U.S. Specialty Generics Market Size, Share & Industry Analysis, By Route of Administration (Injectable, Oral, and Others), By Indication (Cancer, Cardiovascular Diseases, Autoimmune Diseases, Infectious Diseases, and Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Country Forecast, 2024-2032

The U.S. specialty generics market size was worth USD 38.70 billion in 2023 and is projected to grow at a CAGR of 15.3% during the forecast period. 

Specialty generics are generic versions of specialty branded drugs once they lose their patent protection. They treat complex, chronic, or life-threatening diseases, such as cancer, rheumatoid arthritis, HIV, and multiple sclerosis. Factors, such as the increasing number of patent expirations and rising prevalence of above-mentioned diseases are projected to drive the U.S. specialty generics market growth over the forecast period.

• For instance, as per data from the U.S. Centers for Disease Control and Prevention (CDC), in 2020, 1.60 billion new cancer cases were reported, and it is projected to grow to around 1.95 billion by the end of 2023.

Furthermore, the development of innovative distribution channels, such as telemedicine platforms and online pharmacies has also driven the specialty generics market progress. In addition, increasing focus of governments and insurance companies on incentivizing or mandating the prescription of generics when they are available is anticipated to boost the product’s demand.

The impact of the COVID-19 pandemic slowed the growth of the market in 2020 as clinical studies were put on hold due to lockdown restrictions.

U.S. Specialty Generics Market Trends

Increased Approvals for Injectable Generic Drugs

Several initiatives have been undertaken by various agencies to deliver safe and effective low-cost generic drugs to the public. In addition, key players are constantly making efforts to commercialize specialty generic drugs in the market. They are highly focused on expanding their geographical presence and product portfolio with the help of innovations. Thus, these players are receiving FDA approvals for their products.

• For instance, in July 2023, Amneal Pharmaceuticals, Inc. announced the U.S. FDA approval for five of its complex generic products. Out of these, three recently approved products are injectables, including the dexmedetomidine injection.

The increasing product approvals provides easy access to low-cost specialty generic drugs to cancer patients, thereby increasing the prescription rate.

U.S. Specialty Generics Market Growth Factors

High Burden of Chronic Diseases and Rising Geriatric Population to Fuel Demand for Specialty Generics

Specialty generics are low-cost and do not incur development and marketing costs. The increasing adoption of specialty generic drugs among the population to treat chronic diseases and their increasing availability are some of the crucial drivers for the market growth.

• For instance, according to data published by the CDC and Health Promotion, in January 2021, 6 in 10 adults suffered from chronic diseases in the U.S., and 4 in 10 adults had two or more chronic diseases.

Moreover, the growing geriatric population is a significant factor in the rising prevalence of chronic diseases due to weak immunity and high incidence of comorbid conditions, such as diabetes, high blood pressure, arthritis, cardiovascular disease, stroke, and other malignant illnesses. For these patients, specialty generics are used to treat such chronic diseases. The above-mentioned factors are projected to drive the growth of the U.S. specialty generics market over the forecast period.

The adult population above 50 years of age with at least one chronic disease is estimated to increase by 99.5% from 71.52 million in 2020 to 142.66 million by 2050.

RESTRAINING FACTORS

Complex Development Process of Specialty Generics

Simple generics usually have a clear development process that has proper guidelines from the FDA Office of Generic Drugs (OGD) explaining the data requirement and endpoints for U.S. approval. Companies are less likely to find regulatory guidance in complex generics, which adds risk and uncertainty to the planning and design process. Having a clear regulatory strategy that leads to product approval is crucial for specialty generics. Thus, this factor can hamper the growth of the U.S. specialty generics market share to a certain extent.

U.S. Specialty Generics Market Segmentation Analysis

By Route of Administration Analysis

Based on route of administration, the U.S. specialty generics market is segmented into injectable, oral, and others.

The oral segment held a larger market share in 2022. The market players are focused on launching oral drugs owing to their convenience in consumption. Moreover, oral drugs are self-administered and pain-free, this is responsible for the segment’s dominance in the market.

• In July 2023, Amneal Pharmaceuticals, Inc. announced the launch of its authorized generic for Xyrem1 (Sodium Oxybate) oral solution CIII in the United States for the treatment of hypersomnia in patients with narcolepsy.

By Indication Analysis

Based on indication, the market is segmented into cancer, cardiovascular diseases, autoimmune diseases, infectious diseases, and others.

The cancer segment held the largest market share in 2022 owing to the growing number of generic drug launches for cancer treatment and increase in cancer cases. The growth in these cases is attributed to high alcohol consumption, smoking, and adoption of western lifestyle, physical inactivity, and poor diet choices. As the number of cancer cases rises, the demand for specialty generics is expected to increase.

• For instance, in March 2022, Teva Pharmaceuticals USA, Inc. announced the launch of the first generic version of Revlimid (lenalidomide capsules), in the U.S. to treat multiple myeloma.

Moreover, the infectious diseases segment is projected to record a significant CAGR during the forecast period owing to the growing prevalence of infectious diseases, such as Hepatitis, HIV, and other conditions.

By Distribution Channel Analysis

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

The hospital pharmacies segment held the largest market share in 2022 owing to increasing prescription of medications at hospitals. In addition, effective distribution management and easy access to medicines at these pharmacies are driving the segment’s growth.

• For instance, according to the data published by the NCBI, the overall spending on prescription drugs in clinics and hospitals increased from 7% to 9% and 3% to 5%, respectively in 2022, compared to 2021.

The online pharmacies segment is projected to expand at a rapid CAGR due to the ease and convenience these stores offer. Furthermore, increasing use of e-prescriptions by healthcare settings to purchase drugs through online phramacies is projected to boost the segment’s growth in the future.

List of Key Companies in U.S. Specialty Generics Market

The U.S. specialty generics market is fragmented and consists of several key players in terms of the competitive landscape. Teva Pharmaceuticals USA, Inc. and Viatris, Inc. are the prominent players in this market. Their dominance is mainly attributed to their broad product portfolios and strong brand presence.

Other companies, such as Mallinckrodt, Amneal Pharmaceuticals LLC, Viatris Inc., Endo Pharmaceuticals Inc., Novartis AG, Pfizer Inc., and Baxter have a considerable presence in the U.S. market. These firms are focused on launching effective specialty generic drugs for people with unmet treatment needs. For instance, Amneal Pharmaceuticals, Inc. announced the launch of 26 new generic products in 2022.

LIST OF KEY COMPANIES PROFILED:

• Teva Pharmaceutical Industries Ltd. (Israel)


• Hikma Pharmaceuticals PLC (U.K.)


• Mallinckrodt (U.K.)


• Amneal Pharmaceuticals LLC (U.S.)


• Viatris Inc. (U.S.)


• Endo Pharmaceuticals Inc. (U.S.)


• Novartis AG (U.S.)


• Pfizer Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• June 2023 – Sun Pharmaceutical Industries Ltd. increased its R&D investment in the specialty generics segment. The company’s current pipeline for generics products for the U.S. market includes 97 ANDAs, while 13 new drug applications are waiting for the U.S. FDA's approval.


• July 2022 – Elixir, a pharmacy services provider and subsidiary of Rite Aid Corp., launched a specialty generic medication to enhance its managed copay solutions.


• January 2021 – Teva Pharmaceutical Inc. announced the launch of a generic version of NuvaRing to prevent pregnancy in women.

REPORT COVERAGE

The report provides a detailed analysis of the market. It focuses on key aspects, such as an overview of the prevalence of major chronic diseases, regulatory framework for specialty generics, and new product launches.  Additionally, it includes key industry developments, such as mergers, partnerships, acquisitions, and the impact of COVID-19 on the market. Besides this, the report also offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, it encompasses several factors that have contributed to the growth of the market in recent years.

Report Scope & Segmentation