In 2025, innovation alone was not enough. Across biotech and pharma, policy, safety, manufacturing reliability, and reimbursement increasingly determined whether breakthroughs could scale in the real world. This first installment (Ranked #10 to #6) focuses on the “infrastructure layer” of the industry—regulation, access, supply dynamics, and public health momentum.
The second installment (to be published on Dec 31) will cover #5 to #1, where capital and competition were shaped most dramatically—obesity drugs and oral GLP-1s, ADCs, China licensing, and accelerating M&A.
#10: Europe Puts “Health Biotech” Front and Center — The European Biotech Act Push
Europe has long been strong in science but fragmented in financing, scale-up, and manufacturing. In late 2025, the EU more explicitly moved to address these bottlenecks by proposing a policy package aimed at funding access, biomanufacturing capacity, and high-impact project support.
What happened
- The European Commission proposed a Biotech Act to strengthen Europe’s health-biotech competitiveness through coordinated investment tools and targeted support.
Why it matters
- This is an attempt to speed up the cycle from capital → clinical execution → manufacturing → access, not merely research output.
- For companies, EU strategy becomes less “secondary market” and more “design from day one,” especially in CMC and supply planning.
What to watch in 2026
- Execution: whether the investment facility and manufacturing support translate into measurable cycle-time gains.
#9: Gene Therapy Hits a Turning Point — Safety Signals Drive Portfolio Selection
Gene therapy momentum remained real, but 2025 brought sharper scrutiny. For several programs, the question shifted from “Can it work?” to “Can it be delivered safely and consistently at scale?”—with dose, immunology management, long-term follow-up, and CMC front and center.
What happened
- FDA actions including distribution suspensions and clinical holds highlighted the rising importance of safety risk management in gene therapy.
Why it matters
- Serious safety events can rapidly impact trust across an entire modality class.
- Manufacturing consistency (CMC) increasingly becomes a value driver on par with efficacy.
What to watch in 2026
- Programs that win will be those with “safety-first design,” tighter patient selection, robust immunology playbooks, and mature manufacturing controls.
#8: Biosimilars Become a Real Market Tool — The “Stelara Era” and Formulary Power
In the U.S., biosimilars continued their shift from “availability” to “replacement at scale,” driven by payer and PBM decision-making. Large-discount strategies made biosimilar competition structurally important for how biologics markets clear.
What happened
- Ustekinumab (Stelara) biosimilars entered and expanded, with aggressive discounting and strong formulary influence.
Why it matters
- Life-cycle management becomes essential—device, dosing convenience, and services matter more.
- Biotech valuation assumptions for future blockbusters must increasingly include post-launch price pressure.
What to watch in 2026
- Which therapeutic classes face the next wave of replacement pressure and how quickly payers enforce switching.
#7: U.S. Pricing & Reimbursement Enters a New Phase — Medicare Negotiation Momentum
In 2025, U.S. pricing policy continued to evolve from political narrative toward concrete operating reality. Medicare negotiation dynamics are now shaping how companies think about value evidence, pricing strategy, and portfolio resilience.
What happened
- Progress and disclosures around Medicare negotiation created clearer signals for price formation heading into 2027.
Why it matters
- Large pharma faces price pressure alongside patent cliffs, reinforcing the logic of partnering and M&A.
- Winning products increasingly require not only clinical value but durable evidence (HEOR/RWE) and “budget impact” narratives.
What to watch in 2026
- More “value-by-design”: building evidence strategies earlier and aligning clinical endpoints with real-world payer needs.
#6: A Symbolic Step Forward in Antimicrobials — New-Class Antibiotics Return to the Spotlight
AMR (antimicrobial resistance) has been a high-need but structurally difficult market. In 2025, the visibility of new-class antibacterial options helped re-energize the narrative—especially for priority pathogens.
What happened
- Gepotidacin (Blujepa) gained attention as a new-class antibiotic, reinforcing momentum for AMR innovation and policy support.
Why it matters
- AMR is a public health priority where “approval” is only step one—adoption models (procurement, stewardship, reimbursement) matter as much as science.
What to watch in 2026
- Whether procurement/stockpile and reimbursement models can align stewardship with sustainable economics.
Wrap-up: What #10–#6 Tell Us About 2025
2025 made one message clear: even great science needs policy alignment, safety confidence, and scalable supply to become a real-world winner. These foundations set the stage for the “headline” forces covered in the next installment (#5–#1).
This article is edited by the Morningglorysciences team based on publicly available information, with added context and implications for 2026.
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