Significance of CDMOs in the Pharmaceutical Industry

Significance of CDMOs in the Pharmaceutical Industry

By: Akhil Pathak (Twitter: @akhilpathak86)

The pharmaceutical or pharma industry plays an incredible role in ensuring the health & wellness of the masses. The ongoing Coronavirus pandemic has made us realise, how crucial it is for the pharma industry to evolve on a continual basis and efficiently address the issue of disease prevention/treatment. 

Gone are the days when drug discovery, formulation and its subsequent commercialised distribution were limited to a handful of big global pharma players. With the advent of technology and availability of a smart ecosystem comprising of CDMOs, more & more pharma companies are registering their presence on the block, leading to faster new drug-substance discoveries, scaled up manufacturing and global distribution of pharma products on an unprecedented level.

What is a CDMO?

CDMO stands for Contract Development and Manufacturing Organisation. A CDMO is an entity that basically offers its services to pharma companies right from as early as the preclinical research phase in the drug development cycle and all the way to the commercial manufacturing & distribution of the drug-substance. CDMOs cater to all the requirements of their clients with respect to the drug that is intended to be launched and offer a partnership that ensures consistency & efficacy.

Image Source: europeanpharmaceuticalreview.com

Salient Features of a CDMO

Drug development is an expensive process that consumes a lot of time & resources. More often than not, despite discovering a promising molecule, it is not commercially viable for certain small pharma companies to go ahead with the process of drug development that requires a huge & costly setup. Be it outsourcing APIs (Active Pharmaceutical Ingredients) or getting licences/approvals as well as meeting deadlines vis-a-vis the delivery schedule of the end product, CDMOs make the process of drug development a lot easier.

CDMOs basically provide clinical research and laboratory services for drug development as well as manufacturing solutions for various drug products & substances such as small molecules and biologics.   

CDMOs track the latest developments in the broader health care sector and have a very good understanding of the current market dynamics as well as the trends that could drive the market in the future. Therefore, partnering with a CDMO considerably helps in a structured & well-planned out launching of a drug.  

However, it is not only the small pharma players that opt for the services of a CDMO. Even the large pharma companies that sometimes find it difficult to cater to their huge order book, readily partner with CDMOs.

A CDMO fundamentally offers: 

• Data Driven Analysis
• Dedicated & Qualified Chemists/Researchers
• Assistance or Navigation in Acquiring Licences/Approvals from Regulatory Bodies
• Setting Up of Specialized Manufacturing Units for the Drug
• Trained Staff/Human Resource
• Timely Delivery
• Understanding of the Consumer Market
• Robust Distribution Mechanism
• A Long Term Client-Partner Relationship

All of the above mentioned aspects make CDMOs an invaluable resource to the pharma companies and thus they are playing a critical role in rapidly getting new drug-substances in the consumer market thereby, directly strengthening the overall health care system.

A Real Trend Changer

While there are multiple types of drug forms that are used to address different health issues/conditions among people, one such form of drug has taken the centre-stage in the times of the COVID-19 pandemic. 

Yes, we are talking about vaccines!

 

Prior to the pandemic, most of the prominent or ‘big-pocketed’ pharma players used to manufacture their vaccines in-house i.e. entirely on their own as they had apprehensions about the ability of CDMOs to handle the complex & sophisticated processes involved in the manufacturing of a vaccine. 

However, the sudden need for billions of doses of vaccine and that too on an expedite basis, has made the CDMOs- an integral part of the pharmaceutical industry and global healthcare system. 

With speedy vaccine productions backed by solid data-driven analysis as well as adequate phased clinical trials and adherence to all regulations as prescribed by the regulatory bodies such as USFDA, DGCI and EMA, a number of CDMOs have successfully lived up to the expectations!

To Sum It Up

A lot has been happening in the CDMO space that is gradually shaping up the future of the pharmaceutical industry. CDMOs have proved their effectiveness in simplifying the task of drug development and have notably brought ease to the process of manufacturing & ultimately distributing the end-pharmaceutical product to the consumer.  

The immensely helpful role that CDMOs have played in tackling the Coronavirus pandemic, has made them emerge as a next-gen integrated & inclusive business model. It is time that the pharmaceutical industry at large, acknowledges the significance of CDMOs and give them their due recognition. One could really hope to see more & more partnerships of big pharma names with CDMOs in the future!

(Akhil Pathak is a Freelance Writer who is an observer of global politics & geo-strategic matters, with special focus on the security framework of India. He keeps a watchful eye on key developments that are related to health, defence and psychology. He also tracks concerning social issues that warrant immediate attention.)