As biologics have increasingly superseded small molecules in the biopharma industry’s pipeline, the mounting complexity of their manufacturing products is putting production and launches under pressure.
In a new report (PDF) from Accenture, the professional services firm found that as manufacturing becomes an increasingly critical component of new pharma rollouts, companies must start wedding their process strategies more tightly from the lab to the production line.
Moreover, emerging technologies like robotic process design and AI-augmented analytics have the potential to reduce costs for companies, accelerate launches and create more reliable and adaptive production networks overall, Accenture found.
Many drugmakers still have a long way to go before they believe their companies can function as fully “connected organizations” in biopharma manufacturing and technical operations, according to the Accenture team, which surveyed 120 manufacturing experts and conducted a more limited pool of interviews with high-level industry execs.
The spread of companies Accenture polled for its report included 80 top biopharma companies, plus another 20 mid-sized companies or biosimilar producers and 20 CDMOs or CMOs.
At the core of Accenture’s report is the finding that 64% of drug-launch delays in 2024 stemmed from chemistry, manufacturing or control (CMC) issues, driven in part by the dovetailing trend that biologics now represent some 55% of the industry’s clinical pipeline.
As the use of artificial intelligence continues to accelerate drug discovery and clinical trial work, process development and manufacturing will also be forced to keep pace, according to Accenture, which added that broader geopolitical and economic volatility, supply chain disruptions and growing competition are reshaping the need for resilient and adaptable production.
Accenture noted that it tracked the 64% launch delay statistic by analyzing FDA Complete Response Letters (CRLs) issued to top pharmas between 2009 and 2024, reiterating that “[m]ost of these setbacks stemmed from the production of complex biologics, underscoring the strain on today’s technical operations functions.”
Again, companies would do well to capitalize on the power of “data and intelligent technologies,” according to Accenture, which singled out advanced analytics, process twins, robotics and AI agents as crucial tools to refine manufacturing processes for the current realities of the biopharma development landscape.
Still, most companies Accenture polled indicated they were somewhere “stuck in the middle” of their digital transformation efforts, with just 35% of the manufacturers touting their firms as fully digitally connected. The majority of executives polled said these sorts of changes had improved their day-to-day supply efficiency, while 45% said that efforts to digitize their networks had improved their tech transfer processes.
The industry’s digital initiatives face multiple obstacles, according to Accenture, which noted that, for one, digital pilots are often limited to low-risk and low-impact areas that restrict more holistic evolutions of a company’s business. Meanwhile, present data infrastructure is largely unequipped to support large-scale digital programs, and those digital functions are often siloed within individual functions.
“The outcome is fragmented solutions with limited return on investment, digital initiatives that cannot scale, and a growing number of ‘digital dead ends,’” Accenture argued in its 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 lost opportunities.”
Manufacturing has continued to emerge as a linchpin for the industry, with the COVID-19 pandemic highlighting strains on global supply chains that have continued to face pressure from geopolitical tensions like U.S. import tariffs and, more recently, the U.S. and Israel’s war with Iran.
Meanwhile, echoing Accenture’s digital recommendations, many drugmakers have turned to the AI industry in recent months in a bid to expand both their development and manufacturing firepower.
Last month, Novo Nordisk unveiled a partnership with OpenAI—of ChatGPT fame—to integrate artificial intelligence “globally from drug discovery to commercial operations,” with the Danish drugmaker specifically highlighting the potential of the tie-up to help “bring new and better treatment options to patients faster.”
Novo’s main metabolic medicine rival Eli Lilly has also teamed up with OpenAI, as have Sanofi, Moderna and Thermo Fisher, to name a few, with Lilly additionally joining forces with Nvidia on an industry-leading supercomputer last year.