The global specialty generics market size is expected to reach USD 148.72 billion by 2030, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 9.9% over the forecast period. The growth in the market is largely driven by increasing product approvals and the rising prevalence of complex chronic diseases, such as multiple sclerosis.
In April 2022, Dr. Reddy’s Laboratories launched a methylprednisolone sodium succinate injection in the U.S. for the treatment of patients with arthritis, blood disorders, and certain rare cancers. Furthermore, in June 2022, Elixir launched copay solutions enhancement program for the management of specialty generic medication prices. Under this program, an eligible patient receives a generic version of specialty medication at zero cost. Thus, the launch of new low-cost generic injectables and the availability of such programs is projected to fuel market growth.
Increased claim settlements and availability of specialty generic drugs increase their prescription rates due to the high safety, efficacy, and tolerability associated with them. According to the Human Resources Benefits Office University of Michigan annual report (2021), around 1,383 claims were settled for specialty generic drugs such as glatiramer acetate (Copaxone/Glatopa), teriflunomide (Aubagio), and fingolimod (Gilenya) in 2021, compared to 1,360 in 2020, with a rise of 1.7% for the treatment of patients with multiple sclerosis.
However, high costs associated with specialty generics may hamper their uptake. The lack of ability to attract patients toward drugs, marketing rights acquired by companies for off-patent drugs with no generic competition, and small target patient pool, subsequently increases the prices of products. According to the University of Michigan Prescription Drug Plan Formulary report, the average cost of specialty generic is over USD 4,500 monthly per person, compared to USD 17 to 22 for a generic prescription.
Specialty Generics Market Report Highlights
- Based on type, the injectables segment dominated the market in 2022. It is estimated to maintain its dominance during the forecast period due to its high prescription rate on account of long-term effects, and immediate absorption compared to oral drugs
- Based on application, the oncology segment is expected to witness significant growth during the projection period owing to the increasing prevalence of cancer. According to Globocan, the number of new cancer cases is anticipated to reach 28.4 million within the next two decades worldwide
- On the basis of end-use, the specialty pharmacy segment dominated the market in 2022 owing to features like timely delivery, optimized patient access, and effective distribution management
- Based on region, North America dominated the market in 2022 due to the presence of supportive regulatory policies regarding the approval of new products. The U.S. FDA introduced Generic Drug User Fee Amendments (GDUFA) under the Hatch-Waxman act to quicken the approval of new generic drugs
Specialty Generics Market Segmentation
Grand View Research has segmented the global specialty generics market by type, application, end-use, and region:
Specialty Generics Type Outlook (Revenue, USD Billion, 2018 - 2030)
- Injectables
- Oral drugs
- Others
Specialty Generics Application Outlook (Revenue, USD Billion, 2018 - 2030)
- Oncology
- Inflammatory conditions
- Multiple sclerosis
- Hepatitis C
- Others
Specialty Generics End Use Outlook (Revenue, USD Billion, 2018 - 2030)
- Specialty pharmacy
- Retail pharmacy
- Hospital pharmacy
Specialty Generics Regional Outlook (Revenue, USD Billion, 2018 - 2030)
- North America
- Europe
- Germany
- UK
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
- Asia Pacific
- Japan
- China
- India
- Australia
- South Korea
- Thailand
- Latin America
- Middle East and Africa (MEA)
- South Africa
- Saudi Arabia
- UAE
- Kuwait
Key Players in the Specialty Generics Market
- Teva Pharmaceuticals Industries Ltd
- Viatris Inc.
- Novartis AG (Sandoz International GmbH)
- Hikma Pharmaceuticals PLC
- Mallinckrodt
- Bausch Health Companies Inc. (Valeant Pharmaceuticals International, Inc.)
- Reddy’s Laboratories Ltd.
- Endo Pharmaceuticals Inc.
- Apotex Corp.
- Sun Pharmaceutical Industries Ltd
- Fresenius Kabi Brasil Ltda
- STADA Arzneimittel AG
Order a free sample PDF of the Specialty Generics Market Intelligence Study, published by Grand View Research.
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