Press Room

Press Clipping / Jun 12, 2026

Outsourcing Formulation Development & Manufacturing: Connecting Your Project to the Right Service Provider

Drug Development & Delivery, 12 June 2026

Key Points

  • The CDMO market is growing rapidly as precision medicine, complex formulations, highly potent APIs, and more advanced delivery systems create greater demand for specialized development and manufacturing partners.
  • CDMOs are increasingly using AI, predictive modeling, integrated development workflows, and data-driven tools to accelerate formulation decisions, reduce material use, improve scale-up, and lower development risk.
  • Across oral solids, injectables, biologics, inhaled therapies, lipid-based systems, and complex dosage forms, successful CDMO partnerships depend on early problem-solving, manufacturability planning, regulatory readiness, and scalable process design.

The global contract development and manufacturing organization (CDMO) market size was valued at $255 billion in 2025 and is projected to grow from $273.40 billion this year to almost $581 billion by 2034. 1 Growing focus on precision medicine, the ability to handle more complex formulations, and a recent interest in highly potent active pharmaceutical ingredients is driving CDMO demand.

To be more efficient, CMDOs are turning to AI and data-driven tools. These technologies play a more practical role in formulation development and manufacturing, particularly in analyzing historical datasets and informing experimental design. While AI isn’t replacing scientific expertise, it is helping teams review larger datasets faster and make more informed decisions.

Many of the leading CDMOs highlight their capabilities and share real-world examples of how they solved clients’ formulation and manufacturing challenges in this exclusive Drug Development & Delivery annual report so that you can find the right provider for your own project.

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Hovione: Seamless One-Site Stop Integration from ASD Development to Drug Product Manufacturing

Hovione is a CDMO provider of Amorphous Solid Dispersions (ASDs) formulations manufactured by spray drying to address solubility and bioavailability challenges. This formulation strategy is integrated with downstream manufacturing of the final dosage form, such as tablets or capsules or nasal drug delivery.

“Hovione’s spray drying expertise is unique thanks to our regulatory track record, a large GMP spray drying capacity, and our ability to offer seamless “one-site stop” integration from ASD development to drug product manufacturing, for both batch and continuous tableting,” says João Ventura, PhD, Senior Director, Strategic Business Management – Pharma, Hovione. ASDs by spray drying has become a leading formulation strategy. This demand has also triggered growth in integrated and specialized offerings from CDMOs that integrate ASD formulation manufacturing with downstream manufacturing services into final dosage forms.

In formulation development, artificial intelligence (AI) tools enable faster, data-driven process and approaches with minimal experimental work and material consumption. Application examples include integrated formulation development and screening tools, such as Hovione’s ASD-HIPROS, capable of rapidly screening for the best combination of drug loads, excipients, and surfactants using advanced formulation models and high-throughput screening methods supported by AI tools. At Hovione, these tools are based on hybrid mathematical models that combine mechanistic understanding with machine learning methods, enabling scientists to predict drug-polymer behavior and optimize formulation composition in a fraction of the time, Dr. Ventura says.

In manufacturing, AI tools are being used to support increased digitalization and automation of manufacturing processes, informing greater understanding and insights from data-rich manufacturing process execution that support continuous improvements. In continuous tableting, advanced control strategies (PAT and real-time quality control) are being deployed to enhance process robustness and scalability.

“In early development stages, we use ASD-HIPROS, our data-driven high throughput screening tool, to rapidly characterize the challenge and select the most appropriate strategy, screening for the best combination of drug loads, excipients, and surfactants to create a robust, scalable spray drying process from the outset,” he explains. “We then apply Quality-by-Design principles and standardized tech transfer methodologies to ensure scalability and derisk the transition to GMP manufacturing.”

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Read the full article at Drug-Dev.com

 

 

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Key Takeaways Commissioning a US-based ConsiGma CDC Flex line enables end-to-end spray drying-to-tablet manufacture within a single site and quality system, reducing comparability and technology-transfer burdens. Elimination of conventional scale-up is enabled by using the same equipment from early development through commercial supply, minimizing engineering runs and conserving scarce API. Operational flexibility spans batch or continuous modes and 1–200 kg/h throughput, with scale adjustment achieved by switching continuous blenders rather than replatforming processes. High-containment design to 1 µg/m³ expands suitability for highly potent oral solid-dose programs while maintaining integrated development-to-commercial workflows. Regulatory momentum for continuous manufacturing is supported by ICH Q13 harmonization, increasing FDA approvals, and platforms leveraging inline PAT and automated control suites for real-time quality assurance. Hovione announced on Oct. 5, 2026, that it will commission the ConsiGma CDC Flex, a next-generation continuous direct compression tableting platform jointly developed with GEA. The investment is designed to link amorphous solid dispersion manufacturing via spray drying with commercial tablet production at a single US site operating under one quality system. The line will run in either continuous or batch mode at throughputs from 1 to 200 kg/h. Formulation development can begin with as little as 1.5 kg of material, and the same equipment can then support everything from very small clinical batches to large commercial runs, enabled by a design that allows the system to switch between continuous blenders of different sizes. The installation will also be contained to 1 µg/m³ to accommodate highly potent compounds. "Hovione will be the first company in the world to offer the ConsiGma® CDC Flex, bringing this next-generation technology with unprecedented flexibility, simplicity and cost-efficiency in continuous tableting," said Marco Gil and António Almeida, co-CEOs, Hovione, said in a press release. "This investment also advances our strategy of building integrated capabilities close to customers in key markets. By adding this new line at East Windsor, we are broadening access to this technology in the U.S. and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines." What Does a Single Development-To-Commercial Line Change? For formulators and process engineers, the most consequential claim is the removal of traditional scale-up. Moving a process from development equipment to commercial equipment typically requires engineering runs, bridging work, and consumption of scarce API, all of which weigh heavily on early programs with limited material. "Installing the CDC Flex at 89 Twin Rivers makes continuous tableting part of an integrated US development and manufacturing workflow," said David Basile, Vice President of Technical Operations, Hovione, in the press release. "Customers can move from formulation and particle engineering to commercial tablets with one Hovione team and one quality system, eliminating traditional scale-up while gaining greater production flexibility, process control and supply continuity." Co-locating spray drying and tableting is also significant because amorphous solid dispersions remain a primary solubility-enhancement route for poorly soluble molecules, and transferring intermediates between sites or vendors adds technology transfer and comparability burdens. The new line builds on the company's earlier US expansion; Hovione recently completed a $100 million investment to bolster US capacity in particle design, amorphous solid dispersions via spray drying, and batch and continuous tableting. How Is the Regulatory Environment Shaping Continuous Tableting Adoption? The company points to the 2022 adoption of ICH Q13, which provides harmonized guidance for continuous manufacturing of drug substances and drug products across the US, Europe, and Japan. Hovione reports that, as of 2024, FDA alone had approved 17 products manufactured under the guidance. Speaking on ICH Q13, FDA's Kelley Burridge, PhD, "Perceived barriers to continuous manufacturing have been falling one by one," and noted an FDA publication showing faster approval times for products with continuous manufacturing elements than for comparable batch products. The platform incorporates inline process analytical technology and automated controls for real-time quality monitoring, along with SimpleCT, an automation and control suite intended to support a single process from development through commercial supply. For sponsors weighing supply resilience and regional sourcing, the East Windsor installation extends a capability that Hovione says only it currently offers as a contract development and manufacturing organization.   Read the full article at PharmTech.com  

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Can Continuous Tableting End Scale-Up for Complex Oral Drugs?

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Formulation Development/Drug Product Manufacturing  Hovione Completes $46-M Tablet Mfg Facility Expansion  Hovione, a CDMO of drug substances and drug products, has completed an expansion of its tablet development and manufacturing center at its main global campus in Loures, Portugal, adding 25% more commercial-scale batch tableting capacity for oral solid dosage products. The expansion strengthens integrated manufacture of amorphous solid dispersions by spray drying and tableting at a single site. The recently inaugurated expansion completes an investment cycle of more than EUR 40 million ($46 million).  Hovione expanded its batch tableting capacity by adding an additional line mirroring the original unit across every local operation: dispensing, blending, dry granulation, tableting, and film coating. The mirrored configuration reinforces capacity at the 300 kg to 400 kg batch scale and provides both redundancy and like-for-like product transfers between lines. Supporting areas, including in-process control and staging space sized to the increased production capacity, were also added as part of the expansion.  Read the full article at DCATVCI.org  

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The company is building out more than 200,000 square feet of space in New Jersey. In April, Contract Pharma had the opportunity to tour Hovione’s expanded manufacturing facility in East Windsor, NJ. The company is planning a formal ribbon-cutting this fall; before that, we got an inside look at some new features. Having established United States operations in 2002, Hovione now has more than 200,000 square feet of space in New Jersey. This will be developed into a large, integrated campus in the next five to ten years. Overall, the company’s recent NJ expansion, which began in 2025, has tripled its total spray-drying capacity in the U.S. Future Facility Upgrades A 125,000-square-foot greenfield acquired by Hovione at the East Windsor campus will eventually be a large-scale production site. This includes enhanced quality control and R&D capabilities. Together, all this adds to Hovione’s stable of manufacturing sites, R&D centers, and other offices spread across three continents. Key to the expansion is a targeted reduction of Hovione’s carbon footprint by 40% by the year 2030. Part of this goal is embracing new and/or changing solvent types to help meet sustainability standards. Additionally, the company says automation that has been put in place at its Portugal site will be replicated in NJ. Hovione Aligns NJ Operations At the Drug, Chemical & Associated Technologies Association (DCAT) Week in New York in March, Contract Pharma met with Hovione. There, David Basile, Vice President of Technical Operations—Americas, further illustrated the New Jersey expansion. “Hovione aims to build an equivalent manufacturing network, where clients can go to any site across the globe,” Basile said. “The design of the facility has been well-thought through with material flows [and] gravity-fed processes. It’s scalable. We call each one of these building segments a finger. You can copy and paste these fingers, and they are built to house both spray drying and drug product assets.” Ultimately, with these moves and a strategic partnership model, Hovione aims to provide customers an opportunity to co-invest and access the company’s proprietary knowledge and assets to accelerate programs and create long-term value. Read the full article at ContractPharma.com    

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