What are the Historical Developments and Current Growth Metrics of the Specialty Generics Market?
The specialty generics market has seen considerable growth due to a variety of factors.
• In recent years, the specialty generics market has experienced significant growth. The market size is projected to increase from $95.87 billion in 2024 to $108.11 billion in 2025, with a compound annual growth rate (CAGR) of 12.8%.
This growth during the historical period is due to several factors. These include the patent expirations of branded drugs, a rising demand for more affordable alternatives, the regulatory backing for the approval of generic drugs, escalating healthcare costs, the increasing prevalence of chronic diseases, and an aging population.
What Does Future Hold for The Specialty Generics Market Size?
The specialty generics market is expected to maintain its strong growth trajectory in upcoming years.
• The market size of specialty generics is anticipated to experience swift expansion in the upcoming years, with a projection to reach $189.72 billion in 2029, registering a compound annual growth rate (CAGR) of 15.1%.
Factors contributing to this predicted growth over the forecast period include the expansion of the biosimilars market, a focus on the development of complex generic drugs, an increased emphasis on specialty generic injectables, the integration of 3d printing into specialty generic production, and the growth of the specialty generics industry in emerging markets. The forecast incidentally foresees key trends such as an inclination towards personalized and targeted specialty generics, strategic alliances, and collaborations in the development of generic drugs, attention towards developing abuse-deterrent formulations, the incorporation of digital health technologies in the specialty generics sector, and the regulatory initiatives promoting quick approval of complex generics.
What Are The Key Drivers Fueling Growth In The Specialty Generics Market?
The rise in long-term health conditions, known as chronic diseases, is anticipated to significantly boost the specialty generic market. Chronic diseases are enduring illnesses that are usually incurable but occasionally treatable and manageable. Contributing factors for these illnesses include a shift in lifestyle, dietary habits, and failure to maintain a healthy body weight. Certain persistent chronic infections can also escalate to cancer. There's an increased demand for specialty generic medications to manage these complex chronic diseases due to the escalating exposure to these conditions. As per the World Health Organization, a Switzerland-based arm of the United Nations, 41 million deaths, or 74% of total deaths, were attributed to NCDs or chronic diseases globally in September 2022. These included 17.9 million deaths from heart-related diseases, 9.3 million deaths from cancer, 4.1 million deaths from chronic respiratory diseases, and 2.0 million deaths from diabetes. Therefore, the escalating trend of chronic diseases fuels growth in the specialty generic market.
What Are The Principal Market Segments In The Global Specialty Generics Industry?
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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Which Emerging Market Trends Are Altering The Specialty Generics Sector?
Key players in the specialty generic market such as Lisdexamfetamine Dimesylate are being granted approval in order to fulfill the urgent need for medication. Speciality generic approvals relate to the regulatory endorsements given to bioequivalent and therapeutically equivalent pharmaceutical products to specialty drugs under brand names, typically used to manage complex or rare medical conditions after their patent protection expires. For example, in August 2023, an FDA approval was granted to Mallinckrodt plc, a specialty pharmaceutical company based in Ireland, for its Lisdexamfetamine Dimesylate Capsules which belong to its SpecGx LLC Specialty Generics division for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Lisdexamfetamine Dimesylate, a specialty generic product, is a federally controlled substance (CII) that is also used to handle ADHD among other indications.
Who Are the Key Players 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.
What are the Regional Insights into 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
