Current drugs pipeline is discouraging and slowing simple manufacturing innovations19 Oct 2017
Experts predict PAT/QbD and CM adoption may take 10 years, with smaller generic players to drop out of the market if unable to innovate in time.
CPhI Worldwide – held in Frankfurt, 24-26 October and organised by UBM – announces the findings of part ii of the 5th edition of the CPhI Annual Report, which focuses on the immediate and long-term trends in pharmaceutical manufacturing and ingredients.
The second part of the report is being launched ahead of CPhI Worldwide, taking place next week (24-26 October 2017), with the full report unveiled to more than 42,000 executives during the event. Three manufacturing and ingredients experts have given their perspectives on both the near- and long-term trends – Emil Ciurczak, President at Doramaxx Consulting; Brian Carlin, the excipients iconoclast, and Girish Malhotra, President at EPCOT International.
The overall findings reveal that the trend towards the increased use of modern manufacturing processes and quality systems is occurring very slowly – with the current small molecule drugs pipeline not yet possessing the economic models and incentives to stimulate faster adoption (e.g., changing to continuous processing is expensive and may not deliver advantages compared with batch for certain drug classes). A lack of excipient innovation and multivariate analysis are also identified as a potential growing risk. Collaboration to develop new excipients will be needed, however, biologics are the most likely to support the development of new excipients, given the high product value and susceptibility to excipient impact on quality.
Girish Malhotra, President of EPCOT International, feels that the global pharma industry is now at a critical point in its history and needs to adopt new business models for the next century. “The current approach of developing new drugs for rare and orphan diseases, and for only the most affluent patient cohorts, is actively discouraging manufacturing innovation” he warns. He adds: “These newer drug are produced in smaller qualities and often feature high margins and profits – meaning the incentive to improve manufacturing processes is not there.” Malhotra presents a number of methods whereby big pharma can sustain long-term profits, open up access to emerging markets by improving manufacturing efficiencies, and therefore reduce their total costs. Most importantly, this will increase the number of patients that can benefit.
“Making drugs affordable is the best long-term way to improve the total sales in the developing countries. Because of the income differences between developed and developing countries, the differences in drug processes will remain for the foreseeable future. Economies of scale and better manufacturing technologies can make drugs more affordable and increase sales. However, to achieve all of this will require a business model review and substantial change. This is not an easy task for an industry that has not aggressively embraced change and innovation. Their focus has always been on new drug development and marketing – drug affordability is an unknown area,” commented Malhotra.
Emil Ciurczak, President at Doramaxx Consulting forecasts that it might take as long as a decade for the industry to see the full potential of its impact – but resistance is futile and, ultimately, only those that adopt QbD/PAT and continuous manufacturing (CM) will survive. However, should the regulators (EMA and FDA) harden their positions and force the industry to work towards a QbD and PAT deadline, we will see rapid purchasing of new equipment, with a race to compete like has happened with serialisation in the last few years.
“Large companies will naturally be the first movers, followed in parallel by their strategic outsourcing partners, and this will become an established practice over the next three-years. For generic companies, and particularly smaller ones, there is an existential debate pending. Do they A, close; B, merge with or acquire other small companies to have the critical mass to invest; or C, as is happening now, partner with the larger pharma companies to produce their off-patent, older (but still in-demand) brands. In ten years, the market will be made of fewer, but larger companies, and the profit generators will be the ones that understand and properly implement QbD”, commented Ciurczak.
Brian Carlin, Excipient Iconoclast, echoed Emil’s thoughts and warned that the industry needs to move to smarter control of its processes, and increased use of PAT, if excipients (amongst other factors) are not to introduce critical and often unforeseen risks into products. He argues that the industry as a whole must now embrace multivariate control over the next couple of years, as current practices are not predictive and will yield passing results until sudden failure. “Investment in PAT and data mining will involve additional costs, but this must be balanced against the increasing Cost of Poor Quality (COPQ) associated with regulatory initiatives on quality metrics and quality culture” added Carlin.
Biologics, he argues, may be the exception to the rule and is the area most likely to support the development of new excipients. Overall, Carlin believes regulators need to provide approval mechanisms for excipients, as the current indirect route of approval via incorporation in a finished product is inimical to innovation. Instead, collaboration between users and the excipient developers must be sought to reduce the commercial risk of new excipient development.
Orhan Caglayan, Brand Director Europe, UBM EMEA: “As the industry’s annual meeting point, the discussions next week at our eponymous global event will be vital in furthering development throughout the industry. From the experts’ point of view, long-term success is dependent on companies adopting modern manufacturing processes, including QbD and PAT, to reduce inefficiencies and excipient risks. We produce this report each year to help our exhibitors and the wider industry to stay ahead of trends and prepare for change, opportunities, and threats. It also helps our attendees to be better informed during discussions with partners at CPhl Worldwide.”
Drivers behind Saudi Arabia’s forecast 10.74 $billion 2022 market
9 Sep 2019
Growing population, increase in non-communicable diseases and major investment in new hospitals, clinics and treatments driving growth.Read more
Take part in pharma’s largest reputation survey
6 Sep 2019
Use your voice to shape CPhI Worldwide's third annual global survey of the major trends, changes and developments in the industry.Read more
Meet Avivia / Excipia at booth B56 Hall 12.1 CPhI Frankfurt 2019
29 Aug 2019
Meet Avivia at booth B56 Hall 12.1 CPhI Frankfurt 2019Read more
Switzerland overtakes Germany as Europe’s biggest drug delivery innovator
16 Aug 2019
Pipeline of new drugs has helped drive increased innovation in packaging and drug delivery devices.Read more
Growing domestic manufacturing creates new opportunities for international pharma in the Middle East
5 Aug 2019
Opportunities abound at CPhI MEA and experts anticipate regional generic companies acting as CMOs for international companies looking to enter the region.Read more
Drive for generics sees Korea increasingly attractive to international pharma
31 Jul 2019
Korean companies are opening more facilities overseas and using CPhI Korea to look for new international partners.Read more
Huge CPhI & P-MEC China a direct result of surging manufacturing
22 Jul 2019
Great Hall of China: Informa adds additional capacity to Asia’s largest pharma event with record 66,000+ visits from 141 countries.Read more
Fresh data on protein interactions in Alzheimer’s disease
2 Jul 2019
Demonstrates the unique ability of diffusional sizing to assess protein binding in-solution and for difficult-to-study systems.Read more
Piramal expands its high potency API capability
25 Jun 2019
Becomes one of only a few companies in the contract development and manufacturing market that can produce HPAPIs at such low OELs.Read more
Inaugural Bio Integrates conference highlights industry's inefficiency in developing products
18 Jun 2019
Industry leaders give voice to issues and trends shaping the biotech sector, including the importance of collaboration.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation