Europe Orphan Drugs Market

Europe Orphan Drugs Market Size (2023 to 2028)

The size of the European Orphan Drugs Market is forecasted to worth USD 60.25 billion by 2028 from USD 41.46 billion in 2023, growing at a CAGR of 7.66% from 2023 to 2028.

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.