Mark Quick
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The 2011 Pharmaceutical Technology's Outsourcing Survey revealed that pharmaceutical companies were expecting to increase
their contract-services spending in 2011 and we have certainly seen an increase in outsourcing requirements during this period.
Both the number of Requests for Proposals (RFPs) and volumes have increased across all dosage forms. The very buoyant areas
however tend to be in sterile forms, for example lyophilised, rather than solid dose—perhaps in part a reflection of supply
and demand.
We have also seen an increase in potent drug enquiries and, certainly within our development services business, for more novel
presentations such as microdosing and melts.
Another trend we have identified is that companies are being more careful and 'smarter' about the way they award contracts.
They are carefully checking that a company has a good track record, as well as ensuring that it is financially robust with
the ability to develop and resolve any issues, such as formulation problems, that may occur during a project. Therefore, they
utilise a lot more resources and effort in the beginning but, in the long run, dividends are often paid.
Standing out in a crowd
Recipharm is operating in quite a crowded market and to be successful it is important to differentiate yourself. We have managed
to this in a number of ways. For example, we try to partner with development and platform companies early on to industrialise
or often optimise a difficult technique or process. This approach gives us a good position to work on the same process or
platform with other molecules. It really helps us to win other contracts too, particularly when you get a reputation for doing
this kind of work!
One of the main challenges for service providers, however, is regulations. These are undoubtedly increasing for all parts
of the pharma industry. For example, where it was once acceptable for a contract manufacturer to accept an assurance from
the marketing-authorisation holder that all testing was in compliance with the licence before commencing manufacturing, this
has changed. We now need to ensure that we verify and check each licence in detail ourselves to ensure it is fully compliant.
This has created several challenges including the need to put in additional checks and balances before the contract is accepted
as well as during manufacturing. It certainly adds costs but ultimately from a compliance perspective this has got to be a
good thing. Because we have manufacturing facilities in a number of territories, we are very lucky because we receive many
audits each year from both regulators and customers. This means we see the latest thinking, which allows us to stay ahead
of the game. In addition, we can share knowledge across our multiple sites.
