What does the future hold for sterile fill-finish CDMOs in a rapidly evolving market?

In this sponsored episode of The Top Line, Denis Johnson, CEO of Grand River Aseptic Manufacturing, discusses the capacity crunch facing U.S. sterile manufacturing and what it means for healthcare stakeholders. As acquisitions reduce available capacity, Annex 1 drives preference for isolator technology, and companies reshore production, competition for specialized sterile fill expertise is intensifying.

Johnson explains why segmentation and specialization are becoming critical differentiators in the CDMO space, particularly as biologics pipelines expand and product launches accelerate. He also shares how GRAM is investing in new facilities, high-volume syringe and cartridge capabilities, and workforce development to stay ahead of client demand while maintaining compliance and flexibility.

For B2B healthcare professionals, marketers and payers seeking clarity on supply chain resilience and manufacturing strategy, this episode delivers timely insight. Listen now to explore how leading CDMOs are preparing for the next wave of sterile manufacturing demand.

What does the future hold for sterile fill-finish CDMOs in a rapidly evolving market?
In this sponsored episode of The Top Line, Denis Johnson, CEO of Grand River Aseptic Manufacturing, discusses the capacity crunch facing U.S. sterile manufacturing and what it means for healthcare stakeholders. As acquisitions reduce available capacity, Annex 1 drives preference for isolator technology, and companies reshore production, competition for specialized sterile fill expertise is intensifying.
Johnson explains why segmentation and specialization are becoming critical differentiators in the CDMO space, particularly as biologics pipelines expand and product launches accelerate. He also shares how GRAM is investing in new facilities, high-volume syringe and cartridge capabilities, and workforce development to stay ahead of client demand while maintaining compliance and flexibility.
For B2B healthcare professionals, marketers and payers seeking clarity on supply chain resilience and manufacturing strategy, this episode delivers timely insight. Listen now to explore how leading CDMOs are preparing for the next wave of sterile manufacturing demand.

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning. 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.&nbsp;

The Top Line

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We’ll analyze the week’s biggest business news—from mergers and marketing to drug R&D and device development. Available every Friday morning.

 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We&rsquo;ll analyze the week&rsquo;s biggest business news&mdash;from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.
&nbsp;

GRAM’s CEO on isolators, re-shoring and rising demand in sterile fill manufacturing.

Inside the sterile fill capacity crunch (Sponsored)

Though uncertainty still surrounds the Trump administration’s pharmaceutical import tariffs, the trade rhetoric set off a clear response across the industry in 2025. Drugmakers accelerated U.S. manufacturing plans, pushing production higher as companies looked to insulate their supply chains. Now, with many of those moves already underway, that breakneck pace is expected to level off through 2026 and 2027, according to a recent outlook from Atradius.

In this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner speaks with Brady McKinney, an underwriter for Atradius' pharmaceuticals sector focusing on the Americas, about the credit insurer's recent industry report. McKinney explains how tariff concerns drove last year’s manufacturing surge and why Atradius expects a period of stabilization ahead. He also discusses how companies are weighing the risk of future trade flare-ups and what that could mean for production, investment and credit conditions across the sector.

To learn more about the topics in this episode: 
Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report
FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program
In quick reversal, Trump calls off tariff threat related to Greenland pursuit
3 biopharma CEOs explain why they are 'authentically optimistic' for 2026

Though uncertainty still surrounds the Trump administration&rsquo;s pharmaceutical import tariffs, the trade rhetoric set off a clear response across the industry in 2025. Drugmakers accelerated U.S. manufacturing plans, pushing production higher as companies looked to insulate their supply chains. Now, with many of those moves already underway, that breakneck pace is expected to level off through 2026 and 2027, according to a recent outlook from Atradius.
In this week&rsquo;s episode of "The Top Line," Fierce Pharma&rsquo;s Fraiser Kansteiner speaks with Brady McKinney, an underwriter for Atradius' pharmaceuticals sector focusing on the Americas, about the credit insurer's recent industry <a href="https://atradius.us/dam/jcr:59079c5d-af53-4382-a069-81e43e2bb033/Industry-trends-pharmaceuticals-January-2026.pdf">report</a>. McKinney explains how tariff concerns drove last year&rsquo;s manufacturing surge and why Atradius expects a period of stabilization ahead. He also discusses how companies are weighing the risk of future trade flare-ups and what that could mean for production, investment and credit conditions across the sector.
To learn more about the topics in this episode:&nbsp;
<ul>
<li><a href="https://www.fiercepharma.com/manufacturing/pharma-manufacturing-output-surged-25-countries-braced-us-tariffs-atradius">Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report</a></li>
<li><a href="https://www.fiercepharma.com/pharma/fda-emphasizes-drug-ingredients-production-pledges-it-debuts-precheck-manufacturing-program">FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program</a></li>
<li><a href="https://www.fiercepharma.com/pharma/trumps-new-tariff-threats-around-greenland-threaten-upend-eu-trade-deal">In quick reversal, Trump calls off tariff threat related to Greenland pursuit</a></li>
<li><a href="https://www.fiercepharma.com/pharma/fierce-talks-3-biopharma-ceos-reasons-be-authentically-optimistic-heading-26">3 biopharma CEOs explain why they are 'authentically optimistic' for 2026</a></li>
</ul>

Trump's tariff threats, measured by manufacturing 

Biopharmaceutical innovation is advancing at an unprecedented pace, yet many patients still face barriers to accessing new medicines. In this episode of Health Matters, John O’Brien, president and CEO of the National Pharmaceutical Council, speaks with Kristin Cahill about why policy, pricing and benefit design are increasingly shaping whether innovation reaches patients.

O’Brien shares insights from his career spanning pharmaceutical companies, health plans and government, including his time as a senior drug pricing advisor during the first Trump administration. He explains why prescription drugs remain a focal point in cost debates, what policymakers often misunderstand about value, and how middlemen and misaligned incentives affect what patients pay at the pharmacy counter.

The conversation also examines emerging approaches such as direct-to-patient models, most-favored-nation pricing and the early effects of the Inflation Reduction Act, highlighting potential benefits as well as risks to access and future innovation. For healthcare professionals, payers and marketers seeking clarity in a complex policy environment, this episode offers a grounded perspective on how to ensure medical breakthroughs translate into meaningful patient benefit. Listen to the full interview.

Biopharmaceutical innovation is advancing at an unprecedented pace, yet many patients still face barriers to accessing new medicines. In this episode of Health Matters, John O&rsquo;Brien, president and CEO of the National Pharmaceutical Council, speaks with Kristin Cahill about why policy, pricing and benefit design are increasingly shaping whether innovation reaches patients.
O&rsquo;Brien shares insights from his career spanning pharmaceutical companies, health plans and government, including his time as a senior drug pricing advisor during the first Trump administration. He explains why prescription drugs remain a focal point in cost debates, what policymakers often misunderstand about value, and how middlemen and misaligned incentives affect what patients pay at the pharmacy counter.
The conversation also examines emerging approaches such as direct-to-patient models, most-favored-nation pricing and the early effects of the Inflation Reduction Act, highlighting potential benefits as well as risks to access and future innovation. For healthcare professionals, payers and marketers seeking clarity in a complex policy environment, this episode offers a grounded perspective on how to ensure medical breakthroughs translate into meaningful patient benefit. Listen to the full interview.

NPC President John O’Brien discusses policy, pricing and why innovation only matters if patients can access it.

Why patient access must keep pace with drug innovation (Sponsored)

Every clinical setback carries lessons. That’s why Fierce revisits major trial failures each year: not to dwell on disappointment, but to understand what went wrong and what it signals for the road ahead.

The 2025 edition of Fierce Biotech’s clinical trial flops report highlights a familiar pattern. Large drugmakers account for a disproportionate share of high-profile misses, reflecting the reality that many of the industry’s most ambitious late-stage programs now sit inside big pharma portfolios.

On this episode of "The Top Line," Fierce Biotech's James Waldron and Fierce Pharma's Fraiser Kansteiner discuss the failures that stood out in 2025 and what they suggest about the challenges facing drug development.

To learn more about the topics in this episode: 
2025's top 10 clinical trial flops
Sanofi ousts Paul Hudson after 'bumpy ride,' enlists Merck KGaA CEO to lead the French pharma

Every clinical setback carries lessons. That&rsquo;s why Fierce revisits major trial failures each year: not to dwell on disappointment, but to understand what went wrong and what it signals for the road ahead.
The 2025 edition of Fierce Biotech&rsquo;s clinical trial flops report highlights a familiar pattern. Large drugmakers account for a disproportionate share of high-profile misses, reflecting the reality that many of the industry&rsquo;s most ambitious late-stage programs now sit inside big pharma portfolios.
On this episode of "The Top Line," Fierce Biotech's James Waldron and Fierce Pharma's Fraiser Kansteiner discuss the failures that stood out in 2025 and what they suggest about the challenges facing drug development.
To learn more about the topics in this episode:&nbsp;
<ul>
<li><a href="https://www.fiercebiotech.com/biotech/2025s-top-10-clinical-trial-flops">2025's top 10 clinical trial flops</a></li>
<li><a href="https://www.fiercepharma.com/pharma/sanofi-ousts-paul-hudson-after-bumpy-ride-poaches-merck-kgaa-ceo-lead-company">Sanofi ousts Paul Hudson after 'bumpy ride,' enlists Merck KGaA CEO to lead the French pharma</a></li>
</ul>

Inside the sterile fill capacity crunch (Sponsored)

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