Page 7 - CW E-Magazine (Oct-Nov-2023)

Point of View

India’s API industry - meeting the new challenges

India’s pharmaceutical industry has greatly benefitted from
the outsourcing trend in APIs over the last decade or so – as has October / November 2023 • Special Issue for CPhI Worldwide / CPhI India
China’s – and the success of the early entrants has prompted
many others to hitch on the bandwagon. This too has not been India’s API industry - meeting
the new challenges
without consequence. Competitive pressures – particularly
in the generic API industry – is intense today, and margins
are under pressure. In response, progressive companies are
reshuffling portfolios, shedding commoditised products and
moving up the value chain through upstream and downstream
integration, and by focussing on specialty segments that de-
mand specialised skills and manufacturing capabilities.

Opportunities in the biotech space ….
The rise of the biological drugs and the strong likelihood
that they will have an even larger role to play in the future, Also in this issue: • Drug Formulation
• Flow Chemistry
• Discovery Pipeline
• Sustainability Practices
poses both opportunities and challenges for Contract Devel- • Pharma Services • Happenings
opment and Manufacturing Organisations (CDMOs).
Serving this market requires specialist equipment and skill-sets, such as aseptic processing. CD-
MOs who invest in new lines and facilities to accommodate such needs can look forward to several
years of growth.

A sizeable portion of the new biologics is coming from boutique firms and their outsourcing needs
and strategies differ from that of Big Pharma – the traditional driver of the CDMO business. While the
latter typically want to outsource a limited component of their needs, biotech companies generally see
outsourcing as fundamental to their business plan.

…. And in small molecules
At the same time, small molecules continue to make up a significant portion of the development
pipeline. An analysis by Global Data reveals that in 2021, 47% of drugs in the pipeline were small
molecules. This is a domain CDMOs are more familiar with, and it will also afford significant growth
opportunities as well.

One or many partners?
For the companies seeking CDMOs, there have historically been a plethora of options – except
in some niche areas. Once the decision to outsource has been taken, the choice then comes down to
whether to go with multiple partners – say, for the API and the FDF – or go with one capable of offer-
ing the full spectrum of services. Some of these choices now need to be made early in the development

Chemical Weekly October / November 2023 3