This Specialty Generics report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
The specialty generics market size has grown rapidly in recent years. It will grow from $95.87 billion in 2024 to $108.11 billion in 2025 at a compound annual growth rate (CAGR) of 12.8%. 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 $189.72 billion in 2029 at a compound annual growth rate (CAGR) of 15.1%. 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.
The increase in chronic diseases is projected to boost the demand for the specialty generic market. Chronic diseases are long-term illnesses that are often incurable, although some can be managed or controlled. Factors such as changing lifestyles, poor eating habits, and inadequate weight management contribute to the prevalence of chronic conditions, with some extended chronic illnesses heightening the risk of cancer. The rising incidence of these diseases amplifies the need for specialty generics to treat complex chronic conditions. For example, in September 2022, the World Health Organization, a specialized agency of the United Nations based in Switzerland, reported that 41 million deaths annually - accounting for 74% of deaths from non-communicable diseases (NCDs) or chronic diseases - occur globally. This includes 17.9 million deaths from cardiovascular diseases, 9.3 million from cancer, 4.1 million from chronic respiratory diseases, and 2 million from diabetes. Therefore, the surge in chronic diseases is fueling the growth of the specialty generic market.
The aging population is expected to propel the specialty generic market in the future. The term 'aging population' denotes the demographic shift characterized by a rising proportion of elderly individuals in a society. Specialty generics are specifically formulated pharmaceuticals designed to address acute conditions prevalent in the elderly, such as postoperative pain, acute infections, or short-term pain relief. This ensures effective treatment options for the aging population while managing healthcare costs. According to the World Health Organization's projections in October 2022, by 2030, one out of every six individuals globally will be 60 years or older, reaching 1. 4 billion. By 2050, the global population of individuals aged 60 and older is expected to double to 2. 1 billion. Therefore, the aging population is a significant driver for the specialty generic market.
Major companies in the specialty generic market are obtaining approvals for medications like Lisdexamfetamine Dimesylate to address critical medical needs. Approval in specialty generics refers to the regulatory authorization granted to pharmaceutical products that are bioequivalent and therapeutically equivalent to brand-name specialty drugs. In August 2023, Mallinckrodt plc, an Ireland-based specialty pharmaceutical company, received FDA approval for Lisdexamfetamine Dimesylate Capsules in SpecGx LLC Specialty Generics segment to treat Attention-Deficit/Hyperactivity Disorder (ADHD). Lisdexamfetamine Dimesylate, a federally controlled substance (CII), is used for ADHD and other indications.
Major companies in the specialty generic market are introducing new products to offer more affordable alternatives. In March 2022, Teva Pharmaceutical Industries Ltd, an Israel-based pharmaceutical company, launched the first generic version of REVLIMID (lenalidomide) in the US, available in 5mg, 10mg, 15mg, and 25mg capsules. REVLIMID is prescribed for adults with multiple myeloma (MM) and is used either in combination with dexamethasone or as a maintenance treatment post-autologous hematopoietic stem cell transplantation.
In October 2022, Aspire Pharma, a UK-based pharmaceutical company, acquired Morningside Pharmaceuticals and Morningside Healthcare, including its subsidiaries like Morningside Healthcare (India), for an undisclosed amount. This strategic acquisition aims to expand Aspire Pharma's market position by combining complementary product portfolios, providing added talent, an increased in-market range, and an industry-leading pipeline, positioning the company as a premier specialty generic pharmaceutical organization.
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.
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. The countries covered in the specialty generics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Canada, Spain.
Specialty generics refer to generic versions of drugs designed to replicate expensive, intricate, or high-touch generic medications. Managing specialty generics requires substantial service participation. This category encompasses biologics and biosimilars, each with distinct regulatory routes. Specialty medications, in general, are commonly used to treat various conditions such as malignancies, rheumatoid arthritis, and multiple sclerosis.
Specialty generics are administered through various routes, including injectables, oral, and others. The injectables route involves diverse methods of drug administration such as intravenous, subcutaneous, intradermal, intraperitoneal, intramuscular, and others. This is applicable in the treatment of medical conditions ranging from cancer to autoimmune disorders. Drug injection typically involves the use of a hollow hypodermic needle to introduce a substance into the bloodstream. Specialty generics find applications in indications like oncology, autoimmune diseases, infectious diseases, and others. These medications are distributed through multiple channels, including retail pharmacies, specialty pharmacies, and hospital pharmacies.
The specialty generics market research report is one of a series of new reports that provides specialty generics market statistics, including specialty generics industry global market size, regional shares, competitors with a specialty generics market share, detailed specialty generics market segments, market trends and opportunities, and any further data you may need to thrive in the specialty generics industry. This specialty generics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The specialty generics market consists of sales of biologics and biosimilars. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 3-5 business days.
The specialty generics market size has grown rapidly in recent years. It will grow from $95.87 billion in 2024 to $108.11 billion in 2025 at a compound annual growth rate (CAGR) of 12.8%. 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 $189.72 billion in 2029 at a compound annual growth rate (CAGR) of 15.1%. 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.
The increase in chronic diseases is projected to boost the demand for the specialty generic market. Chronic diseases are long-term illnesses that are often incurable, although some can be managed or controlled. Factors such as changing lifestyles, poor eating habits, and inadequate weight management contribute to the prevalence of chronic conditions, with some extended chronic illnesses heightening the risk of cancer. The rising incidence of these diseases amplifies the need for specialty generics to treat complex chronic conditions. For example, in September 2022, the World Health Organization, a specialized agency of the United Nations based in Switzerland, reported that 41 million deaths annually - accounting for 74% of deaths from non-communicable diseases (NCDs) or chronic diseases - occur globally. This includes 17.9 million deaths from cardiovascular diseases, 9.3 million from cancer, 4.1 million from chronic respiratory diseases, and 2 million from diabetes. Therefore, the surge in chronic diseases is fueling the growth of the specialty generic market.
The aging population is expected to propel the specialty generic market in the future. The term 'aging population' denotes the demographic shift characterized by a rising proportion of elderly individuals in a society. Specialty generics are specifically formulated pharmaceuticals designed to address acute conditions prevalent in the elderly, such as postoperative pain, acute infections, or short-term pain relief. This ensures effective treatment options for the aging population while managing healthcare costs. According to the World Health Organization's projections in October 2022, by 2030, one out of every six individuals globally will be 60 years or older, reaching 1. 4 billion. By 2050, the global population of individuals aged 60 and older is expected to double to 2. 1 billion. Therefore, the aging population is a significant driver for the specialty generic market.
Major companies in the specialty generic market are obtaining approvals for medications like Lisdexamfetamine Dimesylate to address critical medical needs. Approval in specialty generics refers to the regulatory authorization granted to pharmaceutical products that are bioequivalent and therapeutically equivalent to brand-name specialty drugs. In August 2023, Mallinckrodt plc, an Ireland-based specialty pharmaceutical company, received FDA approval for Lisdexamfetamine Dimesylate Capsules in SpecGx LLC Specialty Generics segment to treat Attention-Deficit/Hyperactivity Disorder (ADHD). Lisdexamfetamine Dimesylate, a federally controlled substance (CII), is used for ADHD and other indications.
Major companies in the specialty generic market are introducing new products to offer more affordable alternatives. In March 2022, Teva Pharmaceutical Industries Ltd, an Israel-based pharmaceutical company, launched the first generic version of REVLIMID (lenalidomide) in the US, available in 5mg, 10mg, 15mg, and 25mg capsules. REVLIMID is prescribed for adults with multiple myeloma (MM) and is used either in combination with dexamethasone or as a maintenance treatment post-autologous hematopoietic stem cell transplantation.
In October 2022, Aspire Pharma, a UK-based pharmaceutical company, acquired Morningside Pharmaceuticals and Morningside Healthcare, including its subsidiaries like Morningside Healthcare (India), for an undisclosed amount. This strategic acquisition aims to expand Aspire Pharma's market position by combining complementary product portfolios, providing added talent, an increased in-market range, and an industry-leading pipeline, positioning the company as a premier specialty generic pharmaceutical organization.
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.
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. The countries covered in the specialty generics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Canada, Spain.
Specialty generics refer to generic versions of drugs designed to replicate expensive, intricate, or high-touch generic medications. Managing specialty generics requires substantial service participation. This category encompasses biologics and biosimilars, each with distinct regulatory routes. Specialty medications, in general, are commonly used to treat various conditions such as malignancies, rheumatoid arthritis, and multiple sclerosis.
Specialty generics are administered through various routes, including injectables, oral, and others. The injectables route involves diverse methods of drug administration such as intravenous, subcutaneous, intradermal, intraperitoneal, intramuscular, and others. This is applicable in the treatment of medical conditions ranging from cancer to autoimmune disorders. Drug injection typically involves the use of a hollow hypodermic needle to introduce a substance into the bloodstream. Specialty generics find applications in indications like oncology, autoimmune diseases, infectious diseases, and others. These medications are distributed through multiple channels, including retail pharmacies, specialty pharmacies, and hospital pharmacies.
The specialty generics market research report is one of a series of new reports that provides specialty generics market statistics, including specialty generics industry global market size, regional shares, competitors with a specialty generics market share, detailed specialty generics market segments, market trends and opportunities, and any further data you may need to thrive in the specialty generics industry. This specialty generics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The specialty generics market consists of sales of biologics and biosimilars. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 3-5 business days.
Table of Contents
1. Executive Summary2. Specialty Generics Market Characteristics3. Specialty Generics Market Trends and Strategies4. Specialty Generics Market - Macro Economic Scenario Including the Impact of Interest Rates, Inflation, Geopolitics, and the Recovery from COVID-19 on the Market32. Global Specialty Generics Market Competitive Benchmarking and Dashboard33. Key Mergers and Acquisitions in the Specialty Generics Market34. Recent Developments in the Specialty Generics Market
5. Global Specialty Generics Growth Analysis and Strategic Analysis Framework
6. Specialty Generics Market Segmentation
7. Specialty Generics Market Regional and Country Analysis
8. Asia-Pacific Specialty Generics Market
9. China Specialty Generics Market
10. India Specialty Generics Market
11. Japan Specialty Generics Market
12. Australia Specialty Generics Market
13. Indonesia Specialty Generics Market
14. South Korea Specialty Generics Market
15. Western Europe Specialty Generics Market
16. UK Specialty Generics Market
17. Germany Specialty Generics Market
18. France Specialty Generics Market
19. Italy Specialty Generics Market
20. Spain Specialty Generics Market
21. Eastern Europe Specialty Generics Market
22. Russia Specialty Generics Market
23. North America Specialty Generics Market
24. USA Specialty Generics Market
25. Canada Specialty Generics Market
26. South America Specialty Generics Market
27. Brazil Specialty Generics Market
28. Middle East Specialty Generics Market
29. Africa Specialty Generics Market
30. Specialty Generics Market Competitive Landscape and Company Profiles
31. Specialty Generics Market Other Major and Innovative Companies
35. Specialty Generics Market High Potential Countries, Segments and Strategies
36. Appendix
Executive Summary
Specialty Generics Global Market Report 2025 provides strategists, marketers and senior management with the critical information they need to assess the market.This report focuses on specialty generics market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
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Description
Where is the largest and fastest growing market for specialty generics? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The specialty generics market global report answers all these questions and many more.The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
- The market characteristics section of the report defines and explains the market.
- The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
- The forecasts are made after considering the major factors currently impacting the market. These include:
- The forecasts are made after considering the major factors currently impacting the market. These include the Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.
- Market segmentations break down the market into sub markets.
- The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth. It covers the growth trajectory of COVID-19 for all regions, key developed countries and major emerging markets.
- The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
- The trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.
Scope
Markets Covered:
1) by Route of Administration: Injectables; Oral; Other Route of Administration2) 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) Injectables2) by Oral: Tablets; Capsules; Liquid Formulations
3) by Other Route of Administration: Topical; Transdermal; Inhalation
Key Companies Mentioned: Teva Pharmaceutical Industries Ltd.; Endo International plc; Akorn Operating Company LLC; Mallinckrodt Pharmaceuticals; Dr. Reddy’s Laboratories Ltd.
Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Russia; South Korea; UK; USA; Canada; Italy; Spain
Regions: Asia-Pacific; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
Time Series: Five years historic and ten years forecast.
Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita.
Data Segmentation: Country and regional historic and forecast data, market share of competitors, market segments.
Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
Delivery Format: PDF, Word and Excel Data Dashboard.
Companies Mentioned
Some of the major companies featured in this Specialty Generics market report 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.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | February 2025 |
| Forecast Period | 2025 - 2029 |
| Estimated Market Value ( USD | $ 108.11 Billion |
| Forecasted Market Value ( USD | $ 189.72 Billion |
| Compound Annual Growth Rate | 15.1% |
| Regions Covered | Global |
| No. of Companies Mentioned | 29 |
