Accelerating Technology Diffusion In Cell And Gene Therapy

By Partha Anbil, Life Sciences Industry Advisor, MIT Sloan, and Mamta Malhotra, consultant

The cell and gene therapy sector stands at a critical inflection point. After nearly a decade of regulatory approvals since 2017, the field has transitioned from scientific promise to clinical reality, yet paradoxically, patient access remains constrained by ecosystem fragmentation. Patients in critical need of cell and gene therapy treatment depend on it as a lifeline and require a personalized delivery model.

In 2024 alone, the FDA approved seven novel cell and gene therapy products, including the first tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell receptor (TCR) therapy, bringing the total number of approved therapies to more than 40 globally.^1,2 The global CAR-T cell therapy market, valued at approximately $5.2 billion in 2025, is projected to exceed $23 billion by 2034, representing a compound annual growth rate of 27%.³ Similarly, the broader cell and gene therapy manufacturing market is projected to grow from $11.6 billion in 2024 to $122.86 billion by 2034.⁴

These impressive market projections mask a fundamental challenge: unlike earlier pharmaceutical breakthroughs, cell and gene therapies cannot diffuse through traditional channels alone. They require the simultaneous development of manufacturing infrastructure, regulatory frameworks, supply chain ecosystems, and care delivery systems — what is identified as the cross-sector collaboration (CSC) pathway.

This article synthesizes recent findings on technology diffusion to address a critical question for industry professionals: How can collaborative knowledge-transfer mechanisms accelerate the transition from clinical approval to widespread patient access?

The Diffusion Gap Between Approval And Access

Rogers' Diffusion of Innovations theory, the foundational framework for understanding technology adoption, describes the diffusion of innovations through an S-curve that spans precursor, nascent, growing, and established stages.⁵ Cell and gene therapies, approved since 2017, should theoretically be entering the "growing" or "established" stage, yet evidence suggests they remain lodged in an extended nascent phase.

Consider the evidence: Despite FDA approval of five CAR-T cell therapies for blood cancers (Kymriah, Yescarta, Tecartus, Breyanzi, and Aucatzyl), only 10% to 15% of eligible patients receive these treatments.⁶ The manufacturing infrastructure capable of serving more than 500 qualified centers is in fewer than 40 locations globally.⁷ Even breakthrough achievements — such as the December 2023 FDA approval of Casgevy, the first CRISPR gene-editing therapy for sickle cell disease and beta-thalassemia — have faced implementation challenges, with fewer than fifty patients enrolled in clinical use by mid-2024 despite decades of disease burden.⁸

This gap between regulatory approval and clinical diffusion reflects a structural reality: cell and gene therapies are disruptive innovations that lack the ecosystem infrastructure of conventional pharmaceuticals. Traditional small-molecule drugs diffuse through existing pharmacy distribution networks, physician training systems, and reimbursement mechanisms. Cell and gene therapies, by contrast, require specialized manufacturing, trained personnel, authorized treatment centers, and novel care delivery models, none of which mature autonomously in response to approval.

The Three Enablers Of Diffusion

Recent research and industry practice have identified three primary mechanisms through which knowledge transfer can accelerate diffusion in complex, knowledge-intensive sectors:^9,10

1. Organizational absorptive capacity

Absorptive capacity, or the ability of organizations to recognize, assimilate, and apply new knowledge, has proven essential across cell and gene therapy adoption.¹¹ Healthcare systems implementing CAR-T programs must develop competencies in patient selection, leukapheresis procedures, cell manufacturing coordination, and the management of cytokine release syndrome. Organizations that proactively invest in research partnerships and clinical trials develop greater absorptive capacity than those that wait for commercial availability.

The California Institute for Regenerative Medicine (CIRM) exemplifies this principle. Through $5.5 billion in state funding since 2004, CIRM has directly supported absorptive capacity development by simultaneously funding:

• basic research at academic institutions,
• phase III clinical trials, and
• manufacturing infrastructure partnerships.¹²

As of March 2025, CIRM-funded efforts support 365 ongoing research programs and more than 80 clinical trials, creating an ecosystem in which knowledge is systematically transferred from discovery through commercialization. This target investment accelerated California's adoption of newly approved therapies.

2. Cross-sector collaboration and knowledge networks

The most striking finding from analysis of successful technology diffusion is the critical role of cross-sector partnerships, particularly between for-profit companies, nonprofit institutions, and government agencies.¹³ The established example: Kymriah and Yescarta^T, the first FDA-approved CAR-T therapies, both emerged from foundational work at nonprofit research institutions (the University of Pennsylvania and the National Cancer Institute, respectively). Novartis and Gilead/Kite invested in commercialization. This linear progression represents an earlier-stage model of collaboration.

Emerging 2025 models demonstrate more dynamic cross-sector interaction. The CIRM Industry Alliance Program, launched in 2021, created a novel mechanism wherein nonprofit and for-profit entities align on shared milestones. For example, Elevate Bio and CIRM agreed to transfer process development, analytical capabilities, and viral vector technology to CIRM-funded academic institutions and biotech startups, effectively democratizing access to proprietary methods that would otherwise remain siloed.¹⁴ This "open innovation" approach compressed development timelines while distributing knowledge across 200-plus participating organizations.

Similarly, the Bespoke Gene Therapy Consortium (BGTC), initiated by the Foundation for the National Institutes of Health in October 2021, established a structured forum for competing companies, academic centers, and regulatory agencies to share pre-competitive data on manufacturing challenges in gene therapy¹⁵ By facilitating candid discussion of manufacturing yield optimization, vector characterization, and process development, BGTC participants collectively advanced the field more rapidly than any individual organization could have achieved on its own.

3. Standardization, intellectual property strategy, and open-source mechanisms

The explosive growth of CAR-T patents — doubling between 2009 and 2019 — created both opportunities and fragmentation.¹⁶ Individual patent protection incentivized innovation but impeded knowledge sharing. The sector's maturation has produced more nuanced IP strategies:

Patent disclosure and knowledge dissemination: Recent high-profile publications on CAR-T manufacturing methods in peer-reviewed journals have accelerated their global diffusion. China's rapid development of locally manufactured CAR-T therapies — with five products approved by the National Medical Products Administration (NMPA) as of 2024 — demonstrates how transparent disclosure, even after patent protection is established, enables knowledge transfer across geographies.¹⁷

Standardization initiatives: The FDA's 2022 guidance documents on CAR-T and gene therapy manufacturing created the first regulatory standardization framework specific to these modalities.¹⁸ This formal guidance reduced uncertainty for smaller manufacturers and academic centers, lowering the barrier to entry for manufacturing. Contrast this with the MP3 audio file technology studied in the original research: the International Organization for Standardization (ISO) establishment of universal audio compression standards in the 1980s-90s preceded consumer adoption by a decade. FDA guidance is now catalyzing similar standardization benefits for cell and gene therapies.

Open-source platforms and technology transfer: Ori Biotech's 2024 launch of an automated cell and gene therapy manufacturing platform represents emerging open-source innovation models.¹⁹ Rather than maintaining proprietary manufacturing methods, the platform is being widely licensed to academic centers and small biotech firms, thereby distributing advanced manufacturing knowledge on a large scale.

The CSC Pathway Framework Starts At Knowledge Transfer And Ends With Diffusion

The CSC pathway synthesizes these three enablers into an operational framework for industry professionals:

Stage 1: Aligned vision and shared metrics

• Define successful metrics that transcend sector interests (e.g., number of patients treated, manufacturing efficiency, time to approval). Artificial intelligence can support predictive modeling for gene target selection, simulation of patient-specific responses using genomic data, integrating clinical trial data and real-world evidence to improve therapy efficacy.
• Establish governance structures balancing for-profit financial sustainability, nonprofit mission alignment, and government public health objectives.
• Create legal frameworks that clarify IP ownership, confidentiality agreements, and benefit-sharing mechanisms.

Stage 2: Structured knowledge exchange

• Establish consortia, alliances, or joint ventures with explicit knowledge-sharing objectives. Artificial Intelligence can provide ecosystem-level integration like real-time data interoperability across stakeholders (biopharma, regulators, manufacturers, providers, logistics partners and patients).
• Implement IT-enabled platforms such as blockchain-based systems, secure cloud infrastructure to facilitate cross-organizational data sharing while protecting proprietary information.
• Create boundary-spanner roles for individuals with expertise in bridging sectors who facilitate translation of knowledge across organizational contexts.

Stage 3: Ecosystem infrastructure development

• Coordinate manufacturing capacity development (centralized vs. decentralized approaches). Artificial intelligence can perform predictive maintenance, create improved visibility in vein-to-vein supply chain processes.
• Build training and certification programs for clinical staff.
• Develop reimbursement models and payer alignment mechanisms to address access barriers.

Stage 4: Scale and sustainability

• Transition from pilot consortia to sustainable institutional mechanisms.
• Monitor diffusion metrics (patient enrollment rates, manufacturing utilization, geographic coverage).
• Adapt governance structures as technology matures and market dynamics evolve.

In cell and gene therapy, timing is directly tied to patient survival. We need a self-aware, adaptive and scalable delivery system- where innovation, regulation and patient urgency converge seamlessly.

2024-25 Case Study: The Expanding Cell Therapy Pipeline

Recent FDA approvals demonstrate the CSC pathway in practice:

Amtagvi (lifileucel), approved in February 2024 for melanoma, represents the first TIL therapy approved for solid tumors after more than 30 years of development. The therapeutic pathway exemplifies cross-sector collaboration: foundational research at the NIH, clinical development at university centers, manufacturing innovation partnerships with biotech companies (Iovance), and now, distribution through established oncology networks.²⁰

Critically, Iovance proactively addressed manufacturing scalability by investing more than $100 million in production facilities across three continents — a decision enabled by confidence in market demand and driven by FDA guidance and clinical trial transparency.

Tecelra (afamitresgene autoleucel), Adaptimmune therapy, approved July 2024 for synovial sarcoma, introduced the first TCR therapy — a technology platform distinct from CAR-T. The approval signals regulatory confidence in the ability to navigate novel manufacturing processes.

It demonstrates that knowledge transfer between CAR-T developers and next-generation TCR developers is accelerating the adoption of next-generation TCRs. Within six months of approval, three academic centers integrated Tecelra into care protocols — substantially faster than the typical two-to-three-year adoption curve for CAR-T therapies.21

Gene Therapies for Hemophilia and Metabolic Disease: Beqvez (fidanacogene elaparvovec), approved for hemophilia B in April 2024, and Kebilidi, approved for AADC deficiency in November 2024, represent the successful translation of gene-delivery technologies into clinical practice.

Both required specialized manufacturing (AAV vector production) and novel delivery mechanisms (intravenous for systemic diseases, intracranial for neurological disorders). The pace of approvals — three gene therapy approvals in 2024, compared with one in 2022 — reflects the diffusion of accumulated manufacturing expertise and regulatory standardization across the biotech sector.²²

The Unresolved Challenge: Manufacturing Scale and Cost

Despite progress on knowledge transfer, cell and gene therapy manufacturing remains the primary bottleneck to diffusion. The manufacturing market, projected to reach $122.86 billion by 2034, is heavily concentrated in "precommercial and R&D scale" operations, encompassing 74% of market share in 2024, with commercial-scale manufacturing representing only 26%.²³ This inverted pyramid reflects the field's ongoing challenge: most manufacturing capacity is allocated to research and early-stage development rather than to patient access.

COGS remains prohibitively high for most cell therapies. Manufacturing a single CAR-T product costs $50,000 to $100,000 per patient, a cost structure that threatens both manufacturers' profitability and payers' willingness to reimburse. Decentralized "point-of-care" manufacturing approaches—wherein treatment centers produce therapies on-site—offer promise for reducing costs and logistical complexity. However, this model requires knowledge transfer to hundreds of hospitals simultaneously: a coordination challenge that traditional pharmaceutical distribution networks are not designed to support.

The CSC pathway directly addresses this manufacturing challenge through:

• standardized manufacturing protocols enabling knowledge replication;
• consortium-based troubleshooting that distributes innovation costs across multiple organizations; and
• government-supported infrastructure investment (as exemplified by CIRM and NIH funding of manufacturing facilities) that creates public goods, reducing individual firms' capital requirements.

Recommendations for Industry Professionals

For biopharmaceutical companies:

• Invest in manufacturing partnerships and technology transfer agreements with CDMOs and academic centers earlier in development, not post-approval.
• Participate in consortia and standards-setting bodies, viewing pre-competitive knowledge sharing as ecosystem investment that accelerates overall market maturation.
• Model financing and manufacturing decisions on platform approaches (enabling multiple indications from core manufacturing processes) rather than single-indication development pathways.

For nonprofit and academic institutions:

• Establish or strengthen technology transfer offices with expertise in cross-sector partnerships and licensing models that accelerate commercialization.
• Consider open innovation models wherein foundational intellectual property is made available to biotech partners on favorable terms, recognizing that ecosystem maturation benefits all stakeholders.
• Invest in manufacturing capability development as part of academic research infrastructure, viewing it as the infrastructural equivalent to mass spectrometry or next-generation sequencing facilities.

Conclusion

Clinical approval is merely the first step toward widespread diffusion of cell and gene therapies. The gap between FDA approval and patient access reflects ecosystem immaturity, not scientific limitation.

Evidence from successful disruptive technology diffusion, examined through augmented reality, MP3 audio technology, and biobanking, demonstrates that cross-sector collaboration, which accelerates knowledge transfer, is not merely beneficial but essential for technologies that require new infrastructure, standards, and human capital. The CSC pathway operationalizes this principle, providing a framework for coordinated action among for-profit manufacturers, nonprofit institutions, and government agencies.

The pace of FDA approvals in 2024-25, which is approaching the FDA's projection of 10 to 20 approvals annually, signals growing regulatory confidence and manufacturing capacity. Yet this trajectory of approval means little without concurrent ecosystem development. Industry professionals across sectors and geographies now face a choice: maintain siloed approaches to manufacturing, training, and knowledge development, or embrace collaborative mechanisms that have demonstrably accelerated diffusion of other disruptive technologies.

The next decade will determine whether cell and gene therapies follow the trajectory of monoclonal antibodies (50-plus years from discovery to market maturation) or whether cross-sector collaboration enables accelerated diffusion, benefiting patients in our lifetime.

References:

1. ISCT Global. (2025). Cell & Gene Therapy Approvals in 2024. International Society for Cellular Therapy. https://www.isctglobal.org
2. Springer. (2025). Cell and Gene Therapy Products: Navigating the Regulatory Landscape of Paradigm Approvals in the US (2020 to 2024). Journal of Pharmaceutical Innovation.
3. Precedence Research. (2025). CAR T-Cell Therapy Market Size, Share and Trends 2025 to 2034. Global market analysis.
4. Precedence Research. (2025). Cell and Gene Therapy Manufacturing Market Size 2025 to 2034. Global market analysis.
5. Rogers, E. M. (2003). Diffusion of innovations (5th ed.). Free Press.
6. Alliance for Cancer Gene Therapy. (2023). Patient access report. [Cited in original research].
7. Cell and Gene Therapy Sector Analysis. (2024). Manufacturing capacity assessment.
8. Clinical Trials Database. (2024). Casgevy enrollment tracking.
9. Dunlap-Hinkler, D., Kotabe, M., & Mudambi, R. (2010). Managing knowledge in subsidiaries. Academy of Management Review, 35(4), 521-532.
10. Bacon, E., Brodie, J., Williams, M. D., & Davies, G. F. (2021). Knowledge transfer in knowledge-intensive service industries. Journal of Knowledge Management, 25(2), 312-335.
11. Cohen, W. M., & Levinthal, D. A. (1990). Absorptive capacity: A new perspective on learning and innovation. Administrative Science Quarterly, 35(1), 128-152.
12. California Institute for Regenerative Medicine. (2024). 2024 Annual Report. https://www.cirm.ca.gov
13. Maine, E., Probert, D., & Ashby, M. (2014). Collaborative research networks: Enabling transformative research. R&D Management, 44(2), 157-175.
14. Schwartz, J. (2022). Elevate Bio and CIRM partnership announcement. Cell and Gene Therapy Insights.
15. Kingwell, K. (2021). Bespoke Gene Therapy Consortium launched. Nature Biotechnology, 39, 886.
16. Lyu, M. A., et al. (2020). Patent landscape analysis of chimeric antigen receptor T-cell therapy. Nature Biotechnology, 38, 1355-1363.
17. NMPA. (2024). China CAR-T approvals registry. National Medical Products Administration.
18. FDA. (2022). Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products. Draft guidance for industry. U.S. Food and Drug Administration.
19. Ori Biotech. (2024). Launch of an automated cell and gene therapy manufacturing platform. Company announcement.
20. Iovance Biotherapeutics. (2024). Amtagvi (lifileucel) FDA approval and manufacturing strategy briefing.
21. Adaptimmune. (2024). Tecelra (afamitresine autologous leukemic cell) adoption tracking and clinical implementation support.
22. FDA. (2024). Novel drug and biological product approvals. U.S. Food and Drug Administration database.

Editor's note: The views expressed in the article are those of the authors and not of the organizations they represent.

About The Authors

Partha Anbil is at the intersection of the life sciences industry and management consulting. He is currently senior vice president of life sciences at Coforge Limited. He held senior leadership roles at WNS, IBM, Booz & Company, Symphony, IQVIA, KPMG Consulting, and PWC. He has consulted with and counseled health and life sciences clients on structuring solutions to address strategic, operational, and organizational challenges. He was a member of the IBM Industry Academy. He is a healthcare expert member of the World Economic Forum (WEF). He is also a life sciences industry advisor at MIT, his alma mater.

Mamta Malhotra is a digital transformation leader with 20-plus years of experience partnering with payer, provider, and life sciences clients, supporting top consulting firms including Accenture, Cognizant, and Gerson Lehrman Group. She helps healthcare and biopharma organizations tackle real-world challenges using advanced AI and analytics, and scalable operating models to accelerate commercialization, IT value, and patient access.