Emerging Market for Clinical Trials in Poland - Cost Advantages of Nearly 30% as Compared to the US

Summary

Company, the leading business intelligence provider, has released its latest report, “Emerging Market for Clinical Trials in Poland - Cost Advantages of Nearly 30% as Compared to the US” which provides key data, information and analysis of the major trends and issues affecting the clinical trial market in Poland. The report provides a comprehensive insight of the reasons for outsourcing clinical trials to Poland and the key services provided by the Clinical Research Organizations (CROs) of Poland. The report provides a detailed analysis of the Polish market in terms of its size, and major service offerings of the CROs in Poland. The report also discusses the factors that are driving the clinical trial market in Poland. The report delves into the key documents required by the investigator and the sponsor before, during and after the conduct of clinical trials. The report also provides key alliances in the CRO market. Furthermore, the report looks into the major challenges that can restrict the growth of the clinical trials market in Poland.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by Company’s team of industry experts.

With increasing cost-cutting pressures due to decreasing Research and Development (R&D) productivity, the patent expiries of blockbusters, drying pipelines and stringent regulations of governments, the cost of conducting research in the Western world is increasing and in turn is putting immense financial pressures on the major pharmaceutical companies. On the other hand, Poland is becoming an attractive location for conducting clinical research. Speed of patient recruitment and quality of clinical trial data are two major advantages in Poland. Moreover, improvements in clinical trial regulation could drive the market in the future. Although Poland controls a very small part of the global clinical research, this share is expected to rise in the future as the Western pharmaceuticals have realized the need to outsource the maximum possible amount of R&D work to low-cost countries. With clinical studies occupying the majority of R&D costs, there is a huge opportunity for significant cost savings.

However, developed countries will face several challenges to continue their growth momentum. Legislative drawbacks and a lack of social awareness towards clinical trials will be the major obstacles for companies in Poland. Moreover, increasing competition from other Eastern European countries is also expected to impede the growth of the clinical trial market in Poland.

Scope

- The need for outsourcing clinical trials to Poland.
- Trends in clinical trial registration in Poland and a comparative analysis of clinical trial registration in Eastern European countries.
- Analysis of the key drivers that are fueling the growth of the clinical trial market in Poland.
- Analysis of the key infrastructural facilities, clinical research professionals and principal investigators in Poland.
- Analysis of key government regulations in Poland affecting the clinical trial market.
- Study of 12 major CROs operating in Poland.

Reasons to buy

- Compare the key capabilities of major clinical trial service providers with your requirements and optimize your R&D costs.
- Develop market entry and market expansion strategies by identifying the key drivers and challenges in the Polish clinical trials market.
- Develop effective strategies to maximize the advantages in Poland through understanding of the regulatory environment.
- Understand the regulatory structure in Poland and key documents required to register clinical trials in Poland.

1.1 List of Tables 5
1.2 List of Figures 7
2 Emerging Market for Clinical Trials - Poland - Introduction 9
2.1 Company Report Guidance 9
3 Emerging Market for Clinical Trials - Poland - Overview 10
3.1 The Clinical Research Process- Overview 10
3.1.1 Drug Discovery 11
3.1.2 Preclinical Study/Development 11
3.1.3 Clinical Trials 11
3.2 Clinical Trial Design and Types 13
3.2.1 Types of Design 13
3.3 Role of CROs 19
3.4 Sponsors of Clinical Trials 20
3.5 The Need for Outsourcing Clinical Trials 21
3.5.1 High Risks and Costs Associated With Drug Development 21
3.5.2 Escalating Costs of Clinical Trials 22
3.5.3 Global Increase in the Number of Clinical Trials Conducted 23
3.5.4 Restructuring the R&D 24
3.5.5 Increased Screening Rates during R&D 25
3.5.6 Expiring Patents Pressurize Pharmaceutical Companies to Reduce Costs 25
4 Emerging Market for Clinical Trials - Poland - Clinical Trial Trends 26
4.1 Clinical Trials Registered Globally 26
4.2 Clinical Trials Registered in Eastern European Countries 27
4.3 Analysis of Clinical Trials Registered in Poland 29
4.3.1 Clinical Trials Registered in 1995-2010 29
4.3.2 Analysis of Clinical Trials Registered in 2010 31
4.3.3 Registration of Phase l Clinical Trials 32
4.3.4 Registration of Phase ll Clinical Trials 33
4.3.5 Registration of Phase lll Clinical Trials 34
4.3.6 Registration of Phase lV Clinical Trials 35
4.3.7 Clinical Trials Registered by Therapeutic Area 36
4.4 Comparative Analysis of Industry Sponsored Clinical Trials Registered in US Trials Registry in the Eastern Europe Countries 37
4.5 Analysis of Clinical Trials Registered by MNCs in Poland 38
4.6 Sites for Industry Sponsored Clinical Trials Worldwide 40
4.7 Sites for Industry Sponsored Clinical Trials Registered in Eastern European Countries 42
4.7.1 Number of Registered Sites for Industry Sponsored Clinical Trials (Phase II/III) 42
4.7.2 Number of Multi-national Sites Registered for Industry Sponsored Trials (Phase II/III) 43
4.7.3 Number of Local Sites Registered for Industry Sponsored Trials (Phase II/III) 46
5 Emerging Market for Clinical Trials - Poland - Market Environment Characterization 49
5.1 Global CRO Market 49
5.1.1 Pipeline Analysis of Five Major Pharmaceutical Companies 50
5.2 Clinical Trial Market in Poland 51
5.3 Key Drivers of Clinical Trials Market in Poland 53
5.3.1 Population Statistics 53
5.3.2 Patient Availability for Major Diseases 56
5.3.3 Patient Recruitment and Speed of Trials 60
5.3.4 Patients and Clinical Trial Sites Density 65
5.3.5 Qualified and Experienced Talent Pool 67
5.3.6 Favorable Clinical Infrastructure in Poland Enhances the Clinical Trial Environment 69
5.3.7 Comparative Analysis of Cost of Clinical Trials amongst Countries Worldwide 72
5.3.8 Quality of Clinical Trial Data 72
5.4 Key Restraints of Clinical Trials Market in Poland 74
5.4.1 Long Trial Registration Process 74
5.4.2 Other Restraints 74
6 Emerging Market for Clinical Trials - Poland - Regulatory Landscape 75
6.1 Introduction 75
6.2 Regulatory Provisions in Poland Related to Clinical Trials 76
6.3 Major Regulatory Authorities and Trial Registration Process in Poland 77
6.4 Documents to be Submitted for Conducting a Clinical Trial in Poland 80
6.4.1 Documents to be Submitted to the Registration Office for Conducting a Clinical Trial 80
6.4.2 Documents to be Submitted to the Bioethics Committee for Conducting a Clinical Trial 81
6.4.3 Documents Required With the Investigator and Sponsor of Clinical Trials 83
6.5 Possible Regulatory Changes in Clinical Trials 87
7 Emerging Market for Clinical Trials - Poland - CRO Landscape 88
7.1 CRO Profiles 88
7.1.1 Quintiles Poland 88
7.1.2 Covance 89
7.1.3 Kendle 90
7.1.4 PPD 91
7.1.5 Chiltern 92
7.1.6 ICON plc. 93
7.1.7 PRA International 94
7.1.8 PAREXEL 95
7.1.9 Lambda Therapeutic Research 96
7.1.10 Synexus 96
7.1.11 KCR 96
7.1.12 Prosen 96
7.2 Major Deals in the CRO Market 97
8 Emerging Market for Clinical Trials - Poland - Appendix 98
8.1 Market Definitions 98
8.2 Abbreviations 98
8.3 Research Methodology 99
8.3.1 Coverage 99
8.3.2 Secondary Research 99
8.3.3 Primary Research 99
8.3.4 Expert Panel Validation 100
8.3.5 Section-wise Research Methodology 100
8.4 Contact Us 102
8.5 Disclaimer 102
8.6 Sources 103

1.1 List of Tables

Table 1: Clinical Trials in Poland, Global, BLA and NME Approvals vs R&D Spending, ($bn), 1995-2010 21
Table 2: Clinical Trials in Poland, US Drug Patent Expiry, ($m), 2011-2016 25
Table 3: Clinical Trials in Poland, Global, Number of Clinical Trials Registered, 2005-2010 26
Table 4: Clinical Trials in Poland, Eastern Europe, Number of Clinical Trials, 2005-2010 27
Table 5: Clinical Trials in Poland, Eastern European Countries, Number of Clinical Trials, 2010 28
Table 6: Clinical Trials in Poland, Poland, Number of Clinical Trials Registered, 1995-2010 30
Table 7: Clinical Trials in Poland, Poland, Number of Clinical Trials Registered by Phase, 2010 31
Table 8: Clinical Trials in Poland, Poland, Number of Phase l Clinical Trials Registered, 2005-2010 32
Table 9: Clinical Trials in Poland, Poland, Number of Phase lI Clinical Trials Registered, 2005-2010 33
Table 10: Clinical Trials in Poland, Poland, Number of Phase lII Clinical Trials Registered, 2005-2010 34
Table 11: Clinical Trials in Poland, Poland, Number of Phase lV Clinical Trials Registered, 2005-2010 35
Table 12: Clinical Trials in Poland, Poland, Clinical Trials Registered by Therapeutic Area, 2005 - 2010 36
Table 13: Clinical Trials in Poland, Eastern European Countries, Comparative Analysis of Industry Sponsored Clinical Trials Registered, 2005 - 2010 37
Table 14: Clinical Trials in Poland, Poland, Number of Clinical Trials Registered by MNCs , 2005 - 2010 39
Table 15: Clinical Trials in Poland, Global, Number of Sites for Industry Sponsored Trials (Phase II/III), 2006 - 2010 41
Table 16: Clinical Trials in Poland, Eastern European Countries, Number of Sites for Industry Sponsored Clinical Trials (Phase II/III), 2006 - 2010 42
Table 17: Clinical Trials in Poland, Eastern European Countries, Number of Multinational Sites for Industry Sponsored Trials (Phase II/III), 2006 - 2010 43
Table 18: Clinical Trials in Poland, Eastern Europe Countries, Number of Multi-national Sites for Industry Sponsored Phase II Trials, 2006 - 2010 44
Table 19: Clinical Trials in Poland, Eastern Europe Countries, Number of Multi-national Sites for Industry Sponsored Phase III Trials, 2006 - 2010 45
Table 20: Clinical Trials in Poland, Eastern Europe Countries, Number of Local Sites for Industry Sponsored (Phase II/III) Trials, 2006 - 2010 46
Table 21: Clinical Trials in Poland, Eastern Europe Countries, Number of Local Sites for Industry Sponsored Phase II Trials, 2006 - 2010 47
Table 22: Clinical Trials in Poland, Eastern Europe Countries, Number of Local Sites for Industry Sponsored Phase III Trials, 2006 - 2010 48
Table 23: Clinical Trials in Poland, Global, CRO Market Size, ($bn), 2006-2015 49
Table 24: Clinical Trials in Poland, Global, Number of Drugs in the Pipeline According to Phase for Five Leading Pharmaceutical Companies, 2011 50
Table 25: Clinical Trials in Poland, Poland, Clinical Trial Market Size, ($m), 2006 - 2015 51
Table 26: Clinical Trials in Poland, Eastern European Countries, Comparison of Population between Eastern European Countries, 2010 53
Table 27: Clinical Trials in Poland, Poland, Population Forecast, (Million), 2005 - 2050 54
Table 28: Clinical Trials in Poland, Poland, Population Forecast, (Million), 60+ Years, 2005 - 2050 55
Table 29: Clinical Trials in Poland, Poland, Number of Deaths by Major Diseases, 2008 56
Table 30: Clinical Trials in Poland, Poland, Population Forecast for HIV/AIDS, 2010- 2015 57
Table 31: Clinical Trials in Poland, Poland, Population Forecast for Diabetes, (Million), 2010- 2015 58
Table 32: Clinical Trials in Poland, Poland, Population Forecast for Cancer, (‘000), 2010-2015 59
Table 33: Clinical Trials in Poland, Global, Patients per Clinical Trial, 2005-2009 60
Table 34: Clinical Trials in Poland, Eastern European Countries, Patients per Clinical Trial, 2005-2009 61
Table 35: Clinical Trials in Poland, Poland, Patients per Clinical Trial, 2005-2009 62
Table 36: Clinical Trials in Poland, Eastern European Countries, Patients per Trial Site, 2005-2009 63
Table 37: Clinical Trials in Poland, Poland, Patients per Trial Site, 2005-2009 64
Table 38: Clinical Trials in Poland, Eastern European Countries, Patients per Million Population, 2005-2009 65
Table 39: Clinical Trials in Poland, Eastern European Countries, Clinical Trial Sites per Million Population, 2005-2009 66
Table 40: Clinical Trials in Poland, Global, Increase in Number of FDA Regulated Principal Investigators, 1996 - 2006 67
Table 41: Clinical Trials in Poland, Poland, Number of FDA Regulated Principal Investigators, 2001 - 2008 68
Table 42: Clinical Trials in Poland, Eastern European Countries, Physicians Density per 10,000 Population, 2009 70
Table 43: Clinical Trials in Poland, Poland, Healthcare Personnel Density per 10,000 Population, 2009 70
Table 44: Clinical Trials in Poland, Eastern European Countries, Hospital Beds Density per 10,000 Population, 2000-2009 71
Table 45: Clinical Trials in Poland, Global, Number of US FDA Data Audit Site Inspections, 1997-2008 73
Table 46: Clinical Trials in Poland, Regulatory provisions for Clinical Trials, 2011 76
Table 47: Clinical Trials in Poland, Documents to be Submitted to Registration Office for Conducting Clinical Trials in Poland, 2011 80
Table 48: Clinical Trials in Poland, Documents to be Submitted to Bioethics Committee for Conducting Clinical Trials in Poland, 2011 81
Table 49: Clinical Trials in Poland, List of Documents Required Before Commencement of Clinical Trials, 2011 83
Table 50: Clinical Trials in Poland, List of Documents Required During Conduction of Clinical Trials, 2011 85
Table 51: Clinical Trials in Poland, List of Documents Required After Completion of Clinical Trials, 2011 86
Table 52: Clinical Trials in Poland, Global, Major Deals in CRO Market, 2007- 2010 97

1.2 List of Figures

Figure 1: Clinical Trials in Poland, Clinical Research Process - Overview 10
Figure 2: Clinical Trials in Poland, Parallel Group Trial Design, 2011 13
Figure 3: Clinical Trials in Poland, Cross Over Trial Design, 2011 14
Figure 4: Clinical Trials in Poland, Adaptive Clinical Trial Design, 2011 15
Figure 5: Clinical Trials in Poland, Wyeth Learn and Confirm Model, 2011 17
Figure 6: Clinical Trials in Poland, Services Offered by CROs, 2011 19
Figure 7: Clinical Trials in Poland, Preclinical Research to Market Launch Via Clinical Trials, 2011 20
Figure 8: Clinical Trials in Poland, Global, BLA and NME Approvals vs R&D Spending, ($bn), 1995-2010 21
Figure 9: Clinical Trials in Poland, Activities of R&D Restructuring, 2011 24
Figure 10: Clinical Trials in Poland, Global, Number of Clinical Trials Registered, 2005-2010 26
Figure 11: Clinical Trials in Poland, Eastern Europe, Number of Clinical Trials, 2005-2010 27
Figure 12: Clinical Trials in Poland, Eastern European Countries, Eastern European Countries, Number of Clinical Trials, 2010 28
Figure 13: Clinical Trials in Poland, Poland, Number of Clinical Trials Registered, 1995-2010 29
Figure 14: Clinical Trials in Poland, Poland, Number of Clinical Trials Registered by Phase, %, 2010 31
Figure 15: Clinical Trials in Poland, Poland, Number of Phase l Clinical Trials Registered, 2005-2010 32
Figure 16: Clinical Trials in Poland, Poland, Number of Phase lI Clinical Trials Registered, 2005-2010 33
Figure 17: Clinical Trials in Poland, Poland, Number of Phase lII Clinical Trials Registered, 2005-2010 34
Figure 18: Clinical Trials in Poland, Poland, Number of Phase lV Clinical Trials Registered, 2005-2010 35
Figure 19: Clinical Trials in Poland, Poland, Clinical Trials Registered by Therapeutic Area, 2005 - 2010 36
Figure 20: Clinical Trials in Poland, Eastern European Countries, Comparative Analysis of Industry Sponsored Clinical Trials Registered, 2005 - 2010 37
Figure 21: Clinical Trials in Poland, Poland, Number of Clinical Trials Registered by MNCs, 2005 - 2010 38
Figure 22: Clinical Trials in Poland, Global, Number of Sites for Industry Sponsored Trials (Phase II/III), 2006 - 2010 40
Figure 23: Clinical Trials in Poland, Eastern European Countries, Number of Sites for Industry Sponsored Clinical Trials (Phase II/III), 2006 - 2010 42
Figure 24: Clinical Trials in Poland, Eastern European Countries, Number of Multinational Sites for Industry Sponsored Trials (Phase II/III), 2006 - 2010 43
Figure 25: Clinical Trials in Poland, Eastern Europe Countries, Number of Multi-national Sites for Industry Sponsored Phase II Trials, 2006 - 2010 44
Figure 26: Clinical Trials in Poland, Eastern Europe Countries, Number of Multi-national Sites for Industry Sponsored Phase III Trials, 2006 - 2010 45
Figure 27: Clinical Trials in Poland, Eastern Europe Countries, Number of Local Sites for Industry Sponsored (Phase II/III) Trials, 2006 - 2010 46
Figure 28: Clinical Trials in Poland, Eastern Europe Countries, Number of Local Sites for Industry Sponsored Phase II Trials, 2006 - 2010 47
Figure 29: Clinical Trials in Poland, Eastern Europe Countries, Number of Local Sites for Industry Sponsored Phase III Trials, 2006 - 2010 48
Figure 30: Clinical Trials in Poland, Global, CRO Market Size, ($bn), 2006-2015 49
Figure 31: Clinical Trials in Poland, Global, Number of Drugs in the Pipeline by Phase for Five Leading Pharmaceutical Companies, 2011 50
Figure 32: Clinical Trials in Poland, Poland, Clinical Trial Market Size, ($m), 2006 - 2015 51
Figure 33: Clinical Trials in Poland, Key Market Drivers and Restraints, 2011 52
Figure 34: Clinical Trials in Poland, Eastern European Countries, Comparison of Population between Eastern European Countries, (%), 2010 53
Figure 35: Clinical Trials in Poland, Poland, Population Forecast, (Million), 2005 - 2050 54
Figure 36: Clinical Trials in Poland, Poland, Population Forecast, (Million), 60+ Years, 2005 - 2050 55
Figure 37: Clinical Trials in Poland, Poland, Number of Deaths by Major Diseases, (%), 2008 56
Figure 38: Clinical Trials in Poland, Poland, Population Forecast for HIV/AIDS, 2010- 2015 57
Figure 39: Clinical Trials in Poland, Poland, Population Forecast for Diabetes, (Million), 2010- 2015 58
Figure 40: Clinical Trials in Poland, Poland, Population Forecast for Cancer, (‘000), 2010-2015 59
Figure 41: Clinical Trials in Poland, Global, Patients per Clinical Trial, 2005-2009 60
Figure 42: Clinical Trials in Poland, Eastern European Countries, Patients per Clinical Trial, 2005-2009 61
Figure 43: Clinical Trials in Poland, Poland, Patients per Clinical Trial, 2005-2009 62
Figure 44: Clinical Trials in Poland, Eastern European Countries, Patients per Trial Site, 2005-2009 63
Figure 45: Clinical Trials in Poland, Poland, Patients per Trial Site, 2005-2009 64
Figure 46: Clinical Trials in Poland, Eastern European Countries, Patients per Million Population, 2005-2009 65
Figure 47: Clinical Trials in Poland, Eastern European Countries, Clinical Trial Sites per Million Population, 2005-2009 66
Figure 48: Clinical Trials in Poland, Global, Increase in Number of FDA Regulated Principal Investigators, 1996 - 2006 67
Figure 49: Clinical Trials in Poland, Poland, Number of FDA Regulated Principal Investigators, 2001 - 2008 68
Figure 50: Clinical Trials in Poland, Eastern European Countries, Physicians Density per 10,000 Population, 2009 69
Figure 51: Clinical Trials in Poland, Eastern European Countries, Hospital Beds Density per 10,000 Population, 2000-2009 71
Figure 52: Clinical Trials in Poland, Global, Number of US FDA Data Audit Site Inspections, 1997-2008 72
Figure 53: Clinical Trials in Poland, Parallel Group Trial Design, 2011 77
Figure 54: Clinical Trials in Poland, Quintiles, Company Profile, 2011 88
Figure 55: Clinical Trials in Poland, Covance, Company Profile, 2011 89
Figure 56: Clinical Trials in Poland, Kendle, Company Profile, 2011 90
Figure 57: Clinical Trials in Poland, PPD, Company Profile, 2011 91
Figure 58: Clinical Trials in Poland, Chiltern, Company Profile, 2011 92
Figure 59: Clinical Trials in Poland, ICON plc, Company Profile, 2011 93
Figure 60: Clinical Trials in Poland, PRA International, Company Profile, 2011 94
Figure 61: Clinical Trials in Poland, PAREXEL, Company Profile, 2011 95

Companies Mentioned

Quintiles Poland
Covance
Kendle
PPD
Chiltern
ICON plc.
PRA International
PAREXEL
Lambda Therapeutic Research
Synexus
KCR
Prosen