CPhI Worldwide, organised by UBM EMEA, releases the findings from its recent roundtable debate on the global growth in finished dosage forms, ahead of the launch of a new co-located event at CPhI Worldwide in October (4-6th). The new Finished Dosage Formulation (FDF) event will be the first global pharma platform dedicated to the manufacture, development and supply of finished dosage forms.
Chief amongst the trends reported was the increased need for different segments of the supply chain to work together in the creation of new patented drugs or value-added generics.
“Outsourcing for delivery systems is another key trend, as is partnering with more established companies in specific segments. For instance, if you only have a single oncology product, partnering and out-licensing with someone who has a wider dossier is a very good strategy.” Alan Sheppard, Principal, Global Generics and Biosimilarsat IMS Health.
Licensing and partnerships are integral to growth because they allow market entry with lower risks, and capitalise on local knowledge to speed-up regulatory approvals and pricing processes.
The key technology challenge for both generic and patented formulations is access to new technologies – spray drying, micronisation, hot melt extrusion and nano formulations – which enable the creation of more advanced, bioavailable and patient friendly combinations.
As the majority of simple formulations have already been created, generic companies must develop innovative delivery mechanisms to add value to the original patented formulation and remain competitive.
“Companies producing finished formulations need to partner and outsource more to get the correct mix of technologies and this is where we saw a huge opportunity for CPhI to introduce a finished dosage event. What we are attempting to do is bring Big Pharma and CMOs, to out-licensing and dossier specialists, end product distributors, and generic pharma companies to one location so that our clients can find new partners.” Cara Turner, Event Manager for Finished Dosage Formulation.
Citing IMS figures, Alan Sheppard reported that, in the last 4-years, the USA (58%) and Europe (17%) have dominated growth in new speciality medicines – with the largest profit opportunities in smaller patient cohorts and speciality drugs, where there are still unmet patient needs. However, in generic formulations, although the US still represents 28% of growth, the pharmerging markets are really the driving force underlying this with 58% of growth. Significantly, and perhaps due to patient concerns in these regions, branded generics in emerging markets, particularly in Asia, are strongly preferred – whereas in the developed economies in-prescribing is most common.
Generic companies and CMOs are now reimagining what is possible – as access to new technologies opens up more opportunities for innovative development. But collaborations are even stretching to excipient technologies says Jim Miller, president of PharmSource, as they help “facilitate matrix and multi-particulate formulations – allowing increased bioavailability, all of which has put new demands on the performance of excipients.”
Sheppard added, “one company cannot offer full development capabilities, we need outsourcing to increase knowledge, whether in terms of local market entry, manufacturing, development or distribution – partnerships are clearly going to increase”.
The analysts concluded that Indian generic producers can anticipate sustained period of growth. For larger manufacturers, supply into global markets will continue – including the resurgent USA market – but small and medium sized enterprises should concentrate on domestic growth.
Two major possible market challenges are the impending costs of GDUFA ii in the United States – particularly for CMOs with limited generics production. And, for generic companies, a longer-term question will be “how to get a fair reward for incremental formulation developments,” added Paul Fleming, Technical Director of the British Generic Manufacturers Association.
Rutger Oudejans, Brand Director – Pharma at UBM EMEA, closed by saying:
“We envisage this sector of CPhI Worldwide to drive considerable growth and importantly, attract a new delegate profile to the event. There are clear opportunities for diagnostic providers, licensors, delivery platforms and distributors, in addition to our current visitor base who will have access to a wider range of partners.”