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Specialty Generics Market Size, Share & COVID-19 Impact Analysis, By Route of Administration (Injectable, Oral, and Others), By Indication (Oncology, Cardiovascular, Autoimmune Diseases, Infectious Diseases, and Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Regional Forecast, 2023-2030

Region : Global | Format: PDF | Report ID: FBI107533



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The global specialty generics market size was valued at USD 67.89 billion in 2022 and is projected to grow from USD 76.65 billion in 2023 to USD 200.80 billion by 2030, exhibiting a CAGR of 14.7% during the forecast period.

Specialty generics is a term used to refer to generic versions of specialty drugs once they get off-patent. These drugs are used to treat complex, chronic conditions such as cancer, multiple sclerosis, and rheumatoid arthritis. Specialty generics are low-cost drugs compared to branded versions as they require low development and marketing costs. The increasing adoption of specialty generic drugs for the abovementioned diseases and the growing prevalence of these diseases are major drivers for the market. For instance, according to data published by the Multiple Sclerosis International Federation (MSIF) in 2020, the number of people suffering from MS across the globe increased from 2.3 million in 2013 to 2.8 million in 2020. The number is expected to grow in the coming years.

Furthermore, the growing generic population and patent expiration of several branded specialty drugs are other factors influencing the global market growth.


Pandemic Decelerated the Market Growth Owing to Lockdown Restrictions

The effect of COVID-19 pandemic led to a slower growth of the market as numerous clinical trials and studies were halted after the major outbreak of the virus and lockdown restrictions in the manufacturing plants and shortage of skilled labor. Moreover, several pharmaceutical companies experienced a decline in their net sales in 2020 due to the impact of COVID-19.

  • For example, Mallinckrodt experienced a decline of -6.6% in this specialty generics segment in 2020 compared to 2019. The decline was driven primarily by increased competition and a change in product mix due to market shifts due to COVID-19.

On the contrary, the market recovered in the year 2021 compared to 2020 owing to mass vaccinations, ease in the lockdown restrictions, and growing demand for specialty medicines to treat chronic conditions.


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Increased Market Player's Emphasis on Mergers and Acquisitions to Expand their Presence in the Specialty Generics Market

Many pharmaceutical, biopharmaceutical, and medical device companies have increased their focus on expanding their market presence by emphasizing on mergers and acquisitions.

  • For instance, in July 2021, Lupin acquired Southern Cross Pharma Pty Ltd (SCP), the Melbourne-based generic drug manufacturer. This acquisition helped Lupin's Australia subsidiary gain access to over 60 registered products with sales of over USD 22.0 million, significantly increasing its Australia market share.

  • In June 2021, Nordic Capital acquired specialty pharmaceutical company ADVANZ PHARMA Corp. Limited. The acquisition strengthened ADVANZ PHARMA’s growth and broadened global choices for doctors and patients.

Such growing mergers and acquisitions will strengthen the healthcare systems while enhancing choice and access to critical medicines globally.


Increasing Cases of Chronic Diseases to Fuel the Demand for Specialty Generics

Increasing cases of various life-threatening diseases, including cancers, Multiple Sclerosis (MS), and HIV, has been increasing globally, which is anticipated to increase the adoption of specialty medicines globally.

  • For instance, as per the data published by Global RA Network in 2021, around 350 million people live with arthritis worldwide, and its burden is expected to grow in the near future.

  • In addition, as per the data published by Globocan in 2020, Europe held for 19.6% of cancer deaths and 22.8% of all cancer cases, demonstrating 9.7% of the global population.

Moreover, chronic disease is a problem primarily prone in emerging countries. Chronic diseases were the primary reason for mortality in five of the WHO's six regions. Contagious diseases, such as HIV and other conditions, are still predominant in Sub-Saharan Africa and are anticipated to prevail in the near future.

The market is expected to grow rapidly due to the high prevalence of life-threatening diseases during the forecast period.

Patent Expiration of Specialty Drugs has been fueling the Market Growth

The demand for specialty generics continues to grow worldwide as payers and consumers seek ways to cut healthcare costs. Various prominent players in the market are focused on launching generic versions of drugs to make complex generic medicines available to the patients who need them.

  • For instance, in March 2022, Teva Pharmaceuticals, Inc. launched Revlimid (lenalidomide capsules) in the U.S. Revlimid is the first generic version launched in 5mg, 10mg, 15mg, and 25mg strengths to treat multiple myeloma in adults.

A key aspect driving pharma companies to focus on generics is the lower cost and production time involved in these medicines. Moreover, expiring drugs create significant growth opportunities for generic manufacturers and are expected to drive the market's growth during the forecast period.


Lack of Awareness of these Drugs and Low Profitability Limit the Market Growth

High complex nature of specialty generic products, low profitability, and brand familiarity and loyalty are critical factors limiting the market's growth to a certain extent.  

Moreover, lack of awareness among common people about the availability of generic drugs at pharmacies is forcing them to spend more on branded drugs due to which people are facing the brunt of increasing healthcare costs.

These factors are expected to restrict the market’s growth during the forecast period.


By Route of Administration Analysis

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Growing Launches and Collaborations by Market Players have been Fueling the Growth of the Oral Segment

Based on route of administration, the market is divided into injectable, oral, and others.

The oral segment garnered the highest revenue in 2022. Oral generics are the most convenient, simplest, and safest route of administration. They are the most used and manufactured form of drugs owing to their convenience for repeated and prolonged use and can be self-administered and are pain-free. The market players are focused on these product launches responsible for the segment’s dominance in the market.

  • For instance, in January 2022, Endo International plc subsidiary Par Pharmaceutical, Inc. (Par) received FDA approval for its first generic version of Merz's CUVPOSA (glycopyrrolate) in the United States.

Furthermore, the injectable segment is projected to grow at a significant CAGR over the forecast period. The growth of the segment is mainly driven by long-term effects and immediate absorption characteristics, leading to higher patient compliance and acceptability.

Moreover, the other segment includes inhalers and patches, which is expected to grow at the fastest CAGR owing to increasing prevalence of chronic diseases globally.

By Indication Analysis

Oncology Segment is Expected to Dominate Owing to the Inadequate Presence for Effective Treatment of Cancer

Based on indication, the market is classified as oncology, cardiovascular, autoimmune diseases, infectious diseases, and others.

The oncology segment accounted for the highest revenue share in 2022. The segmental growth is due to increasing number of generic drugs for treating cancer and growing demand for effective cancer treatment therapies.

  • For instance, in January 2023, Sun Pharmaceutical Industries Ltd. launched the generic version of Pfizer's breast cancer medicine Palbociclib in India. 

Furthermore, the infectious diseases segment is expected to grow at a significant CAGR during the forecast period. The increase in the prevalence of infectious diseases, such as Hepatitis, HIV, and other conditions, is anticipated to enhance the segment's growth.

  • For instance, according to data published by the Joint United Nations Program on HIV/AIDS (UNAIDS), there were approximately 38.4 million people with HIV globally in 2021.

Moreover, due to the high global prevalence of autoimmune disease, the autoimmune diseases segment is expected to grow substantially during the forecast period.

  • For instance, as per the data published by National Stem Cell Foundation (NSCF) in 2022, there are around 80 different types of autoimmune diseases and around 4.0% of the total global population is affected by at least one of more of these diseases such as multiple sclerosis, rheumatoid arthritis, and type 1 diabetes.

By Distribution Channel Analysis

Ease and Convenience of Buying Specialty Drugs have been Fueling the Hospital Pharmacies Segment Growth

Based on distribution channel, the market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies.

The hospital pharmacies segment dominated the market with the highest revenue in 2022. The dominance was mainly attributed to increasing prescription of medications at hospitals due to more frequent diagnoses at these institutions.

Moreover, the online pharmacies segment is likely to expand with the highest CAGR due to its rising popularity along with ease and convenience. Nowadays, the surging use of e-prescriptions among healthcare settings to purchase drugs through online pharmacies is driving the segmental growth.


North America Specialty Generics Market Size, 2022 (USD Billion)

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North America accounted for a significant specialty generics market share with revenue of USD 36.33 billion in 2022. Pharmaceutical corporations are constantly making efforts to commercialize specialty drugs in the region. This has been driving the growth of the market in North America.

  • For instance, in June 2022, Amneal Pharmaceuticals, Inc. launched LYVISPAH, a baclofen oral granules (5, 10, and 20 mg) specialty product approved by the U.S. FDA for the treatment of multiple sclerosis and other spinal cord disorders.

The Europe market accounted for a considerable market share in 2022 and is projected to experience still growth. The growth of the market in the region is due to the supportive regulatory policies regarding the approval and launch of new generic drugs in the region.

  • For instance, in July 2019, Neuraxpharm Group launched its first products in the U.K. to treat the Central Nervous System (CNS). The company planned to launch differentiated and specialty generics within the U.K., which comprised 11% of the Europe market in CNS pharmaceuticals.

Moreover, the market in the region of Asia Pacific is anticipated to grow at a strong CAGR during the study period. The growth of biopharmaceutical companies in China and India is expected to propel the market in Asia Pacific.


Companies with a Strong Focus on the Expansion of Product Portfolio to Grab Significant Market Share

Teva Pharmaceutical Industries Ltd. and Viatris Inc. are the prominent key players, capturing a considerable global market share in 2022. The leading position of these companies is mainly attributed to strong product offerings, including specialty generics.

Sun Pharmaceutical Industries, Ltd. and Amneal Pharmaceuticals LLC had significant market shares in 2022. This is due to their strong emphasis on launching effective specialty generic medicines for people with unmet treatment needs.

  • For instance, in August 2022, Amneal Pharmaceuticals, Inc. received ANDA approval from the U.S. FDA for four generic products, including vasopressin injection 1mL (single-dose).

Similarly, Hikma Pharmaceuticals PLC held a substantial part in the market in the year 2022. This was due to the company’s robust brand presence and broad product portfolio.

Other various important players operating in the market, such as Mallinckrodt, Endo Pharmaceuticals Inc., and Lupin, accentuate various planned developments such as mergers, acquisitions, and product launches.



  • March 2022- Viatris Inc. announced receipt of the first FDA approval for a generic version of Symbicort Inhalation Aerosol, Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol), in partnership with Kindeva Drug Delivery L.P. for the treatment of chronic obstructive pulmonary disease (COPD).

  • January 2022- Lupin Limited partnered with the Chinese Shenzhen Foncoo Pharmaceutical Co., Ltd. The partnership aimed to sell complex generics and specialty medicines to China.

  • December 2021- Biocon Limited announced a partnership with Tabuk Pharmaceutical Manufacturing Company, a pharmaceutical company to commercialize its specialty generic medicines in the Middle East.

  • July 2021- Amneal Pharmaceuticals, Inc. received ANDA approval from the U.S. FDA for the generic version of TobraDex, strengthening the company’s generic portfolio.

  • April 2021- Amneal Pharmaceuticals LLC completed the acquisition of Kashiv BioSciences LLC. This acquisition has strengthened the Amneal Pharmaceuticals LLC product portfolio of branded and complex generic drugs.


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The market research report provides a detailed competitive landscape. It includes the number of specialty generics drugs and key industry developments such as partnerships, mergers, and acquisitions. Additionally, it focuses on key points such as new product launches in the market. Furthermore, the report covers regional analysis of different segments, company profiles of key market players, specialty generics market trends, and the impact of COVID-19 on the market. The report consists of quantitative and qualitative insights that contribute to the market growth.

Report Scope & Segmentation



Study Period


Base Year


Estimated Year


Forecast Period


Historical Period


Growth Rate

CAGR of 14.7% from 2023-2030


Value (USD Billion)


By Route of Administration, Indication, Distribution Channel, and Region

By Route of Administration

  • Injectable

  • Oral

  • Others

By Indication

  • Oncology

  • Cardiovascular

  • Autoimmune Diseases

  • Infectious Diseases

  • Others

By Distribution Channel

  • Hospital Pharmacies

  • Retail Pharmacies

  • Online Pharmacies

By Region

  • North America (U.S. and Canada)

  • Europe (U.K., Germany, France, Italy, Spain, Scandinavia, and Rest of Europe)

  • Asia Pacific (Japan, China, India, Australia, Southeast Asia, and Rest of Asia Pacific)

  • Rest of the World

Frequently Asked Questions

Fortune Business Insights says that the global market stood at USD 67.89 billion in 2022 and is projected to reach USD 200.80 billion by 2030.

The market is expected to exhibit a CAGR of 14.7% during the forecast period (2023-2030).

The oral segment is set to lead the market by route of administration.

The key factors driving the market are increasing prevalence of chronic diseases and growing number of patent expiration of specialty drugs.

Teva Pharmaceuticals USA, Inc., Viatris Inc., and Sun Pharmaceutical Industries, Ltd. are the top players in the market.

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