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What fueled the previous growth in the specialty generics market?

Over recent years, the specialty generics market has seen swift expansion. It is projected to accelerate from a market size of $95.87 billion in 2024, reaching $108.11 billion in 2025, with a compound annual growth rate (CAGR) of 12.8%. Factors contributing to this growth during the historic period include the expiration of brand-name drug patents, boosted demand for affordable alternatives, regulatory encouragement for generic drug authorization, mounting pressure due to climbing healthcare costs, as well as the increase in chronic diseases coupled with an aging population.

What will be the specialty generics market size in the future?

Anticipated to experience swift expansion in the succeeding years, the market size for specialty generics is predicted to reach a sum of $189.72 billion by 2029, showcasing a compound annual growth rate (CAGR) of 15.1%. Various factors contributing to this projected inclination during the forecast period encompass the growing biosimilars market, increased concentration on the development of complex generic drugs, the rising attention towards specialty generic injectables, the incorporation of 3D printing in specialty generic production, and the surge of specialty generics in developing markets. The forecast period also discloses significant trends including personal and targeted specialty generics, strategic alliances, and partnerships in the development of generic drugs, a focus on creating abuse-deterring formulations, the inclusion of digital health technology in specialty generics, and regulatory actions for sped-up approval of complex generics.

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What main drivers are fueling expansion in the specialty generics market?

The rise in long-term illnesses is anticipated to fuel demand in the specialty generic market. Chronic diseases are typically enduring and not always curable, yet sometimes controllable. Factors such as shifting lifestyles, dietary habits, and the lack of body weight management contribute to such enduring illnesses, and some can even increase the risk of cancer. As exposure to these diseases increases, the necessity for specialty generics also escalates, primarily to manage complex chronic diseases. For example, in September 2022, World Health Organization, a specialized UN agency based in Switzerland, reported 41 million deaths globally, 74% of which were due to non-communicable or chronic diseases. Breakdown showed 17.9 million cardiovascular-related deaths, 9.3 million cancer-related deaths, 4.1 million chronic respiratory disease-related deaths, and 2.0 million diabetes-related deaths. Consequently, the sharp rise in chronic illnesses is a primary driver of growth for the specialty generic market.

What key areas define the segmentation of the global specialty generics market?

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

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Who are the dominant players expanding their reach in the specialty generics market?

Major companies operating in the specialty generics market 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, Aspen Pharmacare Holdings Limited, Pfizer Inc., Accord Healthcare Limited, Amneal Pharmaceuticals Inc., Sandoz International GmbH, Zydus Lifesciences Ltd., Torrent Pharmaceuticals Ltd., Perrigo Company plc, Impax Laboratories Inc., Par Pharmaceutical Companies Inc., Alvogen, Alkem Laboratories Ltd., Wockhardt Ltd., Strides Pharma Science Limited, Indoco Remedies Ltd., Unichem Laboratories Ltd., Alembic Pharmaceuticals Ltd., Jubilant Life Sciences Ltd.

How are evolving market trends shaping specialty generics Strategies?

Leading businesses in the specialty generic market, such as Lisdexamfetamine Dimesylate, are acquiring approvals to fulfill the vital necessity for medications. Such approvals indicate the formal clearance given by regulatory bodies for pharmaceutical products, equivalent both bioequivalently and therapeutically to brand-name specialty drugs often used for complicated or rare health conditions, once their patent cover has expired. For example, the Ireland-based specialized pharmaceutical firm, Mallinckrodt plc, in August 2023, secured FDA approval for their Lisdexamfetamine Dimesylate Capsules under the SpecGx LLC Specialty Generics segment, intended for treating Attention-Deficit/Hyperactivity Disorder (ADHD). Lisdexamfetamine Dimesylate constitutes a kind of specialty generic and is a federally regulated substance (CII), used in ADHD and other medical treatments.

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Which regions are emerging as leaders in the specialty generics market?

North America was the largest region in the specialty generics market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the specialty generics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa

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