Pharmaceutical Commerce - September/October 2017 - 21

Cold Chain Directory
of thermal blanketing (along with, or
instead of, an insulated container) to make
deliveries. GDPs have already wrought
considerable changes in Europe, and the
industry practices are gradually taking hold
in the US and the rest of the world.
The CEIV Pharma (Center of
Excellence for Independent Validators
in Pharmaceutical Logistics) program,
promulgated by the International Air
Tr anspor t Assn., is becoming more
widely accepted in the pharma logistics
community. Although it originated with
the airfreight world, it is being applied to
warehouses, storage facilities and ground
transportation services.
GDPs are also driving more sophisticated
use of electronic monitoring and reporting
equipment, ranging from throwaway
sensors to elaborate global communications
networks to track shipments by geography
and by environmental conditions. Logistics
providers are now capable of providing
near-real-time monitoring of shipments,
from the warehouse to the loading docks of
pharmacies and hospitals.
Economic trends
All pharmaceutical products, as well as
blood, other tissue-derived materials (which
are usually regulated in the US as "medical
devices") and clinical trial materials used in
drug trials, require close supervision when
being transported from place of origin to
place of use. Most products can be shipped
at what is considered "room temperature;"
the approved "label" (a detailed description
of how the product is to be dispensed, along
with side effects and other data) specifies
the temperature range within which the
product is safely stored and transported.
To varying degrees around the world,
regulators inspect storage facilities and
review documentation of shipments
to ensure that products remain safe and
effective.
From roughly the 1990s to today, the
regulatory framework around the pharma
cold chain has become vastly more detailed;
at the same time, the entry of biologically
derived products has come to dominate
much of the new drug development around
the world, and almost by definition, biotech
products require cold chain handling. The
major pharma companies themselves have
internal staffs of packaging and logistics
engineers that work out acceptable devices
and practices to ensure safe delivery. At the
same time, a continually growing number
of vendors, in transportation packaging,
freight forwarding and transportation, and
electronic monitoring of both a package's
internal conditions, and the processes
followed by carriers, has arisen to meet the
industry's needs.
Pharmaceutical Commerce analyzes the
biopharma cold chain industry annually,
and publishes its findings in its Sourcebook.
The analysis is based on a large number of
government, industry and private-company
data and forecasts, both of volumes and
costs. This analysis is supplemented with

direct contact with many of the leading
pharma companies and logistics providers.
The analysis is refined as more data
become available from year to year (so, to
a certain degree, it is not valid to measure
the forecasts in an earlier edition of the
Sourcebook with later editions.) On the
other hand, our analysis, confirmed by six
years of publishing the Sourcebook, has been
validated by numerous consumers of the
publication and its data.
The Sourcebook, as in the previous
editions, is premised primarily on two
things: a methodical review of the labels of
most common pharmaceutical and biotech
products to calculate how much of the
overall pharma supply chain is dedicated
to cold chain practices; and an analysis of as
much data as can be collected on the costs
of pharmaceutical logistics in the US and
globally. A third element is an evaluation of
the pharmaceutical "pipeline"-the pace at
which drugs under development will come
on the market, and how the market will
grow for those and for existing commercial
products. The forecast time frame is five
years (2016-2020).
Our updated forecast for cold-chain
logistics spending in 2017 is that it will be
more than $13 billion worldwide, in an
$80 billion overall pharma logistics market,
of which $9 billion will be transportation
and $4 billion will be specialized tertiary
packaging and instrumentation, such
as insulated boxes, blankets, phasechange materials, active-temperaturecontrol shipping containers, and various
temperature sensors and recorders. By 2021,
cold-chain biopharma logistics spending
will expand to more than $16 billion (Fig.
3).
The bulk of this spending is on
refrigerated (2-8 °C) products. The amount
of frozen and cryogenic products is small
by comparison. There is a trend toward
more spending on devices and system
for controlled room temperature (CRT)
shipping, but to date, most of this involves
more careful monitoring of shipping
conditions, and greater use of temperaturecontrolled transport vehicles, and not
necessarily extensive use of insulation or
other environmental controls. With the
expansion of cord-blood stem cell products,
and other cellular therapies, there is also
a trend to more cryogenics, below -150°C
conditions maintained typically with liquid
nitrogen.
The overall $80 billion biopharma
logistics market can be further broken
down by what is spent for transportation,
and what is spent for packaging and
instrumentation. For 2017, the breakout for
cold-chain and non-cold-chain transport
and packaging is shown in Fig. 2.
Finally, there is an analysis of logistics
by mode-air, truck and ocean shipping.
Most intercontinental shipping of cold
chain products is by air. "Parcel" is
generally regarded as packages smaller than
pallets, and shipped internationally by air.
Domestic parcel delivery is a combination

Global biopharma sales ($billions) trend 2015-2021

Sources: 2016 forecasts by QuintilesIMS Institute and Evaluate Pharma; Pharma Commerce analysis

Fig. 2. Sales volume of cold chain products continues to grow
at double the rate of non-cold chain

Global biopharma spending ($billions)

Fig. 3. Cold chain logistics costs represent 16.7% of overall pharma logistics spend in 2017

Global clinical trials logistics spending, drugs and biologicals,
Phase I-IV ($billions)

Fig. 4. Clinical trial logistics continues a gradual upward climb
September | October 2017 Visit our website at www.PharmaceuticalCommerce.com 21


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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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