Clinical Trial Supply and Logistics: World Market Outlook 2013-2023

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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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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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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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5.3 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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6.3.1 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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7.1.4.2 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 Parexels 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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8.1.5 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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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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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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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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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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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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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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Companies and Other Organisations Mentioned in This Report
3C Alliance AbbVie AbbVie Contract Pharmaceutical Manufacturing (part of AbbVie) ACM Global Central Lab Agncia Nacional de Vigilncia Sanitria (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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Catalent Pharma Solutions Celesio Cenduit Central Drugs Standard Control Organization (CDSCO) [India] China Food and Drug Administration (CFDA) ClinStar (part of PRA International) Comisso Nacional de tica em Pesquisa (CONEP) [Brazil] Consorcio de Apoyo a la Investigacin Biomdica Plataforma Espaola de Ensayos Clnicos (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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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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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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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 30C in the Western cities in the summer to well below -10C 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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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. 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 countrys appeal as a trial destination.

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.

Drivers

Source: visiongain 2013

Table 3.11 Russian Clinical Trial Supply and Logistics: Submarket Forecast ($bn), 2012-2023
2012 Submarket Size ($bn) Annual Growth (%) CAGR (%) 2018 Submarket Size ($bn) Annual Growth (%) CAGR (%) 0.17 12 2019 0.19 13 2020 0.22 13 2021 0.24 13 2022 0.27 12 0.09 2013 0.10 9 2014 0.11 9 2015 0.12 10 2016 0.14 10 2017 0.15 12 10.0 2023 0.30 11 12.3

Source: visiongain 2013

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