From Blockbusters to Niche Medicines

CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, today released Part II of the CPhI annual industry report, in which expert industry panel members share their views on trends that will drive growth and innovation across the pharmaceutical industry over the coming years and beyond.

The pharmaceutical industry is shifting away from the blockbuster model towards the development of personalized medicines and niche, individualized therapies and associated companion diagnostics, noted Sam Venugopal, director, healthcare, PricewaterhouseCoopers. These drugs target specific populations and genomic makeups and are known to have greater efficacy. William Botha, Sensei at Interlean, added that there will also be companies moving towards commodity-based, low-margin products. As a result, one can expect to see increased specialization, particularly amongst small and medium companies.

In the

, Venugopal also highlighted that collaboration is increasing within companies and “we are seeing much more information sharing within companies,” for example, sharing of best practices between sister sites. Social networks and technologies have enabled information to be shared in a way that ensures intellectual property is protected.

“Our ability to increase collaboration and knowledge has increased with our ability to manage data,” Venugopal said. “We can now gather and analyze knowledge to an unprecedented degree, and we’re getting better at taking vast forms of data and parsing them out. Larger companies are finally taking advantage of data and sharing more information.

Collaboration between industry and academia will play an important role in driving innovation, observed Bikash Chattejee, president and CTO at Pharmatech Associates. “The activities between invention and execution will contract as the industry looks for ways to compress R&D timelines and increase the potential success rate for products in development,” said Chattejee. Partnerships with academic institutions could provide companies with more opportunities for new drug therapies and drug delivery platforms. Ajaz Hussain, an independent consultant, concurred and added that academia has the potential to contribute significantly both in technology and policy.

While Venugopal believes that outsourcing will continue to be a trend with pharmaceutical companies outsourcing more processes, materials and operations, Botha pointed that outsourcing may not always be the answer although in the short term, most companies will try to outsource. There is a new trend, according Botha, and it is not insourcing but rather sourcing in the location of the customer. “We see this very clearly in Jurong, Singapore’s biopharma manufacturing island, in which a couple of square miles are decoted entirely to biotech, and companies are setting up operations there,” explained Botha.

Chattejee noted that the role of CMOs must evolve to keep pace with new world market challenges given that a lot of start-up innovator companies will turn to highly qualified CMOs to help them move their molecules through the development stage. “While some CMOs do tout development services, the nature of the support is often limited to equipment support and providing resources for supporting development batches.” Chattejee, however, believes that the role of CMOs will extend to include key tactical elements related to regulatory and licensing procedures for launching a product in a new emerging market.

The report also revealed that new developments in quality by design (QbD) and question-based review (QbR) concepts will be universally adopted over the next five years. QbD is essential not only in safeguarding quality but also in reducing development costs, especially as the industry moves towards harmonization of product and process development cycles.