Factors, such as conducive government legislation, marketing exclusivity for orphan drugs, and the growing unmet need for treatment of orphan diseases, foster the market growth during the forecast period.

Infoholic Research LLP, a global market research and consulting organization, has published a study titled “Orphan Drugs Market – Global Drivers, Restraints, Opportunities, Trends, and Forecasts: 2017–2023” (November 2017).

According to Infoholic Research, the orphan drugs market is highly lucrative due to the increasing regulatory feasibility and growing funding scenario. Along with that, marketing exclusivity and the increasing prevalence of rare diseases are some of the factors driving the growth of the orphan drugs market. The increasing novel indications with orphan drugs designation and large untapped markets are the key opportunities of the market. However, the availability of small patient pool for clinical trials & marketing and high treatment cost of diseases are the factors hampering the market.

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Orphan diseases or rare diseases are rare occurrences in the population, which is nearly 7 out of 10,000 individuals. Around 5,000 to 8,000 rare diseases have been recognized and the origin of approximately 80% of these diseases is from the genes. Cancers, metabolic diseases, blood diseases, immunologic disease, neurologic diseases, and others are the types of diseases that are addressed by orphan drugs. Cystic fibrosis, glioma, pancreatic cancer, acute myeloid leukemia, multiple myeloma, renal cell carcinoma, ovarian cancer, and Duchenne muscular dystrophy are some of the common indications among the various disease types.

The Orphan Drugs market is expected to grow at a CAGR of 11.4% during the forecast period 2017–2023 to touch an aggregate of $246.55 billion by 2023.

The market is analyzed based on three segments, namely types, application, and regions. The regions covered in the report are North America, Europe, Asia Pacific, and Rest of the World (RoW). In North America, the US is set to be the leading country. Europe is set to be the second leading country and held more than 22% of the market share in 2016. In Asia Pacific, India, Japan, and China are the most attractive countries for the players and holds huge business opportunities. The RoW region is set to be an emerging market for the next 5–6 years.

The global orphan drugs market by products is segmented into biologics and non-biologics. The biologics orphan drugs is the largest segment in the market with a market share of more than 60% in 2016. It is expected to grow at double-digit CAGR in the market. However, non-biologic orphan drugs are still expected to hold more than quarter of the market share by 2023. The market is also witnessing various mergers, acquisitions, and collaborations among the top players, which is defining the future of the global orphan drugs market.

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“Rituxan by Roche is the leading orphan drug in the market, with a total revenue of $7.4 billion in 2016 and is expected to see a decline in its market share by 2020 as drug is expected to lose its patent rights in the US by 2018. Further, many other pharmaceutical companies are developing new biologics to compete against Rituxan. While company like Celitrion that was a competitor and has backed off for developing orphan drugs due to lack of efficiency of the product. However, Amgen, is developing biologic orphan drug causing a serious threat to Rituxan and is expected to give intense competition to the market in future.” – Rikitha K Murthy, Research Analyst (Research – Healthcare) at Infoholic Research

• In-depth analysis of the key business opportunities in countries and verticals


• Complete details about the various types of orphan drugs overview


• Complete details of trending top 15 orphan drugs


• Complete details about the analysis of top 10 players


• Industry outlook including current and future market trends, drivers, restraints, and emerging technologies