Innovation in the Prefilled Syringe Market - Biologics and Autoinjection Devices Shaping Future R&D Trends by GBIResearch

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									Innovation in the Prefilled Syringe Market
Biologics and Autoinjection Devices Shaping Future R&D Trends
GBI Research Report Guidance




                                              GBI Research Report Guidance
                                              The report discusses the innovations made in prefilled syringes market.
                                              ·     The report begins with an executive summary that captures the key takeaways of the report.
                                              ·     Chapter three introduces prefilled syringes, discusses their current position in the market along with
                                                    the drivers and barriers.
                                              ·     Chapter four details the technology currently employed in the development and manufacture of
                                                    prefilled syringes and some of the issues that need to be addressed in their use.
                                              ·     Chapter five analyses the formulation properties to be considered by pharmaceutical companies while
                                                    manufacturing syringes to store them.
                                              ·     Chapter six discusses innovative ways of overcoming the current barriers in production of prefilled
                                                    syringes. Some of these include use of plastic syringes; extractables and leachables; integrated needles;
                                                    safety innovations and automation.




  © GBI Research. This is a licensed product and is not to be photocopied                                                     GBIHC258MR / Published DEC 2012
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Innovation in Prefilled Syringes Market - Executive Summary




                                              Innovation in Prefilled Syringes Market - Executive Summary
                                              Move towards Home Healthcare Drives the Use of Prefilled Syringes and Autoinjection Devices
                                              The market for prefilled syringes is being driven by the rise in popularity of autoinjection devices for the
                The market for                home-use market. As health authorities seek to reduce costs, facilitating patients in self-administering their
                prefilled syringes is         medication is one major way of reducing the strain on resources for providers. Additionally, patients prefer
                being driven by the           this option as it does not require them to travel to hospital and can be accommodated in their own home.
                rise in popularity of         This makes compliance to the therapy more likely. There are issues with self-injection, such as patient fear
                autoinjection devices         of needles, but companies manufacturing autoinjectors have taken innovative steps to overcome this
                for the home-use              barrier, with novel ways to shield the needle from view and create button-push mechanisms. The increase
                market                        in the home-use trend in the future is likely to continue to drive the market for prefilled syringes and
                                              encourage innovation in the area as companies seek to tailor their autoinjector devices to the requirements
                                              of patients with specific diseases, which may, for example, impair joint flexibility and create challenges in
                                              successful delivery.
                                              Legislation Regarding Needlestick Injuries Increases Popularity of Prefilled Syringes with Integrated Safety
                                              Mechanisms
                                              Safety is one area that 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 legislated, 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. Currently, most safety devices are attached following syringe manufacture, and can be made
                                              by different companies, bringing in an element of inefficiency and possible compatibility issues. Making
                                              safety devices part of a syringe’s basic design will be an important step in the future potential of the market.
                                              The Rise of Biologic Therapies Requires a Concurrent Rise in Prefilled Syringe Technologies
                                              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. The incompatibility of many biologics with the silicone used in glass syringes necessitates a move to
                                              plastic syringes and innovation in this area is likely to continue with new polymers and coating for the
                                              syringe to minimize reactions between the syringe materials and the drug product.




  © GBI Research. This is a licensed product and is not to be photocopied                                                      GBIHC258MR / Published DEC 2012
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Table of Contents




                                              1         Table of Contents
                                              1   Table of Contents ........................................................................................................................................ 4
                                                  1.1      List of Figures................................................................................................................................... 5
                                              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


  © GBI Research. This is a licensed product and is not to be photocopied                                                                                          GBIHC258MR / Published DEC 2012
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Table of Contents




                                                  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


                                              1.1       List of Figures
                                              Figure 1: Innovation of a Drug Product to Improve Market Differentiation, Prefilled Syringes, 2012 ............ 15




  © GBI Research. This is a licensed product and is not to be photocopied                                                                                         GBIHC258MR / Published DEC 2012
                                                                                                                                                                                           Page 5
Innovation in Prefilled Syringes - Overview




                                              2        Innovation in Prefilled Syringes - Overview
                                              2.1      Overview
                                              Pre-filled syringes are one of the fastest growing markets in the drug delivery and packaging sectors, driven
                                              by a marked rise in the success of biological drugs and vaccines, which require the drug to be injected
                                              directly into the bloodstream. The attractiveness of prefilled syringes for healthcare providers is partially
                                              based around their potential to minimize costs and waste. Additionally, prefilled syringes have the potential
                                              to improve efficiency in that the overfilling of syringes and spillage can be minimized in cutting out the
                                              human error present in self-filling. Packaging drugs in prefilled syringes is convenient, easy to use and allows
                                              untrained individuals to self-administer drugs. This increases compliance to therapy. As a result, continued
                                              innovation in prefilled syringes is required to keep pushing adherence rates, and therefore revenues, higher.
                                              Many companies seek prefilled syringe products as a means of life-cycle extension, offering an update to a
                                              product that may be losing its ground or approaching patent expiry. Developing more efficient and
                                              convenient ways to administer drugs can increase uptake, but can also differentiate products from
                                              competitors by offering innovative advantages. In addition, developing liquid-stable formulations, long-
                                              acting formulations and multidose preserved formulation are all ways in which a company can fend off
                                              generic and biosimilar products. Prefilled syringes are an integral part of this sort of innovation.




  © GBI Research. This is a licensed product and is not to be photocopied                                                      GBIHC258MR / Published DEC 2012
                                                                                                                                                        Page 6
Innovation in Prefilled Syringes - Introduction




                                                  3       Innovation in Prefilled Syringes - Introduction
                                                  3.1     What are Prefilled Syringes?
                                                  Prefilled syringes are syringes filled with medication before they are supplied to the healthcare provider or
                                                  patient; this means that the pharmaceutical or biotechnology company producing the drug has decided to
                                                  make that medicine available packaged within a syringe rather than as a liquid or powder that needs to be
                                                  placed into an empty syringe by healthcare providers. There are obvious advantages to offering drugs in this
                                                  form; a reduction in human error in filling, the ability for untrained people to administer injections, a
                                                  reduction in time and resources required to prepare an injection, and less waste. As such, their popularity
                                                  has been growing.
                                                  Prefilled syringes encompass not only standard prefilled syringe devices but also autoinjectors and pen
                                                  injectors. These are often used in the self-injection market, allowing patients with chronic conditions such
                                                  as diabetes or rheumatoid arthritis to inject themselves with the necessary medication and eliminating the
                                                  need for them to attend hospital or general practice surgeries to receive their treatment. This reduces costs
                                                  and increases compliance, providing patients get used to self-injecting. Autoinjectors and pen injectors are
                                                  important in facilitating this. They require minimal input from the patient and increase safety. In addition,
                                                  many can be stored for long periods.

                                                  3.2     The Current Position of Prefilled Syringes in the Pharmaceutical Market
          
								
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