Biologics are increasingly replacing small molecules in the biopharmaceutical industry pipeline, and the increasing complexity of manufactured products is putting pressure on production and launches.
In a new Accenture report (PDF), the professional services firm finds that as manufacturing becomes an increasingly important element in the rollout of new medicines, companies need to more tightly link their process strategies from the lab to the production line.
Additionally, emerging technologies such as robotic process design and AI-enhanced analytics have the potential to reduce costs for companies, accelerate ramp-up, and create more reliable and adaptable production networks overall, Accenture found.
According to the Accenture team, many pharmaceutical companies still have a long way to go before they are confident that they can function as fully connected organizations in biopharmaceutical manufacturing and technology operations. The Accenture team surveyed 120 manufacturing professionals and conducted more limited interviews with high-level industry executives.
The scope of companies Accenture surveyed for the report included 80 top biopharmaceutical companies, plus 20 mid-market or biosimilar manufacturers and 20 CDMOs or CMOs.
At the heart of Accenture’s report is the finding that 64% of new drug launch delays in 2024 will be due to chemistry, manufacturing, and control (CMC) issues, driven in part by the consistent trend that biologics now account for approximately 55% of the industry’s clinical pipeline.
As the use of artificial intelligence continues to accelerate drug discovery and clinical trial efforts, process development and manufacturing will need to keep pace, Accenture said, adding that growing geopolitical and economic instability, supply chain disruption, and increased competition are reshaping the need for resilient and adaptive production.
Accenture noted that it tracked the 64% launch delay statistic by analyzing FDA Complete Response Letters (CRLs) issued to top pharmaceutical companies between 2009 and 2024, and reiterated that “(the majority) of these setbacks are attributable to the production of complex biologics, highlighting the strain on today’s technology operations functions.”
Again, according to Accenture, companies are wise to harness the power of “data and intelligent technology,” citing advanced analytics, process twins, robotics, and AI agents as key tools to improve manufacturing processes in line with the current realities of the biopharmaceutical development environment.
Still, most companies surveyed by Accenture said they were “stuck” somewhere along their digital transformation journeys, with only 35% of manufacturers touting their companies as fully digitally connected. The majority of executives surveyed said these types of changes have improved day-to-day supply efficiency, and 45% said network digitization efforts have improved technology transfer processes.
Accenture said the industry’s digital efforts face multiple obstacles, including digital testing that is often limited to low-risk, low-impact areas, limiting companies’ ability to evolve their businesses more holistically. Meanwhile, current data infrastructures are poorly equipped to support large-scale digital programs, and those digital capabilities are often siled within individual functions.
“The result is fragmented solutions with limited return on investment, digital initiatives that cannot scale, and a growing number of ‘digital dead ends,'” Accenture argued in the report. “These disconnects widen the gap between ambition and execution. If left unresolved, the industry’s digital momentum risks stalling, potentially leading to costly rework and missed opportunities.”
Manufacturing continues to emerge as an industry linchpin as the COVID-19 pandemic highlights strains in global supply chains that continue to face pressure from U.S. import tariffs and geopolitical tensions such as the recent U.S.-Israel war on Iran.
Meanwhile, following Accenture’s digital recommendations, many pharmaceutical companies have turned to the AI industry in recent months to expand both their development and manufacturing capabilities.
Last month, Novo Nordisk announced a partnership with OpenAI, of ChatGPT fame, to integrate artificial intelligence “globally from drug discovery to commercial operations.” The Danish pharmaceutical company specifically highlighted the potential for collaboration to “bring new and better treatment options to patients faster.”
Novo’s main rival in metabolic medicine, Eli Lilly, also partners with OpenAI, as do Sanofi, Moderna and Thermo Fisher, and Lilly also partnered with Nvidia last year on an industry-leading supercomputer.
