From global mega-seller arthritis and cancer drugs, Humira and Keytruda, to popular asthma inhaler Symbicort, 24 major blockbuster drugs are set to lose their patents by 2030, according to a study by the Department of Pharmaceuticals. Overall drugs worth annual sales of more than $250 billion or Rs 20.75 lakh crore are set to lose patent protection by 2030, opening a huge market for generic drug makers across the globe, especially in India.
Rheumatoid arthritis drug Humira clocked a revenue of $21.20 billion or Rs 1.76 lakh crore in 2022 followed by anti-cancer drug Keytruda ($21 billion or Rs 1.74 lakh crore), blood cancer drug Revlimid ($10 billion or Rs 83,000 crore) and Crohn’s disease drug Stelara ($9.72 billion or Rs 80,510).
According to the study conducted by the Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilizers, the period from 2023 to 2030 is projected to witness a “significant patent cliff” in the pharmaceutical industry, with numerous high-revenue drugs facing patent expirations.
The department, which launched the study last year, analysed that the patent cliff between 2023 and 2030 would lead to heightened competition from generic drug producers across the globe – a sector typically dominated by Indian pharmaceutical companies.
“Expiry of patents is very promising for the Indian generic drug market as it is expected to expand and grow further with the inclusion of these new drugs. With ongoing developments, India has started focusing on self-reliance at a large scale,” said the study while adding that it is imperative to identify these drugs beforehand, draft and implement strategies which help in their timely entry into the market by promoting generic drug manufacturing.
A 121-page study, titled “An analysis on leveraging the patent cliff with drug sales worth $251 billion going off-patent and analysis of different drug pricing methodologies for Indian generic pharmaceutical companies”, has been conducted by the DOP by engaging Biovantis Healthcare Private Limited (Biovantis).
Drug Prices to Fall by At least 50 Percent
According to the study’s findings, the expiration of patents will significantly reduce costs for patients, almost by half or more.
“On average, generic chemical drugs after launch tend to cost around 51 % less than brand-name drugs for a few years. In the case of biosimilars, the cost can be around 60% less than innovator products for a few years,” it said and added that it is to be noted that with the passage of time and the entry of new players, the prices of both chemical generics and biosimilars reduce substantially.
The reason is, the study said, the lower R&D and manufacturing costs, and relatively easier and quick regulatory approvals that bring cost efficiencies and promote inter-generic competition, when combined, offers price benefits to patients and insurance providers, especially for chronic conditions or high-prevalence diseases.
Biologics Likely to Dominate Pharma Industry
As per data analysis conducted for the sales of 24 blockbuster drugs, the study said biologics like biosimilars, immunomodulators and monoclonal antibodies are going to further dominate the pharmaceutical industry between 2022 to 2030.
“The biosimilar revenues which comprised 69 percent of overall revenues of these 24 blockbuster drugs in 2022 is going to increase to 75% by 2030,” it said.
The reason is that the new advancements in drug development, like personalised medicine, are making treatments more tailored to individuals. This means more biological drugs are available now, thanks to the latest techniques such as high-throughput screening, molecular profiling, next-generation sequencing and bioinformatics analysis.
How Indian Companies Should Prepare
According to the study, “Indian companies need to closely monitor patent expiration dates, patent challenges, and legal developments to identify opportunities for generic drug development.”
However, as per the study, one of the main obstacles Indian pharmaceutical companies face in taking advantage of upcoming market opportunities is the impending patent expirations involving navigating a complex intellectual property (IP) landscape. This complexity arises as originator companies opt to pursue patent litigation against Indian generic manufacturers.
Resolving these disputes can consume considerable time and money. As a result, the approval and launch of generic versions are delayed, and Indian generic firms incur substantial legal expenses, the study said. It also added that the patent environment is constantly evolving, with new patents or alterations to existing ones affecting the development of generic drugs.
While Indian generics possess the necessary technical expertise for these processes, they require significant investment in research and development (R&D) to ensure bioequivalence with the original branded drugs. Overall, the study said that Indian companies are, thus, challenged with striking a balance between R&D investments and the cost pressures of generic manufacturing.
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