For more information on this report please contact ediz.ibrahim@visiongain.com (+44 (0) 2075499976) or refer to our website: http://www.visiongain.com/Report/1133/Clinical-Trial-Supply-and-Logistics-World-Market-Outlook-2013-2023

1. Clinical Trial Supply and Logistics:
World Market Outlook 2013-2023
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2. Contents
1. Executive Summary
1.1 Clinical Trial Supply and Logistics: World Market Overview 2013
1.2 Report Contents
1.2.1 Benefits of this Report
1.3 Study Methods
1.3.1 Who is this Report for?
1.3.2 Defining the Clinical Trial Supply and Logistics Market
1.4 An Introduction to the Clinical Trial Supply and Logistics Market
1.4.1 Clinical Trials are Becoming Increasingly Complex
1.4.1.1 Clinical Trial Globalisation: Access to New Markets and New Patients
1.4.2 Outsourcing Clinical Trial Supply and Logistics
1.4.2.1 What Services Are Most Commonly Outsourced?
1.4.3 Which Companies Participate in the Clinical Trial Supply and Logistics Market?
1.4.4 Clinical Trial Supply and Logistics: Trends and Future Outlook
2. Clinical Trial Supply and Logistics: World Market Outlook and
Forecast 2013-2023
2.1 The World Clinical Trial Supply and Logistics Market 2012
2.1.1 Which Were the Leading Market Sectors in 2012?
2.2 The World Clinical Trial Supply and Logistics Market Forecast 2013-2023
2.2.1 What Will Drive Market Growth in this Decade?
2.2.2 Clinical Trial Supply and Logistics: Market Restraints 2013-2023
2.3 Clinical Trial Manufacturing Submarket 2013-2023
2.3.1 Outlook and Forecast for the Clinical Trial Manufacturing Submarket 2013-2023
2.3.2 Complex Manufacturing and Packaging to Drive Growth 2013-2023
2.3.3 Clinical Trial Packaging Submarket Forecast 2013-2023
2.4 Clinical Trial Logistics and Distribution Submarket 2013-2023
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3. Contents
2.4.1 Clinical Trial Logistics and Distribution Submarket Forecast 2013-2023
2.4.2 Submarket Drivers and Restraints 2013-2023
2.4.3 Clinical Trial Cold Chain Distribution Submarket Forecast 2013-2023
2.5 Clinical Trial Supply Chain Management Submarket 2013-2023
2.5.1 Clinical Trial Supply Chain Management Submarket Forecast 2013-2023
2.5.2 Drivers and Restraints for the Clinical Trial Supply Chain Management Submarket 20132023
3. Leading National Markets for Clinical Trial Supply and Logistics
2013-2023
3.1 Defining National Submarkets for Clinical Trial Supply and Logistics
3.2 Leading National Submarkets for Clinical Trial Supply and Logistics 2012
3.2.1 How Will These Leading Submarkets Grow 2013-2023?
3.3 Clinical Trial Supply and Logistics in the US 2013-2023
3.3.1 How Will Demand for Clinical Trial Logistics Grow in the US to 2023?
3.4 Western Europe
3.4.1 Western Europe: Clinical Trial Supply and Logistics Submarket Forecast 2013-2023
3.4.2 The EU5: National Submarket Forecasts 2013-2023
3.5 Japan: A New and Growing Market for Outsourced Logistics
3.5.1 Japanese Clinical Trial Supply and Logistics Submarket Forecast 2013-2023
3.6 Clinical Trial Supply in Emerging Markets
3.7 The Latin American Clinical Trial Supply and Logistics Market 2013-2023
3.7.1 Challenging Distribution Conditions
3.7.2 Brazilian Clinical Trial Supply and Logistics Submarket Forecast 2013-2023
3.8 Russia and Central and Eastern Europe (CEE)
3.8.1 Outsourcing Will Grow Strongly in Russia
3.8.2 Russian Clinical Trial Supply and Logistics Submarket Forecast 2013-2023
3.9 India: An Emerging Destination for Outsourced Clinical Trials
3.9.1 New Clinical Trial Rules Restrain Growth in 2013
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4. Contents
3.9.2 Indian Clinical Trial Supply and Logistics Submarket Forecast 2013-2023
3.10 Clinical Trial Supply and Logistics in China 2013-2023
3.10.1 Foreign Investment in Chinese Clinical Trial Logistics
3.10.2 Strong Growth for Clinical Trial Supply and Logistics in China 2013-2023
4. Clinical Trial Supply and Logistics: Regulatory Outlook 2013-2023
4.1 How do Regulatory Standards Affect Clinical Trial Supply?
4.1.1 Good Practices (GxP) in Clinical Trial Distribution
4.1.1.1 Good Manufacturing Practice (GMP)
4.1.1.2 Good Distribution Practice (GDP)
4.1.2 Import Regulations Complicate International Manufacturing and Trials
4.2 Clinical Trial Supply Regulations in the US 2013
4.2.1 Importing Drugs into the US: A Reinterpretation of the Rules
4.3 Clinical Trial Regulations in the EU 2013
4.3.1 Manufacturing Requirements for Clinical Trial Materials in the EU
4.3.2 The European Commission Releases New GDP Guidelines 2013
4.4 GMP and Importation Regulations for Pharmaceuticals in Japan 2013
4.5 Clinical Trial Supply Chain Regulations in Emerging Markets
4.5.1 China: Tougher Regulations for Pharmaceutical Companies and Service Providers
4.5.1.1 Improving Supply Chain Security in China 2013
4.5.2 India: Drug Manufacturing and Imports for Clinical Trials
4.5.2.1 The CDSCO Drafts New GDP Guidelines 2013
4.5.3 Brazil: Slow Regulatory Approval for Clinical Trials
4.5.4 Recent Updates to Pharmaceutical Regulation in Russia
5. Clinical Trial Supply and Logistics: Industry Trends 2013-2023
5.1 Clinical Trial Supply and Logistics Market: Strengths and Weaknesses 2013
5.2 Clinical Trial Supply and Logistics Market: Opportunities and Threats 2013-2023
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5. Contents
5.3 Clinical Trial Supply and Logistics Market: STEP Analysis 2013-2023
5.3.1 Social Factors
5.3.2 How Will Novel Technologies Affect the Market to 2023?
5.3.3 Economic Pressures: Demands for Lower Cost Trials and Logistics
5.3.4 Political Issues
5.4 Securing the Clinical Trial Supply Chain 2013-2023
5.4.1 How Will Technology Improve Supply Chain Security?
5.5 How Will Clinical Trial Globalisation Impact Supply and Logistics?
5.6 Trends in Clinical Trial Manufacturing 2013-2023
5.6.1 The Challenge of Comparator Sourcing for Clinical Trials
5.6.1.1 Comparators Are a Source of Risk for Supply Chain Security
5.6.1.2 Regulators and Payers Will Increasingly Demand Comparative Effectiveness
Research
5.6.2 Trends in Packaging for Clinical Trials 2013-2023
5.7 Clinical Trial Supply Chain Management Trends to 2023
5.7.1 Forecasting and Modelling to Ensure Sufficient Supply
5.7.2 IT Systems Improve Clinical Trial Planning: IVRS and IWRS
5.7.3 Home-Based Trial Participation: Opportunities and Challenges for Logistics
5.7.4 How Will Greater Use of Adaptive Clinical Trials Impact Trial Logistics?
5.8 Outsourcing Clinical Trial Supply and Logistics
5.8.1 Managing Multiple Supplier Networks
6. The Rise of Cold Chain Logistics in Clinical Trials 2013-2023
6.1 An Introduction to Cold Chain Supply and Distribution
6.1.1 The Importance of Cold Chain for Clinical Trials
6.1.2 Maintaining the Cold Chain
6.2 The Regulatory Outlook for Cold Chain Logistics
6.2.1 International Air Transport Regulations and Guidance: The Temperature Sensitive Label
6.3 Cold Chain Will Account for an Increasing Proportion of Clinical Trial Logistics 2013-2023
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6. Contents
6.3.1 Biologic Drug Development Will Drive Demand
6.3.1.1 Emerging Trends in Biological Drug Development
6.3.2 Pharma Cold Chain Logistics in Emerging Markets
6.4 The Role of Technology in Clinical Cold Chain Logistics
6.4.1 Active and Passive Temperature Control
6.4.2 There Are Many Ways to Maintain Temperature in the Cold Chain
6.4.2.1 Developments in Phase Change Materials
6.4.2.2 The Benefits of Liquid Nitrogen for Sample Transportation
6.4.3 Advances in RFID for Temperature Monitoring
6.4.3.1 Will Uptake for RFID Grow Among Biopharma Companies to 2023?
6.4.4 Future Technologies for Cold Chain Supply Management
6.4.4.1 Demand for Reusable Cold Chain Packaging
7. Clinical Trial Supply and Logistics Market: Leading Players 2013
7.1 Third Party Logistics Providers: Leading Clinical Distributors 2013
7.1.1 World Courier: A Pharmaceutical Supply Specialist
7.1.1.1 Distribution Services for Pharma, CROs and Central Laboratories
7.1.1.2 World Courier Is the Clinical Trial Distribution Market Leader
7.1.1.3 World Courier Opens New Service Depots in Europe and Latin America 2012
7.1.2 DHL: A Global Leader in Supply Chain Logistics
7.1.2.1 Life Sciences: A Fast-Growing Source of Revenue for DHL Supply Chain
7.1.2.2 DHL Adds New Services for Healthcare and Clinical Trial Clients 2013
7.1.3 Marken
7.1.3.1 What Services Does Marken Offer Clinical Trial Sponsors?
7.1.3.2 Marken: Challenging Market Conditions 2008-2012
7.1.3.3 Marken Continues to Expand Worldwide
7.1.3.4 Expertise in Biological Sample Management
7.1.4 Other Leading and Emerging Players in the Market 2013
7.1.4.1 TNT Express
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7. Contents
7.1.4.2 FedEx
7.1.4.3 Movianto Is a European Healthcare Specialist
7.2 Clinical Trial Manufacturing: Submarket Leaders 2013
7.2.1 Catalent Pharma Solutions
7.2.1.1 Clinical Trial Manufacturing and Supply Services
7.2.1.2 Strong Growth for Clinical Manufacturing Revenue, 2010-2013
7.2.1.3 Catalent Increases its Focus on Clinical Trial Manufacturing
7.2.2 Patheon
7.2.2.1 Patheon Is a Leader in Pharmaceutical Development Services
7.2.2.2 Patheon Completed 370 Clinical Projects in FY 2012
7.2.3 Almac Group: Manufacturing, Packaging and Logistics Services
7.2.3.1 Clinical Trial Supply and Management Solutions
7.2.3.2 Almac Opens New Facilities to Expand its Clinical Trial Expertise
7.3 The Role of CROs in the Clinical Trial Supply and Logistics Market
7.3.1 Parexel International
7.3.1.1 Parexel’s Clinical Trial Supply and Logistics Services
7.3.1.2 Parexel Expands Worldwide 2012-2013
7.4 Other Leading Companies in the Clinical Trial Supply and Logistics Market 2013
7.4.1 Fisher Clinical Services (FCS)
7.4.1.1 FCS Offers Manufacturing, Packaging, Storage and Distribution Services
7.4.1.2 Fisher BioServices: Clinical Logistics for the Cell Therapy Industry
7.4.2 Packaging Coordinators Inc. (PCI)
8. Research Interviews 2013
8.1 Alex Guillen, CEO, Escort Cold Chain Solutions
8.1.1 Escort Cold Chain Solutions (ECCS)
8.1.2 Uptake of RFID for Pharmaceutical Cold Chain
8.1.3 RFID Beyond Temperature Monitoring
8.1.4 Emerging Technologies for Cold Chain Monitoring
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8. Contents
8.1.5 Emerging Packaging Technologies
8.2 Onno Boots, Managing Director, Asia Pacific, MNX
8.2.1 MNX
8.2.1.1 MNX Is Expanding in Asia
8.2.2 Challenges in Clinical Trial Logistics
8.2.3 The Appeal of the Clinical Trial Logistics Market
8.2.4 Challenges in Asian Logistics
8.2.5 Future Expectations for the Clinical Trial Logistics Market
8.2.6 Demand for Cold Chain Services
8.2.7 The Cost of Clinical Trial Sample Logistics
8.2.8 New Technologies for Clinical Trial Logistics
8.2.9 MNX: A New Logistics Model for Clinical Research
9. Conclusions of Our Study
9.1 The Clinical Trial Supply and Logistics Market 2012-2013
9.2 Outlook for the Market 2013-2023
9.3 Growing Demand for Clinical Logistics in Emerging Markets
9.4 Technology and Innovation to Drive Outsourcing
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9. Contents
List of Tables
Table 1.1 Currency Exchange Rates
Table 1.2 Clinical Trials Registered by Country/Region, 2013
Table 2.1 R&D Outsourcing Market: Revenue ($bn) and Market Share (%) by Sector, 2012
Table 2.2 Clinical Trial Supply and Logistics Market: Revenue ($bn) and Market Share (%) by
Sector, 2012
Table 2.3 Clinical Trial Supply and Logistics Market: Overall Market and Revenue Forecasts by
Sector ($bn), 2012-2023
Table 2.4 Clinical Trial Supply and Logistics Market: Submarket Shares (%), 2012-2023
Table 2.5 Clinical Trial Manufacturing Submarket: Revenue ($bn) and Submarket Share (%) by
Sector, 2012
Table 2.6 Clinical Trial Manufacturing Submarket: Overall Submarket and Revenue Forecasts by
Sector ($bn), 2012-2023
Table 2.7 Clinical Trial Packaging Submarket Forecast ($bn), 2012-2023
Table 2.8 Clinical Trial Logistics and Distribution Submarket: Revenue ($bn) and Submarket
Share (%) by Sector, 2012
Table 2.9 Clinical Trial Logistics and Distribution Submarket: Overall Submarket and Revenue
Forecasts by Sector ($bn), 2012-2023
Table 2.10 Clinical Trial Cold Chain Logistics Submarket Forecast ($bn), 2012-2023
Table 2.11 Clinical Trial Supply Chain Management Submarket Forecast ($bn), 2012-2023
Table 3.1 Clinical Trial Supply and Logistics Market: Revenues ($bn) and Market Shares (%) by
Country/Region, 2012
Table 3.2 Clinical Trial Supply and Logistics Market: Regional and National Submarket Revenue
Forecasts ($bn), 2013-2023
Table 3.3 Clinical Trial Supply and Logistics Market: Regional and National Submarket Shares
(%), 2012-2023
Table 3.4 US Clinical Trial Supply and Logistics: Submarket Forecast ($bn), 2012-2023
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10. Contents
Table 3.5 Western European Clinical Trial Supply and Logistics: Submarket Forecast ($bn), 20122023
Table 3.6 Western European Clinical Trial Supply and Logistics Submarket: Revenues ($bn) and
Market Shares (%) by Country, 2012
Table 3.7 Western European Clinical Trial Supply and Logistics Submarket: National Submarket
Forecasts ($bn), 2012-2023
Table 3.8 Japanese Clinical Trial Supply and Logistics: Submarket Forecast ($bn), 2012-2023
Table 3.9 Selected Clinical Trial Logistics Investments in Latin America, 2012
Table 3.10 Brazilian Clinical Trial Supply and Logistics: Submarket Forecast ($bn), 2012-2023
Table 3.11 Russian Clinical Trial Supply and Logistics: Submarket Forecast ($bn), 2012-2023
Table 3.12 Indian Clinical Trial Supply and Logistics: Submarket Forecast ($bn), 2012-2023
Table 3.13 Selected Clinical Trial Logistics Investments in China, 2011-2013
Table 3.14 Chinese Clinical Trial Supply and Logistics: Submarket Forecast ($bn), 2012-2023
Table 4.1 ICH Guidelines Manufacturing Guidelines, 2000-2013
Table 5.1 Clinical Trial Supply and Logistics Market: Strengths and Weaknesses, 2013
Table 5.2 Clinical Trial Supply and Logistics Market: Opportunities and Threats, 2013-2023
Table 5.3 Clinical Trial Supply and Logistics Market: STEP Analysis, 2013-2023
Table 5.4 Commonwealth of Independent States: Registered Clinical Trials, 2013
Table 5.5 Comparative Costs of Orphan and Non-Orphan Clinical Trials, 2013
Table 5.6 TransCelerate BioPharma Member Companies, 2013
Table 5.7 The Benefits of Advanced Forecasting Tools for Clinical Trial Logistics
Table 5.8 Selected Clinical Trial Supply Forecasting Tools Available, 2013
Table 5.9 Selected IVRS/IWRS Tools Available for Clinical Trials, 2013
Table 5.10 Home-Based Clinical Trial Distribution: Advantages and Disadvantages, 2013
Table 5.11 Outsourcing Clinical Trial Supply and Logistics: Benefits and Weaknesses, 2013
Table 6.1 Top Ten Prescription Drugs: Biologics Share, 2012 and 2018
Table 6.2 Leading Providers of RFID Tags for the Pharmaceutical Market, 2013
Table 7.1 AmerisourceBergen: Other Service Revenue ($bn) by Company, 2012
Table 7.2 DHL Supply Chain: Revenue ($bn) by Sector, 2012
Table 7.3 Marken: Revenue ($bn), 2008-2012
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11. Contents
Table 7.4 Catalent: Development and Clinical Services Facilities, 2013
Table 7.5 Catalent Development and Clinical Services: Revenue ($bn), 2010-2013
Table 7.6 Patheon Pharmaceutical Development Services: Revenue ($bn), 2009-2012
Table 7.7 Almac Group: Revenue ($bn), 2008-2011
Table 7.8 Parexel: Clinical Research Services Revenue ($bn), 2010-2013
Table 9.1 Clinical Trial Supply and Logistics Market: Revenue ($bn) and Market Share (%) by
Sector, 2012, 2017 and 2023
Table 9.2 Clinical Trial Supply and Logistics Market: Revenue ($bn) and Market Share (%) by
Region, 2012, 2017 and 2023
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12. Contents
List of Figures
Figure 1.1 Sectors and Services in the Clinical Trial Supply and Logistics Market, 2013
Figure 1.2 Clinical Trials Registered by Country/Region, 2013
Figure 1.3 World Pharmaceutical Market Shares (%) by Country/Region, 2012
Figure 1.4 Trends Affecting the Clinical Trial Supply and Logistics Market, 2013-2023
Figure 2.1 R&D Outsourcing Market: Market Share (%) by Sector, 2012
Figure 2.2 Clinical Trial Supply and Logistics Market: Market Share (%) by Sector, 2012
Figure 2.3 Clinical Trial Supply and Logistics Market Forecast ($bn), 2012-2023
Figure 2.4 Clinical Trial Supply and Logistics Market: Submarket Shares (%), 2017
Figure 2.5 Clinical Trial Supply and Logistics Market: Submarket Shares (%), 2023
Figure 2.6 Clinical Trial Supply and Logistics: Market Drivers, 2013-2023
Figure 2.7 Clinical Trial Supply and Logistics: Market Restraints, 2013-2023
Figure 2.8 Clinical Trial Manufacturing Submarket: Sector Shares (%), 2012
Figure 2.9 Clinical Trial Manufacturing Submarket Forecast ($bn), 2012-2023
Figure 2.10 Clinical Trial Manufacturing: Submarket Drivers and Restraints, 2013-2023
Figure 2.11 Clinical Trial Packaging Submarket Forecast ($bn), 2012-2023
Figure 2.12 Clinical Trial Logistics and Distribution Submarket: Sector Shares (%), 2012
Figure 2.13 Clinical Trial Logistics and Distribution Submarket Forecast ($bn), 2012-2023
Figure 2.14 Clinical Trial Logistics and Distribution: Submarket Drivers and Restraints, 20132023
Figure 2.15 Clinical Trial Cold Chain Logistics Submarket Forecast ($bn), 2012-2023
Figure 2.16 Clinical Trial Supply Chain Management Submarket Forecast ($bn), 2012-2023
Figure 2.17 Clinical Trial Supply Chain Management: Submarket Drivers and Restraints, 20132023
Figure 3.1 Clinical Trial Supply and Logistics Market: Market Share (%) by Country/Region, 2012
Figure 3.2 Clinical Trial Supply and Logistics Market: Market Share (%) by Country/Region,
2012-2023
Figure 3.3 US Clinical Trial Supply and Logistics: Submarket Drivers and Restraints, 2013-2023
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13. Contents
Figure 3.4 US Clinical Trial Supply and Logistics Submarket Forecast ($bn), 2012-2023
Figure 3.5 US Clinical Trial Supply and Logistics Market Share (%), 2012-2023
Figure 3.6 Western European Clinical Trial Supply and Logistics Submarket Forecast ($bn), 20122023
Figure 3.7 Western European Clinical Trial Supply and Logistics Market Share (%), 2012-2023
Figure 3.8 Western European Clinical Trial Supply and Logistics: Submarket Drivers and
Restraints, 2013-2023
Figure 3.9 Western European Clinical Trial Supply and Logistics Submarket Shares (%) by
Country, 2012
Figure 3.10 German and French Clinical Trial Supply and Logistics Submarket Forecasts ($bn),
2012-2023
Figure 3.11 UK, Italian and Spanish Clinical Trial Supply and Logistics Submarket Forecasts
($bn), 2012-2023
Figure 3.12 Japanese Clinical Trial Supply and Logistics: Submarket Drivers and Restraints,
2013-2023
Figure 3.13 Japanese Clinical Trial Supply and Logistics Submarket Forecast ($bn), 2012-2023
Figure 3.14 Japanese Clinical Trial Supply and Logistics Market Share (%), 2012-2023
Figure 3.15 Brazilian Clinical Trial Supply and Logistics Submarket Forecast ($bn), 2012-2023
Figure 3.16 Brazilian Clinical Trial Supply and Logistics Market Share (%), 2012-2023
Figure 3.17 Brazilian Clinical Trial Supply and Logistics: Submarket Drivers and Restraints, 20132023
Figure 3.18 Russian Clinical Trial Supply and Logistics: Submarket Drivers and Restraints, 20132023
Figure 3.19 Russian Clinical Trial Supply and Logistics Submarket Forecast ($bn), 2012-2023
Figure 3.20 Russian Clinical Trial Supply and Logistics Market Share (%), 2012-2023
Figure 3.21 Indian Clinical Trial Supply and Logistics Submarket Forecast ($bn), 2012-2023
Figure 3.22 Indian Clinical Trial Supply and Logistics: Submarket Drivers and Restraints, 20132023
Figure 3.23 Indian Clinical Trial Supply and Logistics Market Share (%), 2012-2023
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14. Contents
Figure 3.24 Chinese Clinical Trial Supply and Logistics: Submarket Drivers and Restraints, 20132023
Figure 3.25 Chinese Clinical Trial Supply and Logistics Submarket Forecast ($bn), 2012-2023
Figure 3.26 Chinese Clinical Trial Supply and Logistics Market Share (%), 2012-2023
Figure 5.1 Players in the Clinical Trial Supply Chain, 2013
Figure 6.1 World Pharmaceutical Market Forecast by Drug Type, 2012 and 2018
Figure 7.1 AmerisourceBergen: Other Service Revenue Share (%) by Company, 2012
Figure 7.2 DHL Supply Chain: Revenue Share (%) by Sector, 2012
Figure 7.3 Marken: Revenue ($bn), 2008-2012
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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15. Contents
Companies and Other Organisations Mentioned in This Report
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
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16. 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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17. 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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18. 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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19. Contents
World Health Organization (WHO)
Worldwide Clinical Trials
WuXi PharmaTech
Y Prime
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20. 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 CEEbased 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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21. 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 $0.09bn in 2012 (Table 3.11 and Figure 3.19). In 2023, the submarket will account for
1.5% of the global market (Figure 3.20).
Figure 3.18 Russian Clinical Trial Supply and Logistics: Submarket Drivers and
Restraints, 2013-2023
Restraints
Service costs will rise in this decade, as a result
of the requirement for local clinical trials and
manufacturing.
A large patient population and fast recruitment
make Russia an appealing destination for clinical
trials.
Knowledge of language and local importation
rules will drive outsourcing in this decade.
Domestic infrastructure will need to improve for
more remote trial sites to be easily reached.
Import regulations and applications can add to
trial delays, potentially limiting the country’s
appeal as a trial destination.
The Russian government is promoting local drug
development, particularly biologics, driving cold
chain demand.
Drivers
Source: visiongain 2013
Table 3.11 Russian Clinical Trial Supply and Logistics: Submarket
Forecast ($bn), 2012-2023
2012
Submarket Size ($bn)
2013
2014
2015
2016
2017
0.09
0.10
0.11
0.12
0.14
0.15
9
9
10
10
Annual Growth (%)
CAGR (%)
12
10.0
2018
2019
2020
2021
2022
2023
Submarket Size ($bn)
0.17
0.19
0.22
0.24
0.27
0.30
Annual Growth (%)
12
13
13
13
12
11
CAGR (%)
12.3
Source: visiongain 2013
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