Cell therapy is moving from highly specialized research into a broader healthcare ecosystem. The challenge now is not only developing effective therapies but also making them manufacturable, affordable, transportable, and accessible to patients across more countries.

According to Towards Healthcare, the global cell and gene therapy market reached USD 8.94 billion in 2025 and is estimated to reach USD 10.44 billion in 2026, with projections of USD 47.18 billion by 2035, representing an 18.1% CAGR. Towards Healthcare also estimates that more than 2,200 companies are active in cell and gene therapy, with 40+ commercially approved therapies, 2,600+ active clinical trials, 500+ production facilities, and research activity across 50+ countries.

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This expansion is creating a race to improve access not only through new therapies, but through manufacturing capacity, treatment centers, cold-chain logistics, clinical infrastructure, and regional partnerships.

Which Companies Are Leading the Expansion?

Based on Towards Healthcare’s 2026 cell and gene therapy analysis, important companies expanding the cell-therapy ecosystem include:

• Gilead Sciences / Kite Pharma
• Bristol Myers Squibb
• Johnson & Johnson / Legend Biotech
• Novartis
• Autolus Therapeutics
• Lonza
• Thermo Fisher Scientific
• Catalent
• WuXi AppTec
• FUJIFILM Diosynth Biotechnologies
• Miltenyi Biotec
• Charles River Laboratories

Their contributions are different. Some develop and commercialize therapies, while others provide the manufacturing, testing, logistics, and infrastructure needed to deliver those therapies globally.

1. Gilead Sciences / Kite: Expanding CAR-T Access

Gilead Sciences, through Kite, is one of the most important companies in commercial CAR-T therapy.

Kite’s portfolio includes Yescarta and Tecartus, and Towards Healthcare identifies Gilead/Kite as the CD19 franchise leader in the global CAR-T landscape.

The company’s contribution to access goes beyond drug development.

Towards Healthcare reports that Gilead/Kite had added more than 40 authorized treatment centers globally, demonstrating how expanding the treatment-center network can be just as important as developing the therapy itself.

This is critical because CAR-T is a living-cell therapy. Patients need specialized centers capable of collecting cells, administering treatment, and managing potential complications.

2. Bristol Myers Squibb: Expanding the BCMA CAR-T Ecosystem

Bristol Myers Squibb (BMS) is another major company helping expand cell-therapy access through Abecma, its BCMA-directed CAR-T therapy.

The FDA’s current approved cellular and gene therapy list identifies Abecma (idecabtagene vicleucel) as a product manufactured by Celgene Corporation, a Bristol Myers Squibb company.

BMS’s role is particularly important in multiple myeloma, where BCMA-directed CAR-T has become an important treatment approach.

Towards Healthcare identifies BMS among the leading companies in the global CAR-T landscape.

3. Johnson & Johnson / Legend Biotech: Scaling CARVYKTI

Johnson & Johnson and Legend Biotech are expanding access through CARVYKTI (ciltacabtagene autoleucel), another BCMA-directed CAR-T therapy.

Towards Healthcare identifies the partnership as one of the major global CAR-T franchises.

The importance of this partnership is that increasing patient access requires more than regulatory approval.

It requires:

Manufacturing capacity → Cell collection → Quality testing → Logistics → Treatment centers → Patient monitoring

The development of this infrastructure is becoming a central competitive factor in cell therapy.

4. Novartis: One of the Early CAR-T Leaders

Novartis was among the earliest companies to commercialize CAR-T therapy through Kymriah (tisagenlecleucel).

The FDA’s approved-products database lists Kymriah among licensed cellular and gene therapy products, with Novartis Pharmaceuticals Corporation identified as the manufacturer.

Towards Healthcare identifies Novartis as one of the leading companies in the global cell and gene therapy landscape, with expertise spanning CAR-T and gene therapy.

The company’s experience is particularly valuable because commercializing cell therapy requires building infrastructure around a highly complex treatment process.

Government Data Shows the Expansion of Cell Therapy

The U.S. FDA’s approved cellular and gene therapy database now includes a growing list of products from companies such as Bristol Myers Squibb, Novartis, Gilead/Kite, Johnson & Johnson, Autolus, Iovance Biotherapeutics, Vertex, Pfizer, Mesoblast, Adaptimmune, Abeona Therapeutics, and others.

This is an important indicator of how the field is moving from experimental research toward regulated clinical use.

The FDA’s 2025 records also show approvals for newer cellular and regenerative therapies, including:

• Zevaskyn – Abeona Therapeutics
• Aucatzyl – Autolus
• Tecelra – Adaptimmune
• Symvess – Humacyte
• Omisirge – Gamida Cell
• Waskyra – Fondazione Telethon

The expanding list means that the access challenge is changing.

It is no longer simply:

“Can we develop a cell therapy?”

It is increasingly:

“Can we deliver this therapy safely and efficiently to more eligible patients?”

5. Lonza: Building the Manufacturing Infrastructure

Lonza plays a different but critical role.

Rather than primarily commercializing patient therapies, Lonza provides development and manufacturing infrastructure for cell and gene therapy developers.

Towards Healthcare identifies Lonza as a major player in cell and gene therapy services and describes capabilities covering viral and non-viral vector manufacturing, autologous and allogeneic cell therapy, iPSC, TIL, and NK-cell programs.

This makes CDMOs important to global access.

A biotech company may have a promising therapy but lack the infrastructure required to manufacture it at clinical or commercial scale.

A specialized CDMO can help bridge that gap.

6. Thermo Fisher Scientific: Connecting Development to Global Supply

Thermo Fisher Scientific also plays a major infrastructure role.

Towards Healthcare reports that Thermo Fisher supports cell and gene therapy developers through 15 global sites offering development, manufacturing, and supply-chain services.

That global footprint is important because cell therapies often have highly sensitive supply chains.

A typical autologous cell-therapy process can involve:

Patient → Cell collection → Transportation → Manufacturing → Quality testing → Return shipment → Treatment center → Patient

Every handoff matters.

7. Catalent: Supporting Gene-to-Patient Manufacturing

Catalent is another company contributing to cell-therapy access through manufacturing and supply-chain services.

Towards Healthcare describes Catalent Cell & Gene Therapy as providing integrated gene-to-patient solutions for cell-therapy development and manufacturing.

This model is important because reducing the number of disconnected suppliers can potentially simplify the manufacturing chain.

For cell therapies, that can translate into better coordination between:

Development + Manufacturing + Quality + Logistics + Patient delivery

8. WuXi AppTec: Supporting Global Development

WuXi AppTec / WuXi Advanced Therapies is another major participant in the infrastructure ecosystem.

Towards Healthcare describes its capabilities across discovery, development, testing, manufacturing, and commercialization of cell and gene therapies.

Its role illustrates how global access increasingly depends on companies that can support therapies across multiple stages rather than simply manufacturing one component.

9. Miltenyi Biotec: Supporting Cell Processing

Miltenyi Biotec contributes through technologies and services used in cell processing and cell-therapy development.

Towards Healthcare highlights the company’s collaboration with India’s Translational Health Science and Technology Institute (THSTI) to address demand for cell and gene therapies for conditions including cancer and sickle cell disease.

This is particularly relevant to global access because regional partnerships can help build capabilities outside the traditional U.S. and European centers.

Global Cell-Therapy Research Is Expanding

A 2025 analysis of global cell-therapy clinical research identified 10,373 cell-therapy clinical trials worldwide.

The largest concentrations were:

• United States — 3,563 trials
• China — 3,365 trials
• Europe — 1,584 trials

Oncology represented 56.1% of global cell-therapy trials, while immune-system diseases represented 9.3%.

This geographic distribution is important.

Cell-therapy development is no longer concentrated in one country.

The U.S., China, Europe, and emerging markets are increasingly developing research, manufacturing, and clinical infrastructure.

CAR-T Is Still a Major Driver

The growth of CAR-T therapy is particularly significant.

A 2025 global analysis identified 1,908 CAR-T clinical trials, with China accounting for 1,006 and the United States accounting for 549. Together, those two countries represented more than 80% of the identified trials.

This shows that China is becoming an increasingly important contributor to the global cell-therapy ecosystem.

Towards Healthcare similarly highlights several Chinese companies—including JW Therapeutics, IASO Bio, CARsgen Therapeutics, Hrain Biotechnology, and Juventas Cell Therapy—as important participants in next-generation CAR-T development.

Europe Is Expanding Treatment Capacity Too

The European Blood and Marrow Transplantation (EBMT) activity report provides another important real-world indicator.

In 2024, EBMT centers reported:

• 47,204 hematopoietic cell transplants
• 43,791 patients
• 688 centers
• 53 countries
• 6,082 CAR-T patients

CAR-T treatment increased 24.5% from 2023, surpassing 20,000 patients treated since 2018.

These numbers show that cell therapy access is increasingly being supported by a distributed network of treatment centers.

Government Programs Are Also Supporting Access

The U.S. government is actively working on access models for cell and gene therapies.

Towards Healthcare reports that in July 2025, CMS announced that 33 states, the District of Columbia, and Puerto Rico would participate in the Cell and Gene Therapy (CGT) Access Model.

This is significant because the barriers to cell-therapy access are not only scientific.

They also include:

Reimbursement → Treatment-center availability → Patient referrals → Manufacturing capacity → Logistics

Government programs that address these barriers can therefore accelerate adoption.

Gilead/Kite vs. Novartis: Two Commercial Cell-Therapy Leaders

Gilead/Kite has built a major position around CD19 CAR-T therapies and continues expanding its treatment-center network.

Novartis has one of the industry’s earliest commercial CAR-T products through Kymriah and has also developed a broader cell and gene therapy portfolio.

In simple terms:

Gilead/Kite → Commercial CAR-T scale + treatment-center expansion

Novartis → Early CAR-T leadership + broader gene/cell therapy portfolio

Both demonstrate that commercialization requires much more than regulatory approval.

Lonza vs. Thermo Fisher: The Infrastructure Perspective

Lonza is particularly strong as a specialized CDMO supporting complex cell and gene therapy manufacturing.

Thermo Fisher Scientific combines manufacturing capabilities with a broader life-science ecosystem and global supply infrastructure.

For biotech companies, the choice may depend on:

• Therapy modality
• Development stage
• Manufacturing scale
• Geographic requirements
• Supply-chain complexity
• Need for integrated services

What Do Buyers Need to Expand Cell-Therapy Access?

For pharmaceutical companies, biotech developers, hospitals, and healthcare systems, several capabilities are becoming essential.

Manufacturing Capacity

Cell therapies require specialized manufacturing environments and highly controlled processes.

Treatment-Center Networks

Patients need access to appropriately trained healthcare teams and qualified treatment facilities.

Cold-Chain Logistics

Many therapies require carefully controlled transportation and storage.

Patient Identification

Eligible patients must be identified and referred quickly enough to fit treatment timelines.

Reimbursement

High-cost advanced therapies require sustainable payment and reimbursement models.

Regional Manufacturing

Localized or decentralized manufacturing could reduce transportation complexity and improve access in certain settings.

Digital Tracking

Chain-of-identity and chain-of-custody systems are critical for personalized cell therapies.

The Future: From Centralized Manufacturing to More Flexible Models

One of the biggest trends identified by Towards Healthcare is the move toward decentralized and point-of-care manufacturing models.

Towards Healthcare notes that commercial manufacturing is projected to be a rapidly expanding area and highlights decentralized manufacturing as a way to potentially improve patient access and reduce risks associated with complex logistics and cold-chain management.

This could eventually change the traditional model:

Today:
Patient → Central manufacturing facility → Long-distance logistics → Treatment center

Potential future:
Patient → Regional manufacturing → Local treatment center

The second model could be particularly valuable for countries where access to centralized cell-therapy manufacturing is limited.

Towards Healthcare’s View

According to Towards Healthcare, the cell and gene therapy ecosystem now includes 2,200+ companies, 500+ production facilities, and research activity across 50+ countries.

The company-level landscape is also concentrated: the top 10 companies account for approximately 67% of cell and gene therapy revenue, despite thousands of companies participating in the broader ecosystem.

This creates a fascinating competitive structure:

A small group of commercial leaders + a large ecosystem of biotech innovators + specialized CDMOs + CROs + logistics companies + treatment centers

Towards Healthcare’s analysis suggests that future access will depend increasingly on how effectively these groups work together.

Insights from Payal Rabde – bringing a strategic perspective to evolving healthcare trends and developments.

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