Large Molecule Drug Substance CDMO Market Size, Share, Growth Analysis, By Service(Contract manufacturing and contract development), By Source(Microbial, mammalian, and other), By Region - Industry Forecast 2025-2032

Large Molecule Drug Substance CDMO Market size was valued at USD 10.86 Billion in 2023 and is poised to grow from USD 11.79 Billion in 2024 to USD 22.81 Billion by 2032, growing at a CAGR of 8.6% during the forecast period (2025-2032).

Large molecule drug substance CDMOs are contract development and manufacturing organizations (CDMOs) that offer services for processing large molecules or biologics pharmacological substances. These are businesses that offer services and serve the pharmaceutical sector by assisting customers in the discovery of new drugs through production capabilities. The main drivers of the market are increase in large molecule drug approvals, particularly with the FDA, an increase in the prevalence of infectious diseases, a high demand for novel therapeutics, and higher capital investments by pharma and biotech firms in cutting-edge technologies for forming partnerships with CDMOs. Prior to the COVID-19 pandemic, there was an increase in investment in large molecule drugs due to the abundance of new therapeutic options it provides. The importance of biologics was made even clearer during the race to create treatments and vaccines against the SARS-CoV-2 virus. In particular, for CDMOs able to provide a broad range of COVID vaccination technologies and, to a lesser extent, therapeutic monoclonal antibody products, the demand for both high-volume and high-quality CGMP drug substance and drug product manufacturing services has increased rapidly.

However, new technologies were adopted and utilized in the production of vaccines, monoclonal antibodies, and diagnostic tests in order to combat the pandemic. The pandemic made it clear how crucial it is to have more regional, US-based contract pharmaceutical services and to work closely with universities, manufacturers, drug innovators, and regulatory bodies to provide patients with therapies. Large molecule (drug substance and drug product) production capacity and supply chain would then be constrained as CDMOs compete to develop COVID-19-related medicines in 2019. Drug substance (DS) development, which involves the creation of master and working cell banks, the development of manufacturing processes, and scale-up, and drug product (DP) development, which entails the placement of the drug substance into the primary container, are the two categories under which the development of large molecules drugs is divided. Like all regulatory bodies, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) offers some guidance on how to characterize and evaluate the effectiveness and quality of medicines. Establishing requirements for DS and DP for novel chemical entities is the focus of ICH Q6.

It is challenging to create a large molecule pharmacological material that is affordable, quick to generate, and both effective and safe. The development of formulations is fraught with challenges because of the fragility and complexity of large molecule active substances. In the early stages of drug development, CDMOs have developed critical drivers that include overcoming obstacles and fulfilling deadlines. Encapsulation and the use of buffers are two revolutionary methods available to medication developers that help in the stabilization and protection of large molecular medicinal substances.

US Large Molecule Drug Substance CDMO Market is poised to grow at a sustainable CAGR for the next forecast year.