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ºñÈ£ÁöŲ¸²ÇÁÁ¾ Áß¿¡¼­µµ Èñ±ÍÇÏ°í °ø°Ý¼ºÀÌ ³ôÀº ¸ÇƲ¼¼Æ÷¸²ÇÁÁ¾(MCL)Àº º¹ÀâÇÑ »ý¹°ÇÐÀû Ư¡, Àå±â ¿¹Èİ¡ ÁÁÁö ¾ÊÀº Á¡, È¿°úÀûÀÎ Ä¡·á Àü·«ÀÇ Çʿ伺 µîÀ¸·Î ÀÎÇØ Àü ¼¼°è Á¾¾çÇаèÀÇ ÁÖ¸ñÀ» ¹Þ°í ÀÖ½À´Ï´Ù. Àüü ºñÈ£ÁöŲ¸²ÇÁÁ¾ÀÇ ¾à 6-8%¸¦ Â÷ÁöÇÏ´Â MCLÀº ¸²ÇÁÀý '¸ÇƲ ¿µ¿ª'ÀÇ B¼¼Æ÷¿¡¼­ ¹ß»ýÇϸç, t(11;&14) ¿°»öü ÀüÁ¿¡ ÀÇÇÑ »çÀÌŬ¸° D1ÀÇ °ú¹ßÇöÀÌ Æ¯Â¡ÀÔ´Ï´Ù. ´ëºÎºÐÀÇ Àú¾Ç¼º ¸²ÇÁÁ¾°ú ´Þ¸® MCLÀº °ø°ÝÀûÀÎ ÀÓ»ó °æ°ú¸¦ º¸ÀÌ´Â °æ¿ì°¡ ¸¹À¸¸ç, Ãʱâ Ä¡·á ÈÄ¿¡µµ Àç¹ßÀ» ¹Ýº¹ÇÏ¸ç ºü¸£°Ô ÁøÇàµË´Ï´Ù. ÀÌ ¶§¹®¿¡ MCLÀº ¿¬±¸¿Í Ä¡·á¹ý Çõ½Å¿¡ ÀÖ¾î ¿ì¼±¼øÀ§°¡ ³ôÀº ÁúȯÀ¸·Î °£Áֵǰí ÀÖ½À´Ï´Ù. ±âÁ¸ÀÇ È­Çпä¹ýÀ̳ª Áٱ⼼Æ÷ À̽ÄÀº °üÇØÀÇ Áö¼Ó¼º¿¡ ÇѰ谡 Àֱ⠶§¹®¿¡ ÀÓ»óÀÇ¿Í ¿¬±¸ÀÚµéÀº Á¶±â ¹ß°ß Àü·«°ú Ç¥Àû Ä¡·á¹ý °³¹ß¿¡ Á¡Á¡ ´õ ¸¹Àº ³ë·ÂÀ» ±â¿ïÀ̰í ÀÖ½À´Ï´Ù. ¶ÇÇÑ, ÀÌ ÁúȯÀÇ ºÒ±ÕÀϼº°ú ȯÀÚ °£ Ä¡·á È¿°úÀÇ ÆíÂ÷´Â ¸ÂÃãÇü ÀÇ·á¿Í ¹ÙÀÌ¿À¸¶Ä¿ ±â¹Ý Á¢±Ù¹ýÀÇ Á߿伺À» °­Á¶Çϰí ÀÖ½À´Ï´Ù. ¶ÇÇÑ, Ç÷¾× Àü¹®ÀÇÀÇ ÀνÄÀÌ ³ô¾ÆÁö°í, Áø´Ü µµ±¸°¡ °³¼±µÇ°í, ºÐÀÚ ÇÁ·ÎÆÄÀϸµ¿¡ ´ëÇÑ Á¢±Ù¼ºÀÌ ³ô¾ÆÁü¿¡ µû¶ó º¸´Ù Á¤È®ÇÑ ºÐ·ù¿Í Àû½Ã °³ÀÔÀÌ °¡´ÉÇØÁ³½À´Ï´Ù. Àü ¼¼°è ¾Ï ºÎ´ãÀÌ °è¼Ó Áõ°¡Çϰí Á¤¹Ð Á¾¾çÇÐÀÇ Á¢±Ù¼ºÀÌ ³ô¾ÆÁü¿¡ µû¶ó MCLÀº ´õ ³ªÀº Ä¡·á ÆÐ·¯´ÙÀÓ°ú Àå±âÀûÀÎ °ü¸® ¿É¼ÇÀÌ Àý½ÇÈ÷ ÇÊ¿äÇÑ ÁúȯÀ¸·Î °¢±¤¹Þ°í ÀÖ½À´Ï´Ù.

»õ·Î¿î Ä¡·á¹ý°ú ¾à¹°ÀÇ ½ÂÀÎÀº MCLÀÇ Ä¡·á »óȲÀ» ¾î¶»°Ô º¯È­½Ã۰í Àִ°¡?

Ãֱ٠ǥÀû Ä¡·áÁ¦, ¸é¿ªÄ¡·áÁ¦, Â÷¼¼´ë ÀúºÐÀÚÀÇ µîÀåÀ¸·Î MCLÀÇ Ä¡·á »óȲÀº Å©°Ô º¯È­Çϰí ÀÖ½À´Ï´Ù. Ãʱâ Ä¡·á´Â R-CHOP, hyper-CVAD¿Í °°Àº È­Çпä¹ý º´¿ë¿ä¹ý¿¡ À̾î Àû°Ý ȯÀÚ¿¡°Ô ÀÚ°¡ Áٱ⼼Æ÷ À̽ÄÀ» ½ÃÇàÇÏ´Â °æ¿ì°¡ ¸¹Áö¸¸, »õ·Î¿î ¾à¹°ÀÇ ½ÂÀÎÀ¸·Î Àç¹ß¼º ¶Ç´Â ³­Ä¡¼º ȯÀÚ¿¡°Ô »õ·Î¿î Ä¡·á ¿É¼ÇÀÌ Á¦°øµÇ°í ÀÖ½À´Ï´Ù. À̺ê·çƼ´Õ, ¾ÆÄ«¶óºê·çƼ´Õ, ÀÚ´©ºê·çƼ´Õ µîÀÇ ºê·çÅæÇü Ƽ·Î½Å Ű³ª¾ÆÁ¦(BTK) ¾ïÁ¦Á¦´Â MCL ¼¼Æ÷ÀÇ »ýÁ¸¿¡ Áß¿äÇÑ B¼¼Æ÷ ¼ö¿ëü ½ÅÈ£Àü´Þ °æ·Î¸¦ ¾ïÁ¦ÇÏ´Â ´É·ÂÀ¸·Î 2Â÷ Ä¡·áÀÇ Áß½ÉÀÌ µÇ°í ÀÖ½À´Ï´Ù. ÀÌ·¯ÇÑ °æ±¸¿ë Ä¡·áÁ¦´Â ³ôÀº ¹ÝÀÀ·ü°ú °ü¸® °¡´ÉÇÑ µ¶¼º ÇÁ·ÎÆÄÀÏÀ» º¸À̸ç, Áö¿ª ¹× Çмú ȯ°æ ¸ðµÎ¿¡¼­ Ä¡·á ¾Ë°í¸®Áò¿¡ º¯È­¸¦ °¡Á®¿À°í ÀÖ½À´Ï´Ù. BTK ¾ïÁ¦Á¦ ¿Ü¿¡µµ º£³×ÅäŬ¶ô½º(venetoclax)¿Í °°Àº BCL-2 ¾ïÁ¦Á¦³ª ·¹³¯¸®µµ¸¶À̵å(lenalidomide)¿Í °°Àº ¸é¿ªÁ¶ÀýÁ¦ÀÇ »ç¿ëÀº ´õ ±í°í Áö¼ÓÀûÀÎ °üÇØ¿¡ ±â¿©Çϰí ÀÖ½À´Ï´Ù. ÀÌ ºÐ¾ß¿¡¼­´Â CAR-T ¼¼Æ÷ Ä¡·áµµ À¯¸ÁÇÑ ºÐ¾ß·Î, Àç¹ß¼º ¶Ç´Â ³­Ä¡¼º MCL¿¡ ´ëÇÑ ºê·º½ºÄ«ºÎŸµò ¿ÀÅä·ÎÀ̼¿ÀÇ ½ÂÀÎÀº ¸ÂÃãÇü ¸é¿ªÄ¡·áÀÇ Å« ÀÌÁ¤Ç¥°¡ µÇ¾ú½À´Ï´Ù. ½Ã³ÊÁö È¿°ú¸¦ ³¾ ¼ö ÀÖ´Â ÀÌÁ߯¯À̼ºÇ×ü ¹× º´¿ë¿ä¹ý¿¡ ´ëÇÑ ¿¬±¸µµ ÁøÇà ÁßÀÔ´Ï´Ù. ÀÓ»ó½ÃÇè¿¡¼­ À¯¸ÁÇÑ °á°ú°¡ °è¼Ó ³ª¿À¸é¼­ MCL Ä¡·áÀÇ ÆÐ·¯´ÙÀÓÀÌ È­Çпä¹ý¿¡ ÀÇÁ¸ÇÏ´ø ¹æ½Ä¿¡¼­ º¸´Ù Ç¥ÀûÈ­µÈ ȯÀÚ Áß½ÉÀÇ Á¢±Ù ¹æ½ÄÀ¸·Î ÁøÈ­Çϰí ÀÖ¾î, ¼±ÅÃÀÇ ÆøÀÌ Á¦ÇÑÀûÀ̾ú´ø ȯÀڵ鿡°Ô Èñ¸ÁÀÌ µÇ°í ÀÖ½À´Ï´Ù.

MCLÀÇ °ü¸®¿¡¼­ Áø´Ü, ȯÀÚ °èÃþÈ­, ÀÓ»ó ¸ð´ÏÅ͸µÀº ¾î¶² ¿ªÇÒÀ» Çϴ°¡?

MCLÀº ħ½À¼ºÀÌ °­Çϰí ÀÓ»ó °æ°ú°¡ ´Ù¾çÇϱ⠶§¹®¿¡ Á¤È®Çϰí Àû½Ã¿¡ Áø´ÜÇÏ´Â °ÍÀÌ Áß¿äÇÕ´Ï´Ù. ¸é¿ª Ç¥ÇöÇü ºÐ·ù, ¼¼Æ÷À¯ÀüÇÐÀû ºÐ¼® ¹× ºÐÀÚ ÇÁ·ÎÆÄÀϸµÀº Àǻ簡 MCLÀÇ Áø´ÜÀ» È®Á¤Çϰí Á¶Á÷ÇÐÀû °Ë»ç¿¡¼­ À¯»çÇÏ°Ô º¸ÀÌ´Â ´Ù¸¥ ¾ÆÇü B¼¼Æ÷ ¸²ÇÁÁ¾°ú °¨º°ÇÒ ¼ö ÀÖ´Â Áß¿äÇÑ µµ±¸ÀÔ´Ï´Ù. ¸é¿ªÁ¶Á÷È­ÇÐÀû °Ë»ç¸¦ ÅëÇÑ »çÀÌŬ¸° D1 °ú¹ßÇö °ËÃâ°ú Çü±¤ in situ hybridization(FISH)À» ÅëÇÑ t(11;&14) ÀüÁÂÀÇ È®ÀÎÀº ¿©ÀüÈ÷ Áø´ÜÀÇ Æ¯Â¡ÀÔ´Ï´Ù. Áø´Ü¿¡ ±×Ä¡Áö ¾Ê°í, ¸ÇƲ¼¼Æ÷ ¸²ÇÁÁ¾ International Prognostic Index(MIPI)¿Í °°Àº ¿¹ÈÄ ¿¹Ãø µµ±¸´Â ȯÀÚ¸¦ À§Çè ¹üÁÖ·Î ºÐ·ùÇϰí, Ä¡·á °áÁ¤ÀÇ ÁöħÀÌ µÇ¸ç, Àüü »ýÁ¸±â°£À» ¿¹ÃøÇÏ´Â µ¥ µµ¿òÀÌ µË´Ï´Ù. Â÷¼¼´ë ½ÃÄö½Ì°ú °°Àº °í°¨µµ ±â¼úÀ» ÀÌ¿ëÇÑ ¹Ì¼¼ÀÜÁ¸º´º¯(MRD) ¸ð´ÏÅ͸µÀº ÀÓ»ó Áõ»óÀÌ ³ªÅ¸³ª±â Àü¿¡ Ä¡·á È¿°ú¸¦ Æò°¡Çϰí Àç¹ßÀ» ¿¹ÃøÇϱâ À§ÇÑ ¼ö´ÜÀ¸·Î Ȱ¿ëµÇ°í ÀÖ½À´Ï´Ù. PET-CT °Ë»ç µîÀÇ ¿µ»ó Áø´Ü¹ýÀº º´±â ºÐ·ù¿Í Ä¡·á È¿°ú Æò°¡¿¡ ¿©ÀüÈ÷ ÇʼöÀûÀÔ´Ï´Ù. ¶ÇÇÑ, À¯ÀüÀÚ ÇÁ·ÎÆÄÀϸµÀ» ÅëÇØ MCLÀÇ µ¹¿¬º¯ÀÌ »óȲÀ» ´õ ±íÀÌ ÀÌÇØÇÒ ¼ö ÀÖ°Ô µÇ¾ú°í, ƯÁ¤ Ä¡·áÁ¦¿¡ ´ëÇÑ ³»¼ºÀ» ¿¹ÃøÇÏ´Â ¸¶Ä¿°¡ ¹àÇôÁ® ¸ÂÃãÇü Ä¡·á Àü·«ÀÇ ±æÀÌ ¿­¸®°í ÀÖ½À´Ï´Ù. ÀÌ·¯ÇÑ Áø´Ü ¹× ¸ð´ÏÅ͸µ µµ±¸°¡ ÀÓ»ó Áø·á¿¡ µµÀԵǸé Ä¡·áÀÇ Á¤È®µµ°¡ Çâ»óµÉ »Ó¸¸ ¾Æ´Ï¶ó, Á¶±â °³ÀÔ°ú ¸ÂÃãÇü Ä¡·á Á¶Á¤À» ÅëÇØ ȯÀÚÀÇ ¿¹Èĵµ °³¼±µÉ ¼ö ÀÖ½À´Ï´Ù. ÀÌ·¯ÇÑ Á¤¹Ð Áø´ÜÀ¸·ÎÀÇ ÀüȯÀº MCL ȯÀÚµéÀÌ Áúº´ÀÇ ÀûÀýÇÑ ´Ü°è¿¡¼­ °¡Àå È¿°úÀûÀÎ Ä¡·á¸¦ ¹ÞÀ» ¼ö ÀÖµµ·Ï ÇÏ´Â µ¥ ¸Å¿ì Áß¿äÇÕ´Ï´Ù.

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Global Mantle Cell Lymphoma Market to Reach US$3.7 Billion by 2030

The global market for Mantle Cell Lymphoma estimated at US$2.5 Billion in the year 2024, is expected to reach US$3.7 Billion by 2030, growing at a CAGR of 6.8% over the analysis period 2024-2030. Laboratory Exams Diagnosis, one of the segments analyzed in the report, is expected to record a 8.3% CAGR and reach US$1.9 Billion by the end of the analysis period. Growth in the Imaging Tests Diagnosis segment is estimated at 5.0% CAGR over the analysis period.

The U.S. Market is Estimated at US$668.7 Million While China is Forecast to Grow at 11.0% CAGR

The Mantle Cell Lymphoma market in the U.S. is estimated at US$668.7 Million in the year 2024. China, the world's second largest economy, is forecast to reach a projected market size of US$769.8 Million by the year 2030 trailing a CAGR of 11.0% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 3.3% and 6.7% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 4.5% CAGR.

Global Mantle Cell Lymphoma Market - Key Trends & Drivers Summarized

Why Is Mantle Cell Lymphoma Garnering Increased Clinical and Research Attention in Oncology?

Mantle cell lymphoma (MCL), a rare and aggressive form of non-Hodgkin’s lymphoma, is drawing increasing attention from the global oncology community due to its complex biology, poor long-term prognosis, and the critical need for effective treatment strategies. Representing approximately 6 to 8 percent of all non-Hodgkin lymphoma cases, MCL arises from B-cells in the “mantle zone” of lymph nodes and is characterized by the overexpression of cyclin D1 due to the t(11;14) chromosomal translocation. Unlike many indolent lymphomas, MCL often follows an aggressive clinical course, progressing rapidly with frequent relapses after initial therapy. This has led to MCL being considered a high-priority condition for research and therapeutic innovation. Clinicians and researchers are increasingly focusing on early detection strategies and the development of targeted therapies, as conventional chemotherapy and stem cell transplants offer limited durability in remission. The disease’s heterogeneity and the variation in treatment response among patients also emphasize the importance of personalized medicine and biomarker-led approaches. Additionally, the growing awareness among hematologists, improved diagnostic tools, and increasing access to molecular profiling are contributing to more accurate classifications and timely interventions. As the global cancer burden continues to rise and precision oncology becomes more accessible, MCL is receiving the spotlight it warrants as a disease that urgently requires better treatment paradigms and long-term management options.

How Are Emerging Therapies and Drug Approvals Transforming the Treatment Landscape for MCL?

Recent years have seen a significant transformation in the treatment landscape for mantle cell lymphoma, largely driven by the emergence of targeted therapies, immunotherapies, and next-generation small molecules. While initial treatment often involves combination chemotherapy regimens such as R-CHOP or hyper-CVAD followed by autologous stem cell transplantation in eligible patients, the approval of novel agents is offering new options for relapsed or refractory cases. Bruton's tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib have become central to second-line treatment due to their ability to interfere with B-cell receptor signaling pathways critical to MCL cell survival. These oral therapies have demonstrated high response rates and manageable toxicity profiles, which has shifted treatment algorithms in both community and academic settings. In addition to BTK inhibitors, the incorporation of BCL-2 inhibitors like venetoclax and the use of immunomodulatory drugs such as lenalidomide are contributing to deeper and more durable remissions. The field is also exploring the promise of CAR-T cell therapy, with brexucabtagene autoleucel receiving approval for relapsed or refractory MCL, marking a major milestone in personalized immunotherapy. Research is ongoing into bispecific antibodies and combination regimens that may provide synergistic benefits. As clinical trials continue to yield promising results, the MCL treatment paradigm is evolving from a reliance on chemotherapy toward a more targeted, patient-centric approach, expanding hope for patients who previously had limited options.

What Role Do Diagnostics, Patient Stratification, and Clinical Monitoring Play in Managing MCL?

Accurate and timely diagnosis is critical in the management of mantle cell lymphoma due to its aggressive nature and variable clinical course. Immunophenotyping, cytogenetic analysis, and molecular profiling are key tools that enable physicians to confirm MCL diagnosis and differentiate it from other subtypes of B-cell lymphomas, which may appear similar under histological examination. The detection of cyclin D1 overexpression through immunohistochemistry or the identification of the t(11;14) translocation via fluorescence in situ hybridization (FISH) remains a diagnostic hallmark. Beyond diagnosis, prognostic tools such as the Mantle Cell Lymphoma International Prognostic Index (MIPI) help stratify patients into risk categories, guiding treatment decisions and predicting overall survival. Minimal residual disease (MRD) monitoring using highly sensitive techniques like next-generation sequencing is increasingly being adopted to assess treatment efficacy and anticipate relapse before clinical symptoms emerge. Imaging modalities such as PET-CT scans remain essential for staging and evaluating treatment response. Furthermore, genetic profiling is allowing for deeper insights into the mutational landscape of MCL, revealing markers that may predict resistance to specific therapies and opening avenues for personalized treatment strategies. As these diagnostic and monitoring tools become more integrated into clinical practice, they are not only improving treatment precision but also enhancing patient outcomes through early intervention and tailored therapy adjustments. This shift toward precision diagnostics is crucial in ensuring that patients with MCL receive the most effective therapies at the right stage of their disease.

What Factors Are Driving Growth in the Global Mantle Cell Lymphoma Market?

The growth in the global mantle cell lymphoma market is driven by a confluence of factors including rising disease awareness, increasing incidence of hematologic malignancies, the emergence of targeted therapies, and expanding healthcare access. The growing burden of cancer globally and improvements in diagnostic accuracy have contributed to a rise in identified MCL cases, particularly in aging populations where the disease is more prevalent. Pharmaceutical innovation is a key driver, as biopharmaceutical companies invest heavily in the development of BTK inhibitors, BCL-2 antagonists, and cellular therapies that offer new hope for patients. Regulatory agencies such as the FDA and EMA are expediting the approval process for breakthrough treatments through fast-track and orphan drug designations, accelerating market entry for novel drugs. The success of targeted therapies and immunotherapies in clinical trials is also encouraging more investment and pipeline expansion from both established players and emerging biotech firms. Additionally, the expansion of clinical infrastructure and cancer care centers in emerging markets is increasing access to advanced treatments and diagnostics, further fueling demand. Growing acceptance of precision medicine and companion diagnostics is also enabling more personalized treatment regimens, increasing the value of each patient encounter and enhancing long-term disease management. Favorable reimbursement policies and expanded insurance coverage in key markets are making high-cost therapies more accessible, thereby driving revenue growth. Together, these factors are creating a dynamic and rapidly evolving market for mantle cell lymphoma treatment, positioning it as a significant focus area in the broader oncology therapeutics sector.

SCOPE OF STUDY:

The report analyzes the Mantle Cell Lymphoma market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:

Diagnosis Type (Laboratory Exams Diagnosis, Imaging Tests Diagnosis, Bone Marrow Biopsy, Other Diagnosis Types); Treatment (Diagnosis Treatment, Therapy Treatment); End-Use (Hospitals & Clinics End-Use, Ambulatory Surgery Centers End-Use, Other End-Uses)

Geographic Regions/Countries:

World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

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TABLE OF CONTENTS

I. METHODOLOGY

II. EXECUTIVE SUMMARY

III. MARKET ANALYSIS

IV. COMPETITION

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