What’s Ahead for Preclinical CROs: Key Opportunities, Challenges & How to Adapt
By Jenna Levenson PhD, RN, MS
The next 2–3 years promise big changes—and big potential—for preclinical contract research organizations (CROs). As the industry evolves, CROs are being called to do more than just deliver services. Sponsors now want innovation, speed, strategic collaboration, and a tech-forward mindset.
Whether you're leading a CRO or partnering with one, here’s what to watch for—and how CROs can adapt to stay competitive and valuable in a fast-moving environment.
Opportunities: Where CROs Can Grow
1. Tapping Into Emerging Therapeutics
Gene editing, cell therapies, and RNA-based treatments are taking off—and sponsors need CROs that understand them inside and out.
How to adapt: Invest in scientific talent, new lab infrastructure, and SOPs tailored to cutting-edge platforms.
2. Rising Outsourcing Demand
More sponsors are outsourcing preclinical work to reduce costs, stay lean, and accelerate development.
How to adapt: Expand your service offerings and build systems that scale without sacrificing quality or turnaround time.
3. Adopting AI and Digital Tools
AI is reshaping how studies are designed and analyzed. Predictive toxicology, data modeling, and automated workflows are quickly becoming standard.
How to adapt: Integrate AI and machine learning into study design, analytics, and reporting. Show sponsors you’re built for speed and accuracy.
4. Expanding in Rare Disease Research
With new funding and FDA incentives, rare disease research is a booming space—especially for preclinical innovation.
How to adapt: Build expertise in patient-specific models and regulatory navigation. Form alliances with advocacy groups to stay aligned with patient needs.
5. Global Market Expansion
Regions like Asia-Pacific and Eastern Europe offer cost advantages and access to diverse populations.
How to adapt: Set up operations or partnerships in key markets, while maintaining high-quality standards and global regulatory alignment.
6. Going Decentralized & Virtual
Remote data capture and virtual labs can streamline operations and cut costs.
How to adapt: Invest in digital platforms that support virtual workflows and enable remote monitoring of preclinical studies.
Challenges: What CROs Need to Watch Out For
1. Navigating Regulatory Complexity
With global trials comes a web of evolving, region-specific regulations.
How to respond: Build in-house regulatory expertise and provide sponsors with proactive compliance support and risk mitigation strategies.
2. Hiring and Retaining Talent
The competition for skilled researchers, technicians, and data scientists is fierce.
How to respond: Offer competitive compensation, create robust training programs, and promote a positive workplace culture to attract and keep top talent.
3. Data Security Risks
With more digital systems comes greater risk. Cybersecurity is now a non-negotiable.
How to respond: Invest in secure data environments, comply with global data standards (like GDPR), and build a strong IT governance framework.
4. Increased Market Competition
As the CRO space grows more crowded, differentiation is essential—especially for small or niche players.
How to respond: Find your niche, double down on client experience, and invest in branding and strategic marketing.
5. Rising Operational Costs
Inflation, supply chain constraints, and expensive new technologies are tightening margins.
How to respond: Streamline internal processes, explore cost-effective alternatives like in silico models, and renegotiate vendor contracts where possible.
6. Sustainability Demands
Sponsors are looking for partners who share their commitment to environmental responsibility.
How to respond: Incorporate green lab practices, reduce reliance on animal models, and showcase your sustainability efforts in proposals and marketing materials.
How Preclinical CROs Can Adapt and Thrive
Let’s face it: the CROs that adapt quickly will lead the next wave of innovation. Here's where to focus:
Invest in technology – Embrace AI, automation, and advanced analytics to stay competitive.
Build niche expertise – Focus on high-growth areas like rare diseases, oncology, and advanced therapies.
Expand your global footprint – Go where the opportunities are, while staying compliant across markets.
Collaborate widely – Partner with sponsors, academics, and advocacy groups to fuel innovation.
Focus on talent – Create a workplace that nurtures and retains top talent through growth and diversity.
Go green – Implement sustainable practices to meet sponsor and societal expectations.
Master regulatory compliance – Stay ahead of changes and support clients with robust, global-quality systems.
Final Thoughts
The preclinical CRO space is no longer about offering just services—it’s about offering solutions, foresight, and flexibility. Those who embrace change, innovate with purpose, and align with sponsor priorities will thrive in the evolving research ecosystem.
Your next competitive edge? It's not just what you do—it's how you adapt.