July 18, 2025
As we have entered Q3, biotech teams are asking a critical mid-year question: Are your IND-enabling studies on track—or are shifting market conditions threatening your 2025 milestones?
In a year marked by economic volatility, reduced biotech funding, and increased pressure to prioritize, many sponsors are reevaluating their R&D roadmaps. For companies aiming to complete IND packages or accelerate critical preclinical milestones, now is the time to assess what’s working, what’s not, and where trusted partnerships can make the difference.
Jake McDonald, CEO of Envol Biomedical, recently took a few minutes for a mid-year reflection on the state of translational research in 2025—and how Envol’s stable foundation and nimble preclinical platform are uniquely positioned to help biotech teams course-correct and finish the year with confidence.
R&D in 2025: A Tumultuous Start for Biotech Sponsors
“The first half of 2025 has been, to say the least, tumultuous,” says McDonald. “We’re seeing the aftershocks of high interest rates, a stagnant IPO market, and a biotech sector facing heavy scrutiny.”
Investor caution has frozen funding in many corners of the industry. IPOs are few and far between—and often either canceled or niche. Venture capital is flowing more slowly, with many early-stage biotech companies reporting less than 12 months of runway. The result? Strategic hesitation, delayed INDs, and a sharp focus on cost containment.
“Even large sponsors are experiencing analysis paralysis,” McDonald notes. “Clinical assets are being prioritized, while earlier-stage discovery and translational programs are slowed or shelved. The question on everyone’s mind is: where should we spend the money we have left?”
Biotech Trends: What’s Moving, What’s Cooling
Despite the broader slowdown, McDonald points to several scientific areas still showing momentum:
- Metabolic disease and weight loss analogs continue to attract investment, with high interest in innovative NHP models to support efficacy claims.
- Gene therapy, while still active, has cooled. McDonald attributes the slowdown to a combination of clinical safety concerns, high AAV manufacturing costs, and uncertainty around long-term reimbursement models.
- Platform technologies and AI-driven tools are attracting funding that previously might have gone toward traditional drug development efforts, creating increased competition for investor attention.
“All of this has led to a very measured, conservative biotech market in the first half of 2025,” says McDonald. “But we are beginning to see an uptick in Q3 as companies begin making go/no-go decisions on 2026 programs.”
Lagging Revenues, Shifting Priorities: The Big Picture for IND Planning
Public CROs and biotech companies alike have reported single- to low-double-digit revenue losses in the first half of 2025—particularly in the discovery and safety assessment sectors. While clinical programs are seeing renewed focus, many discovery-stage programs have experienced delayed timelines and reduced budgets.
McDonald emphasizes the lag in revenue visibility: “Safety assessment revenue often reflects prior-year decisions. What we’re watching now is how Q1 and Q2 sales activity flows through into late 2025 and 2026.”
The bottom line? Companies that delay IND-enabling studies now may struggle to hit 2026 clinical goals. Sponsors who act decisively in the second half of 2025—partnering with stable, responsive CROs—can protect their program timelines and maintain momentum.
Why Sponsors Are Choosing Envol Biomedical in 2025
In a climate of uncertainty, Envol Biomedical is standing out as a partner that delivers speed, stability, and value.
“Many sponsors are worried about whether their CRO will even be around six months from now,” says McDonald. “We’ve seen lab shutdowns—even from groups with significant investment just a few years ago.”
Envol offers biotech sponsors a safer bet, with:
- Private, diversified funding that insulates operations from market whiplash
- A 20+ year history of NHP research, IND support, and translational program execution
- Expertly trained staff and modern facilities optimized for precision surgical modeling and study reliability
- A reputation for quick turnarounds, flexible study design, and responsive communication—without the high costs or bureaucracy of larger CROs
“Stability doesn’t mean being stagnant,” McDonald adds. “We’re continuing to expand our capabilities, evolve our technology platforms, and train our team to add more value to every sponsor engagement.”
Built for the Biotech Realities of Today—and Tomorrow
At a time when sponsors need to move quickly—but can’t afford missteps—Envol Biomedical is proving to be the CRO partner biotech companies can count on.
Whether you’re:
- Racing to finalize an IND package,
- Trying to maximize Q3–Q4 budget allocations, or
- Seeking a more stable alternative to larger, less nimble vendors—
Envol is ready to help you de-risk your timeline, protect your study quality, and keep your program on track.
“We expect continued headwinds through late 2025,” McDonald acknowledges. “But the pressure to act is building. And when teams are ready to move, they’ll need CRO partners who are still standing—and still delivering.”
Don’t Let a Slow Start Define Your Year
If you’re facing delays, budget pressures, or vendor uncertainty, now is the time to act. Envol Biomedical’s IND-enabling NHP platform is designed to help you move fast, stay focused, and hit your next milestone with confidence.Contact Envol Biomedical today to discuss your 2025 IND goals and how we can help you end the year strong.