Contract Pharma recently interviewed several industry experts for their insights on today’s oral solid dosage trends across drug development, manufacturing and more. They discussed the current state of the market, key growth drivers, evolving demand, challenges and emerging trends set to shape the future of the sector. Read the full article to get the CDMO and CRO perspective on the OSD market.

We also asked each company to share their most recent business highlights—partnerships, expansions, new technology and more—from the past twelve months on the OSD front. The following is a snapshot of what’s new from these CDMOs and CROs. Together, these updates paint a picture of a sector that remains active and robust.

ACG

Over the past 12 months, ACG has strengthened its presence in the OSD market through strategic partnerships with leading pharmaceutical and large nutraceutical organizations in the Americas. These collaborations are accelerating the development of innovative solutions for patients and consumers, particularly in the areas of drug delivery, bioavailability enhancement, and functional health applications.

As part of its global expansion strategy, ACG has significantly expanded its manufacturing footprint worldwide, extending operations in Thailand, Croatia, India and Latin America. This not only increases its capacity but also serves as a contingency plan for its customers, ensuring supply chain resilience and responsiveness to market needs.

On the technology front, ACG has introduced a range of next-generation capsules tailored to meet evolving market demands, such as:

• Pullulan capsules for oxidation-sensitive formulations to ensure product stability
• Enteric and delayed-release capsules for gut health solutions offering targeted delivery
• Liquid-filled capsules and beadlets for fast-acting or controlled-release formulations to improve efficacy and patient experience

Looking ahead, ACG continues to focus on expanding its portfolio with specialized polymer-based capsules that address industry trends in sustainability, clean-label products, and advanced drug delivery systems. Additionally, its continued collaborations with global pharma- and nutraceutical leaders will further drive innovation in customized solutions for diverse therapeutic and wellness applications.

Adare Pharma Solutions

In 2024, Adare partnered with Laxxon Medical to offer 3D screen printing of pharmaceuticals to our customers. This capability is now available at its Pessano facility in Milan, Italy, with plans to expand to our Vandalia facility in Ohio, USA in the near future.

In other news, Adare developed a 12-week process for nitrosamine mitigation, drawing from expertise gained through work on its own products. The company collaborates closely with its customers to identify and implement the right combination of mitigation strategies, with a strong emphasis on the use of additives—the only approach that keeps manufacturers in control of their formulations. This allows for a more reliable and scalable solution compared to other methods, helping pharmaceutical companies meet FDA requirements efficiently.

Also in 2024, Adare made significant investments at its Pessano facility in Milan, Italy, expanding both packaging and manufacturing operations to better serve its customers.

The company began construction of a two-story, 2,800 square-meter expansion, housing a new purpose-built packaging hall and a Marchesini Integra 220S MA260 blister packaging line. With the ability to package over 50 million blisters annually, this investment strengthens its ability to support global supply chains.

Adare also expanded Pessano’s warehousing capacity by 1,000 square meters, adding space for 900 pallets.

On the manufacturing side, the company further enhanced its oral dose capabilities by integrating an IMA 600-L Roto Mix high-shear mixer to complement our existing fluid bed capabilities. This allows Adare to provide wet granulation using both aqueous and organic-based solutions.

Finally, a major milestone for Adare in 2024 was the relocation of its global headquarters to Philadelphia, Pennsylvania. This move will result in a $16.8 million expansion that will create at least 115 new, well-paying jobs while also sustaining 200 existing Pennsylvania jobs.

Almac

Almac’s £65 million, 100,000sq ft commercial manufacturing facility recently became operational. This 18-suite custom-built center of excellence complements its existing capabilities in this area by significantly increasing its current capacity and will include an extension to current scales of production for products involving potent and highly potent APIs.

In October, Almac announced an £11 million investment to expand its global analytical offering. This significant investment in innovative technology, skilled talent, and state-of-the-art laboratories underscores Almac’s dedication to providing comprehensive analytical solutions for its clients worldwide.

Almac also recently announced the completion of a multi-million-pound expansion of its commercial manufacturing and packaging facility with a 32,000 square feet custom-built high-volume facility. This investment included additional large-scale manufacturing suites, automated primary and secondary sachet packaging technologies and also expanded its QC Laboratory Testing capacity.

Looking forward, Almac has significant investments planned at all four of its locations in the coming 12 months including expanding its Ultra Low Temperature packaging capabilities into the US at its facility in Pennsylvania as well as expanding capacity in that service offering at its Dundalk site.

Almac also has plans to enhance its product development offering from its Charnwood, UK site which will enable it to support poorly soluble drug development through the very latest bioavailability enhancement technologies and techniques. These initiatives are aimed at strengthening Almac’s position in the market and ensuring it continues to deliver high-quality services to clients, and ultimately advance treatment together.

Bora Pharmaceuticals

Within its Mississauga facility, Bora has invested in flexible containment and adapted lab working to make highly potent API and excipients easier and safer to handle. 

Across its network, the company also continues to invest in an improved working experience, continually adapting workstation on wheels (WOW) and to EHS guidelines. 

Bora says it is experiencing strong demand for OSDs and it believes that demand will continue and even increase. In anticipation of strong demand, the company has made investments including: 

• The acquisition of Upsher-Smith (Maple Grove, Minnesota) to provide customers with OSD and other small molecule capacity within the United States 
• The grand unveiling of a new small molecule dose form facility in Zhongli, Taiwan, designed to provide a comprehensive range of dose form manufacturing services including complex tablets and capsules and segregated areas for potent and hormonal products
• The acquisition of a sterile manufacturing facility in Baltimore, Maryland to add drug product fill/finish capabilities 
• The acquisition of Pyros Pharmaceuticals, a specialty pharmaceutical company that develops treatments for rare diseases.

Douglas CDMO

Douglas CDMO is growing its capability in modified release OSDs with the purchase of a GEA multiprocessor for clinical scale and small volume commercial supply.  This technology allows the company to process multiple-unit pellet OSDs as well as powders for reconstitution as liquids. Such technology is particularly suited to drug repurposing, reducing dosing frequency, helping patients who have trouble swallowing tablets, and optimizing drug delivery for new indications.

LGM Pharma

LGM Pharma recently invested in a new high-speed tablet press to increase its production capacity, thereby improving its efficiency and price competitiveness in the OSD marketplace.

Additionally, LGM Pharma offers contract analytical testing to the pharmaceutical market that is very attractive to smaller and virtual pharmaceutical companies. To enhance this offering, the company has made substantial investments in its analytical testing capabilities that strengthen the ability of its partners to forge new pathways in OSD development. These investments also enhance the abilities of its CDMO clients to bring OSD products to market.

Noramco

Noramco is investing in downstream commercial packaging (commercial scale blister packaging) to complement its OSD manufacturing capabilities. It is also looking at adding larger scale roller compaction equipment for dry granulations and new, more modern tablet presses that offer greater precision in operation and data collection capabilities.

Piramal Pharma Solutions

Piramal is upgrading its existing comprehensive SAP system to the latest version, S/4HANA. This implementation is being rolled out across all its global biologic, API, and drug product sites in Europe, India, the US, and Canada.

At its Lexington, KY sterile/fill finish site, Piramal announced a significant expansion of $85 million. This expansion includes the addition of two high-speed filling lines, which are based on the site’s isolator technology. The expansion also includes the construction of QC and Product Development Labs, as well as two IMA lyophilizers.

Piramal’s Ahmedabad, India facility has made notable additions. A new Buchi spray dryer has been installed, along with an Xcelodose, to facilitate the fast-track first-time in human clinical development of Xcelodose. Additionally, a companion enabling technology has been introduced to provide scientists with additional options for enhancing bioavailability.

Furthermore, Piramal’s Sellersville, PA site has taken steps to comply with Japanese markets by commissioning a fully automated tablet/capsule inspection system. This year, the facility will also see the addition of more HPAPI suites to further enhance the handling of potent products.

PLD Pharma Services

PLD has continued to invest in its CDMO capabilities. In fact, one reason why it rebranded Avéma is that it wanted to emphasize among its customers that they benefit from the full scope of PLD’s capabilities and experience.

As a company, PLD has invested in a new FDA and CGMP-compliant gummy manufacturing facility to cater to the growing demand for gummies. PLD’s facility was designed and built to support OTC and Rx drugs, rather than being converted from candy manufacturing, so it has all the controls in place to develop products. It recently secured a multimillion-dollar development agreement with a key client to develop an OTC gummy product.

This year PLD released the first FDA-approved US-made Omeprazole Magnesium OTC product, which required several years of BE studies and overcoming the scale up challenges inherent in such a complex formulation.

PLD also successfully developed an oral care product line from formulation development to full commercial launch.

Additionally, PLD added three full-turnkey bottling, labeling and packaging lines in its Lynwood facility to support the growth of OTC liquids

In Miami, PLD added two new Korsch tablet presses, known for their precision and efficiency in tablet production, brought in fluid bed coating capabilities and advanced granulation techniques. It also expanded and enhanced its Analytical Development and R&D Labs, installing new equipment and adding headcount. The Analytical Development Lab is already up and running and its new R&D lab will go live in Q2.

Quotient Sciences

Quotient recently announced a new preclinical technology screening service that uses Quotient Sciences’ excellence in small molecule development to screen different solubility enhancement technologies to improve exposure in preclinical animal models. From its facility in Nottingham, UK, three different platforms can be evaluated in less than 8 weeks, with the generation of fit-for-purpose formulations for dosing in animal non-GLP PK studies over the subsequent 3-4 weeks. This service is intended to help Quotient’s customers on their path to achieving proportional dose-exposure profiles in dose range finding (DRF) studies and hit targeted high dose toxicology concentrations as per ICHM3R2 guidance. Following GLP toxicology studies, Quotient can later offer a transition into a clinical, Phase I trial with on-demand drug product manufacturing using its Translational Pharmaceutics platform for integrated drug development.

Adding to its in silico development capabilities, Quotient now offers ASAPPrime stability modeling, a software platform from Freethink Technologies, to predict long term product shelf-life. This is a powerful tool to select and rank formulations or packaging options for further development based on short-term stability data, enabling science-based decisions to accelerate drug development.

Finally, Quotient is committed to the continued growth of the Translational Pharmaceutics platform in the U.S. Last year, its Philadelphia and Miami sites conducted several such studies under an Investigational New Drug (IND) application, including RapidFACT studies that utilized a formulation design space. 

Syngene

Syngene continues to strengthen its OSD capabilities through strategic investments in formulation development, analytical sciences, and GMP manufacturing. It has managed to successfully progress more than 15 molecules from preclinical to Phase 1 (FIH) clinical supplies, which involved both conventional and enabling formulation approaches like spray drying, hot melt extrusion, nano milling and liquid in a capsule filling line.

Syngene’s recent expansions include the addition of a new non-GMP capability center which was established to address the market’s need for agile, cost-effective early-phase development and scale-up services. It has also invested in upgrading its manufacturing equipment to provide it with more information, which will help it in scaling up its manufacturing process.