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Contents
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
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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
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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
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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
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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
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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
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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
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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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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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