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Specialty Generic Pharmaceuticals Market Size Worth $169.8 Billion By 2025 | CAGR: 20.8%

The global specialty generic pharmaceuticals market is expected to grow at growth rate of 20.8% to reach USD 169.8 billion by 2025.

Over the past few years have shown a shift in the focus of pharmaceutical firms from branded drugs to specialty generics owing to several products going off-patent and high impact of the loss of exclusivity. Branded specialty generics are facing increasing patent expiration, thus they are expected to face competition from generic versions in the near future. For example, during the forecast period, approximately 72 branded specialty injectables are expected to lose patent protection in the U.S. only. Such factors will boost the demand and utilization of specialty generic pharmaceuticals among end-users, leading to driving the market growth.

Favorable government initiatives are also expected to boost the market growth to great extent. In 2016, the U.S. FDA approved 73 ANDAs and it was found that approximately 65% of the approved ANDAs were applied by major generic competitors. For instance, ANDA for mycophenolate mofetil hydrochloride injection (500mg/vial) was filed by Par Sterile Products LLC, which received approval in 2016. The patent of its branded version, CellCept, expired in 2009. In addition, as per the database of the U.S.FDA, 46 drugs received approval in 2017, this shows the widening scope for growth of specialty injectable generics market. Other factors such as demand for low-cost therapeutics and growing awareness level for generic pharmaceuticals will spur the market growth to some extent.

However, a strict regulatory guideline for generic therapeutics hampers the market growth. For example, the presence of a stringent regulatory process has led to the delay in the launch of specialty injectable generics significantly. The regulatory bodies in the U.S. are increasingly focusing on thorough inspections of these drugs, thereby leading to slow approval procedure.

Also, a wide gap in adherence to Good Manufacturing Practices (GMP) protocol creates a significant rise in quality issues, and demands rapid integration & streamlining of operations and strict actions by FDA. On the other hand, some of the investments in maintaining quality standards are not justified by margins offered by various government-run programs, such as Medicare, which has led to rationalization of product portfolio for several players.

The global specialty generic pharmaceutic market is categorized in terms of injectables, oral drugs, and others. Among which, oral and self-injectable specialty therapeutics has been increasing owing to the technological advancements. Injectable generic therapeutics is considered to be the fast catching market segment, growing constantly over the forecast period. Injectable generics for oncology treatment is widely in demand across the globe.

Based on the indication, the market is divided as Oncology, Inflammatory conditions, Multiple sclerosis, Hepatitis C, and Others. The end-user segment is covered under Specialty pharmacies, Retail pharmacies, and Hospital pharmacies. Specialty pharmacies accounted for the largest share of the global market, captured around USD 21.6 billion in 2016 and are expected to dominate the market over the forecast period.

Major market players are consistently striving to achieve consolidation in the industry by deploying extensive collaborative strategies and mergers & acquisitions to sustain the competition. Leading players such as Sandoz; Teva Pharmaceuticals, Inc., Valeant Pharmaceuticals; Sun Pharmaceuticals; Mylan N.V.; Pfizer, Inc.; and other are present in this market. These market leaders are involved in the establishment of extensive distribution systems as well as increasingly involving in mergers &acquisitions to capture a larger share of the market.

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The scope of this report covers the market by its major segments, which include as follows:

Market Segmentation

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