A Cambrex Webinar- De-Risking the Solid Form Landscape of an API

Sponsored by Cambrex

February 24, 2020

Minimizing development timelines and cost

Dr. David Pearson, Chief Scientific Officer of Cambrex Edinburgh, discusses how a full understanding of the crystalline landscape of an active pharmaceutical ingredient (API) molecule can predict stability and solubility, minimizing development timelines and cost, and how hydrates can be both a challenge and an opportunity.

The market for solid state services is largely driven by the dynamics of the small molecule pipeline, which has been growing strongly over the last five years. The compound annual growth rate (CAGR) for preclinical and Phase I to Phase III clinical trials for the period from 2014–2018 ranged from just under 6% to almost 10%; market research carried out by Cambrex indicates that the number of small molecules in the pipeline has risen from 5,500 small molecules five years ago to more than 7,000 small molecules in 2018.

The progression of a small molecule drug through the clinical pipeline to commercialization typically requires extensive solid-state analytical data, ranging from salt screening, polymorph screening, crystallization studies and process development, to intellectual property screens. The larger pharmaceutical companies will usually have access to in-house screening capabilities, but it is becoming increasingly common within the industry to outsource these analyses to expert laboratories. Some large drug companies have started to divest this capability completely, while several have expanded or set up as service providers.

The total market for solid state services is estimated to be in excess of $150 million¹, of which the outsourced contract development and manufacturing organization (CDMO) market represents more than half of the total at $80 million. The CDMO solid state services market is forecast to grow at a CAGR of 7.3% over the next five years, reaching an estimated value of $114 million by 2024¹.

In the global market there are approximately 30 CDMOs that offer salt selection, polymorph screening, co-crystal screening or related services, of which two-thirds are based in the UK and Europe.

Cambrex is the largest global CDMO focusing on small molecules and has 12 facilities across the US and Europe, in which it has invested significantly. Much of the company’s growth has been organic but recent acquisitions have allowed the company to expand into new markets and broaden Cambrex’s small molecule reach from API all the way through to drug product, early clinical trial supply and analytical services. The site in Edinburgh, Scotland, is the hub for its solid-state services and was part of the 2019 acquisition of Avista Pharma Solutions.

¹Cambrex Marketing & Intelligence; (2019)

 

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