The global specialty generics market size was valued at USD 69.90 billion in 2022 and is expected to reach USD 148.72 billion by 2030, growing at a compounded annual growth rate (CAGR) of 9.9% from 2023 to 2030. The rising adoption of specialty generics for treating complex chronic diseases, such as hepatitis C, coupled with the increasing prevalence of such conditions, is a major driver of market growth.
According to the World Health Organization (WHO) 2022 report, around 58 million people globally live with chronic hepatitis C virus infection, with approximately 1.5 million new cases recorded annually. Age remains a significant risk factor for chronic diseases like arthritis, cardiovascular disorders, and cancer, as older populations face weakened immunity and higher rates of comorbidities.
The geriatric population is expanding rapidly. As per WHO, the global elderly population increased from 1 billion in 2020 to 1.4 billion in 2021, and by 2030, one in six people worldwide will be aged 60 years or older. This demographic shift is expected to create substantial opportunities for specialty generics.
Market players are actively pursuing mergers and acquisitions to strengthen their presence. For instance, in October 2021, BioCena acquired a Pfizer-owned plant in Australia to manufacture drug therapies. Earlier, in 2020, BioCena completed the acquisition of Hospira Adelaide (owned by Pfizer Inc.), a key supplier of over 200 specialty injectable generics in the U.S. Such strategic initiatives are anticipated to enhance product availability and support market expansion.
However, factors such as strong brand loyalty, the complexity of developing specialty generics, and lower profit margins pose challenges for new entrants. These barriers often contribute to higher drug prices. For example, Teva Pharmaceutical Industries Ltd. offers smart co-pay cards for multiple sclerosis (MS) patients purchasing COPAXONE, enabling eligible patients to access treatment at zero cost. Such branded programs increase customer retention for original drugs, thereby restraining the growth of specialty generics.
Key Market Trends & Insights
- North America dominated the market with a share of 36.3% in 2022.
- By type, the injectables segment held the highest share at 64.2% in 2022.
- By application, the inflammatory conditions segment accounted for a 27.47% revenue share in 2022.
- By end-use, the specialty pharmacy segment led the market with a 76.87% revenue share in 2022.
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Market Performance
- 2022 Market Size: USD 69.90 Billion
- 2030 Projected Market Size: USD 148.72 Billion
- CAGR (2023–2030): 9.9%
- North America: Largest market in 2022
- Asia Pacific: Fastest-growing market
Competitive Landscape
Market players are increasingly focusing on regional expansion, product innovation, and partnerships. For example, in June 2020, Sun Pharmaceutical Industries Ltd. and Hikma Pharmaceuticals PLC entered into an exclusive licensing and distribution agreement for Ilumya in the MEA region, expanding access to affordable and effective specialty generic treatments for moderate to severe plaque psoriasis.
Key Companies
- Teva Pharmaceutical 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.
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Conclusion
The specialty generics market is positioned for strong growth, driven by the rising burden of chronic diseases, expanding geriatric populations, and strategic initiatives by leading pharmaceutical companies. Despite challenges related to brand loyalty and profitability, the demand for affordable, effective, and accessible treatment options ensures that specialty generics will play an increasingly vital role in the global healthcare landscape.
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