Cynthia A. Challener Ph.D.
While the pharmaceutical contract services market is growing at a healthy rate, CROs and CDMOs are competing head-to-head to earn the right to be preferred providers, while other contract and specialty service providers are excelling to be top providers. Only organizations with specialized capabilities ranging from the technical to the strategic will be successful.
Nigel Walker
Growth in demand for biopharmaceuticals will remain
strong in 2016, further boosting both internal
investments and outsourcing of drug discovery,
development, and manufacturing activities.
Syed T. Husain
Outsourcing companies pursuing
an integrated services model aim
to facilitate drug development
and commercialization for drug
sponsors by enabling them to work
with a single partner for activities
that often require multiple,
specialized vendors.
Greg Flyte
Biopharmaceutical companies are increasingly
turning to service providers for all aspects of
drug development. More often than not, they
are looking to contract development and
manufacturing organizations (CDMOs) with
integrated service offerings across the entire
pharmaceutical development cycle, from discovery
to commercialization, for APIs and formulated
drug products with lifecycle management that
can help drug manufacturers meet aggressive
development timelines for complex products
while realizing greater efficiencies.
Wes Wheeler, Ariette van Strien
Numerous changes in the pharmaceutical industry
have affected the nature of clinical trials, which in
turn have led to the evolution of systems used for
the supply of clinical trial materials.
Stephen A. Munk
Although many reports have focused on growth in
the biopharmaceutical sector, small-molecule drugs
continue to account for the vast bulk of drugs on
the market and in development. New classes of
increasingly potent small-molecule therapeutics are
addressing more unmet medical needs with fewer
side effects, often at a significant cost advantage
compared to biologics.
Filipe Gaspar, Marco Gil, Phd, Nuno Matos
A number of trends in the pharmaceutical industry are
placing pressure on drug manufacturers to reduce both
development times and costs.
Matt Hicks
Major trends in the pharmaceutical and
biotechnology manufacturing industries are driving
significant shifts in the management of laboratory
and processing equipment inventory. Product pipeline
changes, mergers and acquisitions, price pressures,
and the increased reliance on contract research,
manufacturing, and packaging service providers
are a few of the trends impacting manufacturers’
equipment needs. At the same time, manufacturers
and contract service providers are striving to keep
costs down, manage their floor space, and ensure
supply of products to the market.
In response to factors affecting drug pricing
around the world — such as shifting markets,
government healthcare mandates, the end of
the blockbuster era, and the linkage of insurance
reimbursement with medical outcomes — pharmaceutical
companies are taking many different actions
to reduce their costs and increase efficiency
and productivity. Equipment needs across the supply
chain are changing, from initial discovery efforts to
the packaging of final products. The Nice Insight 2015
Pharmaceutical Equipment Annual Study found that
54% of respondents (n=560) spent over $100 million
on equipment per year (see Figure 1). And suppliers
of research and development and production equipment,
analytical instrumentation, and packaging systems
are responding with innovative technologies
that meet these needs.
Kevin Haehl
Poor adherence to patient treatment plans is a
widely recognized and significant issue in healthcare
today. Because elderly patients often take numerous
medications and can suffer from cognitive impairment
and physiological problems, correctly following
prescribed regimens can be challenging.
Guy Tiene, MA, Robert Leeuwendal, MSc
This article reviews alternative approaches to improve
the customer experience that can be taken by both
growing and established contract manufacturing
organizations (CMOs), and contract development and
manufacturing organizations (CDMOs).
For over 10 years, inbound marketing, as
a concept and practice, has been the most
effective marketing method for doing business
online. In addition to traditional “outbound”
marketing methods of buying ad
space in print and online with various emarketing
tools to nurture leads, inbound marketing
focuses on creating content that pulls
people toward your company or product.
Christopher Conway, Rajesh Shenoy, Ph.D.
With quality ranked as the main driver for contract
development and manufacturing organization
(CDMO) selection, the organization that consistently
delivers is likely to be a key market player. In order
to consistently provide high-quality products and
services, certain CDMOs are placing an emphasis on
Good Laboratory Practices (GLPs) that can be readily
scaled to Good Manufacturing Practices (GMPs).
Marga Viñes
As active pharmaceutical
ingredients (APIs) become
more sophisticated, drug
delivery options have
followed suit. Innovations in
intravenous administration
have contributed to an
increase in patient safety.
Gustavo Mahler
The vigorous growth of the biopharmaceutical
market has
boosted the demand for biopharmaceutical
contract manufacturing
services.1
Today, pharmaceutical
and biotechnology companies outsource
a broad spectrum of services from earlystage
drug development (e.g., cell line,
process, analytical, and formulation development)
all the way to commercial-scale
manufacturing. The outsourcing decision
is often made by the need to expedite research
and development, shorten the time
to market, gain access to novel technologies
and regulatory expertise, and minimize
risks, at competitive cost.
Increasing consumption of medicines around
the world; a more robust pipeline of drug candidates
and an increasing rate of FDA NDA/
BLA approvals; the growing number of biologic
drugs in development, many by traditional pharma
companies that lack biotech expertise; the entrance
of numerous small, virtual startups into the market
that have no manufacturing capacity; the rise in patent
expiries and increasing generics competition, which
is driving a greater need for cost efficiencies and access
to novel, proprietary technologies for achieving
product differentiation; and the increasing complexity
of both small- and large-molecule drugs such as antibody-drug
conjugates and highly potent compounds
will all continue to drive growth in the contract manufacturing
market in 2016.
In the 2016 Nice Insight CRO Outsourcing Survey,
a few new and exciting trends emerged in sponsors’
outsourcing practices. Pharma-biotech
companies, regardless of size or type, demand a
broad spectrum of services in preclinical and clinical
phases for their research and development needs. An
increased level of focus on many therapeutic areas was
observed.