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Pharmaceutical contract manufacturing and API sourcing in Central Europe and the Balkan states 2011 |
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The main aim of the report is to localise the most attractive companies for contract manufacturing or API sourcing in Central Europe:
- Poland
- Czech Republic
- Slovakia
- Romania
- Bulgaria
- Hungary
as well as Balkan states such as:
- Croatia
- Serbia
- Slovenia.
By contract manufacturing we understand the outsourcing of pharmaceutical production of finished dosage forms. API sourcing is buying active pharmaceutical ingredients from other companies.
The report also provides an analysis of pharmaceutical outsourcing in the analysed countries and the region as a whole, describes key drivers and barriers of contract manufacturing in each country, and presents the current and future trends in contract manufacturing.
The report also provides an analysis of pharmaceutical outsourcing in the analysed countries and the region as a whole, describes key drivers and barriers of contract manufacturing in each country, and presents the current and future trends in contract manufacturing.
Why a report on that subject?
Did you know...
“Pharmaceutical manufacturers in Europe are obliged to use active substances which are GMP compliant.”
“There are numerous companies which specialise in API production in the Czech Republic.”
“Pharmaceutical contract manufacturing will be growing rapidly in the subsequent years.”
“An increasing number of companies have decided to move their production to locations in Central Europe.”
“Pharmaceutical companies in Serbia are eager to cooperate with large multinational players.”
“There are not many typical CMOS in Central Europe.”
- Many attractive companies in the region offer API and contract manufacturing
- Region characteristics are increasingly competitive to China and India
- Sourcing is increasingly popular nowadays, as is contract manufacturing
- We want to show the complex offer of such companies and help potential customers to find partners in the region
Key topics covered
- Characteristics of pharmaceutical contract manufacturing and API sourcing in the analysed countries
- Key drivers and barriers of contract manufacturing and API sourcing in the analysed countries
- Comparison to other regions, such as the Far East
- The most attractive countries – why?
- Key drivers and barriers of contract manufacturing in each country
- Possibilities of manufacturing finished dosage forms
- Possibilities of manufacturing API and fine chemicals
- Current and future trends in contract manufacturing
- Detailed profiles of companies that offer contract manufacturing services and produce APIs in particular countries, especially in terms of their specialisation and experience in contract manufacturing, products within contract manufacturing, additional services offered by the company, financial information, contact details, quality certificates, production capacity etc.
Find answers for the following questions
- Which companies in the CE region/Balkan region manufacture finished dosage forms of drugs within contract manufacturing?
- Which companies in the CE region/Balkan region manufacture dietary supplements within contract manufacturing?
- Which companies in the CE region/Balkan region offer API production?
- What are the strengths of each country in the area of contract manufacturing?
- What are the weaknesses of each country in the area of contract manufacturing?
Report strengths
- An analysis of six CE countries and Balkan states in one publication
- Detailed profiles of companies which offer contract manufacturing services and API sourcing (potential partners for clients of the report)
- Over 140 companies profiles presented!
- An analysis of strengths and weaknesses of individual countries in contract manufacturing and API sourcing
- Presentating the location of manufacturers on the map (easy navigation)
When will the report be useful?
- Analysis of a potential partner offer in terms of contract manufacturing API sourcing
- Company capabilities regarding API sourcing and contract manufacturing
- Brief analysis of potential partners for pharmaceutical companies
Extract from this report
- Substantial changes in manufacturing infrastructure started only a few years ago, and the global contract manufacturing market, including the CE area in question, will still be growing rapidly in subsequent years.
- Market growth will be accelerated by the expiry of patents on several blockbusters in the next few years. This will compel large multinational companies, whose revenues are expected to decline significantly, to look for savings. One of the solutions could be the outsourcing of pharmaceutical production.
- In 2010, 14 Good Manufacturing Practice (GMP) non-compliance reports were filed on the EudraGMP database by the EU National Competent Authorities, and 12 of these resulted from inspections outside the EU.
Market commentary by expert
According to our analyses, Central European and Balkan countries offer possibilities of manufacturing not only APIs and other specialty chemicals and plant raw materials, but also various finished dosage forms of pharmaceuticals, dietary supplements, semi-finished products and biotechnology products. Within the area in question, the most attractive countries for pharmaceutical contract manufacturing and API sourcing are Poland and the Czech Republic. In each of these countries, there are several dozen companies which offer such services. There is quite strong competition from companies not just from the Far East, but also from Western Europe. On the other hand, the region seems to have considerable potential.Agnieszka Skonieczna, Senior pharmaceutical market analyst
Request sample pages/interactive screenshare
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Report methodology p. 15
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Executive summary p. 19
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General overview of contract manufacturing and API sourcing in CE and the Balkan states p. 27
- Key recent trends and events on the contract manufacturing and API sourcing markets in CE and the Balkan states p. 27
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Comparison of CE and Balkan region with other competitive regions p. 31
- Comparison with Far East (India and China) p. 31
- Key obstacles to contract manufacturing and API sourcing in comparison with China and India p. 33
- Comparison with Western Europe p. 34
- Possibility of contract manufacturing and API sourcing in specific CE and Balkan countries p. 36
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Czech Republic p. 37
- Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 37
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Key drivers of, and obstacles, to contract manufacturing and API sourcing p. 40
- Key drivers of contract manufacturing and API sourcing p. 40
- Key obstacles to contract manufacturing and API sourcing p. 41
- Profiles of key companies offering contract manufacturing services and API p. 43
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Poland p. 79
- Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 79
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Key drivers of, and obstacles to, contract manufacturing and API sourcing p. 81
- Key drivers of contract manufacturing and API sourcing p. 81
- Key obstacles to contract manufacturing and API sourcing p. 82
- Profiles of key companies offering contract manufacturing services and API p. 83
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Hungary p. 133
- Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 133
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Key drivers of, and obstacles, to contract manufacturing and API sourcing p. 134
- Key drivers of contract manufacturing and API sourcing p. 134
- Key obstacles to contract manufacturing and API sourcing p. 135
- Profiles of key companies offering contract manufacturing services and API p. 136
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Romania p. 155
- Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 155
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Key drivers of, and obstacles, to contract manufacturing and API sourcing p. 156
- Key drivers of contract manufacturing and API sourcing p. 156
- Key obstacles to contract manufacturing and API sourcing p. 156
- Profiles of key companies offering contract manufacturing services and API p. 158
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Bulgaria p. 181
- Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 181
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Key drivers of, and obstacles, to contract manufacturing and API sourcing p. 182
- Key drivers of contract manufacturing and API sourcing p. 182
- Key obstacles to contract manufacturing and API sourcing p. 182
- Profiles of key companies offering contract manufacturing services and API p. 184
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Slovakia p. 193
- Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 193
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Key drivers of, and obstacles, to contract manufacturing and API sourcing p. 194
- Key drivers of contract manufacturing and API sourcing p. 194
- Key obstacles to contract manufacturing and API sourcing p. 195
- Profiles of key companies offering contract manufacturing services and API p. 196
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Slovenia p. 209
- Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 209
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Key drivers of, and obstacles, to contract manufacturing and API sourcing p. 209
- Key drivers of contract manufacturing and API sourcing p. 209
- Key obstacles to contract manufacturing and API sourcing p. 210
- Profiles of key companies offering contract manufacturing services and API p. 211
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Croatia p. 215
- Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 215
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Key drivers of, and obstacles, to contract manufacturing and API sourcing p. 216
- Key drivers of contract manufacturing and API sourcing p. 216
- Key obstacles to contract manufacturing and API sourcing p. 216
- Profiles of key companies offering contract manufacturing services and API p. 217
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Serbia p. 223
- Main characteristics of, and current trends in, API manufacturing and manufacturing under contract p. 223
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Key drivers of, and obstacles, to contract manufacturing and API sourcing p. 224
- Key drivers of contract manufacturing and API sourcing p. 224
- Key obstacles to contract manufacturing and API sourcing p. 25
- Profiles of key companies offering contract manufacturing services and API p. 226
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Profiles of companies present in more than one CE or Balkan country p. 235
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Legal environment p. 241
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GMP rules p. 241
- General prevalence of GMP rules p. 241
- PIC/S member state obligations p. 242
- GMP certificates p. 242
- GMP in API manufacturing p. 242
- REACH Regulation p. 243
- Changes anticipated in EU legislation – draft Directive 2001/83/EC p. 244
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GMP rules p. 241
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Business climate in CE and Balkans p. 245
- Individual competitive advantages of CE and Balkan countries p. 245
- Degree of sophistication of the production process in the CE and Balkan countries p. 246
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Import and export indicators p. 246
- Length of procedures p. 246
- Number of documents required p. 248
- Costs p. 249
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Key macroeconomic and demographic indicators in CE and Balkan countries p. 253
- GDP growth p. 253
- Inflation rates p. 256
- Labour market p. 257
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List of graphs p. 259
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List of tables p. 261
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About PMR p. 263
List of graphs
- Value of sales of products at risk of generic competition ($ bn), 2002-2012
- Number of pharmaceutical manufacturing companies in the Czech Republic, 2005-2009
- Location of CMOs and API producers in the Czech Republic, 2011
- Farmak sales by product groups, by value, 2008-2010
- Spending on innovation activity for product and process innovation in the pharmaceutical manufacturing industry in Poland (PLN m), 2008-2009
- GMP inspections in Poland, by category, 2010
- Location of CMOs and API producers in Poland, 2011
- Location of CMOs and API producers in Hungary, 2011
- Egis: export sales of APIs (€ m), H1 2009/2010 and H1 2010/2011
- Location of CMOs and API producers in Romania, 2011
- Value share of products manufactured by Antibiotice in Romania, 2010
- Location of CMOs and API producers in Bulgaria, 2011
- Location of CMOs and API producers in Slovakia, 2011
- Sales of Biotika pharmaceutical substances, by value, by substance name, 2010
- Location of CMOs and API producers in Slovenia, 2011
- Location of CMOs and API producers in Croatia, 2011
- Location of CMOs and API producers in Serbia, 2011
- Nature of country’s competitive advantage, 2009-2010
- Sophistication of production process in selected CE and Balkan countries, 2009-2010
- Length of export process in CE and Balkan countries in comparison with other countries (days), 2010
- Length of import process in CE and Balkan countries in comparison with other countries (days), 2010
- Documents required for export process in CE and Balkan countries in comparison with other countries (number of documents), 2010
- Import documents required in CE and Balkan countries in comparison with other countries (number of documents), 2010
- Export costs in CE and Balkan countries in comparison with other countries ($ per container), 2010
- Import costs in CE and Balkan countries in comparison with other countries ($ per container), 2010
- Countries with the highest GDP growth in the CE and Balkan region (%), 2004-2010
- Countries with the lowest GDP growth in the CE and Balkan region (%), 2004-2010
- Total GDP in CE and Balkan countries ($ bn), 2004-2010
- GDP of selected CE and Balkan countries ($ bn) and their shares as a proportion of the total GDP of the region, 2010
- Countries with the lowest inflation rates in the CE and Balkan region (%), 2004-2010
- Countries with the highest inflation rates in the CE and Balkan region (%), 2004-2010
- Countries with the lowest unemployment rates in the CE and Balkan region (%, yearly average), 2004-2010
- Countries with the highest unemployment rates in the CE and Balkan region (%, yearly average), 2004-2010
List of tables
- FDA warning letters sent to Indian and Chinese companies, 2011
- Approval received by Indian pharmaceutical manufacturing companies, by regulatory agency, September 2009
- The possibility of contract manufacturing of dietary supplements, biotech products and other finished dosage forms in addition to the sourcing of API and other pharmaceutical ingredients in CE and Balkan countries, 2011
- Industrial production in the Czech pharmaceutical industry (CZK m), 2008-2009
- Jelfa production capacity (m), 2008-2010
- Products manufactured, GMP certificates, and production capacity of Antibiotice in Romania, 2010
- Production, revenues and gross profit of pharmaceutical manufacturing companies in Slovakia (€ m), 2009-2010
- Production capacity at JGL, 2011
- Hemofarm production capacity, 2011
- GDP growth in selected CE and Balkan countries (%), 2004-2010
- CPI in selected CE and Balkan countries (%), 2004-2010
- Unemployment rate in selected CE and Balkan countries (%, yearly average), 2004-2010
- Gross average monthly wages in selected CE and Balkan countries (€), 2004-2010
Pharmaceutical contract manufacturing and API sourcing in Central Europe and the Balkan states 2011
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