Investigational New Drug CDMO Market Size (2024 - 2029)

Investigational New Drug CDMO Market Analysis

The Investigational New Drug CDMO Market size is estimated at USD 4.45 billion in 2024, and is expected to reach USD 7.49 billion by 2029, growing at a CAGR of 6.55% during the forecast period (2024-2029).

The market is majorly driven by factors such as increasing demand for outsourcing services in the pharmaceutical and biotechnology industry and rising research and development (R&D), as well as favorable government support.

For many businesses in the pharmaceutical sector, pharmaceutical outsourcing has emerged as a critical business strategy. Several developments, including cost reduction, globalization, regulatory compliance, faster drug development, virtual and hybrid business models, technical advancements, and risk management, have transformed the pharmaceutical outsourcing environment. For instance, in October 2023, Ampio Pharmaceuticals Inc. announced that it had selected Ascendia Pharmaceuticals Inc. to provide services to support the clinical development of OA-201, a new drug for the treatment of symptomatic osteoarthritis pain. Ascendia Pharmaceuticals, a CDMO, will be responsible for helping the company with the IND application process. Hence, with the activities that are being carried out by such contract development and manufacturing organizations, the market is expected to witness significant growth in the coming years.

Outsourcing offers various productivity benefits, including access to new technology, variability costs, and risk sharing. With contract manufacturing, significant costs can be saved. Besides, it also eliminates the need to juggle between vendors, which helps avoid unexpected costs and significantly reduces labor costs. According to the 20th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, published in April 2023, biomanufacturers incurred more expenses, demanded better technologies, and expressed greater optimism, with 86.9% of biopharmaceutical respondents reporting outsourcing of at least some activities in 2023, up from 82.6% in 2022. Therefore, with the rising outsourcing of biopharmaceuticals, the market is expected to benefit significantly.

However, compliance issues associated with outsourcing are expected to hinder market growth in the long run.

Investigational New Drug CDMO Industry Segmentation

As per the scope of the report, an Investigational New Drug (IND) is a drug that is in the early stages of development and has not yet been approved by regulatory authorities like the US Food and Drug Administration (FDA). IND status allows the drug's sponsor (often a pharmaceutical company) to conduct clinical trials to assess its safety and effectiveness in humans.

The investigational new drug CDMO market is segmented by product, services, end user, and geography. By product, the market is segmented into small molecules and large molecules. By services, the market is segmented into contract development and contract manufacturing. By end user, the market is segmented into pharmaceutical companies, biotechnology companies, and others. By geography, the market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD) for all the above segments.