The Drug, Chemical & Associated Technologies Association (DCAT) 2024 event held in New York City on March 18-21 showcased product and technology innovations and capabilities presentations by member companies. Industry participants highlighted capability expansion, recent developments, and breakthroughs in pharmaceutical development and manufacturing to support drug development.
The key developments highlighted below underscore a growing focus on complex drug development, emphasizing drug performance optimization, patient compliance, and the adoption of innovative technologies for producing next-generation biomedicines.
Fuelling Growth: Strategic Investments, Acquisitions, and Expansions
- Samsung Biologics unveiled plans to expand capacity and geographic reach by initiating the construction of Bio Campus II with a $6 billion investment scheduled to begin operations in 2025 while completing its CGMP antibody-drug conjugate manufacturing facility within 2024.
- SCHOTT Pharma announced expansion plans in the US to meet the growing demand for mRNA vaccines, GLP1 drugs, and biologics.
- Simtra BioPharma Solutions announced over $250 million expansion of its sterile fill/finish manufacturing campus in Bloomington, Indiana.
- Seqens announced acquisition of Novartis’s cell therapy business to build its cell therapy and gene therapy manufacturing capabilities.
Delving Deeper: More Key Themes Explored
Supply chain optimization and disruption handling strategies
A major theme at DCAT sessions focused on tackling rising drug shortages and quality issues. Contract development and manufacturing organizations (CDMOs) are mitigating supply chain risks by scaling operations and diversifying supplier networks. Global CDMOs are embracing agile production models, expanding capabilities across diverse geographic locations. For instance,
- Adragos Pharma announced network expansion, including a new Kawagoe facility offering visual inspection and packaging for US clients targeting the Japanese market.
- FUJIFILM Diosynth Biotechnologies invested $1.6 billion in a large-scale cell culture capacity in Denmark, $2 billion for expanding its North Carolina facility, and enhanced its cell therapy capacity in California under the KojoX framework, ensuring unparalleled supply chain agility for customers.
CDMOs adopting Industry 4.0 technologies for sustainable and resilient supply chains
AI is pivotal for demand forecasting, logistics, inventory, and supplier risk management. Tools like supply network modeling, disruption sensing, and resiliency analytics identify challenges and opportunities in drug supply chains.
- Biogen unveiled the adoption of Rondaxe’s SimpliDATA platform to implement a sustainability efficiency scorecard and assess the manufacturing process using green chemistry metrics to drive continuous improvements.
- PTC Therapeutics highlighted a joint audit program approach with cost-sharing among sponsors to establish best practices for supply chain security.
- Everstream Analytics, a leading provider of services to monitor and anticipate potential supply-chain disruptions, showcased its increased usage by several bio/pharmaceutical companies to predict and manage supply chain disruptions.
Growing interest in continuous manufacturing and sustainability
CDMOs and pharma firms are adopting continuous “powder-to-tablet” manufacturing to enhance quality, resource efficiency, and environmental sustainability.
- Hovione has expanded its collaboration with GEA, a global process technology provider, by introducing ConsiGma CDC flex and installing a new lab-scale R&D Continuous Tableting rig in Portugal. This partnership aims to streamline access to continuous manufacturing for pharma customers, reducing time to market, cutting costs, and improving quality and sustainability.
- Adare Pharma also expanded its European capabilities to facilitate the diversification of oral dosage expertise with a new high-shear mixer granulator designed for easy cleaning, reducing changeover times, water, and energy usage.
Frost & Sullivan’s analysis of industry developments and strategic viewpoints has identified key growth opportunities and innovative companies in the small molecule oral solid dosage (OSD) sector.
Growth Opportunity 1 – Combination Products and Nanopharmaceuticals
Pharma companies are creating patient-centered fixed-dose combination products (FDCs) using mini tablets and capsules with multiple APIs, leading to better patient outcomes and adherence while reducing healthcare costs.
- WuXi STA partnered with Multiply Labs for robotic capsule manufacturing with customized combinations of multiple APIs and their formulations.
- Kindeva Drug Delivery invested $100 million in a Missouri facility for drug-device combination products. The company’s acquisition of Summit Biosciences Inc. in January 2024 further enhanced its portfolio of complex drug-device combination products.
- Recipharm collaborated with Medspray and Resyca for developing both single and combination drug products.
- Skyepharma and Nanoform Plc pioneer use of nanopharmaceuticals to enhance drug efficacy and bioavailability (BA). Notably Skyepharma’s proprietary Microfluidizer Technology enables BA enhancement for OSDs and Nanoform Plc’s Controlled Expansion of Supercritical Solutions (CESS®) technology converts poorly soluble active pharmaceutical ingredients (APIs) into solubility-enhanced API nanoparticles, further optimizable for performance based on client specifications.
Growth Opportunity 2 – Medical Cannabidiol (CBD)
Global regulatory shifts toward legalizing medical cannabis and CBD products highlight the growing interest in cannabis-based treatments. Partnerships with specialty CDMOs experienced in manufacturing schedule 1 products can accelerate clinical trials and R&D.
- Noramco, known for producing controlled substances for the pharmaceutical industry, acquired CDMO Halo Pharma which will support Noramco’s API customers and its CBD-focused subsidiary Purisys with a robust North American-based supply chain and expand capabilities in drug formulation, manufacturing, and packaging for cannabinoid-based treatments. This move strengthens Noramco’s position in the emerging medical CBD market.
Growth Opportunity 3 – Phase-Appropriate Services for Orphan Drugs
Rare disease drug development faces challenges due to limited API supply and the need for small batch manufacturing of which presents challenges in proving the robustness of the processing equipment. A vital requirement is to successfully scale the formulation from clinical to commercial manufacturing quickly.
AbbVie introduced a customized risk-based governance model for agile and compliant operations in a highly regulated and risk-sensitive environment. Implementing the model can support streamlining processes and controls, managing critical risks to allocate resources effectively.
CDMOs are adopting quality by design (QbD) and design of experiments approaches to secure API supply, de-risking development programs, making it easy to scaleup. Alcami successfully developed a capsule formulation for two dosage strengths for an orphan drug, with minimal API amount, using QbD to overcome API shortages.
Demand is rising for phase-appropriate services, customized formulation R&D and manufacturing for first-in-class novel drugs. Wuxi STA expanded its partnership with Ark Biopharmaceutical for the commercial supply of Ziresovir, a first-in-class oral antiviral for respiratory syncytial virus, which has completed the phase III clinical trial globally, for which a New Drug Application has been accepted and granted Priority Review by the China NMPA.
Frost & Sullivan notes that CDMOs will continue to expand their service offerings by means of backward and forward integration and by providing value-added services and innovative technology platforms as integrated services providers.
Learn more from our analysis on the “Growth Opportunities in Oral Solid Dosage Formulation Market” and “Global Small Molecule Contract Development and Manufacturing Organization (CDMO) Growth Opportunities” and schedule a Growth Pipeline Dialog™ with our Healthcare and Life Sciences experts and coaches to dive into the growth priorities for your organization in 2024 and beyond.
Written by Supriya Lala Kundu
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