B Cell Chronic Lymphocytic Leukemia - Market Insights, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Chronic Lymphocytic Leukemia (CLL) makes up about one-quarter of all new leukemia cases. The lifetime risk of developing CLL for the average person is around 0.57%, or 1 in 175.
• B-cell CLL accounts for about 95% of all CLL cases and is characterized by cancerous B lymphocytes in the bone marrow and blood.
• According to SEER, an estimated 21,000 new cases of CLL/SLL were reported in the United States in 2024, while approximately 215,200 individuals were living with CLL during the same year.
• Richter syndrome, also known as Richter transformation, is a dangerous complication where CLL transforms into a more aggressive lymphoma. It most commonly transforms into diffuse large B-cell lymphoma, but can also transform into classic Hodgkin lymphoma or an unusual Hodgkin-Reed-Sternberg-like cell morphology. Approximately 2-7% of patients with CLL develop Richter syndrome, with an incidence rate of ~0.5% per year of observation.
• While CLL remains incurable, symptomatic cases are treated with various options, and a pre-treatment assessment is crucial. This assessment should include factors like age, overall health, and specific leukemia cell characteristics (like TP53 abnormalities or unfavorable cytogenetics), as well as whether the patient is treatment-naive or has relapsed.
• CLL treatment has advanced significantly, offering multiple effective options. However, not all patients require immediate therapy. For those with early-stage disease and no signs of progression, a watch-and-wait (active surveillance) approach is often appropriate. Treatment is typically initiated when CLL impacts quality of life, causes complications, or poses a threat to survival.
• IMBRUVICA (Ibrutinib) is the first-line therapy to improve progression-free survival and response to treatment in Relapsed/Refractory (R/R) CLL.
• In June 2025, Nurix Therapeutics announced positive clinical data from the Company's ongoing NX-5948-301 study, a Phase Ia/b clinical trial of bexobrutideg (NX-5948) in patients with R/R B-cell malignancies. The data include findings from the fully enrolled Phase Ia dose escalation study in patients with R/R CLL.
• In March 2024, the US Food and Drug Administration (FDA) granted accelerated approval to BREYANZI (lisocabtagene maraleucel; liso-cel), a CD19-directed Chimeric Antigen Receptor (CAR) T cell therapy, for the treatment of adult patients with R/R CLL/SLL who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. BREYANZI is the first and only CAR T cell therapy approved for this patient population.
• The pipeline of B-CLL is very robust, emerging therapies such as Nemtabrutinib (MK-1026) (Merck), Lisaftoclax (APG-2575) (Ascentage Pharma), Sonrotoclax (BGB-11417) (BeOne Medicines), Bexobrutideg (NX-5948) (Nurix Therapeutics), and others are being developed for safe and efficacious treatments.

DelveInsight's "B-cell Chronic Lymphocytic Leukemia (B-CLL) - Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth analysis of B-CLL epidemiology, market, and clinical development in B-CLL. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the B-CLL market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

The B-CLL market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted B-CLL market size from 2020 to 2034 in 7MM. The report also covers current B-CLL treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

B-cell Chronic Lymphocytic Leukemia (B-CLL) Disease Understanding and Treatment Algorithm

B-CLL Overview

B-CLL is a type of B-cell non-Hodgkin Lymphoma (NHL), and the most common form of leukemia in Western countries, affecting elderly adults (mean age of 67 and 72 years) with a slight male predominance (1.7:1), and characterized by a highly variable clinical presentation that can include asymptomatic disease or non-specific B-symptoms such as unintentional weight loss, severe fatigue, fever (without evidence of infection), and night sweats as well as cervical lymphadenopathy, splenomegaly and frequent infections.

B-CLL Diagnosis

B-CLL is diagnosed primarily by persistent elevation of B lymphocytes in the blood for at least 3 months, confirmed by flow cytometry showing a typical immunophenotype (CD19+, CD5+, CD23+, and clonality for light chains) and by ruling out other causes of lymphocytosis; additional genetic or bone marrow tests are occasionally used for prognosis or to clarify ambiguous cases, but are not routinely required for diagnosis.

B-CLL Cancer Treatment

Not all patients diagnosed with CLL will require treatment because CLL is a heterogeneous disease. Certain patients receiving no treatment have survival rates similar to those of a normal population; current treatment regimens cannot cure CLL except for allogeneic hematopoietic stem cell transplantation (HCT). Randomized control trials between immediate versus delayed treatments found no significant improvement in long-term survival with early treatment initiation.

Targeted therapies-particularly BTK and BCL-2 inhibitors-are now the standard of care for CLL. FDA-approved BTK inhibitors include acalabrutinib, zanubrutinib, and the non-covalent agent pirtobrutinib. Venetoclax, a BCL-2 inhibitor, is also widely used. These agents may be given alone or with anti-CD20 antibodies like obinutuzumab or rituximab.

B-cell Chronic Lymphocytic Leukemia (B-CLL) Cancer Epidemiology

The B-CLL cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total incident cases of B-CLL, gender-specific incident cases of B-CLL, age-specific incident cases of B-CLL, stage-specific incident cases of B-CLL, line-wise treatable cases of B-CLL (first line, second line, and above), and mutation-specific incident cases of B-CLL in the 7MM, covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• In 2024, around 21,000 new cases of CLL/SLL were reported in the US, the highest among the 7MM.
• CLL affects elderly adults (mean age of 67 and 72 years) with a slight male predominance (1.7:1). Additionally, CLL is extremely rare in children.
• According to secondary research, in 2018, the estimated number of new incident cases of CLL in France was 4,674. The male predominance is marked, with 59.3% of CLL cases identified in men (2,770 patients) and 40.7% of cases identified in women (1,904 patients).
• Approximately 20% to 25% of patients at the time of initial diagnosis of CLL are in the earliest clinical stage (stage 0), approximately 25% are in the advanced stages (stages III and IV), and the remaining 50% are in stage I or II.

B-cell Chronic Lymphocytic Leukemia (B-CLL) Drug Chapters

The drug chapter segment of the B-CLL report encloses a detailed analysis of B-CLL's late, mid, and early-stage (Phase III, Phase II, and Phase I) pipeline drugs. It also deep dives into B-CLL's pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

CALQUENCE (acalabrutinib): AstraZeneca

CALQUENCE is a second-generation, selective inhibitor of BTK. CALQUENCE binds covalently to BTK, thereby inhibiting its activity. In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.

• In November 2019, the US FDA approved CALQUENCE for adult patients with CLL/SLL. The US approval was granted under the FDA's Real-Time Oncology Review and newly established Project Orbis Program.
• In June 2025, the European Union approved a fixed-duration regimen of AstraZeneca's CALQUENCE in combination with venetoclax, with or without obinutuzumab, for the treatment of adult patients with previously untreated CLL.

BREYANZI (lisocabtagene maraleucel): Bristol-Myers Squibb

BREYANZI is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. BREYANZI is made from a patient's T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment.

In March 2024, the US FDA granted accelerated approval to BREYANZI for the treatment of adult patients with R/R CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. This indication is approved under accelerated approval based on response rate and duration of response.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Emerging Drugs

Nemtabrutinib (MK-1026): Merck

Nemtabrutinib is an investigational oral, reversible, non-covalent BTK inhibitor, being evaluated for the treatment of certain patients with CLL/SLL. Nemtabrutinib was acquired as part of the acquisition of ArQule.

Merck has initiated the pivotal Phase III randomized BELLWAVE-011 clinical trial (NCT06136559) evaluating nemtabrutinib versus the investigator's choice of ibrutinib or acalabrutinib in patients with previously untreated CLL and SLL.

As per Merck's ASCO Investor Event presentation, published in June 2025, the company anticipates pivotal read-outs for Nemtabrutinib's BELLWAVE-010 (NCT05947851) and BELLWAVE-011 (NCT06136559) by Q4 2029.

Lisaftoclax (APG-2575): Ascentage Pharma

Lisaftoclax is a proprietary, novel, orally administered small-molecule Bcl-2 selective inhibitor developed to treat patients with malignancies by selectively blocking the antiapoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells.

Recently, in July 2025, Ascentage Pharma announced that lisaftoclax has been approved by China's National Medical Products Administration (NMPA) for the treatment of adult patients with CLL/SLL who have previously received at least one systemic therapy, including BTK inhibitors, which makes lisaftoclax the first Bcl-2 inhibitor receiving conditional approval and marketing authorization for the treatment of patients with CLL/SLL in China, and the second Bcl-2 inhibitor approved globally.

Notably, lisaftoclax is an investigational compound and has not been approved by the US FDA.

According to Ascentage Pharma's 2024 annual presentation, published in March 2025, the FDA has cleared the Phase III (GLORA) registrational trial of lisaftoclax in combination with a BTK inhibitor for BTK inhibitor-treated CLL/SLL. Additionally, the company is looking for a Phase III (GLORA-2) registrational trial in combination with acalabrutinib for newly diagnosed CLL/SLL.

B-cell Chronic Lymphocytic Leukemia (B-CLL) Drug Class Insights

BTK Inhibitor

BTK inhibitors work in B-CLL by blocking BTK, a critical enzyme in the B-cell Receptor (BCR) signaling pathway. This pathway normally promotes the survival, proliferation, and migration of CLL cells. BTK inhibitors, such as ibrutinib and acalabrutinib, bind covalently to BTK's active site, preventing its activation and thus interrupting downstream signals that support leukemia cell growth and survival. By inhibiting BTK, these drugs effectively reduce CLL cell proliferation and promote cell death, leading to disease control even in high-risk patients. This targeted blockade also modulates the tumor microenvironment and immune response, contributing to improved patient outcomes.

B-cell Chronic Lymphocytic Leukemia (B-CLL) Market Outlook

CLL remains incurable despite improvements in clinical outcomes from the identification of prognostic markers and the introduction of targeted therapies. Recent studies have identified changes in the epigenome and regulatory landscape between CLL cells and normal B-cells that may serve to better determine disease prognosis and provide targets for therapeutics to selectively target CLL cells. Advances in clinical testing and management of CLL patients using Optical Genome Mapping (OGM) are poised to improve the sensitivity of current testing methods and may lead to therapeutic developments.

Even though the treatment sequence with covalent BTK inhibitor and venetoclax-based therapies, including retreatment approaches, is effective, many patients eventually progress after treatment with both classes of targeted therapy. Prospective clinical data on this "double refractory disease" are very limited. Most of the clinical evidence derives from retrospective studies, and the definitions of clinical resistance to targeted therapies are not consistent, particularly for fixed-duration venetoclax-based therapies. Even though a covalent BTK inhibitor can achieve long-term remissions, many patients develop secondary resistance.

The most common secondary resistance mechanism to covalent BTK inhibitors is BTK C481 mutations. Therefore, novel agents that non-covalently bind to BTK at non-C481 sites have been developed with promising clinical efficacy. Pirtobrutinib (LOXO-305) is a novel oral non-covalent BTK inhibitor, with activity against both wild-type and C481-mutated BTK. Nemtabrutinib (MK-1026, formerly ARQ-531) is another ncBTKi with high potency against both wild-type and C481S-mutated BTK.

Novel BCL2 inhibitors are currently under development, and there are some preliminary data for RR-CLL, although the clinical data among patients who progressed on venetoclax are very limited.

Key players, such as Merck, Ascentage Pharma, BeOne Medicines, Nurix Therapeutics, and others, are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of B-CLL.

Key Updates

• As per news released in June 2025, Nurix Therapeutics' bexobrutideg as monotherapy was well tolerated with no new safety signals observed with longer duration on study or higher doses in patients with R/R CLL/SLL. Additionally, Nurix remains on track to initiate pivotal trials of bexobrutideg in 2025.
• In November 2024, the EMA granted PRIME designation to bexobrutideg for the treatment of adult patients with R/R CLL/SLL after at least two lines of therapy, including a BTK inhibitor and a BCL2 inhibitor. Earlier in January 2024, the US FDA granted Fast Track designation (FTD) to bexobrutideg for the same.

B-cell Chronic Lymphocytic Leukemia (B-CLL) drug uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

B-cell Chronic Lymphocytic Leukemia (B-CLL) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for B-CLL cancer therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Doctor of Philosophy (PhD) Immunology, MD, Medical/scientific writers, Professors, Researchers, and Others.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Louisiana State University HSC, University of Cologne, Center for Integrated Oncology Aachen Bonn Koln Dusseldorf, Cancer Research UK Barts Centre in London, LUNGevity Foundation, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or B-CLL market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT Analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of B-CLL, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the B-CLL market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM B-CLL market.

B-cell Chronic Lymphocytic Leukemia (B-CLL) Report Insights

• Patient Population
• Therapeutic Approaches
• B-CLL Pipeline Analysis
• B-CLL Market Size and Trends
• Existing and future Market Opportunity

B-cell Chronic Lymphocytic Leukemia (B-CLL) Report Key Strengths

• Ten-Years Forecast
• 7MM Coverage
• B-CLL Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

B-cell Chronic Lymphocytic Leukemia (B-CLL) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

• What is the historical and forecasted B-CLL patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of B-CLL?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?
• How many key players are developing therapies for B-CLL?
• Which drug is the major contributor B-CLL market by 2034?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the B-CLL market.
• Insights on patient burden/disease Incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.