Breakthrough Drugs Set to Achieve Blockbuster Status by 2030

A new report, Drugs to Watch 2025, by Clarivate, provides an overview of breakthrough treatments making their way into market, which are expected to have major implications for improving patient outcomes on a global scale.¹

The list of 11 drugs includes those developed by makers in the US, UK, France, Denmark, and Spain, including Novo Nordisk, Eli Lilly, and GSK, spanning disease areas such as obesity, oncology, and gene therapy.

Alzheimer Disease

One of the drugs mentioned in the report is xanomeline/tropsium chloride (Cobenfy; Karuna Therapeutics, acquired by Bristol Myers Squibb), used to treat patients with schizophrenia and psychosis related to Alzheimer disease.² The drug selectively targets M1 and M4 receptors, rather than using traditional dopamine pathways. The drug is expected to help with both the positive and negative symptoms of schizophrenia, with a better side effect profile.

“For me, the sort of standout is Cobenfy, which was approved by the FDA [in] September 2024,” said Mike Ward, global head of life sciences and health care thought leadership at Clarivate, in an interview with The American Journal of Managed Care® (AJMC®). “It’s the first schizophrenia drug with a novel mechanism of action for 2 and a half decades.”

Obesity and Weight Loss

Another standout drug is cagrilintide plus semaglutide (CagriSema), a once-weekly subcutaneous (SC) drug developed by Novo Nordisk, for patients with obesity and type 2 diabetes (T2D). The drug combined a GLP-1 receptor agonist with an amylin analog, offering superior efficacy compared with existing treatments. The drug is expected to launch for obesity in the US in 2026 and for T2D in major markets by 2028.

RSV Vaccine

Within the respiratory syncytial virus (RSV) landscape is MRNA-1345 (mResvia), the first mRNA vaccine for RSV, developed by Moderna. The vaccine is a single injection, which can be fine-tuned for different strains of RSV, offering a significant advantage over traditional protein vaccines, according to Ward. While this vaccine will competition with other RSV vaccines in the market and in late-stage development, the report noted that it’s approval helps address the significant need for infectious disease control, reduced morbidity and mortality, and decreased hospital burden.

Tyrosine Kinase Inhibitor Development

XL092 (Zanzalintinib) is a third-generation tyrosine kinase inhibitor (TKI) developed by Exelixis Inc, which targets various kinases involved in tumor growth and immunosuppression. The once-daily oral administrated drug is being investigated in non-clear-cell renal cell carcinoma (nccRCC), colorectal cancer (CRC), and squamous cell carcinoma of the head and neck (SCCHN).

This drug was found to have a more favorable safety profile compared with earlier TKIs, with fewer severe adverse events, making it more tolerable for long-term use, explained Ward.

Challenges in Achieving Market Potential

With the increasing complexity of molecules, there is a need for pharmaceutical companies to embrace these innovative modalities, which can pose as a challenge, said Ward. Additionally, manufacturing challenges are significant, particularly for novel molecules like GLP-1 receptors agonists and radiopharmaceuticals.

“The industry has to work with key opinion leaders [and] has to work very, very closely with the regulators to ensure that we have robust regulatory mechanisms that ensure that the products are safe and effective, but don’t in any way sort of slow down the pace of innovation,” explained Ward. “Because, while the regulators’ first task is to ensure that the medicines are safe and effective, they also want to get them to patients, particularly in those areas where there’s a huge unmet medical need.”

Biotechnology and Pharmaceutical Collaboration

The collaboration between biotechnology and big pharmaceutical companies is crucial for driving new approvals and innovations, noted Ward. This is largely because biotechnology companies often are the developers of these niche drugs and new modalities, which are then acquired by large pharmaceutical companies.

“Almost 50% of the drugs approved by the FDA are coming from biotech companies,” said Ward. “They’re not only coming from biotech companies, but the biotech company tends to commercialize these.”

Therefore, pharmaceutical companies need to collaborate with biotechnology companies through deals or acquisitions to access these emerging modalities and drive new approvals.

References

1. Clarivate identifies 11 potential blockbuster and transformative drugs in annual Drugs to Watch report. Clarivate. News release. January 8, 2025. Accessed January 28, 2025. https://clarivate.com/news/clarivate-identifies-eleven-potential-blockbuster-and-transformative-drugs-in-annual-drugs-to-watch-report/.

2. Drugs to Watch 2025. Clarivate. January 8, 2025. Accessed January 28, 2025. https://clarivate.com/drugs-to-watch/?campaignname=Drugs_to_Watch_Annual_Report_LeadGen_LS_Global_2025&campaignid=701VO00000N5xJyYAJ&utm_campaign=Drugs_to_Watch_Annual_Report_LeadGen_LS_Global_2025&utm_source=Press_Release&utm_medium=Earned_Press&utm_content=&utm_term=.