Outsourcing
consolidation, with a wave of mergers and acquisitions in the outsourcing space. You’ll often see larger CROs acquiring smaller CROs, or CDMOs merging with their rivals. However, the industry is also beginning to witness a more profound shift. That’s the rise of the CRDMO – contract research, development and manufacturing organisations, which provide a full-service offering under one roof. “Integration is indeed a trend,” remarks Kevin Li, chief marketing officer at BioDuro-Sundia. “It can accelerate drug development and bring speed, lower risks and simplified vendor management to the customer. I see an increasing push towards integration, both from the CDMO world and from the customer side.”
End-to-end solutions
BioDuro-Sundia was itself formed by a merger between two companies: the CRO company BioDuro and the CDMO company Sundia. Since the two joined forces in 2020, they have provided fully integrated drug discovery, development and manufacturing across both active pharmaceutical ingredients (APIs) and drug products. Li notes that different types of service provider will approach the question of expansion in different ways. Classic CMOs (contract manufacturing organisations) may want to add a D (development) to that title, or move even further back into the research phase. Meanwhile, CROs may wish to expand from discovery to development, and then into clinical or commercial manufacturing. “Whatever direction they are going in, a lot of companies want to expand their capabilities, to broaden their services, to create that synergy,” Li points out.
Jennifer Cannon, president commercial operations pharma services at Thermo Fisher Scientific, agrees. The shift towards CRDMOs, she says, reflects the need for accelerated timelines, agility, and flexibility in today’s complex drug development landscape. “Companies face intense pressure to manage timelines and navigate regulatory demands without sacrificing quality,” she says. “While some suppliers are able to offer integrated services, the ability to provide end-to-end CDMO and CRO services is exceptional.”
Thermo Fisher Scientific has made several tactical acquisitions, with a view to offering just that. First came Patheon in 2017, a company with a longstanding history in drug manufacturing. This was followed by PPD in 2021, which added clinical research services to an already robust foundation. “This shift created a unique, end-to-end solution that spans drug development, from early clinical research through commercial production,” says Cannon. “The integration of Patheon’s manufacturing
Clinical Trials Insight /
www.worldpharmaceuticals.net Why opt for a CRDMO?
So why is integration such a buzzword in the CDMO/ CRO space? Part of it is the desire for simplicity – if a single provider can take care of everything, the pharma company doesn’t need to deal with multiple quality systems and multiple sites. There’s no need to conduct hand-offs between separate providers, which smooths the pathway from one stage to the next. “Different teams tend to share a single quality system, which accelerates material transfer and knowledge sharing,” says Li. “The customer can greatly simplify their vendor management. Usually, these integrated projects have a dedicated project manager, so you have a single point of contact.” Simplicity tends to come with time savings and cost efficiency. If development and manufacturing can be considered at the very earliest stages of research, these different activities are likely to be better aligned from the outset, which can accelerate time to market.
At BioDuro-Sundia, for instance, API teams and drug product teams often work in parallel. That means the latter can receive some API internally, to start work on a pre-formulation right away. Meanwhile, at Thermo Fisher Scientific, timeline reductions are achieved via centralised programme governance, along with cross-site databases and digital platforms.
“Our model brings an added level of responsiveness,” says Cannon. “Our real-time demand planning view offers us visibility across timelines and processes, allowing us to proactively mitigate risks and minimise project delays. This approach not only saves time but also allows for flexible and just-in-time decision making.” A further advantage is better risk management. Outsourcing, however necessary, can be a risky endeavour. The more parties involved in a project, the greater the chance of errors, inconsistencies, and
$70bn Grand View Research 13
strengths with PPD’s research expertise enables Thermo Fisher to provide continuity across development phases, offering customers real-time data visibility, risk management, and operational efficiencies across the entire drug life cycle.” Thermo Fisher’s offering, she claims, exceeds the typical CDMO/CRO model, not least because it includes clinical supply chain and lab services. In fact, it more resembles a cohesive ecosystem than a series of standalone services.
“It allows customers to address key industry challenges, such as risk mitigation, cost management, and speed to market, while maintaining high standards for quality and compliance,” she says. “This model supports clients in achieving strategic goals across development and manufacturing in a unified way.”
The amount that the biotech and pharma outsourcing market is predicted to reach by 2030, up from $46bn in 2023.
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