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Analysts examine the latest trends in finished dosage forms.
CPhI released findings from its roundtable debate on the global growth of finish dosage forms, according to a June 6, 2016 press announcement. 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 Biosimilars at IMS Health, said in a statement. Licensing and partnerships are integral to growth because they allow market entry with lower risks, and capitalize on local knowledge to speed-up regulatory approvals and pricing processes.
The key technology challenge for both generic and patented formulations is getting access to new technologies including spray drying, micronization, hot melt extrusion, and nano formulations that enable the creation of more advanced, bioavailable, and patient friendly combinations. Generic companies must develop innovative delivery mechanisms to add value to original patented formulation and remain competitive.
Citing IMS figures, Sheppard reported that in the past four years, the United States and Europe have dominated growth in new specialty medicines-with the largest profit opportunities in smaller patient cohorts and specialty drugs, where there are still unmet patient needs. Branded generics in emerging markets, particularly in Asia, are strongly preferred, whereas in the developed economies, in-prescribing is most common.
Generic companies and contract manufacturing organizations (CMO) are now reimagining what is possible, as access to new technologies opens up more opportunities for innovative development. Collaborations are 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.”
According to the analysts at CPhI, Indian generic producers can anticipate a sustained period of growth. For larger manufacturers, supply into global markets will continue, including the resurgent US market-but small and medium sized enterprises should concentrate on domestic growth. Two major possible market challenges are the impending costs of Generic Drug User Fee Amendments II in the US, particularly for CMOs with limited generics production.
CPhI Worldwide’s new Finish Dosage Formulation event is a global platform dedicated to the manufacture, development, and supply of finished dosage forms. CPhI will take place from October 4–6, 2016 in Barcelona, Spain.