Overview
The issue of high drug costs has brought both President Joe Biden and former President Donald Trump into a rare agreement. Both have taken significant actions they claim help control these costs, each pointing to their unique policy approaches as key achievements. For Biden, the highlight is his signing of the Inflation Reduction Act, which allows Medicare to set prices for certain drugs. This act distinguishes between small-molecule drugs and biologics, setting prices for the former nine years after FDA approval, and for biologics, thirteen years after. The law has faced opposition and is currently the subject of 14 lawsuits from major pharmaceutical companies like AstraZeneca and Bristol Myers Squibb.
Trump’s tenure saw the implementation of several executive orders aimed at reducing drug prices. These orders mandated federally qualified health centers to provide insulin and epinephrine discounts to low-income individuals. They also permitted the importation of cheaper prescription drugs from countries like Canada and prohibited agreements that reduced discounts between drug manufacturers and pharmacy benefit managers. Furthermore, Trump’s policies aimed to ensure that the United States would pay the lowest price available among economically advanced nations for Medicare Part B drugs.
The backdrop to these policy measures is a pharmaceutical industry grappling with ever-increasing drug development costs. A report from Deloitte estimated the average cost of developing a new drug at about $2.3 billion among the top 20 global biopharmaceutical companies. This significant financial burden is one reason the industry struggles to lower drug prices.
Top 10 Best-Selling Prescription Drugs
An updated list of the top 10 best-selling prescription drugs for 2023 reveals some key insights. For the first time in a decade, AbbVie’s Humira did not top the chart. Humira’s sales have seen a gradual decline, primarily due to biosimilar competition. The drug’s sales outside the US plummeted by 31% in 2019 due to this competition, and the US market saw its own competitors emerging. Despite these challenges, the overall market for top-selling drugs is still significant, with the collective value of the top 10 drugs reaching $145.495 billion in 2023.
Keytruda, a cancer treatment drug from Merck & Co., took the top spot with $25.011 billion in sales, showing a 19.5% increase from the previous year. Eliquis, a blood thinner co-produced by Bristol Myers Squibb and Pfizer, followed with $18.953 billion in sales, a modest rise from 2022. The COVID-19 vaccine Comirnaty, produced by Pfizer and BioNTech, saw a dramatic drop in sales, down 72.9% from the previous year, indicating a return to more typical demand levels as the pandemic wanes.
Here’s a summary of the top 10 best-selling drugs:
| Rank | Drug | Manufacturer(s) | 2023 Sales ($B) | 2022 Sales ($B) | % Change |
|---|---|---|---|---|---|
| 1 | Keytruda (pembrolizumab) | Merck & Co. | 25.011 | 20.937 | 19.5% |
| 2 | Eliquis (apixaban) | BMS, Pfizer | 18.953 | 18.269 | 3.7% |
| 3 | Comirnaty (COVID-19 vaccine) | Pfizer, BioNTech | 15.379 | 56.660 | -72.9% |
| 4 | Humira (adalimumab) | AbbVie | 14.404 | 21.237 | -32.2% |
| 5 | Ozempic (semaglutide) | Novo Nordisk | 13.929 | 8.695 | 60.2% |
| 6 | Eylea (aflibercept) | Regeneron, Bayer | 12.875 | 13.121 | -1.9% |
| 7 | Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) | Gilead | 11.850 | 10.390 | 14.1% |
| 8 | Dupixent (dupilumab) | Sanofi, Regeneron | 11.669 | 9.031 | 29.2% |
| 9 | Stelara (ustekinumab) | Janssen Biotech | 10.858 | 9.723 | 11.7% |
| 10 | Opdivo (nivolumab) | BMS, Ono Pharmaceutical | 10.567 | 10.368 | 1.9% |
Trends and Analysis
The list of top-selling drugs in 2023 highlights several important trends in the pharmaceutical industry. For one, the reliance on top-performing drugs like Keytruda and Eliquis reflects a focus on high-impact therapeutic areas such as oncology and cardiology. Both of these drugs have shown consistent sales growth, indicating their sustained importance in clinical practice.
Conversely, the significant drop in Comirnaty‘s sales underscores the fluctuating demand for COVID-19 treatments as the pandemic’s acute phase recedes. Humira’s decline, brought on by biosimilar competition, signals a broader trend of increased market penetration by these lower-cost alternatives, particularly in regions outside the US initially, and more recently within.
Newcomers like Ozempic, used for managing diabetes and obesity, have shown explosive growth. Ozempic’s sales skyrocketed by 60.2%, reflecting a growing market for treatments targeting chronic conditions with large patient populations. This trend is particularly notable as it underscores the pharmaceutical industry’s pivot towards addressing prevalent conditions with broad therapeutic applications.
Financial Impact
With the best-selling drugs collectively generating $145.495 billion in 2023, it’s clear that top-performing medications remain highly lucrative. However, this figure represents a 27% decrease from 2022’s totals, which were inflated by pandemic-specific treatments. Despite this decline, there is growth in key segments, suggesting a stabilizing market returning to pre-pandemic patterns.
The financial health of pharmaceutical companies often hinges on a handful of blockbuster drugs. For instance, Merck’s reliance on Keytruda is critical, as it constitutes a significant portion of their revenue. Similarly, Eliquis is vital for both Bristol Myers Squibb and Pfizer, highlighting these companies’ strategic focus on anticoagulants.
The evolving dynamics also reflect the importance of biologics and small molecules. The balance between these two categories is crucial, as indicated by the differences in Medicare price-setting timelines established in Biden’s Inflation Reduction Act. Biologics, having a longer exclusivity period, remain central to many companies’ strategies due to their high development costs and significant therapeutic impact.
Biosimilars and Generics
The entry of biosimilars and generics continues to reshape the market. Humira, long a top seller, faced its first US biosimilar competition in 2023. Amgen’s Amjevita (adalimumab-atto) entered the market, generating significant sales and carving out a share of Humira’s market segment. This competition led to Humira’s notable 32.2% drop in sales from 2022 to 2023.
The impact of biosimilars extends beyond just one product. For instance, drugs like Stelara and Opdivo could face similar pressures as competitors emerge. The market’s response to these biosimilars will be a key indicator of pricing trends and insurance coverage policies in the coming years.
Insurers have also played a role in driving down prices through discounts and rebates as they negotiate these terms aggressively to manage rising healthcare costs. This dynamic can be seen in the relatively flat sales growth for some top drugs compared to others with more pronounced changes, whether positive or negative.
Future of Drug Development
Looking ahead, the future of drug development remains both promising and challenging. Companies are investing heavily in innovative therapies, particularly in precision medicine and gene editing technologies. These advanced therapies promise to address unmet medical needs but come with high development costs.
Driven by advances in biotechnology, new drugs are targeting complex diseases at the molecular level. This shift presents opportunities for breakthrough treatments but also requires substantial investment in research and development. Cutting-edge therapies like CAR-T cell treatments and CRISPR-based gene editing are at the forefront of these innovations.
Policies like Biden’s Inflation Reduction Act and Trump’s executive orders will significantly influence how these new drugs are priced and accessed by patients. As drug development costs remain high, pharmaceutical companies will need to balance innovation with affordability to meet policy requirements and market demands.
In conclusion, the landscape of best-selling prescription drugs in 2023 showcases both stability and transformation within the pharmaceutical industry. While familiar names like Keytruda dominate, the entry of new therapies and the increasing influence of biosimilars and generics signal an evolving market. Companies must navigate these changes while continuing to innovate and meet the world’s healthcare needs.
