Pharmaceutical Commerce - September/October 2017 - 22

Cold Chain Directory
of air and truck transport (Fig. 3).
Capacity additions
Predictions of pharmaceutical shipments
are one measure of the market growth;
another is the warehousing, storage and
transfer capacity going into place at thirdparty logistics (3PL) providers, air carriers
and the depots of clinical trial materials
providers. From a logistics industr y
perspective, the volumes of life sciences
products are relatively insignificant,
co m p a re d to m i n e r a l s , a u to m o t ive
parts, foodstuffs and other high-volume
industries; yet because life sciences can
usually command premium-level service,
it draws the attention of global players. And
while it's possible to use most temperaturecontrolled perishables space in the logistics
industry for life sciences products, providers
are increasingly building dedicated spaces
for those products alone.
Near the end of last year, FedEx Supply
Chain (formerly Genco) added 1.1 million
sq. ft. in Memphis, TN and another 400,000
sq. ft. in Toronto, primarily for healthcare
products (only an unspecified portion is
refrigerated). The company can provide
kitting and relabeling from the facilities, as
well as basic logistics services.
Over the summer, Life Science Logistics
brought on an additional 132,000 sq. ft.
of capacity at its Indianapolis, IN facility,
which has quintupled in size over the past
two years. About 12% of the new capacity
is given over to refrigerated product. LSL
has four locations in the US. Its neighbor in
Indianapolis, MD Logistics, also brought on
more cold-chain capacity at its 173,000-sq.
ft. facility; it also operates in Reno, NV.
UPS Healthcare Logistics, which operates
more than 60 facilities for healthcare
products worldwide, built a second facility
near Bogotá, Colombia in the past year,
adding 76,000 sq. ft. there, and bringing
its global footprint to more than seven
million sq. ft. The company also expanded
its Express Critical delivery service, which
has been in place in the US, to Europe.
Arch-rival DHL Global Forwarding
opened a new Life Sciences Center of
Excellence in Ireland, the 43rd country
with such a facility (some countries have
multiple Centers). The 40,000-sq. ft. facility
is close to Dublin Airport, and features
room-temperature, refrigerated and frozen
dedicated capacity, along with repackaging
services.
2017 clinical trials logistics forecast
The Sourcebook also evaluates logistics
spending trends in the clinical trials market.
There are both pallet and parcel shipments
of clinical trial materials, but no good way
to characterize their respective volumes. A
factor that is somewhat outside the scope
of the Sourcebook is return logistics that
occur during clinical trials-the delivery of,
for example, blood or tissue samples from
a trial. Our analysis is based primarily on
the trend in trial startups, enrollments and
locations, along with estimates based on

how much of a trial's budget is dedicated to
logistics issues (Fig. 4).
Clinical trial logistics involves shipment
of products to be used in trials to study sites
which may be dispersed around the globe,
as well as shipment of medical samples to
centralized analytical laboratories. This
year, we are updating our estimate for the
market size to about $3.2 billion in 2017,
due to continued growth in the number and
enrollment of trials, as well as pharma R&D.
Based on estimates of trail volume, location
and industry R&D spending overall, our
forecast now is for a continued expansion of
clinical trials logistics at a rate of about 2%
per year, to about $3.4 billion by 2021.
In the clinical arena, the two market
leaders are World Courier (now a unit of
AmerisourceBergen) and Marken (now a
unit of UPS). Both have been expanding
capacity and technical offerings to the
clinical market; last year, World Courier
announced the Cocoon, a passive, palletsize container to handle larger volumes of
shipments in one container. World Courier
is also stepping into handling commercial
(as opposed to clinical) deliveries; a pilot
program set up in Australia is being
expanded to more of its network.
For its part, Marken moved into a
new HQ in Research Triangle Park, NC
this summer, noting that the company's
global staffing had expanded 40% over
the past three years. The company also
opened a Patient Communications Center
in Philadelphia, intended to serve "the
logistics needs of patients who participate
in home-based clinical trials," according to
the company. Most freight forwarders or
carriers have 24-hour control towers for
their logistics partners, but a provider like
Marken extending the service to clinical
trial patients represents a deeper integration
of logistics and life sciences.
Cold chain regulation
T h e r e i s a b e w i l d e r i n g a r r ay o f
regulations and industry standards in
biopharma cold chain transportation;
in addition, nearly every nation of any
significant size has a Ministry of Health
(or equivalent) that publishes its own
regulations. The most central regulatory
f r a m e w o r k , g l o b a l l y, i s t h e G o o d
Distribution Practices issued by the
European Union. Many shipping processes
within the EU are already influenced by
this regulation, and many countries around
the world are adopting versions of it. GDP
standards are vitally important for crossborder shipments, because customs and
health inspectors are charged with ensuring
compliance. Within many countries,
however, inspection and compliance with
GDP standards are less strict; one factor
justifying this is that the shipments can
be delivered fairly expeditiously to local
destinations once they have cleared
customs (there are many exceptions to this,
of course.) The Sourcebook reviews GDP
standards and other relevant guidance.
CEIV Pharma program of IATA entails

22 Visit our website at www.PharmaceuticalCommerce.com September | October 2017

audits and reviews of logistics practices,
training and facilities, carried out by
independent auditors. Compliance with
IATA Temperature Control Regulations
(TCR), EU GDPs and relevant standards
of the US Pharmacopeia, among others,
is part of the process. According to IATA
literature, some 170 entities have already
obtained the CEIV Pharma certification,
mostly in the developing world, although
the Brussels International Airport and
France's Charles de Gaulle airport have also
won certification.
Kuehne + Nagel announced in January
that it had obtained CEIV Pharma
certification for all 86 airfreight facilities
around the world that are part of its KN
PharmaChain network. DHL Global
Forwarding had seven of its 11 US facilities,
plus Bogotá, Colombia, CEIV Pharmacertified as of last spring, and is rolling the
program out to more of its global facilities.
Delta Cargo obtained CEIV certification
earlier this year, saying that it is the first
US global passenger carrier to receive this
certification.
American Airlines is in the process of
obtaining certification for its Philadelphia,
PA p h a r m a h u b ; t h e co m p a ny a l s o
announced widebody aircraft transit
between Puerto Rico and that Philadelphia
center, mentioning its pharma logistics

specifically as one of the motivations for
the expansion. (AA also serves that route
with narrow-body aircraft.) Further
enhancing its Philadelphia hub, AA opened
an expanded life sciences storage facility at
London's Heathrow Airport.
IATA's goals are ambitious; although its
main business is airfreight, it is promoting
CEIV Pharma for other supply chain
entities, including warehouses and ground
transportation.
Logistics service providers
and carriers
Although pharma logistics is a relatively
minor part of the overall logistics industry,
it is generally a premium service that
justifies higher prices. This, combined
with the competitive pressure from service
providers and carriers, has led to significant
investment by the leading global firms, as
well as expanded services from regional
3PLs and others. Several of the major global
air cargo carriers have networks of cold
chain "stations" around the globe to process
healthcare products specifically. Innovative
tracking systems have been developed, both
by the logistics providers themselves, as well
as by third parties, to monitor shipments,
in real time in some cases. Logistics
providers and freight forwarders have also
set up "control towers" where dedicated

Fig. 5. A blanketed pallet ready for transport. Credit: QSales

Fig. 6. Cryogenic storage and shipment is in demand for cellular therapies


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Table of Contents for the Digital Edition of Pharmaceutical Commerce - September/October 2017

Table of Contents
Pharmaceutical Commerce - September/October 2017 - Cover1
Pharmaceutical Commerce - September/October 2017 - Cover2
Pharmaceutical Commerce - September/October 2017 - Table of Contents
Pharmaceutical Commerce - September/October 2017 - 4
Pharmaceutical Commerce - September/October 2017 - 5
Pharmaceutical Commerce - September/October 2017 - 6
Pharmaceutical Commerce - September/October 2017 - 7
Pharmaceutical Commerce - September/October 2017 - 8
Pharmaceutical Commerce - September/October 2017 - 9
Pharmaceutical Commerce - September/October 2017 - 10
Pharmaceutical Commerce - September/October 2017 - 11
Pharmaceutical Commerce - September/October 2017 - 12
Pharmaceutical Commerce - September/October 2017 - 13
Pharmaceutical Commerce - September/October 2017 - 14
Pharmaceutical Commerce - September/October 2017 - 15
Pharmaceutical Commerce - September/October 2017 - 16
Pharmaceutical Commerce - September/October 2017 - 17
Pharmaceutical Commerce - September/October 2017 - 18
Pharmaceutical Commerce - September/October 2017 - 19
Pharmaceutical Commerce - September/October 2017 - 20
Pharmaceutical Commerce - September/October 2017 - 21
Pharmaceutical Commerce - September/October 2017 - 22
Pharmaceutical Commerce - September/October 2017 - 23
Pharmaceutical Commerce - September/October 2017 - 24
Pharmaceutical Commerce - September/October 2017 - 25
Pharmaceutical Commerce - September/October 2017 - 26
Pharmaceutical Commerce - September/October 2017 - 27
Pharmaceutical Commerce - September/October 2017 - 28
Pharmaceutical Commerce - September/October 2017 - 29
Pharmaceutical Commerce - September/October 2017 - 30
Pharmaceutical Commerce - September/October 2017 - 31
Pharmaceutical Commerce - September/October 2017 - 32
Pharmaceutical Commerce - September/October 2017 - 33
Pharmaceutical Commerce - September/October 2017 - 34
Pharmaceutical Commerce - September/October 2017 - Cover3
Pharmaceutical Commerce - September/October 2017 - Cover4
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