years of expertise in this area can help drug manufacturers to
speed-up time to market and reduce the overall cost of developing and manufacturing drugs in this way. There is also growing
demand for controlled substances, which require specialist facilities and in some cases controlled release technology. Our site was
originally established in 1941 to produce morphine active pharmaceutical ingredient (API) and controlled substances in API and
finished dosage form (FDF), which is still a focus area for Saneca
Quick: This very much depends on the type of customer. While
big pharma may use CDMOs for greater flexibility and efficiency
throughout the drug development lifecycle, smaller companies,
including the growing number of virtual pharma firms, rely on
contract partners to access specific specialist services, expertise
or manufacturing capacity that they do not have in-house. Outsourcing is particularly prevalent in areas where specialist technology and expertise is required, so we are experiencing increasing demand for our development services. This is particularly the
case in areas including formulation development, clinical supply
manufacture and trial management to achieve first in human
milestones, as well as chemistry services.
In terms of manufacturing, the greatest demand remains in
the production of solid dosage forms, representing more than 47
percent of the CDMO market. However, the manufacture of injectables is set to rise and reach 46 percent of the market share
by 2020. This is directly related to the increasing development of
cytotoxic drugs and biologics.
Leal: There are many opportunities in specialized or niche contract manufacturing. The capacity to handle highly potent compounds and the flexibility to manufacture small-scale batches
are becoming very important for many of our customers and
products. The availability of innovative technological platforms
able to improve cost and process efficiencies, product safety and
bioavailability or patient compliance also constitute a number of
CP: HOW DO YOU SEE THE FUTURE OF OUTSOURCING
AND WHAT WILL THE IMPACT BE ON CURRENT SPON-
Madden-Smith: The outsourcing trend looks set to continue for
the foreseeable future and we are seeing more long-term strategic relationships building where, not only is there a technical fit
but also a strong cultural fit between sponsor and partner.
Mackay: We envisage the outsourcing sector to continue to grow
steadily and it is showing no signs of slowing down. In a recent
industry survey, the OSP William Reed State of the Industry report 2017, 44 percent of pharmaceutical companies surveyed said
they expect to outsource more business this year than last, which
is interesting market feedback.
We therefore expect this trend to continue, with growth in the
parenteral manufacturing space coming from biopharma companies as they continue to progress new drug products to market,
significantly driven by an increase in industry funding.
While many CMOs continue to expand their offerings, there
will continue to be demand for niche manufacturing services from
specialist providers that can offer the flexibility needed to meet increasingly tight timescales in the drug development pipeline.
Success in outsourcing is underpinned by technical capabilities and effective communication in the sponsor-partner relationship. As a result, we expect to see more and more clients
moving away from tactical outsourcing initiatives in favor of a
relationship-oriented strategic partnership with CMO partners
across a collaborative supply chain.
Sheehan: It is likely that the CDMO landscape will continue
evolve, perhaps at a slightly slower pace, further changing the relationship between contract partners and their customers. New and
more challenging drugs entering the supply chain will continue to
drive the demand for comprehensive development services, particularly controlled release technologies. There will continue to be
demand for competitive pricing, without compromising on quality.
Whereas in the past companies have looked to Eastern countries,
such as India, to generate these savings, increasing concerns surrounding the quality of drugs produced in this market means more
and more pharmaceutical companies are keen to move their operations back to Europe. With this in mind, full-service CDMOs
in lower cost markets such as Slovakia will find themselves ideally
placed to deliver a service that combines cost effectiveness, quality,
technical expertise and speed-to-market.
Quick: Ongoing transformations in the pharmaceutical industry, including pricing pressures, more stringent regulation, modernization
and market complexities, are all driving demand for outsourcing and
we expect this to continue in the years to come. As the population
continues to age and we see higher incidence of lifestyle and chronic
ailments, demand for innovation and new drug development will
grow too. As the CDMO space is subject to more and more consolidation, we expect that pharmaceutical companies will begin to work
with a smaller number of contract partners that are able to deliver a
wider range of services. This will help to simplify the supply chain,
enable the development of closer, more strategic relationships and
ultimately, speed up new drugs to market. Pharma companies will
continue to rationalize their manufacturing footprint and focus on
their core business, while more virtual companies will appear with
limited infrastructure. Both of these trends will help to feed CDMO
pipelines and allow the outsourcing sector to grow. Pharmaceutical
demand in emerging markets is also expected to increase between
eight and nine percent per annum until 2020 and pharmaceutical
companies will naturally evaluate CDMOs in terms of location/ proximity to market, labor cost and the ability to meet variable demand.
Leal: The higher efficiency of the outsourcing model in the
pharma industry will lead to sustained growth, helped by factors
such as the need for higher specialization. There is still room for
improvement though: it is necessary for all parties involved to
move from tactical collaborations to real strategic partnerships
and then to client-supplier integration in order to be totally flexible and fully exploit the potential of outsourcing. This will help
products keep competitive in the market while complying with
the growing regulatory requirements. CP