Number of pages: 100 | Report Format: PDF | Published date: June 23, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
Report Attribute |
Details |
Market Size Value in 2022 |
US$ 68.3 billion |
Revenue Forecast in 2031 |
US$ 168.80 billion |
CAGR |
10.2% |
Base Year for Estimation |
2022 |
Forecast Period |
2023 to 2031 |
Historical Year |
2021 |
Segments Covered |
Route of Administration, Indication, Distribution Channel, and Region |
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global specialist generics market was valued at US$ 68.3 billion in 2022 and is expected to register a revenue CAGR of 10.2% to reach US$ 168.80 billion by 2031.
Specialty Generics Market Fundamentals
Specialty generic medications are more specialized and frequently call for specific administration, handling, or monitoring as opposed to ordinary generic medicines, imitations of name-brand medications with lapsed patents. Due to their complicated manufacturing procedures, significant expenses associated with research and development, and small patient populations, specialty generics frequently have high drug costs. They can be costly for people and healthcare systems since they are sometimes more expensive than conventional generic medications. Instead of oral pills or capsules, they may need delivery techniques, such as injections, infusions, or specialized devices. This could involve patient education or help from medical personnel.
Numerous specialized generics need rigorous monitoring of treatment responses and potential issues or adverse effects. They can need certain storage conditions, such as refrigeration or light protection. Specialty generics could also have a short shelf life to maintain their integrity and efficacy.
Specialty Generics Market Dynamics
One of the main factors driving the market is the rising use of specialty generic medications to treat complicated chronic illnesses like hepatitis C and their rising prevalence. Globally, around 58 million individuals are infected with the chronic hepatitis C virus, and each year, 1.5 million people are impacted by this illness, according to a World Health Organization (WHO) study from 2022.
Due to weakened immunity and a high incidence of comorbid disorders, aging is a key risk factor for the increased prevalence of complicated chronic diseases, including cancer, cardiovascular diseases, and arthritis. The number of older adults grew from 1 billion in 2020 to 1.4 billion in 2021, according to the World Health Organization (WHO). One in six people will be 60 or older by 2030. Consequently, it is anticipated that the market will see lucrative growth due to the fast-increasing elderly population. Major pharmaceutical corporations have engaged in mergers and acquisitions to increase their market share. In October 2021, BioCina purchased the Australian medication manufacturing facility from Hospira Adelaide - Pfizer. It is the nation's top provider of 200 specialty generic injectables. Over the projected period, such strategic initiatives are predicted to fuel market expansion.
As suppliers and patients seek methods to save healthcare costs, the demand for specialty generics is expanding globally. To ensure that patients who require sophisticated generic medicines have access to them, several well-known market participants are concentrating on releasing generic versions of medications. For instance, Teva Pharmaceuticals, Inc. introduced Revlimid (capsules containing lenalidomide) in the United States in March 2022. To treat multiple myeloma in adults, the first generic version of Revlimid was introduced in strengths of 5mg, 10mg, 15mg, and 25mg. The lower cost and quicker production times for these medications are major factors encouraging pharmaceutical corporations to concentrate on generics.
Additionally, the market expansion is anticipated to be fueled by pharmaceuticals approaching patent expiry since they present considerable growth prospects for generic makers. Introducing injectable generic medications is projected to fuel the expansion during the projection period. For example, Adalvo completed marketing authorization in the European Union for its generic version of Firazyr (icatibant injectable), licensed for acute attacks in people with hereditary angioedema (HAE). As a result, the demand for generic injectables is predicted to rise shortly.
Specialty Generics Market Ecosystem
The global specialty generics market is analyzed from the following perspectives by route of administration, indication, distribution channel, and region.
Specialty Generics Market Route of Administration
Based on the route of administration, the global specialty generics market is segmented into injectables, oral drugs, and others.
The global specialty generics market was dominated by the injectables segment in 2022, accounting for 60% of the total market. The advantages of injectables, such as quick absorption and long-lasting effects, which increase patient compliance and acceptance, can be credited for the segment's domination. Furthermore, due to increased product approval and greater market penetration, the injectables category is anticipated to grow at the quickest rate throughout the projection period. For instance, a generic version of Revlimid called Nat-lenalidomide & Reddy-lenalidomide, which Health Canada authorized for the treatment of patients with myelodysplastic syndrome and multiple myeloma in Canada was released in September 2021 by Dr. Reddy's Laboratories in collaboration with Natco Pharma. This clearance makes it simple for cancer patients to obtain affordable specialized generic medications, increasing the prescription rate.
Specialty Generics Market by Indication
Based on the indication, the global specialty generics market is segmented into oncology, inflammatory conditions, multiple sclerosis, hepatitis c, and others.
The oncology segment had the largest revenue share in 2022. The segmental increase results from the rising demand for efficient cancer treatment techniques and the expanding availability of generic cancer medications. For instance, Sun Pharmaceutical Industries Ltd. introduced the generic version of Palbociclib, a breast cancer treatment from Pfizer, in India in January 2023. The segment growth results from the rising demand for efficient cancer treatment techniques and the expanding availability of generic cancer medications.
The infectious illnesses segment is also anticipated to expand at a sizable CAGR throughout the forecast period. The prevalence of infectious diseases, including Hepatitis, HIV, and other ailments, is expected to rise, accelerating the segment growth. The Joint United Nations Program on HIV/AIDS (UNAIDS) estimated that 38.4 million individuals worldwide had HIV in 2021. Furthermore, the market for autoimmune illnesses is anticipated to expand significantly throughout this period due to the increasing global incidence of autoimmune diseases. For instance, the National Stem Cell Foundation (NSCF) reported in 2022 that there are about 80 different types of autoimmune diseases and that 4.0% of the world's population has at least one or more of these conditions, including type 1 diabetes, rheumatoid arthritis, and multiple sclerosis.
Specialty Generics Market by Distribution Channel
Based on the distribution channel, the globalspecialty generics market is segmented into specialty pharmacy, retail pharmacy, and hospital pharmacy.
With a revenue share of 74.56% in 2022, the specialty pharmacy sector led the market and is anticipated to develop profitably during the forecast years. Due to low distribution costs and convenient medication access, major specialty generic manufacturers and insurance companies select specialty pharmacies to distribute their goods. The top five specialty pharmacies worldwide, according to the Drug Channels Institute's study for 2021, were CVS specialty, Accredo, Optum specialty pharmacy, Walgreens shops, and Humana specialty pharmacy.
Specialty Generics Market by Region
Based on the region, the global specialty generics market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America held most of the market with a share of 33.0% in 2022. The region has strong regulatory frameworks that are receptive to the approval of new drugs. The U.S. FDA has launched several attempts to streamline the entire approval procedure. Thus, the U.S. FDA introduced the Hatch-Waxman Act's Generic Drug User Fee Amendments (GDUFA) to speed up the distribution of affordable, safe, and effective generic medications to the general population. Therefore, the major producers continuously work to commercialize specialty generic medicines on the market. Amneal Pharmaceuticals Inc. introduced LYVISPAH (baclofen) in June 2022. The U.S. FDA authorized LYVISPAH to treat multiple sclerosis and other spinal cord illnesses.
The market in Europe held a sizeable portion of global sales, and this trend is anticipated to continue. The favorable regulatory rules governing the clearance and introduction of new generic medications in the region are to blame for the expansion of the market in the area. For instance, Neuraxpharm Group introduced its first CNS-related drugs in the United Kingdom in July 2019. The business intended to introduce specialty and differentiated generics in the U.K., which accounted for a sizeable portion of the market for CNS medications in Europe. During the forecast period, a significant revenue CAGR is expected for the Asia Pacific market. The market is anticipated to expand due to the expansion of biopharmaceutical businesses in China and India.
Specialty Generics Market Competitive Landscape
Some of the prominent players in the global specialty generics market include,
Specialty Generics Market Strategic Development
Specialty generics are generic versions of specialty drugs, post-patent expiry.
The estimated size of the specialty generics market in 2031 is US$ 163.80 billion.
The revenue CAGR of the specialty generics market during the forecast period is 10.6%.
Some prominent global specialty generics market players include Teva Pharmaceuticals Industries Ltd, Sun Pharmaceutical Industries Ltd, and Endo Pharmaceuticals Inc.
The oncology indication segment led the global specialty generics market.
*Insights on financial performance are subject to the availability of information in the public domain