Page 8 - CW E-Magazine (Oct-Nov-2023)

Point of View

process, especially in the case of biologics
where capacity is limited and highly sought
after.

While there are pros and cons of both ap-
proaches, pharma innovators today are more
routinely partnering with their CDMO on an
integrated basis – seeking assisting across the
entire development process, spanning early-
stage development; filing for an investiga-
tional new drug (IND) application; late stage
development; and even commercialisation.
This trend is driven by the multiple benefits
that accrue from this approach including speed
to market, cost efficiency, seamlessness of the
technology transfer process, and ease of man-
aging the relationship.

Mitigating supply chain risks
COVID has brought into sharp focus the
need to avoid disruptions in supply chains for
pharmaceuticals and for ensuring a reasonable
level of security of supplies. In every large
market concern in governments is prompting
strategies to build internal capabilities for key drugs and their raw materials, and/or to ‘near-shore’
outsourcing. How this will play out in terms of the opportunities for Indian CDMOs remains to be
seen, but the industry does not seem too perturbed by the development.

Rising complexity
As drug production becomes more complex, biopharma companies are looking to CDMOs with
specific, specialised technical expertise. Examples include the ability to handle highly potent APIs
(HPAPIs), complex monoclonal antibodies, and the ability to create spray-dried dispersions to over-
come solubility challenges. In areas like gene therapy, mammalian biologics, whole cell therapies,
etc., the number of CDMOs is still limited and capacity is falling behind rising demand. Though
India’s presence in these domains is still limited, it poses an opportunity that cannot be overlooked.

In summary, while India’s API and CDMO industry faces several challenges in its quest to serve
global and local opportunities, opportunities abound as well. The industry is built on a strong platform
and has many decades of proven performance behind it to prove its credentials to global customers.
But it will do well to recognise the new world now evolving – shaped not just by technological evolu-
tion, but also by geo-politics and security concerns.

4 Chemical Weekly October / November 2023