Bolstering the Burgeoning Biologics Boom and Beyond
CDMOs expand and innovate to meet industry demand
Noncommunicable diseases—which include conditions like heart disease, stroke, cancer and diabetes—account for 74% of all worldwide deaths, according to the World Health Organization. Biologics are designed to target specific biological pathways and have proven effective in managing these conditions. It then comes as no surprise that the biologics industry expects spectacular growth, namely a compounded annual growth rate (CAGR) of 9.96% from 2025 to 2034, when the market is expected to reach US$1.14 trillion. “This growth is driven by the increasing number of programs at various stages of development. Within biologics, bispecifics and ADCs are seeing the most growth,” explained Adam Pietruszkiewicz, chief commercial officer at Mabion.
In 2024, 18 of the 50 FDA approved drugs were pure play biologics, representing 36% of total approvals. This number is up from 2023’s 29%. Biologics are compounds derived from organic, rather than chemical, origin. They include monoclonal and bispecific antibodies, along with cell and gene therapies and ADCs. 11 out of the 13 top modalities that most interest investors are biologics, according to the Oppenheimer 2025 Annual Biopharma Outlook Survey, which surveys 49 institutional life sciences investors. Bispecifics and monoclonal antibodies took the first and third spots on the list, with small molecules sandwiched in second.
According to the 2024 CPHI Annual Report, 54% of executives believe investments in biologics will deliver the best marginal and overall returns for CDMOs over the next five years. The contract manufacturing space is aware of this potential, and many have already began expanding to help meet demand.
Of the 31 CDMOs and CMOs interviewed for GBR’s report, 18 recently completed, are undergoing, or announced plans to expand capabilities, either organically or inorganically. Companies expanding capabilities with new technologies are also included in this total. Of these expansions, 50% are centered around biologics. Put simply, “Biological drugs represent the future,” said Marianne Späne, chief business officer of drug substances and drug products at Siegfried.
Siegfried is bringing the future to the present with recent moves in the biologics space. In November 2024, to strengthen its offering in biologics, specifically in cell and gene therapy (CGT), DINAMIQS, a 2023 acquisition, inaugurated laboratories in Zurich’s Bio-Technopark. “Siegfried DINAMIQS bridges drug design and process development in the CGT space,” continued Späne.
Across the pond, Thermo Fisher Scientific launched Accelerator Drug Development in October 2024. It combines contract development, manufacturing and clinical research services into a unified solution across major therapeutic modalities—including biologics, viral vector, CGT— reducing trial-and-error, eliminating redundancies and preserving know-how, intellectual property, time and resources explained Anil Kane, executive director and global head of technical and scientific affairs. In 2023, the firm expanded in St. Louis, doubling the company’s biologics manufacturing capacity, growing from 2,000 L to 5,000 L to produce complex biologic treatments for diseases including cancer, autoimmune conditions and rare disorders. “Large-molecule biologics remain a key focus, with services ranging from cell line development to process evaluation, scale-up, and sterile fill-finish production,” said Kane.
With CRISPR-Cas9 becoming a tool in 2012, CGT has a lot of potential. “The progress over the last 15 years has been incredible, and I am excited to take all of our learnings into the next decade of gene therapy drug development – the future is bright,” emphasized Steve Favaloro, chairman and CEO of Genezen, a US-based CGT CDMO.
In Kentucky, India-based Piramal invested US$80 million to expand its sterile injectables facility, giving the firm the ability to provide fill-finish services for ADCs. It will include a high-speed line to double annual production capacity and increase fill-finish capabilities. Peter DeYoung, CEO of Piramal Pharma, explained: “The expansion was driven by the demand for differentiated capabilities, including expertise in ADCs, sterile fill-finish, high potency APIs and peptides.”
Also in the South, Alcami added a new sterile fill/finish line with isolator and two lyophilizers in its Charleston, South Carolina manufacturing site in 2024. The expansion meets growing industry demands for onshore sterile fill/finish capabilities amidst tightening capacity as the pipeline of biologics grows, according to the press release. Alcami opened a pharma storage facility near Research Triangle Park, offering LN2 storage to walk-in -80, -40, -20, and CRT ambient pallet storage. “The long-term goal is to expand further into the biologics space, building on our existing services while adding additional redundancies and scale,” highlighted Timothy Compton, chief strategy officer at Alcami.
Expansions to the Pace Life Sciences’ facilities in New Hampshire and Minnesota will add sterile fill-finish capacity and enhanced analytical capabilities to support clients developing biologics, gene therapies and other novel molecules. “Biologics and gene therapies hold enormous potential,” said Dean Bornilla, head of commercial. “The new sites strengthen our ability to support analytical testing needs from early development through commercialization.”
Grand River Aseptic Manufacturing announced the construction of a 150,000 square foot syringe and cartridge filling center. The firm also expanded its inspection, finishing and warehouse center. “These expansions enable us to handle longer production runs, accommodate more specialized devices, and meet the increasing demand in biologics,” said Derek Hennecke, GRAM’s CEO.
Lifecore Biomedical recently installed a five-head isolator filler which doubled manufacturing capacity. “This new five-head filler allows us to expand in a fast-growing market in water-based biologics like GLP-1s and monoclonal antibodies,” said Paul Josephs, president and CEO.
Biologics manufacturing capacity increased significantly over the last two decades from nearly 600 kL in 2000 to just over 6,700 kL in 2024. Capacity is projected to increase to 9,000 kL by 2028. However, biologics CDMOs were seen by the industry as the most likely to see capacity shortfalls in the next year, according to the CPHI Annual Report. Biologics manufacturing is also expensive. Luckily, firms are innovating to meet these challenges.
One step for CDMO, one giant leap for biologics
US$260 billion of the US’s US$568 billion spent on pharmaceuticals in 2021 went toward biologics. Biologics demand 46% of the nation’s annual drug spend but represent only 2% of prescriptions.
Executives in CPHI’s Annual Report identified continuous biologics manufacturing as the most likely technology to lower biological production costs over the next five years. Only two contract manufacturers operate continuous biologics set-ups: Enzene Biosciences and Just Evotec.
Enzene is in the final stages of launching its US manufacturing site in New Jersey, housing two production lines powered by EnzeneX™ platform, a continuous manufacturing technology. The platform, originally scaled at 200-500 L, expanded to 1,000 L and delivers up to 40 kg per batch. The technology offers 10x increase in productivity, though a client achieved a 30x increase, and 50% reduction in carbon emissions, explained Himanshu Gadgil, the CEO. The firm’s 2025 goal is unprecedented— “breaking the US$40/gram cost barrier for production of mAbs.”
The technology is a worthwhile capital expenditure. “Our initial US$50 million investment in the US facility enables nearly one ton of production capacity per year. In contrast, a traditional batch manufacturing setup would require US$200-US$300 million for the same output,” Gadgil continued.
“Cell and gene therapy and neurodegenerative diseases are gaining significant traction. These fields are advancing rapidly, and there is increasing interest from both biotechs and larger pharmaceutical companies.”
Paula Brown Stafford, CEO, Allucent
Beyond biologics: The GLP-1 wave reshapes manufacturing
The contract manufacturing landscape is being reshaped by demand surges for novel drug classes, none more so than GLP-1 receptor agonists. Though not biologics themselves, the meteoric rise of these peptide-based therapies for diabetes and weight management has sent shockwaves through the CDMO industry, forcing rapid strategic and operational adjustments. The sheer scale of demand created unprecedented pressure on specific manufacturing capabilities, particularly sterile fill-finish for injectables like prefilled syringes and autoinjectors. As Martin Meeson, CEO of Axplora noted: “If there was an acronym to characterize the industry today it would be GLP-1.”
This intense demand formed a crucial backdrop to the most significant M&A event in the CDMO history, and the largest deal of 2024: Novo Holdings’ US$16.5 billion acquisition of Catalent. Novo Holdings simultaneously struck a deal to sell three of Catalent’s fill-finish sites (in Italy, Belgium and Indiana, USA) to Novo Nordisk, the maker of blockbuster GLP-1 drugs Ozempic and Wegovy. This move was widely interpreted as an effort by Novo Nordisk to secure dedicated manufacturing capacity for its high-demand products, effectively taking significant fill-finish capacity off the open market for other drug developers.
Analyzing the deal a year later reveals profound ripple effects. For competitors and smaller biotech firms, the acquisition intensified existing capacity constraints. “One immediate consequence has been a reduction in available manufacturing capacity, particularly for injectables, forcing many clients to seek alternative partners,” said Dirk Lange, CEO of Pyramid Labs.
“The ripple effects of the Catalent acquisition and the surging demand for GLP-1 drugs are reshaping the market. Companies need stable, reliable CDMO partners, and we are strategically positioned to fill that gap,” Dirk added.
This sentiment reflects a broader industry scramble as companies reassess their manufacturing partnerships in the wake of the capacity squeeze. Paul Josephs, president and CEO of Lifecore Biomedical noted the favorable impact for remaining CDMOs: As giants like Novo Nordisk and Eli Lilly bolster internal capacity or acquire external sites for GLP-1s, multinationals’ other blockbuster products could be pushed to outsourced manufacturers, along with others going into pre-filled syringes or cartridges.”
However, the acquisition poses challenge for smaller players. “A single pharma company absorbing so much CMO capacity has significant implications... Smaller biotechs, smaller pharma, and smaller commercial production are underserved in a market where everyone is rushing to service ultra-blockbuster drugs... Many companies struggle to secure CMO capacity because they are not large enough to compete,” said Colleen Dixon, president and CEO of Selkirk Pharma.
The void of capacity in the market led to a slurry of expansions across the country. One such was Afton Scientific’s US$200 million plant expansion in Albemarle County. “The facility can support six to eight lines of Vial, syringe/cartridge, and lyophilization capacity. We are adding pre-filled syringe capacity to our Avon I building to respond to demand from our existing customers and add options for new customers,” said Thomas Thorpe, CEO and founder of Afton Scientific. “We anticipate continued growth in prefilled syringe demand, especially driven by the surge in GLP-1 drug demand, which has significantly impacted the CDMO industry. Afton’s expansion comes at a pivotal time to help meet this demand, particularly for sterile fill/finish services.”
Pharmaceutical companies are increasingly seeking secure and reliable capacity, often prioritizing domestic supply chains to mitigate geopolitical risks. The search for stability, combined with the specific technical demands of new drugs is driving investment, expansions and strategic positioning among CDMOs eager to capture the displaced demand and serve the next wave of innovative therapies, whether they are biologics, peptides or other complex modalities. The ability to offer specialized capabilities and demonstrate long-term reliability has become paramount in this dynamic manufacturing environment.
Article header image courtesy of Novartis