1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6
2 Introduction 7
2.1 GBI Research Guide 7
3 Overview of the CMO Industry 8
3.1 Current Status of Pharmaceutical Industry 8
3.2 The Need to Outsource for Pharmaceutical Companies 8
3.2.1 Reduction in Physical Assets 9
3.2.2 Restructuring of Product Portfolio 9
3.2.3 Downsizing Manufacturing 9
3.2.4 Reduction in R&D Spending 10
3.3 What CMOs are and Reasons for Outsourcing to Them 11
3.3.1 Different Types of CMOs and the Range of Services Provided by Them 12
3.3.2 How Does Outsourcing to CMOs Take Place? 13
3.3.3 Key Outsourcing Models 15
3.3.4 Key Benefits of Outsourcing 17
4 Contract Manufacturing in Eastern Europe - Market Characterization 19
4.1 Market Forecasts 21
5 Geographical Landscape 22
5.1 Comparative Analysis of Eastern European Countries 22
5.2 Infrastructural Facilities – Railways, Roadways, Airways, Power and Overall Logistics Support 23
5.3 Labor - Availability of Skilled Labor at Affordable Rates and Labor Flexibility 24
5.4 Broad Economic Indicators – GDP, Availability of Credit, Taxation Policies 25
5.5 Ease of Doing Business – Overall Government and Regulatory Support 26
5.5.1 Key Takeaway 27
5.6 Individual Strengths and Weaknesses for Each Country 28
5.6.1 Poland 28
5.6.2 Czech Republic 30
5.6.3 Lithuania 32
5.6.4 Ukraine 33
5.6.5 Hungary 35
5.6.6 Slovakia 37
5.6.7 Slovenia 38
5.7 Analysis of Other Emerging CMO markets 40
5.7.1 Chinese CMO Market 40
5.7.2 Indian CMO Market 41
6 Market Drivers and Restraints 43
6.1 Drivers 44
6.1.1 Availability of Low-cost Skilled Manpower 44
6.1.2 Better Infrastructure and Government Policies 46
6.1.3 Increased Consumptions of Generics 47
6.1.4 Better Intellectual Property Rights Protection 52
6.1.5 Increasing Uptake of Biologics and Entry of Biosimilars into Market 53
6.2 Restraints 56
6.2.1 Competition from Low-cost Asian CMOs 56
6.2.2 Capacity Utilization Issues Affecting the Profitability of CMOs 57
6.2.3 Reduced Number of New Drug Approvals 57
6.2.4 Complex Cost Structures in Outsourcing 59
7 Regulatory Landscape 61
7.1 EU GMP 62
7.1.1 EU cGMP Guidelines for API Manufacturing 63
7.1.2 Key Changes in EU GMP Guidelines 66
7.2 PIC/S 66
8 Prominent Players 68
8.1 Polpharma S.A. 68
8.1.1 Services Offered 69
8.2 Hasco-Lek S.A. 70
8.2.1 Services Offered 71
8.3 Sanitas AB (Sanitas Group) 72
8.3.1 Pharmaceutical Company JELFA SA 73
8.3.2 Laboratorium Farmaceutyczne Homeofarm sp. z o.o. 73
8.4 Lonza Biotec sro 74
8.4.1 Services Offered 74
8.5 Grindeks A.S. 75
8.5.1 Services Offered 76
8.6 Galilaeus Oy 77
8.6.1 Services Offered 77
8.7 FSP Galena 78
8.7.1 Services Offered 78
8.8 Noventis sro 79
8.8.1 Services offered 79
8.9 Zentiva N.V. 80
8.9.1 Services Offered 80
8.10 SVUS Pharma a.s. 81
8.10.1 Services offered 81
8.11 Notable CMOs in Eastern Europe 82
8.11.1 Nycomed 82
8.11.2 Polfa Tarchomin S.A. 82
8.11.3 Biogened S.A. 82
8.11.4 Pliva Lachema a.s. 82
8.11.5 Aflofarm 82
8.11.6 TAPI 83
9 Major Events and Trends in the CMO Industry 84
9.1 US Healthcare Reforms in 2010 Will Affect CMOs Positively due to Increased Demand for Medicines in the US. 84
9.2 Upcoming Blockbuster Drugs will Create a Positive Impact on the CMO Industry 85
9.3 Increased Focus on Emerging Markets by Major Pharmaceutical Companies will Affect CMOs Positively 86
9.4 Developments Leading to an Anti-counterfeiting Trade Agreement will Affect CMOs Positively 87
9.5 Increased M&A Activity During 2009-10 is Likely to Affect the CMO Business Positively 88
9.6 Tightening of GMP Guidelines by the FDA and the EU in Near Future will Increase Costs for the CMOs and will Negatively Affect their Profitability. 89
9.7 Lower Capacity Utilization in the Biologics Manufacturing Industry is Negatively Affecting the Profitability of the CMOs 90
9.8 Drug Price Cuts Across Western Europe will Negatively Affect the CMOs 91
10 Appendix 92
10.1 Market Definitions 92
10.2 Abbreviations 92
10.3 Research Methodology 93
10.3.1 Coverage 93
10.3.2 Secondary Research 94
10.3.3 Primary Research 94
10.3.4 Expert Panel Validation 94
10.4 Contact Us 95
10.5 Disclaimer 95
10.6 Sources 95
1.1 List of Tables
Table 1: Contract Manufacturing in Eastern Europe, Market Characterization, Eastern Europe CMO Market Size, $bn, 2007-2016
Table 2: Market Drivers, All Employees: Indexes of Hourly Compensation Costs (United States = 100)
Table 3: Market Drivers, Better Government Policies Supporting Business Operations in Eastern Europe
Table 4: Market Drivers, Major Drug Patent Expirations, 2010-2016
Table 5: PIC/S Members from Eastern Europe
Table 6: Promising Biologic Drugs likely to get Approved by FDA in 2010
1.2 List of Figures
Figure 1: Cost Optimization Steps in the Pharmaceutical Industry
Figure 2: Impact Analysis of Various Cost Optimization Methods
Figure 3: Global CMO Industry Structure
Figure 4: Process for Selection of CMO and Management of Outsourcing Project
Figure 5: Key Benefits of Outsourcing to CMOs
Figure 6: Increasing Share of CMOs in Overall Pharmaceutical Manufacturing
Figure 7: Revenue Split of Global CMO Market by Geography
Figure 8: Break-up of Global CMO Market by Services Provided
Figure 9: Contract Manufacturing in Eastern Europe, Market Characterization, Eastern Europe CMO Market Size ($bn), 2007-2016
Figure 10: Parameters Considered for Ranking of Different Eastern European Nations
Figure 11: Ranking on Infrastructure of Different Eastern European Nations
Figure 12: Rankings for Attractiveness of Labor of Different Eastern European Nations
Figure 13: Rankings for Broad Economic Indicators of Different Eastern European Nations
Figure 14: Rankings for Ease of Doing Business for Different Eastern European Nations
Figure 15: Ranks for Overall Business Attractiveness
Figure 16: Geographical Landscape, Strengths and Weaknesses, Poland
Figure 17: Geographical Landscape, Strengths and Weaknesses, Czech Republic
Figure 18: Geographical Landscape, Strengths and Weaknesses, Lithuania
Figure 19: Geographical Landscape, Strengths and Weaknesses, Ukraine
Figure 20: Geographical Landscape, Strengths and Weaknesses, Hungary
Figure 21: Geographical Landscape, Strengths and Weaknesses, Slovakia
Figure 22: Geographical Landscape, Strengths and Weaknesses, Slovenia
Figure 23: Contract Manufacturing in Eastern Europe, Market Driver and Restraints
Figure 24: Market Drivers, Difference in Hourly Wage Costs in Euro Area v/s Eastern Europe
Figure 25: Market Drivers, Percentage of Tertiary Graduates by Disciplines, Eastern Europe v/s Developed Nations
Figure 26: Market Drivers, Increasing Generics Opportunities Due to Patent Expiries for Major Drugs
Figure 27: Market Drivers, Market Opportunity for CMOs Due to Patent Expiry for Blockbuster Drugs
Figure 28: Market Drivers, Increased Opportunities for CMOs Due to Generics Manufacturing
Figure 29: Market Drivers, IPR Protection Eastern European v/s Asian CMO Markets
Figure 30: Market Drivers, Growth in Global Biologics Market, 2009-2016
Figure 31: Market Drivers, Analysis of Increasing Opportunities for Biologics Manufacturing for CMOs
Figure 32: Market Drivers, Increased Biologics Manufacturing Opportunities for CMOs
Figure 33: Market Restraints, Cost Comparison Between Eastern European and Asian CMOs
Figure 34: Market Restraints, Reduction in Drug Approval Rates by FDA Affecting CMOs
Figure 35: Market Restraints, Opportunities Lost by CMOs Due to Reduced Approval Rates by FDA
Figure 36: Regulatory Landscape, Manufacturing Regulatory Framework in Eastern Europe
Figure 37: Steps in API Manufacturing Governed by EU GMP Guidelines
Figure 38: Prominent Players, Polpharma S.A.
Figure 39: Prominent Players, Hasco-Lek S.A.
Figure 40: Prominent Players, Sanitas Group
Figure 41: Prominent Players, Lonza Biotec sro
Figure 42: Prominent Players, Grindeks A.S.
Figure 43: Prominent Players, Galilaeus Oy
Figure 44: Prominent Players. FSP Galena
Figure 45: Prominent Players, Noventis sro
Figure 46: Prominent Players, Zentiva N.V.
Figure 47: Prominent Players, SVUS Pharma a.s
Figure 48: Comparison of CMOs
Figure 49: Major Trends and Events and Their Impact on the CMO Industry