Plasma Cell Leukemia - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Plasma cell leukemia (PCL) is a rare and aggressive form of multiple myeloma, characterized by a high number of plasma cells in the peripheral blood. According to the World Health Organization (WHO) and the International Myeloma Working Group (IMWG), PCL is defined by the presence of 20% or more plasma cells in peripheral blood or an absolute plasma cell count exceeding 2 X 10⁹/L.
• Approximately 60-70% of reported cases are classified as primary PCL (pPCL), which occurs de novo, while nearly 30-40% are secondary PCL (sPCL), which evolves from previously diagnosed multiple myeloma.
• In recent years, the incidence of secondary PCL has been increasing, likely due to improved survival outcomes and clonal selection resulting from more effective therapies.
• Currently, treatment options for PCL are limited and include chemotherapy, immunomodulatory agents, and stem cell transplantation. These approaches often show limited efficacy in PCL, underscoring the urgent need for novel therapies. The narrow treatment landscape also presents opportunities for innovative drug development in this area.
• The drug development pipeline for PCL remains sparse, with CARsgen Therapeutics standing out as a key player.
• In December 2024, CARsgen's investigational CAR-T therapy, CT071, received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma and relapsed/refractory primary PCL.
• Subsequently, in April 2025, CARsgen initiated a Phase I/II clinical trial to evaluate CT071 in patients with relapsed or refractory multiple myeloma or relapsed/refractory PCL.
• With few available treatment options and growing demand for effective therapies, developments like CT071 represent a promising direction for addressing the critical unmet needs in PCL.

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

PCL 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 PCL market size from 2020 to 2034 in 7MM. The report also covers current PCL 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

Plasma Cell Leukemia (PCL) Understanding and Treatment Algorithm

Plasma Cell Leukemia (PCL) Overview

PCL, also known as plasma cell myeloma, is a rare type of cancer characterized by unusually high levels of abnormal plasma cells in the blood. PCL is similar to myeloma in the way it affects the plasma cells that are normally found in the bone marrow and form part of the immune system. In both myeloma and PCL, the plasma cells become abnormal and multiply out of control.

Plasma Cell Leukemia (PCL) Diagnosis

Diagnosis of PCL requires more than 2000 circulating plasma cells per milliliter of peripheral blood and/or several plasma cells representing more than 20% of total white blood cells in the peripheral blood. The diagnosis of primary PCL may be suggested by the presenting signs and symptoms, which have a more rapid onset than in multiple myeloma, with a greater tendency of symptoms of increased metabolic rate, such as fevers, sweating, weight loss, and fatigue. In addition, organ involvement, hypercalcemia, and renal involvement are common in primary PCL. Leukemic plasma cells are regularly found in the liver, spleen, and spinal fluid in patients with PCL. In addition, central nervous system involvement is associated with high-risk chromosome abnormalities, which are also seen more frequently in primary PCL than with multiple myeloma. To confirm the diagnosis of a patient with suspected PCL, peripheral blood smear, blood laboratory tests (complete blood count with differential, electrolyte levels, creatinine, liver enzymes, bilirubin, alkaline phosphatase, lactate dehydrogenase, uric acid, B2 microglobulin, bone marrow aspiration and biopsy, serum protein electrophoresis with immunofixation, and Magnetic Resonance Imaging (MRI) scan and cerebrospinal fluid examination in patients with neurological symptoms can be performed.

Plasma Cell Leukemia Treatment

The ideal outcome of treatment for patients with PCL is achieving complete remission. People with PCL are treated with some of the same therapies that doctors use to treat multiple myeloma. However, the treatment regimens may be more aggressive because PCL is a more severe, faster-growing cancer. Additionally, people who previously had multiple myeloma before developing PCL have usually already gone through treatment. Their leukemia cells might be refractory (resistant) to these myeloma treatments. People with refractory PCL may need to switch to other therapies. The treatment often involves a combination of intensive chemotherapy, immunomodulatory drugs, and proteasome inhibitors, followed by stem cell transplantation for eligible patients. Maintenance therapy with certain drugs may also be used.

VELCADE (bortezomib)

It is a proteasome inhibitor that is used as a first-line treatment for newly diagnosed multiple myeloma patients and the treatment of relapsed/refractory multiple myeloma and Mantle Cell Lymphoma (MCL). A recent retrospective study of new drugs with primary PCL also showed that drug combinations that included bortezomib showed efficacy, decreased the rate of early mortality, and also achieved an overall survival of 18 months.

Immunomodulators

Results with immunomodulators such as lenalidomide or thalidomide for the treatment of PCL have been mixed. In a prospective study of newly diagnosed primary PCL patients, lenalidomide combined with dexamethasone resulted in an overall survival rate of 63% after a median follow-up of 15 months.

Autologous Stem Cell Transplantation (ASCT)

In an ASCT, the patient's healthy stem cells are collected from the bone marrow before they receive the high-dose chemotherapy. Following the chemotherapy treatment to kill the cancerous plasma cells, the healthy stem cells are transplanted back into the patient. This prevents the stem cells from being damaged by the high-dose chemotherapy.

Allogeneic Stem Cell Transplantation (SCT)

In an allogeneic SCT, healthy stem cells from a matching donor, who must at least be a partial match, are transplanted into the patient. A sibling, parent, or child is likely to be a good match. Donors who are not related may be found through national bone marrow registries. Allogeneic transplantations are generally considered for younger patients.

Tandem Stem Cell Transplantation

The tandem SCT treatment approach leads to a significant improvement in survival for patients. Results with an allogeneic SCT are poor compared with tandem SCTs because they have a higher mortality rate following relapse. Therefore, an allogeneic SCT should only be performed if options are limited.

Plasma Cell Leukemia (PCL) Epidemiology

The PCL epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total incident cases of PCL, type-specific incident cases of PCL, and total treatable cases of PCL in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• As a rare indication, it is estimated to be 1 per million of the general population diagnosed each year.
• Secondary PCL occurs in one to four out of 100 cases of myeloma and is becoming more common as myeloma patients are living longer.
• The incidence of PCL ranges between 2% and 4% of patients with multiple myeloma.
• 60-70% of PCLs are primary, and the remaining 30-40% are secondary.
• About 1,200 people are diagnosed with PCL each year in the US, which makes up about 0.6% of all multiple myeloma cases.

Plasma Cell Leukemia (PCL) Drug Chapters

Currently, there are no approved drugs, particularly in PCL. However, therapies like bortezomib, carfilzomib, and ixazomib, immunomodulatory drugs (IMiDs) such as lenalidomide and pomalidomide, and targeted therapies like daratumumab, elotuzumab, and isatuximab are used to treat PCL.

Emerging Drugs

CT071: CARsgen Therapeutics

CT071 is a CAR T-cell therapy candidate developed utilizing our proprietary CARcelerate platform, targeting GPRC5D. The CARcelerate platform can shorten the manufacturing time for the CAR T cells to about 30 hours.

In April 2025, CARsgen Therapeutics initiated the Phase I/II trial evaluating participants with relapsed/refractory multiple myeloma or relapsed/refractory PCL.

Drug Class Insights

The emerging landscape of PCL is very scarce. However, the CAR T-cell therapy candidate, CT071, is the highlight of the landscape. The marketed therapies available for the treatment of PCL include has proteasome inhibitor, bortezomib, the most important therapy to treat multiple myeloma and PCL.

Plasma Cell Leukemia (PCL) Market Outlook

The goal of PCL treatment is to lower the number of plasma cells in the blood and bone marrow, ideally achieving complete remission. Because PCL is very aggressive, treatment must begin as soon as possible. Currently, the market holds treatments like induction, stem cell transplant, maintenance therapy, and supportive treatment.

CARsgen Therapeutics is evaluating its lead candidate in the Phase I/II stage of clinical development. The company aims to investigate its products for the treatment of PCL.

Plasma Cell Leukemia (PCL) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034, 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.

Plasma Cell Leukemia (PCL) Activities

The report provides insights into different therapeutic candidates in the 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 PCL 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 Medical/scientific writers, Professors, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as UT Health San Antonio MD Anderson Cancer Center, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or PCL 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, in event-free survival, 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 PCL, 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 elaborate profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the PCL 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 PCL market.

Plasma Cell Leukemia (PCL) Report Insights

• Patient Population
• Therapeutic Approaches
• PCL Pipeline Analysis
• PCL Market Size and Trends
• Existing and future Market Opportunity

Plasma Cell Leukemia (PCL) Report Key Strengths

• Ten-Year Forecast
• 7MM Coverage
• PCL Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Plasma Cell Leukemia (PCL) 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 PCL patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Which combination of treatment approaches will have a significant impact on the PCL drug treatment market size?
• 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 PCL?
• 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 primary PCL?
• Which drug is the major contributor PCL 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 PCL 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 current and 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.