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Current Issue:
Prefilled syringes: device suppliers meeting pharmaceutical standards

CONTENTS:

The next generation of prefillable syringes: specialised plastics lead the way
Bernie Lahendro (West Pharmaceutical Services)

Pre-filled syringe plungers from RTS to RTU: cleanliness & convenience
Jean-Pierre Merceille (Stelmi)

Company profile
Ypsomed

A better fill for prefilled syringes: applications & advantages of bubble-free filling for today’s parenteral products
Shawn D. Kinney, PhD (Hyaluron Contract Manufacturing)
Auto-injection devices: convenience items, or a key component of injectable products?
Mike Kasprick (Antares Pharma)

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INTRODUCTION

PREFILLED SYRINGES: WHERE HAVE WE GOT TO

The mood in the prefilled syringes segment was upbeat when I first started writing about it four or five years ago, and it has continued to be positive since. Current evidence shows that the prefilled syringes market is still, and will carry on, expanding steadily.

However, this is not new information for most readers. The major drivers for growth have been written about often, continue to be written about often, and still apply today as they did several years back. (For a quick reminder of the many fac- tors driving the prefilled syringes sector, see the summary box on page four.) So, in this article, instead of going over old ground I want to focus on some of the more recent developments.

First though, just a few reassuring figures to con- firm that there has indeed been no let up in the pre- filled market’s growth since last time we checked! In his article on page six of this issue, Bernie Lahendro, Vice-President of Daikyo Crystal Zenith Technologies at West Pharmaceutical Services, states that over the past three years, unit sales of prefilled syringes have risen almost 22% from US$1.19 billion to US$1.45 billion. In an April 2007 article in P&MP, Patrick Grueninger of Schott forma vitrum said: “We see strong movement to prefilled syringes from vials and ampoules on new and existing products with sus- tainable growth rate between 10-15%.” And a recent study conducted by IMS Health and Becton Dickinson predicted growth at more than 12% per year in the prefilled syringes market. In 2006, 1.4 bil- lion prefilled syringe units were sold and this, the study said, would grow to 2.4 billion units by 2010.

 

AN INCREASINGLY INTERESTING SECTOR
Over the past few years, at the same time as it has become larger and more valuable, the prefilled syringes sector has also become more interesting, on various fronts.

We have seen the numbers of pharmaceutical products launched onto the market in prefilled syringe formats growing, and as such the pharma industry is tending to view these systems, and the technologies and services associated with them, as “market proven”. As anyone involved in drug deliv- ery technology partnering will know, a proven mar- ket track record is one of the most important boxes that pharma wants ticked before entering into rela- tionships with suppliers and partners.

The prefillable syringe has gained broad accep- tance in the pharmaceutical industry – often as the format of choice for many injectable products.

Furthermore, from an initially narrow range of ther- apeutic applications in the diabetes, growth hor- mone, heparin and emergency injections markets around ten years ago, the application of prefilled syringes has broadened into the rheumatoid arthritis, osteoporosis, multiple sclerosis, cancer, fertility, anaemia and haemophilia markets, among others.

While the commercial success of prefilled syringes has continued, the anticipated wave of products based on non-invasive drug delivery tech- nologies – especially those for biologics – has still not arrived. Not in a big way in any case. Exubera’s launch, which I myself once wrote could signal the opening of the floodgates for systemic pulmonary protein and peptide products, and the dawn of a new age of non-invasive drug delivery, has not registered as the key event it might have been. The lack of a boom in non-invasive drug delivery has, to some extent, left the way clear for prefilled syringes to go from strength to strength. (...)

Guy Furness
Publisher, ONdrugDelivery

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