Recently, Nature Reviews Drug Discovery released an article titled "Top Product Forecasts for 2024", predicting the top 10 pharmaceutical products in 2024, all of which are projected to exceed ten billion dollars in sales.
Figure 1. Top Product Forecasts for 2024 [1]
NO. 1 Keytruda
Company: Merck & Co.
2024 worldwide sales forecast: $27.19 billion
In September 2014, the U.S. Food and Drug Administration (FDA) approved Keytruda (Pembrolizumab), a PD-1 monoclonal antibody for the treatment of cancer. For the first four years since approval, the Keytruda underperformed Opdivo in sales. But this trend reversed in 2018, with Keytruda’s sales becoming higher than Opdivo's.
Currently, Keytruda has 45 indications in 18 tumors and is in development or under regulatory review for a range of new indications. In addition to focusing on new indications, Merck is also betting on Keytruda's combination therapies. Recently, the FDA approved Keytruda in combination with Padcev (an antibody-drug conjugate targeting Nectin-4) for first-line treatment of locally advanced or metastatic urothelial carcinoma. This marks the world's first approved "PD-1+ADC" combination therapy. On December 14th, Merck announced that, within three years, the combination of Keytruda with the mRNA vaccine mRNA-4157 (V940) can reduce the risk of recurrence by nearly half in patients with cutaneous melanoma.
Keytruda's sales are expected to continue growing at least until 2027. The expiration of patents in 2028 may open the door for biosimilars, but the formidable barriers in the field of oncology for Pembrolizumab (Keytruda) are not easily shaken.
NO.2 Ozempic
Company: Novo Nordisk
2024 worldwide sales forecast: $ 16.13 billion
Novo Nordisk's Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist used to treat type 2 diabetes. Semaglutide is available in three formulations: the injectable Ozempic, Wegovy, and the oral tablet Rybelsus. It has been approved for marketing in over 50 countries and regions, including the United States, Europe, Canada, and Japan. Wegovy is characterized by its stronger weight loss effects, requiring only once-weekly administration. Currently, Novo Nordisk is actively developing oral formulations for weight loss.
With indications for both type 2 diabetes and weight loss, Novo Nordisk achieved a remarkable sales figure of DKK 100.222 billion (approximately USD 14.232 billion) in the first three quarters of 2023, marking an impressive year-on-year growth of 86% despite limited production capacity. Novo Nordisk is actively acquiring and constructing factories to expand its production capabilities, aiming for rapid scaling. There is a possibility that the sales of the three semaglutide products may surpass Keytruda in 2024.
In terms of research and development pipeline, the focus of semaglutide product development is primarily on the development of new formulations and the expansion into new indications.
Figure 2. Semaglutide pipelines
NO.3 Dupixent
Company: Sanofi/Regeneron
2024 worldwide sales forecast: $13.45 billion
Dupixent (Dupilumab) is a fully human monoclonal antibody co-developed by Regeneron and Sanofi. It can inhibit the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.
In 2017, Dupixent was first approved for marketing in the United States for the treatment of atopic dermatitis. Subsequently, it received approvals for indications such as asthma, chronic rhinosinusitis with nasal polyps, nodular prurigo, and eosinophilic esophagitis. Recently, there are plans to submit a marketing application to the FDA for the treatment of chronic obstructive pulmonary disease (COPD), aiming to become the first approved biologic for this serious condition.
Up to now, over 60 clinical trials have been conducted to evaluate Dupixent, involving more than 10,000 patients with various chronic diseases, some of which are driven by type 2 inflammation. More indications are in advanced stages of clinical development, such as chronic spontaneous urticaria, unexplained chronic itching, pemphigoid, and ulcerative colitis.
Figure 3. Dupixent pipelines
NO.4 Eliquis
Company: BMS/Pfizer
2024 worldwide sales forecast: $13.31 billion
Eliquis (apixaban) is an orally administered selective factor Xa inhibitor jointly developed by BMS and Pfizer, starting in 2007. Eliquis was initially approved in the European Union in 2011 and received approval in the United States the following year. As of now, Eliquis has been approved to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF), for treatment of prophylaxis of DVT, and for treament of pulmonary embolism (PE). It is the third globally marketed new-generation oral anticoagulant.
Since its marketing, Eliquis' sales have consistently shown a steady upward trend. In 2015, its global sales reached $1.86 billion. In 2021, the annual sales of the drug surpassed $10 billion for the first time, reaching $10.76 billion. In 2022, Eliquis achieved an annual revenue of $11.789 billion, representing a year-on-year growth of 10%.
NO.5 Biktarvy
Company: Gilead
2024 worldwide sales forecast: $12.57 billion
Biktarvy is a fixed-dose combination (FDC) tablet comprising bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for the treatment of HIV-1 infection. It received approvals from the U.S. FDA in February of 2018 and the European Medicines Agency (EMA) in June of 2018.
Within less than 2 years of being on the market, Biktarvy achieved an annual sales revenue of nearly $5 billion, setting a new record for the annual sales of a single HIV drug. From 2018 to 2021, Biktarvy's sales were $1.18 billion, $4.74 billion, $7.26 billion, and $8.62 billion, respectively. In 2022, Biktarvy’s sales surpassed $10 billion for the first time, reaching $10.39 billion.
NO.6 Darzalex
Company: Johnson & Johnson
2024 worldwide sales forecast: $11.98 billion
Darzalex (Daratumumab) is a novel, high-affinity, therapeutic human monoclonal antibody against unique CD38 epitope with broad-spectrum killing activity. It has a favorable safety profile as monotherapy in patients with relapsed/refractory myeloma and also demonstrates significant single-agent activity.
In 2015, the FDA approved Darzalex for the treatment of multiple myeloma (MM), making it the first CD38 antibody approved globally for MM treatment. Since then, Darzalex has received multiple FDA approvals to expand its scope of treatment for MM patients. Sales have also steadily increased, reaching a global revenue of $7.977 billion in 2022.
In 2020, Darzalex Faspro (Daratumumab and hyaluronidase-fihj) subcutaneous injection was approved for marketing, reducing the administration time from several hours with intravenous (IV) injection to 3-5 minutes with subcutaneous (SC) injection. To better protect this improved formulation, Johnson & Johnson submitted an international patent application PCT/US2016/059893 in November 2016 to safeguard the Daratumumab subcutaneous injection formulation.
NO.7 Opdivo
Company: BMS
2024 worldwide sales forecast: $11.33 billion
Opdivo (nivolumab) is the world's first approved PD-1 monoclonal antibody. It was approved in Japan in July 2014 for the treatment of unresectable melanoma. Later, it was approved by FDA in December 2014.
As of now, Opdivo has obtained 29 indications in 11 types of tumors. Opdivo's patent is set to expire in 2028, but the exploration of immunotherapy and combination therapies continues. Recently, BMS terminated the Phase III RELATIVITY-123 trial investigating the combination of Opdivo and the LAG-3 antibody relatlimab in a fixed dose for patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC). The termination was not due to safety concerns but rather because the trial was deemed unlikely to meet its primary endpoint. Although the "PD1and LAG3" combination therapy faced setbacks in MSS mCRC, BMS has stated that research on this combination therapy for treating other types of tumors will proceed as planned.
In recent years, Opdivo's sales have fallen below expectations, experiencing a decline for the first time in 2020. While it reversed the declining trend in 2021, it still lags significantly behind Keytruda, with sales nearly half of the latter's.
NO.8 Comirnaty
Company: Pfizer/BioNTech
2024 worldwide sales forecast: $10.79 billion
Comirnaty is a COVID-19 mRNA vaccine co-developed by Pfizer and BioNTech. It first received Emergency Use Authorization (EUA) from the FDA in December 2020. Due to COVID-19, the drug has consistently achieved robust sales since its introduction. In 2021, Comirnaty's sales reached $40.4 billion, securing the top position, and in 2022, it maintained its leading position with annual sales of $37.81 billion.
However, with reduced attention on COVID-19, sales of Comirnaty have sharply declined. In 2023, Pfizer announced a 500% price increase for the Comirnaty; however, the price hike has proven insufficient to address the downturn in product sales. On October 13th, Pfizer announced plans to cut billions of dollars in expenses and implement layoffs to adapt to the decreased demand for its COVID-19 drug Paxlovid and the Comirnaty vaccine.
NO.9 Gardasil
Company: Merck & Co.
2024 worldwide sales forecast: $10.03 billion
Gardasil includes 9-valent HPV vaccine (Gardasil 9, 9vHPV), quadrivalent HPV vaccine (Gardasil, 4vHPV). The quadrivalent HPV vaccine has not been in use in the United States since May 1, 2017; currently, Gardasil 9 is the standard.
9vHPV is a noninfectious, virus-like particle (VLP) vaccine. Similar to quadrivalent HPV vaccine (4vHPV), 9vHPV contains HPV 6, 11, 16, and 18 VLPs. In addition, 9vHPV contains HPV 31, 33, 45, 52, and 58 VLPs.
GARDASIL 9 helps protect individuals ages 9 to 45 against the following diseases caused by 9 types of HPV: cervical, vaginal, and vulvar cancers in females, anal cancer, certain head and neck cancers, such as throat and back of mouth cancers and genital warts in both males and females.
NO.10 Skyrizi
Company: AbbVie
2024 worldwide sales forecast: $9.93 billion
Skyrizi (Risankizumab) is an IL-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23 is a cytokine involved in the inflammatory process and is considered to be associated with various chronic immune-mediated diseases.
As of now, Skyrizi has received approval from the U.S. FDA and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease. Currently, phase 3 trials for Skyrizi in the treatment of psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis are also underway.
It is worth noting that in October, AbbVie announced positive results from the head-to-head phase 3 SEQUENCE study, showing non-inferiority compared to Johnson & Johnson's Stelara (predefined non-inferiority margin of 10%). The primary endpoints were met, including clinical response rates at week 24 (59% vs. 40%) and endoscopic response rates at week 48 (32% vs. 16%).
References:
https://www.nature.com/articles/d41573-023-00198-3
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