Market Demands and Emerging Technologies Shape Outsourcing Models

Three groups of people are connected by lines. Coordination and knowledge sharing. Outsourcing. | Image Credit: © Uladzislau - stock.adobe.com

The role of contract development and manufacturing organizations (CDMOs) is at an inflection point at the midpoint of the 2020s, mainly taking into account the impacts of two seismic factors: geopolitical shifts, driven in large part by the tariffs enacted in the first several months of United States President Donald Trump’s second term, and the seemingly omnipresent prevalence of artificial intelligence (AI).

The versatility provided by CDMOs is, by necessity, changing with the times. At the Drug, Chemical & Associated Technologies Association (DCAT) Week 2025, India-based Shilpa Medicare said it was launching a newly formed, full-service, “hybrid” CDMO aiming to serve both small- and large-molecule customers in addition to peptides, with a therapeutic specialization in oncology (1,2). Shilpa said the hybrid model would adopt a dual approach: offering comprehensive discovery, clinical, and commercial outsourcing services, but also including commercially ready, “off-the-shelf” novel formulations for business-to-business licensing.

In April 2025, a new CDMO, Meribel Pharma Solutions, was announced to be headquartered in the United Kingdom (3,4). The creation of this mid-sized CDMO was made possible by an acquisition of Synerlab Group, another CDMO, combined with the securing of seven manufacturing sites in Europe formerly belonging to Recipharm. The new company offers 10 manufacturing sites and three drug development services sites in France, Spain, and Sweden, and has established centers of excellence in drug development, lyophilization, preservative-free multidose technologies, and flexible stick-pack and sachet production, meant to support both human and veterinary health products while operating under stringent global regulatory certifications.

One initiative that had been announced prior to the start of 2025 was Thermo Fisher Scientific’s Accelerator Drug Development service, described at the time of its October 2024 launch as the company’s 360° CDMO and contract research organization (CRO) drug development solutions (5). In January 2025, Lyndra Therapeutics, of Watertown, Mass., announced a strategic collaboration with Thermo Fisher leveraging the Accelerator Drug Development platform and allowing Lyndra to use Thermo Fisher’s end-to-end, advanced pharmaceutical manufacturing capabilities based out of Cincinnati, Ohio, to manufacture commercial materials at scale (6,7).

This partnership is indicative of a current trend toward custom, specialized relationships based on specific needs—in this case, Lyndra’s long-acting oral therapies including its lead investigational product, oral weekly risperdone (LYN-005)—rather than a more generalized shared-services approach. Even with that, or perhaps because of it, new concepts like the “hybrid” CDMO are emerging with more frequency. And the presence of artificial intelligence (AI) and a push for smart and/or automated technologies to pick up more and more of the work are all contributing to the shifting landscape.

Reinforcing the importance of CDMOs

In the May 2025 edition of Pharmaceutical Technology®’s Drug Digest video series, Adi Kaushal, director and Technology Head of Bioavailability Enhancement at Lonza, discussed the growing preference in the market for oral solid dosage (OSD) forms, like Lyndra’s candidate, and how CDMOs can leverage their experience in performing much-sought-after expert techniques to improve OSD bioavailability to meet demand.

“CDMOs like Lonza are important partners for the smaller biotechs and emerging biotechs, and that is really driven by the experience and the expertise that CDMOs bring to the table, especially for smaller companies that may not have that experience in that space,” Kaushal said (8). “Alongside that, what comes into the picture is investment into state-of-the-art facilities and equipment, which is essential for the manufacture of a lot of these drug products. And then the final part is the regulatory knowledge and the technical knowledge that the CDMOs bring to the drug development process, partnering with the smaller biotechs. That’s really important, because the regulatory landscape is ever-changing, and it is often inherently linked to the technology in question. And so that technology expertise and regulatory expertise, from a regulatory standpoint or compliance standpoint, [are] critical to the progression of molecules into real therapies, and commercializing those.”

What these myriad areas of expertise can potentially result in, according to Kaushal, is a watertight, seamless partnership at any point of the drug product lifecycle that is desired.

“For the smaller biotechs and emerging biotechs, it’s important to partner with CDMOs such as Lonza that can work all along the value chain and can provide an end-to-end offering,” he said (8). “That’s really the key that we have seen in terms of preserving the knowledge, or building on the momentum, that you develop early on in the drug development process and then, keeping that knowledge all the way to be able to commercialize.”

AI enters the equation

In Pharmaceutical Technology®’s coverage of CPHI Americas, held in Philadelphia from May 20–22, 2025, Christy Eatmon, global subject matter expert for Sterile Drug Products at Thermo Fisher, talked about the progress made in the company’s Accelerator Drug Development offering since the fall 2024 launch, but also offered her perspective on the role of CDMOs in the industry in general.

It’s not just about partnerships between companies, Eatmon said. The connection goes further and deeper.

“I think in the past, CDMOs functioned as ‘just the hands,’ just a manufacturing house. Now we really want to partner with our customers,” she said (9).

And, she added, if those customers are using AI, companies should logically be keeping up.

“We want to be the trusted partner, the team that’s bringing innovation to the market. We have added some aspects of AI to our processes,” Eatmon said. “One of those to know, especially on the drug product side, is that we’ve integrated AI-assisted inspection. This is for large-scale commercial programs right now, but basically, we have a module where we’ve been able to decrease rejects, improving our yields, and then also using very expedited, very fast automated visual inspection—as every serial product, every unit, needs to be inspected, either by person, manually, or automated by a system of cameras.”

One usually thinks of AI as improving efficiency, but contrary to what examples from some platforms in everyday life have shown, in pharmaceutical operations, Eatmon said AI can be a boost to accuracy as well.

“This AI can actually make a huge library of potential defects and can actually go through those defects very quickly, to predict whether something the camera sees that may or may not be a defect is truly a defect,” she said (9). “We’re [also] using AI in other ways, like predictive modeling, which we’ve used for solid dose in the past. Now we’re looking to implement that for sterile products as well, to predict shelf life and things like that. So, I know pharmaceuticals [are] not always cutting-edge with things like AI, but we’re trying to implement where possible.”

From hybrid to 'IDMO'

The Shilpa Medicare example of a “hybrid” CDMO was just one instance of how companies are redefining not only their partnerships with each other, but also their definitions of what they themselves offer. In Pharmaceutical Technology® Group’s May 2025 Trends in Manufacturing eBook, John Tomtishen, senior vice president and general manager of the IDMO business at Cellares, discussed the industry’s long-awaited incorporation of Industry 4.0 concepts, including the novel model appearing in his job title: the IDMO, or integrated development and manufacturing organization (10).

“As the name implies, this includes fully integrated smart manufacturing facilities for true end-to-end scale,” Tomtishen said (10). “It relies on flexible manufacturing capabilities without requiring changes to hardware, meaning process modifications are entirely managed through software. As a result, technology transfer between smart facilities in any geography is streamlined through the leverage of platform standards. Combined, these aspects will make it easier to scale cell therapies globally and meet total patient demand.”

However, Tomtishen said, not just any company can call themselves an IDMO for a new spin on an old acronym. There are certain standards which must be met and maintained.

“The tenets of the IDMO concept can be viewed from the top down: manufacturing facilities must be standardized and interconnected; technology within each smart factory must ensure end-to-end integration; and the platform technologies themselves must be robust enough to serve multiple functions,” he said (10).

Cellares’ IDMO services primarily deal with easing patient accessibility to cell and gene therapies (CGTs), but the principles at the heart of the idea are universal.

“Ultimately, the promise of the IDMO is to accelerate access to life-saving cell therapies for all patients in need,” Tomtishen said (10). “Patients are not concerned about how their drug is manufactured, so long as it is safe, efficacious, affordable, and available when they need it. As such, the IDMO model is well positioned to solve the CGT bottlenecks. This will allow therapeutic developers to focus on what truly matters to their patients and not the manufacturing process, which will further drive drug development innovations across therapeutic indications.”

Whether there will be another abbreviation to come for these partner companies, perhaps working AI into the formation of letters, is a development that is yet to be seen, but one which might not be too far in the future. For now, though, outsourcing models are trending in more specified, more automated, and more customer-focused directions, keeping in mind that the pathway that gets treatments to patients with an optimal combination of safety and efficiency is the preferred path to take.

References

1. Lavery, P. Shilpa Medicare Launches ‘Hybrid CDMO’ at DCAT Week 2025. PharmTech.com, March 17, 2025.
2. Shilpa Medicare. Shilpa Launches ‘Hybrid CDMO’ at DCAT. Press Release. March 11, 2025.
3. Lavery, P. New CDMO Meribel Pharma Solutions Launches with 13 Sites in Europe. PharmTech.com, April 16, 2025.
4. Meribel Pharma Solutions. Meribel Pharma Solutions Launches with Big Ambitions to Elevate Pharma Services to New Heights. Press Release. April 15, 2025.
5. Lavery, P. Thermo Fisher Launching New CDMO, CRO Services at CPHI Milan. PharmTech.com, Oct. 8, 2024.
6. Lavery, P. Lyndra, Thermo Fisher to Partner on R&D for Long-Acting Oral Therapies. PharmTech.com, Jan. 15, 2025.
7. Lyndra Therapeutics. Lyndra Therapeutics Announces Strategic Clinical Research and Commercial Manufacturing Services Collaboration with Thermo Fisher Scientific for Long-Acting Oral Therapies. Press Release. Jan. 15, 2025.
8. Lavery, P. Drug Digest: Patient Preference Drives Solid Dosage Trends. PharmTech.com, May 22, 2025.
9. Lavery. P. CPHI Americas 2025: The Evolving Role of the CDMO. PharmTech.com, May 28, 2025.
10. Tomtishen, J. Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck. Pharmaceutical Technology® Trends in Manufacturing eBook, May 2025.

About the author

Patrick Lavery is an Editor for Pharmaceutical Technology^®.

Article details

Pharmaceutical Technology®
Vol. 49, No. 5
June 2025
Pages: 30–32

Citation

When referring to this article, please cite it as Lavery, P. Market Demands and Emerging Technologies Shape Outsourcing Models. Pharmaceutical Technology 2025 49 (5).