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 |
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| By Application |
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| By End-Use |
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| Regions Covered | North America, Europe, Asia-Pacific, Latin America and Middle East & Africa |
Report Highlight:
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:
Drivers:
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.
Restraints:
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.
Opportunities:
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:
Major Key Players:
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