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한글목차
주요 하이라이트
다발성 골수종 시장 규모는 2023년 약 213억 달러로 추정되며, 2034년까지 플러스 성장이 예상됩니다. 이는 우발적 사례 증가, 기존 치료제의 적응증 확대 및 초기 라인으로의 침투, CAR-T 세포치료제 및 항BCMA 치료제를 중심으로 한 신규 치료제의 높은 채택률, 풍부한 신흥 파이프라인, 연구개발 활동에 대한 투자 증가에 기인합니다.
2023년에는 미국이 주요 7개국 시장 전체에서 가장 큰 점유율, 즉 약 143억 달러를 차지할 것으로 예상되며, EU 4개국 및 영국이 그 뒤를 이을 것으로 보입니다.
IMiDs (lenalidomide, pomalidomide), anti-CD38 monoclonal antibodies (daratumumab, isatuximab), anti-SLAM7 monoclonal antibody (elotuzumab), new proteasome inhibitors (carfilzomib, ixazomib) 등 다양한 생물학적 제제와 그 병용요법 등 다양한 생물학적 제제들이 다발성 골수종 치료의 큰 발전에도 불구하고, 대부분의 다발성 골수종 환자들에게 1차 치료 후 재발은 여전히 흔한 문제입니다.
DARZALEX는 일선 다발성 골수종 임상시험에서 성공을 거두었으며, 현재 표준 치료제로 간주되고 있습니다. 달자렉스는 유효성과 안전성 측면에서 경쟁사들의 예상을 뛰어넘는 결과를 보여줌으로써 다발성 골수종 시장을 독점할 것으로 기대되고 있습니다.
SARCLISA라는 두 번째 CD38 항체가 다발성 골수종 치료제로 승인되었으며, SARCLISA는 주요 시장에서 빠르게 받아들여지고 있습니다. 그러나 DARZALEX는 SARCLISA에 비해 4년 이상 우위를 점하고 있습니다. 두 단일클론항체 모두 이식적격 및 부적격 환자 모두에서 4제 병용요법에서 서로 경쟁하고 있으며, 두 CD38 항체는 이식 부적격 환자에서도 최종 결전에 임박해 있습니다. CD38-RVd 병용요법에 대한 증거의 물결은 이식적격 환자군을 대상으로 한 연구에서 비롯되었습니다.
2024년 3월, 존슨앤드존슨은 미국 식품의약국(FDA) 종양약물자문위원회(ODAC)가 프로테아좀 억제제 및 IMiD를 포함한 최소 한 가지 이상의 이전 치료를 받고 레날리도미드에 내성을 보이는 재발성/불응성 다발성 골수종(RRMM) 성인 환자의 치료제로 CARVYKTI를 권고했다고 발표했습니다.
CAR T 세포 치료는 FDA의 엄격한 GMP 제조 요건과 다양한 환자군에 대한 치료의 현실적인 적용으로 인해 표준 진료에서 CAR T 세포 치료를 시행하는 것이 어려울 수 있습니다.
본 보고서는 미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인, 영국, 일본의 다발성 골수종, 역사적 역학, 다발성 골수종 시장 동향에 대한 상세한 이해를 제공합니다.
이 보고서는 현재 치료법, 신약, 개별 치료법별 시장 점유율, 2020년에서 2034년까지 주요 7개국 다발성 골수종 시장 규모 현황 및 예측을 제공합니다. 또한, 현재 다발성 골수종 치료법/알고리즘과 미충족 의료 수요도 다루고 있으며, 최적의 기회를 발굴하고 시장 잠재력을 평가했습니다.
다발성 골수종은 클론성 형질세포의 조절되지 않는 증식을 특징으로 하는 악성 질환으로, 장기 기능 장애 및 궁극적으로 사망에 이르는 다양한 합병증을 유발하는 질환입니다. 이 난치성 악성 종양은 골수에 축적된 말단 분화 단클론성 형질세포(PC)에서 발생하며, MM의 작용기전은 특이적인 말단 장기 장애를 나타내는 단클론성 파라단백질의 비정상적인 증가를 특징으로 하는 클론성 형질세포 증식성 질환이라는 것입니다. 감마글로불린혈증의 일부입니다. 최근 몇 년동안 골수종 병태에 변화가 생겨 다발성 골수종 환자의 관리가 크게 개선되었습니다.
다발성 골수종은 종종 검사, 골통, 쇠약감, 고칼슘혈증과 같은 환자의 증상, 의사의 신체 검사에 따라 진단됩니다. 이러한 증상에 따라 주로 혈액 검사, 소변 검사 등 임상 검사를 실시합니다. 이러한 검사 후 생검(골수 흡인, 세침흡인)을 시행합니다. 이러한 검사 외에도 다발성 골수종 진단을 확정하기 위해 몇 가지 검사를 시행합니다. 즉, 형질세포가 어느 정도의 비율로 분열하고 있는지를 나타내는 형질세포 증식, 혈액의 농도를 측정하는 혈청 점도, 심장이 어느 정도 박동하여 혈액을 내보내고 있는지를 확인하는 초음파 검사인 심초음파 검사 등이 있습니다. 진단 후에는 연소형 골수종인지 활동형 골수종인지 확인하는 것도 중요하며, 이에 따라 치료를 시작하게 됩니다.
다발성 골수종 치료는 환자의 증상 유무와 전신 상태에 따라 달라집니다. 대부분의 경우 의사는 환자와 협력하여 최선의 치료 계획을 결정합니다. 치료 목표는 골수종 세포를 제거하고, 종양의 성장을 억제하고, 통증을 조절하고, 환자가 적극적으로 생활할 수 있도록 하는 것입니다. 다발성 골수종을 완치할 수 있는 치료법은 없지만, 많은 환자들이 수년 동안 암을 잘 조절할 수 있습니다. 증상성 골수종 환자의 치료는 질병을 조절하는 치료와 증상 완화, 좋은 영양 상태 유지 등 삶의 질을 개선하기 위한 지지 요법을 포함합니다. 다발성 골수종의 표준 치료는 세 가지 약물을 조합하여 사용하는 경우가 많으며, 이를 삼제 병용요법이라고 부르기도 합니다. 삼제 병용요법이라고 부르기도 합니다. 삼제 병용요법에는 표적치료제, 면역조절제, 코르티코스테로이드가 포함되는 경우가 많습니다.
주요 7개국에서 다발성 골수종 환자 수가 가장 많은 국가는 미국이며, EU 4개국 및 영국이 그 뒤를 이었습니다.
EU 4개국 및 영국 중 2023년 다발성 골수종 환자 수가 가장 많은 국가는 독일, 가장 적은 국가는 스페인이었습니다.
다발성 골수종은 여성에 비해 남성에게 더 많이 발생합니다. 미국에서는 남성의 50% 이상이 다발성 골수종 진단을 받습니다.
새로 다발성 골수종 진단을 받은 환자의 약 절반은 이식 부적격자이며, 이식 적격자의 약 1/3은 이식을 받지 못하고 있습니다. 미국에서는 2023년 다발성 골수종 환자 중 전임상 이식 부적격 환자는 약 2만 3,600명, 이식 적격 환자는 9,200명입니다.
다발성 골수종의 연령별 환자 수는 미국에서는 65세 이상 연령층이 70% 이상으로 가장 많고, 55-64세, 0-54세가 그 뒤를 잇고 있습니다.
시판 중인 약품
CARVYKTI (ciltacabtagene autoleucel): Johnson & Johnson Innovative Medicine
CARVYKTI는 B세포 성숙 항원(BCMA) 지향성 유전자 재조합 자가 T세포 면역요법으로, BCMA를 발현하는 세포를 식별하고 제거하는 키메라 항원 수용체(CAR)를 암호화하는 도입 유전자로 환자의 T세포를 재프로그래밍합니다.2024년 4월,Johnson & Johnson 는 프로테아좀 억제제 및 면역조절제를 포함한 최소 한 가지 이상의 이전 치료를 받고 레날리도미드에 내성을 보이는 RRMM 성인 환자의 치료제로 CARVYKTI(ciltacabtagene autoleucel;&cilta-cel)가 미국 FDA의 승인을 받았다고 발표했습니다. 2022년 2월, 존슨앤드존슨 이노베이티브 메디신은 프로테아좀 억제제, 면역조절제, 항CD38 단일클론항체를 포함한 4회 이상의 전치료를 받은 재발성 또는 불응성 다발성 골수종(RRMM) 성인 환자 치료제로 CARVYKTI(ciltacabtagene autoleucel;;cilta-cel)를 승인받았습니다. ciltacabtagene autoleucel;&cilta-cel)을 미국 FDA가 승인했다고 발표했습니다.
현재 치료 경험이 1-3회인 RRMM을 대상으로 한 CARTITUDE-4 임상 3상, 다발성 골수종 전임상 이식적격자를 대상으로 한 CARTITUDE-6 임상 3상, 조혈모세포 이식이 예정되어 있지 않은 NDMM을 대상으로 한 CARTITUDE-5 임상 3상을 진행 중입니다. 본 제제를 검토하고 있습니다.
TALVEY (talquetamab): Johnson & Johnson Innovative Medicine
TALVEY는 T세포 표면에 발현하는 CD3 수용체 및 G단백질 공액형 수용체 클래스 C 그룹 5 멤버 D(GPRC5D)에 결합하는 이중특이적 T세포 결합 항체로, 다발성 골수종 세포 및 비악성 형질세포, 피부 및 혀의 상피세포 등 정상조직의 표면에서 고도로 발현하는 새로운 다발성 골수종 표적 치료제입니다. TALVEY는 프로테아좀 억제제, 면역조절제, 항CD38 단일클론항체 등 최소 4가지 이상의 이전 치료를 받은 재발성 또는 불응성 다발성 골수종 성인 환자의 치료에 적응증을 갖고 있습니다.
신약
Mezigdomide (CC-92480): Bristol Myers Squibb
Mezigdomide는 셀레브론을 포함한 E3 유비퀴틴 리가제 복합체(CRL4-CRBN E3 유비퀴틴 리가제)의 강력한 조절제이며, 면역조절 작용 및 항악성종양 작용이 기대됩니다. Mezigdomide는 투여 시 셀레브론(CRBN)에 결합하여 유비퀴틴 E3 리가제 활성에 영향을 미치고 특정 기질 단백질을 유비퀴틴화의 표적으로 삼는다. 이는 프로테아좀을 통해 특정 전사 인자의 분해를 유도하고, 그 중 일부는 T 세포에서 전사 억제 인자가 됩니다. 회사는 NDMM과 RRMM을 치료하기 위한 다양한 계열의 임상시험에서 이 약물을 평가하고 있으며, 2023년 1월에는 RRMM 2L+ 환자를 대상으로 CC-92480과 카필조밉 및 덱사메타손 병용요법(480kd)과 카필조밉 및 덱사메타손 병용요법(SUCCESSOR)을 비교하는 임상 3상을 진행할 예정입니다. 병용요법(SUCCESSOR-2) 임상 3상을 개시했습니다. 회사는 2026-2027년 사이에 Mezigdomide가 최초로 승인될 것으로 기대하고 있습니다.
Linvoseltamab (REGN5458): Regeneron
Linvoseltamab은 RRMM 환자를 대상으로 하는 BCMAxCD3 이특이성 항체입니다. 다발성 골수종 세포의 BCMA와 T세포의 CD3 수용체에 결합하여 양자를 연결하여 T세포에 의한 암세포 사멸을 활성화하도록 설계되었습니다. 이 약은 리제네론의 독자적인 '인간 항체 마우스' 기술(VelocImmune)과 '완전장 이중 특이성 항체' 플랫폼(VelociBi)을 통해 천연 인간 항체와 매우 유사하게 설계되었습니다. Linvoseltamab의 임상 개발 프로그램에는 현재 등록 중인 R/R MM 환자를 대상으로 한 임상 3상 확인 시험(LINKER-MM3)이 포함되어 있습니다. 또한, 초기 치료에서 I/II상 시험, 고위험군 스모크형 MM 환자를 대상으로 한 II상 시험, 미결정 단클론성 감마글로불린혈증 환자를 대상으로 한 II상 시험 등 더 빠른 치료 라인 및 병기에서의 추가 시험이 계획 중이거나 진행 중입니다. 이와 별도로, 리제네론의 CD38xCD28 코스티뮬레이티드 리비특이적 제제와 Linvoseltamab을 병용하여 MM을 대상으로 한 임상 1상 시험도 계획되어 있으며, 2024년 2월 미국 FDA는 최소 3회 이상의 이전 치료 후 RRMM이 진행된 성인 환자를 치료하기 위한 Linvoseltamab을 Linvoseltamab의 생물학적 제제 승인 신청(BLA)을 우선 심사 대상으로 접수했다고 발표했습니다. FDA의 결정 목표는 2024년 8월 22일입니다.
기존 다발성 골수종 치료제는 주로 프로테아좀 억제제, 면역조절제, 단클론항체, 핵수출 억제제, CAR-T 세포치료제, 이중 특이성 항체 등이 있습니다. 이 외에도 히스톤 탈아세틸화효소(HDAC) 억제제도 치료 요법에 포함되었으나, 현재 미국 시장에서 철수한 상태입니다.
현재 다발성 골수종 시장에는 프로테아좀 억제제, 면역조절제, 히스톤 탈아세틸화효소(HDAC) 억제제, 단일클론항체, 화학요법, 부신피질 스테로이드, 핵수출 억제제, CAR-T 세포치료제, 이중 특이성 항체 등 다양한 치료옵션이 존재합니다. 수십년동안 다발성 골수종의 표준 치료는 멜파란, 사이클로포스파미드를 중심으로 한 알킬화제와 덱사메타손, 프레드니손과 같은 부신피질스테로이드의 병용요법이었습니다.
본 보고서는 주요 7개국의 다발성 골수종 시장에 대해 조사했으며, 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지 시장 규모 예측, 미충족 의료 수요 등을 조사하여 전해드립니다.
VENCLEXTA (VENETOCLAX): ABBVIE AND ROCHE (GENENTECH)
LINVOSELTAMAB: REGENERON PHARMACEUTICALS
IBERDOMIDE (CC-220): BRISTOL MYERS SQUIBB/CELGENE
CEVOSTAMAB: ROCHE (GENENTECH)
제13장 다발성 골수종 : 주요 7개국 시장 분석
주요 조사 결과
주요 7개국의 다발성 골수종 전체 시장 규모
시장 전망
주요 시장 예측의 전제조건
미국 시장 규모
EU 4개국 및 영국 시장 규모
일본 시장 규모
제14장 미충족 요구
제15장 SWOT 분석
제16장 KOL(Key Opinion Leader)의 견해
제17장 시장 접근과 상환
제18장 부록
제19장 DELVEINSIGHT 서비스 내용
제20장 면책사항
제21장 리서치사에 대해
LSH
영문 목차
영문목차
Key Highlights:
The total market size in the 7MM for multiple myeloma was estimated to be nearly USD 21,300 million in 2023, which is expected to show positive growth by 2034, owing to rise in incident cases, label expansion and penetration of current therapies in earlier lines, high adoption of newer therapies mainly CAR-T cell therapies and anti-BCMA, rich emerging pipeline, and expected increase in investment in the R&D activities
In 2023, the US accounted for the maximum share of the total market in the 7MM, i.e., approximately USD 14,300 million followed by EU4 and the UK.
Despite the significant advancements in multiple myeloma treatment, including various biological drugs and their combinations like IMiDs (lenalidomide, pomalidomide), anti-CD38 monoclonal antibodies (daratumumab, isatuximab), anti-SLAM7 monoclonal antibody (elotuzumab), and new proteasome inhibitors (carfilzomib, ixazomib), relapse after first-line therapy remains a common challenge for most multiple myeloma patients.
In frontline multiple myeloma clinical studies, DARZALEX was successful and is now considered the standard of therapy. DARZALEX has outperformed rivals' expectations regarding effectiveness and safety and is expected to rule the multiple myeloma market.
A second CD38 antibody called SARCLISA has been approved for the treatment of multiple myeloma. SARCLISA continues its rapid acceptance in key markets. But DARZALEX has an advantage over SARCLISA of more than four years. Both monoclonal antibodies are competing against one another in a quadruplet regimen in both transplant-eligible and ineligible settings. The two CD38 antibodies are also close to a final showdown in patients who are not eligible for transplant. This wave of evidences for the CD38-RVd combinations comes from studies in the transplant-eligible group.
In March 2024, Johnson & Johnson announced that the United States Food and Drug Administration (US FDA) Oncologic Drugs Advisory Committee (ODAC) recommended CARVYKTI for the treatment of adult patients with Relapsed/Refractory Multiple Myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an IMiD and who are refractory to lenalidomide
Implementing CAR T-cell therapy in standard practice can be challenging due to the stricter GMP manufacturing requirements mandated by the FDA and the real-world application of the treatment across diverse patient populations.
DelveInsight's "Multiple Myeloma - Market Insight, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of multiple myeloma, historical and forecasted epidemiology as well as multiple myeloma market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The multiple myeloma market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM multiple myeloma market size from 2020 to 2034. The report also covers current multiple myeloma treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Geography Covered:
The United States
EU4 (Germany, France, Italy, and Spain) and the United Kingdom
Japan
Study Period: 2020-2034
Multiple Myeloma Disease Understanding and Treatment Algorithm
Multiple Myeloma Overview
Multiple myeloma is a malignant disorder characterized by uncontrolled proliferation of clonal plasma cells, causing various complications leading to organ dysfunction and eventually death. This incurable malignancy develops from accumulating terminally differentiated monoclonal plasma cells (PC) in the bone marrow. The mechanism of action of MM is that it is a clonal plasma cell proliferative disorder characterized by the unusual increase of monoclonal paraprotein leading to evidence of specific end-organ damage. MM is part of the spectrum of monoclonal gammopathy. Recently, there has been a change in the pathogenesis of myeloma leading to major improvements in managing patients with multiple myeloma.
Multiple Myeloma Diagnosis
Multiple myeloma is often diagnosed based on tests, the patient's symptoms, including bone pain, weakness, hypercalcemia, etc., and the doctor's physical exam. Following these symptoms, lab tests are conducted, mainly blood and urine tests. After these tests, a biopsy (bone marrow aspiration, fine needle aspiration) is conducted. Apart from these tests, a few other tests are also used to confirm the diagnosis of multiple myeloma, namely plasma cell proliferation, which shows what percentage of plasma cells are dividing; serum viscosity which measures the thickness of the blood; echocardiogram, an ultrasound that checks how well the heart is beating and pumping blood. After the diagnosis, it is also important to check whether it is smoldering or active myeloma; depending on this, treatment is initiated.
Multiple Myeloma Treatment
The treatment of multiple myeloma depends on whether the patient is experiencing symptoms and the patient's overall health. Often, doctors work with the patient to determine the best treatment plan. The treatment goals are to eliminate myeloma cells, control tumor growth, control pain, and allow patients to live actively. While there is no cure for multiple myeloma, the cancer can be managed successfully in many patients for years. Treatment for people with symptomatic myeloma includes treatment to control the disease and supportive care to improve quality of life, such as by relieving symptoms and maintaining good nutrition. The standard treatment for multiple myeloma often involves a combination of three medications- sometimes called triplet therapy. This often includes a targeted therapy, an immunomodulator, and a corticosteroid.
Multiple Myeloma Epidemiology
The multiple myeloma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of multiple myeloma, total symptomatic cases of multiple myeloma, gender-specific cases of multiple myeloma, age-specific cases of multiple myeloma, transplant-eligible cases of multiple myeloma, and treated patient pool across all lines of therapies in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034. The total incident cases of multiple myeloma in the 7MM comprised nearly 75,000 in 2023 and are projected to increase during the forecast period.
In the 7MM, the highest incident cases of multiple myeloma were seen in the United States, followed by EU4 and the UK.
Among EU4 and the UK, Germany accounted for the highest number of incident cases of multiple myeloma, whereas Spain accounted for the lowest in 2023.
Multiple myeloma is more common in males as compared to females. More than 50% of males in the United States are diagnosed with multiple myeloma.
Data suggests that roughly half of newly diagnosed multiple myeloma patients are ineligible for transplant, and around a third of eligible patients do not receive the transplant. In the US, there were around 23,600 frontline transplant-ineligible patients and 9,200 transplant-eligible patients of multiple myeloma patients in 2023.
Regarding age-specific cases of Multiple myeloma, the age group of 65 and above has the highest number of cases accounting for more than 70% of cases in the United States, followed by 55-64 and 0-54 years.
Multiple Myeloma Drug Chapters
The drug chapter segment of the multiple myeloma report encloses a detailed analysis of the marketed and late-stage (Phase III) pipeline drug. The marketed drugs segment encloses drugs such as DARZALEX (Johnson & Johnson Innovative Medicine), CARVYKTI (Johnson & Johnson Innovative Medicine), BLENREP (GSK), ABECMA (Bristol-Myers Squibb/Bluebird bio), and others. Furthermore, the current key players for the upcoming emerging drugs and their respective drug candidates include Bristol Myers Squibb (mezigdomide), AbbVie and Roche (VENCLEXTA), Regeneron (linvoseltamab), and others. The drug chapter also helps understand the multiple myeloma clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.
Marketed Drugs
CARVYKTI (ciltacabtagene autoleucel): Johnson & Johnson Innovative Medicine
CARVYKTI is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient's T cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. In April 2024, Johnson & Johnson announced that the US FDA approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. In February 2022, Johnson & Johnson Innovative Medicine announced that the US FDA had approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Currently, the company is investigating the drug in the Phase III CARTITUDE-4 trial for RRMM with 1-3 prior lines of therapy, in the CARTITUDE-6 trial for frontline multiple myeloma transplant eligibility, and CARTITUDE-5 trial for NDMM for whom hematopoietic stem cell transplant is not planned as initial therapy.
TALVEY (talquetamab): Johnson & Johnson Innovative Medicine
TALVEY is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T cells and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel multiple myeloma target which is highly expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as some healthy tissues such as epithelial cells of the skin and tongue. TALVEY is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Emerging Drugs
Mezigdomide (CC-92480): Bristol Myers Squibb
Mezigdomide is a highly potent modulator of the E3 ubiquitin ligase complex containing cereblon (CRL4-CRBN E3 ubiquitin ligase), with potential immunomodulating and antineoplastic activities. Mezigdomide binds to cereblon (CRBN) upon administration, affecting the ubiquitin E3 ligase activity and targeting certain substrate proteins for ubiquitination. This induces proteasome-mediated degradation of certain transcription factors, some of which are transcriptional repressors in T cells. The company is evaluating the drug in different clinical trials in different lines of therapies for treating NDMM and RRMM. In January 2023, the company initiated the Phase III trial of CC-92480 in combination with carfilzomib and dexamethasone (480kd) vs. carfilzomib and dexamethasone in 2L+ participants with RRMM (SUCCESSOR-2). The company is expecting the first approval of mezigdomide by 2026-2027.
Linvoseltamab (REGN5458): Regeneron
Linvoseltamab is a BCMAxCD3 bispecific antibody in patients with RRMM. It is designed to bind to BCMA on multiple myeloma cells and the CD3 receptor on T cells, bridging them together and activating T-cell killing of the cancer cell. The drug is designed to closely resemble natural human antibodies, using Regeneron's proprietary 'human antibody mouse' technology (VelocImmune) and 'full-length bispecific antibody' platform (VelociBi). The linvoseltamab clinical development program includes a Phase III confirmatory trial in patients with R/R MM (LINKER-MM3) that is currently enrolling. Additional trials in earlier lines of therapy and stages of disease are planned or underway, including a Phase I/II trial in the first-line setting, a Phase II trial in high-risk smoldering MM, and a Phase II trial in monoclonal gammopathy of undetermined significance. Apart from that, a Phase I trial of linvoseltamab in combination with a Regeneron CD38xCD28 costimulatory bispecific in MM is also planned. In February 2024, the company announced that the US FDA had accepted for priority review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with RRMM that has progressed after at least three prior therapies. Moreover, the target action date for the FDA decision is August 22, 2024.
Drug Class Insights
The existing multiple myeloma treatment is mainly dominated by classes such as Proteasome Inhibitors, Immunomodulating Agents, Monoclonal Antibodies, Nuclear export inhibitors, CAR-T cell therapy, and Bi-specific antibodies. Apart from these classes, Histone Deacetylase (HDAC) inhibitors were also included in the treatment regimen, but now it has been withdrawn from the US market.
Immunomodulators (IMiDs)
Immunomodulators (IMiDs) for multiple myeloma arose from the revival of thalidomide - sold under the name THALOMID by Celgene Corporation. Initially, the US FDA did not approve it for multiple myeloma. Followed by thalidomide, REVLIMID (lenalidomide) came into existence. It is similar to thalidomide and works well in treating multiple myeloma. In June 2006, the US FDA approved REVLIMID plus dexamethasone for use in multiple myeloma patients who have received at least one prior therapy. To this date, the regulatory authorities for the treatment of multiple myeloma have approved IMiDs, including thalidomide (THALOMID), lenalidomide (REVLIMID), and pomalidomide (POMALYST).
Proteasome Inhibitors (PI)
Proteasome Inhibitors are also a widely used class of therapy for the treatment of multiple myeloma, which includes VELCADE (bortezomib), KYPROLIS (carfilzomib), and NINLARO (ixazomib). The US FDA approved Millennium Pharmaceuticals' (Now a part of Takeda Pharmaceuticals) VELCADE (bortezomib) injection for patients with multiple myeloma that has relapsed after two prior treatments and has shown resistance to the last treatment. In addition, carfilzomib and ixazomib are other approved second-generation proteasome inhibitors for managing multiple myeloma.
Anti CD38
At present, two types of monoclonal antibodies are available for the management of multiple myeloma; one of them is antibodies against CD38 [DARZALEX (daratumumab) and SARCLISA (isatuximab)]. DARZALEX is used by healthcare experts in combination with existing therapies for good treatment strategies and better outcomes. For example, in 2021, the US FDA approved the expansion of the KYPROLIS US prescribing information to include its use in combination with DARZALEX FASPRO and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy and in 2020, the US FDA approved the expansion of the KYPROLIS US prescribing information to include its use in combination with DARZALEX plus dexamethasone (DKd) in two dosing regimens - once weekly and twice weekly - for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy. A second CD38 antibody called SARCLISA has been approved for treating multiple myeloma. Comparing SARCLISA and DARZALEX, the latter has an advantage over the former.
Moreover, the upcoming treatment landscape is poised to expand further classes such as cellMoDs, BCL-2 inhibitors, ADCs, CAR-Ts, etc.
Multiple Myeloma (MM) Market Outlook
At present, the market holds a diverse range of therapeutic alternatives for treatment, which includes Proteasome Inhibitors, Immunomodulating Agents, Histone Deacetylase (HDAC) inhibitors, Monoclonal Antibodies, Chemotherapy, Corticosteroids, Nuclear export inhibitors, CAR-T cell therapy, and Bispecific antibody in different lines of treatment. For several decades, the standard therapy for multiple myeloma included a combination of alkylating agents, primarily melphalan and cyclophosphamide, together with corticosteroids, such as dexamethasone and prednisone, all of which were augmented in the mid-1980s by the introduction of autologous stem cell transplantation.
XPOVIO (selinexor), which is a nuclear export inhibitor has emerged as a novel class for treatment. The nucleus of a cell holds most of the cell's genetic material (DNA), which is required for the protein production used for proper cell functioning. In July 2019, Selinexor received accelerated approval from the US FDA in combination with dexamethasone for adult patients with R/R MM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. In December 2023, EMA's human medicines committee (CHMP) confirmed its initial recommendation not to renew the conditional marketing authorization for BLENREP because recent data did not confirm its effectiveness; the benefits of BLENREP are therefore considered to no longer outweigh its risks.
The relapsed/refractory multiple myeloma landscape is undergoing a radical transformation with the FDA approvals of two CAR-Ts and one bispecific antibody, opening up new avenues for companies developing later lines of therapy. Several key players are racing to bring their candidates to the market, and we estimate that few bispecific antibodies and CAR-Ts will join the fray by 2025. Some of the frontrunners in this space are Pfizer, Johnson & Johnson, Regeneron Pharmaceuticals, Roche, Abbvie, CARsgen Therapeutics, and others, who are harnessing the power of CAR-Ts and bispecific antibodies for relapsed/refractory multiple myeloma.
The total market size in the 7MM for multiple myeloma was estimated to be nearly USD 21,300 million in 2023, which is expected to show positive growth by 2034.
The total market size for multiple myeloma in the US was around USD 14,300 million in 2023, expected to rise by 2034.
Among the EU4 and the UK, Germany captured the maximum market share in 2023, whereas Spain was at the bottom of the ladder in the same year.
In the 4L+ setting, approved CAR-Ts (ABECMA and CARVYKTI) were expected to garner nearly USD 828 million in 2023 in the US and will rise with the approval of other emerging CAR-Ts during the forecast period.
Multiple Myeloma (MM) Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. The landscape of multiple myeloma treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.
Although CAR-T treatments have demonstrated significant effectiveness, they also come with safety issues such as CRS. Initially, cost, convenience, and manufacturing turnaround time could prevent CAR-T from being widely adopted, but companies may reduce side effects and speed up manufacturing time over time. CAR-Ts might not pose a significant threat to DARZALEX due to its better efficacy and safety profile and evolving use in earlier lines of setting.
Multiple Myeloma Pipeline Development Activities
The report provides insights into therapeutic candidates in Phase III, Phase II, and Phase I. 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 multiple myeloma's emerging therapy.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on multiple myeloma evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including oncologists, radiation oncologists, surgical oncologists, and others.
Delveinsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Dana-Farber Cancer Institute, Colorado Blood Cancer Institute, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or multiple myeloma market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Market Access and Reimbursement
MyCARVYKTI patient support program: The MyCARVYKTI Patient Support Program, sponsored by Janssen and Legend Biotech, is designed to help eligible patients prescribed CARVYKTI and their caregivers with support during treatment.
Patients who meet financial and other eligibility requirements and their caregivers may receive:
Assistance with transportation, lodging, and out-of-pocket costs related to meals and other travel expenses associated with treatment at the CARVYKTI Certified Treatment Center.
Support from MyCARVYKTI patient support specialists, who are available to help guide eligible patients through the enrollment process and assist with program benefits.
Janssen CarePath helps verify insurance coverage for the patients taking TECVAYLI and provides reimbursement information. Affordability support to help the patients start and stay on the treatment prescribed: Janssen CarePath can help the patient find out what affordability assistance may be available for the patients taking TECVAYLI. Janssen CarePath Savings Program for TECVAYLI can help eligible patients save on their out-of-pocket medication costs for TECVAYLI. Depending on the patient's health insurance plan, savings may apply toward copay, co-insurance, or deductible. Eligible patients will pay USD 5 per dose for medication costs, with a USD 26,000 maximum program benefit each calendar year. It is not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications.
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, 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, and a descriptive overview of multiple myeloma, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
A detailed review of the multiple myeloma 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 shape and drive the 7MM multiple myeloma market.
Multiple Myeloma Report Insights
Patient Population
Therapeutic Approaches
Multiple Myeloma Pipeline Analysis
Multiple Myeloma Market Size and Trends
Existing and Future Market Opportunity
Multiple Myeloma Report Key Strengths
Eleven Years Forecast
The 7MM Coverage
Multiple Myeloma Epidemiology Segmentation
Key Cross Competition
Drugs Uptake and Key Market Forecast Assumptions
Multiple Myeloma Report Assessment
Current Treatment Practices
Unmet Needs
Pipeline Product Profiles
Market Attractiveness
Qualitative Analysis (SWOT)
FAQs:
What was the multiple myeloma market size, the market size by therapies, market share (%) distribution in 2023, and what would it look like by 2034? What are the contributing factors for this growth?
What are the pricing variations among different geographies for approved therapies?
What can be the future treatment paradigm of multiple myeloma?
What will be the impact on the sales of REVLIMID after its patent expiry?
What are the disease risks, burdens, and unmet needs of multiple myeloma? What will be the growth opportunities across the 7MM concerning the patient population with multiple myeloma?
What is the impact of generics on the sales of REVLIMID?
Who is the major competitor of daratumumab in the market?
How much market share will be captured by bispecific antibodies and CAR-Ts by 2034?
What are the current options for the treatment of multiple myeloma? What are the current guidelines for treating multiple myeloma in the US, Europe, and Japan?
What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
What is the patient share in frontline transplant-eligible and transplant-ineligible?
Which countries within EU4 and the UK do not have access to CAR-T therapies?
What is the right place to use CAR-T cell therapies and Bispecific antibodies?
Reasons to Buy:
The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the multiple myeloma market.
Insights on patient burden/disease prevalence, 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 Analyst view section to provide visibility around leading classes.
Highlights of access and reimbursement policies of current 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.
Table of Contents
1. KEY INSIGHTS
2. REPORT INTRODUCTION
3. EXECUTIVE SUMMARY
4. MULTIPLE MYELOMA MARKET OVERVIEW AT A GLANCE
4.1. MARKET SHARE (%) DISTRIBUTION BY LINE OF THERAPIES IN 2020
4.2. MARKET SHARE (%) DISTRIBUTION BY LINE OF THERAPIES IN 2034
5. KEY EVENTS
5.1. ASH 2023 COVERAGE FOR MULTIPLE MYELOMA
6. EPIDEMIOLOGY AND MARKET FORECAST METHODOLOGY
7. DISEASE BACKGROUND AND OVERVIEW
7.1. INTRODUCTION
7.2. MULTIPLE MYELOMA FEATURES
7.2.1. Low Blood Counts
7.2.2. Bone and Calcium Problems
7.2.3. Infections
7.2.4. Kidney Problems
7.3. CAUSES OF MULTIPLE MYELOMA
7.4. RISK FACTORS OF MULTIPLE MYELOMA
7.5. SIGNS AND SYMPTOMS
7.5.1. Bone Problems
7.5.2. Low Blood Counts
7.5.3. High Blood Levels of Calcium
7.5.4. Nervous System Symptoms
7.5.5. Kidney Problems
7.5.6. Infections
7.5.7. Pathogenesis of Multiple Myeloma
7.5.8. Pathophysiology of Multiple Myeloma
7.5.9. Patient-related Risk Factors
7.6. DIAGNOSIS OF MULTIPLE MYELOMA
7.6.1. Blood Tests
7.6.2. Urine Tests
7.6.3. Tissue Tests
7.6.4. Lab Tests
7.6.5. Imaging Tests
7.6.6. Special Tests Used in Certain Cases
7.6.7. Stages of Multiple Myeloma
7.7. TREATMENT AND MANAGEMENT
7.7.1. Drug Therapy for Multiple Myeloma
7.7.2. Bone Marrow Transplant/Stem Cell Transplant
7.7.3. Radiation Therapy
7.7.4. Surgery
7.7.5. Adjunctive Treatment and Supportive Care
7.8. FACTORS INFLUENCING THE CHOICE OF THERAPY AT RELAPSE
7.9. TREATMENT GUIDELINES AND RECOMMENDATIONS FOR MULTIPLE MYELOMA
7.9.1. NCCN Guideline for Multiple Myeloma
7.9.2. ESMO Guideline for Multiple Myeloma
7.9.3. Japanese Society of Hematology
8. EPIDEMIOLOGY AND PATIENT POPULATION
8.1. KEY FINDINGS
8.2. ASSUMPTIONS AND RATIONALE
8.3. 7MM EPIDEMIOLOGY
8.3.1. Total Incident cases of Multiple Myeloma in the 7MM
8.3.2. Total Symptomatic Cases of Multiple Myeloma in the 7MM
8.4. UNITED STATES EPIDEMIOLOGY
8.4.1. Total Incident Cases of Multiple Myeloma in the United States
8.4.2. Total Symptomatic Cases of Multiple Myeloma in the United States
8.4.3. Gender-specific Cases of Multiple Myeloma in the United States
8.4.4. Age-specific Cases of Multiple Myeloma in the United States
8.4.5. Transplant Eligible and Ineligible Cases in Multiple Myeloma in the United States
8.4.6. Treated Cases across the lines of therapies in the United States
8.5. EU4 AND THE UK
8.5.1. Total Incident Cases of Multiple Myeloma in EU4 and the UK
8.5.2. Total Symptomatic Cases of Multiple Myeloma in EU4 and the UK
8.5.3. Gender-specific Cases of Multiple Myeloma in EU4 and the UK
8.5.4. Age-specific Cases of Multiple Myeloma in EU4 and the UK
8.5.5. Transplant Eligible and Ineligible Cases in Multiple Myeloma in EU4 and the UK
8.5.6. Treated Cases across the lines of therapies in EU4 and the UK
8.6. JAPAN EPIDEMIOLOGY
8.6.1. Total Incident Cases of Multiple Myeloma in Japan
8.6.2. Total Symptomatic Cases of Multiple Myeloma in Japan
8.6.3. Gender-specific Cases of Multiple Myeloma in Japan
8.6.4. Age-specific Cases of Multiple Myeloma in Japan
8.6.5. Transplant Eligible and Ineligible Cases in Multiple Myeloma in Japan
8.6.6. Treated Cases across the lines of therapies in Japan
