Branded Generics Market To Rise At Modest Growth With CAGR And Revenue Till 2030

Posted by Mrudula Anil Karmarkar on February 23rd, 2023

The global branded generics market size is expected to reach USD 375.95 billion by 2030, according to a new report by Grand View Research, Inc. Furthermore, the market is projected to expand at a CAGR of 5.7% from 2021 to 2030. Factors such as patent expiry of major products, the rising prevalence of chronic diseases, high penetration of generic products, and government initiatives to promote them for reducing the overall healthcare expenditure are among the primary growth drivers.

The patent expiry of branded products primarily fuels industry growth. Drugs, such as Revlimid and Alimta, may cost up to USD 500 a month, which affects the overall healthcare expenditure and affordability for patients suffering from chronic diseases. Eli Lilly & Company’s Alimta is expected to lose its patent protection by May 2022. This expiry of product patents creates opportunities for generics and biosimilar manufacturers.

However, over the past few years, the trend of ANDA approvals for generic drugs had been steadily decreased. It can be observed that the number of ANDA approvals decreased from 1,014 in 2022 to 948 in 2020 and further declined to 776 in 2021. Such factors could slow down industry growth in the coming years.

The growing burden of infectious & non-infectious diseases, coupled with the rising geriatric population, which is more susceptible to chronic diseases such as diabetes, hypertension, and obesity, is expected to positively impact the industry growth. According to an NCBI article, there were 537 million patients suffering from diabetes in 2021 globally.

The COVID-19 pandemic moderately impacted the branded generics space. Due to lockdown situations and stringent government regulations to curb the pandemic, a slowdown and disruption in the supply of pharmaceuticals had been observed in the initial phase of the pandemic. In addition, regulatory operations also affected reimbursement decisions and approvals of new products in the space. However, the market regained its pace by the end of 2020 in most countries.

Companies are introducing novel products to strengthen their product portfolio. In March 2022, Viatris, Inc. received the U.S. FDA’s approval for Breyna, the first generic version of AstraZeneca's Symbicort, intended for the treatment of COPD. Moreover, in February 2022, Mylan N.V. introduced the first generic version of ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder) under the brand Wixela Inhub for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) or asthma. This branded generic was claimed to be 70% cheaper than the originator product.

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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. 

Branded Generics Market Report Highlights

  • The anti-hypertensive drug class segment contributed to a significant revenue share of 15.67% in 2021, due to factors such as increasing demand owing to the rising burden of cardiovascular diseases and the growing penetration of generic products
  • The oral dosage form was the largest segment in 2021, due to several advantages of oral dosage such as the ease of administration and no nursing requirements, leading to higher patient acceptability and compliance
  • The retail pharmacy distribution channel dominated the space in 2021 owing to factors such as the growing presence of retail pharmacy chains and tie-ups of these chains with established hospitals
  • Asia Pacific dominated the space in terms of revenue in 2021, mainly due to the presence of key players, high prescription rate & preference for branded generics, increasing prevalence of chronic diseases, and growing geriatric population 

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 2022 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.

List of Key Players in the Branded Generics Market

  • Viatris Inc.
  • Sun Pharmaceutical Industries Ltd.
  • LUPIN
  • GlaxoSmithKline plc
  • Sanofi
  • Endo International plc
  • Dr. Reddy’s Laboratories Ltd.
  • Apotex, Inc.
  • Pfizer, Inc.

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Mrudula Anil Karmarkar

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Mrudula Anil Karmarkar
Joined: July 2nd, 2020
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