Investigational New Drug CDMO Market

Investigational New Drug CDMO Market Analysis

The Investigational New Drug CDMO Market size is estimated at USD 4.74 billion in 2025, and is expected to reach USD 6.51 billion by 2030, at a CAGR of 6.55% during the forecast period (2025-2030).

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 Market Trends

The Contract Manufacturing Segment is Expected to Witness Significant Growth During the Forecast Period

Pharmaceutical drugs have a complex structure, which makes it difficult for companies to meet the requirements of specific techniques and equipment during mass production. Therefore, companies usually opt for a contract manufacturing process.

Segmental growth is majorly driven by factors such as increasing strategic activities taken by the companies and the growing demand for contract manufacturing in the pharmaceutical and biotechnology sectors. For instance, in May 2022, ALSA Ventures collaborated with Lonza to help ALSA’s development of pre-clinical and early clinical biotechnology products and manufacture biologics and small molecule drug candidates. The collaboration aimed to significantly increase the chances for the future success of these therapies by providing early de-risking, development, and manufacturing services. Such company activities in contract manufacturing are expected to propel segmental growth over the forecast period.

In September 2022, Bora Pharmaceutical Laboratories Inc. (Zhunan), a division of Bora Pharmaceuticals, partnered with TaiRx Inc., a new drug development company based in Taiwan, to manufacture a novel anti-cancer drug, CVM-1118. In various human cancer cell lines, CVM-1118, a novel small molecule chemical entity, exhibits substantial anti-cancer efficacy, a large safety margin, and multiple modes of action in targeting cancer-specific components.

Therefore, owing to rapid movement by the CDMOs, the segment is expected to grow significantly during the forecast period.

North America is Expected to Hold a Significant Market Share Over the Forecast Period

The North American countries have well-established pharmaceutical and biotechnology sectors, which is beneficial for the market. Also, these countries have made significant investments in research and development activities, fueling market growth across the region.

The growing focus on expanding and launching manufacturing facilities in various countries to fuel the production of biopharmaceutical drugs is expected to propel the growth of the market. For instance, in September 2023, Bolt, a California-based clinical-stage biotechnology company, partnered with Samsung Biologics to accelerate the execution of its early-phase drug development for IND submission. With such partnerships, the market is expected to witness considerable growth in the United States.

Companies that are involved in investigational new drugs tend to wait for the FDA's Safe To Proceed letter before proceeding further. The process is time-consuming; hence, companies are taking advantage of a pre-IND labeling and packaging strategy for their clinical studies. Companies such as PCI Pharma Services are doing this by working with a CDMO operating in Canada. PCI Pharma Services is the only company in Canada that provides clinical trial services. Hence, with the emergence of such companies, the IND CDMO market in the country is expected to grow significantly in the coming years.

Therefore, with increasing company activities and high investments in R&D, the market is expected to grow in the region during the forecast period.

Investigational New Drug CDMO Industry Overview

The investigational new drug CDMO market is semi-consolidated, with several companies operating globally. Most companies are engaged in strategic activities like mergers and acquisitions, collaborations, and partnerships to sustain in the market. Some of the key players involved in the market are Lonza, Charles River Laboratories International Inc., Labcorp Corporation, Recipharm AB, and Syneous Health.

Investigational New Drug CDMO Market Leaders

Investigational New Drug CDMO Market News

• September 2023: Societal CDMO Inc. announced new project expansion agreements with several existing customers. The six new scopes of work across four different current customers highlight Societal’s ability to drive revenue growth through the ongoing strengthening and maturation of existing relationships.
• April 2023: Lonza signed an agreement with ABL Bio, a pioneering Korean biologics company with a focus on bispecific antibodies for immuno-oncology and neurodegenerative diseases. As part of the collaboration, Lonza provides ABL Bio with an end-to-end solution to support its Investigational New Drug (IND) application.