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Prefilled Syringes the Trend for Growth Strengthens

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Prefilled Syringes the Trend for Growth Strengthens OnDrugDelivery Pre filled 6/8/06 22:29 Page 1 PREFILLED SYRINGES THE TREND FOR GROWTH STRENGTHENS www.ondrugdelivery.com OnDrugDelivery Pre filled 6/8/06 22:29 Page 2 “Prefilled syringes: the trend for growth strengthens” CONTENTS This edition is one in a series of sponsored themed publications from ONdrugDelivery Ltd. Each issue will focus on a specific topic within the field of drug delivery, and contain up to eight Introductory comment articles contributed by industry experts. Guy Furness 3 Full contact information appears alongside each Trends and requirements on prefillable syringes: article. Contributing companies would be delighted past, present and future developments to hear from interested readers directly. Dr Thomas P Schoenknecht ONdrugDelivery would also be very pleased to (Buender Glas GmbH) 4-8 pass on to authors, or answer as appropriate, any queries you might have in relation to this publication or others in the series. Meticulous attention to detail: the key in prefilled syringe production Forthcoming editions cover: nasal drug delivery; Horst Koller, Walter Schiess (Schott AG) 10-12 oral drug delivery; delivering injectables; novel biomaterials for drug delivery; safer injections; Reducing time-to-market: nanotechnology in drug delivery; transdermal successful drug manufacturing delivery; and pulmonary delivery, among other Dr Juergen Koch topics. To find out more about receiving or (Vetter Pharma-Fertigung GmbH & Co. KG) 14-17 participating with any of these issues, please contact ONdrugDelivery Ltd. Packaging in prefilled syringe systems: Contact: selection and evaluation Guy Furness, Publisher Frances L DeGrazio T: +44 1273 831 370 (West Pharmaceutical Services, Inc.) 20-22 E: [email protected] Current market and key trends of devices used in self-injection Joël Cotten (BD Medical - Pharmaceutical Systems) 25 “Prefilled syringes: the trend for growth Company Profile: strengthens” The Medical House plc 29 Published by ONdrugDelivery Ltd, Cedar Company Profile: Cottage, Newtimber Place Lane, Newtimber, Ypsomed AG 30 West Sussex, BN6 9BU, United Kingdom. Registered in England: No 05314696. Copyright © 2006 ONdrugDelivery Ltd* The views and opinions expressed in this issue are those of the authors. Due care has been used in producing this publication, but the publisher makes no claim that it is free of error. Nor does the publisher accept liability for the consequences of any decision or action taken (or not taken) as a result of any information contained in this publication. * except for the article “Reducing time to market: successful drug manufacturing” © 2006 Vetter Pharma-Fertigung GmbH & Co. KG. Front cover image, Validated washing process for aseptically prefilled application systems, reproduced with kind permission from Vetter Pharma- Fertigung. The image also appears on page 16 of this issue in Vetter’s article entitled: “Reducing Time to market: successful drug manufacturing”. 2 www.ondrugdelivery.com Copyright © 2006 ONdrugDelivery Ltd OnDrugDelivery Pre filled 6/8/06 22:29 Page 3 INTRODUCTION Some of the cornerstones upon which the grow at a compound annual rate of 3.3% wild or staggering. prefilled syringes sector’s growth has been between 2004 and 2011. “A major portion They are not going lead built are: (16.8%) of this revenue is set to come from the to a transformation of fastest growing prefilled syringes sector,” it medicine as we know it in the same way that, • the continuing growth of the injectables adds. Another 2005 publication from Frost and for instance, intelligent biomechanical implants market, underpinned by the growing number Sullivan, The European Prefilled Syringes and other micro- and nanotechnologies might. of biotech product launches Market, estimates that “the European market Instead, with prefilled syringes, we encounter • the growing emphasis on safety, particularly for prefilled syringes is worth $300 million and measured, solid improvements over previous, sharps safety is growing at 8-10 % per annum”. conventional systems. • the increasing realisation that a delivery So how have prefilled syringes achieved this? There are many examples, but one which system’s convenience, speed of use and ease Looking in from outside, almost every aspect of typifies the type of benefit I am referring to is of use benefit treatment outcomes the prefilled syringes sector appears balanced that prefilled syringes contain the precise • the rising numbers of high-cost drugs and well grounded. I believe this is the key. amount of drug that is to be injected. In reaching the market, which make it important For example, in terms of their technological contrast, vials and ampoules have to contain to reduce or eliminate overfill and other complexity, prefilled syringes are positioned more liquid than the actual dose in order for the sources of wastage. midway along the spectrum of delivery systems. correct amount to be withdrawn, so the excess They fall between high-technology devices like formulation is wasted. Especially with These and other drivers have been aqueous droplet inhalers or needle-free jet expensive biotech products, elimination of discussed previously in various publications injectors, and simple, “low-tech” systems such wastage allows the manufacturer to make (including in ONdrugDelivery’s 2005 issue, as traditional syringe and vials, for example, or significant cost savings. Prefilled syringes Prefilled syringes: innovations that meet the oral capsules and blister packs. Prefilled reduce wastage of pharmaceutical product. This growing demand), and are touched upon in syringes are neither extremely high-tech, high- kind of ostensibly unremarkable advance does several of the articles that follow here. value products, nor are they mere commodities. not typically make the front covers of eminent Growth drivers, although the prerequisite for journals, but the millions of dollars that can be success, cannot bring about success on their own. RISK AND REWARD saved certainly causes drug manufacturers and Organisations must come forward to develop drug purchasers to sit up and take notice. technologies and products to meet the need. This Similarly, from the point of view of the risk The restrained nature of the prefilled is what I would like to discuss here. What to pharmaceutical and biotech companies, syringes sector is even borne out in the way it characteristics of the companies involved in prefilled syringes fall into the low- to medium- presents itself to the pharmaceutical industry. prefilled syringe production, and of their products risk category among the available delivery As evidenced by the articles contained within and technologies, have led to their success? options for a given product. this issue from prefilled syringe producers, First, it is important to qualify that prefilled Switching to a prefilled syringe format is component manufacturers and fillers, the focus syringe sales are indeed continuing to grow. not a totally risk-free process of course. for success – instead of being on lofty claims or Evidence from recent announcements made by Stability of the drug within the device (since a a constant push for ambitious innovations – the major prefilled syringe producers suggests prefilled syringe is both container and delivery appears to be on perfecting and excelling in so. Gerresheimer pharmaSystems’ (Buender device), for example, is a source of risk. their stated capabilities. Prefilled syringe Glas’s) financial results release for the first Lubrication of the plunger within the barrel is companies do not inhabit a fantasy world of quarter of 2006 states: “The positive another. A prefilled syringe might be stored for ingenious, revolutionary technologies that development in the RTF-syringe segment some time before it is used and it is essential might just, if they’re lucky, achieve astounding continued with considerably higher sales in that the plunger moves freely when required to success one day. Rather, meticulously planned Q1/2006 as opposed to Q1/2005.” Similarly do so, and does not become stuck to the barrel and monitored manufacturing and filling BD, in its 2005 annual report, highlights the during storage. Proper processes must be in processes generate real products today. Sterility, contribution of prefilled syringes. It said that a place to minimise the chances of these failsafe processes, quality checks, back-up lines 6% increase in its US revenues was generated problems hindering a product’s approval. and timeliness are strong themes, and they crop “primarily from strong sales of safety- However, these risks are minimal and easily up in several of the articles published here. engineered devices and prefillable syringes”. identifiable compared with, for example, the Again and again, we gain a sense of Likewise, Schott’s 2004/5 annual report says: “knowns” and “unknowns” involved in opting moderation and stability. Even the very growth “The strongly growing sterile syringes business to develop, say, the first systemic inhalable which we are attributing to the prefilled sector was extended this year.” format of a previously injection-only product. syringe sector’s poise – with an annual rate in Independent market analyses paint an The same balance is seen when considering the high single digits – seems considered and equally positive picture. Frost and Sullivan’s the reward side of the risk and reward equation. deliberate rather than a runaway boom 2005 report, The US Pharmaceutical The claims made by prefilled syringe companies happening at breakneck
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