5 Advantages of Outsourcing GMP API Production to CMOs

30 Jun.,2025

 

5 Advantages of Outsourcing GMP API Production to CMOs

Contract Manufacturing Organizations (CMOs) are manufacturing companies that produce drugs, medical devices, and Active Pharmaceutical Ingredients (APIs) for pharmaceutical companies. 

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The pharmaceutical CMOs market was valued at US$98,487 million in and is expected to grow at a CAGR of 6.9% from -. This article outlines why pharmaceutical companies are increasingly outsourcing production to CMOs, lists associated industry benefits, and provides a market outlook.

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Sourcing pharmaceutical materials can be challenging for some companies, mainly when specific pharmaceutical ingredients are unavailable or cost-intensive. CMOs help streamline the drug production process, allowing pharmaceutical companies to focus on research and development. 

Other benefits of contracting production to CMOs include:

1. CMOs fill in gaps when specific substances are unavailable.

CMOs usually manufacture drugs that have been developed by biotech firms or pharmaceutical companies and approved by regulatory bodies. However, CMOs may also produce pharmaceutical products currently unavailable for several reasons, including those still undergoing clinical trials

4. CMOs can help ensure regulatory compliance.

CMOs typically have strict quality control procedures in place, producing APIs to high standards in accordance with Good Manufacturing Practices (GMP)

5. CMOs enable a faster time-to-market.

Contracting API production to CMOs can help pharmaceutical companies bring drugs to market quickly. CMOs typically achieve faster manufacturing by leveraging streamlined processes and economies of scale when compared to in-house manufacturing.

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Types of Drugs Produced by CMOs

CMOs manufacture a wide range of pharmaceutical products, including:

  • Active Pharmaceutical Ingredients (APIs)
  • Small Molecules
  • Generic Drugs
  • Biologics
  • Biosimilars
  • Over-The-Counter (OTC) drugs
  • Pharmaceutical Intermediates 

APIs vs. Pharmaceutical Drugs

APIs refer to one or more active substances within a drug, while the drug is the final product administered to the consumer.  

APIs vs. Pharmaceutical Intermediates

Pharmaceutical intermediates are chemical compounds synthesized during the API manufacturing process. 

Intermediates are not intended for final use by consumers, but are essential components that are subjected to additional processing to manufacture the API. In contrast, APIs are biologically active compounds associated with the effect of the drug.

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CMO Market Outlook

According to the Milan-based Chemical Pharmaceutical Association (CPA), the World Pharmaceutical Contract Research and Manufacturing Services (PCRAMS) industry is growing rapidly. 

The association recently released a report claiming that revenues rose 10.8% on average every year to reach $70 billion in  . Regions of focus include China with 26% year-over-year growth, and India. 

Recent research by Visiongain reveals that the CMO industry is expected to grow at a CAGR of 6.9% from -. According to the report, growth is catalyzed by technological innovation, specifically data integration across multiple systems, data repositories that provide insights into drug performance, and software applications that improve trial design.

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