Specialty Generics Market: Adopting The Medication And Needs Of Aging Populations

Published Date : 06 Apr 2023

The total size of the specialty generics market was USD 75.12 billion in 2022, and it will hit USD 164.68 billion by 2032, at a CAGR of 8.17%.

The specialty generics market's growth is driven by the population aging, many branded specialty drugs' patents are about to expire, the prevalence of various life-threatening diseases like cancer, multiple sclerosis, HIV, etc. is rising, healthcare providers are taking steps to contain costs; emerging markets are growing, etc.

Market Overview:

"Specialty generics" are non-patent medications used to treat chronic or complicated medical disorders. These medications frequently require prior authorization before being ordered and may require special administration, monitoring, or handling. The number of elderly people increased from 1 billion in 2020 to 1.4 billion in 2021, according to the World Health Organization (WHO). One in six people on the planet will be 60 or older by the year 2030.

The rapidly growing geriatric population will most likely offer profitable expansion opportunities. Major pharmaceutical companies have taken part in mergers and acquisitions to increase their market share. To prevent suppliers from making money off of generic products, the FDA is also putting more pressure on them to follow GMP. This is considered to be the main barrier preventing the global expansion of the specialty generics industry.

Specialty Generics Market Report Scope:

Report Coverage Details
Market Size in 2022 USD 75.12 Billion
Projected Forecast Value in 2032 USD 164.68 Billion
Growth Rate 8.17% from 2023 to 2032
Largest Market North America
Base Year 2022
Forecast Period 2023 to 2032
By Type
  • Injectables
  • Oral drugs
  • Others
By Application
  • Oncology
  • Inflammatory Conditions
  • Multiple Sclerosis
  • Hepatitis C
  • Others
By End-Use
  • Specialty Pharmacy
  • Retail Pharmacy
  • Hospital Pharmacy
Regions Covered North America, Europe, Asia-Pacific, Latin America and Middle East & Africa

Report Highlight:

  • By Type: In 2022 the injectable segment generated more than 61% of revenue share and will maintain it’s dominance between 2023 and 2032. The advantages of injectables, such as their long-lasting effects and rapid absorption, which increase patient compliance and acceptance, are responsible for the segment's dominance. Furthermore, the injectable category is anticipated to grow at the fastest rate throughout the projection period due to rising product approval and greater market penetration.  For the treatment of patients with myelodysplastic syndrome and multiple myeloma in Canada, Dr. Reddy's Laboratories and Natco Pharma released a generic version of Revlimid, Nat-lenalidomide, and Reddy-lenalidomide in September 2021. Health Canada has approved this medication.
  • By Application: Due to the rising prevalence of inflammatory diseases like rheumatoid arthritis, the inflammatory conditions segment dominated the market and captured more than 28% of the revenue share in 2022. 350 million people are thought to have arthritis worldwide, according to the Global RA Network. Additionally, over 10 million people suffer from arthritis, according to the NHS. Significant corporations have been able to increase their market share in this industry as a result of the rise in the prevalence of inflammatory diseases. For instance, Dr.  Health Canada has given this drug the go-ahead to treat myelodysplastic syndrome and multiple myeloma in Canadian patients.
  • By End-Use: In 2022, the specialty pharmacy segment contributed more than 77% of the revenue share. It is anticipated that the market will expand profitably over the predicted time frame. Major specialty generic manufacturers and insurance companies choose specialty pharmacies for product distribution because they have low distribution costs and easy access to medications.  Additionally, specialty generic drug inventory costs less and provides a higher return on investment than branded goods. Specialty pharmacies draw customers and contribute to the market’s expansion by offering prompt delivery, maximizing patient access, and efficient distribution management.

Regional Insight:

In 2022, North America region led the market and recorded more than 37% of revenue share, as a result of favorable regulatory guidelines guiding the clearance of new pharmaceuticals. Several initiatives to streamline the overall approval process have been launched by the American FDA.

The U.S. FDA thus proposed the Generic Drug User Fee Amendments (GDUFA) to the Hatch-Waxman Act to speed up the distribution of low-cost, secure, and efficient generic medications to the general public.  For example, according to the National Center for Chronic Disease Prevention (CDC) and Health Promotion (January 2021), 6 in 10 adults in the United States have a chronic disease, and 4 in 10 adults have two or more chronic diseases. These conditions place a 3. 8 trillion USD annual burden on the nation's healthcare system, although generic drugs are much less expensive than other prescribed medications.

On the other hand, in Asia Pacific, it is anticipated that the market for specialty generics will expand quickly throughout forecasting. High, unmet low-cost medical demand and the introduction of new generic pharmaceuticals in the area are the main drivers of the region's growth. For the treatment of uncommon tumors like acute myeloid leukemia (AML), BDR Pharma released a generic version of midostaurin under the trade name MSTARIN in 2021.

According to research conducted by the International Institute for Population Sciences (IIPS), there were roughly 75 million chronically ill Indians over the age of 60 in January 2021. Around 20 million people worldwide suffer from cardiovascular disease, hypertension, and diabetes. Thus, as chronic diseases become more common in the country, there will be a greater demand for affordable treatments, which will drive the market under study.

Market Dynamics:


The market for generic medicines is being driven by the rising number of people with chronic diseases

Chronic diseases affect people of all ages worldwide. These chronic conditions are brought on by a confluence of psychological, genetic, environmental, and behavioral variables. The most common illnesses are non-communicable diseases (NCDs), which include diabetes, cancer, chronic respiratory conditions like COPD and asthma, and cardiovascular issues. Aging populations, rapid, unplanned urbanization, and the globalization of unhealthy lifestyles all contribute to the spread of these diseases. Long-term treatment is required because chronic condition medications are expensive to market.

As a result, more patients select generic versions of medications as the demand for pharmaceuticals rises over time. In the US, about 27.2% of people had several chronic diseases, compared to about 51.8% who had just one, according to the National Health Interview Survey (NHIS). WHO estimates that NCDs are responsible for 41 million deaths a year, or 71% of all fatalities worldwide. 17.9 million of these deaths are caused by cardiovascular disorders, followed by cancer at 9.3 million, respiratory diseases at 4.1 million, and diabetes at 1.5 million. Even though older age groups are typically affected by NCDs.


Concentrated despite the absence of individuals

Specialist generics face stronger market competition than standard generics since they have more complex production requirements, higher capital requirements, and typically lower volumes because of a smaller patient base.  As a result, there is a smaller price decline than with branded medication and higher profits than with regular generics. Specialized generic drugs frequently need special administration, handling, and monitoring, as well as prior authorization for ordering.


An increase in the demand for generic drugs

Throughout the past ten years, the global pharmaceutical market has experienced significant growth. The local pharmaceutical industry is becoming more alluring despite the ongoing political and economic unrest in some regions. Additionally, even though the original drugs dominated the market, new laws favoring generic drugs are being implemented globally. Health systems that receive media funding are under more pressure to reduce their steadily rising drug costs. The government is funding initiatives to rebalance the budget by providing more funding to patients and private health insurance. The ongoing increase in healthcare spending, which makes up a significant portion of a country’s GDP, is due to generic medication manufacturers offering high-quality products at competitive prices.

Recent Development:

  • In June 2020, Ilumya, a medication used to treat moderate to severe plaque psoriasis, was given exclusive licensing and distribution rights for the MEA region by Sun Pharmaceutical Industries Ltd. and Hikma Pharmaceuticals PLC.
  • In October 2021, A Pfizer-owned pharmaceutical production facility in Australia was bought by BioCena. In 2020, BioCena also completed the acquisition of Pfizer Inc., which was held by Hospira Adelaide. It is the top supplier of 200 specialized generic dermal fillers in the country.

Major Key Players:

  • Teva Pharmaceuticals Industries Ltd.
  • Viatris Inc.
  • Novartis AG (Sandoz International GmbH)
  • Hikma Pharmaceuticals PLC
  • Mallinckrodt
  • Bausch Health Companies Inc. (Valeant Pharmaceuticals International, Inc.)
  • Dr. Reddy’s Laboratories Ltd.
  • Endo Pharmaceuticals Inc.
  • Apotex Corp.
  • Sun Pharmaceutical Industries Ltd.
  • Fresenius Kabi Brasil Ltd.
  • STADA Arzneimittel AG

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