The Challenges CDMOs Face in 2025 – And How to Tackle Them

The Contract Development and Manufacturing Organisation (CDMO) industry is evolving at pace. With stricter regulations, supply chain vulnerabilities, and rising competition, 2025 presents new challenges for CDMOs looking to stay ahead.

Success in this shifting landscape requires digital transformation, automation, and strategic partnerships. Here’s a look at the key obstacles CDMOs face – and how to tackle them.

1. Stricter Regulatory Compliance

Regulatory frameworks are becoming increasingly complex. Policies such as the BIOSECURE Act  aim to reduce reliance on Chinese CDMOs, forcing global manufacturers to rethink their supply chains and compliance strategies.

How to Stay Ahead:

• Automate compliance tracking and streamline documentation management
• Invest in regulatory intelligence tools to stay ahead of evolving legislation
• Enhance data security measures to meet stringent global standards

📌 Proactive compliance isn’t just about meeting regulations – it’s about building trust and long-term competitiveness.

2. Supply Chain Disruptions & Risk Management

Ongoing global disruptions, geopolitical tensions, raw material shortages, and fluctuating demand continue to impact CDMOs. These challenges can delay production, increase costs, and create supply bottlenecks.

How to Strengthen Supply Chains:

• Diversify suppliers to reduce dependency on single-source vendors
• Use real-time data analytics to improve supply chain visibility
• Build strategic partnerships to secure critical materials

📌 The Pharma IQ – 2025 Pharma Contract Manufacturing Report  the need for greater resilience to navigate regulatory compliance, cost optimisation, and capacity constraints.

3. Rising Competition & Increasing Client Expectations

Pharmaceutical and biotech companies expect faster turnaround times, greater flexibility, and seamless collaboration from their CDMO partners. Those that fail to meet these demands risk losing contracts to more agile competitors.

How to Maintain a Competitive Edge:

• Invest in AI-driven automation to optimise production timelines
• Implement cloud-based collaboration tools to improve client communication
• Leverage predictive analytics to enhance decision-making and efficiency

🚀 Example: PCI Pharma Services recently expanded its sterile manufacturing facilities in New Hampshire and Ireland to meet rising demand for injectable and lyophilised drugs. Investing in specialist capabilities is critical for long-term competitiveness.

4. Digital Transformation & Data Management

Despite advancements in pharmaceutical manufacturing, many CDMOs still rely on outdated, disconnected legacy systems, leading to inefficiencies in sales, operations, and customer relationship management (CRM).

How Digital Transformation Helps:

• Implement a centralised CRM system to track leads and contracts efficiently.
• Use AI-powered forecasting to anticipate demand and optimise resources.

• Break down data silos to improve collaboration across sales, marketing, and operations teams.

• Implenting a platform like Salesforce® allows CDMOs to efficiently track leads, manage contracts, and streamline customer interactions—all in one place. This reduces manual errors, enhances customer insights, and accelerates sales cycles.
• Setting up AI to predict demand patterns with greater precision forecasting. This enables better resource planning, inventory management, and overall operational efficiency.
• By integrating Sales, Marketing, and Operations (including Finance) data will improve collaboration and decision-making. Data transparency leads to smarter strategies and improved customer engagement.

📊 The CPHI 2024 Annual Report highlights how AI-driven forecasting and digital twins are revolutionising CDMO operations.

5. Talent Shortages & Workforce Challenges

The demand for highly specialised professionals in the CDMO sector is outpacing supply, making recruitment and retention a growing challenge.

How to Attract and Retain Talent:

• Upskill existing employees through training and development initiatives
• Prioritise employee retention with career growth and job satisfaction strategies
• Use AI-driven workforce planning to anticipate and bridge skill gaps

📌 A strong workforce is a CDMO’s greatest asset – investing in talent development ensures long-term success.

The Role of Digital Transformation in CDMO Success

Addressing these challenges requires a strategic focus on automation, data-driven decision-making, and business development optimisation.

At Mint®, we help CDMOs modernise their sales pipelines and business development processes with Salesforce®-powered solutions. Our platform enables CDMOs to:

✔ Track contracts and improve forecasting accuracy
✔ Prioritise high-value leads to accelerate contract cycles
✔ Enhance collaboration across teams for faster decision-making
✔ Leverage real-time analytics to drive business growth

📢 In our next blog, we’ll introduce our Salesforce®-powered demo org, showcasing how CDMOs can harness digital transformation for success. Stay tuned!