The sourcing of key raw materials by Contract Development & Manufacturing Organizations CDMOs was severely impacted and continues as a significant bottleneck post-COVID. Managing optimal inventory levels remains vital as CDMOs work on multiple projects simultaneously. This can lead to inventory management issues, including understocking or overstocking of materials, expiration of materials, and increased costs due to inventory holding. With speed and timely delivery of products emerging as primary criteria for partner selection, strategies around minimizing the supply chain issues emerged as vital drivers to growth. Therefore, a multi-sourcing strategy and right-shoring to address cost and efficiency concerns are transforming CDMOs.
To discuss supply chain issues, recent developments, and innovations in pharmaceutical development, and manufacturing, industry participants shared their strategic viewpoints and growth strategies during DCAT 2023. Based on the key takeaways, Frost & Sullivan has identified the top innovative growth opportunities and game-changing companies in the small molecule CDMO market.
Growth Opportunity 1—Innovative and Connected Packaging Solutions
Pharmaceutical companies continue to face sustainability, serialization, and supply-chain issues. Circulation of counterfeit drugs impacts supply chain integrity, results in significant revenue leakage in the pharmaceutical industry, and hampers patient safety. Drug manufacturers are focusing on developing recyclable and intelligent packaging to address these issues.
Thermo Fischer Scientific pointed out that “proximity of manufacturing sites to markets” is vital for drug development (developing molecules, clinical packaging, labeling, and distribution to clinical sites cost-effectively) and managing the commercial products’ supply. Understanding regional regulations, sustainability, and serialization guidelines is vital to market the product in different countries. Adare Pharma Solutions leveraged Vantage Solutions software to upgrade its pharmaceutical packaging capabilities and become fully compliant with the new Drug Supply Chain Security Act (DSCSA) regulations for tracing prescription drug products through the pharmaceutical supply distribution chain (effective November 2023). Almac Group developed its own serialization solution and partnered with Optel Vision to provide flexible serialization solutions based on customized packaging designs. Pharmaceutical packaging company NOSCO teamed with Systech to advance eFingerprint technology to address drug counterfeiting.
Companies will introduce packaging innovations to support pharma clients in ensuring product quality, better patient experience, and supply chain management. CDMOs can collaborate/invest in connected packaging solutions to ensure traceability, limit counterfeits, meet compliance and serialization guidelines, and optimize supply chain management across different countries for their pharma clients.
Growth Opportunity 2—Capacity and Capability Expansion for Highly Potent APIs and Complex Molecules
Increasingly pharma companies are focusing on developing highly potent active pharmaceutical ingredient (HPAPI)-based life-saving oncology drugs, anticipated to drive significant market share by 2025. HPAPI-based small molecule oncology therapies require specialized manufacturing techniques and bioavailability enhancement solutions for poorly soluble compounds.
Axplora is offering a broader technology portfolio and focuses on highly potent and complex molecules as a vital growth opportunity. Polpharma‘s strategic investments in HPAPI-focussed specialized facility for R&D and GMP kilo lab production with occupational exposure limits (OEL) over 10ng/m3 highlighted the growing importance of these complex molecules. Wuxi STA launched the first high-potency oral drug product manufacturing facility lines in Wuxi City and a second HPAPI plant at its Changzhou site, increasing its HPAPI manufacturing capacities. To guarantee a consistent and flexible product supply, CDMOs are considering backward integration and right-shoring by moving segments of the supply chain and processes at strategic locations. Flamma USA re-commissioned the HPAPI suite to provide a viable alternative for customers seeking the development of early-stage HPAPIs to address the lengthy lead times by other vendors. Flamma allows clients to conduct early development of their small molecule drug candidates domestically and move mature projects to its cGMP facility in Italy later.
Enhancing capacity and capabilities for manufacturing and deploying effective containment strategies for HP API and molecule strategy execution will be a fundamental growth driver.
Growth Opportunity 3—Patient-centric Manufacturing for Oral Solid Formulations
Another crucial focus was on novel drug delivery approaches through patient-centricity in manufacturing. It centered around designing patient-centric formulations and drug products for oral solid dosage (OSD), the most convenient and patient-friendly dosage form. Employing techniques to bolster release profiles (moderate/extended) at targeted locations (nasal, buccal, and colon) is enabling CDMOs to support pharma companies in improving drug efficacy. Aenova leveraged Microcaps’ technology to offer micro- and convention capsule formulations solution, including enhanced taste masking, controlled and targeted release, and improved API stability. PCI Pharma Services’ micro-dosing technology quickens first-in-human (FIH) studies on behalf of its clients while eliminating API wastage. Nanoform, a specialist drug delivery CDMO is innovating around novel drug delivery from a targeted therapeutics perspective. Its nanoparticle drug delivery technology propels precision applications in oncology and rare diseases. Ascendia Pharma, Inc offers Nanosol®, LipidSol®, EmulSol®, and AmorSol® proprietary technologies for improving the solubility and bioavailability of new molecules and complex generics.
Companies will strategize around designing customized tablet/capsule sizes for age-appropriate delivery (pediatric and geriatric populations), improved swallowability, palatability, and reduced-pill burden. CDMOs can focus on building expertise for offering unique dosage formats, targeted releases, and API combinations to drive patients’ adherence to prescribed frequency.
Frost & Sullivan notes the small molecule CDMOs will continue to focus on backward and forward integration, expanding their offering to include value-added services and innovative technology platforms as an integrated services provider. Companies will be expanding to high-value areas such as specialized packaging services (primary and tertiary) and complex molecule development and manufacturing HPAPI, owing to the ever-growing focus on oncology. Patient-centric manufacturing of medications, primarily oral solid dose form, with product differentiation through bioenhancement services and novel drug delivery technologies, will be key growth opportunities in 2023.
Learn more from our upcoming analysis on the “Growth Opportunities in Small Molecule Contract Development and Manufacturing Organizations Market” and schedule a Growth Pipeline Dialog™ https://frost.ly/8ms with our #Healthcare and #LifeSciences experts and coaches to dive into the growth priorities for your organization in 2023 and beyond.
