Market Overview

The global CAR T-Cell Therapy Market is projected to reach more than USD 22.2 billion by 2032 from USD 2.1 billion in 2023, growing at a CAGR of 30% from 2024-2032.

The global CAR T-Cell Therapy Market is experiencing extraordinary demand, fueled by revolutionary results in treating certain blood cancers. As of 2022, the more than 487,294 people were diagnosed with leukemia around the world. The boom was caused by three things: increasing cancer rates, CAR-T’s clinical success (it cures 80% of some leukemias), and the hundreds of CAR-T clinical trials being run around the world. CAR-T therapies have had the most success so far targeting B-cell CD19 antigens (which is why Kymriah and Yescarta exist). But researchers are hunting down a range of other antigens in a wide variety of cancers. In addition, they’re also looking at how to treat solid tumors with CAR-T cells. There are still many hurdles to overcome. The cost — over $450,000 per treatment — limits accessibility, as does the complexity of their manufacture. Severe side effects like cytokine release syndrome (CRS) and neurotoxicity are also acting as a solid barrier for the market growth.

On the other hand, Allogenic CAR-T drugs promise to streamline treatment by discarding the patient-specific approach in the global CAR T-Cell Therapy Market; combining them with checkpoint inhibitors may let doctors fight solid tumors; and researchers are already building on this platform to develop treatments for conditions beyond cancer, like autoimmune illnesses or even HIV. Kymriah, Yescarta, Tecartus and Breyanzi are some of the key drugs that work against specific blood cancers; Abecma and Carvykti do the same against multiple myeloma. Glioblastomas have been particularly difficult targets for all drugmakers, not just those working on CAR-T cures. 

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Market Dynamics

Driver

Increasing Adoption of Combinational Approaches

The demand for CAR T-Cell Therapy Market is driven primarily by the increasing adoption of combinational approaches. The CAR-T therapy strategy has many hurdles to leap over like tumor resistance, limited cell function, and solid tumors being complex. Combining other treatments with CAR-T helps to tackle cancer from multiple angles, enhance the engineered immune cell’s effectiveness, and manage side effects.

Here are some examples of promising combination therapies in the CAR T-Cell Therapy Market. Today, oncologist are combining CAR-T cells with various checkpoint inhibitors (pembrolizumab or nivolumab) to fully unlock their anti-cancer activity. BiTEs as a bridge between the CAR-T cells and additional immune cells increase your chances of killing a tumor. Cytokines like interleukin-2 (IL-2) boosts persistence in a CAR-T cell. Oncolytic viruses strategically infecting and destroying cancer cells attract other healthy cells towards it and primes the immune response. Lastly, targeted therapies disrupt specific cancer pathways to work synergistically with a CAR-T.

With over 65% of ongoing clinical trials involving some kind of combination approach in place, these therapies have massive potential to provide effective outcome. For instance, studies show positive outcomes when combining CAR-T with checkpoint inhibitors for lymphomas and solid tumors and there are synergistic effects when combining them for cytokine therapy. BiTEs might be the key to unlocking solid tumor outcomes. Preclinical studies suggest oncolytic viruses can also improve CAR-T cell function.

Restraint

High Pricing of CAR-T Therapies and Reimbursement Challenges

The extraordinary potential of CAR T-Cell Therapy Market is undeniably hampered by its exorbitant cost. Treatments can range from $500,000 to upwards of $1 million per patient, creating a massive financial barrier. Treatments can range from $500,000 to over $1 million per patient — a financial obstacle. Although reimbursement policies like the Centers for Medicare & Medicaid Services (CMS) MS-DRG 018 in the US offer some coverage, but there are major out-of-pocket costs that make treatment inaccessible. Without patients, this market doesn't stand a chance of taking off. Another struggle lies in maintaining cell viability as treatments move forward. This discrepancy between collection and infusion impacts both cost and success rates on a larger scale. In reality, it's no secret that CAR-T therapies often act as a last resort for people who have already tried everything else. Typically, these patients face relapse after conventional haematological cancer treatments don’t work. Their effectiveness further emphasizes just how invaluable they are as an option for saving lives — even if they do come at such an immense cost.

With each year, progress is being made toward combining multiple approaches to improve efficacy while addressing struggles such as accessibility and affordability so that more patients can benefit from them. The idea behind combining CAR-T with checkpoint inhibitors in the CAR T-Cell Therapy Market, BiTEs, cytokines, oncolytic viruses and targeted therapies is that doing so will not only reduce risks of relapse but theoretically also cut down on treatment cycles needed — which would be much cheaper long term. Plus, innovations like allogeneic "off-the-shelf" CAR-T cells could streamline manufacturing and the overall treatment process thereby cutting down costs associated with personalized CAR-T therapies and allowing more people access to them in general.

Trend

Beyond CD19: The Quest for New CAR-T Targets to Conquer More Cancers

CAR-T therapy's success in treating a specific cancer antigen has been hailed as a medical breakthrough. With their sights set on improving the groundbreaking treatment, scientists in the CAR T-Cell Therapy Market are hustling to find more targets. The goal is to expand CAR-T’s reach into a broader spectrum of hematological malignancies and challenging solid tumors. To effectively treat cancer, researchers need to discover antigens that are present on cancer cells and not on healthy ones, or at least hardly expressed on them. Without these antigen profiles, treatments could inadvertently damage patients' bodies even more. That is why scientists are considering several potentially safe antigens like BCMA for multiple myeloma and CD22 for other B-cell lymphomas. Early clinical testing on some of these targets have garnered positive results with drugs like Abecma already receiving FDA approval.

Solid tumors require additional work due to their complexity and skill of suppressing immune responses. However, they also come with the biggest rewards if successfully targeted by CAR-T cells — the potential for broad patient applicability. Some of the antigens being researched across the global CAR T-Cell Therapy Market include mesothelin (found in mesothelioma and pancreatic cancer), GD2 (neuroblastoma) and HER2 (breast cancer). It will be difficult to overcome the challenges solid tumors pose but doing so would mean many more patients could benefit from CAR-T therapy. In addition to targeting multiple cancers at once, researchers are testing dual-targeting CAR-T cells that can attack two different antigens simultaneously. Should tumor cells lose one antigen, this double attack would ensure their demise. This strategy could prove especially useful against tumor heterogeneity often seen in solid cancers that have various subgroups within them.

Segmental Analysis

The global CAR T-Cell Therapy Market is segmented by indication, source, type of therapy, product, and administration setting. 

By Indication

By indication, the CAR T-Cell Therapy Market is segmented into leukemia, lymphoma, and myeloma. Wherein, hematological cancers account for ~9% of all new cancer cases in the US. Lymphoma is estimated to be a major market segment, occupying more than 40% of the market share. The initial success of CAR-T therapies that targeted the CD19 antigen (which is highly expressed on many B-cell lymphomas) was a huge reason they are now being used to treat this type of cancer. These therapies were used for relapsed and refractory B-cell lymphomas and had amazing results, which led to them becoming so widely adopted. Lymphomas also have a more favorable environment for CAR-T therapies than solid tumors usually do. 

Blood cancers are much easier for these cells to access, and their tumor microenvironment tends to be less immunosuppressive too. On top of all that, patients who relapse after chemotherapy or stem cell transplants often don’t respond well to those treatments the second time around. That’s why there’s such a high demand for CAR T-Cell Therapy Market in this field; it’s an alternative that works when other options fail. This has caused clinical trials investigating CAR-T for different lymphoma subtypes to multiply rapidly as well. Kymriah, Yescarta, Tecartus, and Breyanzi are four types of CAR-T therapy that have already been approved by the FDA for specific B-cell lymphomas too — just another thing boosting their popularity and use.

By Type

By type, the CAR T-Cell Therapy Market is bifurcated into autologous and allogenic. Autologous CART is in the lead, having made waves in clinical trials and offering hope for patients with relapsed and refractory B-cell blood cancers. It was the first to show such success, propelling its reputation as a powerful treatment option. The FDA has also approved numerous autologous CAR-T therapies, like Kymriah, Yescarta, Breyanzi, Tecartus, and Abecma. Experts have said years of hard work on this type of therapy has produced extensive clinical data and clear treatment procedures that make it easy for doctors to follow. Furthermore, researchers have built up the necessary infrastructure to manufacture personalized autologous CAR-T therapies. 

However, allogeneic or “off-the-shelf” CAR-T therapies are becoming increasingly popular. They’re known for their faster treatment delivery times, reduced costs compared to autologous options (which are very expensive), and wider patient access. As a result of these potential benefits – along with the complicated manufacturing process associated with personalized cell production – scientists are starting to put more stock into pre-made allogenic therapies.

By Type Of Therapy

Based on type of therapy, the CAR T-Cell Therapy Market is further segmented into monotherapy and combination therapy. Over 80% of CARTs are autologous, with most being used as monotherapy. As a standalone treatment, CAR-T therapy was initially very successful. The promising results targeting CD19 in B-cell cancers prompted its development and regulatory approvals. Most of the currently FDA-approved CAR-T therapies - including Kymriah, Yescarta, and Breyanzi - were designed to be used as monotherapy. This reaffirms the use of CAR-T as a lone treatment option. Furthermore, while investigation into combination therapies is quickening up, managing the potential complications of combining CAR-T with other treatments like checkpoint inhibitors remains at an early stage. Especially since the focus on CAR-T for solid tumors — where combinations may be more important — is still less developed than for blood cancers across the global CAR T-Cell Therapy Market.

For instance, patients with relapsed or refractory B-cell lymphomas often show a significant response to commercial CAR-T monotherapies like Kymriah and Yescarta. In multiple myeloma, BCMA-targeted CAR-T therapies such as Abecma are also predominantly used as monotherapy after other lines of treatment have already been exhausted.

By Administration Setting

By administration setting, the CAR T-Cell Therapy Market is further segmented into inpatient and outpatient settings. CAR-T therapy is primarily an inpatient treatment due to the need for close monitoring and management of potentially serious side effects. The side effects can be serious and life threatening like cytokine release syndrome (CRS) or neurotoxicity. Therefore, staying at the hospital helps make sure they are caught early. It also allows the staff to give immediate medical attention when necessary, such as medication or supportive therapies. Another reason why patients are kept at the hospital is because of all of the professionals who need to be involved in their care. From oncologists to pharmacists, there are many important people needed to ensure safety and effectiveness of treatment. 

Regional Analysis

By region, the CAR T-Cell Therapy Market is divided into the Americas, Europe, Asia Pacific, and the Middle East and Africa. The Americas is segmented into North America and South America. North America is a global leader in the market owing to the presence of developed economies like US and Canada. A high prevalence of hematological cancers followed by the presence of required infrastructure and market players makes the region enjoy highest revenues. 

In the US, CARTs are at the forefront of a transforming cancer treatment. Breakthroughs have propelled CARTs to the center of discussion, offering a beacon of hope for hematological patients. This exploration examines the unique dynamics shaping the US CART market. Regulatory support and adaptive framework can be seen as the backbone of the market in the US. The US regulatory landscape has demonstrated adaptability to the unique challenges posed by cellular therapies. FDA's commitment to expedite the R&D and approval processes for novel CAR-T therapies is a reflective of country’s patient centric approach in the CAR T-Cell Therapy Market. Favorable regulatory support continues to play a pivotal role in shaping the trajectory of the U.S. CAR-T market. 

Strategic collaborations and investments are also seen in the US CAR-T market. These collaborations occur between pharmaceutical companies, biotech firms, and academic institutions. Such partnerships are aimed at accelerating research, optimizing manufacturing processes, and navigating regulatory pathways. These collaborations contribute to a vibrant ecosystem fostering innovation and driving the market forward.

Followed by Americas, Europe is the second largest CAR T-Cell Therapy Market. The presence of major regulated markets and growing support for reimbursement is projected to boost market growth within the region. The region acquires more than 20% of the market share. Within Europe, Western Europe is a major market for CARTs. While Eastern Europe is showing the high growth. 

Asia Pacific is estimated to be the fastest growing region. CARTs are being increasingly launched in Asian economies. Yescarta is the first CART therapy launched in Japan in 2019. Besides countries like China and India can be seen as untapped revenue pockets. In India, government support foreign direct investments (FDIs) and local production through production linked incentive scheme (PLIs). This alongside a presence of large patient pool makes the country lucrative for investments and product launches. Besides, reopening of China after the pandemic is making the regional market attractive.

Currently, the Middle East and Africa holds the least market share owing to marginalized healthcare and CART infusion infrastructure mainly in the African region. GCC countries like Saudi Arabia and United Arab Emirates are seen as growth beacons for the region. 

Key Developments

Oct 2023: ImmunoACT announced that CDSCO has approved NexCAR19 as India’s first CAR-T cell therapy for treating relapsed/refractory B-cell lymphomas and leukemia. Established in 2018, ImmunoACT is incubated at the Indian Institute of Technology (IIT) Bombay under SINE (Society for Innovation and Entrepreneurship).

May 2023: Laurus Labs further invested INR 80 crores in lmmunoACT for an additional stake of 7.24%, making Laurus hold 33.8% of ImmunoACT in total. ImmunoACT has a portfolio of CARTs under development for multiple auto immune diseases and oncology indications. 

Dec 2022: Bristol-Myers Squibb received the Japanese approval for Breyanzi for treating relapsed/ refractory large B-cell lymphoma (LBCL), i.e., regardless of whether autologous hematopoietic stem-cell transplantation (AHSCT) is intended or not. 

Oct 2022: Allogene Therapeutics launched ‘CAR T Together’ initiative with top oncologists. The goal of the initiative is to accelerate the development and recruiting for clinical trials for "off-the-shelf" allogeneic cell therapy trial products.

Oct 2022: J&J and Legend doubled their CART manufacturing investment to USD 500 million amid restricted supply of their Carvykti CART for heavily pretreated multiple myeloma patients with an aim to double the production.

Key Players in Global CAR T-Cell Therapy Market

• Novartis AG
• Bluebird Bio, Inc.
• Cellectis
• Bristol-Myers Squibb
• Merck & Co., Inc.
• Juno Therapeutics, Inc.
• Celyad Oncology
• Celgene Corporation
• Sorrento Therapeutics, Inc.
• Miltenyi Biotech
• Intellia Therapeutics
• Pfizer, Inc.
• Autolus Therapeutics
• Gilead Sciences, Inc. (Kite Pharma Inc.)
• Cartesian Therapeutics, Inc.
• Caribou Biosciences, Inc.
• Other Prominent Players

Market Segmentation Overview

By Indication

• Leukemia
• Lymphoma
• Myeloma

By Source 

• Autologous
• Allogenic

By Type of Therapy

• Monotherapy
• Combination therapy

By Product

• ABECMA
• Breyanzi
• Carvykti
• Kymriah
• Tecartus
• Yescarta

By Administration Setting

• Inpatient
• Outpatient 

By Region

• North America
  • The U.S.
  • Canada
  • Mexico
• Europe
  • Western Europe
    • The UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Western Europe
  • Eastern Europe
    • Poland
    • Russia
    • Rest of Eastern Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia & New Zealand
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
• Middle East & Africa (MEA)
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of MEA
• South America
  • Argentina
  • Brazil
  • Rest of South America