Contract Manufacturing Organizations (CMO) in Eastern Europe - Inconsistent Demand and Competition from Asia Raises Concerns

Date: October 1, 2010
Pages: 95
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US$ 3,500.00
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Publisher: GBI Research
Report type: Strategic Report
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Contract Manufacturing Organizations (CMO) in Eastern Europe - Inconsistent Demand and Competition from Asia Raises Concerns
Contract Manufacturing Organizations (CMO) in Eastern Europe - Inconsistent Demand and Competition from Asia Raises Concerns

Summary

GBI Research, the leading business intelligence provider, has released its latest report, “Contract Manufacturing Organizations (CMO) in Eastern Europe - Inconsistent Demand and Competition from Asia Raises Concerns” that provides key data, information and analysis of the major trends and issues affecting the Contract Manufacturing Organizations (CMO) in Eastern Europe. The report provides a comprehensive insight into Contract Manufacturing Organizations (CMO) in Eastern Europe. The report also provides a detailed analysis of Contract Manufacturing Organizations (CMO) in Eastern Europe market characterization in terms of its market size, segmentation by key CMO and the major market drivers and barriers. The report also provides competitive landscape of the market that profiles key market players along with their brief business description, pipeline, major products and major M&A and partnership deals.

Scope

The scope of the report includes:
  • Detailed overview of CMO’s along with their efficiency and limitation
  • Key market drivers and restraints shaping the CMO’s
  • Competitive landscape analysis with competitive profiling of leading companies such as Analysis of partnership deals
  • Analysis of M&A deals

Reasons to buy

The report will enhance your decision making capability. It will allow you to
  • Develop better strategies for CMO’s by understanding the market dynamics.
  • Develop market-entry and market expansion strategies by identifying the key cancer areas for high growth and high opportunities
  • Understand the factors shaping the CMO’s
  • Identify the key players
  • Exploit partnership and acquisition opportunities by identifying the products that could fill the portfolio gaps.
1 TABLE OF CONTENTS

1.1 List of Tables
1.2 List of Figures

2 INTRODUCTION

2.1 GBI Research Guide

3 OVERVIEW OF THE CMO INDUSTRY

3.1 Current Status of Pharmaceutical Industry
3.2 The Need to Outsource for Pharmaceutical Companies
  3.2.1 Reduction in Physical Assets
  3.2.2 Restructuring of Product Portfolio
  3.2.3 Downsizing Manufacturing
  3.2.4 Reduction in R&D Spending
3.3 What CMOs are and Reasons for Outsourcing to Them
  3.3.1 Different Types of CMOs and the Range of Services Provided by Them
  3.3.2 How Does Outsourcing to CMOs Take Place?
  3.3.3 Key Outsourcing Models
  3.3.4 Key Benefits of Outsourcing

4 CONTRACT MANUFACTURING IN EASTERN EUROPE - MARKET CHARACTERIZATION

4.1 Market Forecasts

5 GEOGRAPHICAL LANDSCAPE

5.1 Comparative Analysis of Eastern European Countries
5.2 Infrastructural Facilities – Railways, Roadways, Airways, Power and Overall Logistics Support
5.3 Labor - Availability of Skilled Labor at Affordable Rates and Labor Flexibility
5.4 Broad Economic Indicators – GDP, Availability of Credit, Taxation Policies
5.5 Ease of Doing Business – Overall Government and Regulatory Support
  5.5.1 Key Takeaway
5.6 Individual Strengths and Weaknesses for Each Country
  5.6.1 Poland
  5.6.2 Czech Republic
  5.6.3 Lithuania
  5.6.4 Ukraine
  5.6.5 Hungary
  5.6.6 Slovakia
  5.6.7 Slovenia
5.7 Analysis of Other Emerging CMO markets
  5.7.1 Chinese CMO Market
  5.7.2 Indian CMO Market

6 MARKET DRIVERS AND RESTRAINTS

6.1 Drivers
  6.1.1 Availability of Low-cost Skilled Manpower
  6.1.2 Better Infrastructure and Government Policies
  6.1.3 Increased Consumptions of Generics
  6.1.4 Better Intellectual Property Rights Protection
  6.1.5 Increasing Uptake of Biologics and Entry of Biosimilars into Market
6.2 Restraints
  6.2.1 Competition from Low-cost Asian CMOs
  6.2.2 Capacity Utilization Issues Affecting the Profitability of CMOs
  6.2.3 Reduced Number of New Drug Approvals
  6.2.4 Complex Cost Structures in Outsourcing

7 REGULATORY LANDSCAPE

7.1 EU GMP
  7.1.1 EU cGMP Guidelines for API Manufacturing
  7.1.2 Key Changes in EU GMP Guidelines
7.2 PIC/S

8 PROMINENT PLAYERS

8.1 Polpharma S.A.
  8.1.1 Services Offered
8.2 Hasco-Lek S.A.
  8.2.1 Services Offered
8.3 Sanitas AB (Sanitas Group)
  8.3.1 Pharmaceutical Company JELFA SA
  8.3.2 Laboratorium Farmaceutyczne Homeofarm sp. z o.o.
8.4 Lonza Biotec sro
  8.4.1 Services Offered
8.5 Grindeks A.S.
  8.5.1 Services Offered
8.6 Galilaeus Oy
  8.6.1 Services Offered
8.7 FSP Galena
  8.7.1 Services Offered
8.8 Noventis sro
  8.8.1 Services offered
8.9 Zentiva N.V.
  8.9.1 Services Offered
8.10 SVUS Pharma a.s.
  8.10.1 Services offered
8.11 Notable CMOs in Eastern Europe
  8.11.1 Nycomed
  8.11.2 Polfa Tarchomin S.A.
  8.11.3 Biogened S.A.
  8.11.4 Pliva Lachema a.s.
  8.11.5 Aflofarm
  8.11.6 TAPI

9 MAJOR EVENTS AND TRENDS IN THE CMO INDUSTRY

9.1 US Healthcare Reforms in 2010 Will Affect CMOs Positively due to Increased Demand for Medicines in the US.
9.2 Upcoming Blockbuster Drugs will Create a Positive Impact on the CMO Industry
9.3 Increased Focus on Emerging Markets by Major Pharmaceutical Companies will Affect CMOs Positively
9.4 Developments Leading to an Anti-counterfeiting Trade Agreement will Affect CMOs Positively
9.5 Increased M&A Activity During 2009-10 is Likely to Affect the CMO Business Positively
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.
9.7 Lower Capacity Utilization in the Biologics Manufacturing Industry is Negatively Affecting the Profitability of the CMOs
9.8 Drug Price Cuts Across Western Europe will Negatively Affect the CMOs

10 APPENDIX

10.1 Market Definitions
10.2 Abbreviations
10.3 Research Methodology
  10.3.1 Coverage
  10.3.2 Secondary Research
  10.3.3 Primary Research
  10.3.4 Expert Panel Validation
10.4 Contact Us
10.5 Disclaimer
10.6 Sources

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

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

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