The global contract manufacturing market is booming, but fragmented. The well-established names of the CDMO space – Lonza, Thermo Fisher, WuXi AppTec, WuXi Biologics, and Samsung Biologics – account for just 15 percent of total revenues.
Beyond these giants, a huge network of smaller, more specialised CDMOs are, in fact, picking up the majority of contract manufacturing work. PharmaBoardroom has spoken to executives at many of these firms over the past 12 months; each solving different, specific problems. These include filling the gaps for modalities with scarce global manufacturing capacity, insuring against over-exposure to China, and fulfilling domestic-supply mandates.
None of them promise to be everything to everyone, but each has picked a lane and gone deep rather than wide. Increasingly, this seems to be what many pharma and biotech CEOs are looking for in a CDMO partner.
USA: Not Everything to Everyone
The world’s biggest pharma market is having a manufacturing boom. The Trump administration’s ‘made in America’ push has seen a slew of major investment announcements, with pharma companies and CDMOs alike keen not to miss out on favourable market conditions for local manufacturers (and the threat of tariffs if they choose not to invest in the US). Where are the gaps for smaller CDMOs to fill?
Two firms – both private equity-owned, built from parts of existing companies rather than developing individually over years – provide an interesting model. Curia, for its part focuses mainly on small molecules and sterile injectables, with a growing push into ADCs, and serves mostly biotech clients rather than large pharma.
CEO Philip Macnabb explicitly rejects the idea that an organisation like his can be “everything to everyone” and, perhaps unusually for a CDMO, does not claim to be an “end-to-end provider,” instead noting the fragmentation of the CDMO market between pure-play specialists like his and the few true broader end-to-end providers.
“We have broad capabilities,” says Macnabb. “We do not cover every segment, but we offer substantial scope.” For example, in drug product, Curia focuses only on sterile injectables and has chosen not to pursue solid oral dose capability. “We still perform drug discovery work that many CDMOs do not, so the model is closer to a CRDMO, covering development, scale-up, and manufacturing,” he adds.
Elsewhere, newly-formed Minaris – a combination of Minaris Regenerative Medicine (formerly owned by Resonac) and the former Advanced Therapies business of WuXi AppTec – has chosen to focus exclusively on cell and gene therapy (CGT) manufacturing.
Capability, as opposed to capacity, is the name of the game for CEO Orla Cloak. “Where Minaris is uniquely positioned is in capability,” she says. “It is no longer about capacity but rather breadth and depth of knowledge. Minaris is uniquely positioned not only to partner with sponsors but also to bring that deep level of technical expertise, understanding that CGT is a very complex process unlike traditional pharmaceuticals.”
However, succeeding with a less-well-known brand in a competitive CDMO market, will require high levels of trust and partnership. “Trust in healthcare operates at multiple levels,” says Macnabb. “Earning and maintaining that trust is what differentiates Curia in a competitive market,” he adds. “Rather than being the lowest-cost provider, we act as partners and problem-solvers, working alongside clients to navigate scientific, operational, and regulatory complexity.”
If a programme needs sterile injectables, complex small molecules, or cell and gene therapy specifically, a narrow specialist like Curia or Minaris may bring more attention and technical depth to that one problem than a broad-capability major would. The trade-off is a shorter track record and less brand recognition.
Korea: Beyond Samsung
Korea’s CDMO sector is almost synonymous with Samsung Biologics. Comfortably among the world’s top five biggest CDMOs, and in the top three by some rankings, it also has the single largest biologics manufacturing capacity of any CDMO worldwide at its sites in Korea. But, in the shadow of such a giant, what else can Korean CDMOs offer?
Lotte Biologics CEO James Park is well aware of Samsung Biologics’ global impact. Park, a Korean American, was tempted to Korea to head up global sales and operations for Samsung Biologics in 2015. After over seven years there, he two years as CEO and president of cell and gene therapy CDMO GC Cell and is now well into his second year as CEO and President of Lotte Biologics.
Originating in Japan, Lotte Group entered the healthcare space through the acquisition of a BMS manufacturing site in the US, which was later complemented by a major facility in Korea.
Park describes this well-established dual US-Korea footprint as a key differentiator for the company. “Having a US-based site has been a considerable advantage, particularly for clinical supply and commercial manufacturing within the US market,” he explains. Park suggests that this applies to both US biotechs as well as Chinese firms looking to conduct clinical trials in – and ultimately access – the US market with their products.
With geopolitical tensions pushing US firms to look beyond Chinese manufacturers, a well-established operation headquartered in a friendly nation with a US footprint becomes even more attractive. Taiwan is also staking its claim along these lines, as we covered earlier this year.
“But the value goes beyond geography alone,” continues Park. “We invested in and built our antibody drug conjugate (ADC) manufacturing facility for bioconjugation, enabling ADC production beginning from January 2025. And we are already seeing strong inbound interest from potential ADC clients as a result.”
He adds “Songdo [the base for Lotte’s Korean operations], meanwhile, offers considerably greater scale, 120,000 litres of capacity compared to 40,000 litres in Syracuse, giving us the flexibility to bring a product in at the clinical stage through Syracuse, and, as it scales toward peak demand, transfer manufacturing internally to Songdo for larger-volume production, with meaningful cost-of-goods benefits.” The idea is that Lotte’s clients have a built-in path between the two sites as their needs develop, removing the need to switch manufacturing partners.
Park is hugely optimistic about the future and Lotte’s differentiated offering. “We are admittedly still a relatively young CDMO and a later entrant to the market, but we bring genuine eagerness to deliver strong service across every part of our business,” he concludes. “Combining the best of both worlds gives us real flexibility, both in terms of capability and capacity, as well as location.”
Lotte’s pitch isn’t to out-build Samsung on scale: it’s a genuine US-Korea dual-site model with a built-in upgrade path, aimed at clients who want a hedge against China exposure without committing to a single, harder-to-reverse manufacturing relationship.
Germany: Out-Specialising the Majors
In Germany, Europe’s largest pharma market and its fifth largest producer by value, local CDMOs are increasingly defining themselves by their specialisms.
For Axolabs, that means oligonucleotides: short, lab-made strands of genetic material which attach to a specific piece of RNA in the body and either silence a disease-causing gene, correct how it is read, or block it from making a harmful protein. Roughly 28 oligonucleotide drugs have reached approval so far, with over 1,000 more in development, but demand is outstripping the number of manufacturers able to produce them well.
“Our differentiation comes from being highly specialised in oligonucleotides, with deep scientific expertise and an integrated model that spans early research and lead optimisation, analytical and process development, and GMP manufacturing,” explains Susanne Leonhartsberger, Axolabs’ CEO and managing director.
“There are, of course, strong competitors in this market, including WuXi, Agilent and Nitto Avecia, while Lonza is a very large global CDMO with strengths across several modalities,” admits Leonhartsberger. “We are not trying to compete simply on scale … as more drug candidates progress through clinical development and move closer to the market, manufacturing demand grows with them. Customers may only need relatively small quantities in the early phases, but as their programmes advance, there is considerable value in working with a manufacturer that can support them throughout clinical development and into commercial supply without having to change partners later.”
Richter BioLogics – a fully-owned subsidiary of Hungarian firm Gedeon Richter – is pursuing a similar strategy, but in the microbial niche, using bacteria or yeast as miniature biological factories to produce drugs. Far more manufacturing capacity globally is built around mammalian cell culture (driven by the boom in biologics and antibody drugs), meaning that microbial manufacturers have become highly sought-after.
“We have chosen to focus entirely on this microbial segment, where we have built a highly specialised niche and face a more limited field of competition,” explains Richter BioLogics CEO Kai Pohlmeyer. “Within microbial manufacturing, we have found a niche where we can differentiate ourselves by offering the flexibility and customer dedication of a small to mid-sized player, combined with more than 35 years of experience and the quality required for late-stage and commercial manufacturing.”
Even within this niche though, selectivity remains paramount. “At the same time, we are selective about the technologies we pursue,” notes Pohlmeyer. “We decided against entering mRNA manufacturing, for example, because it was too different from our established technologies. We continuously observe new technologies as they develop and then decide whether they fit our expertise and where it makes sense for us to invest and develop further.”
Also plugging away in the microbial manufacturing niche is Wacker Biotech, a 21-year-old outfit which rose to global prominence manufacturing mRNA drug substance for CureVac’s vaccine during the COVID-19 pandemic.
“Wacker Biotech is fundamentally a specialised microbial CDMO,” proclaims Guido Seidel, the firm’s managing director. “Rather than competing across all modalities, we have focused on microbial expression systems, recombinant proteins and nucleic acids, building deep expertise in these areas over many years,” he continues. “Our strategy is not based on scale, but on scientific expertise and the ability to solve challenging manufacturing problems.”
Seidel concludes, “Our ambition is not to be the largest CDMO, but to be recognised for scientific expertise, speed, flexibility and close collaboration with customers.”
All three German firms are betting that a client with a genuinely hard technical problem – oligonucleotide chemistry, microbial fermentation and refolding – will pay for depth of expertise over raw capacity. If your programme is a commodity biologic, that trade-off won’t matter to you; if it’s a narrow, technically demanding modality, it might be the whole decision.
France: Riding the Reindustrialisation Wave
Clustered around the city of Lyon, three of France’s leading local CDMOs are both benefiting from – and contributing to – the country’s push to manufacture more of the medicines it needs at home,
Skyepharma, which specialises in complex oral solid forms of drugs, recently opened a new 450 m² high-potency zone dedicated to medicines to be handled with particular care. Freshly installed CEO Sébastien Mas explains that this investment closely aligns with France’s national pharmaceutical sovereignty goals.
“Skyepharma was selected under the France 2030 relocalisation programme for essential medicines and received EUR 1.6 million in public support to strengthen our manufacturing capacity, which confirms the contribution we can make to this national priority,” he notes.
Benta Lyon, which produces multiple dosage forms at its site near Lyon, is also contributing to France’s attempts to produce more affordable generic medicines at home. Many of these products are now sourced from lower-cost Asian countries, creating a risk of shortages in Europe.
“Through the France 2030 programme, we were selected in 2023 for a project dedicated to developing essential generics,” says CEO Damien Parisien. “In 2025 we received a second France 2030 award for paediatric paracetamol oral suspension to help secure supply and mitigate shortages.”
Also in the affordable medicines space, the larger and more diversified SEQENS group is stepping up to the plate. “I am a strong advocate for France’s reindustrialisation, and more broadly, for rebuilding Europe’s industrial footprint,” proclaims CEO Pascal Villemagne.
“A flagship example of this strategy is our paracetamol (Acetaminophen) project in Roussillon, near Lyon, where we are finalising the construction of a new API plant, a public investment exceeding EUR 100 million,” he says. “This project embodies our contribution to France’s and Europe’s industrial sovereignty.”
With these contributions to France’s reindustrialisation goals well underway, all three companies are now attempting to scale the value chain: Skyepharma into more challenging, higher-value oral solid forms; Benta Lyon adding a regulatory consultancy to its offering and moving into high-potency products; and SEQENS moving into biologics and cell and gene therapy.
