Experts analyse growth in the finished dosage market ahead of CPHI Worldwide launch
New drug delivery and bioavailability technology driving growth globally.
CPHI Worldwide 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, 4-6 October. 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,” said Alan Sheppard, Principal, Global Generics and Biosimilars at 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,” said Cara Turner, Event Manager for Finished Dosage Formulation.
Citing IMS figures, Alan Sheppard reported that, in the last 4 years, the US (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 US 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 US – 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.”
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News Pharmapack 2024 - From the Floor
Paris once again welcomes Europe’s leading trade show in pharmaceutical packaging and drug delivery innovation. Join our content team as Pharmapack 2024 opens its doors to leading experts and innovators in pharmaceutical packaging and drug delive... -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most. -
News CPHI Barcelona 2023: Loading Potential – Artificial Intelligence for Pharma Manufacturing
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most. -
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News CPHI Podcast Series: Start-ups take centre stage at CPHI Barcelona
The first episode of the CPHI Podcast Series since we attended CPHI Barcelona in October covers the Start-up market at the event, with expert Matthew Wise joining Editor Lucy Chard to discuss the event.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance