GBI Research, the leading business intelligence provider, has released its latest research, Innovation in the Prefilled Syringe Market Biologics and Autoinjection Devices Shaping Future R&D Trends, which provides insights into possible future avenues of R&D in the prefilled syringe market. This includes an overview of problems and possible solutions, as well as discussion of how the devices have developed to date to address problems with contamination, safety, fragility and ease of use.

The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Researchs team of industry experts.

The market for prefilled syringes is being driven by the rise in popularity of autoinjection devices for the home-use market. As health authorities seek to reduce costs, facilitating patients in self-administering their medication is one major way of reducing the strain on resources for providers. Additionally, patients prefer this option as it does not require them to travel to hospital and can be accommodated in their own home.

Innovation is also being driven by safety. This area has seen increasing innovation in response to regulations and guidelines concerning needlestick injury. This is an area of rising concern as the number of logged needlestick injuries in healthcare workers is high and thought to be considerably under-reported. Measures to ensure healthcare provider safety have been put in place, and pharmaceutical companies are responding by improving the safety of their prefilled syringes in order to increase their appeal and gain market share. Safety devices have moved from active devices, which require activation by the user, to passive, which are automatically activated. The next steps are being made in integrating the safety device into the needle during manufacture.

The development of injectable biologic therapies is a major factor in the future prospects of prefilled syringes. Although oral biologics are something that companies are aiming for and there are some in development, many peptides are broken down too quickly in the stomach and are therefore not useful in treatment. The mainstay of biologic treatment is likely to remain injectable, whether intravenous, subcutaneous or intramuscular, for the foreseeable future. As such, companies need to overcome the limitations of prefilled syringes in order to provide convenient method of administration and win market share.

• An overview of issues in the market.
• Innovative solutions to these problems.
• Future developments expected in the market by leading players

• Understand how the prefilled syringe market has adapted to issues.
• Predict which innovations are likely to be most successful in the future.
• Gain an understanding of areas of unmet need in the market

2 Innovation in Prefilled Syringes - Overview 6
2.1 Overview 6

3 Innovation in Prefilled Syringes - Introduction 7
3.1 What are Prefilled Syringes? 7
3.2 The Current Position of Prefilled Syringes in the Pharmaceutical Market 7
3.3 Factors Fueling Growth of Prefilled Syringes 7
3.4 Issues around the Use of Prefilled Syringes 8
3.5 Where Does Innovation Lie? 8

4 Innovation in Prefilled Syringes - Current Device Technologies and Associated Drivers and Barriers 9
4.1 Glass Syringes versus Plastic Syringes 9
4.1.1 Fragility 9
4.1.2 Dimensional Variability 9
4.1.3 Siliconization 9
4.1.4 Delamination 10
4.1.5 Tungsten Contamination 10
4.2 Autoinjection Devices 11
4.3 Safety Devices on Prefilled Syringes 11
4.4 Prefilled Diluent Syringes 12
4.5 Biologics Driving Innovation in Prefilled Syringes 12

5 Innovation in Prefilled Syringes - Formulation Considerations and Challenges for Pharmaceutical Companies 13
5.1 Drug Viscosity 13
5.2 Extractables and Leachables 13
5.3 Lyophilized Drugs versus Liquid-stable Formulations 14

6 Innovations in Prefilled Syringes - Overcoming Current Barriers and Trends in Development 15
6.1 Innovative Ways of Gaining Life Cycle Extensions for Existing Products 15
6.2 Plastic Syringes Offer Some Improvements over Traditional Glass Syringes 16
6.2.1 Polypropylene 16
6.2.2 Cyclo-olefin Polymers and Co-polymers 16
6.3 Extractables and Leachables 18
6.3.1 Glass Coatings - Reducing Silicone and Silicone Baking 18
6.3.2 Coated Stoppers 18
6.4 Safety Innovations 19
6.5 Integrated Needles - Advancements on the Luer Lock System 20
6.6 Filling Technologies and Removing the Air Bubble 20
6.7 Needle Length - Reducing Length can Increase Accuracy of Subcutaneous Injections 20
6.8 Manufacturing Advances - Sterilizing Syringes 21
6.8.1 Restricted Access Barrier Systems 21
6.8.2 Electron Beam Sterilization Tunnels 21
6.9 Automating and Streamlining the Manufacture of Prefilled Syringes 22
6.10 Manufacturing Flexibility and Integrated Systems 22
6.11 Testing of Prefilled Syringes 23
6.12 Customization of Prefilled Syringes 23
6.13 Self-injection Improvements 24
6.14 Patient-centric Focus for CMOs 24

7 Appendix 25
7.1 Market Definitions 25
7.2 Abbreviations 25
7.3 Bibliography 25
7.4 Research Methodology 26
7.4.1 Coverage 26
7.4.2 Secondary Research 27
7.4.3 Primary Research 27
7.4.4 Expert Panel Validation 27
7.5 Contact Us 28
7.6 Disclaimer 28