Trends in Prefills

WHAT HAVE BEEN THE KEY DRIVERS FOR THE GROWTH OF PREFILLS?

In general, the prefilled market has been growing at a promising rate in recent years. Looking at projections from our clients for the next four years, although sales growth won't be in double digits it will be at the higher end of the singledigit range—around 5–7% per annum, depending on the segment.

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One of the key drivers at the moment is injectable biologics. If you look at the pipeline in the biotech world, roughly a third of all new projects are injectable biologics. The other driving factor is globalization. Many of our clients have international expansion plans and we're also seeing a strong focus on pharmerging markets. In the past, the ratio of growth in the established markets was in aggregate about double that of the pharmerging markets. For the next 4–5 years, however, projections show that the markets are basically on a par; the pharmerging markets will see growth of about $120–$140 billion until 2014 and the figure is similar for the established markets. In percentage terms, the pharmerging markets will grow at an annual rate of 14–17%, while the established markets vary between 3–6%.

HOW IMPORTANT DO YOU THINK PREFILLABLE SYRINGES ARE AS AN ALTERNATIVE TO INJECTABLES THAT ARE GOING OFF-PATENT FOR COMPANIES THAT ARE LOOKING TO EXTEND THE BRAND LIFE OF THEIR PRODUCT?

We always have clients coming to us for life-cycle propositions. I don't see it as more or less compared with the past, but in the pipeline reviews we do with our clients we find that a number of them want to upgrade the products they already have on the marketplace by changing the form of administration. For instance, we're in discussion with a number of customers to propose that they move from a vial to a syringe (single or dualchamber) or to a cartridge.

One important factor driving companies towards prefillable devices is the healthcare market's need for cost containment. Healthcare payers want to reduce costs by making products more convenient to administer at home. If you're a patient needing an injectable medication and you always have to go to a doctor for administration, this is a huge cost. Because of this, reimbursement authorities and insurance providers are happy if people can administer medicines at home. A syringe, a pen, or an auto-injector supports patient convenience, and both the handling and overall treatment costs can be significantly reduced. This is one of the key reasons for the industry to develop more of these systems. Indeed, within the prefilled area, this is the segment that is growing the strongest.

IS THE US THE BIGGEST MARKET FOR PREFILLED SYSTEMS?

Actually, the US and Europe are almost level if you look at the syringe market. In a recent study, we found that the US accounts for 43% of the global prefilled market sales, while Europe accounts for 42%. Only part of this market, is for pens and auto-injectors, but it's a growing segment that is seeing doubledigit sales growth. Singledigit growth is only being experienced in the conventional syringe area.

WHAT ARE THE THERAPEUTIC AREAS WITH MOST GROWTH POTENTIAL?

In the injectable world, the therapeutic areas with the most growth potential are multiple sclerosis, diabetes, HIV, and oncology. Indeed, the requests we get are mainly for finding the most convenient drug-delivery system for these areas.

WITH MORE ADVANCED PREFILLED SYRINGES, IS COST AN OBSTACLE WHEN CONSULTING WITH CLIENTS?

Initially, cost is not an obstacle, but it becomes a point of heavy discussion in later stages. First, companies need to understand the technical challenges involved in the project. How long does it take? What are the benefits? What is the optimal drug-delivery solution from a patient's point of view? As soon as the client knows exactly what solution or option they want to pursue, they ask about the cost and begin weighing up the benefits.

We try to make our clients aware that it's the total cost of doing business that's important. It's also vital to consider the robustness of the supply chain, as well as quality. Whenever the supply chain or quality become disrupted, cost is usually no longer an issue as companies are willing to do whatever it takes to mend the situation.

ARE CLIENTS PLACING ANY PRIORITY ON ENVIRONMENTALLY FRIENDLY SOLUTIONS FOR THE DISPOSAL OF INJECTABLE SYSTEMS?

Looking back over our consultations during the past year, there is usually a small discussion about a product's environmental impact, but it's not really a major concern. It's not that companies are ignoring the issue, but there is huge pressure on too many other factors.

SUPPLY CHAIN SECURITY IS ONE OF THE TOP ISSUES OF CONCERN ON PHARMA COMPANIES' LIST. ARE YOU INNOVATING IN THE AREA OF TAMPER-EVIDENT SYSTEMS?

We offer the opportunity for tamperevident features, but not all companies use these. In general, we find that it's not the main priority, but discussions about it can fluctuate. If three or four tampering cases appear in the press then every discussion we have will involve tamper evident systems.

HOW ARE YOU PLANNING TO DEAL WITH THE LATEST TRENDS IN THE PREFILLED MARKET?

The world of injectable processing and syringes has a lot to do with the materials used. At the moment, siliconization is important so we're continuing to optimize this process by, for example, defining the optimal degree of siliconization that matches the active ingredient.

Another issue is the stability of all the compounds used. Glass breakage, in particular, is a big topic. It has always been an industry issue, but has extremely high visibility at the moment because the FDA is giving it a very strong focus. To deal with this, we have intensive discussions with all suppliers along our supply chain to finding ways of reducing glass breakage, such as by making the glass components more optimal for use with combination products. In parallel, we have increased the number of our automated visual inspection systems to help detect and minimize glass breakage. We're putting programs in place and are considerably increasing our quality teams.

FDA's view has changed quite rapidly compared with the past. With FDA's 2007 Safety Act, companies are requested to conduct ongoing stability monitoring and to have risk-evaluation processes in place. The tolerance of minor defects has also decreased significantly. If you make 6 million units and after half a year there is a report of three broken units in a pharmacy, you need to detect when it happened and how. This requires investment in infrastructure and technology, which adds costs to the supply chain.

Several years ago, there were clear contracts that outlined the responsibilities of the different parties involved, such as the component manufacturer and the secondary packager. Now, however, we are made coresponsible. If there is a problem then we have to show documented proof that we have done everything we can to resolve the matter. As a CMO, this means we have to have dialogue with all our supply chain members.

DO YOU THINK THE INCREASINGLY STRINGENT REGULATIONS WILL CAUSE A PHASING OUT OF SMALLER CMOS/CDOS THAT CAN'T KEEP UP?

If you look at press releases from the last year, you'll notice that FDA has put out a number of serious observations to manufacturing organizations that can't keep up with quality standards or new regulatory expectations, leading to market recalls, for example. If you look at the number of events that have happened globally, companies who have not been able to correct their problems have been severely punished from a financial perspective.

This is where the shake out takes place: the company either operates to cGMP and cGLP standards and has a future, or doesn't and gets punished! Companies have to find the financial resources to make sure their quality systems and operating processes are state of the art. For CMOs, there is increased pressure to do this for the client—if the CMO is producing their product, then the client will want to ensure that the CMO can keep up with industry developments and GMP. The ones who can't keep up will not be in the business for long.