The global branded generics market size was estimated at USD 229.06 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 5.7% from 2021 to 2030. The rising prevalence of chronic diseases, increasing penetration of branded generic drugs, increasing government initiatives to promote generic products, and patent expiry of major drugs are some of the primary industry growth drivers. The expiry of patent exclusivity of innovator drugs provides opportunities for generic manufacturers to introduce products at a reduced price. The low cost of generic drugs improves patients' affordability and helps reduce healthcare expenditure per capita. For instance, as the U.S. patent exclusivity period of Bristol-Myers Squibb Company proprietary Sprycel (Dasatinib) ended in 2020, generic companies such as Apotex and Dr. Reddy's Laboratories have filed ANDA for the launch of generic versions of the product.
Moreover, the high frequency of ANDA approvals and the launch of generic products is another crucial factor supporting market growth. According to the FDA’s annual report, in 2021, FDA approved 93 first generics, while the number was 72 in 2020. However, it can be observed that the number of ANDA approvals decreased from 1,014 in 2019 to 948 in 2020, and further decreased to 776 in 2021. Such a decrease in the trend of ANDA approvals for generic drugs could impede industry growth.
The market has been moderately impacted by the COVID-19 pandemic. During this period, a slowdown and disruption in the supply chain of pharmaceuticals was observed, due to the strategies designed to control the spread of the pandemic. In addition, regulatory operations were also affected, such as the authorization and the Health Technology Assessment process. Decisions on reimbursements have been de-prioritized. It also affected drug prescription and uptake rate moderately.
For instance, in the U.K., according to the NHS, approximately 20 million antidepressant medications were prescribed in March 2021; in January 2021, the number was around 20.5 million. However, the impact of COVID-19 reduced significantly by the end of 2020 in most countries. Whereas in some countries affected by the third wave of COVID-19, the effect lasted until the third quarter of 2021.
The growing burden of non-infectious & infectious diseases and the increasing geriatric population, which is more susceptible to chronic diseases, such as hypertension, diabetes, and obesity, are anticipated to positively impact the market growth. There were 537 million patients suffering from diabetes in 2021 globally. The prevalence rate of diabetes is growing rapidly in low- and middle-income countries. According to the International Diabetes Federation data for 2021, approximately 643 million people will be suffering from diabetes by 2030 and 783 million by 2045.
Companies are introducing novel products to strengthen their portfolio. For instance, in April 2020, Dr. Reddy's Laboratories Ltd. introduced Invista in India. This product is the branded generic version of Sprycel (dasatinib) indicated for the treatment of adult patients with Chronic Myeloid Leukemia (CML).
The anti-hypertensive segment dominated the marketspace in 2021 with a revenue share of 15.67%, due to the rising ANDA approvals and product launches over the past few years. For instance, in June 2019, Teva Pharmaceuticals Industries Ltd. and Hikma Pharmaceuticals PLC introduced the generic version of Tracleer in the U.S.
The hormones segment is anticipated to expand at a high growth rate through the projection period, due to rising investments to develop value-added or complex generics. An increasingly sedentary lifestyle is driving the prevalence of various metabolic disorders. Hormonal imbalance is a growing concern in a majority of the countries. These disorders include thyroid and sex hormone imbalance.
The oncology segment is projected to advance at the fastest CAGR of 6.2% by 2030, due to the patent expiry of key drugs in this area. The increasing disease burden may also contribute to market growth. According to WCRF International, in 2020, there were an estimated 18.1 million cancer cases globally, of which 8.8 million cases were among women and 9.3 million cases were among men.
The gastrointestinal diseases segment is projected to advance at a moderate CAGR during the forecast period, due to the growing demand for related products. An NCBI article suggests that around 113 million prescription proton pump inhibitors were sold globally in 2020.
The oral segment accounted for the largest revenue share of 59.25% in 2021 in the branded generics market, due to several advantages of oral dosage over other forms, such as ease of administration and no nursing requirements, thus leading to higher patient acceptability and compliance.
On the other hand, the parenteral segment is expected to advance at the fastest CAGR of 6.9% during the forecast period. An increase in the prevalence of target diseases, such as cancer, hepatitis C, multiple sclerosis, and others, has resulted in the high demand for generic injectables. This segment covers chemotherapy agents, small molecule antimicrobials, insulin, and peptide hormones, among others.
The retail pharmacy distribution channel segment held the highest share of 58.75% in the market in 2021. This can be attributed to the growing burden of chronic diseases in the general population, and the various discounts offered by retail pharmacies. The market has witnessed consolidation in retail pharmacy chains in the U.S.
On the other hand, the hospital pharmacies segment is expected to show moderate growth during the forecast period. Injectable drugs account for a significant proportion of hospital pharmacy sales.
North America accounted for a revenue share of 19.83 % in the global market in 2021 and is expected to advance at a steady CAGR during the forecast period. Moderately high penetration of branded generic drugs and the growing disease burden and geriatric population in the region are among the factors driving growth.
On the other hand, the Asia Pacific market is expected to progress at the highest CAGR of 6.4% during the projection years. The increasing penetration of products in countries such as Japan and India is expected to be a major growth driver. In addition, countries in this region are focusing on the development of their manufacturing hubs to tackle the shortage of life-saving medicines, thus addressing the unmet needs. In countries such as India, doctors prescribe drugs using brand names instead of INN and hence there is a higher demand for branded generics in this region.
Players in the industry leverage agreements and partnership strategies to increase their production capabilities and promote the reach of their product offerings. For instance, in July 2020, Takeda Pharmaceutical Company Limited entered into a joint venture with Teva Pharmaceutical Industries Ltd. to focus on the commercialization of complex generics, specialty assets, and other pipeline opportunities. Some of the key players in the global branded generics market include:
Teva Pharmaceutical Industries Ltd.
Lupin
Sanofi
Sun Pharmaceutical Industries, Ltd.
Dr. Reddy's Laboratories Ltd.
Endo International plc
GlaxoSmithKline plc
Pfizer, Inc.
Apotex, Inc.
Viatris, Inc.
Report Attribute |
Details |
Market size value in 2022 |
USD 240.75 billion |
Revenue forecast in 2030 |
USD 375.95 billion |
Growth rate |
CAGR of 5.7% from 2021 to 2030 |
Base year for estimation |
2021 |
Historical data |
2018 - 2020 |
Forecast period |
2022 - 2030 |
Quantitative units |
Revenue in USD Billion and CAGR from 2021 to 2030 |
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
Segments covered |
Drug class, application, route of administration, distribution channel, region |
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
Country scope |
U.S.; Canada; Germany; U.K.; France; Italy; Spain; China; Japan; India; Australia; South Korea; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE |
Key companies profiled |
Teva Pharmaceutical Industries Ltd.; Lupin; Sanofi; Sun Pharmaceutical Industries, Ltd.; Dr. Reddy's Laboratories Ltd.; Endo International plc; GlaxoSmithKline plc; Pfizer Inc.; Apotex, Inc.; Viatris, Inc. |
Customization scope |
Free report customization (equivalent up to 8 analyst's working days) with purchase. Addition or alteration to country, regional & segment scope. |
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
This report forecasts revenue growth and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global branded generics market report on the basis of drug class, application, route of administration, distribution channel, and region:
Branded Generics Drug Class Outlook (Revenue, USD Billion, 2018 - 2030)
Alkylating Agents
Antimetabolites
Hormones
Anti-hypertensive
Lipid Lowering Drugs
Anti-depressants
Anti-psychotics
Anti-Epileptics
Others
Branded Generics Application Outlook (Revenue, USD Billion, 2018 - 2030)
Oncology
Cardiovascular Diseases
Neurological Diseases
Gastrointestinal Diseases
Dermatological Diseases
Acute And Chronic Pain
Others
Branded Generics Route of Administration Outlook (Revenue, USD Billion, 2018 - 2030)
Topical
Oral
Parenteral
Others
Branded Generics Distribution Channel Outlook (Revenue, USD Billion, 2018 - 2030)
Hospital Pharmacy
Retail Pharmacy
Online Pharmacy
Branded Generics Regional Outlook (Revenue, USD Billion, 2018- 2030)
North America
U.S.
Canada
Europe
Germany
U.K.
France
Italy
Spain
Asia Pacific
Japan
China
India
Australia
South Korea
Latin America
Brazil
Mexico
Argentina
Middle East and Africa (MEA)
South Africa
Saudi Arabia
UAE
b. The global branded generics market size was estimated at USD 229.06 billion in 2021 and is expected to reach USD 240.75 billion in 2022.
b. The global branded generics market is expected to witness a compound annual growth rate of 5.7% from 2021 to 2030 to reach USD 375.95 billion in 2030.
b. Based on route of administration, the oral segment held the largest share of 59.25% in 2021, owing to a high preference for oral dosage form due to ease of use and a higher number of approved products.
b. Some key players operating in the branded generics market include Teva Pharmaceutical Industries Ltd.; Lupin; Sanofi; Sun Pharmaceutical Industries, Ltd.; Dr. Reddy's Laboratories Ltd.; Endo International plc; GlaxoSmithKline plc; and Pfizer, Inc.amongst others
b. Key factors driving the branded generics market growth include rising penetration of branded generic products, patent expiry of key drugs, and rising prevalence of chronic diseases.
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Multiple therapeutic regimens are being followed across the globe in attempts to come up with a reliable treatment for Covid-19. One line of treatment includes the use of hydroxychloroquine, while a second treatment line focuses to use antiviral drugs used in the disease management of HIV. Both these approaches have surged demand from advanced antivirals and antimalarial drugs. This impacts the drug manufacturers as an off label indication for these drug classes has to be worked upon. At the moment, the WHO has not prescribed any of these approaches, neither they have commented if one is better than the other. The report will account for Covid19 as a key market contributor.
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