The Business Research Company’s Specialty Generics Global Market Report 2025 – Market Size, Trends, And Forecast 2025-2034

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LONDON, GREATER LONDON, UNITED KINGDOM, November 21, 2025 /EINPresswire.com/ -- How Big Is The Specialty Generics Market In 2025?
In the last few years, the size of the specialty generics market has experienced swift growth. It is projected to expand from $95.87 billion in 2024 to $107.14 billion in 2025, boasting a Compound Annual Growth Rate (CAGR) of 11.7%. This sizable growth in the historical period can be ascribed to various factors: the expiration of patents on brand-name drugs, a heightened demand for more affordable alternatives, supportive regulations for the approval of generic drugs, the increasing cost pressures on healthcare, the escalation in chronic diseases, and an aging population.

The market size of specialty generics is anticipated to expand significantly in the forthcoming years, reaching a value of $185.68 billion in 2029. This indicates a compound annual growth rate (CAGR) of 14.7%. Factors contributing to the projected growth within the forecast period include the burgeoning biosimilars market, efforts targeted towards complex generic drug development, rising interest in specialty generic injectables, the utilization of 3D printing in specialty generic production, and the surge of specialty generics in developing markets. The future trend projections during this period involve a focus on personalized and targeted specialty generics, strategic alliances and partnerships in generic drug development, a shift in focus towards producing abuse-resistant formulations, the integration of digital health technologies in specialty generics, and regulatory actions to speed up the approval of complex generics.

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What Are The Key Driving Factors For The Growth Of The Specialty Generics Market?
The rise in long-term illnesses is predicted to increase the need for the specialty generic market. These chronic diseases are typically enduring illnesses that are often not curable, but can sometimes be cured or managed. Factors such as alterations in lifestyle, food consumption habits, and not sustaining an optimum body weight, contribute to the occurrence of chronic diseases. Moreover, certain long-term chronic infections can escalate the risk of cancer. The escalating exposure to such diseases emphasizes the requirement for specialty generic, intended to treat complicated chronic diseases. For example, in September 2022, the World Health Organization, a specialized agency of the United Nations based in Switzerland, reported that there were 41 million deaths worldwide, 74% of which were due to non-communicable diseases (NCDs) or chronic diseases. This included 17.9 million deaths from cardiovascular diseases, 9.3 million deaths from cancer, 4.1 million deaths from chronic respiratory diseases, and 2.0 million deaths from diabetes. Hence, the increase in chronic diseases is a significant factor propelling the growth of the specialty generic market.

Who Are The Key Players In The Specialty Generics Industry?
Major players in the Specialty Generics include:

• Teva Pharmaceutical Industries Ltd.
• Endo International plc
• Akorn Operating Company LLC
• Mallinckrodt Pharmaceuticals
• Dr. Reddy’s Laboratories Ltd.
• Fresenius Kabi Brasil Ltda
• STADA Arzneimittel AG
• Cipla Limited
• Lupin Ltd
• Aurobindo Pharma Limited

What Are The Upcoming Trends Of Specialty Generics Market In The Globe?
Leading businesses in the specialty generic market, such as Lisdexamfetamine Dimesylate, are obtaining authorization to meet the urgent need for medication. This license for specialty generics implies regulatory consent for pharmaceutical items that are therapeutically and bioequivalent to high-end specialty medicines, typically employed for complicated or uncommon health problems after their patent expiry. For example, Mallinckrodt plc, a specialty pharmaceutical firm from Ireland, got FDA approval in August 2023 for its Lisdexamfetamine Dimesylate Capsules in the SpecGx LLC Specialty Generics division, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Lisdexamfetamine Dimesylate is a kind of specialty generic and a federally regulated substance (CII), utilized for treating ADHD and other indications.

What Segments Are Covered In The Specialty Generics Market Report?
The specialty generics market covered in this report is segmented –

1) By Route Of Administration: Injectables, Oral, Other Route Of Administration
2) By Indication: Oncology, Autoimmune Diseases, Infectious Diseases, Other Indication
3) By Distribution Channel: Retail Pharmacies, Specialty Pharmacies, Hospital Pharmaciesx

Subsegments:
1) By Injectables: Intravenous (IV) Injectables, Intramuscular (IM) Injectables, Subcutaneous (SC) Injectables
2) By Oral: Tablets, Capsules, Liquid Formulations
3) By Other Route Of Administration: Topical, Transdermal, Inhalation

Which Region Is Expected To Lead The Specialty Generics Market By 2025?
In 2024, North America dominated the specialty generics market. However, Asia-Pacific is anticipated to experience the most rapid growth in the upcoming forecast period. The market report for specialty generics encompasses regions including Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.

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