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Pulished Date April, 2021
ID: 1595
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Europe Orphan Drugs Market Research Report – Segmented By Type, Therapeutic, Country (UK, France, Spain, Germany, Italy, Russia, Sweden, Denmark, Switzerland, Netherlands, Turkey, Czech Republic and Rest of Europe) - Industry Analysis, Size, Share, Growth, Trends, Forecast | 2021 to 2026

Pulished: April, 2021
ID: 1595
Pages: 145

Europe Orphan Drugs Market Size (2021 to 2026)

The size of the European Orphan Drugs Market is forecasted to worth USD 55.65 billion by 2026 from USD 38.48 billion in 2021, growing at a CAGR of 7.66% from 2021 to 2026.

Benchmarks for the designation of orphan disease differ from country to country; in Europe, if the disease is prevalent in fewer than 10000 people, it’s termed a rare disease. The growth of the Europe Orphan Drugs Market is powered by factors such as prolonged market exclusivity and government enticements for orphan medicine. In Europe, ten years of marketing exclusivity from approval is granted to orphan drug developing companies.

The focus on developing orphan drugs is becoming more day by day, whereby both private and public organizations are much more useful than non-orphan drugs to cure rare diseases. It is the key driving factor for the European Orphan Drugs Market to grow eventually. The rise in the incidences of chronic and infectious diseases is fuelling up the growth rate of the market. FDA (Food and Drug Administration) is making reasonable efforts to increase the commercialization of orphan drugs is accelerating the demand for the European Orphan Drugs Market. Government support is also another primary reason for the market to grow eventually, as they invest considerable amounts in improving the quality of drugs. The rise in healthcare expenditure, especially in urban areas, is fuelling the demand for Orphan Drugs in European countries. 

However, fluctuations in the availability of raw materials, rising prices of the drugs, lack of complete knowledge in manufacturing the drugs with the latest formula are majorly inhibiting the demand of the European orphan drugs market. Strict rules and regulations by the government in approving new drugs and the rise in the complications due to uncertainty in the development of novel orphan drugs further impede the market growth. 

Growing demand to produce quality drugs with the latest technologies in pharmaceutical companies, rising capita income in developed and developing countries, and increasing awareness over the availability of different treatment procedures are to open growth opportunities to the market.

This research report on the European orphan drugs market is segmented and sub-segmented into the following categories:

By Type: 

  • Biological 
  • Non-biological

By Therapeutic: 

  • Hematology
  • Neurology
  • Oncology 
  • Others

By Country: 

  • UK
  • France
  • Spain
  • Germany
  • Italy
  • Russia
  • Sweden
  • Denmark
  • Switzerland
  • Netherlands
  • Turkey
  • Czech Republic
  • Rest of Europe 

Geographically, UK, Italy, France, and Spain are majorly contributing the highest shares to the European market. Only 5 % of people are affected out of 10000 people in Europe. Currently, 986 products are designated in Europe, and the regulatory body approves more than 67 orphan drugs. In Europe, orphan designation takes six months for documentation with authority reference & condition to complete the process.

The growing number of rare diseases, health issues, and investment in drug production drive the European market of orphan drugs. Europe has its own regulatory body for orphan drugs, i.e., the European medicines Agency for orphan designation medicinal products. It will open opportunities for orphan drug manufacturing and pharmaceutical companies. 

Germany and the UK are the largest consumer of orphan drugs in the European region. On-going research & development activities are potentially making the market grow in the UK. The rise in the investments in pharmaceutical companies by government authorities is leveling the market demand. The launch of online pharmacy is additionally boosting up the growth rate of the market. 

Prominent companies dominating the European Orphan Drugs market in this region are Novartis, GlaxoSmithKline, Roche, Alexion, Sanofi, Bristol Myers Squibb, Pfizer, Vertex, Celgene, and Merck.


                1.1 Market Definition                    

                1.2 Study Deliverables                  

                1.3 Base Currency, Base Year and Forecast Periods                           

                1.4 General Study Assumptions                

2. Research Methodology                                           

                2.1 Introduction                              

                2.2 Research Phases                      

                                2.2.1 Secondary Research            

                                2.2.2 Primary Research 

                                2.2.3 Econometric Modelling     

                                2.2.4 Expert Validation  

                2.3 Analysis Design                         

                2.4 Study Timeline                          

3. Overview                                      

                3.1 Executive Summary                

                3.2 Key Inferences                         

                3.3 Epidemology                             

4. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)                                      

                4.1 Market Drivers                          

                4.2 Market Restraints                    

                4.3 Key Challenges                         

                4.4 Current Opportunities in the Market               

5. Market Segmentation                                              

                5.1 Type                              

                                5.1.1 Introduction           

                                5.1.2 Biological

                                5.1.3 Non Biological        

                                5.1.4  Y-o-Y Growth Analysis, By Type     

                                5.1.5  Market Attractiveness Analysis, By Type   

                                5.1.6  Market Share Analysis, By Type    

                5.2 Therapeutic                                

                                5.2.1 Haematology         

                                5.2.2 Neurology

                                5.2.3 Oncology 

                                5.2.4 Others      

                                5.2.5  Y-o-Y Growth Analysis, By Therapeutic       

                                5.2.6  Market Attractiveness Analysis, By Therapeutic     

                                5.2.7  Market Share Analysis, By Therapeutic      

6. Geographical Analysis                                              

                6.1 Introduction                              

                                6.1.1 Regional Trends    

                                6.1.2 Impact Analysis     

                                6.1.3 Y-o-Y Growth Analysis        

                                       By Geographical Area

                                       By Type

                                       By Therapeutic

                                6.1.4  Market Attractiveness Analysis     

                                       By Geographical Area

                                       By Type

                                       By Therapeutic

                                6.1.5  Market Share Analysis      

                                       By Geographical Area

                                       By Type

                                       By Therapeutic

                6.2 U.K                

                6.3 Spain                             

                6.4 Germany                     

                6.5 Italy                               

                6.6 France                          

7.Strategic Analysis                                        

                7.1 PESTLE analysis                         

                                7.1.1 Political     

                                7.1.2 Economic 

                                7.1.3 Social         

                                7.1.4 Technological         

                                7.1.5 Legal          

                                7.1.6 Environmental      

                7.2 Porter’s Five analysis                              

                                7.2.1 Bargaining Power of Suppliers        

                                7.2.2 Bargaining Power of Consumers    

                                7.2.3 Threat of New Entrants     

                                7.2.4 Threat of Substitute Products and Services

                                7.2.5 Competitive Rivalry within the Industry      

8.Market Leaders' Analysis                                          

                8.1 Novartis                       

                                8.1.1 Overview

                                8.1.2 Product Analysis   

                                8.1.3 Financial analysis  

                                8.1.4 Recent Developments       

                                8.1.5 SWOT analysis       

                                8.1.6 Analyst View          

                8.2 GlaxoSmithKline                      

                8.3 Roche                           

                8.4 Alexion                        

                8.5 Sanofi                           

                8.6 Bristol Myers Squibb                              

                8.7 Pfizer                            

                8.8 Vertex                          

                8.9 Celgene                       

                8.10 Merck                        

9.Competitive Landscape                                            

                9.1 Market share analysis                            

                9.2 Merger and Acquisition Analysis                        

                9.3 Agreements, collaborations and Joint Ventures                          

                9.4 New Product Launches                          

10.Market Outlook and Investment Opportunities                                           


                a) List of Tables                

                b) List of Figures                              

  • Regional and country-level analysis and forecasts of the study market; providing Insights on the major countries/regions in which this industry is blooming and to also identify the regions that are still untapped
  • Segment-level analysis in terms of technology, component, and type along with market size forecasts and estimations to detect key areas of industry growth in detail
  • Identification of key drivers, restraints, opportunities, and challenges (DROC) in the market and their impact on shifting market dynamics
  • Study of the effect of exogenous and endogenous factors that affect the global market; which includes broadly demographic, economics, and political, among other macro-environmental factors presented in an extensive PESTLE Analysis
  • Study the micro environment factors that determine the overall profitability of an Industry, using Porter’s five forces analysis for analysing the level of competition and business strategy development
  • A comprehensive list of key market players along with their product portfolio, current strategic interests, key financial information, legal issues, SWOT analysis and analyst overview to study and sustain the market environment
  • Competitive landscape analysis listing out the mergers, acquisitions, collaborations in the field along with new product launches, comparative financial studies and recent developments in the market by the major companies
  • An executive summary, abridging the entire report in such a way that decision-making personnel can rapidly become acquainted with background information, concise analysis and main conclusions
  • Expertly devised analyst overview along with Investment opportunities to provide both individuals and organizations a strong financial foothold in the market


  1. Europe Orphan Drugs Market By Type, From 2021 to 2026 (USD Million)
  2. Europe Biological Market By Region, From 2021 to 2026 (USD Million)
  3. Europe Non Biological Market By Region, From 2021 to 2026 (USD Million)
  4. Europe Orphan Drugs Market By Therapeutic, From 2021 to 2026 (USD Million)
  5. Europe Haematology Market By Region, From 2021 to 2026 (USD Million)
  6. Europe Neurology Market By Region, From 2021 to 2026 (USD Million)
  7. Europe Oncology Market By Region, From 2021 to 2026 (USD Million)
  8. Europe Other therapeutics Market By Region, From 2021 to 2026 (USD Million)
  9. U.K. Orphan Drugs Market By Type, From 2021 to 2026 (USD Million)
  10. U.K. Orphan Drugs Market By Therapeutic, From 2021 to 2026 (USD Million)
  11. Germany Orphan Drugs Market By Type, From 2021 to 2026 (USD Million)
  12. Germany Orphan Drugs Market By Therapeutic, From 2021 to 2026 (USD Million)
  13. France Orphan Drugs Market By Type, From 2021 to 2026 (USD Million)
  14. France Orphan Drugs Market By Therapeutic, From 2021 to 2026 (USD Million)
  15. Italy Orphan Drugs Market By Type, From 2021 to 2026 (USD Million)
  16. Italy Orphan Drugs Market By Therapeutic, From 2021 to 2026 (USD Million)
  17. Spain Orphan Drugs Market By Type, From 2021 to 2026 (USD Million)
  18. Spain Orphan Drugs Market By Therapeutic, From 2021 to 2026 (USD Million)

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