Specialty Generics Market 2024-2033: Trends, Analysis & Growth Forecast

The specialty generics market size has grown rapidly in recent years. It will grow from $85.85 billion in 2023 to $96.94 billion in 2024 at a compound annual growth rate (CAGR) of 12.9%. The growth in the historic period can be attributed to patent expirations of brand-name drugs, growing demand for cost-effective alternatives, regulatory support for generic drug approvals, increasing healthcare cost pressures, rise in chronic diseases and aging population.

The specialty generics market size is expected to see rapid growth in the next few years. It will grow to $164.57 billion in 2028 at a compound annual growth rate (CAGR) of 14.1%. The growth in the forecast period can be attributed to expansion of biosimilars market, emphasis on complex generic drug development, increasing focus on specialty generic injectables, adoption of 3d printing in specialty generic manufacturing, growth of specialty generics in emerging markets. Major trends in the forecast period include personalized and targeted specialty generics, strategic partnerships and collaborations in generic drug development, focus on developing abuse-deterrent formulations, integration of digital health technologies in specialty generics, regulatory initiatives for accelerated approval of complex generics.

Market Overview -
The specialty generics refer to generic versions of drugs used to describe expensive, intricate, or high-touch generic versions of medications. It requires substantial service participation to manage. This specialty generic includes biologics and biosimilars, which have separate regulatory routes. The majority of specialty medications are used to treat various malignancies, rheumatoid arthritis, and multiple sclerosis.

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Surge In Chronic Diseases Spurs Demand For Specialty Generics Market
The surge in chronic diseases is expected to propel the demand for the specialty generic market. Chronic diseases are long-lasting sicknesses that often cannot be healed. However, it is occasionally curable and controllable. The changing lifestyle, eating habits, and not maintaining body weight are the reason for chronic conditions; a few more prolonged chronic infections lead to cancerous risk. Growing exposure to these diseases raises the need for specialty generic for a patient to treat complex chronic diseases. For instance, in September 2022, according to the World Health Organization, a Switzerland-based specialized agency of the United Nations, there were 41 million deaths, which is 74% of those caused by non-communicable diseases (NCDs) or chronic diseases every year globally. There were 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. Therefore, the surge in chronic diseases is driving the specialty generic market growth.

Competitive Landscape -
Major companies operating in the specialty generics market report are Teva Pharmaceutical Industries Ltd., Endo International plc, Akorn Operating Company LLC , Mylan NV, Mallinckrodt Pharmaceuticals, Dr. Reddy's Laboratories Ltd., Apotex Corp., 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.

New Approval To Address The Critical Need For Medication
Major companies operating in the specialty generic market are receiving approval such as Lisdexamfetamine Dimesylate to address the critical need for medication. Approval in specialty generics refers to the regulatory authorization granted to pharmaceutical products that are bioequivalent and therapeutically equivalent to brand-name specialty drugs, typically used in the treatment of complex or rare medical conditions, after the expiration of their patent protection. For instance, in August 2023, Mallinckrodt plc, an Ireland-based specialty pharmaceutical company, received FDA approval for its Lisdexamfetamine Dimesylate Capsules in SpecGx LLC Specialty Generics segment, to treat Attention-Deficit/Hyperactivity Disorder (ADHD). . Lisdexamfetamine Dimesylate is a type of specialty generic, and a federally controlled substance (CII) used to treat ADHD and other indications .

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Key Segments -
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 Pharmacies

Key highlights covered in the report -
1. Detailed market size forecast and historical data analysis
2. Key drivers influencing market growth
3. Identification of upcoming trends and potential opportunities in the market
4. Analysis of major players strategies, to understand competitive dynamics and market positioning
5. Evaluation of regional dynamics

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