PCL 치료의 목적은 혈액과 골수의 형질 세포 수를 줄이고 이상적으로는 완전한 완화를 달성하는 것입니다. PCL은 매우 진행이 빠르기 때문에 치료는 가능한 한 빨리 시작해야합니다. 현재 시장에는 도입 요법, 줄기 세포 이식, 유지 요법, 지지 요법 등의 치료법이 있습니다.
CARsgen Therapeutics는 I/II 임상 개발 단계에서 주력 후보 약물을 평가 중입니다. 이 회사는 자사 제품을 PCL 치료제로 조사하는 것을 목표로합니다.
본 보고서는 형질세포 백혈병(PCL)의 주요 7개 시장(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본)에 대해 조사 분석하여 각국 시장 규모, 역학 데이터, 각 치료법 시장 점유율, 신치료법, 암멧 필요 등의 정보를 제공합니다.
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.
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.
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.
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.
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.