Customizable Relationships Enhance Speed to Market

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Just a few of the topics Pharmaceutical Technology® has covered thus far in 2025 that involve outsourcing in some way include artificial intelligence (AI), quality support expertise, process development optimization, and the future of antibody-drug conjugates (1–4).

The crucial nature of the relationship between sponsor companies and contract development and manufacturing organizations (CDMOs) came into full focus at the Drug, Chemical & Associated Technologies Association (DCAT) Week in March 2025, where India-based Shilpa Medicare announced that it was launching a full-service, “hybrid” CDMO that aims to 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 (b2b) licensing (5).

The changing demands of customers, along with continuous advancements in modalities and technologies, are all trends in outsourcing that deserve a deeper look.

Under multiple roofs

According to Sridevi Khambhampaty, CEO of Shilpa Biologicals, a fully owned subsidiary of Shilpa Medicare, the bio/pharmaceutical industry is constantly evolving both in terms of the technology that is driving innovation in the field, and in novel treatment modalities (6). Because of this, Khambhampaty said, the outsourcing market is continuing to grow, placing even more emphasis on the sponsor–CDMO dynamic.

“With this plethora of technologies and modalities, it's quite challenging for any company to have all of these under their roof,” Khambhampaty said (6). “So, the small biotechs which want to pursue several new ideas in the novel therapeutic modalities would like to use the CDMO services, because they obviously don't want to invest in all the capex [capital expenditure] required for taking their ideas to market.”

Novel modalities are not the only thing causing change. Smart technologies such as AI and machine learning are keeping outsourcing partnerships in a state of constant evolution, said Ashu Tandon, chief commercial officer at Aragen Life Sciences.

“I think both of these are in some way connected to a broader trend that I've been seeing in the industry, and that broader trend is essentially moving from what was historically a very transactional-based partnership or collaboration model to one where it is much more longer-term, much more integrated, [and] much more involved engagements that we see from customers, and obviously from our side as well,” Tandon said. “And all of these take into account the fact that companies are moving from a transactional relationship to one where they are heavily invested in working with Aragen, and some of our peers, to look at how we can bring their drugs more efficiently to the market.”

“The industry has seen a flood of several strategic alliances being announced, with organizations looking for first rights, resource prioritization, and/or dedicated slots for manufacturing,” Robert Cornog, senior director of product development of Quotient Services, said. “There are clear advantages to these partnerships including stability, predictability, and organizational alignment. However, the most successful organizations will be those that can uphold those strategic relationships without losing the operational flexibility to support clients, particularly those with low volume or niche drug programs.”

As both the market itself and the range of outsourced services that are desired have gotten bigger, said John McQuaid, president and managing director of Almac Pharma Services, the strategies of CDMOs have changed by necessity, including, as in Shilpa’s case, starting their own CDMO.

“What started as a largely tactical capacity player for large pharma [companies], and probably what was basic manufacturing and packaging services, I think it's really turned into something a lot more diverse and strategic in nature,” McQuaid said (6). “Today, CDMOs, we're important partners for both large and smaller pharma companies. It's not just capacity that we offer. It's also technical and scientific knowledge. We have specialisms and technology platforms, and in some cases, proprietary platforms of our own.”

Where the action is

Jagruti Patel, senior director of commercial development for Integrated Biologics at Lonza, told Pharmaceutical Technology® in its July 2025 Drug Digest installment that an increasing number of strategic partnerships are homing in on the chemistry, manufacturing, and controls (CMC) part of the process.

“What is really key is working with a CDMO who has a proven track record in this space,” Patel said. “They can provide you the scientific experts to work closely with you on the CMC journey. The scientific experts could design or develop a really tailored tech transfer package strategy, they can establish a design space for process parameters to allow for flexibility and establishing risk management tools like FMEA [failure mode and effects analysis] ... really pinpointing your critical quality attributes.”

Novel modalities are emerging, McQuaid said, but not only that—companies are finding that the ones driving the most activity have shifted over time.

To name one area, according to Cornog, Quotient Sciences’ Philadelphia-area drug product manufacturing sites recently made facility improvements to expand its capabilities for handling products containing highly potent APIs.

Shifts like this have matured relationships between sponsor companies and CDMOs from at one time being merely transactional to now being closer to true, evenly matched partnerships (6).

“When I started, [outsourcing activity] was dominated by small molecules, and whilst we still see strong demand in this area, we've seen higher percentage growth in areas such as biologics, vaccines, [and] cell and gene therapies,” McQuaid said (6). “We've got ADCs [antibody-drug conjugates] and of course most recently, peptides. Another trend we've definitely seen is the growth in personalized medicines. That's brought about by better drug target identification, [and] advances in genomics and biomarkers.”

Sometimes a change can come when least expected, as Tandon mentioned with one of Aragen’s clients who is a major player in the oral solid dosage market. He said the COVID-19 pandemic was the impetus for both sides to huddle up and re-examine their relationship.

“We both sat together and said there has to be a better way of discovering these new compounds, testing them, and getting them into the clinic. There just has to be a better way,” Tandon said, explaining that the two teams “essentially devised or drew out a process map ... from early synthesis, to all the testing that happens on the biology side, to all the efficacy studies, the animal toxicology studies, to essentially putting together a development candidate up for review by the internal committee.”

The nature of outsourcing partnerships may be changing, as McQuaid illustrated, but both he and Patel agree that there are simply more of these alliances being formed now than there used to be—with no end in sight.

“In 2024, we saw the CDMO share of installed mammalian capacity at around 49%, and that is expected to increase to around 56% by 2029, so as you see the CDMO share increasing, we also see a trend in accelerating strategic partnerships between CDMOs and our customers,” Patel said. “In addition to that, we're also seeing customers asking for more integrated solutions, and that, to me, is a no-brainer when you're looking for simplified logistics, accelerated timelines, [and] harmonized technologies.”

Faster time to market, for all ages

The emergence of personalized medicines is emblematic of a larger trend in customization of services that extend not just to the patient, but within outsourcing partnerships themselves.

“To cater to these diverse modalities, I think flexibility is the key, and being able to offer modular services is also one of the key things,” Khambhampaty said (6). “For example, at Shilpa, we managed to create multiple suites, which I think a lot of the CDMO industry is also adapting to—to be able to make plasmid DNA in one suite, make mRNA [messenger RNA] in one, and then make ADC conjugation in one, and so on and so forth.”

This ideally results, Khambhampaty said, in an increased ability for molecules to be advanced more quickly to the clinical stage, the area in which she sees most of the demand in the CDMO sector currently concentrated with respect to new modalities (6). And to attack that demand on a smaller scale, rather than relying on a large-scale facility, can prove advantageous in the long run.

“A one-stop shop is always welcome, just from the ease of coordination, because you don't have to deal with multiple partners to get a project done,” Khambhampaty said (6). “But the key advantage [to outsourcing] is that the various moving parts within a project can be handled much better. So, for example, delays, let's say, in certain upstream processes will impact your downstream and will impact your safe filling. But all of these slots, if they are under the same umbrella—if the same CDMO was doing your drug substance and your drug product—then obviously they will make adjustments to the timelines.”

“On the other hand, while large pharmas are capable of a huge amount of expansive capacity, they often don't have open capacity, and they want to pursue multiple molecules in their portfolio without having to invest on new capacity,” she continued (6). “So outsourcing is really the only way to get to fast clinical studies, even for the large biopharma [companies].”

Aragen’s COVID lightbulb moment paid measurable dividends, according to Tandon.

“The customer estimates that for each one of those candidates, by virtue of this process that we have put together, we have essentially shaved off about 18 months each in that whole cycle, from when you first look at target identification all the way to development and candidate nomination,” he said.

One newer focus in expediting drug development is addressing the youngest patient population, according to McQuaid, and that brings its own set of challenges.

“There's a growing demand for age-appropriate formulations, pediatric drug presentations, so we have to invest and try and get ahead in those areas,” he said (6). “When you look at the cell and gene therapies and biologics, they bring requirements. So, we're investing in storage and pack, label, and distribution solutions for cold chain products, ultra-low temperature products.”

And when time is of the essence, it may not be the most expeditious approach to have one single company handle everything; however, choosing a partner that has demonstrated experience in as many key areas of development as possible is a wise decision.

“It's really accelerated time to market that's certainly in the development sphere, that's what we hear,” McQuaid said (6). “It's definitely true that if you can bundle activities, if you can leverage a connected network of internal experts within the CDMO, you can eliminate risk, you can eliminate downtime.”

“CDMO-sponsor relationships will continue to evolve as sponsors look for regional global distribution, licensing, and commercialization partners,” Cornog said. “While it does support accelerating time to broader commercial markets, these partnerships also provide insight back into the development stages for incorporating region-specific regulatory requirements and mitigating any future post-approval changes.”

Geopolitical shifts change what clients want

The tariff policies of United States President Donald Trump’s administration have been the impetus for an entirely separate trend, albeit one whose story is not yet fully told, and won’t be as long as tax rates continue to be tweaked, imposed, or revoked.

Companies based in the US are taking a look at what services they can onshore or reshore, and companies with headquarters elsewhere in the world are rethinking their stateside relationships.

“We're also seeing an increase in demand for on- and near-shoring manufacturing,” Patel said. “Not only does it provide the customer leaner management and logistics, but it also means that they have minimal exposure to geopolitical shifts that they're seeing today.”

Cornog concurred, saying that Quotient Sciences is seeing evidence of the same pattern and that alliances close to home can have particular advantages.

“Having local partners means sponsors can better manage their risk and supply chains, avoiding disruption from geopolitical instability and tariff fluctuations while achieving better regulatory alignment and a more stabilized cost structure,” he said.

Tandon said China is a major area of focus after the Trump White House zeroed in there, as well as on Canada and Mexico.

“From a geopolitical standpoint, a lot of customers are looking for a non-China alternative,” Tandon said. “We've had a lot of global pharma companies, a lot of biotechs that historically have not really worked with service providers in India, come in and do a first round of projects, and many of them have scaled up with companies such as ours.”

The words “supply chain” became a somewhat dreaded refrain at various points of the COVID-19 pandemic, but in the bio/pharmaceutical industry, keeping the pipeline moving effectively has always been a top objective. And if turning to outsourcing keeps sponsor companies running as cleanly as they can, according to McQuaid, then they are in favor of it. Plus, he said, having the right amount of drug in the right place at the right time is the ultimate goal.

“We definitely see more and more clients with a really strong preference to co-locate manufacturing, packaging, release testing, and then the final QA [quality assurance] release and batch release capabilities,” he said (6). “I think for them, that reduces the supply chain burden on themselves, having to manage all those different factors. It can have a financial return in terms of reducing inventory levels—not having to have safety stocks in so many different places—and ultimately, simplifying and de-risking the supply chain.”

At the same time, quality standards, regulatory landscapes, and the challenges of new technologies also continue to evolve along with market demands. This includes the rise of the use of AI, which Khambhampaty said can certainly benefit from checks and balances.

“Now, with the advent of AI-based drug discovery, there are a lot of smart scientists who are coming up with designer medicines and virtual labs,” she said. “They do need to find a CDMO to develop their concept to reality.”

“I think ultimately, the clients and pharma companies are seeking best-in-class services,” McQuaid said. “So, I think as CDMOs, we have to be cognizant of that. I think we have to be very transparent about our specialisms. What are our strong points? And if there's an area that we can't do, we need to be upfront about that. No one wants to be experimenting on their product.”

Choosing to collaborate with a CDMO is a step more and more sponsor companies have been making in an attempt to speed up timelines of certain drugs they have in development without sacrificing quality. To ensure that, selecting a partner that not only has a flexible knowledge base, but can also reliably deliver on that expertise, is a crucially important decision that neither side of the equation is taking lightly.

References

1. Lavery, P. Authentic Intelligence: Finding Diverse Talent in the Age of AI. Pharmaceutical Technology 2025, 49 (4) 30–31.
2. Thomas, F. Qualifying Expertise for Quality Support. Pharmaceutical Technology 2025, 49 (3) 32–33.
3. Haigney, S. Steps to Process Development Optimization. Pharmaceutical Technology 2025, 49 (1) 31–33.
4. Mirasol, F. Advancing ADCs to the Next Level. Pharmaceutical Technology 2025, 49 (1) 29–30.
5. Shilpa Medicare. Shilpa Launches ‘Hybrid CDMO’ at DCAT. Press Release. March 11, 2025.
6. Thomas, F. Drug Digest: Strategic Partnerships. PharmTech.com, March 28, 2025.

About the author

Patrick Lavery is an Editor for Pharmaceutical Technology^®.

Article details

Pharmaceutical Technology®
Vol. 49, No. 6
July/August 2025
Pages: 10–11, 15

Citation

When referring to this article, please cite it as Lavery, P. Customizable Relationships Enhance Speed to Market. Pharmaceutical Technology 2025 49 (6).