This research report analyzes the global orphan drugs market by product, geographical regions, and market leaders. Numerous trends are shaping up the orphan drugs market and it becomes imperative for stakeholders to learn about these trends and be prepared for change.
Orphan drugs are a relatively niche segment because they are used for the treatment of rare or ‘orphan’ diseases. For a disease that has low prevalence, finding the right balance between cost and profit can be a tightrope walk. The market study offers a thoroughly competitive analysis of the current market trends, growth drivers, factors restricting market growth, and projections for the future.
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Recent developments in technology have been included in the report as well. The findings of this study are especially useful for financial modeling, creating marketing campaigns, understanding pipeline products, and for R&D purposes.
Diseases that have low prevalence rates are no less important than ones that have a higher incidence. Pharmaceutical agents developed for treating such rare or low-prevalence diseases are referred to as orphan drugs. Countries often laws determining the treatment and approach to orphan diseases, and there are criteria that establish whether or not a disease can be classified such in the first place. In Japan, for instance, a disease that affects less than 50,000 persons is an orphan disease. In the United States, this number is 200,000.
Orphan drugs are often also referred to as ‘niche busters’ because they provide an ideal avenue for companies to offset the lapsing patents and shrinking pipelines of blockbuster drugs. In such a scenario, orphan drugs bring forth a new business model that could help create new revenue streams.
The total number of diseases categorized as orphan stands at about 7,000 currently, with nearly 250 new diseases being appended to this list annually. The orphan drugs market has been stimulated to a great extent by pertinent laws introduced in the United States, Australia, Singapore, and Japan. A few countries in the European Union also have specific laws governing the
orphan diseases market.
A highly conducive atmosphere currently prevails for the growth of the orphan drugs market. These include: Grants and R&D benefits, FDA fee waivers, and rapid clinical trial timelines, favorable reimbursement options, premium pricing, and prolonged exclusivity. Enticed by these initiatives, more companies are moving into the orphan drugs market space.
Currently, the market for orphan drugs constitutes only about 6% of the entire pharmaceutical market. The aforementioned factors will help this market achieve double-digit CAGR through the forecast period of the report. Yet, growth in the market will be curtailed to some extent by challenges such as finding the desired number of patients for clinical trials.
The most prominent names in the orphan drugs market are: Janssen Biotech, Inc., Sanofi Aventis, Pfizer, Abbott Laboratories, Genentech, and Amgen, Inc.
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