An analysis of FDA approvals across these five years shows small molecules remain central to modern therapeutics, even as complex biologics—particularly monoclonal antibodies (mAbs), antibody–drug conjugates (ADCs), and next-generation modalities—are on the rise. Steady R&D investment in these advanced approaches reflects growing clinical confidence in targeted therapies that address difficult or rare disease pathways.
1. Small molecules continue to show staying power
Like the resilient villager in Monty Python and the Holy Grail who cries, “I’m not dead yet!,” small molecules have proven durable despite the biologics boom. They continue to command a significant share of annual FDA approvals—hovering around 45–48% in recent years. Monte Carlo modeling suggests a market-share crossover with mAbs may not arrive until the mid-to-late 2030s.
Key Approvals:
- Veklury (remdesivir) in 2020 signaled a milestone as the first FDA-approved COVID-19 antiviral,
- Lumakras (sotorasib) in 2021 became the first targeted KRAS G12C therapy, and
- Paxlovid (nirmatrelvir/ritonavir) gained full FDA approval as a pivotal COVID-19 antiviral in 2023.
FDA approval types. Source data from FDA. Classification done manually.
2. Monoclonal antibodies gradually gain market share
mAbs may still trail small molecules in overall approvals, but their year-over-year climb is reshaping the industry. Oncology and immunology remain prominent therapeutic categories, though mAbs continue expanding into new areas like neurology and rare diseases. Bispecific formats and other enhanced antibody constructs are especially promising.
Key Approvals:
Tepezza (teprotumumab) kicked off 2020 as the first treatment for thyroid eye disease,
Leqembi (lecanemab) brought fresh hope for early Alzheimer’s disease in 2023, and
Alhemo (concizumab) in 2024 highlights hemophilia prophylaxis. Expect ongoing innovation in mAb-based immunotherapies, especially in combination regimens.
This graph of approval count shows the uptick in mAbs from 2022 to 2024
3. ADCs show growing momentum
Antibody–drug conjugates (ADCs) harness the targeting precision of antibodies plus the cytotoxic force of potent small molecules. While overall approval numbers are small, the class commands significant R&D and financial backing. From breast cancer to lymphomas, ADCs continue to expand the “armed antibody” concept, reducing off-target toxicity compared to traditional chemotherapy.
Key Approvals:
Trodelvy (sacituzumab govitecan-hziy) in 2020 and
Tivdak (tisotumab vedotin-tftv) in 2021 highlight oncology breakthroughs, though 2023–2024 have not seen major ADC launches. However, the pipeline remains robust with ongoing clinical trials.
Network of therapeutic areas linked by shared drug modalities. Larger circles indicate areas with more approved treatments, and lines show where therapeutic areas share similar drug technologies. Because of the high number of “other” and “oncology,” the size of the circles were capped for clarity.
4. Novel modalities reshaping rare and intractable diseases
Beyond mAbs and ADCs, emerging modalities—such as siRNA, antisense oligonucleotides, aptamers, and TCR-fusion proteins—keep carving out niches in rare and severe diseases. While they comprise a smaller approval slice, these therapies often deliver transformative outcomes at the molecular level where standard treatments fail.
Key Approvals:
siRNA agents like Oxlumo (lumasiran) and Leqvio (inclisiran), TCR-fusions such as Kimmtrak (tebentafusp-tebn), and antisense options like Qalsody (tofersen) exemplify novel treatments for conditions once considered untouchable by conventional means. In 2024, Tryngolza (olezarsen) and Rytelo (imetelstat) extended this category’s impact on rare disorders and oncology.
FDA approvals by therapeutic area over time, highlighting the major categories and excluding the ‘Other’ bucket. Oncology’s share relative to other indications has rebounded in recent years.
Filed Under: Oncology, Regulatory affairs
