Biotech and pharma will enter 2026 after a year marked by intense dealmaking, rapid modality evolution and major advances in AI-enabled R&D. In 2025 alone, several billion-dollar acquisitions — including Genmab’s agreement to acquire Merus and Roche’s acquisition of 89bio — signaled how aggressively large companies are reshaping their pipelines.
Emerging areas like in vivo CAR-T and radiopharmaceuticals also gained ground through expanded collaborations and early trial activity. These shifts unfolded alongside major progress in AI-native drug design, gene therapy approvals for rare diseases and a surge of investment into cardiometabolic assets.
In our blog, we point to four defining pharma & biotech industry trends for 2026, each already visible across real 2025 milestones.
AI Becomes Biopharma Infrastructure
AI has moved upstream into the core of biopharma R&D, spanning target discovery, molecular design, simulation and data workflows that traditionally required months of manual coordination.
Example from 2025:
Eli Lilly partnered with NVIDIA to build an AI supercomputer designed to run trillions of molecular simulations annually. The platform is built to unify chemistry, biology, toxicology and imaging workflows, signaling that large pharma increasingly sees AI not as experimental tooling but as enterprise-level scientific infrastructure.
Another example from 2025:
Weave Bio and Parexel, working in partnership with Takeda Pharmaceuticals, expanded the use of AI in regulatory operations. Parexel used Weave’s AutoIND system to prepare IND submissions up to 50% faster, while Takeda co-developed HAQ Manager, an AI-native workflow that drafts and coordinates responses to FDA and EMA review questions, one of the most time-critical phases of drug development.
Cell & Gene Therapies Gain Regulatory Momentum
By August 2025, the FDA had approved 46 cellular and gene therapy (CGT) products, a sign that the field is steadily progressing from isolated milestones into a repeatable therapeutic category.
In November, FDA leadership also introduced a “plausible mechanism” pathway in The New England Journal of Medicine, outlining how certain highly personalized therapies — especially for rare, severe genetic diseases — could qualify for earlier approvals when a strong mechanistic link supports the observed clinical benefit.
Example from 2025:
The FDA approved Papzimeos (zopapogene imadenovec-drba), the first gene therapy for recurrent respiratory papillomatosis (RRP). In the pivotal single-arm study, 51% of participants required no surgeries for 12 months, a meaningful outcome in a rare HPV-driven airway disease that can force patients into 20 to 40 surgeries over a lifetime.
In Vivo CAR-T and Bispecifics Reshape Oncology Pipelines
New oncology modalities — including in vivo CAR-T, bispecific antibodies and emerging radiopharmaceuticals — are offering more precise ways to engage immune cells or deliver therapeutic payloads directly to tumors.
Example from 2025 (in vivo CAR-T):
Nona Biosciences and Umoja Biopharma expanded their collaboration to develop in vivo CAR-T, which delivers genetic instructions directly inside the patient using vectors or nanoparticles. If durability and safety hold up, this approach could reduce the complexity and manufacturing load associated with traditional ex vivo CAR-T.
Example from 2025 (bispecifics):
Abbvie’s epcoritamab (Epkinly) earned FDA approval in combination with rituximab and lenalidomide for relapsed or refractory follicular lymphoma. As a T-cell-redirecting bispecific, bringing it earlier into the treatment sequence highlights growing clinical confidence in this class for an incurable, relapsing disease.
Big Ticket Deals and Obesity Programs Reorder Pipeline Strategy
After a cautious 2024, investment surged back into biopharma in 2025, particularly in cardiometabolic disease and scalable platforms. Companies are concentrating resources on assets that can anchor commercial franchises well into the 2030s.
Example from 2025:
Pfizer’s acquisition of Metsera became one of the most scrutinized transactions of the year. Pfizer initially offered $4.9 billion, then ultimately secured the deal for up to roughly $10 billion (cash + contingent value right) after a fierce bidding contest with Novo Nordisk, both vying to strengthen their obesity pipelines. The battle was a very public example of how aggressively big pharma is competing for next-gen GLP-1 and amylin-based programs.
Overall, 2026 will likely be shaped by AI-driven R&D, maturing advanced therapies, smarter oncology modalities and a sharper investment focus on obesity and scalable platforms.
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