The market size of the global Investigational New Drug CDMO market in the year 2021 is valued at 4.69 billion and is predicted to reach 7.47 billion by the year 2030 at an 5.56% CAGR during the forecast period.
A growing number of pharmaceutical companies have recognized the potential profitability in working with a CMDO for both clinical and commercial stage manufacturing due to the rising demand for generic drugs and biologics, the capital-intensive nature of the industry, and the complex manufacturing requirements. The market is expected to rise due to factors like pharmaceutical companies' greater reliance on outsourcing, more R&D spending, and stringent regulations for the conduct of clinical trials. When the drug's sponsor decides to look into the new molecule's diagnostic or therapeutic potential in humans, the FDA becomes involved in developing a novel drug. New molecules are initially screened for pharmacological activity and acute toxicity potential in animals. Following that, the molecule acquires a unique legal standing as a novel drug under the Federal Food, Drug, and Cosmetic Act, subject to the particular requirements of the drug regulatory system.
The pharmaceutical business will experience an increase in innovation, with cancer and rare diseases anticipated to profit the most, according to the post-pandemic pharmaceutical environment. Contract services are likely to significantly increase due to the recent spike in investigational new drug (IND) applications, with an estimated 75 yearly FDA approvals anticipated by 2025. 3,806 IND applications were submitted to the FDA between April 2020 and June 2020, surpassing the total for the previous eight years (3,576 from 2012-2019).
The Investigational New Drug CDMO market is segmented on the product, service and end-user. Based on product, the market is segmented into small and large molecules. Based on service, the market is segmented into Contract Development (Small Molecule (Bioanalysis and DMPK studies, Toxicology Testing, Pathology and safety pharmacology studies, Drug substance synthetic route development, Drug substance process development, Form selection crystallization process development, Scale-up of drug substance, Preformulation, Preclinical formulation selection, First in Man Formulation/Process Development, Analytical method development/validation, Release testing of drug substance and drug product, Work up Purification Steps, Telescoping & Process Refining, Initial Optimization, Formal stability of drug substance and drug product)), Large Molecule (Cell Line development, Process Development (Upstream (Microbial, Mammalian, Others), Downstream (MABs, Recombinant proteins, Others)), Contract Manufacturing (Small Molecule (Oral Solids, Liquid and Semi-solids, Injectables, Others), Large Molecule (MABs, Recombinant proteins, Others))). Based on the end-user, the Investigational New Drug CDMO is segmented into Pharmaceutical Companies, Biotech Companies and Others (Government, Research Institutes, Academic Institutes, etc.).
Based on product, the small molecules segment is accounted as a major contributor to the Investigational New Drug CDMO market.
Based on product, the market is segmented into small and large molecules. The small molecule category dominated the market, and the growing number of small molecules under research is partly to blame for this. More than 90% of the medications available today are small molecules. Throughout the forecast period, the large molecule category is predicted to grow fastest. This is essentially a result of pharmaceutical and biotech firms spending more money on the discovery and development of large molecule therapeutic proteins because of their specificity, which enables the targeting of disease states like oncology, neurology, and metabolic disease that were previously challenging to treat.
The contract development segment witnessed growth at a rapid rate.
Based on service, the market is segmented into Contract Development and Contract Manufacturing. The contract development category dominated the market. Contrary to internal drug development, contract development has several advantages, including easier access to industry specialists, a quicker time to market, lower costs, and a stronger emphasis on core skills. Due to a lack of internal resources, most small pharmaceutical and biopharmaceutical companies seek to outsource their drug development efforts. Over the projected period, this is anticipated to boost the market.
In the region, the North America Investigational New Drug CDMO market holds a significant revenue share.
The North American Investigational New Drug CDMO market is expected to register the highest market share shortly. This can be linked to the rise in R&D expenditures by pharmaceutical and life sciences firms, which are anticipated to raise the demand for contract manufacturing in the area. An investigational drug must travel an average of 12 years in the United States before it reaches the pharmacy. Only five of 5,000 drugs that go through preclinical research reach human clinical trials. One of the five drugs that have undergone human testing has received FDA approval. As a result, only 1 in 5,000 innovative drugs make it to the market. In addition, Asia Pacific is projected to grow rapidly in the global Investigational New Drug CDMO market. The region will probably increase substantially because of the quick expansion of pharmaceutical companies and contract manufacturing organizations in developing nations like China and India. Businesses involved in biotech are growing in the area. Principal Investigators (PIs) and well-known opinion leaders have also increased.
The key players in the Investigational New Drug CDMO market have shifted their focus toward product manufacturing and are initiating significant strategies such as mergers, acquisitions, and joint ventures of major and domestic players to enhance their product portfolio and strengthen their global market footprint. Some key players in the Investigational New Drug CDMO market are Lonza; Catalent; Recipharm AB; Siegfried Holding AG; Thermo Fisher Scientific Inc.; Covance Inc.; Charles River Laboratories; Cambrex Corporation; IQVIA Holdings Inc.; Syneous Health.