As per Future Market Insights (FMI) latest industry analysis, the global small molecule CMO/CDMO industry demand is valued at around US$ 74,998.1 Million in 2024. The market is anticipated to exhibit a CAGR of 5.2% over the forecast period 2024 to 2034. It is anticipated to attain a valuation of US$ 124,532.4 Million by 2034.
A small-molecule active pharmaceutical ingredient (API) refers to the chemically synthesized, low-molecular-weight compound that constitutes the active therapeutic component of a pharmaceutical product. It is responsible for the desired therapeutic effect of the drug by interacting with specific biological targets in the body.
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Demand for Small-molecule API are characterized by their well-defined chemical structures, relatively simple molecular configurations, and the ability to be synthesized using established chemical processes. Pharmaceutical firms can use the knowledge and resources of outside organizations for manufacturing and development. This can help them concentrate on their core strengths, such as research and development, thanks to the outsourcing strategy.
The expansion of the biopharmaceutical pipeline means that pharmaceutical companies have a large number of drug candidates in multiple stages of development. This increasing workload can lead to resource constraints across pharmaceutical companies. This is set to promote them to seek external partners such as CMOs and CDMOs to handle aspects of drug development and manufacturing.
Different small-molecule drug candidates have unique characteristics and requirements. CMOs and CDMOs that offer specialized expertise in areas such as formulation, process optimization, and analytical testing are sought after to address the specific needs of each drug candidate.
With more drug candidates in the pipeline, pharmaceutical companies are under pressure to accelerate development timelines to bring promising drugs to market sooner. Outsourcing to CMOs and CDMOs can help streamline development processes and expedite time-to-market.
A growing pipeline often leads to the need for global market expansion. CMOs and CDMOs with global manufacturing capabilities can support pharmaceutical companies in reaching new markets and ensuring consistent supply. Moreover, outsourcing to CMOs and CDMOs provides access to their innovative technologies, advanced manufacturing processes, and formulation expertise, contributing to the successful development of novel drug candidates.
Key Takeaways from the Small Molecule CMO/CDMO Market Study:
- By product, the standard API segment held a lucrative small molecule CMO/CDMO market share of 7% in 2023.
- By service, the process development segment is expected to hold over 8% market value share by the end of 2034.
- By company size, the mid-sized company segment is set to progress at a 8% CAGR, totaling a valuation of US$ 55,615.8 million by 2033.
- By the scale of operation, the commercial segment is set to expand at a high CAGR of 6%, totaling US$ 90,027.3 million in 2033.
- East Asia is considered the leading region, with a value share of 0% at the end of the forecast period.
“Increasing funding, research grants, public-private investments, and technological advancements, such as continuous manufacturing and process automation, are responsible for the growth of the small molecule CMO/CDMO market,” opines Sabyasachi Ghosh Associate Vice President at Future Market Insights (FMI).
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Competitive Landscape:
Acquisition and expansion among leading companies or brands is the key strategy of renowned manufacturers in the global small molecule CMO/CDMO market. Companies such as Ajinomoto Bio-Pharma Services and Asymchem are aiming to enhance their presence in the market and compete with other players during the estimated years.
Key Companies Profiled:
- Pfizer CentreOne
- Baxter BioPharma Solutions
- Catalent
- Lonza
- Syngene International
- Boehringer Ingelheim
- Piramal Pharma Solutions
- Wuxi AppTec
- Patheon (Thermo Fisher Scientific Inc.)
- Adare Pharma Solutions
- Ajinomoto Bio-Pharma Services
- Ascendia Pharma
- Asymchem
- August Bioservices
- Cambrex
- Nanoform
- PCI Pharma Services
- Quotient Sciences
- Societal™ CDMO
- Siegfried Holding AG
- Corden Pharma International
Following are a handful of examples of acquisitions made by them to be at the top position:
- In August 2020, Ajinomoto Bio-Pharma Services added a new 8,500-square-meter production facility to its Visakhapatnam, India site, increasing its capability for manufacturing small molecules.
- In November 2022, Snapdragon Chemistry, a United States-based chemical technology company that offers experience in continuous manufacturing and early-stage chemical process development services to the pharmaceutical and fine chemical industries, was acquired by Asymchem. It is a contract development and manufacturing organization (CDMO) catering to the global pharmaceutical and biotech industry.
Key Market Segments Covered in Small Molecule CMO/CDMO Industry Research:
By Product:
- Standard API
- HPAPI
By Service:
- Process Development
- Analytical Method Development
- GMP Manufacturing Service
- Scale-Up and Tech Transfer
- Quality Control and Quality Assurance
- Regulatory Assistance
- Technology and Innovation
By Company Size:
- Large
- Mid-sized
- Small
By Scale of Operation:
- Clinical
- Phase I
- Phase II
- Phase III
- Commercial
By Region:
- North America
- East Asia
- Western Europe
- Eastern Europe
Author By:
Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.) holds over 12 years of experience in the Healthcare, Medical Devices, and Pharmaceutical industries. His curious and analytical nature helped him shape his career as a researcher.
Identifying key challenges faced by clients and devising robust, hypothesis-based solutions to empower them with strategic decision-making capabilities come naturally to him. His primary expertise lies in areas such as Market Entry and Expansion Strategy, Feasibility Studies, Competitive Intelligence, and Strategic Transformation.
Holding a degree in Microbiology, Sabyasachi has authored numerous publications and has been cited in journals, including The Journal of mHealth, ITN Online, and Spinal Surgery News.
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