Specialty Generics are the generic versions of specialty pharmaceutical products. They are cost-effective when compared with specialty pharmaceuticals. Specialty generics include biopharmaceuticals, blood derived products and complex molecules.

Several blockbuster specialty drug molecules are coming off patent in the coming years. Hence, companies are foraying into this market to launch generic versions of the products by developing novel formulations. Additionally, global saturation of conventional generics market and low margins for generic drugs is also forcing companies to look for newer opportunities. However, commercialisation and development of specialty generics is more complex when compared with conventional generics products. Originator companies are adopting multiple strategies to hold on to specialty drug market share by mix of regulatory, commercial and product development strategies.

Various companies are actively engaged in license, collaborations and acquisitions to expand their specialty generics capacities. For instance, in October 2016, Intellipharmaceutics entered into an exclusive license and supply agreement with Mallinckrodt to market, distribute, and sell its extended release drug product candidates in the U.S. market and to strengthen its specialty generics portfolio. Further, in October 2015, Teva Pharmaceutical Ltd. acquired Representaciones e Investigaciones Médicas, S.A. de C.V. (Rimsa) that involved in development specialty generic products, to enhance their sales in specialty generics market. In March 2016, County Line Pharmaceuticals —that involved in development of specialty generics —was acquired by Alvogen to boost its sales in U.S. market and increase its portfolio in specialty generics.

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Favorable reimbursement policies, increasing prevalence of cancers, specialty drugs patent expiries, reforms enacted by government bodies, payer’s pressures to reduce the drug prices, and lack of generic drugs to treat complex diseases are expected to boost demand for speciality generics during the forecast period. According to National Cancer Institute, 16 million cases of cancers are newly diagnosed every year in U.S. and 0.5 million deaths occur due to different type of cancers.

Development of speciality generics is a complex process and requires skilled workforce and sourcing of raw materials. These longstanding challenges can impede the growth of the market during the forecast period.

The global specialty generics market is classified on the basis of disease indication, route of administration, distribution channel, and geography.

Based on disease indication, the global specialty generics market is segmented into the following:

• Oncology
• Infectious diseases
• Multiple Sclerosis
• Others

Based on route of administration, the global specialty generics market is segmented into the following:

• Oral
• Parenteral
• Topical
• Others

Based on distribution channel, the global specialty generics market is segmented into the following:

• Retail Pharmacies
• Hospital Pharmacies
• Mail order Pharmacies

Development of cost-effective drugs to treat oncology, multiple sclerosis and other infectious diseases can create significant opportunities for the specialty generics manufacturers. For instance, a patient has to spend around US$ 72,000 annually to treat multiple sclerosis conditions by using copaxone (Glatiramer). However, Novartis developed generic version of copaxone that costs only US$ 63,000. Hence, many insurance companies are showing interest to reimburse the specialty generics owing to their low cost. Based on disease indication, Oncology and Infectious diseases segment is expected to grow with a significant CAGR owing to increasing product patent expirations over the forecast period.

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Region-wise, the global specialty generics market is classified into regions namely, North America, Latin America, Western Europe, Eastern Europe, Asia-Pacific excluding Japan, Japan, and Middle East and Africa. North America expected to dominate the global market for specialty generics due to favorable government policies and increasing specialty generic product launches over the forecast period. Large number of generic players and lack of specialty drugs in the Asia -Pacific market expected to boost the growth of the specialty generics market growth in APEJ region over the forecast period.

Some of the players in global specialty generics market include Valeant Pharmaceuticals International, Inc., Novartis,Pfizer Inc., Turing Pharmaceuticals, Teva Pharmaceutical Ltd., Mylan N.V.,Akorn, Inc., and Mallinckrodt

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