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iStock, mechichi Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, global consistency and broader patient access to CAR T therapies. The cell and gene therapy (CGT) field has reached a pivotal moment—one many of us saw coming when the first CAR T cell therapy was approved in 2017. The efficacy of these therapies is undeniable, with curative outcomes for patients who have exhausted every other option. Yet the existing manufacturing infrastructure simply wasn’t built to meet the scale of patient demand. Today, manual labor is estimated to account for 5 0% of cell therapy manufacturing cost . In my view, streamlined automation is the only path forward to unlocking scale. Before joining Cellares as Chief Operating Officer, I spent more than two decades bringing life-saving medicines to patients—leading the commercialization and global capacity ramp-up of Novartis’ Kymriah, the first commercially approved cell therapy, and later Johnson & Johnson and Legend Biotech’s Carvykti, which has been called the most successful cell therapy launch to date. Along the way, one truth became clear: the way we manufacture cell therapies must be fundamentally reimagined. That reimagination is now underway. A wave of regulatory, technological and geopolitical changes has converged to push the field toward automated, standardized and domestically anchored production. A Changing Landscape and Growing Urgency Recent U.S. policy shifts, such as the BIOSECURE Act and the FDA’s new data-security rules, underscore an urgent move to strengthen domestic CGT manufacturing. At the same time, the FDA’s Advanced Manufacturing Technologies (AMT) program is accelerating the adoption of automation platforms that improve product consistency and scalability. We received the very first AMT designation in cell therapy, for Cellares’ Cell Shuttle, a fully closed, end-to-end automated manufacturing system purpose-built to overcome commercialization challenges. Since then, two others have been handed out to Oribiotech and Cellino, also involving cell-based manufacturing techniques. Manufacturing As Ori Wins Designation, FDA’s Advanced Manufacturing Program Nears Proof Point Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines. September 9, 2025 · 5 min read · Nick Paul Taylor Meanwhile, clinical success is expanding patient eligibility. CAR T therapies such as Carvykti are now moving earlier in the treatment journey, and approvals in autoimmune diseases are approaching fast , potentially expanding the addressable population by orders of magnitude. Until now, CAR T therapies have benefited from regulatory flexibility as last-line therapies. As they move earlier, regulators will expect developers to meet the same universal-supply standard applied to other medicines—a tall order under today’s limited capacity. Automation and digitalization are no longer optional; they are prerequisites for sustainable access. Automated Solutions for an Unscalable System Legacy cell therapy manufacturing remains constrained by semi-automated systems that depend on expensive cleanrooms and error-prone manual handling that require costly revalidation for even minor process changes. The next generation of fully automated platforms, such as Cell Shuttle, leverage flexible, software-defined manufacturing within single-use cartridges to reduce contamination risk, minimize operator touchpoints and enable parallel batch processing across multiple patient runs. Equally important is the digital integration of manufacturing with quality control (QC), a hidden bottleneck for cell therapy commercialization that is starting to gain notice. Fragmented analytical instruments and manual documentation risk batch failure and delayed drug product release. Automation of in-process and drug product release testing reduces error, allows real-time data capture and generation of audit-ready batch records. For drug developers, integrated automation delivers consistent manufacturing across sites, simplifies tech transfer and shortens development timelines. Faster, more reproducible production enables earlier IND submissions, lower clinical supply costs and a more efficient path to commercialization. In competitive indications, where trial enrollment can take up to 30% of total development time, the ability to manufacture and release products faster accelerates recruitment, data generation and approval. For patients, these gains mean faster access to potentially curative therapies and a future where breakthrough science reaches everyone who needs it. Opinion Fixing CGT Manufacturing Requires Not Automation, but a Return to Basics The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually every other industry. August 5, 2025 · 5 min read · Josh Ludwig

AUSTIN, Texas and TOKYO, Dec. 29, 2025 /PRNewswire/ -- According to DataM Intelligence, the global cell and gene therapy market reached a value of US$13.90 billion in 2024 and is projected to expand significantly to US$105.83 billion by 2033, registering a robust compound annual growth rate (CAGR) of 21.5% during the forecast period from 2025 to 2033. This exceptional growth trajectory reflects the accelerating transition of cell and gene therapies from experimental and early-stage clinical research into commercialized, life-altering treatments. Increasing regulatory approvals, expanding clinical pipelines, and rising investments in advanced therapeutic platforms are positioning cell and gene therapy as one of the most transformative segments within the global biopharmaceutical industry. Request Executive Sample | Cell and Gene Therapy Market Intelligence: Market Overview Cell and gene therapies represent a fundamental shift in how diseases are treated by addressing conditions at their biological root rather than managing symptoms. These approaches can be deployed independently or combined to create gene-modified cell therapies, offering unprecedented therapeutic potential. In combined approaches, a patient's cells are genetically modified through gene therapy techniques and then reintroduced into the body as a cell therapy. One of the most prominent examples is CAR-T cell therapy, where a patient's T cells are engineered to recognize and destroy cancer cells before being reinfused. This approach has demonstrated remarkable success in oncology and continues to expand into additional disease indications. Both cell and gene therapies are increasingly being explored for chronic, inherited, and life-threatening diseases that have limited or no effective treatment options. Their ability to provide long-term or potentially curative outcomes has significantly increased interest from healthcare providers, regulators, and investors worldwide. Market demand is being fueled by a growing number of therapy approvals, a rapidly expanding clinical development pipeline, and rising recognition of the unmet medical needs these therapies can address. Clinical Pipeline Momentum According to the American Society of Cell and Gene Therapy, the sector maintained strong momentum into early 2024, with several notable therapy approvals and sustained growth across all stages of clinical development. Currently, more than 4,000 gene, cell, and RNA-based treatments are in research and development globally. The clinical pipeline has expanded significantly across all phases, with Phase I trials experiencing the highest growth, increasing by approximately 11%. This surge highlights the industry's strong innovation engine and underscores the long-term commercial potential of next-generation therapies entering early-stage development. Market Dynamics Drivers: Advancements in Delivery Vectors One of the most significant growth drivers in the cell and gene therapy market is the increasing utilization of advanced delivery vectors. These vectors are essential for transporting genetic material-DNA or RNA-into target cells safely and efficiently. Traditional delivery systems have limitations related to targeting accuracy, immune response, and dosage efficiency. As a result, next-generation viral and non-viral vectors are being developed to improve therapeutic outcomes while reducing adverse immune reactions. Enhanced delivery systems can also lower dosage requirements, improving both safety and cost-effectiveness. In May 2023, AGC Biologics introduced its BravoAAV and ProntoLVV viral vector platforms, offering faster, scalable, and reproducible production under Good Manufacturing Practice (GMP) conditions. These platforms are designed to support both clinical and commercial-scale manufacturing. Similarly, in May 2024, Charles River Laboratories International, Inc. launched reference materials for adeno-associated virus (AAV) and lentiviral vector (LVV) portfolios to streamline cell and gene therapy research and enable smoother transitions to GMP-quality production. Restraints: High Development and Manufacturing Costs Despite strong growth prospects, high development costs and complex manufacturing processes remain significant restraints for the cell and gene therapy market. Production requires specialized cleanroom facilities, highly skilled personnel, and strict adherence to regulatory standards. Many therapies-particularly autologous treatments such as CAR-T-must be customized for each individual patient, substantially increasing production time and cost. Manufacturing costs for CAR-T therapies can exceed US$100,000 per patient, while certain gene therapies, such as one-time treatments for rare genetic diseases, can cost over US$2 million per patient. These high costs create challenges related to reimbursement, scalability, and patient access. In addition, the production of viral vectors and specialized raw materials is both capital- and time-intensive, with limited suppliers further increasing expenses. According to simulations by the National Institutes of Health (NIH), annual spending on gene therapies could reach approximately US$20.4 billion, even under conservative assumptions. Purchase Corporate License | Cell and Gene Therapy Market Intelligence: Market Segmentation Analysis By Therapy Type The global cell and gene therapy market is segmented into cell therapy and gene therapy, with cell therapy accounting for the dominant share. In 2024, the cell therapy segment held approximately 61.2% of the global market share. The segment demonstrated strong growth, reaching US$13.39 billion in 2022 and increasing further to US$14.66 billion in 2023. Cell therapies have gained widespread adoption due to their strong clinical success, particularly in oncology and regenerative medicine. CAR-T therapies and stem cell-based treatments have shown high efficacy, accelerating approvals and market uptake. A notable milestone occurred in April 2024, when India launched its first indigenously developed CAR-T cell therapy, developed by the Indian Institute of Technology (IIT) Bombay and Tata Memorial Centre. The therapy is being offered at nearly one-tenth of the global cost, significantly improving accessibility and highlighting the role of innovation in cost reduction. Substantial funding from governments and research institutions continues to support cell therapy development. For example, researchers at the University of California, San Francisco (UCSF) initiated a clinical trial for a next-generation CAR-T therapy targeting glioblastoma, supported by an US$11 million grant from the California Institute for Regenerative Medicine (CIRM). Geographical Analysis North America North America dominates the global cell and gene therapy market, accounting for approximately 43.7% of the total market share. The region recorded a market size of US$10.94 billion in 2022, which expanded to US$11.97 billion in 2023. The region's leadership is supported by a strong biotechnology ecosystem, advanced healthcare infrastructure, and the presence of leading academic research institutions. The United States, in particular, benefits from proactive regulatory frameworks that accelerate development and commercialization. The U.S. Food and Drug Administration (FDA) has introduced specialized pathways such as the Regenerative Medicine Advanced Therapy (RMAT) designation, which expedites the review of promising therapies. In August 2024, Ocugen, Inc. received FDA clearance to initiate an expanded access program for OCU400, a modifier gene therapy for retinitis pigmentosa, highlighting continued regulatory support for innovative treatments. Competitive Landscape The cell and gene therapy market features a combination of established pharmaceutical companies and innovative biotechnology firms. Leading players focus on expanding clinical pipelines, improving manufacturing capabilities, and forming strategic collaborations. Key Market Players Emerging players such as Editas Medicine, Intellia Therapeutics, Rocket Pharmaceuticals, Regenxbio, and Affinia Therapeutics are contributing to innovation through next-generation gene-editing and vector technologies. Novartis AG Key CGT products: Kymriah (CAR-T), Zolgensma (AAV gene therapy) Technology focus: CAR-T cell therapy, in-vivo AAV gene therapy Competitive positioning: Novartis is a first-mover and scale leader in CGT, with strong manufacturing capabilities, regulatory experience, and global commercialization across oncology and rare genetic diseases. Primary markets served: US, Europe, Japan, China Gilead Sciences, Inc. Key CGT products: Yescarta, Tecartus (CAR-T therapies) Technology focus: Autologous CAR-T cell therapy (via Kite Pharma) Competitive positioning: Gilead is a dominant CAR-T oncology player, focusing on hematological malignancies with continuous innovation in manufacturing efficiency and next-generation CAR designs. Primary markets served: US, Europe Bristol Myers Squibb Company Key CGT products: Breyanzi, Abecma (CAR-T therapies) Technology focus: CAR-T cell therapies for blood cancers Competitive positioning: BMS has built a robust CAR-T franchise through strategic acquisitions and partnerships, emphasizing differentiated safety profiles and broader patient eligibility. Primary markets served: US, Europe, Japan Vertex Pharmaceuticals Incorporated Key CGT products: Casgevy (exagamglogene autotemcel; gene-edited therapy, partnered) Technology focus: CRISPR/Cas9 gene editing (functional cure approach) Competitive positioning: Vertex is redefining CGT with curative, one-time gene-editing therapies, particularly in hemoglobinopathies, moving the market beyond symptomatic treatment. Primary markets served: US, Europe, select global markets Orchard Therapeutics Key CGT products: Libmeldy (ex-vivo gene therapy for metachromatic leukodystrophy) Technology focus: Ex-vivo autologous hematopoietic stem cell gene therapy Competitive positioning: Orchard is a pure-play rare pediatric gene therapy innovator, specializing in ultra-rare, life-threatening genetic disorders. Primary markets served: Europe, United States Krystal Biotech, Inc. Key CGT products: Vyjuvek (topical gene therapy for dystrophic epidermolysis bullosa) Technology focus: Redosable, non-invasive gene therapy platforms Competitive positioning: Krystal stands out for non-systemic, localized gene therapy delivery, significantly lowering safety and manufacturing complexity compared with systemic CGTs. Primary markets served: United States, Europe Request Customized Intelligence Aligned to Your Business Strategy: Recent Industry Developments The market continues to evolve through technological advancements and strategic initiatives: September 2024: CPC (Colder Products Company) launched a new aseptic micro-connector designed specifically for freeze cassettes used in cell and gene therapy processing. April 2024: Walgreens announced plans to work directly with drug manufacturers to expand patient access to cell and gene therapies through its specialty pharmacy division, including AllianceRx. May 2024: ProPharma, in partnership with Italy-based PBL, launched the Cell Factory Box (CF Box)-a fully automated system enabling decentralized CGT manufacturing in controlled environments. Conclusion The global cell and gene therapy market is entering a period of unprecedented growth, driven by rapid innovation, expanding clinical pipelines, and increasing regulatory support. While challenges related to cost, scalability, and manufacturing complexity persist, ongoing advancements in delivery vectors, automation, and decentralized production are expected to address many of these barriers. With strong momentum across research, development, and commercialization, cell and gene therapies are poised to redefine treatment paradigms and deliver long-term value to healthcare systems worldwide through 2033 and beyond. 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