The global specialty generics market size was estimated to be USD 69.84 billion in 2023 and is expected to reach at USD 197.7 billion by 2033 with a CAGR of 9.92% during the forecast period 2023-2033. Growing regulatory support, rising use of generic drugs, an ageing population, and expired patents will all contribute to the market's expansion. There will also be an increased focus on biosimilars.
Specialty generic medications called 'biosimilars' are copies of sophisticated biologic drugs. The possibility for significant cost savings and improved access to biologic medicines are driving the growing attention on biosimilars. To cut healthcare costs, governments and healthcare systems are promoting the creation and use of biosimilars, which is causing the market for specialty generics to expand. For instance, Teva Pharmaceutical Industries declared in April 2023 that the FDA had approved the generic version of Neulasta (pegfilgrastim), which is manufactured by Amgen. A biologic medication called Neulasta is used to keep cancer patients receiving chemotherapy from getting sick.
By type, injectable specialty generics was the highest revenue-grossing segment in the global specialty generics market in 2022 owing to rising products approval. For instance, in September 2021, in collaboration with Natco Pharma, Dr Reddy's Laboratories has introduced a generic version of Revlimid in Canada. Health Canada has granted approval for Nat-lenalidomide and Reddy-lenalidomide, which can be used to treat patients with myelodysplastic syndrome and multiple myeloma. This approval enables cancer patients in Canada to have convenient access to cost-effective specialty generic drugs, leading to an increase in the prescription rate. Additionally, Oral specialty generics is predicted to grow at fastest CAGR during the forecast period owing to their convenience for repeated and prolonged use and rising new drug approvals by regulatory bodies.
By application, oncology was the highest revenue-grossing segment in the global specialty generics market in 2022 owing to increasing prevalence of cancer and increasing launch of new drugs. For instance, in March 2022, Teva Pharmaceuticals Inc. has introduced the generic version of Revlimid (lenalidomide capsules) in the United States. This marks the first launch of a generic alternative available in strengths of 5mg, 10mg, and 25mg, providing treatment options for adults with multiple myeloma. Additionally, Cardiovascular is predicted to grow at fastest CAGR during the forecast period owing to increase in number of patients suffering from heart attacks.
By end-user, specialty pharmacies was the highest revenue-grossing segment in the global specialty generics market in 2022 owing to the increasing popularity along with low cost associated with specialty generic drug inventory and increase in effective distribution management of specialty pharmacies. Additionally, Hospitals is predicted to grow at fastest CAGR during the forecast period owing to increase in number of cancer patients visiting to hospitals, surge in prescription of medications at hospitals, and rising initiatives by market players. For instance, in June 2021, Specialty pharmaceutical company ADVANZ PHARMA Corp. Ltd. was acquired by Nordic Capital. This acquisition bolstered ADVANZ PHARMA's expansion and expanded the range of international options available to doctors and patients.
North America region is anticipated for the highest revenue share during the forecast period owing to the increasing launch of novel drugs and surge in product approvals by US FDA. For instance, in June 2022, LYVISPAH (baclofen), a specialty product indicated for multiple sclerosis and other spinal cord disorders, has been introduced by Amneal Pharmaceuticals Inc. following approval from the U.S. FDA. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the cost effectiveness of medicines, and rising launch of new generic drugs. For instance, in 2021, BDR Pharma has released a generic version of Midostaurin under the brand name MSTARIN, aimed at treating rare cancers such as acute myeloid leukemia (AML).
Specialty generic medications called 'biosimilars' are copies of sophisticated biologic drugs. The possibility for significant cost savings and improved access to biologic medicines are driving the growing attention on biosimilars. To cut healthcare costs, governments and healthcare systems are promoting the creation and use of biosimilars, which is causing the market for specialty generics to expand. For instance, Teva Pharmaceutical Industries declared in April 2023 that the FDA had approved the generic version of Neulasta (pegfilgrastim), which is manufactured by Amgen. A biologic medication called Neulasta is used to keep cancer patients receiving chemotherapy from getting sick.
By type, injectable specialty generics was the highest revenue-grossing segment in the global specialty generics market in 2022 owing to rising products approval. For instance, in September 2021, in collaboration with Natco Pharma, Dr Reddy's Laboratories has introduced a generic version of Revlimid in Canada. Health Canada has granted approval for Nat-lenalidomide and Reddy-lenalidomide, which can be used to treat patients with myelodysplastic syndrome and multiple myeloma. This approval enables cancer patients in Canada to have convenient access to cost-effective specialty generic drugs, leading to an increase in the prescription rate. Additionally, Oral specialty generics is predicted to grow at fastest CAGR during the forecast period owing to their convenience for repeated and prolonged use and rising new drug approvals by regulatory bodies.
By application, oncology was the highest revenue-grossing segment in the global specialty generics market in 2022 owing to increasing prevalence of cancer and increasing launch of new drugs. For instance, in March 2022, Teva Pharmaceuticals Inc. has introduced the generic version of Revlimid (lenalidomide capsules) in the United States. This marks the first launch of a generic alternative available in strengths of 5mg, 10mg, and 25mg, providing treatment options for adults with multiple myeloma. Additionally, Cardiovascular is predicted to grow at fastest CAGR during the forecast period owing to increase in number of patients suffering from heart attacks.
By end-user, specialty pharmacies was the highest revenue-grossing segment in the global specialty generics market in 2022 owing to the increasing popularity along with low cost associated with specialty generic drug inventory and increase in effective distribution management of specialty pharmacies. Additionally, Hospitals is predicted to grow at fastest CAGR during the forecast period owing to increase in number of cancer patients visiting to hospitals, surge in prescription of medications at hospitals, and rising initiatives by market players. For instance, in June 2021, Specialty pharmaceutical company ADVANZ PHARMA Corp. Ltd. was acquired by Nordic Capital. This acquisition bolstered ADVANZ PHARMA's expansion and expanded the range of international options available to doctors and patients.
North America region is anticipated for the highest revenue share during the forecast period owing to the increasing launch of novel drugs and surge in product approvals by US FDA. For instance, in June 2022, LYVISPAH (baclofen), a specialty product indicated for multiple sclerosis and other spinal cord disorders, has been introduced by Amneal Pharmaceuticals Inc. following approval from the U.S. FDA. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the cost effectiveness of medicines, and rising launch of new generic drugs. For instance, in 2021, BDR Pharma has released a generic version of Midostaurin under the brand name MSTARIN, aimed at treating rare cancers such as acute myeloid leukemia (AML).
Segmentation: Specialty Generics Market Report 2022-2033
Specialty Generics Market Analysis & Forecast by Type 2022-2033 (Revenue USD Bn)
- Oral Specialty Generics
- Injectable Specialty Generics
- Topical Specialty Generics
- Inhalation Specialty Generics
Specialty Generics Market Analysis & Forecast by Application 2022-2033 (Revenue USD Bn)
- Cardiovascular
- Central Nervous System (CNS)
- Respiratory
- Oncology
- Dermatology
- Gastroenterology
Specialty Generics Market Analysis & Forecast by End-user 2022-2033 (Revenue USD Bn)
- Hospitals
- Clinics
- Retail Pharmacies
- Specialty Pharmacies
Specialty Generics Market Analysis & Forecast by Region 2022-2033 (Revenue USD Bn)
North America
- U.S
- Canada
Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Specialty Generics: Type Estimates & Trend Analysis
8. Small Animal Imaging: Application Estimates & Trend Analysis
9. Small Animal Imaging: End-user Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Specialty Generics Market
12. Europe Global Specialty Generics Market
13. Asia Pacific Global Specialty Generics Market
14. Latin America Global Specialty Generics Market
15. MEA Global Specialty Generics Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Teva Pharmaceutical Industries Ltd.
- Mylan N.V. (now part of Viatris Inc.)
- Sandoz International GmbH (a division of Novartis)
- Hikma Pharmaceuticals PLC
- Lupin Limited
- Sun Pharmaceutical Industries Ltd.
- Dr. Reddy's Laboratories Ltd.
- Fresenius Kabi AG
- Endo International plc
- Alvogen
- Lannett Company Inc.
- Zydus Cadila
- Cipla Limited
- Amneal Pharmaceuticals Inc.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 145 |
| Published | July 2023 |
| Forecast Period | 2022 - 2033 |
| Estimated Market Value ( USD | $ 69.84 Billion |
| Forecasted Market Value ( USD | $ 197.7 Billion |
| Compound Annual Growth Rate | 9.9% |
| Regions Covered | Global |
| No. of Companies Mentioned | 14 |
