Cell & Gene Therapy Manufacturing: The Next Frontiers of Scalability and Strategy

3 September 2025.

Smart Manufacturing & AI Integration

The adoption of Pharma 4.0 principles is redefining CGT manufacturing operations. Leading CDMOs are now integrating AI, machine learning, robotics, and digital twins to increase production yield, reduce batch failures, and streamline compliance.

One example is Lonza’s Odyssey platform, launched in 2024, which uses AI-driven analytics to monitor vector production and cell expansion in real-time. This proactive quality control approach enhances consistency across batches, vital for high-cost, low-volume advanced therapies.

Visiongain Analyst Insight: In July 2025, Cellular Origins, CGT Catapult, and Resolution Therapeutics formed a UK-based consortium to launch a fully automated robotics CGT manufacturing platform. This signals a transition from pilot initiatives to production-grade automation, positioning the UK as a potential leader in CGT smart manufacturing.

Decentralised & Point-of-Care Manufacturing

To minimise turnaround time and overcome cold chain logistics challenges, CDMOs and CGT developers, particularly in autologous therapies, are embracing point-of-care and decentralised production models.

A notable example is Miltenyi Biotec’s CliniMACS Prodigy, which powers on-site cell processing at over 150 clinical sites globally. By enabling real-time manufacturing within hospitals and research centres, the platform has reduced vein-to-vein time by up to 7 days.

Mobile cleanroom units are also gaining traction, particularly in emerging and rural healthcare systems, such as those in Latin American countries, where access to centralised facilities remains limited.

Sustainable CGT Manufacturing

Sustainability is emerging as a core manufacturing priority across the CGT value chain. CDMOs are actively investing in three areas to reduce environmental impact:

  • Energy-efficient systems
  • Eco-friendly culture media
  • Single-use technologies

These shifts are not only aligned with corporate ESG targets, but are also becoming a differentiator as procurement and reimbursement models evolve to include sustainability criteria.

Digital Supply Chain & Traceability

In a field defined by patient-specific therapies, traceability is critical. Blockchain and IoT solutions are being deployed to ensure chain-of-identity and chain-of-custody from sample collection to patient infusion.

Platforms such as TrakCel, which integrates with World Courier logistics, enable real-time tracking across the entire CGT workflow. This ensures compliance, reduces error rates, and supports the scalability of decentralised manufacturing models.

Key Players Making Headlines

Strategic acquisitions continue to shape the competitive landscape in cell and gene therapies, as pharmaceutical leaders bolster their pipelines with scalable CGT platforms:

  • AstraZeneca (May 2025): Completed its acquisition of EsoBiotec, a pioneer in in vivo cell therapies. The company’s ENaBL platform enables rapid, immune-based cancer targeting, reducing manufacturing time from weeks to minutes.
  • Roche (November 2024): Acquired Poseida Therapeutics, a clinical-stage biopharma specialising in donor-derived CAR-T therapies and associated manufacturing technologies.
  • Novartis (November 2024): Acquired Kate Therapeutics for US$1.1 billion, enhancing its gene therapy offering for inherited neuromuscular disorders.

These deals reflect an industry-wide pivot toward next-generation platforms with greater scalability, durability, and commercial readiness.

Visiongain Analyst Insight: AstraZeneca’s $50 billion US investment through 2030, which includes expanded CGT facilities, signals a reshoring trend driven by geopolitical risks, tariff exposure, and supply chain resilience planning.

CDMO Players Making Headlines

Contract manufacturers are scaling rapidly to meet demand, with a focus on modular capacity, regulatory integration, and AI-enhanced production:

  • Lonza: Launched an AI-enabled Route Scouting Service to accelerate synthetic route identification for novel APIs.
  • Fujifilm Diosynth Biotechnologies: Invested US$8 billion in parallel large-scale facilities in the US and Europe, leveraging modular designs.
  • Resilience: Raised over US$800 million to build AI-integrated CGT manufacturing sites.
  • Charles River & Miltenyi Bioindustry: Expanding CGT services with built-in regulatory and compliance support.
  • Porton Advanced (China): Gaining global recognition for its end-to-end CGT manufacturing capabilities.
  • Rocket Pharma & Orchard Therapeutics: Attracting investor attention for their expertise in rare disease approvals.

Together, these CDMOs represent the industrial infrastructure underpinning the next generation of personalised medicines.

Market Drivers Triggering CGT Manufacturing

Multiple structural drivers are accelerating the maturity and scale of CGT manufacturing:

  1. Surge in CGT Clinical Trials: Over 2,000 trials globally focused on oncology, rare, and regenerative conditions are creating sustained demand for manufacturing scale-up.
  2. Rise of Personalised Medicine: As curative potential grows for gene-based therapies, there is increased urgency to industrialise production for genetic and haematological disorders.
  3. Outsourcing Growth: Complexity in CGT production has pushed more developers to rely on CDMOs for viral vector supply, modular cleanroom capacity, and end-to-end logistics.
  4. Significant Capital Inflows: Corporate investments from companies such as Novartis, Roche and Pfizer, and institutional investors such as Blackstone Life Sciences (invested for Resilience), Temasek (invested in Porton Advanced), SoftBank Vision Fund (exploring opportunities in CGT manufacturing in Japan and Korea) and OrbiMed Advisors (invested in Kate Therapeutics now acquired by Novartis) are fuelling expansion and consolidation.
  5. Sustainability Pressure: Industry-wide momentum to adopt greener processes, energy efficiency, and environmentally conscious supply chains.
  6. Surge in CGT Clinical Trials: Visiongain projects the global gene therapy R&D market to grow at a 29.8% CAGR through to 2034, reinforcing demand for industrialised, scalable CGT infrastructure.

Strategic Questions for Executives

As manufacturing moves closer to the patient, executives must re-evaluate infrastructure, risk management, and delivery models:

  • How can AI and automation reduce batch failures and manual errors?
  • Should your organisation build internal CGT manufacturing or partner with a specialist CDMO?
  • Can your logistics infrastructure support decentralised, cryogenic workflows?
  • Are your systems prepared for real-time traceability and regulatory compliance?

What’s Next from Visiongain?

At Visiongain, we deliver trusted intelligence on the forces shaping advanced biomanufacturing and precision medicine. Our reports combine granular data with actionable insight tailored to commercial decision-makers and strategic planners. Explore our most recent titles:

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