Behind the Headlines Episode 27

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

Artificial intelligence, machine learning, and novel instruments are helping drug developers.

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

J.P. Morgan Report Lists Biologics, Obesity, China

Top Trends Reshaping Pharma R&D

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

In Episode 28, Miroslav Gasparek, Lizzy Lawrence, and Joe Lewis go behind the headlines.

Behind the Headlines Episode 28: Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines bi-weekly episodes examine the ongoing trends, factors and fashions that cause pharmaceutical news to happen. Panelists are a mix of consultants, venture capitalists, scientists, patient advocates, journalists, and editors. Each episode talks about the current headlines of the preceding weeks that are on everyone’s lips but seeks to highlight the more enduring lessons that hide behind these headlines.

In Episode 28, Miroslav Gasparek, CEO and co-founder, Sensible Biotechnologies; Lizzy Lawrence, FDA reporter, STAT; and Joe Lewis, managing director, Deloitte Consulting, focus on an accelerating loss of expertise at FDA’s vaccine center. While 

, the organizational structure is fractious at best (some say unstable), as 

, officially as “resigned,” along with many others. This creates “uncertainty on top of uncertainty,” one of our panelists exclaimed. It is a highly charged moment for the organization but also for all industry stakeholders, including patients.

The same day as recording, as if to emphasize this point, the seemingly certain approval of UniQure’s Huntington disease (HD) candidate AMT-130 suddenly seems unlikely (1). UniQure described the feedback as a "key shift from prior communications," and said the timing of its plan to ask for approval of AMT-130 now looks bleak. Leerink Partners analyst Joseph Schwartz said the news is a "confusing" and "unexpected" twist (2). "QURE has been thoroughly aligned with the FDA over the past year, has breakthrough therapy designation and the data update QURE presented in September was very strong," he said in a note. So, while patients look likely to wait longer for improved therapies, the upshot for Uniqure is a plummeting share price, dropping nearly 50% at close of the stock market day. The HD community has been enthusiastically hopeful about what AMT-130 could mean for HD treatment, with key HD opinion leaders calling these results 'game-changing,'" Schwartz said. "So we expect there could be a rallying effort on that front to support QURE in the coming weeks."

As a discussion point, the panel noted a LinkedIn post from Amedo Vetere, senior group leader, Arena BioWorks, that reads “the obesity wars are getting spicy” (3). Pfizer isn’t just suing Novo Nordisk, they’re going after Metsera too. Breach of contract. Fiduciary duty. Interference. All because Metsera said “thanks, but no thanks” to Pfizer’s $7B and leaned toward Novo’s $9B counteroffer… The science is hot. The business is cutthroat. And in this arena, who gets to treat obesity may depend less on biology…and more on who survives the merger. All the while, Eli Lily raises guidance to $65Billion, on the back of a stronger-than-expected US revenue increase of 45% “driven by Zepbound and Mounjaro, despite a 15% price decline due to a one-time adjustment in Q3 2024. European revenue increased by over 100% in constant currency, bolstered by Mounjaro uptake and a $380 million milestone benefit (4). Revenue for Japan, China, and Rest of World grew 24%, 22%, and 51% respectively, with Mounjaro volume as the primary driver.”

UniQure Plummets 49% On A 'Confusing' And 'Unexpected' Twist For Its Gene Therapy

UniQure’s FDA submission for its Huntington’s disease therapy thrown into question

Lilly Raises 2025 Revenue Guidance to $63–$63.5B with 54% Q3 Growth and Major Pipeline Advances

Videos

In Episode 28, Miroslav Gasparek, Sensible; Lizzy Lawrence, STAT; and Joe Lewis, Deloitte, go behind the headlines.

Everything to Know About Pharmaceutical Tariffs in 2025

What should industry professionals know about pharmaceutical tariffs?

Pharmaceutical professionals need to recognize that tariffs can drive up operational costs, disrupt supply chains, create drug shortages, and alter global investment decisions (1-21). While these measures aim to boost domestic manufacturing, which is reflected in reports of US domestic manufacturing investment, and the observation that tariffs localize biopharma supply chains, they often introduce immediate and multifaceted challenges for the industry.

How do pharmaceutical tariffs impact supply chains?

Pharmaceutical tariffs raise costs, delay deliveries, and risk shortages, complicating logistics and straining inventories for hospitals and pharmacies. Companies may eventually diversify supply chains and boost domestic production, reflecting industry trends toward supply chain localization, strengthening the domestic API supply chain, and pursuing resilience goals, but immediate effects often mean reduced patient access to medicines (11-14).

Why do pharmaceutical tariffs increase operational costs?

Pharmaceutical tariffs raise operational costs by increasing prices for raw materials, Active Pharmaceutical Ingredients (APIs), and finished drugs through added taxes. The API market is a critical industry topic (15,16). This results in higher production expenses, supply chain disruptions, which directly conflicts with industry goals for resilience, and greater administrative burdens. These increased costs may be passed on to consumers, while smaller companies could face challenges absorbing them, potentially reducing research and development activities or leading to market exit.

How do pharmaceutical tariffs lead to potential drug shortages?

Internationally dependent supply chains are vulnerable to disruptions that can raise drug prices and cause shortages. Western pharma vulnerability stems from market loss to Asia, caused largely by short-sighted offshoring (11,12). The EU’s proposed Critical Medicines Act (CMA) aims to curb supply dependence and shortages (17). Since many generics rely on ingredients like APIs and excipients from China and India, tariffs may drive up their costs (11,14,16-18). If profit margins drop too low, manufacturers might stop producing certain generics, further limiting their availability. The industry emphasizes the need to eliminate all vulnerabilities in ingredient delivery.

How do pharmaceutical tariffs cause shifts in global investment strategies?

Companies are increasingly reshoring manufacturing to domestic markets to avoid tariff costs, leading to significant new investments, particularly in high-margin drug production. This trend is reflected in the observation that tariffs localize biopharma supply chains (8,10,11)) and in reports of US domestic manufacturing investment and efforts such as SK pharmteco strengthening its domestic API supply chain with a new peptide facility (19). In response, firms are also diversifying supply chains, seeking raw materials and APIs from countries unaffected by tariffs, and establishing new regional manufacturing hubs. This supports the key industry trend driving supply chain localization. However, the rising operational costs and market uncertainty from tariffs are squeezing profit margins, often resulting in reduced spending on research and development. Investor confidence has taken a hit as well, leading to more volatile foreign direct investment—U.S. outbound investment is falling, while global firms ramp up domestic presence to maintain market access. Generic drug manufacturers, who are more sensitive to cost fluctuations, may exit or scale back, driving market consolidation. Overall, tariffs are prompting pharmaceutical companies to prioritize resilience and access over cost efficiency, reshaping the global industry landscape, a strategy frequently discussed in the context of achieving supply chain resilience and meeting global sustainability and resilience goals (5,8,11-14).

What strategies can help minimize the impact of pharmaceutical tariffs?

To mitigate the impact of pharmaceutical tariffs, companies should diversify and regionalize supply chains, aligning with the trend toward supply chain localization (5,8,11-14), optimize inventory through strategic stockpiles, and enhance operational efficiency with lean manufacturing. Contract flexibility and vulnerability analysis are key for resilient planning, especially since the industry is focused on the need to eliminate all vulnerabilities in ingredient delivery (20). Financially, firms should review invoice processing and pursue tariff engineering to reduce duty costs, while also considering investments in domestic production for long-term stability (21). Transparent communication with stakeholders and engagement in alternative policies—like subsidies or government purchasing platforms—help address price shifts for customers. Global collaboration and international agreements further strengthen medicine supply security and resilience, which is a core goal in pharma manufacturing, especially concerning API and excipient supply chain resilience (8-11,14,17).



Sullivan S, Grueger J, Sullivan A, Ramsey D. 

The Consequences of Pharmaceutical Tariffs in the United States

How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains

Tariffs & Trade Policy: What to Watch for, Cost Impacts, and Supply Chain Strategies

Trade Policy Shifts: Compliance and Cost Strategies for Pharma

How Pharma Can Build Resilient Supply Chains Amid Trade and Tariff Shifts

Tariffs & Trade Policy: Results of a Bio/Pharma Peer Survey

PharmTech Weekly News Roundup — Week of October 20, 2025

The Key Trends Driving Supply Chain Localization and Data Scrutiny in Biopharma

Drug Digest: Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Supply Chain Challenges and Solutions Outlined in Capgemini Report

US and European Pharma Manufacturing Face Diverging Paths to Resilience

Standardizing Operations to Meet Global Sustainability and Resilience Goals

Excipient Innovation, Safer Solvents, and Supply Chain Resilience

CPHI Frankfurt 2025: The Current API Market

The CMA: Transforming Procurement to Ensure API and Excipient Supply Chain Resilience

Sustainability and Stability in Excipients

SK pharmteco Strengthens Domestic API Supply Chain with New Peptide Facility

Maggie Saykali on the Critical Medicines Act and the Mandate for Local Production

Articles

Pharmaceutical tariffs significantly impact the industry by increasing operational costs, disrupting supply chains, and causing potential drug shortages. These tariffs lead to higher prices for raw materials and finished drugs, complicating logistics and straining inventories. Companies are reshoring manufacturing to avoid tariffs, resulting in new investments and supply chain localization. However, rising costs and market uncertainty can reduce research and development spending. To mitigate these effects, firms should diversify supply chains, optimize inventory, and enhance operational efficiency, while engaging in global collaboration to strengthen medicine supply security.

With pharmaceutical tariffs fundamentally impacting costs, global supply chains, and more, it’s important for industry professionals to understand the basics.

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

We take a look at what was most on the minds of key opinion leaders.

Building Resilience in Pharma: Our Top 10 Questions from CPHI Frankfurt

The COVID-19 pandemic brought light to the global importance of vaccines and ensuring they are manufactured to quality standards for every region in which they are used. 

Vishal Mukund Sonje, Vaccine Manufacturing Lead at the Coalition for Epidemic Preparedness Innovations 

(CEPI), discusses some of the challenges faced for vaccine manufacturers, especially those working hard to get these products to remote regions, including complex regulatory requirements.

PharmTech: How do complex global regulations and legal rules inhibit or help vaccine manufacturing?

 Development and manufacturing regulations for vaccine development are quite stringent. However, these requirements are essential, since it ensures product safety and efficacy. The main regulatory bodies [FDA and European Medicines Agency] enforce rigorous standards from maintaining high quality of vaccines, and this is essential, since vaccines are injected into healthy individuals.

There are also efforts to harmonize regulatory standard across countries, for example, ICH [International Council for Harmonisation] guidance, WHO [World Health Organization] pre-qualification. These guidances ensure that there is streamlined approval and global distribution possible, mainly in the LMIC [low- and middle-income] countries.

Are there specific manufacturing issues pharmaceutical companies should consider when manufacturing a vaccine that will be used globally, especially in areas where the vaccine may be most needed?

Vaccine manufacturing involves complex bioprocessing, and it needs years, if not decades, of experience to develop technical depth and know-how. It also involves significant CapEx [capital expenditure] investment. Apart from that, knowing post-pandemic COVID periods, it is essential [that] each region enables different platforms that can be used in a pandemic situation. The platforms that can be used are mainly categorized into recombinant protein, viral vector, and mRNA [messenger RNA].

Thirdly, manufacturers need to keep in mind [the] overall ecosystem and external environment that could have [a] large impact on the success of manufacturing capabilities, for example, maturity of the regulatory authority, input material, supply chain, cold chain infrastructure, finished goods supply chain. For example, shortage of critical components could be challenging to manage and can have detrimental effects on the planning of manufacturing. These factors are essential for any region or manufacturer to keep in mind before moving into vaccine manufacturing.

For these reasons, there are some advantages for manufacturers in certain regions like global north or Asian economies, like India and China, while it is challenging to set up new facilities in new LMIC regions, such as Africa or [the] Latin American region.

Are manufacturers moving to patient-centered manufacturing for vaccines and creating modular manufacturing centers closer to where the vaccines are specifically needed?

Overall, the trend in [the] pharmaceutical industry is more personalized medicine, or [closer] to the end user. However, for vaccines, we still do not have [a] personalized vaccine development base. Having said that, post-COVID pandemic, there is [an] increased sense of urgency from all regions to enable vaccines’ self-sufficiency, and many manufacture within the region, so that during [a] pandemic period, the companies can shift their manufacturing base to manufacture vaccines and counter the pandemic situation.

Keeping that in mind, as I said earlier, three platforms that are mainly looked after or developed by these companies in LMIC regions are, namely, viral vector, [recombinant] protein, and mRNA. So LMIC regions, for example, Africa, together with Africa CDC, a newly formed health agency in Africa, is looking to develop capabilities in Africa for manufacturing based on these three platforms.

The COVID-19 pandemic underscored the critical role of vaccines and the necessity for stringent manufacturing standards globally. Vaccine manufacturing faces challenges, particularly in remote regions, due to complex regulatory requirements. Harmonization efforts, like ICH guidance and WHO pre-qualification, aim to streamline approvals, especially in LMICs. Vaccine production requires significant expertise, investment, and consideration of external factors like supply chains. While personalized medicine is trending, vaccine manufacturing remains region-focused, with efforts to develop capabilities in LMICs using platforms like viral vector, recombinant protein, and mRNA.

Vishal Mukund Sonje, Vaccine Manufacturing Lead, CEPI, talks about the challenges that arise in the manufacturing of vaccines in various global regions.

Challenges for the Global Manufacturing of Vaccines

Sustainable energy sources concept | Image Credit: ©Proxima Studio -stock.adobe.com

Early efforts in sustainability have moved from a "nice-to-have" benefit to a 

foundational endeavor across the pharmaceutical landscape

 (1). Understanding and implementing sustainable practices is no longer peripheral; it is a strategic focus dictated by evolving client expectations, rigorous environmental audits, and respecting planetary boundaries (1, 2). This industry shift is a response to global climate pressures—the healthcare sector contributes 4.4% of global carbon emissions—and a recognition that profitability and responsibility must converge (3,4).

The complexity of environmental impact can be seen in the pharma supply chain; up to 75% of a typical pharmaceutical company's greenhouse gas (GHG) emissions originates from scope 3 (2). According to the 

, “Scope 3 emissions are the result of activities from assets not owned or controlled by the reporting organization, but that the organization indirectly affects in its value chain. An organization’s value chain consists of both its upstream and downstream activities. Scope 3 emissions include all sources not within an organization’s scope 1 and 2 boundary. The scope 3 emissions for one organization are the scope 1 and 2 emissions of another organization. Scope 3 emissions, also referred to as value chain emissions, often represent the majority of an organization’s total GHG emissions” (5).

Because scope 3 covers the entire value chain, pharma scientists should integrate sustainability into R&D, manufacturing, and sourcing strategies (6,7).

How does green chemistry optimize API manufacturing?

significant producer of emissions from pharmaceutical companies

 (8). The largest contributors to the carbon footprint in these operations are the use of solvents, reagents, and precious metal catalysts (6). Applying the principles of green chemistry early in process development is one strategy to reduce emissions (6), because it allows for the implementation of eco-friendly processes and may foster acceptance by regulatory authorities (6).

Recycling solvents and catalysts offers measurable resource savings and carbon footprint reduction by minimizing incineration waste and the need for new raw material production (6). For instance, specialized companies perform the external transformation of used catalysts back into active species. Innovative technologies are emerging to support this, such as Evonik's process for concentrating precious metal-containing organic waste streams using membrane cross filtration (6), and the development of the "Chemistry in Water" platform, which reduces the consumption of organic solvents. Minimizing or eliminating solvent use may be the best sustainability approach (6).

How is sustainability by design used in bioprocess development?

Similar to quality by design, the concept of sustainability by design is taking root (7). This approach requires integrating sustainable practices from the beginning of the development process, because 80% of a drug’s final environmental impact is determined during the early design stages (7).

Key elements of sustainability by design are resource and energy efficiency, waste minimization, and the use of less-hazardous chemicals (7). Driving efficiency may be achieved with higher titer in smaller volumes through process intensification, which lowers the cost of goods while simultaneously reducing emissions (7). Examples of intensification include using high-density cell banking to skip lengthy seed expansions and implementing single-use bioreactors with high turndown ratios (7). Reducing utility usage by specifying a lower quality of purified water (e.g., reverse osmosis quality water) for media makeup and general early-stage buffers can create impactful improvements in resource management (7).

How do innovations in packaging and supply chain collaboration contribute?

Packaging is a significant contributor to scope 3 emissions, but optimizing packaging solutions offers a way to reduce a company’s GHG (2). Fiber-based packaging, derived from sustainably sourced wood and featuring a high recyclability rate (86.6% in the European Union in 2023), is gaining prominence as an option (2). Efforts to reduce packaging’s carbon footprint involve utilizing fossil-free energy in production and maximizing material efficiency through light weighting (2).

For single-use applications, which remain standard due to contamination risks, innovation focuses on alternatives to traditional materials (9). These include adopting PVC- and halogen-free alternatives (such as APET, PP, or PE) in blistering applications and developing recyclable materials for which the forming and lidding components are made of the same substance (9).

The pharmaceutical supply chain is wide and complex and includes a variety of suppliers, such as material producers, contract manufacturers, and packaging and distribution players. Effective sustainability requires collaboration across this entire supply chain (2,7). Because up to 92% of bioprocess emissions come from upstream activities, companies must engage suppliers early and prioritize partners committed to environmentally friendly practices, responsible sourcing, and strong environmental, social, and governance policies (4,7).

Digital technologies are essential enablers of sustainability goals (9). Smart tools like digital and laser printing technologies support traceability and increase flexibility for smaller or personalized batches (9). Energy-efficient manufacturing equipment is gaining traction, particularly technologies that capture and reuse waste heat (9).

Digital advancements, including real-time monitoring and advanced analytics, facilitate the complex assessment of environmental impacts (7,10). The integration of artificial intelligence (AI) and machine learning (ML) is proving indispensable for overcoming the challenge of insufficient or complex data needed for sustainability assessments (7). ML models can efficiently fill data gaps and provide higher accuracy predictions. Sustainability implications, therefore, may be assessed alongside technical and cost considerations (7).

The goal of sustainability is a commitment to transformative change (3). By embedding these practices into process design, sourcing strategies, and supply chain partnerships, pharmaceutical manufacturers are solidifying environmental responsibility as a strategic competitive advantage, ensuring the delivery of high-quality products in a socially responsible manner (1,7).

Cole, C. and Miller, D. Sustainability Becomes Essential: Green Manufacturing and Supply Chain Resilience in Bio/Pharma. 

https://www.pharmtech.com/view/sustainability-becomes-essential-green-manufacturing-and-supply-chain-resilience-in-bio-pharma

Haigney, S. CPHI Frankfurt 2025: Fiber-Based Packaging for Sustainability. 

Haigney, S. Working Together to Improve the Environment. 

Pharm. Technol. Bio/Pharma Outsourcing Innovation

https://www.epa.gov/climateleadership/scope-3-inventory-guidance

Challener, C. A. Improving the Sustainability of API Manufacturing with Recycling Technologies. 

Challener, C. A. Sustainability by Design in the Context of Bioprocess Development. 

Witte, C.; Perez, L.; Fernandez, M.; Weskamp, T. Decarbonizing API Manufacturing: Unpacking the Cost and Regulatory Requirements. McKinsey & Company. July 26, 2024. 

https://www.mckinsey.com/industries/life-sciences/our-insights/decarbonizing-api-manufacturing-unpacking-the-cost-and-regulatory-requirements

Lavery, P. How Smart Technology Is Helping Reach Sustainability Goals in Drug Packaging. 

Sustainability has become a strategic imperative in the pharmaceutical industry, driven by client expectations, environmental audits, and climate pressures. The sector's significant carbon footprint, particularly from scope 3 emissions, necessitates integrating sustainable practices across the value chain. Green chemistry and sustainability by design are pivotal in reducing emissions in API manufacturing and bioprocess development. Innovations in packaging and supply chain collaboration further contribute to sustainability goals. Smart technologies, including AI and ML, enhance environmental impact assessments, supporting the industry's commitment to transformative change and competitive advantage.

Pharma companies are focusing on sustainability efforts to meet client expectations, environmental audits, and climate pressures.

Integrating Sustainability into the Core of Pharmaceutical Science

 managing director, Arcinova, a Quotient Sciences company, about what makes a contract development and manufacturing organization (CDMO) that offers end-to-end service beneficial to sponsor companies and how digital technologies are changing the industry.

PharmTech: How is early development of drug products enhanced by a CDMO that offers end-to-end services?

Dowdeswell (Arcinova): I think to some extent, this depends a little bit on who you're doing the work for. So, if I was to take a small biopharma company, for example—and they're important because they own the majority of clinical molecules in early clinical development—typically, that sort of company has limited resources to conduct that sort of work themselves. So, they outsource heavily. They perhaps have a limited number of people who are really going to be in a position to manage their service providers. So, that really brings you to the first benefit, but actually having a single partner reduces the complexity you have in managing multiple partners; you have a single point of contact across the continuum.

And, actually, there can be some really more tangible benefits than that. So where you have a single partner developing both your drug substance and drug product, and in fact, in some of the areas around it, what you can find is that they're able to talk to each other directly without you having to get in the way of communication because they're part of the same company, there's no confidentiality issues.

It also means that maybe there's some work that can be overlapped. So, you can start work on a drug product before you've finished all the work on the drug substance, which might not be quite so easy when you have separate parties.

It may be an example to bring that to life. One of the things that we find here is that we can have great communication between the team that's working on the API around the material form of the drug substance, with the drug product team who's doing the work to translate that into a viable drug product. So [there’s] that interplay between how do we optimize the drug substance [and] how does that feed into what we're doing with drug product that can actually bring you to stronger technical outcomes?

I think in our particular case as well, because we're part of Quotient, we're able to go further downstream, into clinical work. The main benefits of that continuity of work through a single provider brings those key benefits, reduction in complexity, especially those smaller companies, reduction in time, which can be quite meaningful, and the reduction in the total cost of ownership.

What role do artificial intelligence (AI) and digital technologies play in accelerating drug discovery and improving manufacturing efficiency?

One of the clearest examples of how digitalization and AI are changing drug discoveries is the use of AI to help design new molecules that target a specific protein site. Now that is quite effective in tailoring a drug to the activity or molecule’s activity you hope it will have, but it has an unexpected consequence in that the number of synthetic steps is increased quite dramatically with that approach. I have some data that shows around the year 2000 there was a paper published by Pfizer and AZ [AstraZeneca] that showed the average number of synthetic steps to get to an API was eight. Round about 2020, you do the same analysis, and you see that number of steps has almost doubled—so, it's like 14 or 15.

And earlier this year, I found some more data, which suggested that the new molecules coming out of novel approaches to drug discovery have often in excess of 30 steps of chemistry to get to the target. So that is a really dramatic step change—that over the past 25 years, you've gone from eight to 30 steps, and that's quite an unexpected consequence. CDMOs are going to have to find a way to deal with that. Now, the time that we have available for CMC [chemistry, manufacturing, and controls] is not going up. In fact, if anything. [it] is coming down. So, you have more complexity, more work to do on the API synthesis. We can leave aside the problems that you have in drug delivery beyond that. But just for the API synthesis, you have to find a way to get all of the work done on CMC and building the synthesis towards providing the small-molecule API in the same time. So, you have to find ways to do that much more efficiently, much more quickly.

One of the things that we've been looking at is around the use of digital twins. We're not alone in doing that, but one of the reasons we've done that work is because it gives us a really great pathway to look at how do we move from the small-scale lab experiment into the initial scale up, which might be to a small kilo lab, 5, 10, 20 liters, and then take that further into the next scale, which might be 100-, 150-, 200-liter scale. And even then, how do we provide data that enable a customer or a future service provider to take that further? So, we've done that work to enable us to model how the reactor is going to behave, how the kinetics of the reaction are going to behave, to enable and facilitate that scale up. And we actually did that. It was part of a sustainability push, originally, that we wanted to be able to do this in a quicker fashion, that we're using less resources to get to the same endpoint. But when you tie that into the complexity part, the amount of work you've got to do, that starts to become essential.

The difficulty in the work that we did was to look at the data architecture. The way that you receive the data from all of the different sensors, because it's not standardized today, requires a lot of data manipulation/adjustment to get it into a format where you can do the modeling. Here's where we're planning on bringing AI in, because AI can help do that data manipulation work in a much smarter, quicker [way], frankly. Quicker is the key here; [AI] enables us to get that modeling done much more quickly, which starts to build this then from a single product or single reaction solution into something that's much more of a platform that you can use across the board.

Some of the other advantages you have is how you can also look at operating in batch or continuous and attend on a particular stage of development. You might want to change that [to] be more appropriate [at] a certain stage of development, to do it continuous and later fit to batch, because that fits a large-scale CD, most manufacturing assets.

I think, as an industry, that's maybe a microcosm of the challenges we face. There's an inconsistency around the state of digitization, and not just company-to-company, but asset-to-asset within companies, because different assets have different ages and different ability to support digitalization.

Innovation, the lack of standardized data architecture, is something that we've seen, really in a microcosm, but [also on] a macro level [and] is something everybody faces. And I think the third one, I'm pretty sure, is a [challenge] across the industry as well, [which] is the availability of expertise. Is there a suitably qualified workforce? Do we have access to the right people that can really support and drive digital initiatives, and, in fact, even who fully understand the true potential of what could be done? I think that's one of the key challenges that, as an industry, we're still coming to grips with.

How is the sector reimagining supply chains to protect against rising tariffs, geopolitical shocks, and global disruptions?

Quite frankly, at the moment, nobody knows. There's a huge amount of change around tariffs and what's happening with some of the other geopolitical situations. And certainly, I don't look to base strategy on social media posts without really understanding how that is going to be implemented. But I think overall, this is part of an ongoing regionalization trend that has really been driving for quite some time, certainly over the past 10 years, this has been happening certainly for innovative pharma. So, companies working in the innovative space, their focus has moved away slightly from just being let's get things done at the lowest cost, which meant moving to Asia, to a realization that their success is much more dependent upon getting their drug advancing through the clinic and hopefully to market in a timely fashion.

Not being first to market or being delayed is a real hit on their revenue. It's a real hit on the business case for developing the drug in the first place. So we're seeing them move away from a cost-first basis to look at how do they best ensure their drug gets through that. The way they do that is by making sure that their CDMO providers are underpinned by strong science, are able to provide good data, are able to execute a plan, have no compromise on quality, are able to really communicate within a very optimal fashion, depending on what that means for an individual organization. Overall, finding that they are able to get more security of supply and more security of delivery.

You can really see that in the past 10 years, the CDMO industry has had quite a revival, and a number of companies that are public demonstrate that really well across Europe and United States. So, I see the trends, the questions around tariffs, BIOSECURE, re-emerged again. The geopolitical factors around the over-dependence on China, I just see that simply accelerating that trend. Because I think our industry has been moving that way anyway. This just maybe makes people much more conscious of it … What it means for us is we have to be consistent or continually re-evaluate what we offer as services to understand [if what we are offering] is still addressing customer problems. What aren't we doing that we should be doing? Are we relevant? Are we going to remain relevant in the future? So really having that continuous dialog with our customers and future customers about what do we need to be doing to really be giving you what you need.

End-to-end services provided by CDMOs streamline drug development for small biopharma companies by reducing complexity, time, and costs. These organizations facilitate seamless communication and collaboration between drug substance and product teams, enhancing technical outcomes. Digital technologies, including AI and digital twins, are revolutionizing drug discovery and manufacturing by improving efficiency and enabling rapid scale-up. However, challenges such as data standardization and workforce expertise persist. The industry is also adapting supply chains to mitigate geopolitical risks, focusing on regionalization and ensuring timely drug advancement over cost reduction.

Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences company, discusses what makes a CDMO that offers end-to-end service beneficial. 

Outsourcing Partners Providing End-to-End Service

We examine what the deal means for the industry.

Kimberly-Clark to Acquire Kenvue

Kimberly‑Clark said on Nov. 3, 2025 that it is planning to acquire Kenvue, the former Johnson & Johnson unit and maker of major United States brands like Band-Aid and Tylenol, for approximately $48.7 billion (1).

In the immediate aftermath of the announcement, Kimberly-Clark shares dipped sharply; Kenvue has 

 of US Health and Human Services Secretary Robert F. Kennedy Jr. for purported links between the use of acetaminophen—the active ingredient in Tylenol—by pregnant women, and the prevalence of autism spectrum disorder and/or attention-deficit hyperactivity disorder in children (1,2).

"This validates how easing rate expectations are fueling large, transformational mergers," Kimberly Forrest, chief investment officer at Bokeh Capital Partners, 

 (1). "Both companies sit side by side on store shelves, so the scale and distribution logic make sense even if the Tylenol overhang remains a shadow any buyer would rather avoid."

Here are some other key considerations of the deal for pharmaceutical industry professionals:

What happens to brand portfolio upstream sourcing?

The merged company’s large product portfolio means upstream sourcing of active ingredients, excipients, and packaging materials may shift significantly, affecting suppliers who service both consumer health and pharmaceutical markets.

How might this influence regulatory risk tolerance?

Litigation involving Kenvue that has resulted from the acetaminophen-autism claims has highlighted how even consumer-facing health products carry regulatory and reputational risks (1). Compliance demands may amplify as sector boundaries blur.

Will manufacturing footprints consolidate or diversify?

With targeted cost synergies and integration benefits cited in the transaction, manufacturing sites for both consumer health and pharma-adjacent products could either be consolidated or repurposed; that may affect manufacturing contract dynamics (1).

Does this signal acceleration of consumer health and pharma convergence?

This deal reinforces the idea that pharmaceutical players may increasingly look to consumer health-adjacent markets for growth, making it essential for drug development teams to monitor consumer health trends and regulatory pathways.

How will supply chain resilience be revisited?

As large-scale acquisitions logically tend to prompt reviews of supply chain robustness, more stringent expectations may be set for dual-use suppliers and end-to-end traceability.

In sum, while the Kimberly-Clark–Kenvue deal resides in the consumer health space, its ripple effects extend into drug discovery, development, and manufacturing, underscoring the importance of cross-sector awareness and adaptive strategy.

Kimberly-Clark Bets $40 billion for Kenvue Despite Tylenol Controversy.

Acetaminophen and Autism: Industry Impacts of the White House Statement.

The planned Kenvue acquisition, expected to close in the second half of 2026, has notable implications for pharmaceutical R&D and manufacturing professionals.

Kimberly-Clark to Buy Tylenol Maker Kenvue: Analyzing Risks and Rewards

In a three-part interview (view those videos 

 coverage, Maggie Saykali, Director – Specialty Chemicals, Cefic (European Chemical Industry Council), reviewed her presentation at the conference, “The Critical Medicines Act: Game-Changing Opportunity for a Sustainable and Resilient Supply Chain?” The discussion focused on the origins, development, and core goals of the 

European Union’s proposed Critical Medicines Act

 (CMA); the necessary structural shifts for the European biopharmaceutical manufacturing sector; and the significant geographical shifts occurring in pharmaceutical manufacturing.

PharmTech: Can you provide an overview of the CMA?

Maggie Saykali: The CMA took a long time to elaborate; the idea for it originated during the pandemic. During the pandemic, we witnessed quite a few shortages that illustrated the existing situation that we all knew about: due to years of offshoring from Europe to Asia, we were very dependent on other regions for the supply of some of our critical medicines, especially generics. From 2020 until 2022, the situation was obviously exacerbated, and it became clear that a solution must come. The European Commission worked with major stakeholders—active pharmaceutical ingredient (API) manufacturers, generics manufacturers, branded medicines manufacturers mainly, but also patient associations, pharmacists, and member states—to identify the root causes for the shortages and find drastic solutions to alleviate or reduce them.

That process began with establishing a methodology to determine what makes a medicine critical. The Commission developed a methodology using a rather complex matrix with different factors, such as the therapeutic family of the medicine, the structure of its supply chain, and the number of suppliers. This helped identify critical medicines and differentiate them from medicines that might be short but do not qualify for criticality. In 2023, the idea arose that Europe needed a Critical Medicines Act, similar to the models for chips or raw materials.

This idea was really pushed hard by a few member states together with the European Commission. A Critical Medicines Alliance was formed, involving about 200 stakeholders. The steering board of this critical alliance included the associations mentioned, plus representatives of patients, pharmacists, and member states. We worked on the possible solutions, and then the Commission compiled this information. In March 2025, the CMA was published by the Director General for Health (DG SANTE)—the directorate in the European Commission responsible for health—with support from the directorates for industry and medical emergencies.

Since then, the CMA has entered the European decision-making process, which involves consultations with the European Parliament and the Council (the European member states). The council, the commission, and the parliament are currently discussing the Act. We think the final vote will happen at the end of this year or the first quarter of 2026, after which it will hold legal value.

What opportunities can the Act bring to EU manufacturers of APIs, intermediates, and starting materials?

We see today a situation in procurement that is completely based on cost and price only, meaning one winner takes the whole tender. This approach provides no guarantees on quality, security of supply, or adherence to environmental or social norms. This is detrimental to European manufacturers, because we have a set of standards (the European regulatory frameworks) that we must comply with. Some suppliers from other world regions do not abide by these standards, resulting in different cost structures.

By addressing the criteria used for procurement, this might give European manufacturers better possibilities to be competitive. By including environmental criteria, as we requested, value will be given to the fact that we produce according to very strict and tight environmental, social, and governance requirements. This means that we will not be penalized because of it, but that it will rather become an advantage for us. Furthermore, we are asking for multi-winner tenders, instead of the "one winner takes it all" approach, which would also be an advantage for those who manufacture in Europe.

The European Union's proposed Critical Medicines Act (CMA) aims to enhance the sustainability and resilience of the pharmaceutical supply chain by addressing shortages and dependencies on non-European regions. Originating during the pandemic, the CMA seeks to redefine procurement criteria, emphasizing quality, security, and environmental standards, thus benefiting European manufacturers. It encourages innovation and competitiveness by valuing advanced, eco-friendly processes. Globally, similar initiatives are emerging, highlighting the importance of local production capabilities. The CMA also emphasizes preparedness and international cooperation to mitigate global supply chain disruptions.

Maggie Saykali reviews the key points of her CPHI Frankfurt presentation on the potential game-changing opportunities of the Critical Medicines Act.

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