The global generic drugs market reached a value of US$ 340 Billion in 2018, registering a CAGR of 6.6% during 2011-2018. A generic drug is a medicine that contains the same active ingredient and has an equivalent therapeutic effect as the branded drug. It is also identical in terms of safety, quality, dosage, strength, route of administration, intended use, effect, form, quality and side effects. These medications can be produced only after the patent expiration of the brand-name drug. As compared to branded drugs, the production of generics costs much less as it does not require the repetition of clinical (human) and animal studies to demonstrate the effectiveness and safety of the medicine. Due to a reduction in the upfront cost of research, generics are typically sold at a substantially lower price in the market.
Due to an aging population and increasing incidences of chronic diseases, governments of developed countries have been making efforts to reduce healthcare costs by promoting the production of generics. Whereas, in developing countries, affordability and accessibility are some of the primary issues faced by the healthcare industry. To address these problems, governments and other regulatory bodies have been encouraging manufacturers to introduce effective generic drugs. However, despite the rapid patent expiry of branded drugs, there has been a shortage of generics. This situation is currently being rectified by various initiatives taken by hospitals, institutions and other organizations across the globe. For instance, in 2018, a coalition of seven hospitals and three philanthropies in the US announced that they would be addressing drug shortages and the high cost of essential medications by launching a generic drug company, named Civica Rx. The company is producing 14 short-supply, FDA-approved drugs that have been available in the market since the beginning of 2019. Other than this, in 2018, the United States Food and Drug Administration (USFDA) created policies to make the process of market entry and generic approval more efficient. It issued guidance documents for the development of both hard-to-copy drug categories and specific complex drugs. Owing to the aforementioned factors, IMARC Group expects the market to reach US$ 475 Billion by 2024, growing at a CAGR of 5.3% during 2019-2024.
Breakup by Therapy Area:
Cardiovascular diseases (CVDs) are the leading therapy area, accounting for the majority of the total market, on account of the increasing cases of CVDs as a result of unhealthy eating habits and sedentary lifestyles.
Breakup by Drug Delivery:
Currently, oral medicines are the most preferred product, owing to the convenience attached to their administration, which requires minimal to no medical assistance.
Breakup by Distribution Channel:
At present, the majority of the generics are distributed through retail pharmacy stores as most generic drugs are over the counter (OTC) medicines that can be bought without a prescription.
On a regional basis, the United States represents the biggest market, accounting for the largest market share. This growth is led by numerous initiatives by the US Government to improve generic drug manufacturing and access in the country.
The market is fragmented in nature with the presence of various small and large manufacturers. Some of the leading players operating in the market include Teva Pharmaceuticals Industries Ltd., Mylan N.V., Novartis AG, Pfizer Inc., Sun Pharmaceutical Industries Ltd., Fresenius SE & Co., Lupin Limited, Endo Pharmaceuticals Inc., Aurobindo Pharma Limited, and Aspen Pharmacare Holdings Limited.
Key Questions Answered in This Report:
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