As per Future Market Insights (FMI)’ latest industry analysis, the global sterile injectable CDMO market was valued at around USD 10.1 billion in 2023 and is anticipated to exhibit a CAGR of 11.7% over the forecast period. The market value is projected to increase from USD 11.1 billion in 2024 to USD 33.7 billion by 2034.
The sterile injectable CDMO market is shifting towards an end-to-end business model, offering comprehensive services from API development to finished drug product manufacturing. This shift is driven by the high demand for accelerated development timelines and speed to market, especially in the biologics sector.
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Leading CDMOs are escalating their integrated capabilities to provide seamless solutions, offering high cost flexibility and mitigating supply chain risks. The industry is also embracing standardized modularization to improve manufacturing efficiency and flexibility.
Increasing number of biologics in the pipeline and the trend of outsourcing are set to fuel growth in the market. Biopharmaceutical companies are expected to dominate the industry due to the rise in end-to-end outsourcing services, especially among small and mid-sized pharmaceutical companies lacking bulk capacity manufacturing expertise.
Key Takeaways from the Market Study:
- By manufacturing, the commercial manufacturing segment set to hold a lucrative share value of 57.2% in 2024.
- By services, the stand-alone segment is projected to hold the highest share of 61.1% in in terms of value in 2024.
- By drug type, monoclonal antibodies held a lucrative value share of 23.5% in 2023.
- By end-user, the pharmaceutical companies segment held a lucrative value share of 39.1% in 2023.
- North America is considered the leading region with a value share of 36.0% in 2023.
“The IV mode of application is gaining traction due to its rapid and precise treatment in emergency and hospital settings. Its growing demand for usage in intravenous drugs in chronic conditions is also pushing sales. Pharmaceutical companies are relying on large-scale production and reliable supply chain management partners to gain a competitive edge in the industry,” says a lead analyst at Future Market Insights (FMI).
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Market Competition:
Key sterile injectable contract manufacturing companies are implementing strategic initiatives like mergers and partnerships while escalating production capacity to enhance industry positioning. Abbvie, Famar, Polfa Tarchomin, Pfizer, Quotient Sciences, Temad Co., Tianjin Hankang Pharmaceutical Biotechnology, and Fareva are the leading manufacturers in the sector.
For instance,
- In July 2023, Evonik and Heraeus Precious Metals collaborated to broaden their range of services for highly potent active pharmaceutical ingredients (HPAPIs).
Leading Sterile Injectable CDMO Brands:
- Sharp
- Astral SteriTech
- Evonik
- Aurigene Pharmaceutical Services
- Prague Scientific
- Ethypharm
- TriRx Pharmaceutical Services
- Biophrama Group
- Gensenta Pharmaceuticals
- BioTechnique
- Mithra CDMO
- S.C. Rompharm Company SRL
- Flagship Biotech International Pvt. Ltd
- Curida AS
- BirgiMefar Group
- Brooks Laboratories Limited
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Key Segments of Market Report:
By Manufacturing:
As per manufacturing, the sector has been categorized into preclinical manufacturing, clinical manufacturing, and commercial manufacturing.
By Services:
The segment is categorized into stand-alone services and integrated services. The stand-alone services segment is further segregated into drug formulation and development, aseptic fillings, analytical development, regulatory support, packaging and assembly services, technology transfer, supply chain management, and quality control and assurance.
By Drug Type:
Different drug types include monoclonal antibodies (mAbs), cytokines, insulin, peptide hormones, vaccines, immunoglobulins, blood factors, peptide antibiotics, and others.
By Organization Size:
Organization size segments include small, mid-sized, large, and very large.
By End-user:
Based on end-users, the sterile injectable CDMO sector is segmented into pharmaceutical companies, biopharmaceutical companies, research institutes, and others.
By Region:
Industry analysis has been carried out in key countries of North America, Latin America, East Asia, South Asia and Pacific, Western Europe, Eastern Europe, and the Middle East and Africa.
About Future Market Insights (FMI)
Future Market Insights, Inc. (ESOMAR certified, recipient of the Stevie Award, and a member of the Greater New York Chamber of Commerce) offers profound insights into the driving factors that are boosting demand in the market. FMI stands as the leading global provider of market intelligence, advisory services, consulting, and events for the Packaging, Food and Beverage, Consumer Technology, Healthcare, Industrial, and Chemicals markets. With a vast team of over 400 analysts worldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries.
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