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Moving Towards Specialty APIs

molIn a recent issue of PharmTech, Agnes Shanley wrote an article on the specialty markets and services driving the growth of APIs in which we were featured. For me, the key takeaway is that ‘specialty markets’ are ceasing to be niches, and are trending towards becoming the norm. I’ve referenced this in the past  – we’re deep into the era of API customization, and it has driven much of Neuland’s growth and expansion over the last decade. Two examples: peptides and deuterated molecules.

I’ve written a great deal about peptides in the last 12 to 18 months. Over the course of the last six years, we’ve transitioned from simply providing building blocks, to synthesizing bulk quantities of fairly long-chain peptides for clients.

Deuteration, as the article notes, is gaining attention as a method for repurposing mature drugs in novel formulations to address a different medical need, provide a better delivery mechanism, etc. It’s an area where we’ve focused on strengthening our niche expertise.

Specialty APIs – More Common, More Complex

Yes – the pharma and biopharma segments are full of specialty APIs. And while becoming more commonplace, the APIs are also getting more complex. It continues to drive expansion as well as merger activity across the industry as CROs, CMOs and CDMOs seek to remain competitive.

At Neuland, we’re continuing to plan for the future of API specialization in a number of ways:

  1. We will continue to emphasize our complex chemistry expertise, which takes on added importance as APIs and formulations grow larger and more complicated. (I shared an example in the article of a material that is more difficult to synthesize and possesses complex particle size requirements – metered dose inhalers for respiratory therapies.)
  2. We recently launched an expansion of our API R&D labs, adding process engineering & parallel processing capabilities and additional tools & instrumentation. The expansion will be complete by the end of this year.
  3. We are also expanding our data mining capabilities to deliver best-in-class drug development services.
  4. We’ve strengthened our emphasis on training & Quality by Design. We’re building a culture that emphasizes QbD – a reflection of its ability to have a positive impact on quality. We are also building the corresponding infrastructure to ensure customer regulatory filings will have the strongest supporting data.

Beyond the scope of what we’re doing at Neuland, the entire article at PharmTech is worth a read, and provides a nice market size/share snapshot of the API and specialty API markets.

 

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