Drug molecules that help in treating specific genetic conditions which don’t have any therapeutic intervention in the market are considered to be as specialty pharmaceuticals. Specialty Pharmaceuticals are more targeted drugs and have less toxic in nature when compared with traditional drugs. Specialty pharmaceuticals include biopharmaceuticals, blood derived products and complex molecules. Pharmaceuticals that are having high cost also falls under the specialty pharmaceuticals. The cost of specialty pharmaceuticals threshold is around $600 per month. The average cost for specialty medical therapy is around $35,000 to $75,000 costs per patient per year. Specialty pharmaceuticals are mainly available at physician offices in another way these are mostly available through prescriptions. Specialty pharmaceuticals are having the fastest growth in the U.S. According to a research study, specialty pharmaceuticals drug spending increased in the US by 26.5% in 2014 this is due to the recent launch of drugs for hepatitis C. Specialty pharmaceuticals are gaining traction in the pharma industry is due to lack of proper interventions for few disease conditions and faster regulatory approvals are driving the growth of this market.
In 2014, around 27 specialty pharmaceuticals got U.S regulatory approvals when compared with 24 traditional drug approvals. Companies are also actively involved in developing specialty pharmaceuticals on rare disease conditions to get orphan drug status for their drugs. In 2015, Europe regulatory authorities approved more medicines for rare diseases around 93 newly approved medicines, and 18 are orphan drugs. Hence, companies are mainly focusing these specialty pharmaceutical owing to their higher revenues and high-profit margins. For instance, in FY 2014, Teva overall revenue was around $ 20 billion out of that 42% of sales revenue was contributed by the specialty pharmaceutical drugs. Among the specialty pharmaceuticals drugs, Copaxone generated around 50% of the sales revenue.
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Based on therapeutic area, the global specialty pharmaceuticals market is divided into following
- Inflammatory conditions
- Multiple sclerosis
- Growth hormone
- Other disease conditions
Based on route of administration, the global specialty pharmaceuticals market is divided into following
Based on distribution channel, the global specialty pharmaceuticals market is divided into following
- Retail Pharmacies
- Specialty Pharmacies
- Mail Order
Based on therapeutic area, specialty pharmaceuticals market is segmented into oncology, inflammatory conditions, multiple sclerosis and other disease indications. Among them, oncology occupies the major market share followed by inflammatory conditions. According to WHO, cancers are the leading cause of mortality and morbidity worldwide with an incidence of 14 million cancer cases and 8.2 million cancer-related deaths. In inflammatory disease condition, rheumatoid arthritis occupies the significant market share for the specialty pharmaceuticals when compared with other inflammatory disease conditions. The higher cost of the drugs is hindering the growth of the specialty pharmaceuticals market. Based on the route of administration, the specialty pharmaceuticals market is segmented into oral, parenteral and transdermal. Parenteral route occupies the major market share followed by the oral route.
On the basis of the distribution channel, specialty pharmaceuticals market is segmented into hospitals, retail, specialty pharmacies and mail order. Hospitals occupy the major pie in the specialty pharmaceutical products this is mainly due to the availability of these drugs over prescription. Other than hospitals, retail pharmacies, and specialty pharmacies are also have good market share during the forecast period. However, during the forecast period, specialty pharmacies are expected to occupy the major market share when compared with retail pharmacies over the forecast period.
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Based on geography, specialty pharmaceuticals market is segmented into five key regions: North America, Latin America, Europe, Asia-Pacific and the Middle East & Africa. North America accounts the significant market share due to high buying power and reimbursement for the specialty pharmaceuticals are the major factors boosting the growth of this market during the forecast period. Asia Pacific specialty pharmaceuticals market is expected to grow over the forecast period owing to the growth of biopharmaceutical industry in China and India.
Major players in the specialty pharmaceuticals market include Teva Pharmaceuticals, Abbvie Inc, Amgen, Johnson & Johnson, Celgene, Gilead Sciences, Roche are the key players in the market. Top 10 U.S specialty pharmaceuticals itself generated around $ 37B revenue in 2012. In U.S specialty pharmaceuticals, Humira is one of the top-selling specialty pharmaceutical drug and it accounted $4.4B in 2012 and expected to dominate the market till 2018.