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.
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. However, shortage of active pharmaceutical ingredients leading to unavailability of generics in the market and increasing FDA pressure on manufacturers regarding manufacturing quality of these drugs are hindering the market growth.
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, the global generic drugs market is segmented into:
- Monoclonal Antibodies
- Peptide Hormones
- Peptide Antibiotics
- Blood Factors
On the basis of Therapeutic Application, the global generic drugs market is segmented into:
- Cardiovascular Diseases
- Infectious Diseases
- Musculoskeletal Diseases
Based on Route of Administration, the global generic drugs market is segmented into:
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.
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.