The global small molecule CDMO market size is calculated at US$ 72.81 in 2024, grew to US$ 78.01 billion in 2025, and is projected to reach around US$ 145.12 billion by 2034. The market is expanding at a CAGR of 7.14% between 2025 and 2034. The rise in chronic conditions and demand for generic medicines is driving the small molecule CDMO market.
For almost a century, small-molecule medications have formed the backbone of the pharmaceutical sector. Any low molecular weight organic substance is referred to by this definition. New and inventive methods for creating small-molecule medications are made possible by the quick development of biopharmaceutical research and technology. In order to successfully navigate small molecule API development and manufacturing from start to finish, biotechnology and pharmaceutical companies seeking to outsource critical components of small molecule drug development and manufacturing should look to a top-tier CDMO with extensive industry experience. Technology breakthroughs, shifting consumer needs, and stricter regulations are all contributing to the quick changes in the small molecule contract manufacturing industry.
In November 2024, Arcturus Therapeutics, Inc., a commercial mRNA medication and vaccine business, and Axcelead, Inc., which oversees a collection of top pharmaceutical and healthcare platform firms, partnered to develop ARCALIS. In addition to contract development and manufacturing organization (CDMO) services, ARCALIS is involved in the development of mRNA medicines and vaccines. In order to produce mRNA vaccines domestically, the business intends to set up a whole system that includes making formulations and active medicinal components as well as developing manufacturing methods.
In 2024, the FDA approved 50 new drugs, slightly down from 55 in 2023, but this raised the ten-year average to 46.5 approvals per year, the highest in over 20 years. According to Nature Reviews Drug Discovery, 64% of these were small molecules (32 drugs), 32% were protein-based (16 drugs), and 4% were oligonucleotides (2 drugs). Oncology saw the most approvals, with 15 drugs (30%), followed by dermatology and hematology with 6 drugs each (12%), and cardiovascular treatments with 5 drugs (10%). Although the total number of approvals and small molecules increased and decreased since 2022, the percentage of small molecules has consistently risen, from 57% in 2022 to 62% in 2023 and 64% in 2024. Over the last five years, small molecules have accounted for 64.6% of FDA approvals, underscoring their major role in pharmaceutical innovation.
Recipharm is a world-leading CDMO that focuses on the development and manufacturing of biologics and small molecules. The full-year 2024 revenue was €827 million, an increase of 7% from 2023. In 2025, the company focuses on expanding continuous manufacturing, high-potency product development and manufacturing, and further investments in sterile fill-finish.
Catalent, Inc. is a leading global CDMO company that provides CDMO services, delivery technologies, and manufacturing solutions to develop pharmaceuticals, biologics, and consumer health products. The net revenue of the company in the fourth quarter of 2024 was $1.3 billion, an increase of 24%. The net revenue in the fiscal year 2024 was $4.38 billion.
In October 2024, according to Thermo Fisher Scientific, Accelerator Drug Development is being launched. Michael Shafer, executive vice president and president of biopharma services at Thermo Fisher Scientific, stated in a press release that the company is revolutionizing drug development and manufacturing procedures to help clients advance vital programs to quickly, effectively, and efficiently address global health concerns.
Partner with our experts to explore the Small Molecule CDMO Market at sales@towardshealthcare.com
