Specialty Generics Market Size, Share & Industry 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, 2024-2032

The global specialty generics market size was valued at USD 76.65 billion in 2023 and is projected to grow from USD 86.86 billion in 2024 to USD 274.76 billion by 2032, exhibiting a CAGR of 15.5% during the forecast period (2024-2032). 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.

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.

Specialty Generics Market Trends

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.

Specialty Generics Market Growth Factors

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.

RESTRAINING FACTORS

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.

In addition, several reasons may limit the use of generic medicines, including misconceptions about the quality, lack of access to more accurate information about these medicines, and lower prescription rates of generic medicines by physicians.

• For instance, as per the data published by Medkart Pharmacy in August 2023, several pharmaceutical companies were engaged in heavy marketing and advertising of their brand-name drugs, which can lead to greater awareness and preference for these medicines over their generic alternatives.

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

Specialty Generics Market Segmentation Analysis

By Route of Administration Analysis

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 generated the highest revenue in 2023. 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 2024, BDR Pharmaceuticals introduced the prostate cancer drug enzalutamide in the form of an oral solution. This “formulation provides an effective dosage form with lesser side effects in comparison to existing oral dosage forms of enzalutamide.”

• Also, 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. Due to the advantages associated with injectable drugs, several companies are focusing on receiving regulatory approvals and launches of injectables.

• For instance, in July 2023, Amneal Pharmaceuticals, Inc. announced that it had received the U.S. FDA's approval for its five complex generics. Out of the five drugs, three drugs belong to the category of injectables.

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 market revenue share in 2023. The segmental growth is due to increasing number of generic drugs for treating cancer and growing demand for effective cancer treatment therapies. Moreover, generic drugs are essential in oncology as some anticancer drugs are only available as generics.

• 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 2023. 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.

REGIONAL INSIGHTS

North America accounted for a significant specialty generics market share with a revenue of USD 41 billion in 2023. 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 share in 2023 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.

• For instance, as per the data published by Niti Aayog in 2021, India has around 60,000 generic brands across 60 therapeutic categories. The country is the world’s largest provider of generic medicines, accounting for 20% of the global generic drug exports (in terms of volume).

List of Key Companies in Specialty Generics Market

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 2023. The leading position of these companies is mainly attributed to strong product offerings, including specialty generics.

Sun Pharmaceutical Industries, Ltd. and Amneal Pharmaceuticals LLC held significant market shares in 2023. 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 share of the market in 2023. 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.

LIST OF KEY COMPANIES PROFILED:

• Teva Pharmaceuticals USA, Inc. (U.S.)


• Hikma Pharmaceuticals PLC (U.K.)


• Mallinckrodt (U.K.)


• Amneal Pharmaceuticals LLC (U.S.)


• Viatris Inc. (U.S.)


• Sun Pharmaceutical Industries, Ltd. (India)


• Endo Pharmaceuticals Inc. (U.S.)


• Lupin (India)


• Dr. Reddy’s Laboratories, Ltd. (India)


• Novartis AG (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• April 2023- Endo International plc announced the launch of a generic version of Noxafil (posaconazole) oral suspension for the treatment of oropharyngeal candidiasis.


• January 2023- BDR Pharmaceutical announced the launch of a generic version of Apalutamide, used in the treatment of prostate cancer, in India. The drug was launched under the brand APATIDE in India.


• November 2022- The JAMP Pharma Group, a Canadian pharmaceutical company, announce the launch of PrJAMP Apremilast, a generic alternative to Amgen’s reference product, Otezla. This product is used for the treatment of adult patients suffering from moderate-to-severe plaque psoriasis.


• 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.

REPORT COVERAGE

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, and specialty generics market trends. The report consists of quantitative and qualitative insights that contribute to the market growth.

Report Scope & Segmentation

ATTRIBUTE	DETAILS
Study Period	2019-2032
Base Year	2023
Estimated Year	2024
Forecast Period	2024-2032
Historical Period	2019-2022
Growth Rate	CAGR of 15.5% from 2024-2032
Unit	Value (USD Billion)
Segmentation	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 (By Route of Administration, By Indication, By Distribution Channel, and By Country) U.S. Canada Europe (By Route of Administration, By Indication, By Distribution Channel, and By Country/Sub-Region) Germany U.K. France Italy Spain Scandinavia Rest of Europe Asia Pacific (By Route of Administration, By Indication, By Distribution Channel, and By Country/Sub-Region) India China Japan Australia Southeast Asia Rest of Asia Pacific Rest of the World ( By Route of Administration, By Indication, and By Distribution Channel)