Sciences Massachusetts Institute of Technology (MIT) Medimop Medical Projects (part of West) Medtronic Merck & Co. Merck Serono (part of Merck KGaA) MG Sterile Products (part of Nipro) MGlas (part of Nipro) Ministry of Health, Labor and Welfare (MHLW) [Japan] Ministry of Labour and Employment [Brazil] Mitsubishi Tanabe Pharma

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National Health Service (NHS) [UK] Nektar Therapeutics Nipro Novartis Novo Nordisk Nuova Ompi (part of Stevanato Group) Nypro (part of Jabil Circuit) Occupational Safety and Health Administration (OSHA) [US] Optrel (part of Stevanato Group) Oval Medical Owen Mumford PA Consulting Group PATH Pfizer PharmaJet Pharmstandard Phillips Medisize Plastef Investissements Polfa-Tarchomin Primequal Revolutions Medical Rexam Roche Roselabs Roselabs Bioscience (part of Roselabs) ROVI CM Safety Syringes (part of BD) Sandoz (part of Novartis) Sanofi Sanofi Pasteur

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Savient Pharmaceuticals Schering-Plough (part of Merck & Co.) Schott Schott Kaisha Schott Xinkang Pharmaceutical Packaging SciGen Shanghai Celgen Bio-Pharmaceutical Shanghai CP Guojian Pharmaceutical SHL Group Spami (part of Stevanato Group) Specialty Coating Systems (SCS) Square Pharmaceuticals Stevanato Group Swedish Orphan Biovitrum (Sobi) Taisei Kako Terumo Teva Pharmaceutical Industries The Medical House (part of Bespak) tip-top Tonghua Dongbao Pharmaceutical UCB UNICEF Unilife University of Virginia US Agency for International Development US Food and Drug Administration (FDA) Vetter Pharma Weigao Group West Pharmaceutical India Packaging Private (part of West) West Pharmaceutical Services

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Wockhardt World Health Organization (WHO) Wyeth (part of Pfizer) Ypsomed Zeon Corporation

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Pre-Filled Syringes: World Industry and Market Prospects 2014-2024

that will challenge pre-filled syringes, pen injectors and autoinjectors in this decade include needlefree injection systems (considered for the purposes of this report to be a different technology) and patch injectors. Other administration routes are being assessed for many leading therapies, including nasal administration for influenza vaccines. Pre-filled syringes are higher cost to manufacture than vials, which may limit uptake in low-income countries. Additional cost factors that may restrain growth in emerging markets included the added storage space required for syringes over vials, which will be a consideration for biological drugs that must be stored and transported under cold chain conditions.

Figure 3.8 Pre-Filled Syringes Market: Restraints, 2014-2024

Extended-release drugs will lead to less frequent injections and, hence, fewer devices required Pre-filled syringe units are higher cost to manufacture than vials

Smaller drug batches for products targeting niche indications and personalised medicine Oral therapies and other drug delivery technologies will challenge standard injectable technologies Pre-filled syringes require increased storage space, resulting in higher cost transportation, particularly for cold chain products

Source: visiongain 2013 Two further restraints on growth in the pre-filled syringe market are the development of extendedrelease formulations and the number of pipeline projects targeting niche indications with small patient populations. Both of these factors will reduce demand for pre-filled syringes. For extended-

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Pre-Filled Syringes: World Industry and Market Prospects 2014-2024

(etanercept) autoinjector was only launched in Japan in 2013, whereas it was first launched in the EU in 2005 and in the US in 2006. Between 2012 and 2024, the Japanese pre-filled syringe submarket will grow with a CAGR of 6.0%, reaching a value of $0.62bn by the end of that period (Table 4.6 and Figure 4.7). Growth will be driven by uptake of autoinjectors in that submarket, as well as growing use of plastic syringes. Rising diabetes incidence will drive demand for insulin pens. Demand for new injection systems will also be driven by the development and launch of new biologics. Companies looking to launch drugs and devices in Japan after the US will benefit from similar regulatory requirements for combination products. Biosimilars will be less of a growth driver here than in the US and EU, we believe. Although follow-on drug use has grown dramatically in recent years in Japan, it still remains below levels in other developed markets. Biosimilars will have a similar impact in this submarket.

Figure 4.7 Japanese Pre-Filled Syringe Submarket Forecast ($bn), 2012-2024

0.65

0.60

0.55 Submarket Size ($bn)

0.50

0.45

0.40

0.35

0.30 2012

2013

2014

2015

2016

2017

2018 Year

2019

2020

2021

2022

2023

2024

Source: visiongain 2013

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Table 8.7 Unilife: Revenue ($m), 2008-2013
2008 Revenue ($m) Annual Growth (%) CAGR (%) 4 2009 20 471 2010 11 -43 2011 7 -42 2012 6 -17 2013 3 -50 -4.8

Source: Unilife annual reports 2013, visiongain 2013

Figure 8.5 Unilife: Revenue ($m), 2008-2013

25

20

Revenue ($m)

15

10

0 2008 2009 2010 Year 2011 2012 2013

Source: Unilife annual reports 2013, visiongain 2013

8.1.6.3 Roselabs Entered the Market in 2012

Roselabs Bioscience, part of the Roselabs Group, is the newest manufacturer of pre-filled syringes in the market. That company opened its manufacturing facility in India at the end of 2012, investing more than $70m in this new sector. The company reports that its new manufacturing facility is capable of producing 800,000 syringes per day. It manufactures both glass and plastic pre-filled syringes. The company reported plans to open a plant manufacturing more than 150 million prefilled syringes per year. However, Roselabs is not just manufacturing and selling ready-to-fill syringes. Like BD, the company has launched a range of generic injectables in its pre-filled syringes. The company is targeting emerging markets in Asia and Latin America for sales of these products. In August 2013, Roselabs announced a marketing agreement with an unnamed Brazilian company to launch the range of injectables in that market.

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