United States Specialty Generics Market Strengthens with FDA Approvals for Oncology and Neurological Treatments | Market to Reach USD 198.9 Billion by 2034, Growing at a 9.1% CAGR

Specialty Generics Market is predicted to reach at a high CAGR 9.1% during the forecast period (2024-2031).

The Specialty Generics Market includes generic versions of complex or high-value drugs used for chronic or rare diseases. Growth is driven by patent expirations, cost containment needs, and rising healthcare demand. Products cover oncology, biologics, and specialty therapies. Pharmaceutical companies focus on regulatory compliance, bioequivalence, and manufacturing quality. Key end-users include hospitals, clinics, and pharmacies. R&D in complex formulations and biosimilars enhances market competitiveness. Global expansion and healthcare affordability initiatives support growth.

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☛ Specialty Generics Market Recent Developments 2025:

United States: Recent Industry Developments

✅ In August 2025, Teva Pharmaceuticals expanded its U.S. specialty generics portfolio by launching a generic version of Copaxone® (glatiramer acetate) for multiple sclerosis, reinforcing its position in the neurological segment.

✅ In July 2025, Amneal Pharmaceuticals received FDA approval for its generic fentanyl transdermal system, enhancing its pain management offerings within the specialty generics space.

✅ In June 2025, Viatris Inc. announced the U.S. launch of a generic ophthalmic solution for glaucoma treatment, emphasizing its focus on high-value therapeutic areas.

Europe: Recent Industry Developments

✅ In August 2025, Sandoz (Novartis division) introduced multiple oncology and cardiovascular specialty generics across key EU markets, including Germany and France, improving treatment accessibility.

✅ In July 2025, STADA Arzneimittel AG expanded its generics portfolio with new injectable formulations for hospital use, strengthening its European specialty drug footprint.

✅ In June 2025, Accord Healthcare launched a generic buprenorphine injectable in the U.K. to support pain and opioid dependence therapy markets.

Japan: Recent Industry Developments

✅ In August 2025, Towa Pharmaceutical Co., Ltd. launched a generic lenalidomide capsule for multiple myeloma treatment following patent expiration, increasing access to affordable oncology care.

✅ In July 2025, Nichi-Iko Pharmaceutical expanded its specialty generics pipeline by acquiring domestic rights for biosimilar insulin and related formulations.

✅ In June 2025, Sawai Pharmaceutical introduced generic antiepileptic tablets and injectable antibiotics, addressing Japan's rising demand for cost-effective specialty treatments.

☛ Specialty Generics Market Competitive Landscape:

Mylan N.V., Teva Pharmaceuticals USA, Inc., Sandoz International GmbH, Mallinckrodt, Akorn, Inc., Valeant Pharmaceuticals International, Inc., Endo Pharmaceuticals, Inc., Pfizer, Inc., Sun Pharmaceutical Industries Ltd, and Apotex Corp

Research Methodology

We follow a hybrid research approach, combining qualitative insights with rigorous quantitative analysis to deliver reliable and comprehensive market intelligence. Our process begins with extensive secondary research, drawing on trusted industry reports, proprietary databases, and credible market sources. This is then reinforced through targeted primary research, including structured surveys and in-depth interviews with industry leaders, subject matter experts, and key market participants.

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☛ Segments Covered in the Specialty Generics Market:

By Indication: Oncology, Inflammatory conditions, Autoimmune Diseases, Infectious Diseases, Others

By Route of Administration: Oral, Injectable, Others

By Distribution Channel: Hospital Pharmacy, Pharmacy Stores, Other

☛ This Report Includes:

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✔ Identification of niche segments and high-growth regions presenting strong opportunities.

✔ Accurate regional forecasts using both top-down and bottom-up approaches.

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☛ Regional Analysis for Specialty Generics Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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