Seattle, WA -- (SBWIRE) -- 09/24/2019 -- Generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. The effect of these drugs is identical to that of the original drug. Generic drugs are prescribed in the same dosing and also have the same route of administration as the original drug. However, the inactive ingredients of generic drugs can be different from those in the branded drugs. A manufacture can market a generic drug when the patent of the original drug is expired. Generic drugs as cheaper than patented branded drugs. These drugs are manufactured under the same safety and manufacturing procedures as the branded drugs. Manufacturers can submit an abbreviated new drug application (ANDA) to the U.S. FDA after the completion of period of patent exclusivity.
Key players in the market focus on development and launch of biosimilars. According to IMS Health data, generic drugs accounted for over 80% of the prescriptions dispensed in the U.S. in 2013. Increasing number of expiring patents in the near future is a major factor boosting growth of the 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. This is expected to offer lucrative opportunity for generic drug manufactures.
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Furthermore, various initiatives by government bodies for the development of biosimilars is also expected to boost the market growth. For instance, the Biologics Price Competition and Innovation Act in the U.S. grants 12 months patent exclusivity with higher profit margins to the first manufacturer than the conventional generic manufacturers bringing the drugs in market later. High prevalence of chronic diseases is also a factor aiding in growth of the market.
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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Market Taxonomy
The global generic drugs market is segmented on the basis of drug type, therapeutic application, route of administration, and region.
On the basis of Drug Type:
Monoclonal Antibodies
Cytokines
Vaccines
Insulin
Peptide Hormones
Immunoglobulin
Peptide Antibiotics
Blood Factors
Others
On the basis of Therapeutic Application:
Oncology
Cardiovascular Diseases
Neurology
Infectious Diseases
Musculoskeletal Diseases
Others
Based on Route of Administration:
Oral
Topical
Injectable
Intra-venous
Others
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.
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