Specialty pharmaceuticals are branded (on patent) injectable, infusions or oral medication that, with high cost, high complexity, and high touch, with limited or exclusive availability and distribution, are used to treat chronic or rare diseases such as cancer, AIDS (Acquired Immunodeficiency Virus Syndrome), Hepatitis C, Crohn’s disease, rheumatoid arthritis, etc.
Specialty pharmaceuticals can be biotechnology products, orphan or ultra-orphan drugs, and medication that are included in the drug class strategy of specialty therapeutics and are typically biology-based that structurally mimic or are analogues of compounds found inside the human body. High touch management is essential for specialty pharmaceuticals as they require; temperature control; safe and specialized handling, shipping, and distribution; appropriate injection or administration technique for medication; drug management by pharmacist or physician having in-depth education of patient as well as the medical condition; and better side-effect management.
Specialty pharmaceuticals are available only through ‘specialty’ wholesalers, while pharmacies can have access to specialty pharmaceuticals through specialty wholesalers with special contract having different price structures and unique terms and conditions.
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The specialty pharmaceuticals market is estimated to witness a lucrative growth due to the plateauing of generic dispensing rate.
The specialty pharmaceuticals market in the U.S is anticipated to play a significant role in the global specialty pharmaceuticals market. For instance, according to a report published by, IMS Health, National Sales Perspectives (June 2016), of the top 20 pharmaceutical products or drugs sold in the U.S (2015), about 11 were specialty pharmaceuticals, which included, Harvoni, Humira, Enbrel, Remicade, and Copaxone.
Drug spending on novel drugs is another factor driving the specialty pharmaceuticals market, due to the increase in number of launches of high-priced specialty drugs. For instance, specialty drugs contribute to less than 2.0% of the total prescriptions in the U.S, but according to a report published by America’s Health Insurance Plans (AHIS) (2016), specialty pharmaceuticals accounted for approximately one-third of the total spending on the commercial prescription pharmaceuticals in 2015 (US$ 337.0 Bn), while it was also reported that about 225 new specialty pharmaceuticals are estimated to be launched in the next five years.
Moreover, according to a report published by National Conference of State Legislatures (NCSL) in Jan 2016, cancer, multiple sclerosis, and inflammatory conditions are rated as the top three specialty therapy classes ranked by number of members on annual basis, while the conditions accounted for more than 60.0% of the total expenditure for specialty pharmaceuticals billed through pharmacy benefit. Thus, rising spending on pharmaceutical as well as anticipated launch of high number of novel specialty drugs is likely to fuel the specialty pharmaceuticals market.
Necessity of special handling, storage, and administration of specialty drug, and high cost of specialty pharmaceuticals are key restraints of the specialty pharmaceuticals market, as high cost treatment is unaffordable for a majority of the population, thus opting for low-cost alternatives. For instance, a specialty drug treatment regimen of about 2 to 8 weeks for Hepatitis C virus infection costs around US$ 65,000 to US$ 189,000 in California.
Moreover, ravicti, carbaglu, lumizyme, actimmune, and soliris, are considerably expensive specialty pharmaceuticals that costs about US$ 793, 632, US$ 585,480, US$ 626,400, US$ 572,292, and US$ 542,640, per patient, per year, respectively. Ravicti and carbaglu specialty pharmaceuticals function to inhibit buildup of nitrogen in the bloodstream, preventing death due to coma.
Lumizyme is employed to treat muscle weakness, preventing heart and respiratory failure. Actimmune is utilized to treat conditions that disrupt normal bone marrow formation and immune system functioning.
Soliris is used to prevent progressive destruction of red blood cells and related life-threatening conditions.
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The specialty pharmaceuticals market has been segmented on the basis of disease indication, mode of administration, distribution channel, and region. In terms of disease indication, the specialty pharmaceuticals market can be segmented into oncology, autoimmune disorders, viral hepatitis, HIV (human immunodeficiency virus) antivirals, multiple sclerosis, and others.
In terms of mode of administration, the specialty pharmaceuticals market can be segmented into oral and injectable/infusions.
In terms of distribution channel, the specialty pharmaceuticals market can be segmented into hospital pharmacies, retail pharmacies, specialty pharmacies, drug stores, and e-commerce. In terms of region, the specialty pharmaceuticals market can be segmented into Asia Pacific (APAC), Europe, Middle East & Africa (MEA), North America (NA), and Latin America (LA).
Key players operating in the global specialty pharmaceuticals market include Otsuka America Pharmaceutical, Inc., AbbVie Inc. Gilead, Pfizer Inc., Amgen Inc., AstraZeneca, Janssen Global Services, LLC, Teva Pharmaceutical Industries Ltd., and rEVO Biologics, Inc.
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