Significantly, continuous processing and QbD will also lead a “paradigm shift at instrument companies” with new models, particularly in spectroscopy, specially created for process monitoring and control. “The instrument companies will cooperate with software vendors to produce a more cohesive operating system(s) that will allow multiple instruments to smoothly work in unison for PAT/QbD applications,” said Emil Ciurczak, president, Doramaxx Consulting. “In many ways this will be similar to the unification of chromatography terms/specifications and the emergence of international standards for dissolution testing.”
Continuous manufacturing (CM), having seen several pharma companies adopt the technology in 2016, is envisaged to enter a new phase of implementation as contract research organizations (CROs) and contract manufacturing organizations (CMOs) adopt it as quickly as large pharma companies. The reasons for this shift are the wider funding environment that is being created for orphan drugs, with foundations (e.g. Clinton Foundation) and smaller patent cohorts meaning development and production is quicker with CM. The shorter turnaround time will also aid CMOs with the larger number of products from client companies. R&D and clinical trials are also being shifted to CROs as larger companies shed sites and personnel.
Girish Malhotra, president, EPCOT International, agreed that drugs for orphan and neglected diseases might give a short-term jump, however affordability will remain a concern for sustained revenue growth. He warns that unless new therapies are created for the global population at affordable prices there will be challenges, as developing marginally better new drugs will not deliver sustained revenue increases in the long term. Instead, he forecasts that the two biggest opportunities for pharma and generic companies will come from the developing economies and process improvements.
“Pharma has to drive innovation from inside and excel in creating efficient drug development, process and technology innovation in manufacturing and the supply chain,” said Mr. Malhotra. “Simplified and innovative processes will produce quality products. Moving away from present practices of quality assurance after the fact can save significant monies.”
Gil Roth, president, Pharma and Biopharma Outsourcing Association (PBOA), says it’s too early to make definitive predictions about the effect Trump’s administration will have on the U.S. healthcare and the contract development and manufacturing organization (CDMO) sectors, especially given his recent commitment to bring-down drug prices, which was post election and contains no specific granularity as of yet. However, with a preference for protectionist strategies, a change in tax status for overseas revenues could well trigger a spate of reinvestment in U.S. facilities by big pharma as well as greater domestic merger and acquisition (M&A) activity.
“Some of the President Trump’s statements on immigration could become problematic if they keep high-value scientific personnel from coming to the U.S.,” said Mr. Roth. “His appointment for FDA Commissioner could shape policy there in ways that benefit or hinder pharma and CMOs. Congress' path to repeal and replace the Affordable Care Act leads through a minefield. It's all too vague at this point.”
The overall pharma industry is in very good health as we enter 2017 and CPhI’s experts highlight a number of good opportunities that should sustain growth in the near- and medium-term, according to Chris Kilbee, group director pharma, UBM EMEA. “Innovation in our industry is also reaching new levels and technologies that have been in their infancy in recent years look well set to permeate through the supply chain,” he said. “Collaboration, supply chain control and partnering will remain essential to the sector’s health and we expect to welcome wider audiences and newer exhibitors to CPhI events throughout the globe.”
• The Good: Orphan drugs, developing world sales and continuous manufacturing to push on in 2017.
• The Bad: Affordability will remain a concern for sustained revenue growth.
• The Donald: The effect his administration will have on the world’s largest pharma economy and the wider implications for the global manufacturing industry is still unclear.