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Figure 7.4 Catalent: Clinical Manufacturing Space by Region (%), 2013
Figure 7.5 Catalent Development and Clinical Services: Revenue ($bn), 2010-2013
Figure 7.6 Patheon Pharmaceutical Development Services: Revenue ($bn), 2009-2012
Figure 7.7 Almac Group: Revenue ($bn), 2008-2011
Figure 7.8 Parexel: Clinical Research Services Revenue ($bn), 2010-2013
Figure 9.1 Clinical Trial Supply and Logistics Market: Revenue ($bn) by Sector, 2012, 2017 and
2023
Figure 9.2 Clinical Trial Supply and Logistics Market: Revenue ($bn) by Region, 2012, 2017 and
2023
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Contents
3C Alliance
AbbVie
AbbVie Contract Pharmaceutical Manufacturing (part of AbbVie)
ACM Global Central Lab
Agência Nacional de Vigilância Sanitária (ANVISA) [Brazil]
Almac Group
AmerisourceBergen
AmerisourceBergen Consulting Services
AndersonBrecon (part of PCI)
Apax Partners
Aptuit
Association of Clinical Trials Organizations (ACTO)
Astellas Pharma
AstraZeneca
Bellwyck Packaging Solutions
BioClinica
Biogen Idec
Biotec Services International
Blackstone Group
Boehringer Ingelheim
Boehringer Ingelheim BioXcellence (part of Boehringer Ingelheim)
Braeburn Pharmaceuticals
Bristol-Myers Squibb
BT
CAEN RFID
Cardinal Systems
Catalent (Shanghai) Clinical Trial Supplies
Companies and Other Organisations Mentioned in This Report
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Contents Catalent Pharma Solutions
Celesio
Cenduit
Central Drugs Standard Control Organization (CDSCO) [India]
China Food and Drug Administration (CFDA)
ClinStar (part of PRA International)
Comissão Nacional de Ética em Pesquisa (CONEP) [Brazil]
Consorcio de Apoyo a la Investigación Biomédica – Plataforma Española de Ensayos Clínicos
(CAIBER)
COREX (part of 3C Alliance)
Covance
Cryoport
Cubist Pharmaceuticals
DHL
Drug Controller General of India (DCGI)
Eli Lilly
EPS Group
Escort Cold Chain Solutions
Escort Data Logging Systems
e-Trial Co. (part of EPS Group)
Eurodifarm (part of DHL)
European Commission
European Medicines Agency (EMA)
FedEx
Fisher BioServices (part of Thermo Fisher Scientific)
Fisher Clinical Services (part of Thermo Fisher Scientific)
Food and Drug Administration (FDA) [US]
Forest Laboratories
Frazier Healthcare
GE Healthcare
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Contents Greenbox
GSK
IATA Time and Temperature Task Force (TTTF)
IBM
ICON
IMP Logistics (part of PRA International)
Intelleflex
Intelsius
International Air Transport Association (IATA)
International Conference on Harmonisation (ICH)
International Pharmaceutical Federation (FIP)
J&J
Komtur Pharmaceuticals
LabCorp
LCAG USA
LifeConEx (part of DHL)
Lonza
Marken
Mawdsleys
Medicines and Healthcare Products Regulatory Agency (MHRA) [UK]
Merck Serono
Ministry of Health [China]
Ministry of Health [Russia]
Ministry of Health, Labor and Welfare (MHLW) [Japan]
Mitsui & Co.
MNX
Movianto
National Institutes of Health (NIH) [US]
NextPharma
Novo Nordisk
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Contents N-SIDE
Nuvilex
Onyx Pharmaceuticals
Owens & Minor
Packaging Coordinators Inc (PCI)
Parexel International
Patheon
Perceptive Informatics (part of Parexel)
Pfizer
Pharmaceutical Quality Group (PQG)
Pieffe Group (part of UPS)
Pluristem Therapeutics
PRA International
Quintiles
Recipharm
Roche
Sanofi
SF Express
ShangPharma
The Riverside Company
TheraCom
Thermo Fisher Scientific
TNT Express
TransCelerate BioPharma
Tufts Center for the Study of Drug Development
University of Florida
UPS
US Pharmacopeial Convention (USP)
Vsoft Infoware
World Courier
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Contents World Health Organization (WHO)
Worldwide Clinical Trials
WuXi PharmaTech
Y Prime
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Clinical Trial Supply and Logistics: World Market Outlook 2013-2023
can be slow to acquire, taking up to 60 days, which can add significant delays to clinical trial supply
chains. Outsourcing to local experts can mitigate the risks of these delays. Local logistics
companies can also offer expertise on local weather conditions - as a large country covering two
continents, weather conditions can vary enormously throughout Russia. Temperatures, for
example, can range from above 30ºC in the Western cities in the summer to well below -10ºC in
the North and East of the country in winter.
As a result of increased demand for expertise in clinical trial logistics, many local and international
service providers have invested in expanding in Russia in recent years. For example:
• At the end of 2010, Parexel opened a new ancillary supplies warehouse to support its
clinical logistics operations in Russia. The new warehouse stores a range of supplies
including lab kits, patient diaries and medical supplies.
• In September 2012, local company COREX opened a new temperature-controlled
storage depot in Moscow. Earlier in 2012, the company was awarded an unrestricted
pharmaceutical licence for storage and distribution of drugs in Russia.
• In March 2013, PRA International acquired ClinStar, a Russian CRO that offers clinical
trial services and logistics services in the region. PRA International has another CEE-
based subsidiary, IMP Logistics, offering clinical trial supply and logistics services,
visiongain notes.
3.8.2 Russian Clinical Trial Supply and Logistics Submarket Forecast 2013-2023 Around a third of NDAs submitted to the FDA now use data from Russian trial sites. Advantages to
conducting clinical trials in Russia include its large, mostly urbanised patient population. However,
the language barrier may be a problem for foreign clients, with levels of spoken English not as high
as in other emerging trial destinations, particularly India. However, leading CROs and logistics
service providers tend to have English versions of their websites, visiongain notes. Since the
middle of 2010, companies planning to launch drugs on the Russian market have been required to
perform local clinical trials. According to the Association of Clinical Trials Organizations (ACTO),
this has driven up the costs of conducting in trials in that market in the past three years.
The requirement for domestic clinical trials will stimulate demand for clinical supply and logistics
services in Russia in the next 10 years, visiongain predicts (Figure 3.18). As well as demand from
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Clinical Trial Supply and Logistics: World Market Outlook 2013-2023
international companies looking to expand in the Russian pharmaceutical market, this demand will
be driven by local drug developers. The Russian government is placing increasing emphasis on
development and manufacture, to improve the domestic life science and biotechnology industries.
Increased development of and demand for biologics - demand for insulin in Russia is expected to
rise as fast as other emerging markets, such as China - will need investment in the pharmaceutical
cold chain. By 2023, the Russian clinical trial supply and logistics submarket will be worth $0.30bn,
up from $0.09bn in 2012 (Table 3.11 and Figure 3.19). In 2023, the submarket will account for
1.5% of the global market (Figure 3.20).
Drivers
Restraints
A large patient population and fast recruitment make Russia an appealing destination for clinical
trials.
Knowledge of language and local importation rules will drive outsourcing in this decade.
The Russian government is promoting local drug development, particularly biologics, driving cold
chain demand.
Service costs will rise in this decade, as a result of the requirement for local clinical trials and
manufacturing.
Domestic infrastructure will need to improve for more remote trial sites to be easily reached.
Import regulations and applications can add to
trial delays, potentially limiting the country’s appeal as a trial destination.
Figure 3.18 Russian Clinical Trial Supply and Logistics: Submarket Drivers and Restraints, 2013-2023