
Pharma and biotech teams struggle with rising capital investment, tight timelines, and complex manufacturing processes. CDMOs now act as true partners by sharing costs and risks and delivering customized, co-invested manufacturing solutions.
Why This Matters
- Rising Costs and Complexity
- The U.S. CDMO market for active pharmaceutical ingredients reached $25.3 billion in 2024 and may grow to $33.9 billion by 2030, with a healthy 5.1% annual growth rate. Globally, CDMO services topped $185 billion in 2024 and are on track to reach $369 billion by 2034 at 7.2% CAGR.
- Capacity Constraints Delay Drug Launches
Development teams for biologics, high-potency APIs, complex injectables, or oral dosage forms often wait for available equipment. These delays push back IND submissions, clinical trials, and final drug approvals.
- Modality-Specific Technical Challenges
Each modality demands different containment, isolators, cleanroom design, and digital controls. Too many CDMOs advertise generic capabilities instead of offering tailored manufacturing solutions.
Real-World Case Study: Alcami and TriPharm Investment
In 2020, Ampersand partnered with Alcami to acquire TriPharm’s sterile manufacturing plant in Raleigh, NC. They upgraded isolator technology, expanded injectable capacity, and shared the financial burden with pharma clients.
How this case fits the story: Alcami scaled quickly without burdening its clients with full capital investment. Upgrades enabled priority production slots and lowered launch risks. This model delivers a strategic, win-win outcome that aligns with our investment partnership approach.
How Hygenix Helps You Overcome Manufacturing Challenges
- You Need to Avoid High Upfront Costs
Building or expanding a facility often requires a financial leap. We provide shared-investment models that combine initial funding, milestone-based payments, and royalty sharing. These models give you access to needed capacity while preserving capital.
- You Require Specific Technical Capabilities
Your programs may need isolators for HPAPI or digital solutions for viral vectors. We audit your facility and technical needs and identify CDMO partners who meet those exact specifications. Then we recommend targeted upgrades to fill any gaps.
- You Want a Clear Path for Tech Transfer
Projects slow down without structured validation, QbD, or regulatory handoffs. We map out validated tech transfer plans that include stage-gate checkpoints and risk assessment. This keeps your program compliant and on schedule.
- You Must Protect IP and Ensure Compliance
Co-investment models can create confusion around intellectual property, data access, and audit access. We implement governance protocols such as SLAs, audit schedules, data protection safeguards, and audit trails to keep your project fully compliant.
Drive Your Manufacturing Forward with Hygenix
By partnering with Hygenix, your team gains:
- Access to affordable, shared-investment CDMO models
- Faster drug development with strategic manufacturing alignment
- Approval-ready facilities that meet your technical requirements
- Confidence that IP and compliance are securely managed
Request a free consultation today to explore how we can help design custom CDMO partnerships and streamline your manufacturing strategy.