SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing - Product Differentiation Is Critical

Lyophilization Technology
Pfanstiehl, INC.

After oral drug administration, parenteral delivery is the second most applied route of drug administration. A steady increase in the number of parenteral drugs has led to rise in demand for various advanced drug delivery devices that ensure ease of administration as well as cost containment. Prefilled syringes (PFS) constitute one of the fastest growing segments of the injectable drug delivery devices market. The various advantages associated with prefilled syringes over conventional delivery systems, such as vials and ampoules, have been the primary foundation for their success to date and are expected to continue to drive market growth during the forecast period 2013 to 2019.1 These advantages include ease of administration, improved safety, reduced risk of contamination, and accurate dosing. Estimates show that the global prefilled syringes market is likely to achieve sales of $6.9 billion by 2018, growing at a compounded annual growth rate of 13.8% from 2012 to 2018.2

Depending on the type of material used to manufacture the syringe barrel, prefilled syringes are available mainly in two types, glass prefilled syringes and plastic (polymer) prefilled syringes. Although the industry is witnessing increasing use of polymer by many manufacturers for plastic syringe manufacturing, and plastic syringe use is expected to increase with the development of improved polymers that offer better leachables and extractables profile, glass is still considered the gold standard and will continue to lead the market in terms of revenue and volume. The market for glass prefilled syringes is expected to lose some of its share at the end of the forecast period, which will be eaten up by the market for plastic syringes that will grow at a CAGR of 25% from 2013 to 2019, states the report.

Rapid growth in the biologics market, technical advances in the sector, and rising preference for self-administration using prefilled syringes, autoinjectors, and pen injectors are the major factors driving growth of the global market for prefilled syringes. Currently more than 60% of the drugs under clinical development are biologics and are likely to be approved for parenteral administration. This is because most of the biologics including monoclonal antibodies, vaccines, and anticoagulants, are large molecules that need to be administered via parenteral route to achieve the desired therapeutic effect. Likewise, technical advances related with siliconization and needlestick safety and prevention are also expected to drive growth of the market for prefilled syringes.

Based on the promise of the market, there is an increasing number of delivery system companies that provide ready-to-fill/sterile prefilled syringes as well as a rise in contract manufacturers developing the drug for those devices. Several of these suppliers and manufacturers spoke to Drug Development & Delivery about the importance of customization and differentiation as the key to pharma companies staying competitive in the prefilled syringe space.

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REFERENCES

• Prefilled Syringes Market (Glass and Plastic)–Global Industry Analysis, Size,Volume, Share, Growth, Trends and Forecast, 2013-2019, Research and Markets, http://www.researchandmarkets.com/research/mrs99n/prefilled.

• The Prefilled Syringe Market report, Roots Analysis, July 2013, http://www.rootsanalysis.com/reports/view_document.html?report_id=18.

• - See more at: http://www.drug-dev.com/Main/Back-Issues/SPECIAL-FEATURE-Prefilled-Syringes-Parenteral-Cont-695.aspx#sthash.VzoeJixf.dpuf