With the rise of mRNA-based treatments, the field of oncology is about to go through a big change. The global market for mRNA-based oncology therapies is expected to reach a record-breaking $2 billion by 2029. BioNTech, a German pharmaceutical company, is expected to lead the market with projected sales of $885 million and a 44.6% share by 2029, according to GlobalData, a leading data and analytics company.

BioNTech’s diverse pipeline includes multiple drugs in Phase I, II, and III clinical trials, predominantly targeting solid tumors such as melanoma, prostate cancer, cervical cancer, non-small cell lung cancer, and pancreatic cancer. At the recent annual meeting of the American Society of Clinical Oncology (ASCO), BioNTech revealed promising Phase I results for the pancreatic cancer drug BNT122.

The trial, conducted in collaboration with Memorial Sloan Kettering Cancer Center and in partnership with Genentech, combines BNT122 with the immune checkpoint inhibitor (ICI) atezolizumab. Early results suggest a favorable safety profile and promising clinical activity, further strengthening BioNTech’s position as the market leader in mRNA oncology.

Melanoma remains the primary focus of advanced mRNA-based therapies, with promising results in Phase II trials. Moderna/Merck‘s mRNA-4157 stands out as the only mRNA-based therapy candidate in the ongoing Phase III clinical trial for stage IIB-IV cutaneous melanoma, in combination with the renowned immune checkpoint inhibitor (ICI)  pembrolizumab. If successful, this trial will mark the first time an mRNA cancer vaccine and an immune checkpoint inhibitor have shown improved recurrence-free survival rates. This targeted approach will open new avenues to boost the potential of mRNA-based therapies by combining them with other ICIs and expanding to other solid tumors.

Biswajit Podder, PhD, Oncology and Hematology Analyst at GlobalData, comments: “mRNA-based therapies have the potential to revolutionize cancer treatment. The technology bears tremendous promise, particularly for difficult-to-treat solid tumors. OTX-2002 from Omega Therapeutics is an mRNA therapy anticipated to generate $658 million in global sales, representing 33.2% of the total mRNA therapy market by 2029. Omega Therapeutics’s share suggests increasing competition and diversification in this innovative field.”

GlobalData’s research shows a dynamic clinical trials landscape, with 36 mRNA-based products participating in 65 distinct Phase I-III trials across multiple cancer indications. In addition, there are 178 mRNA-based therapies in the discovery, preclinical, and clinical stages of development for oncology. This range of research activity highlights the potential applications of mRNA therapies in treating various types of cancer.

However, despite clinical advancements, the healthcare industry is still waiting for the first regulatory approval of mRNA-based therapy for oncology indications.

Podder concludes: “The road to market approval for mRNA-based therapies is fraught with obstacles, such as mRNA stability and delivery specificity. Consequently, advancements in foundational mRNA biology and delivery platforms are critically important for companies specializing in mRNA-based therapeutics. Moderna/Merck should focus on generating Phase III data for mRNA-4157 as quickly as possible to expedite the Biologics License Application (BLA) process and to enjoy the first-to-market advantage.”