Report: Biologics Market to Grow to $1.37 Trillion by 2033

The global biologics market is expected to reach $1.37 trillion by 2033, growing more than 10% from 2023, according to a recent report by Nova One Advisor. Contributing to this growth will be the approvals of novel biologics, such as gene therapy, RNA-based therapeutics, and antibody-drug conjugates.

Monoclonal antibodies account for the largest number of biologics currently approved by regulatory authorities, and oncology had the largest share (29.4%) of approved biologics in 2023. From now to 2033, the hematological disorder segment is expected to expand at the fastest compound annual growth rate of 11.8%. Researchers said the approvals of gene therapies to treat people with hemophilia that have been approved over the last few years will contribute to this growth.

Additionally, in the coming decade, next-generation antibodies such a bispecific-monoclonal antibodies, antibody fragments, radio-immunotherapies, nanobodies, and antibody-drug conjugates will drive the growth of this segment, the authors of the Nova One Advisor report suggest.

The antisense and RNAi therapeutics segment is anticipated to expand at a compound annual growth rate of 20.7% during the forecast period. RNA therapies target a function that cells use to make proteins. Antisense and RNAi therapies take advantage of a process the immune system uses to destroy double-stranded RNA, which is not produced naturally and is considered a sign of a viral infection.

Antisense therapies introduce short single-stranded RNA sequences that target messenger RNA and destroy the double-stranded RNA before proteins are produced. An example of this type of therapy is Spinraza (nusinersen), which was approved by the FDA in 2016 and is used to treat adults and children with spinal muscular atrophy (SMA), a rare neuromuscular disorder.

RNA interference (RNAi) therapies create double-stranded RNA that is cut into fragments and adds another protein that then attaches to the target messenger RNA. The immune system is then able to identify and destroy the double-stranded RNA. The RNA therapy, Onpattro (patisiran), was approved by the FDA in 2018 to treat patients with polyneuropathy (malfunction of peripheral nerves) associated with hereditary transthyretin amyloidosis. This is rare, inherited and fatal disease caused by mutations of the transthyretin (TTR) gene and leads to amyloid protein build up the heart, kidneys, liver and other organs.

As of Jan. 31, 2024, at least 131 RNA-based therapies are being studied in clinical trials, according to a recent report by Avalere. These therapies span 15 different therapeutic areas, with 37% being studied for rare diseases. Most of the RNA therapies are in early development, but 29 are in late-stage clinical trials.

The Avalere report, however, indicates that there is some ambiguity in how the FDA will regulate these RNA therapies. Some may be regulated as small molecules and be approved under a new drug application instead of a biologics license application.

The regulatory ambiguity could impact both pharmaceutical companies and payers because drugs chosen for Medicare’s Drug Price Negotiation Program are based on how the FDA approved them, the Avalere report suggested. For example, biologics become eligible for Medicare negotiation 11 years after FDA approval and small molecules become eligible after 7 years.