Pharma Blockbusters Face Medicare Challenges and Loss of Exclusivity

In the pharmaceutical industry’s fast-changing landscape, blockbuster drugs – those generating over a billion dollars in annual revenues – continue to shape healthcare and economic strategies on a worldwide scale.

2023 Overview

Copyright Genchrome | Source: Genchrome Analysis based on Company Report 2023

There were 152 drug products with at least $1 billion in full-year 2023 revenue.

Merck’s Keytruda emerged as the world’s top-selling drug in 2023, setting a record for the highest revenue ever achieved by a drug product in a single year, excluding COVID-19 vaccines.

The landscape of 2023’s blockbuster drugs reveals a balance between biologics and small molecules, with biologics predominating at the upper echelons of revenue generation. Notably, the pharmaceutical market has seen a surge in the popularity of anti-obesity drugs, particularly those that evolved from diabetes treatments, such as products from Novo Nordisk and Eli Lilly. Despite being peptide-based, these drugs are regulated as small molecules, which introduces a new dynamic that could influence future market trends and revenue models.

Copyright Genchrome | Source: Genchrome Analysis based on Company Report 2023

Oncology drugs led the way, with a quarter of all blockbuster drugs treating various types of cancer. This isn’t surprising, considering the global burden of cancer and the continuous need for innovative treatments. The high cost associated with cancer treatment, along with the ongoing development of targeted therapies and immunotherapies, often results in these drugs commanding high prices.

The cardiometabolic category was the second most prevalent therapeutic area. Given the rising prevalence of diabetes, obesity, and associated cardiovascular diseases, it is clear why treatments like insulin and drugs targeting metabolic disorders are in high demand. These conditions are often chronic, requiring long-term treatment and management, which contributes to the sustained sales of these drugs.

The remaining blockbuster drugs covered a spectrum of other therapeutic areas, from infectious diseases to neurology, addressing disorders such as multiple sclerosis and Alzheimer’s disease. There were also drugs for respiratory conditions, and autoimmune and rare diseases, among others.

Strategic Market Dynamics

Copyright Genchrome | Source: Genchrome Analysis based on Company Report 2023

The U.S. remains the primary revenue source for blockbuster drugs, representing 58% of the 5 main blockbuster owners’ revenue, a trend that underscores the significant pricing freedom afforded by the American healthcare system. Companies like Roche and Johnson & Johnson are aligning their drug development pipelines with areas of high unmet medical need and high market potential. The focus on oncology, immunology, and cardiometabolic diseases is a targeted strategy influenced by both the disease prevalence and the potential for long-term patent protection, ensuring prolonged market exclusivity.

The strategic pricing of blockbuster drugs often involves a delicate balance between recouping R&D investments and exploiting market exclusivity. While this approach has proven profitable, it poses significant challenges in terms of accessibility and affordability, prompting ethical debates within the industry. The introduction of the Inflation Reduction Act is set to challenge existing pricing models by imposing stricter price controls in the U.S. This shift may necessitate a strategic overhaul for pharmaceutical giants, as they must now navigate tighter regulations while striving to maintain profitability.

Medicare Price Negotiation and Upcoming LoEs

Copyright Genchrome | Sources: Genchrome Analysis based on CMS Gov, Investors Report

With Medicare negotiating lower prices, the cost of these drugs could drop significantly, leading to lower spending for Medicare and more affordable prices for patients. This change is likely to influence the drug pricing strategies to come, the valuation of pharmaceutical companies, and the access to medication for the Medicare population.

These blockbusters, selected for their therapeutic significance and financial impact, are facing a pivotal moment as their patent protections near expiration. Drugs in this table are just a few that will soon face generic competition. The 2023 sales data underscores the weight of these drugs in their respective company’s portfolios, with some drugs accounting for over a quarter of their company’s global sales. For instance, some blockbusters stands out with over 27% contribution to company’s sales, underscoring the profound impact its LoE could have.

The LoE not only anticipates increased accessibility and affordability for patients but also necessitates strategic foresight from pharmaceutical companies to mitigate the impact on their revenue.

It emphasizes the crucial need for pharmaceutical companies to diversify and expand their drug pipelines to navigate financial challenges posed by patent cliffs and the changes brought about by the IRA and Medicare drug price negotiations.

Caroline Boulliat
Caroline Boulliat

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