The global specialty generic drugs market was valued at USD 63.83 billion in 2020 and is expected to grow at a CAGR of 25.3% during the forecast period. Specialty Generics drugs are the generic forms of pharmaceutical products. These drugs are economical when compared with branded pharmaceuticals. These drugs include complex molecules, biopharmaceuticals, and blood-derived products.
Companies are entering into this market to manufacture generic forms of the products by forming new drug formulations as several specialty drug molecules are approaching patent in the upcoming years. Additionally, the global capacity of the traditional generic drugs market is also forcing companies to seek newer opportunities. Nonetheless, the development and commercialization of specialty generics drugs are more critical when compared with conventional generics drugs.
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Healthcare expenses have increased due to costly pharmaceuticals products; therefore, governments are pressuring pharmaceutical manufacturers to produce cost-effective drugs. The rising prevalence of cancers is one of the major factors enhancing the global market growth. According to National Cancer Institute, approximately 16 million cancers are diagnosed every year in the U.S., leading to around half a million deaths due to various types of cancers.
In addition, specialty drugs patent expiries, payer’s pressures to reduce the drug prices, lack of generic drugs to treat complex diseases, and favorable reimbursement policies are other factors anticipated to bolster the demand for specialty generics drugs during the forecast period.
Augmentation in the number of off-patent specialty drugs is a factor estimated to propel the market growth significantly. North America is the highest spending region in healthcare, yet this region recently began cutting healthcare expenditure.
The current economic & financial crisis and the existence of a high geriatric population are some of the key reasons for the cost cut in healthcare infrastructure over this region. This creates the need for developing novel, enhanced, and economic methods for the production of specialty generics drugs. This factor is further anticipated to boost the global market over the forecast period.
The market is primarily segmented on the basis of application, route of administration, distribution channel, and region.
By Application |
By Route of Administration |
By Distribution Channel |
By Region |
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On the basis of route of administration, the global market is categorized into Oral, Parenteral, Topical, injectable, and Others. In 2020, the injectable segment is estimated for the largest market share majorly owing to benefits, such as long duration of action, immediate dose distribution, and quick absorption.
On the basis of application, the global market is segmented into Oncology, Infectious diseases, Multiple Sclerosis, Hepatitis C, and Others. Based on the application the oncology segment dominated the global market for specialty medicines in 2020.
Increased prevalence of cancer, such as melanoma, lung cancer, breast cancer, leukemia, prostate cancer, and colon cancer has directed to rise in demand for specialty medicines globally. According to the International Agency for Research on Cancer (IARC), in 2020, approximately 19.3 million cancer cases were diagnosed, and this number is projected to rise during the coming period.
On the basis of the distribution channel, the global market for specialty generic medicines is segmented into Retail Pharmacies, Hospital Pharmacies, and Online Pharmacies. In 2020, hospital pharmacy is estimated to share the major industry globally as these specialty medicines are highly compound, expensive, and required to be handled very carefully. Thus, these medicines are generally distributed by manufacturers through hospital pharmacies.
By geography, the global specialty generic drugs market is segmented into five major regions, North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. In 2020, North America dominated the industry with the largest share due to favorable healthcare developments by the government and strapping healthcare infrastructure in this region.
Furthermore, healthcare organizations, such as World Health Organizations (WHO), are widely involved in framing policies, such as the National Cancer Control Programs, which are anticipated to expand the growth in this region. Asia Pacific is anticipated to dominate the global industry during the forecast period.
The industry is driven by a rise in the prevalence of chronic diseases as well as the high demand for cost-effective generic medicines. In addition, a rise in per head income increases the prospect of usage of specialty generics, and continual up-gradation of healthcare infrastructure is recognized to provide the market with global growth opportunities over the forecast period.
Prominent players operating in the global specialty generic drugs market are Valeant Pharmaceuticals International Inc., Endo Pharmaceuticals Inc., Pfizer Inc., Mylan N.V., Teva Pharmaceuticals USA, Inc., Sandoz International GmbH, Mallinckrodt, Akorn Inc., Apotex Corp, and Sun Pharmaceutical Industries Ltd., among others.