Madrid, 15 October 2015:CPhI Worldwide, (#cphiww) organised by UBM EMEA, today announces the findings of the final section of its 2015 annual report (part iv, entitled: ‘the Outsourcing perspective’) live from CPhI Worldwide 2015 in Madrid. Four leading experts on the global pharma outsourcing industry give their perspectives on the unique challenges that lie ahead in the near and medium term.
The overall findings reveal that our experts see a continued growth in this sector, and predict further consolidation amongst players, as well as a transforming manufacturing environment with biologics increasingly taking a larger and larger share of global sales. The end result of which will be a smaller number of more flexible and adaptable CMOs and CDMO. All four experts agree that we are entering a crucial period, whereby the ability to move with changing regulatory standards and acquire new niche technologies will be integral in establishing strategic partnerships with pharma.
Gil Roth, President, Pharma and Biopharma Outsourcing Association, states that unlike previous industry consolidations that were chiefly concerned with reaching a critical size and global reach. What we are now seeing is CMOs and CDMOs looking ahead for technologies that either enable them to work with clients earlier in the drug development chain or for solutions that help increase bioavailability – as this remains key challenge across most emerging drug targets. Moreover, a consequence of these processes being essential to a drug’s manufacture, Hedley Rees (Managing Consultant at PharmaFlow Ltd) believes we will increasingly see pharma ‘locked-in’ to certain partners as they are unable to source key platforms elsewhere. This is going to be especially true for biologics, as the regulatory approval is entwined with manufacturing process used during the clinical trial – although QbD may offer more flexibility, despite the high initial set-up costs.
Another factor is the changing storage needs and volumes with biologics, which Hedley warns is at risk of breaking as new biologics, biosimilars and ATMPs arrive. Fiona Withey, Managing Director, UK Clinical Services, PCI Pharma Services, however, argues this is both an opportunity and a threat for the outsourcing community – particularly as many biologic targets are coming from virtual companies with no experience of managing the supply chain. This means that cold chain distribution amongst the CDMO community is going to be absolutely vital to those looking to garner an increasing share of the biologics market coming through into clinical and commercial production. And, in fact, new technologies for real time monitoring of the integrity of the supply chain are going to be sought as a means of competitive advantage. Additionally, market trends for custom parenteral delivery forms such as the auto-injector – to aid patient convenience for injectable medicines – will further complicate the global supply chain.
Biocon CEO & Joint Managing Director, Dr. Arun Chandavarkar foresees a much wider global role for biosimilars in making biologics affordable and accessible, but is imploring Government and regulatory agencies to develop smarter and abridged regulatory processes to enable ‘speed to market’ so that low and middle income countries can receive benefits sooner. He argues that regulators in these jurisdictions will also need to develop capability and confidence to operationalize their biosimilar guidelines if adoption is to be increased rapidly.
Some of the challenges that the industry needs to address are:
‘Interchangeability’ of biosimilars with their original biologic drugs, the recent naming convention guidelines and the long drawn patent litigations, which will determine th e future course. The new substitution policies in Australia and crucially, the FDA’s impending guidelines on interchangeability. These will hopefully lead to simpler processes and faster adoption. However, “Emerging market regulators should be empowered to make the risk-benefit decisions that are most appropriate for the healthcare system in their country, and in many cases, to carve out faster clinical pathways than used in other countries with different risk-benefit equations. However, in all cases, they will need to ensure that the standards of quality and compliance for biosimilar products are at par with the best in the world.” states Dr Chandavarkar.
Finally, Gil Roth also identified the upcoming GDUFA reauthorization in 2017 as a key moment for CDMO prospects in the medium term, as many are struggling with an overly stringent fee burden. And, his feedback from industry watchers is that they are skeptical U.S. regulations under the Drug Supply Chain Security Act will be implemented on time, but no one doubts that serialization will become the norm in the years ahead.
Chris Kilbee, Group Director Pharma at CPhI: “Outsourcing is continuing to grow, but as the drug pipeline is shifting towards biologics and complex formulations we are seeing both the regulatory and business environment evolve. It is crucial that CMOs and CDMOs meet at ICSE to explore new partnerships, new ways of working, and technological collaborations that will be essential in formulating new targets. The short and medium prospects for contract services remain highly positive for those companies that can adapt to market and conditions. But it is clear that information and contacts are doing to essential for companies to remain pro-active rather than reactive and I would encourage all our exhibitors to study our experts findings closely.
The full article will be featured within the CPhI Annual Report (parts i-iv), for more details or to review part iv of the annual report online, please visit: http://www.cphi.com/europe/networking/cphi-pharma-insights
Please also join the debate on Twitter and look out for our live tweet chat at CPhI Worldwide 2015 using the hashtag (#cphichat2015) – which will be displayed throughout the event.
-ENDS-
Notes to editors
About CPhI
CPhI drives growth and innovation at every step of the global pharmaceutical supply chain from drug discovery to finished dosage. Through exhibitions, conferences and online communities, CPhI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities and expand the global market. CPhI hosts events in Europe, Korea, China, India, Japan, South East Asia, Turkey and Russia and co-locates with ICSE for contract services, P-MEC for machinery, equipment & technology, InnoPack for pharmaceutical packaging and BioPh for biopharma. CPhI provides an online buyer & supplier directory at CPhI-Online.com.
For more information visit: www.cphi.com
The UBM EMEA annual schedule of Pharmaceutical events includes; CPhI, ICSE, P-MEC and InnoPack Worldwide (13-15 October 2015, IFEMA- Feria de Madrid, Spain); CPhI, P-MEC, ICSE and BioPh India (1-3 December, 2015 at the Bombay Convention and Exhibition Centre, Mumbai, India); InformEx (02-04 February, 2016); CPhI Russia (30 March – 01 April, 2016 at JSC VDNH (VVC), Pavilion 75, Hall A, Moscow); CPhI, P-MEC and Innopack South East Asia (06-08 April, 2016 at the Jakarta International Expo- Jakarta, Indonesia); CPhI, ICSE, P-MEC, BioPh and InnoPack Japan (20-22 April, 2016 at the Big Sight Exhibition Centre- Tokyo); CPhI Istanbul (1-3 June, 2016 at the ICC Istanbul Congress Center, Istanbul, Turkey); CPhI China and P-MEC (21-23 June, 2016 at SNIEC, Shanghai, China); CPhI Korea (23-25 August, 2016).
About UBM EMEA
UBM EMEA connects people and creates opportunities for companies across five continents to develop new business, meet customers, launch new products, promote their brands, and expand their market. Through premier brands such as TFM&A, Internet World, IFSEC, MD&M, CPhI, Cruise Shipping Miami, the Concrete Show, and many others, UBM Live exhibitions, conferences, awards programs, publications, Websites, and training and certification programs are an integral part of the marketing plans of companies across more than 20 industry sectors.
For media enquiries, please contact:
Alex Heeley or Tristan Jervis
De Facto Communications
T: +44 207 203 6745 / 6740
E: a.heeley@defacto.com / t.jervis@defacto.com
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