The global Investigational New Drug CDMO Market size is expected to reach USD 6.8 billion by 2028, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 6.9% from 2021 to 2028. This is largely due to the increased R&D investments, along with stringent regulations pertaining to IND.
The U.S. FDA and the European Medicines Agency (EMA) are
health authority bodies that regulate the use of investigational drugs in the
U.S. and the European Union, respectively. In addition, investigational review
boards (IRBs) in the U.S. and ethics committees (ECs) in the European Union
must approve the use of drugs in humans.
It is the requirement of a federal law that a drug be the
subject of an approved marketing application prior to it is distributed or
transported across the state lines. Hence, sponsors aiming to conduct clinical
studies that involve an IND should gain exemption from the FDA to permit the
shipping of the investigational drug to clinical investigators in several
states.
The pandemic has significantly impacted the global
economy in 2020 and has an ongoing impact on various industries. However, the
market for IND CDMO has benefited from the pandemic. Prior to COVID-19,
prospective sponsors demanded facility audits to ensure CDMOs had the required
capacity, equipment, and personnel to undertake their projects. Nowadays, CDMOs
should find new ways to attract new sponsors, such as through videos, virtual
reality, and other technologies that allow sponsors to virtually experience the
site.
Related Press
Release@ Investigational
New Drug CDMO Market Report
Investigational New Drug CDMO Market Report Highlights
- In
terms of product, the small molecule segment dominated the market with a
revenue share of 89.0% in 2020. This is largely due to the increasing
number of small molecules in development. Besides, in 2019, the small
molecules dominated the new drug approvals accounting for 79% of all the
NME approvals
- Based
on service, the contract development segment led the market with a revenue
share of 85.5% in 2020. The contract development offers several benefits
over in-house development of drugs, such as access to industry experts,
less time to market, cost-effectiveness, and more focus on core
competencies
- By
end user, pharmaceutical companies accounted for the largest share of
69.4% in 2020. This is due to the changes in the pharmaceutical industry
that have an impact on research and development strategies, which, in
turn, influence new drug approval trends
- Asia
Pacific to register the fastest growth rate of 7.7% over the forecast
period. Due to the rapid growth of pharmaceutical firms and contract
manufacturing organizations in developing countries, such as India and
China, the region is likely to overtake Europe and North America in the
near future
Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, the company offers market intelligence studies ensuring relevant and fact-based research across a range of industries including technology, chemicals, materials, healthcare and energy.
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