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CBER pathway: EUA vs BLA

Executive context Most gene therapies and vector-enabled products will follow full BLA pathways; EUA is situational (e.g., emergency public-health vaccines). The Viral Vectors report tracks rising approval velocity—with >30 FDA/EMA approvals expected 2025–2030—making early alignment on CMC, comparability, and post-marketing commitments essential. itsallaboutpatents.com Decision guardrails • Evidence planning: IND → pivotal → BLA with validated assays and stability packages matched to vector type.• Comparability: lock change-control;…
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Cold-chain & distribution constraints

Executive context Fill-finish, storage, and distribution are now the critical path for vector programs. Missed temperature windows or packaging mis-specs can erase CMC gains, push out launch, and inflate COGS. Use this page to align operations with the scale-up trajectory outlined in the Viral Vectors report (capacity build-out, process adoption, and trial volume). itsallaboutpatents.com Operational focus • Fill-finish readiness: vial/stopper compatibility, sterility assurance, line speed vs.…
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Vaccine platforms & CMC scale-up

Executive context Platform choice (AAV, LVV, adenovirus, retrovirus) drives CMC complexity and unit economics. In the 2025–2033 outlook, AAV is on track for ~54% share by 2033, with tangible upstream gains (10–50×) and downstream recoveries >90% for full capsids. The scaling agenda: move to suspension (target ~94% adoption), standardize analytics, and phase continuous processing where justified by throughput and cost curves. itsallaboutpatents.com Buyer checklist • Upstream:…
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Reimbursement & CPT coverage

Overview: Reimbursement & CPT coverage — context, definitions, and current market posture. What is Reimbursement & CPT coverage?The global cell therapy market is not merely evolving; it is experiencing a profound revolution, reshaping the entire biopharmaceutical landscape. From groundbreaking gene-editing techniques to innovative cell-based interventions, this sector promises unprecedented advancements in patient care and presents unparalleled opportunities for strategic investment and market leadership. Our latest comprehensive…
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Allogeneic Cell Therapy Manufacturing Market

Allogeneic Cell Therapy Manufacturing Market The allogeneic cell therapy manufacturing market is rapidly expanding, driven by advances in production technologies and rising demand for off-the-shelf cell therapies. Global investment in manufacturing infrastructure, including CDMOs like Lonza and Sartorius, exceeded $1 billion in CAPEX between 2023 and 2025, focusing on scalable, cost-effective production. Manufacturing capacity has grown to support increasing clinical and commercial supply, yet bottlenecks remain…
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Top Players

Top Players in Allogeneic Cell Therapy Manufacturing Leading contract development and manufacturing organizations (CDMOs) dominate the allogeneic cell therapy manufacturing landscape. Notable players include: Lonza Group: A market leader investing heavily in scalable manufacturing capacity across North America, Europe, and Asia, focusing on advanced process automation and quality compliance. Sartorius AG: Provides integrated bioprocessing solutions and single-use technologies tailored for cell therapy production, with facilities expanding…
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CMC / GxP regulatory compliance

Overview: CMC / GxP regulatory compliance — context, definitions, and current market posture. What is CMC / GxP regulatory compliance? CMC/GxP regulatory compliance in gene therapy refers to the stringent quality and safety standards governing product development and manufacturing. CMC (Chemistry, Manufacturing & Controls) ensures every batch meets defined criteria for identity, purity, potency, and consistency through documented process controls, quality attribute monitoring, and robust analytical…
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AAV/lentiviral vector capacity

Overview: AAV/lentiviral vector capacity — context, definitions, and current market posture. What is AAV/lentiviral vector capacity? AAV/lentiviral vector capacity refers to the global manufacturing infrastructure and throughput for adeno-associated virus (AAV) and lentiviral gene delivery systems. As of 2025, there are 28 cGMP-certified production sites across the US and EU dedicated to viral vector manufacturing, supported by $950 million in automation investments. These facilities collectively produce…
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CAR-T FDA approval pathway

Overview: CAR-T FDA approval pathway — context, definitions, and current market posture. What is CAR-T FDA approval pathway? The CAR-T FDA approval pathway begins with an Investigational New Drug (IND) application, supported by comprehensive preclinical safety and efficacy data. Once IND clearance is granted, CAR-T therapies advance through phased clinical trials (Phase I–III), during which Good Clinical Practice (GCP) and Chemistry, Manufacturing & Controls (CMC) compliance…
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quantum computing outlook

Executive context Quantum’s enterprise value shows up when paired with AI workflows (optimization, simulation, sampling). The core buyer decision isn’t “quantum vs. AI,” it’s sequencing: which AI workloads to keep on accelerators, which to trial on quantum, and when. Our flagship report quantifies the market at $74.8B by 2033 (28.9% CAGR) with three adoption scenarios and documents median <22-month payback for early pilots launched in 2025–26.…