2026 cell and gene therapy predictions

As advanced therapies transition from promising science to industrial maturity, investors will increasingly favor late-stage programs with strong data, proven scalability and credible paths to adoption. Developers that fail to reduce manufacturing complexity, control costs and expand access risk delayed adoption or limited commercial success — despite strong clinical efficacy.

In short, ‘beautiful science’ alone is no longer enough. Commercial viability must be built into development strategies from the earliest stages.

Many thought leaders also see 2026 as a turning point for AI, where it’s long-promised potential finally meets pragmatic execution, particularly in addressing clinical trial inefficiencies.

At the same time, the industry will increasingly look to China for scientific innovation. AstraZeneca’s recently announced $15 billion investment in China through 2030 to expand manufacturing and R&D underscores this shift. In 2026, more partnerships with Chinese biotechs and tech providers are expected, alongside greater use of investigator-sponsored trials in China generate early human data more quickly and cost-effectively.

Overall, industry leaders anticipate a more grounded, mature CGT landscape in 2026. Here’s a closer look at their predictions for the year ahead. (Don't miss our editorial advisory board predictions.)

Scalability & access

Success will hinge on execution, access and trust

By 2026, the biggest shift in cell and gene therapy won’t come from new modalities, but from how the industry operationalizes access. We’ll see a clear move away from ‘one-size-fits-all’ manufacturing and launch strategies toward more specialized, digitally enabled, and regionally adaptive models. This will be driven by a collision of realities: constrained capital, increasing regulatory scrutiny on comparability, and growing pressure from health systems to demonstrate real-world value faster and faster, more direct access for patients. 

Manufacturers that succeed will be those that integrate digital infrastructure, supply chain visibility, and manufacturing strategy early — not as bolt-ons once at commercialization. At the same time, communication will become a strategic function, not a marketing one: aligning regulators, providers, payers and patients around how these therapies are delivered, not just what they do. The winners in 2026 will be companies that treat execution and trust as core assets.

-Ry Leahy, founder, Science Communication Foundry

CGTs must prove scalability and durability quickly to secure capital

Cell and gene therapy faces a pivotal moment in 2026 as regulatory reforms and investor expectations converge. In Europe, mandatory Joint Clinical Assessments under the new EU HTA Regulation aim to speed access, while U.S. FDA guidance on RMAT pathways and flexible trial designs supports faster approvals for small populations. Yet, the investment landscape has shifted since the 2024 peak: venture capital deals have declined, average deal sizes are smaller, and investors now favor assets nearing clinical proof-of-concept with clear scalability. This funding reality pressures developers, CDMOs, and pharma to prioritize automation, continuous vector manufacturing, and robust clinical validation to deliver mature, scalable therapies. EMA’s updated GMP Part IV and quality guidelines reinforce safety and reliability, addressing contamination control and genome editing. The message is clear — CGTs must prove scalability and durability quickly to secure capital and meet patient needs.

-Simona Guidi, associate Director, Q&C cell & gene therapy, ProPharma 

Developers will balance scientific ambition with pragmatic execution

The CGT landscape in 2026 will be shaped by an increased urgency to realize the promise of these transformative treatments. This urgency is being driven by two key factors: delayed regulatory approvals and the growing need for broader patient access. As timelines slip and endpoints face scrutiny, companies will need to rethink how they bring therapies to market efficiently and equitably.

One major shift we anticipate is the rise of alternative commercialization strategies. Expanded Access Programs (EAPs) will become a critical bridge for patients awaiting approval, while launch sequencing will be increasingly strategic rather than linear. Instead of a traditional global rollout, companies will prioritize markets based on: pricing potential; regulatory flexibility and endpoint acceptance; and operational timelines. Ultimately, 2026 will be a year where CGT developers balance scientific ambition with pragmatic execution. Those who adapt quickly, leveraging EAPs, optimizing launch sequences, and engaging payers early, will be best positioned to deliver on the sector’s promise.

-Tom Smith, strategic director, cell and gene therapies, Uniphar Access

Autopheresis will be central to CGT scalability

In 2026, the cell and gene therapy industry is shifting faster than ever, and autopheresis providers are right at the center of that transformation. As demand grows for decentralized, high-quality collections, our role isn’t just to harvest cells — it’s to bridge donors, patients, manufacturers, and innovative technologies. The providers who succeed will be the ones who deliver consistency, flexibility, and access at a scale this industry has never seen before.

-Kevin King, senior scientific advisor, cell and gene therapy, BioIVT

Those who invest early in scalability will succeed commercial manufacturing

CGT investment post-COIVD did not dry up because patients or diseases disappeared, but because investment was heavily driven towards achieving clinical milestones in the shortest possible timeline. In doing so, manufacturing automation and digitization was moved to “we’ll address it later.” There is no later as successful safety studies lead to pivotal studies in a similar compressed timeline. The only time to determine commercial manufacturing is during pre-clinical work. It requires sufficient investment to ensure a therapy that can be manufactured safely and effectively at commercial scale. Those who makes this initial investment in 2026 will have the most efficient commercial manufacturing.

-Jon Ellis, CEO, Trenchant BioSystems

Increased knowledge transfer and regional infrastructure will be critical for access

In 2026, global growth in cell and gene therapy will continue accelerating — led by the U.S., China, Brazil, and the UK. Yet, major regions remain underserved. Despite having the world’s highest melanoma rates, Australia and New Zealand still face gaps in treatment options, and countries across India, South Africa, the Middle East and parts of the Asia-Pacific rim often lack the infrastructure and access needed to deliver advanced cellular therapies.

Tumor infiltrating lymphocytes (TILs) hold transformative potential for melanoma and other solid tumors. As leaders in TIL research and development, we believe there is a responsibility to share our expertise and help build regional skills. Increased knowledge transfer, establishing local manufacturing capacity, and enabling regional infrastructure will be critical steps toward expanding global access and improving patient outcomes in 2026 and beyond.

-Amy Hay, chief business officer, CTMC

Winners will be those who translate biological complexity into scalable processes

In 2026, investors will — or should — demand a sharper distinction between scientific and manufacturing risk in cell and gene therapy assets. We expect those companies to thrive that can show both manufacturing costs quantified and strategies de-risked. We will also see the market diverge further between therapies aiming to treat disease versus those seeking tissue regeneration, the latter often facing hurdles in localization, immune rejection, and differentiation fidelity. In an environment where AI attracts most risk capital, biotech programs with a clear line from mechanism of action to clinical relevance will rank highest in probability of securing funding or even an industry partnership. As the field matures, the winners will be those who succeed in translating biological complexity into predictable, scalable processes — ushering in a new era where living medicines are manufactured with the same confidence as small molecules today.

-Max Baumann, partner, Treehill Partners

The industry will shift from problem-solving to industrial maturity

The overarching theme for the CGT sector in 2026 is its strategic shift from problem-solving to industrial maturity. This transition requires the industry to abandon bespoke processes and embrace mandatory, scalable industrialization, a transformation driven by the need to capitalize on digital standardization.

First, financial requirements will shift the industry conversation from technology adoption to verifiable return on investment, meaning companies must prove operational efficiency and lower batch failure rates to secure funding and avoid divestment. Second, regulatory convergence is driving a strong shift from reactive document review toward proactive, automated validation. AI/ML for automated deviation classification will grow in acceptance, helping to reshape QA and accelerate product disposition. Third, decentralization is creating pressure for data standardization and integration across the ecosystem (hospitals, CDMOs). The industry will increasingly treat the supply chain not as a set of independent partners, but as a unified, digitally integrated ecosystem where shared process templates and data are managed securely.

-Alexa Crăciunescu, VP, product commercialization, Autolomous

Investment in enabling technologies to scale manufacture will accelerate 

In 2026, the CGT sector will accelerate investment in technologies and platforms that enable scalable and cost-efficient manufacture, building on momentum such as the recent $40M Series A for the automated CGT robotics manufacturing platform developer, Cellular Origins.

As CGT developers consolidate and pivot toward indications with broader patient populations, the limitations of current manufacturing models will become more obvious and critical. Specifically, innovation around process closure will be needed to address the high facility costs of manual, open processes and move towards parallel and higher-intensity manufacturing. At the same time, the CGT sector will increasingly recognize that scalability extends beyond just core processing steps, driving further demand for automation and digitalization across QC workflows and ancillary material supply chains. These pressures will catalyze a new wave of enabling more affordable CGT technologies in 2026.

-Douglas Bradshaw, head of business development, TTP plc

There will be increased demand for flexible, scalable upstream solutions

We remain cautiously optimistic about the CGT space in 2026. Distek continues to see the industry wrestle with scalability challenges, high manufacturing costs, and regulatory complexity. These factors have cooled some of the early momentum driven by large VC rounds and rapid expansion seen in prior years, shifting the focus toward more disciplined investment and cost-conscious development. As CGT organizations prioritize process robustness and manufacturability, we anticipate increased demand for flexible, scalable upstream solutions that support efficient development and long-term production goals.

-Joshua Ross, national sales manager, Distek Inc.

A shift towards China

New deals and trials will take place in China

As the VC investment continues risk-averse and dazzled with the new kid in town — the in vivo — those with value propositions are trying for alternative solutions of funding. In 2026, CGT companies will go for BD and M&A sources of funding alongside public dilutive and non-dilutive funding. The role of VC in taking risk at the initial step of translation from preclinical to initial clinical data is currently significantly underserved with potential negative implications on the pipeline of CGT company creation and industrial translation down the road.

The focus of CGT development and company creation is also shifting from the U.S. and Europe to Asia, specifically China. CGT deals involving Chinese companies are increasing and new deals and trials in CGT are taking place in China. The world should wake up to the incoming China science leadership. There is an opportunity for a collaborative competition with players from China and elsewhere going forward.

-Miguel Forte, ISCT president, ARM board member and CEO, Kiji Therapeutics

China will solidify its role as a global source of novel CGT assets

China's unmatched R&D velocity for CGT, enabled by AI, vast patient pools, and a 30-day fast-track clinical approval channel, will solidify its role as the world's premier source of novel CGT assets. Outbound BD licensing deals will continue their surge, with Chinese-originated assets projected to account for nearly 50% of global licensing deals in 2025. This momentum is driven by global pharma’s need to replenish CGT pipelines cheaply and quickly, and Chinese firms' focus on next-gen modalities like bi/tri/multi-specifics, in vivo CAR therapy, and targeted protein degradation, effectively exporting 'Innovation 2.0' to the West.

-Lance Han, founder & chief innovation officer, Cyagen Biosciences

Tech, platforms and strategies

Companies will shift toward flexible, platform-based vectors for multiple indications

2026 is widely seen as a recovery year for cell and gene therapy, with renewed momentum across the field despite recent funding constraints. Companies continue to invest in a diverse set of modalities — including LVVs, LNPs, AAVs and emerging vector platforms — rather than selecting a single dominant approach. A key trend is the shift toward more flexible, platform-based vectors, such as targeted LNPs and adaptable AAV systems, designed to address multiple indications and tissues. 
 
At the same time, high manufacturing costs remain the biggest barrier to adoption and investment. Innovation is therefore advancing in parallel across therapeutic development and manufacturing reinvention, with a growing focus on fit-for-purpose analytical tools that can support complex modalities and emerging decentralized production models. Increased regulatory flexibility from the FDA, combined with stabilizing funding, are creating space for renewed innovation. Bringing robust analytics earlier into development will be critical to reducing risk, shortening timelines, and lowering costs — making 2026 an exciting inflection point for both CGT developers and tech providers. 

-Gabriella Kiss, director, market development, Refeyn

Advances will improve throughput, flexibility and process control

Over the past few months, we’ve seen customers accelerate their transition from manual, open workflows to closed, automated systems that reduce contamination risk, improve reproducibility, and support scale-up from early clinical to commercial manufacturing. At the same time, pressure continues to grow to shorten vein-to-vein time. We are especially excited about next-generation and allogeneic ‘off-the-shelf’ CAR-T platforms, including bicistronic and multi-target constructs, which are showing promising early clinical results and have the potential to transform manufacturing scale and access. From our perspective as a device manufacturer for cell collection and processing, these advances represent both significant opportunities and meaningful challenges: enabling higher throughput, greater flexibility, and tighter process control while helping customers navigate cost, complexity, and increasingly rigorous regulatory expectations.

-Liza Loidolt, general manager, cell and gene therapies, global therapy innovations, Terumo Blood and Cell Technologies

CDMOs will help industry overcome production constraints

In 2026, bringing therapies directly to patients will require CDMOs to combine innovation with operational excellence. Modular, platform-based manufacturing allows facilities to adapt quickly to different modalities and disease targets, overcoming the limits of hospital-based production. AI and digitalization further enhance process predictability, reduce batch failures, and shorten scale-up timelines for complex therapies such as CAR-T, AAVs and bispecifics.

This convergence enables CDMOs to deliver high-quality, consistent products while providing strategic insights into manufacturing and supply chain optimization. By embracing these trends, CDMOs become true partners beyond production, accelerating patient access, lowering costs, and ensuring advanced therapies reach those who need them most, while maintaining regulatory and operational rigor across an increasingly complex CGT ecosystem. Manufacturing thus becomes a strategic enabler, transforming innovation into tangible patient impact.

-Janet Hoogstraate, Ph.D., CEO, NorthX Biologics

Industry will move toward end-to-end manufacturing systems that can scale

ReiThera expects 2026 to be a pivotal year in optimizing the foundations of viral vector manufacturing. As demand for scalable, cost-efficient CGT production grows, the sector will shift from relying on generic cell substrates to adopting proprietary, purpose-built cell lines. These platforms will improve productivity, stability, and regulatory readiness, accelerating development timelines and reducing manufacturing risk. Next-generation production systems can reshape the field. Advances across adenovirus and MVA manufacturing will broaden the toolbox for both gene therapy and vaccine developers. In 2026, competitive licensing models, tighter integration of manufacturing and analytical capabilities, and IP-secure platforms will enable faster, more reliable delivery of advanced therapies. The industry’s focus will increasingly move toward smart, engineered manufacturing ecosystems that ensure consistency, scalability and global accessibility.

-Michela Gentile, cell line development supervisor, ReiThera

The need for novel excipients will increase

A key challenge in the CGT sector — indeed, across the entire pharma industry — is in overcoming the risk-averse culture around the use of novel excipient technologies. As drug molecules become increasingly more complex, the need for novel excipients that enhance solubility, bioavailability, stability, safety and simpler formulation has never been greater. Many of today’s commonly used excipients were developed decades ago, often not even for pharmaceutical use, and they can be suboptimal for CGT therapies. Yet with excipients typically assessed only as part of a complete product submission package, developers may prefer to settle for familiar ingredients with precedence of use in an approved drug, despite the availability of superior novel excipients. Going forward, early and active collaboration between excipient manufacturers and drug developers will be key in building formulator confidence in the advantages of novel excipients for promising CGT therapeutics.

-Meera Raghuram, director, regulatory and sustainability strategy, Lubrizol

Developers will move away from bacterial systems toward cell-free DNA platforms

For 2026, the CGT sector will increasingly treat cell-free DNA not as an alternative, but as the default foundation for advanced genetic medicines. From Touchlight’s perspective, pressure to accelerate timelines, reduce risk, and meet sustainability goals will push developers away from bacterial systems toward enzymatic, cell-free DNA platforms that are faster, cleaner, and more scalable from discovery through GMP.

Cell-free DNA will become critical in enabling next-generation architectures — including large, complex payloads, custom circles, and gene-editing constructs — where consistency, purity, and design flexibility are non-negotiable. As programs move faster into the clinic, confidence in cell-free manufacturing will grow, reinforcing adoption at later clinical and commercial stages. By 2026, success in CGT will be defined less by whether companies adopt cell-free DNA — and more by how effectively they integrate it end-to-end to de-risk development, shorten timelines, and future-proof scale.

-Jill Makin, CSO, Touchlight

Therapeutic strategies beyond T-cell-based approaches will expand

I predict that therapeutic strategies beyond T-cell-based approaches will expand to include other immune cell types, especially the use of natural killer (NK) cells, leading to more off-the-shelf approaches and solid tumor targets. I also think that there will be a stronger push for manufacturing scale up and cost control, as well as further investigations into how AI can support cell and gene therapy discoveries and approaches. After the first successful use of base editing to treat a baby with a metabolic disease in 2024, similar approaches to treat metabolic diseases, especially those targetable in the liver and caused by point mutations, will be developed. Lastly, I envision a broadening of delivery options to viral-like particles and lipid nanoparticles.

-Michael Haugwitz, Ph.D., director, cell biology R&D, Takara Bio USA

Delivery systems will evolve, while manufacturing becomes more automated

Delivery systems are developing quickly with a range of new and improved approaches offering more accurate, efficient, and safer tissue-specific targeting. We are likely to see benefits for established viral-based delivery, like AAV, but also a range of non-viral delivery technologies that have the potential to address challenges related to high dosages, immunogenicity, and direct targeting of specific organs and tissues. From a manufacturing perspective, further development and adoption of automation and digitalization technology have the potential to improve scalability, efficiency, and reduce production errors. These technologies could have a huge impact on more complex cell therapy products supporting scale-out for autologous therapies and scale-up for allogeneic.

A key enabling factor for long-term improvement is investment in early-stage development. Should investors continue to focus more toward established later-stage assets, as they have done in 2025, novel funding models, partnership agreements, and collaborative approaches could become critical.

-Andrew Frazer, associate director, scientific solution, Charles River CDMO

The services ecosystem that supports CGTs will reshape

The cell & gene therapy landscape in 2026 is poised for measurable gains and maturation, marked by expanding approvals, advancing next-generation platforms, and meaningful progress toward scalable, digitally enabled manufacturing systems. At the same time, the expansion of CDMO capacity, increased competitive and funding pressures, and ongoing consolidation are slowly reshaping the services ecosystem that supports these products. These shifts indicate a move from early-stage, tailored development to a sector that is more operationally scalable, while still facing the scientific and clinical uncertainties inherent to these therapies. 

-Ahmad Hussin, VP, Charles River CDMO

Winners will be platforms that preserve T-cell fitness while proving safety and efficacy

By 2026, we expect the CAR-T landscape to split into two tracks. Ex vivo CAR-T will remain the benchmark in hematologic cancers because it delivers high response rates with durable remissions, and offers tight control over T-cell selection, engineering, potency testing, and dosing. Interest and investments in in vivo CAR-T will grow as will new questions about the consistency of in-patient transduction, risk of off-target gene delivery, and whether persistence and functional durability can match ex vivo products. The potential benefits of in vivo CAR-T, which reprograms a patient’s T-cells directly in the bloodstream, are agreed upon; however, concerns about patient safety and delivery specificity remain open as we enter 2026. The winners will be platforms that preserve T-cell fitness while proving safety and repeatable clinical benefit.

-Chantale Bernatchez, Ph.D., head of process development, CTMC

Moving beyond oncology

CGT will redefine ophthalmology

In 2026 and beyond, cell and gene therapy will redefine ophthalmology, shifting the focus from slowing vision loss to restoring sight. Beyond rare inherited retinal diseases, gene therapy is now being evaluated for high-prevalence conditions such as neovascular age-related macular degeneration, diabetic retinopathy and diabetic macular edema, and geographic atrophy — offering the potential for a ‘one-and-done’ treatment where current standards require frequent intravitreal injections. Breakthroughs in gene editing, targeted delivery systems, and regenerative approaches will enable durable outcomes for these challenging diseases. Manufacturing scalability and streamlined regulatory pathways will be essential as therapies move toward broader patient populations. Collaboration among biotech innovators, CROs, and research sites will drive efficient trials, patient access, and continued demonstration of safety and efficacy. Ultimately, the convergence of advanced analytics, minimally invasive delivery technologies, and patient-centric care models will make CGT a cornerstone of ophthalmic care — offering hope where none existed and setting new standards for precision medicine.

-David Tanzer, MD, chief medical officer, Lexitas

The industry is positioned for expansion

In 2026, the CGT space will be defined by an expanding clinical focus moving beyond oncology, more intelligent R&D through enhanced technologies, scalable manufacturing, and greater access to therapies for patients. Developers are moving beyond oncology and rare disease into more prevalent conditions such as diabetes, through advances in allogeneic cell therapies and in vivo gene editing.

Manufacturing will pivot toward closed systems, increased automation and hybrid models that fuse centralized facilities with decentralized, point-of-care production to mitigate logistical risks and decrease turnaround times. CDMOs will continue to scale at an accelerated clip, increasing their standing as partners for process development, regulatory readiness, and quality control. The infusion of AI and other digital tools will drive predictive analytics and real-time insights and controls into manufacturing processes to create efficiencies, reduce batch failures, and ultimately lower costs. Challenges will continue, including labor shortages, vector shortages, high costs, and lack of standardization/infrastructure for data sharing, but the CGT space is positioned for expansion and new successes in 2026.

-Jonathan Wofford, CCO, Title21

The industry will move from proof-of-concept to proof-of-practicality

In 2026, we will see the cell and gene therapy field broaden beyond oncology and rare diseases, with growing focus on autoimmune conditions. That shift will sit alongside more products reaching late-stage clinical trials and the first wave of approved autologous cell therapies gaining commercial traction. As those therapies move into wider use, manufacturing automation will become a central priority. It will be needed to scale production and to bring costs closer to what health systems can sustain.

At the same time, in vivo cell and gene therapies will gain momentum as early-phase studies begin to translate promising science into clinical experience. Together, these trends signal an important point for the sector. We are moving from proof of concept to proof of practicality, where reliable and repeatable manufacture becomes as critical to success as the science itself.

-Lucy Foley, CEO, eXmoor Pharma

Antibody-oligo conjugates will become an enabling modality alongside CGT

By 2026, we expect antibody-oligonucleotide conjugates to emerge as a standout new modality bridging biologics and gene-based therapeutics—an important development for the cell and gene therapy field. Pairing antibody specificity with oligo-driven mechanisms enables developers to more precisely modulate gene expression or intracellular pathways in ways that complement cell and gene therapies, including targeted conditioning, immune rewiring, and combination strategies that reduce off-target burden. What’s changing now is feasibility: improved conjugation chemistry and linker stability are making these constructs more reproducible, scalable, and clinically realistic. As early pipelines mature, antibody-oligo conjugates could become an enabling modality alongside CGT — helping deliver genetic precision with biologic-level targeting and control.

-Catherine Bladen, Ph.D., VP, regional executive and principal advisor, Vector Laboratories

Investments and funding

Strong data, scalable platforms and a path to patients will win funding

The cell and gene therapy sector will continue to operate in a K-shaped economy through 2026. A clear divide is emerging between programs that are well funded and clinically validated and those still struggling to secure early capital. Companies with strong data, scalable platforms and a credible path to patients will continue to move forward, while earlier-stage programs without differentiation or validation may face longer timelines and tougher funding conditions.

Big pharma will play an increasingly influential role in determining which companies rise on the upper arm of that “K.” Investors are gravitating toward programs with late-stage proof of concept, clear manufacturing strategies and strategic pharmaceutical partnerships. As a result, Series B financings are expected to remain strong, while Series A investment lags, reflecting a broader shift toward de-risked, partnership-backed innovation.

-Kimberley Barnes, president, Phacilitate

The industry will see consolidation and product maturation 

Cell and gene therapies are potentially curative medicines. Yet the translation from academia to GMP and from bench to clinics has presented significant challenges, and various CGT programs and companies have been struggling on their journey. 2026 will see some consolidation in the CGT space and should provide more product maturity for these essential medicines. This also applies to adequate formulation, choice of primary packaging, and suitable delivery devices to ensure a robust supply chain and usability.

-Hanns-Christian Mahler, CEO, ten23 health

Companies with good data and solutions to broad industry challenges will thrive

Financing internationally in the CGT sector has been significantly suppressed for a number of years now. This has specially applied to Scandinavia. Green funding shoots have appeared in the last two years, but these shoots have not materialized as a ‘spring.’ However, at the end of 2025, the CGT sector has expanded from VCs to more innovative funding sources and is experiencing success. Companies like Circio that demonstrated good data, therapies applicable across multiple disease areas, solutions to broader industry challenges, and big pharma partnerships in 2025 are seeing share price gains into 2026.

-Erik Wiklund, CEO, Circio

Time has run out for the sector to demonstrate commercial viability

Last year, Treehill forecast the continuation of the paucity of CGT capital and this has proved correct. We are now seeing evidence of innovative and novel financing for CGT obtaining dividends, and we expect this to continue through 2026, but only for those that can demonstrate properly-considered investable proposals, with long-term development and manufacturing strategies leading to a commercially viable product. Specifically, the greater degree of accountability and ownership being asked not only of management but also CGT service providers to ensure optimal trial design and trial execution will further increase. This may come in time to save some of the backlog of CGT companies seeking to go public and the plethora of public companies needing to raise follow-on capital.

-Ali Pashazadeh, CEO, Treehill Partners

Collaborations will foster progress while complicating BD processes

Small CGT companies have always been aiming at striking deals with or being acquired by big pharma, while fiercely competing with each other. That target is still there. However, development of data packages which move the needle for big pharma or specialized investors becomes increasingly challenging as clinical CGT candidates grow ever more complex and multifaceted. This forces CGT companies to collaborate in areas where technologies are synergistic or interdependent. The push towards formation of an interactive mesh of companies working on the same CGT candidate will foster progress while complicating BD processes even further.

-Victor Levitsky, CSO, Circio

The CGT sector will stabilize

With the recent changes in administration, I think we’ll start to see the cell and gene therapy sector stabilize in 2026. There’s still a huge unmet need for patients, and that will continue to drive innovation. I also expect investors to gain a clearer picture of the market, which should bring renewed confidence and more funding back into cell and gene therapy. That combination of stability and investment will help move therapies forward and get us closer to meeting patient demand.

-Van Tran, site director, manufacturing operations, Charles River CDMO

AI and automation

Winners will be those who build digital-first manufacturing foundations now

By 2026, CGTs will still be the most complex and operationally complex therapeutic modality we’ve created. AI’s first real impact will be upstream, accelerating early-stage discovery, target selection and process understanding rather than GMP execution. Operationally, digitalization becomes the critical prerequisite. Without fully digitized processes, data continuity and orchestration layers, AI cannot be deployed safely or at scale in CGT. The winners will be those who build digital-first manufacturing foundations now, enabling AI to progressively drive robustness, insight and operational excellence as the field matures.

-Dan Strange, CTO, Cellular Origins

Robotics will move from promise to a prerequisite

For 15 years we’ve bemoaned artisanal CGT manufacturing and prophesied a future of blissful automation to deliver these therapies into the mainstream. Non-believers sought alternative modalities, allogeneic or in vivo cell therapies, but 2025 marked a turning point. Serious capital and partnerships were invested into robotic, fully digitalized manufacturing platforms finally realizing commercial production in all these modalities. In 2026, this becomes decisive. Robotics moves from promise to a prerequisite, from prophecy to practice, reshaping commercial and competitive dynamics as industrialized manufacturers pull decisively ahead. In CGT, the rise of the robots is here, and it is very, very welcome.

-Jason Jones, VP, Cellular Origins

AI will advance the shift towards faster, smarter process development

Early and tangible gains from AI in bioprocessing are likely to emerge from streamlining cell and gene therapy process development. While the promise of AI-enabled CGT manufacturing operations remains compelling, meaningful impact and innovations will take time to materialize. In the near term, the greatest value will come from making better use of data, accelerating insight generation and democratizing biological understanding.

As cell and gene modalities diversify and pressure to reduce the cost of goods intensifies, data-driven development approaches will become essential. This includes emerging applications such as using large language models to expedite the creation of digital twins.

-Stuart Lowe, head of advanced therapies, TTP plc

The industry will undergo an intense period of problem-solving and maturation

The CGT sector in 2026 will be defined by an intense period of problem-solving and maturation, moving beyond hype toward grounded, scalable success. Impractical ideas are being filtered, leaving a focus on addressing core pain points: delivery, cost, and reliability. R&D is diversifying, with over 51% of new gene therapy trials targeting non-oncology indications like neurodegenerative and cardiovascular disorders, demanding digitally-flexible, multi-indication platforms. Therapeutically, impactful successes in solid tumors, showing the "wow" clinical factor, will continue to command premium investment. The manufacturing shift is defined by the digitization and automation imperative. To combat the $500,000+ batch cost and enforce consistency, companies are implementing intelligent, closed-system automation. This automation is rendered effective through GMP-compliant software designed for purpose, replacing legacy systems to ensure data integrity, SOP enforcement, and real-time visibility. The FDA’s emphasis on QbD further validates this digital focus, as data-rich processes are required to demonstrate built-in quality.

-Alexander Seyf, CEO, Autolomous

Biotechs will look to optimize manufacturing processes with automation

Driven by the mixed commercial experiences of the past and the need, in the current context of uncertainty and pressure on prices, to make cell and gene therapies more competitive, biotechs will be looking to optimize their manufacturing processes by integrating, among other things, automation technologies and intelligent systems augmented by AI. This will involve partnerships with equipment manufacturers who have invested early in the development of these production technologies. Thanks to this renewed competitiveness, the business model for cell and gene therapies is once again becoming bankable, making it possible to treat diseases that are nevertheless poorly served, and for which a curative therapy provides a very attractive solution compared with conventional chronic treatments.

-Matthieu de Kalbermatten, CEO, CellProthera

AI will unlock the keys for improved clinical development

Clinical development is bottlenecked by manual processes. Clinical research associates are overworked, often experiencing burn out. In 2026, agentic AI will unlock the keys for improved clinical development, starting by alleviating within trial white space and empowering clinical research associates to focus more on sites and the trial operations rather than administrative tasks. To achieve value, agents must be measured against the outcomes they deliver, including end-to-end autonomy. In 2026, we will see agents begin to deliver extremely valuable aspects of the value chain — ultimately enabling full clinical development autonomy with as needed human oversight for key activities.

-Michelle Longmire, MD, CEO/co-founder, Medable

2026 will be an inflection point for how AI is governed in clinical research

The FDA and EMA have been moving (thoughtfully but decisively) toward a more aligned, forward-looking set of rules that do more than protect the public; they create room for responsible progress. With the EU AI Act coming into effect in the first half of 2026 and the FDA beginning to deploy generative AI tools to support and accelerate regulatory review, there will be a new regulatory position: guidance that is faster, more data-driven, and anchored in transparency, explainability, and continuous performance monitoring.

In 2026, there will also be a tiered approach to autonomy. Regulators appear to be increasingly prepared to let AI handle routine, low-risk research tasks with minimal friction, while keeping firm human control over decisions that directly shape safety, ethics, and public trust. That is the right hierarchy. If they stay on this course, international coordination and iterative learning between agencies will not just keep up with AI, they will shape it. The result is substantial: more efficient drug development, lower costs, and more timely, representative access to better therapies. The challenge, which we cannot underestimate, is to ensure that the governance, safeguards, and ethical commitments evolve as quickly as the technology they aim to oversee.

-Pamela Tenearts, MD, chief medical officer, Medable

Drug development will transform into an agentic-AI-supported pipeline

2026 will feel less like a ‘slow-pipelines’ world and more like a ‘smart-pipelines’ world. Expect the transformation of drug development from a predominantly human-driven, sequential process into a continuously learning, agentic-AI-supported pipeline. Instead of researchers and clinicians manually generating hypotheses, designing studies, reviewing data, and coordinating decisions across long cycle times, agentic AI systems will autonomously propose targets, run virtual experiments, optimize protocols, monitor safety signals, and surface decision-ready recommendations.

Humans won’t be removed from the process — they’ll shift into higher-value oversight roles, validating AI-generated options and steering strategy while AI handles the labor-intensive, multi-step analytical and coordination work. The result will be a funnel that’s faster, more adaptive, less linear, and increasingly self-optimizing, marking the first true structural redesign of the R&D model in decades.

-Andrew Mackinnon, global executive general manager, Medable

Clinical trials will utilize a more resilient, hybrid model

Clinical trials in 2026 will undergo a critical adjustment period as the current administration’s policies reshape the life sciences landscape. Tariffs on imported pharmaceuticals, coupled with rhetoric about bringing trials and manufacturing “back home,” are prompting sponsors and service providers to reassess global footprints. While intended to strengthen domestic production and patient participation, these measures introduce new cost pressures and operational complexity, with indirect but meaningful impacts on trial supply chains and site selection.

At the same time, incentives tied to U.S. economic growth may benefit CROs, site networks, and sponsors with strong domestic infrastructure, digital and AI-enabled capabilities, and efficient U.S. patient recruitment. Those heavily reliant on offshore operations may face rising costs and delays. The sector’s ability to adapt – balancing resilience and insight with cost efficiency – will determine how disruptive these shifts become.

While political cycles may drive temporary uncertainty, the fundamentals of good clinical research remain global. The likely outcome next year is not a wholesale return of trials to the U.S., but rather a recalibration: a more resilient, hybrid model that strengthens domestic participation without sacrificing global reach.

-Patrick Flanagan, CEO, Veristat

AI will transform clinical trials

Next year, trial stakeholders will return to the fundamentals of good partnership to pave the path to AI transformation in clinical trials. Sponsors and CROs will formalize their positions on the use of AI in clinical trials by embedding detailed policies and official statements into trial agreements before trials begin. However, the lightning speed of AI evolution will make these nuanced policies nearly obsolete before a multi-year trial even finishes enrolling patients.

Companies can avoid AI policy churn by replacing rigid AI mandates with flexible language rooted in transparency — something that should already be foundational to sponsor/CRO/site relationships but often isn’t today. Transparency and communication will be more important than ever for companies hoping to leverage the potential benefits of AI for operational efficiency — and, ultimately, to bring drugs to patients faster. Next year, the clinical trials industry will return to the fundamentals of a good partnership to ensure that the door to AI transformation remains open and not limited or stifled by inflexible legalese contained in standard operating procedures.

-Cindy Henderson, chief strategy officer, Veristat

AI will improve research data integrity

AI will be implemented across research biometrics and data operations to improve data integrity. Clinical trials are all about data, and the responsible use of AI in biometrics and data operations represents a major back-office opportunity that will emerge in 2026. By automating data cleaning, anomaly detection, and statistical modeling, AI can increase the speed, insights, and precision of clinical trial data analysis and submission assembly. These efficiencies help shorten development timelines and improve data integrity.

Ultimately, AI will not eliminate the human element but will be the tool that amplifies it. The leaders in this next phase of clinical research will be those who use AI to inform decisions, not replace judgment, ensuring smarter trial design, faster activation, and more reliable data across the clinical life cycle.

-Kim McLean Boericke, chief operations officer, Veristat

AI will make a dent in clinical trial inefficiency

AI will make a measurable dent in clinical trial inefficiency, particularly in study startup timelines. Next year will be a turning point where AI’s promise in life sciences finally meets pragmatic execution. By targeting the administrative bottlenecks that have plagued clinical trials for decades including contracting, budgeting, and payment processing, AI will begin to demonstrate return on investments and accelerate trials significantly.

Early estimates show AI can reduce study startup timelines by 15-20% on average, saving millions in overhead costs per global trial. AI has proven it doesn’t need to design the next blockbuster molecule to transform the business of clinical research. The future of clinical trials is not just smarter science, but also smarter operations, powered by AI that quietly handles the laborious tasks fast and allow researchers to re-focus on supporting sites and patients.

-John Chinnici, CEO, Ledger Run

Next year will be the ‘year of the research site’

As sponsors face growing pressure to attract and retain high-performing research sites, 2026 will likely bring a renewed focus and greater investment in strategies designed to support and empower sites. These efforts will range from reassessing sourcing models (CRO vs. FSP vs. in-house) to adopting more flexible and responsive engagement tools.

Unfortunately, many sites remain skeptical of new ‘support’ systems that often add complexity rather than reduce it. A recent Tufts Center for the Study of Drug Development Impact Report found that 70% of global investigative site staff believe trials have become significantly harder to manage over the past five years. So, while sponsors and CROs share a commitment to improving transparency and trial execution, it’s essential that any changes minimize the operational burden on sites. The next wave of advancement will leverage technologies like AI to streamline operations and enhance visibility without disrupting the natural flow of daily site activities.

-Kevin Williams, EVP & chief strategy officer, Ledger Run