Messenger RNA (mRNA) technology has evolved from a niche research concept to a transformative force in global healthcare. While the COVID-19 pandemic accelerated its visibility, the scope of mRNA extends far beyond vaccines. From oncology to rare genetic diseases, mRNA-based therapeutics are reshaping the way diseases are treated, driving both clinical innovation and regulatory recalibration.

For pharmaceutical companies, this rapid evolution creates a dual challenge: navigating complex approval frameworks while staying ahead in a highly competitive innovation race. Understanding the current regulatory landscape and how it is adapting to novel modalities like mRNA is critical for ensuring market readiness and long-term success.

Current Status of mRNA Technology

The success of COVID-19 vaccines from Moderna and Pfizer-BioNTech demonstrated the scalability and speed of mRNA deployment. A major milestone followed in May 2024, when the U.S. FDA approved Moderna’s RSV vaccine (mRESVIA) for adults aged 60+. In September 2025, the FDA further expanded its indication to include adults 18–59 at higher risk of RSV infection. These approvals highlight growing regulatory confidence in the adaptability and safety of mRNA beyond COVID-19.

mRNA technology leverages the body’s own cellular machinery to produce therapeutic proteins in vivo, rather than delivering proteins directly. This enables a versatile platform across infectious diseases, oncology, rare genetic conditions, and regenerative medicine.

The global mRNA therapeutics market is projected to reach USD 42.6 billion by 2034 at a CAGR of ~8.3% (BioSpace, 2025), underscoring its expanding role in modern medicine.

Read the blog in detail about mRNA technology from DDReg Experts: https://resource.ddregpharma.com/blogs/how-mrna-technology-is-expanding-beyond-vaccines/