Generic Drugs Market To Witness Widespread Expansion During 2026

Generic Drugs Market To Witness Widespread
Expansion During 2026
Generic Drugs Market, By Drug Type (Monoclonal Antibodies, Cytokines,
Vaccines, Insulin, Peptide Hormone, Immunoglobulin, Peptide Antibiotics, Blood
Factors, and Others), By Therapeutic Application (Oncology, Cardiovascular
Diseases, Neurology, Infectious Diseases, Musculoskeletal Diseases, and
Others), By Route of Administration (Oral, Topical, Injectable, Intra-venous, and
Others), and By Geography- (North America, Latin America, Europe, Asia
Pacific, Middle East and Africa) - Global Industry Insights, Trends, Outlook, and
Opportunity Analysis, 2026
Generic drugs refers to medication that have the same active ingredient as that of a branded drugs.
These drugs also yield the same therapeutic effect and are prescribed in the same dosing, with the same
quality, and same the way of consumption and usage. However, the inactive ingredients of generic
drugs can differ as compared to their branded counter parts. These drugs are mainly marketed after a
patent expiry of a branded drug and are significantly lower in costs as compared to the patented
branded drugs. Generic drugs are of equivalent quality as compared to the branded drugs and are
manufactured under the same safety and manufacturing procedures. Various manufacturers submit an
abbreviated new drug application (ANDA) to the FDA after the completion of period of patent
exclusivity. Click To Read More On Generic Drugs Market.
Patent expiry of branded drugs is a factor expected to boost growth of the global generic drugs
market
Manufacturers of generic drugs are focusing on development and introduction of various innovative
medication and formulation such as biosimilars. According to IMS Health data, generic drugs
accounted for over 80% of the prescriptions dispensed in the U.S. in 2013. The number of patents
expiring in the near future serves to be a major driver for growth of generic drugs market. For instance,
Cetuximab (Erbitux) is an epidermal growth factor receptor inhibitor that is indicated in the treatment
of metastatic colorectal cancer and head and neck cancer. It is manufactured under the patent by
Bristol-Myers Squibb and Eli Lily Company in Europe. The drug’s patent expires in 2018 and thus, is
expected to provide opportunity for a large number of market players to manufacture its generic
version.
Furthermore, supportive initiative by FDA to promote development of biosimilars is encouraging
manufacturers to focus towards its development. For instance, the Biologics Price Competition and
Innovation Act in the U.S. gr ants 12 months patent exclusivity with higher profit margins to the first
manufacturer than the conventional generic manufacturers bringing the drugs in market later. Various
other factors contributing to growth of generic drugs market include rampant growth in incidence of
chronic diseases.
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New drug launches and market approvals from the U.S. FDA to generic manufacturers are bolstering
growth of the generic drugs market. For instance, in December 2017, Zydus Phamaceuticals — a
subsidiary of Cadila Healthcare — received U.S. FDA approval to market Pramipexole
Dihydrochloride extended-release tablets for the treatment of Parkinson ’s disease in the U.S. market.
Key players operating in the global generic drugs market are Teva Pharmaceutical Industries, Mylan
N.V., Novartis International AG, Pfizer, Inc., Allergan Plc, Sun Pharmaceuticals, Fresenius Kabi,
Sanofi, Endo International, Lupin Ltd., Abbott Healthcare, AstraZeneca Plc, and Novo Nordisk.
Asia Pacific to gain significant traction in the global generic drugs market owing to increasing
number of local players
On the basis of region, the global generic drugs market is segmented into North America, Latin
America, Europe, Asia Pacific, Middle East, and Africa. North America held a dominant position in the
global generic drugs market in 2016. This is attributed to favorable regulatory policies that are revised
and amended to encourage generic drugs business in the region. For instance, Generic Drug User Fee
Amendment (GDFUA) was reauthorized in 2017 after its initiation in 2012 by FDA for increasing
consumer access to high quality, safe, and affordable drugs.
On the other hand, Asia Pacific is expected to show a significant traction in the market over the forecast
period. This is attributed to lower manufacturing costs and high skilled workforce in the Asian
countries. According to India Brand Equity Foundation, India has the second largest number of U.S.
FDA manufacturing plants outside the U.S. that are involved in generic drugs manufacturing.
Additionally, the cost of manufacturing is 33% lower in India than that in the U.S., increasing
accessibility to generics in these countries.
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Generic drugs refers to medication that have the same active ingredient as that of a branded drugs. These drugs also yield the same therapeutic effect and are prescribed in the same dosing, with the same quality, and same the way of consumption and usage.

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