Future of Prefilled Syringes: Manufacturer's Perspective – Challenges and Opportunities -- MEDICA - World Forum for Medicine

A prefilled syringe is a single-dose packet of vaccine to which a needle has been fixed by the manufacturer. In the past metal or glass syringes were popular, but increasingly there has been a movement towards plastic and disposable syringes so the needle is protected and cannot be re-used (prefilled disposable systems). This has stimulated the demand for convenient and safe prefilled syringes in the medical field over conventional glass vials for packing parental drugs. Parental packaging innovations and applications have made devices easier to use for both the healthcare professional and the patient.

Prefilled syringes have actually been around for more than two decades. The European market for prefilled syringes is relatively more mature compared to the US market, which is still relatively smaller and younger. However, the market for prefilled syringes has seen healthy growth in recent years as the pharmaceutical industry has grown and become more sophisticated. The European market for prefilled syringes is worth $300 million and is growing at between 8-10 percent per annum. Prefilled syringe manufacturers have had to therefore respond to increasing demand, new requirements and more sophisticated forms of drug delivery. There has been great development in syringes. New products are being put in syringes now. Prefilled syringes are used to package injectable drugs and diluents. Some of the categories of drugs packaged in prefilled syringes are vaccines, blood stimulants, therapeutic proteins, erythroproteins, interferons, and rheumatoid arthritis. Many new products that must be injected should be prefilled, with security being the main reason why.

The usage of prefilled syringe has risen because of the disadvantages in the traditional process. The advantages prefilled syringes have over traditional packaging in vials include ease of use. Prefilled syringes essentially eliminate the processes that are required before you use a drug in a vial. Additionally, it helps eliminate dosing errors because prefilled syringes actually contain the exact dose. Many Pharmaceuticals manufacturers overfill vials by up to 25% to make sure the end user is guaranteed to withdraw the dose required. However, this overfill can cause errors that are virtually removed with prefilled syringes. With the advent of more expensive biotech drugs, this is advantageous as it means less waste, especially if some vaccines are in short supply or are really costly.

The major challenges in this industry for the manufacturers include the interaction of prefilled syringes with the drug. This causes great concern because it creates stability issues. Manufacturers need to eliminate the interaction between drugs and packaging materials. Regulatory bodies, companies and customers will scrutinise and look carefully at every aspect of needles and syringes especially as they are being used more and more today. Processing and quality control issues are therefore important. Manufacturing costs are rising, especially because of the growing concern of needle stick injuries. Safety measures to eliminate needle stick injuries are the major concern in the healthcare industry. The safety systems are very costly, and the safety system providers are continuously researching to develop low cost alternatives. The percent of prefilled syringes with safety systems is very low and this trend is expected to change in the forthcoming years with more focus of the healthcare industry on needle stick safety aspects.

Manufacturers need to keep up with the pace of Pharmaceutical and Biotechnology developments. More complex technology is required and thus more investment in manufacturing. There are a growing number of compounds in new therapeutic classes. The numbers of injectible products available are increasing. This means technology needs to adapt to these new innovations and this trend is likely to continue in the foreseeable future. If a greater number of new drugs are placed in prefilled syringes, the likelihood is that the penetration rate and uptake of these by end users will increase, as they get used to this format. Manufacturers will need to keep up with demand. Presently there is not enough supply of prefilled syringes. Pharmaceutical companies are requiring more sophisticated forms of delivery as their requirements become more complex. This means greater investment is required by the manufacturers in order to maintain competitiveness in the market place.

The prefilled syringe market worldwide and at a European level too is dominated by 3 or 4 key players. This creates high barriers of entry for new players that are thinking of entering. Often location and customer inertia through time has built up brand loyalty. This is a major challenge for the smaller players wishing to make an impact in this market. The increasing popularity of non invasive drug delivery systems, needle free and other alternative systems could potentially cannibalise the sales of prefilled syringes in the distant future. Many patients do not like having injections. Although efforts have been made by manufacturers to make needles thinner and therefore less painful for the end user, many non-invasive methods of drug delivery are being considered. However, many of these delivery routes are yet to be verified because of regulatory issues as the actual drug formulation has to be modified in order for it to be used in this new way. Therefore, this area has not come of age yet.

Becton-Dickinson Pharmaceuticals system is the market leader in the European prefilled syringe market with a significant gap between the number two player Buender Glas (a subsidiary of Gerresheimer). MGlas and Schott forma vitrum are third and fourth respectively. They are even further from the number two player in terms of market share. BD is number one in this market because of first mover advantages, growing with their customers. Regional bias and locational advantages to some extent have helped them achieve number one position because they are located in France. They have close relationships with many of the top Pharmaceuticals companies (GSK in Belgium) and proximity to them has been advantageous. BD, the market leader will be behaving more like it is in the maturity stage of the product life cycle in the near future. Its main strategy will be to sustain and defend its market share. The remaining players are looking to grow in this lucrative market and develop a strong brand name and develop brand loyalty. Like BD, they will look to extend their product range and increase their revenues and profits. BD will aim to consolidate in order to grow, because eventually the number two, three and four players will eat into some of their market share in the future. So therefore instead of focusing on manufacturing, BD will be focussing on value-facturing by further modifying the core product (the syringe itself), developing new distribution channels and offering value added services. Leaders tend to grow by inorganic means such as acquisitions (typically acquiring followers). In this case, BD may look to acquire Buender Glas, Schott or MGlas. Buender Glas is big in size, with a relatively good market share. Schott and MGlas are big in size but prefilled syringes are not their core competencies. They have a strong portfolio but are weak in this area.

So essentially it is about survival of the fittest and incorporating the whole value chain – not just the prefilled syringe itself, but the safety elements, the after sales service, the additional features. Value-facturing is essential to create a point of differentiation and a competitive edge in this market.

For further information please contact:

Katja Feick
Corporate Communications
+44 (0) 207 915 7856