多発性骨髄腫市場 - 市場の洞察、疫学、市場予測：2034年

主なハイライト

• 多発性骨髄腫の市場規模は、2023年には約213億米ドルと推計され、2034年までにはプラス成長が見込まれます。これは、偶発症例の増加、既存治療薬の適応拡大および早期ラインへの浸透、CAR-T細胞療法や抗BCMA療法を中心とする新規治療薬の高い採用率、豊富な新興パイプライン、研究開発活動への投資の増加が背景にあります。
• 2023年には、米国が主要7ヶ国市場全体の最大シェア、すなわち約143億米ドルを占め、EU4ヶ国と英国がこれに続きます。
• IMiDs（レナリドミド、ポマリドミド）、抗CD38モノクローナル抗体（ダラツムマブ、イサツキシマブ）、抗SLAM7モノクローナル抗体（エロツズマブ）、新規プロテアソーム阻害剤（カーフィルゾミブ、イクサゾミブ）など、様々な生物学的製剤とその併用療法を含む多発性骨髄腫治療が大きく進歩しているにもかかわらず、ほとんどの多発性骨髄腫患者にとって、一次治療後の再発は依然として一般的な課題です。
• 最前線の多発性骨髄腫臨床試験において、ダルザレックスは成功を収め、現在では標準治療と見なされています。ダルザレックスは、有効性と安全性に関してライバルの予想を上回っており、多発性骨髄腫市場を独占することが期待されています。
• SARCLISAと呼ばれる第二のCD38抗体が多発性骨髄腫の治療薬として承認されました。SARCLISAは主要市場で急速に受け入れられ続けています。しかし、DARZALEXはSARCLISAに対して4年以上のアドバンテージを持っています。両方のモノクローナル抗体は、移植適格および不適格の両方の設定において、4剤併用レジメンで互いに競合しています。2つのCD38抗体は、移植不適格患者においても最終決戦に近づいています。このCD38-RVd併用療法に対するエビデンスの波は、移植適格群における研究からもたらされたものです。
• 2024年3月、Johnson & Johnsonは、米国食品医薬品局（FDA）腫瘍薬諮問委員会（ODAC）が、プロテアソーム阻害剤とIMiDを含む少なくとも1つの前治療を受け、レナリドミドに抵抗性を示す再発/難治性多発性骨髄腫（RRMM）成人患者の治療にCARVYKTIを推奨したと発表しました。
• CAR T細胞療法を標準的な診療で実施することは、FDA別義務付けられたより厳しいGMP製造要件や、多様な患者人口における治療の現実的な適用により、困難な場合があります。

当レポートは、米国、EU4ヶ国（ドイツ、フランス、イタリア、スペイン）、英国、日本の多発性骨髄腫、歴史的疫学、多発性骨髄腫市場動向の詳細な理解を提供します。

現在の治療法、新薬、個々の治療法の市場シェア、2020年から2034年までの主要7ヶ国の多発性骨髄腫市場規模の現状と予測を提供しています。また、現在の多発性骨髄腫の治療法/アルゴリズムやアンメットメディカルニーズも網羅しており、最良の機会を発掘し、市場の可能性を評価しています。

多発性骨髄腫は、クローン性形質細胞の制御不能な増殖を特徴とする悪性疾患であり、臓器機能障害や最終的には死に至る様々な合併症を引き起こします。この難治性の悪性腫瘍は、骨髄に蓄積した末端分化単クローン性形質細胞（PC）から開発されます。MMの作用機序は、特異的な末端臓器障害を示す単クローン性パラ蛋白の異常な増加を特徴とするクローン性形質細胞増殖性疾患であるということです。MMは単クローン性ガンマグロブリン血症の一部です。近年、骨髄腫の病態に変化が生じ、多発性骨髄腫患者の管理に大きな改善が見られるようになりました。

多発性骨髄腫は多くの場合、検査、骨痛、脱力感、高カルシウム血症などの患者の症状、医師の身体診察に基づいて診断されます。これらの症状に続いて、主に血液検査や尿検査などの臨床検査が行われます。これらの検査の後、生検（骨髄吸引、細針吸引）が行われます。これらの検査とは別に、多発性骨髄腫の診断を確定するために、いくつかの検査も行われます。すなわち、形質細胞がどの程度の割合で分裂しているかを示す形質細胞増殖、血液の濃さを測定する血清粘度、心臓がどの程度拍動し血液を送り出しているかを確認する超音波検査である心エコー図などです。診断後は、くすぶり型骨髄腫か活動型骨髄腫かを確認することも重要で、これに応じて治療が開始されます。

多発性骨髄腫の治療は、患者さんの症状の有無や全身状態によって異なります。多くの場合、医師は患者さんと協力して最良の治療計画を決定します。治療目標は、骨髄腫細胞を除去し、腫瘍の増殖を抑制し、疼痛をコントロールし、患者さんが積極的に生活できるようにすることです。多発性骨髄腫を完治させる治療法はありませんが、多くの患者さんでは何年にもわたり、がんをうまくコントロールすることができます。症候性骨髄腫の患者さんに対する治療には、病気をコントロールする治療と、症状の緩和や良好な栄養状態の維持など、生活の質を改善するための支持療法が含まれます。多発性骨髄腫の標準的な治療では、3種類の薬剤を組み合わせて使用することが多く、三剤併用療法と呼ばれることもあります。三剤併用療法と呼ばれることもあります。三剤併用療法には、標的療法、免疫調節剤、およびコルチコステロイドが含まれることが多いです。

• 主要7ヶ国において、多発性骨髄腫の罹患数が最も多いのは米国であり、次いでEU4ヶ国と英国でした。
• EU4ヶ国と英国の中で、2023年の多発性骨髄腫の罹患数が最も多かったのはドイツであり、最も少なかったのはスペインでした。
• 多発性骨髄腫は女性に比べ男性に多くみられます。米国では男性の50%以上が多発性骨髄腫と診断されています。
• 新たに多発性骨髄腫と診断された患者の約半数は移植不適格者であり、移植適格者の約3分の1は移植を受けていないです。米国では、2023年の多発性骨髄腫患者の前臨床移植不適格患者は約2万3,600人、移植適格患者は9,200人です。
• 多発性骨髄腫の年齢別症例数については、米国では65歳以上の年齢層が最も多く70%以上を占め、次いで55～64歳、0～54歳となっています。

上市済み薬剤

CARVYKTI（シルタカブタジェンオートロイセル）：Johnson & Johnson Innovative Medicine

CARVYKTIは、B細胞成熟抗原（BCMA）指向性の遺伝子組換え自己T細胞免疫療法であり、BCMAを発現する細胞を同定・排除するキメラ抗原受容体（CAR）をコードする導入遺伝子で患者のT細胞を再プログラムします。2024年4月、Johnson & Johnsonは、プロテアソーム阻害剤と免疫調節剤を含む少なくとも1つの前治療を受け、レナリドミドに抵抗性を示すRRMM成人患者の治療薬として、CARVYKTI（ciltacabtagene autoleucel;cilta-cel）を米国FDAが承認したと発表しました。2022年2月、Johnson & Johnsonイノベーティブメディシンは、プロテアソーム阻害剤、免疫調節剤、抗CD38モノクローナル抗体を含む前治療を4ライン以上受けた再発または難治性の多発性骨髄腫（RRMM）の成人患者に対する治療薬として、CARVYKTI（ciltacabtagene autoleucel;cilta-cel）を米国FDAが承認したと発表しました。

現在、前治療歴1～3行のRRMMを対象とした第III相CARTITUDE-4試験、多発性骨髄腫の前臨床移植適格者を対象としたCARTITUDE-6試験、および初回治療として造血幹細胞移植が予定されていないNDMMを対象としたCARTITUDE-5試験において、本剤を検討しています。

TALVEY（タルケタマブ）：Johnson & Johnson Innovative Medicine

TALVEYは、T細胞表面に発現するCD3受容体およびGタンパク質共役型受容体クラスCグループ5メンバーD（GPRC5D）に結合する二重特異性T細胞結合抗体であり、多発性骨髄腫細胞および非悪性形質細胞、ならびに皮膚や舌の上皮細胞などの健常組織の表面に高発現する新規多発性骨髄腫標的です。TALVEYは、プロテアソーム阻害剤、免疫調節剤、抗CD38モノクローナル抗体を含む少なくとも4種類の前治療を受けた再発または難治性の多発性骨髄腫の成人患者の治療に適応があります。

新薬

メジグドミド（CC-92480）：Bristol Myers Squibb

Mezigdomideは、セレブロンを含むE3ユビキチンリガーゼ複合体（CRL4-CRBN E3ユビキチンリガーゼ）の強力なモジュレーターであり、免疫調節作用および抗悪性腫瘍作用が期待されます。メジグドミドは、投与によりセレブロン（CRBN）に結合し、ユビキチンE3リガーゼ活性に影響を与え、特定の基質タンパク質をユビキチン化の標的とします。これにより、プロテアソームを介した特定の転写因子の分解が誘導され、そのうちのいくつかはT細胞における転写抑制因子となります。同社は、NDMMとRRMMを治療するための異なる系統の臨床試験でこの薬剤を評価しています。2023年1月、同社はRRMMの2L+患者を対象に、CC-92480とカーフィルゾミブおよびデキサメタゾンの併用療法（480kd）対カーフィルゾミブおよびデキサメタゾンの併用療法（SUCCESSOR-2）の第III相試験を開始しました。同社は、2026～2027年までにメジグドミドが初めて承認されることを期待しています。

リンボセルタマブ（REGN5458）：Regeneron

Linvoseltamabは、RRMM患者を対象としたBCMAxCD3二特異性抗体です。多発性骨髄腫細胞上のBCMAとT細胞上のCD3受容体に結合し、両者を橋渡ししてT細胞によるがん細胞の殺傷を活性化するように設計されています。この薬剤は、Regeneron独自の「ヒト抗体マウス」技術（VelocImmune）と「完全長二重特異性抗体」プラットフォーム（VelociBi）を用いて、天然のヒト抗体に酷似するように設計されています。リンボセルタマブの臨床開発プログラムには、現在登録中のR/R MM患者を対象とした第III相確認試験（LINKER-MM3）が含まれます。また、初回治療における第I/II相試験、高リスクのくすぶり型MMを対象とした第II相試験、意義不明の単クローン性ガンマグロブリン血症を対象とした第II相試験など、より早い治療ラインや病期における追加試験が計画または進行中です。これとは別に、リグネロンのCD38xCD28コスティミュレイトリーバイスペシフィック製剤とリンボセルタマブの併用によるMMを対象とした第I相試験も計画されています。2024年2月、同社は米国FDAが、少なくとも3回の前治療後に進行したRRMMの成人患者を治療するためのリンボセルタマブの生物製剤承認申請（BLA）を優先審査として受理したと発表しました。また、FDAの決定目標は2024年8月22日です。

既存の多発性骨髄腫治療は、プロテアソーム阻害剤、免疫調節剤、モノクローナル抗体、核輸出阻害剤、CAR-T細胞療法、二重特異性抗体などのクラスが主です。これらのクラスとは別に、ヒストン脱アセチル化酵素（HDAC）阻害剤も治療レジメンに含まれていたが、現在は米国市場から撤退しています。

現在、多発性骨髄腫市場には、プロテアソーム阻害剤、免疫調節剤、ヒストン脱アセチル化酵素（HDAC）阻害剤、モノクローナル抗体、化学療法、副腎皮質ステロイド、核輸出阻害剤、CAR-T細胞療法、二重特異性抗体など、多様な治療選択肢が存在します。数十年にわたり、多発性骨髄腫の標準治療は、メルファランやシクロホスファミドを中心とするアルキル化剤と、デキサメタゾンやプレドニゾンなどの副腎皮質ステロイドの併用療法でした。

当レポートでは、主要7ヶ国における多発性骨髄腫市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2034年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 重要な洞察

第2章 報告書のイントロダクション

第3章 エグゼクティブサマリー

第4章 多発性骨髄腫市場概要

• 2020年の治療ライン別市場シェア（％）分布
• 2034年の治療ライン別市場シェア（％）分布

第5章 主要な出来事

第6章 疫学と市場予測の調査手法

第7章 疾患の背景と概要

• イントロダクション
• 多発性骨髄腫の特徴
• 多発性骨髄腫の原因
• 多発性骨髄腫の危険因子
• 兆候と症状
• 多発性骨髄腫の診断
• 治療と管理
• 再発時の治療法の選択に影響を与える要因
• 多発性骨髄腫の治療ガイドラインと推奨事項

第8章 疫学と患者人口

• 主な調査結果
• 仮定と根拠
• 主要7ヶ国
• 米国
• EU4ヶ国と英国
• 日本

第9章 患者動向

第10章 多発性骨髄腫における重要なエンドポイント

第11章 上市済み薬剤

• 主な競合
• サルクリサ（イサツキシマブ-IRFC）：Sanofi
• FARYDAK（パノビノスタット）：SECURA BIO
• XPOVIO/NEXPOVIO（セリネキソール）：KARYOPHARM THERAPEUTICS
• ABECMA（イデカバタゲンビクルセル）：Bristol Myers Squibb/BLUEBIRD BIO
• ブレンレップ（ベランタマブマフォドチン）：GLAXOSMITHKLINE
  • 重要な臨床試験
• ペパックスト/ペパックスティ（メルフルフェン/メルファランフルフェナミド）：ONCOPEPTIDES AB
• ダーザレックス（ダラツムマブ）：JOHNSON & JOHNSON (JANSSEN)
• ベルケイド（ボルテゾミブ）：TAKEDA PHARMACEUTICAL AND JANSSEN PHARMACEUTICAL
• エンプリシティ（エロツズマブ）：Bristol Myers SquibbとABBVIE
• テクバイリ（テクリスタマブ-CQYV）：JOHNSON & JOHNSON (JANSSEN)
• カイプロリス（カルフィルゾミブ）：AMGENとONO PHARMACEUTICAL REVLIMID (LENALIDOMIDE)
• レブラミド（レナリドミド）：BMS（CELGENE）
• POMALYST/IMNOVID（ポマリドマイド）：BRISTOL MYERS SQUIBB COMPANY（CELGENE）
• カルビクティ（シルタカバタゲンオートロイセル）：JOHNSON & JOHNSON (JANSSEN)
• ニンラーロ（イキサゾミブ）：TAKEDA PHARMACEUTICAL
• タルビー（タルケタマブ）：JOHNSON & JOHNSON INNOVATIVE MEDICINE
• エルレキソフィオ（エルラナタマブ）：PFIZER

第12章 新たな治療法

• 主な競合
• メジグドミド（CC-92480）：Bristol Myers Squibb/CELGENE
• アニトセル（CART-DDBCMA）：ARCELLX
• PHE885（ドゥルカバタゲンオートロイセル）：ノNOVARTIS
• REGN5459：REGENERON PHARMACEUTICALS
• デカルト-11：CARTESIAN THERAPEUTICS
• HDP-101：HEIDELBERG PHARMA
• BGB-11417（ソンロトクラックス）：BEIGENE
• ゼボルカバタゲン・オートロイセル：CARSGEN THERAPEUTICS
• CFT7455：C4 THERAPEUTICS
• ABBV-383（TNB-383B）：ABBVIE (TENEOONE)
• アルヌクタマブ：Bristol Myers Squibb
• BMS-986393/CC-95266：Bristol Myers Squibb
• ベネトクラックス（VENETOCLAX）：ABBVIE とROCHE（GENENTECH）
• リンボセルタマブ：REGENERON PHARMACEUTICALS
• イベルドミド（CC-220）：Bristol Myers Squibb/CELGENE
• セボスタマブ：ROCHE (GENENTECH)

第13章 多発性骨髄腫：主要7ヶ国市場分析

• 主な調査結果
• 主要7ヶ国における多発性骨髄腫の総市場規模
• 市場見通し
• 主要な市場予測の前提条件
• 米国の市場規模
• EU4ヶ国と英国の市場規模
• 日本市場規模

第14章 アンメットニーズ

第15章 SWOT分析

第16章 KOLの見解

第17章 市場アクセスと償還

第18章 付録

第19章 DELVEINSIGHTのサービス内容

第20章 免責事項

第21章 調査会社について

List of Tables

• Table 1: Summary of Multiple Myeloma Market, and Epidemiology (2020-2034)
• Table 2: Blood Chemistry Tests Used to Detect Multiple Myeloma
• Table 3: The Revised International Staging System
• Table 4: The NCCN Recommendations for Primary Therapy for Transplant Candidates
• Table 5: The NCCN Recommendations for Maintenance Therapy
• Table 6: The NCCN Recommendations for Primary Myeloma Therapy for Non-transplant Candidates
• Table 7: The NCCN Recommendations for Myeloma Therapy
• Table 8: The NCCN Recommendations Therapies for Previously Treated Multiple Myeloma
• Table 9: The NCCN Recommendations Therapies for Previously Treated Multiple Myeloma
• Table 10: Total Incident Cases of Multiple Myeloma in the 7MM (2020-2034)
• Table 11: Total Symptomatic Cases of Multiple Myeloma in the 7MM (2020-2034)
• Table 12: Total Incident Cases of Multiple Myeloma in the United States (2020-2034)
• Table 13: Total Symptomatic Cases of Multiple Myeloma in the United States (2020-2034)
• Table 14: Gender-specific Cases of Multiple Myeloma in the United States (2020-2034)
• Table 15: Age-specific Cases of Multiple Myeloma in the United States (2020-2034)
• Table 16: Transplant Eligible and Ineligible Cases in Multiple Myeloma in the United States (2020-2034)
• Table 17: Treated Cases across the lines of therapies in the United States (2020-2034)
• Table 18: Total Incident Cases of Multiple Myeloma in EU4 and the UK (2020-2034)
• Table 19: Total Symptomatic Cases of Multiple Myeloma in EU4 and the UK (2020-2034)
• Table 20: Gender-specific Cases of Multiple Myeloma in EU4 and the UK (2020-2034)
• Table 21: Age-specific Cases of Multiple Myeloma in EU4 and the UK (2020-2034)
• Table 22: Transplant Eligible and Ineligible Cases in Multiple Myeloma in EU4 and the UK (2020-2034)
• Table 23: Treated Cases across the lines of therapies in EU4 and the UK (2020-2034)
• Table 24: Total Incident Cases of Multiple Myeloma in Japan (2020-2034)
• Table 25: Total Symptomatic Cases of Multiple Myeloma in Japan (2020-2034)
• Table 26: Gender-specific Cases of Multiple Myeloma in Japan (2020-2034)
• Table 27: Age-specific Cases of Multiple Myeloma in Japan (2020-2034)
• Table 28: Transplant Eligible and Ineligible Cases in Multiple Myeloma in Japan (2020-2034)
• Table 29: Treated Cases across the lines of therapies in Japan (2020-2034)
• Table 30: Marketed Drug Key Cross
• Table 31: SARCLISA (isatuximab-irfc), Clinical Trial Description, 2024
• Table 32: XPOVIO/NEXPOVIO (selinexor), Clinical Trial Description, 2024
• Table 33: ABECMA (idecabtagene vicleucel/ide-cel), Clinical Trial Description, 2024
• Table 34: BLENREP (belantamab mafodotin), Clinical Trial Description, 2024
• Table 35: DARZALEX (daratumumab), Clinical Trial Description, 2024
• Table 36: EMPLICITI (elotuzumab), Clinical Trial Description, 2024
• Table 37: TECVAYLI (teclistamab), Clinical Trial Description, 2024
• Table 38: KYPROLIS (carfilzomib), Clinical Trial Description, 2024
• Table 39: POMALYST/IMNOVID, Clinical Trial Description, 2024
• Table 40: CARVYKTI (ciltacabtagene autoleucel), Clinical Trial Description, 2024
• Table 41: NINLARO (ixazomib), Clinical Trial Description, 2024
• Table 42: TALVEY, Clinical Trial Description, 2024
• Table 43: ELREXFIO, Clinical Trial Description, 2024
• Table 44: Late Phase Emerging Drugs Key Cross
• Table 45: Early Phase Emerging Drugs Key Cross
• Table 46: Mezigdomide, Clinical Trial Description, 2024
• Table 47: Anito-cel, Clinical Trial Description, 2024
• Table 48: PHE885, Clinical Trial Description, 2024
• Table 49: REGN5459, Clinical Trial Description, 2024
• Table 50: Descartes-11, Clinical Trial Description, 2024
• Table 51: HDP-101, Clinical Trial Description, 2024
• Table 52: BGB-11417, Clinical Trial Description, 2024
• Table 53: Zevorcabtagene autoleucel, Clinical Trial Description, 2024
• Table 54: CFT7455, Clinical Trial Description, 2024
• Table 55: ABBV-383, Clinical Trial Description, 2024
• Table 56: Alnuctamab, Clinical Trial Description, 2024
• Table 57: BMS-986393, Clinical Trial Description, 2024
• Table 58: VENCLEXTA (Venetoclax), Clinical Trial Description, 2024
• Table 59: Linvoseltamab, Clinical Trial Description, 2024
• Table 60: Iberdomide, Clinical Trial Description, 2024
• Table 61: Cevostamab, Clinical Trial Description, 2024
• Table 62: Market Size of Multiple Myeloma in the 7MM, USD million (2020-2034)
• Table 64: Key Market Forecast Assumption of Multiple Myeloma in the US
• Table 65: Key Market Forecast Assumption of Multiple Myeloma in EU4 and the UK
• Table 66: Key Market Forecast Assumption of Multiple Myeloma in Japan
• Table 63: Market Size of Multiple Myeloma in the United States, USD million (2020-2034)
• Table 64: Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in the United States, USD million (2020-2034)
• Table 65: Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in the United States, USD million (2020-2034)
• Table 66: Market Size of Multiple Myeloma by Second-line Therapies in the United States, USD million (2020-2034)
• Table 67: Market Size of Multiple Myeloma by Third-line Therapies in the United States, USD million (2020-2034)
• Table 68: Market Size of Multiple Myeloma by Fourth-line Therapies in the United States, USD million (2020-2034)
• Table 69: Market Size of Multiple Myeloma in EU4 and the UK, USD million (2020-2034)
• Table 70: Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in Germany, USD million (2020-2034)
• Table 71: Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in France, USD million (2020-2034)
• Table 72: Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in Italy, USD million (2020-2034)
• Table 73: Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in Spain, USD million (2020-2034)
• Table 74: Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in the United Kingdom, USD million (2020-2034)
• Table 75: Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in EU4 and the UK, USD million (2020-2034)
• Table 76: Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in Germany, USD million (2020-2034)
• Table 77: Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in France, USD million (2020-2034)
• Table 78: Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in Italy, USD million (2020-2034)
• Table 79: Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in Spain, USD million (2020-2034)
• Table 80: Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in the United Kingdom, USD million (2020-2034)
• Table 81: Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in EU4 and the UK, USD million (2020-2034)
• Table 82: Market Size of Multiple Myeloma by Second-line Therapies in Germany, USD million (2020-2034)
• Table 83: Market Size of Multiple Myeloma by Second-line Therapies in France, USD million (2020-2034)
• Table 84: Market Size of Multiple Myeloma by Second-line Therapies in Italy, USD million (2020-2034)
• Table 85: Market Size of Multiple Myeloma by Second-line Therapies in Spain, USD million (2020-2034)
• Table 86: Market Size of Multiple Myeloma by Second-line Therapies in the United Kindgom, USD million (2020-2034)
• Table 87: Market Size of Multiple Myeloma by Second-line Therapies in EU4 and the UK, USD million (2020-2034)
• Table 88: Market Size of Multiple Myeloma by Third-line Therapies in Germany, USD million (2020-2034)
• Table 89: Market Size of Multiple Myeloma by Third-line Therapies in France, USD million (2020-2034)
• Table 90: Market Size of Multiple Myeloma by Third-line Therapies in Italy, USD million (2020-2034)
• Table 91: Market Size of Multiple Myeloma by Third-line Therapies in Spain, USD million (2020-2034)
• Table 92: Market Size of Multiple Myeloma by Third-line Therapies in the United Kingdom, USD million (2020-2034)
• Table 93: Market Size of Multiple Myeloma by Third-line Therapies in EU4 and the UK, USD million (2020-2034)
• Table 94: Market Size of Multiple Myeloma by Fourth-line Therapies in Germany, USD million (2020-2034)
• Table 95: Market Size of Multiple Myeloma by Fourth-line Therapies in France, USD million (2020-2034)
• Table 96: Market Size of Multiple Myeloma by Fourth-line Therapies in Italy, USD million (2020-2034)
• Table 97: Market Size of Multiple Myeloma by Fourth-line Therapies in Spain, USD million (2020-2034)
• Table 98: Market Size of Multiple Myeloma by Fourth-line Therapies in the United Kingdom, USD million (2020-2034)
• Table 99: Market Size of Multiple Myeloma by Fourth-line Therapies in EU4 and the UK, USD million (2020-2034)
• Table 100: Total Market Size of Multiple Myeloma in Japan, USD million (2020-2034)
• Table 101: Market Size of Multiple Myeloma by First-line Tranplsant Eligible Therapies in Japan, USD million (2020-2034)
• Table 102: Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in Japan, USD million (2020-2034)
• Table 103: Market Size of Multiple Myeloma by Second-line Therapies in Japan, USD million (2020-2034)
• Table 104: Market Size of Multiple Myeloma by Third-line Therapies in Japan, USD million (2020-2034)
• Table 105: Market Size of Multiple Myeloma by Fourth-line Therapies in Japan, USD million (2020-2034)
• Table 106: NICE Assessment for Multiple Myeloma Therapies
• Table 107: IQWiG Assessment for Multiple Myeloma Therapies
• Table 108: HAS Assessment for Multiple Myeloma Therapies
• Table 109: AEMPS Assessment for Multiple Myeloma Therapies
• Table 110: AIFA Assessment for Multiple Myeloma Therapies

List of Figures

• Figure 1: Factors Influencing the Choice of Therapy at Relapse
• Figure 2: NCCN Recommendation for Multiple Myeloma
• Figure 3: NCCN Recommendation for Symptomatic Treatment
• Figure 4: NCCN Recommendation for Relapse or Progressive Disease
• Figure 5: NCCN Recommendation for Relapse After Primary Therapy
• Figure 6 ESMO Recommendations for Multiple Myeloma Front-line Therapy
• Figure 7: Second-line Options for Multiple Myeloma Patients Who Received VRd and Dara-based Front-line Therapies
• Figure 8: Recommendations for Multiple Myeloma Patients Who Receive a Third or Subsequent Line of Therapy
• Figure 9: Total Incident Cases of Multiple Myeloma in the 7MM (2020-2034)
• Figure 10: Total Symptomatic Cases of Multiple Myeloma in the 7MM (2020-2034)
• Figure 11: Total Incident Cases of Multiple Myeloma in the United States (2020-2034)
• Figure 12: Total Symptomatic Cases of Multiple Myeloma in the United States (2020-2034)
• Figure 13: Gender-specific Cases of Multiple Myeloma in the United States (2020-2034)
• Figure 14: Age-specific Cases of Multiple Myeloma in the United States (2020-2034)
• Figure 15: Transplant Eligible and Ineligible Cases in Multiple Myeloma in the United States (2020-2034)
• Figure 16: Treated Cases across the lines of therapies in the United States (2020-2034)
• Figure 17: Total Incident Cases of Multiple Myeloma in EU4 and the UK (2020-2034)
• Figure 18: Total Symptomatic Cases of Multiple Myeloma in EU4 and the UK (2020-2034)
• Figure 19: Gender-specific Cases of Multiple Myeloma in EU4 and the UK (2020-2034)
• Figure 20: Age-specific Cases of Multiple Myeloma in EU4 and the UK (2020-2034)
• Figure 21: Transplant Eligible and Ineligible Cases in Multiple Myeloma in EU4 and the UK (2020-2034)
• Figure 22: Treated Cases across the lines of therapies in EU4 and the UK (2020-2034)
• Figure 23: Total Incident Cases of Multiple Myeloma in Japan (2020-2034)
• Figure 24: Total Symptomatic Cases of Multiple Myeloma in Japan (2020-2034)
• Figure 25: Gender-specific Cases of Multiple Myeloma in Japan (2020-2034)
• Figure 26: Age-specific Cases of Multiple Myeloma in Japan (2020-2034)
• Figure 27: Transplant Eligible and Ineligible Cases in Multiple Myeloma in Japan (2020-2034)
• Figure 28: Treated Cases across the lines of therapies in Japan (2020-2034)
• Figure 29: Market Size of Multiple Myeloma in the 7MM, USD million (2020-2034)
• Figure 30: Market Size of Multiple Myeloma in the United States, USD million (2020-2034)
• Figure 31: Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in the United States, USD million (2020-2034)
• Figure 32: Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in the United States, USD million (2020-2034)
• Figure 33: Market Size of Multiple Myeloma by Second-line Therapies in the United States, USD million (2020-2034)
• Figure 34: Market Size of Multiple Myeloma by Third-line Therapies in the United States, USD million (2020-2034)
• Figure 35: Market Size of Multiple Myeloma by Fourth-line Therapies in the United States, USD million (2020-2034)
• Figure 36: Market Size of Multiple Myeloma in EU4 and the UK, USD million (2020-2034)
• Figure 37: Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in EU4 and the UK, USD million (2020-2034)
• Figure 38: Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in EU4 and the UK, USD million (2020-2034)
• Figure 39: Market Size of Multiple Myeloma by Second-line Therapies in EU4 and the UK, USD million (2020-2034)
• Figure 40: Market Size of Multiple Myeloma by Third-line Therapies in EU4 and the UK, USD million (2020-2034)
• Figure 41: Market Size of Multiple Myeloma by Fourth-line Therapies in EU4 and the UK, USD million (2020-2034)
• Figure 42: Total Market Size of Multiple Myeloma in Japan, USD million (2020-2034)
• Figure 43: Market Size of Multiple Myeloma by First-line Tranplant Eligible Therapies in Japan, USD million (2020-2034)
• Figure 44: Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in Japan, USD million (2020-2034)
• Figure 45: Market Size of Multiple Myeloma by Second-line Therapies in Japan, USD million (2020-2034)
• Figure 46: Market Size of Multiple Myeloma by Third-line Therapies in Japan , USD million (2020-2034)
• Figure 47: Market Size of Multiple Myeloma by Fourth-line Therapies in Japan, USD million (2020-2034)

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

9. PATIENT JOURNEY

10. KEY ENDPOINTS IN MULTIPLE MYELOMA

11. MARKETED DRUGS

• 11.1. KEY COMPETITORS
• 11.2. SARCLISA (ISATUXIMAB-IRFC): SANOFI
  • 11.2.1. Product Description
  • 11.2.2. Regulatory Milestones
  • 11.2.3. Pivotal Clinical Trials
  • 11.2.4. Other Developmental Activities
  • 11.2.5. Current Pipeline Activity
  • 11.2.6. Safety and Efficacy
  • 11.2.7. Product Profile
• 11.3. FARYDAK (PANOBINOSTAT): SECURA BIO
  • 11.3.1. Product Description
  • 11.3.2. Regulatory Milestones
  • 11.3.3. Other Developmental Activities
  • 11.3.4. Pivotal Clinical Trials
  • 11.3.5. Product Profile
• 11.4. XPOVIO/NEXPOVIO (SELINEXOR): KARYOPHARM THERAPEUTICS
  • 11.4.1. Product Description
  • 11.4.2. Regulatory Milestones
  • 11.4.3. Other Developmental Activities
  • 11.4.4. Pivotal Clinical Trials
  • 11.4.5. Current Pipeline Activity
  • 11.4.6. Safety and Efficacy
  • 11.4.7. Product Profile
• 11.5. ABECMA (IDECABTAGENE VICLEUCEL): BRISTOL-MYERS SQUIBB/BLUEBIRD BIO
  • 11.5.1. Product Description
  • 11.5.2. Regulatory Milestones
  • 11.5.3. Other Developmental Activities
  • 11.5.4. Pivotal Clinical Trials
  • 11.5.5. Current Pipeline Activity
  • 11.5.6. Safety and Efficacy
  • 11.5.7. Product Profile
• 11.6. BLENREP (BELANTAMAB MAFODOTIN): GLAXOSMITHKLINE
  • 11.6.1. Product Description
  • 11.6.2. Regulatory Milestones
  • 11.6.3. Other Developmental Activities
  • 11.6.4. Pivotal Clinical Trial
  • 11.6.5. Current Pipeline Activity
  • 11.6.6. Safety and Efficacy
  • 11.6.7. Product Profile
• 11.7. PEPAXTO/PEPAXTI (MELFLUFEN/MELPHALAN FLUFENAMIDE): ONCOPEPTIDES AB
  • 11.7.1. Product Description
  • 11.7.2. Regulatory Milestones
  • 11.7.3. Other Developmental Activities
  • 11.7.4. Pivotal Clinical Trial
  • 11.7.5. Safety and Efficacy
  • 11.7.6. Product Profile
• 11.8. DARZALEX (DARATUMUMAB): JOHNSON & JOHNSON (JANSSEN)
  • 11.8.1. Product Description
  • 11.8.1. Regulatory Milestones
  • 11.8.2. Other Developmental Activities
  • 11.8.3. Pivotal Clinical Trial
  • 11.8.4. Current Pipeline Activity
  • 11.8.5. Safety and Efficacy
  • 11.8.6. Product Profile
• 11.9. VELCADE (BORTEZOMIB): TAKEDA PHARMACEUTICAL AND JANSSEN PHARMACEUTICAL
  • 11.9.1. Product Description
  • 11.9.2. Regulatory Milestones
  • 11.9.3. Other Developmental Activities
  • 11.9.4. Pivotal Clinical Trial
  • 11.9.5. Product Profile
• 11.1. EMPLICITI (ELOTUZUMAB): BRISTOL-MYERS SQUIBB AND ABBVIE
  • 11.10.1. Product Description
  • 11.10.2. Regulatory Milestones
  • 11.10.3. Other Developmental Activities
  • 11.10.4. Pivotal Clinical Trials
  • 11.10.5. Current Pipeline Activity
  • 11.10.6. Product Profile
• 11.11. TECVAYLI (TECLISTAMAB-CQYV): JOHNSON & JOHNSON (JANSSEN)
  • 11.11.1. Product Description
  • 11.11.2. Regulatory Milestones
  • 11.11.3. Other Developmental Activities
  • 11.11.4. Pivotal Clinical Trials
  • 11.11.5. Current Pipeline Activity
  • 11.11.6. Safety and Efficacy
  • 11.11.7. Product Profile
• 11.12. KYPROLIS (CARFILZOMIB): AMGEN AND ONO PHARMACEUTICAL
  • 11.12.1. Product Description
  • 11.12.2. Regulatory Milestones
  • 11.12.3. Other Developmental Activities
  • 11.12.4. Pivotal Clinical Trials
  • 11.12.5. Current Pipeline Activity
  • 11.12.6. Product Profile
• 11.13. REVLIMID (LENALIDOMIDE): BMS (CELGENE)
  • 11.13.1. Product Description
  • 11.13.2. Regulatory Milestones
  • 11.13.3. Other Developmental Activities
  • 11.13.4. Pivotal Clinical Trials
  • 11.13.5. Product Profile
• 11.14. POMALYST/IMNOVID (POMALIDOMIDE): BRISTOL MYERS SQUIBB COMPANY (CELGENE)
  • 11.14.1. Product Description
  • 11.14.2. Regulatory Milestones
  • 11.14.3. Other Developmental Activities
  • 11.14.4. Pivotal Clinical Trials
  • 11.14.5. Current Pipeline Activity
  • 11.14.6. Safety and Efficacy
  • 11.14.7. Product Profile
• 11.15. CARVYKTI (CILTACABTAGENE AUTOLEUCEL): JOHNSON & JOHNSON (JANSSEN)
  • 11.15.1. Product Description
  • 11.15.2. Regulatory Milestones
  • 11.15.3. Other Developmental Activities
  • 11.15.4. Pivotal Clinical Trials
  • 11.15.5. Current Pipeline Activity
  • 11.15.6. Safety and Efficacy
  • 11.15.7. Product Profile
• 11.16. NINLARO (IXAZOMIB): TAKEDA PHARMACEUTICAL
  • 11.16.1. Product Description
  • 11.16.2. Regulatory Milestones
  • 11.16.3. Other Developmental Activities
  • 11.16.4. Pivotal Clinical Trials
  • 11.16.5. Current Pipeline Activity
  • 11.16.6. Safety and Efficacy
  • 11.16.7. Product Profile
• 11.17. TALVEY (TALQUETAMAB): JOHNSON & JOHNSON INNOVATIVE MEDICINE
  • 11.17.1. Product Description
  • 11.17.2. Regulatory Milestones
  • 11.17.3. Other Developmental Activity
  • 11.17.4. Pivotal Clinical Trials
  • 11.17.5. Current Pipeline Activity
  • 11.17.6. Safety and Efficacy
  • 11.17.7. Product Profile
• 11.18. ELREXFIO (ELRANATAMAB): PFIZER
  • 11.18.1. Product Description
  • 11.18.2. Regulatory Milestones
  • 11.18.3. Other Developmental Activity
  • 11.18.4. Pivotal Clinical Trial
  • 11.18.5. Current Pipeline Activity
  • 11.18.6. Safety and Efficacy
  • 11.18.7. Product Profile

12. EMERGING THERAPIES

• 12.1. KEY COMPETITORS
• 12.2. MEZIGDOMIDE (CC-92480): BRISTOL MYERS SQUIBB/CELGENE
  • 12.2.1. Product Description
  • 12.2.2. Other Developmental Activities
  • 12.2.3. Clinical Development
  • 12.2.4. Safety and Efficacy
• 12.3. ANITO-CEL (CART-DDBCMA): ARCELLX
  • 12.3.1. Product Description
  • 12.3.2. Other Developmental Activities
  • 12.3.3. Clinical Development
  • 12.3.4. Safety and Efficacy
• 12.4. PHE885 (DURCABTAGENE AUTOLEUCEL): NOVARTIS
  • 12.4.1. Product Description
  • 12.4.2. Other Developmental Activities
  • 12.4.3. Clinical Development
  • 12.4.4. Safety and Efficacy
• 12.5. REGN5459: REGENERON PHARMACEUTICALS
  • 12.5.1. Product Description
  • 12.5.2. Clinical Development
  • 12.5.3. Safety and Efficacy
• 12.6. DESCARTES-11: CARTESIAN THERAPEUTICS
  • 12.6.1. Product Description
  • 12.6.2. Other Developmental Activities
  • 12.6.3. Clinical Development
• 12.7. HDP-101: HEIDELBERG PHARMA
  • 12.7.1. Product Description
  • 12.7.2. Other Developmental Activities
  • 12.7.3. Clinical Development
  • 12.7.4. Safety and Efficacy
• 12.8. BGB-11417 (SONROTOCLAX): BEIGENE
  • 12.8.1. Product Description
  • 12.8.2. Other Developmental Activities
  • 12.8.3. Clinical Development
  • 12.8.4. Safety and Efficacy
• 12.9. ZEVORCABTAGENE AUTOLEUCEL: CARSGEN THERAPEUTICS
  • 12.9.1. Product Description
  • 12.9.2. Other Developmental Activities
  • 12.9.3. Clinical Development
  • 12.9.4. Safety and Efficacy
• 12.1. CFT7455: C4 THERAPEUTICS
  • 12.10.1. Product Description
  • 12.10.2. Other Developmental Activities
  • 12.10.3. Clinical Development
  • 12.10.4. Safety and Efficacy
• 12.11. ABBV-383 (TNB-383B): ABBVIE (TENEOONE)
  • 12.11.1. Product Description
  • 12.11.2. Other Developmental Activities
  • 12.11.3. Clinical Development
  • 12.11.4. Safety and Efficacy
• 12.12. ALNUCTAMAB: BRISTOL MYERS SQUIBB
  • 12.12.1. Product Description
  • 12.12.2. Other Developmental Activities
  • 12.12.3. Clinical Development
  • 12.12.4. Safety and Efficacy
• 12.13. BMS-986393/CC-95266: BRISTOL MYERS SQUIBB
  • 12.13.1. Product Description
  • 12.13.2. Other Developmental Activities
  • 12.13.3. Clinical Development
  • 12.13.4. Safety and Efficacy
• 12.14. VENCLEXTA (VENETOCLAX): ABBVIE AND ROCHE (GENENTECH)
  • 12.14.1. Product Description
  • 12.14.2. Other Developmental Activities
  • 12.14.3. Clinical Development
  • 12.14.4. Safety and Efficacy
• 12.15. LINVOSELTAMAB: REGENERON PHARMACEUTICALS
  • 12.15.1. Product Description
  • 12.15.2. Other Developmental Activities
  • 12.15.3. Clinical Development
  • 12.15.4. Safety and Efficacy
• 12.16. IBERDOMIDE (CC-220): BRISTOL MYERS SQUIBB/CELGENE
  • 12.16.1. Product Description
  • 12.16.2. Other Developmental Activities
  • 12.16.3. Clinical Development
  • 12.16.4. Safety and Efficacy
• 12.17. CEVOSTAMAB: ROCHE (GENENTECH)
  • 12.17.1. Product Description
  • 12.17.2. Other Developmental Activities
  • 12.17.3. Clinical Development
  • 12.17.4. Safety and Efficacy

13. MULTIPLE MYELOMA: 7MM MARKET ANALYSIS

• 13.1. KEY FINDINGS
• 13.2. TOTAL MARKET SIZE OF MULTIPLE MYELOMA IN THE 7MM
• 13.3. MARKET OUTLOOK
• 13.4. KEY MARKET FORECAST ASSUMPTIONS
• 13.5. UNITED STATES MARKET SIZE
  • 13.5.1. Total Market Size of Multiple Myeloma in the United States
  • 13.5.2. Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in the United States
  • 13.5.3. Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in the United States
  • 13.5.4. Market Size of Multiple Myeloma by Second-line Therapies in the United States
  • 13.5.5. Market Size of Multiple Myeloma by Third-line Therapies in the United States
  • 13.5.6. Market Size of Multiple Myeloma by Fourth-line Therapies in the United States
• 13.6. EU4 AND THE UK MARKET SIZE
  • 13.6.1. Total Market Size of Multiple Myeloma in EU4 and the UK
  • 13.6.2. Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in EU4 and the UK
  • 13.6.3. Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in EU4 and the UK
  • 13.6.4. Market Size of Multiple Myeloma by Second-line Therapies in EU4 and the UK
  • 13.6.5. Market Size of Multiple Myeloma by Third-line Therapies in EU4 and the UK
  • 13.6.6. Market Size of Multiple Myeloma by Fourth-line Therapies in EU4 and the UK
• 13.7. JAPAN MARKET SIZE
  • 13.7.1. Total Market Size of Multiple Myeloma in Japan
  • 13.7.2. Market Size of Multiple Myeloma by First-line Transplant Eligible Therapies in Japan
  • 13.7.3. Market Size of Multiple Myeloma by First-line Transplant Ineligible Therapies in Japan
  • 13.7.4. Market Size of Multiple Myeloma by Second-line Therapies in Japan
  • 13.7.5. Market Size of Multiple Myeloma by Third-line Therapies in Japan
  • 13.7.6. Market Size of Multiple Myeloma by Fourth-line Therapies in Japan

14. UNMET NEEDS

15. SWOT ANALYSIS

16. KOL VIEWS

17. MARKET ACCESS AND REIMBURSEMENT

• 17.1. UNITED STATES MARKET ACCESS AND REIMBURSEMENT
• 17.2. THE NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE (NICE): UK
• 17.3. INSTITUTE FOR QUALITY AND EFFICIENCY IN HEALTH CARE (IQWIG): GERMANY
• 17.4. HAUTE AUTORITE DE SANTE (HAS): FRANCE
• 17.5. SPANISH AGENCY OF MEDICINES AND MEDICAL PRODUCTS (AEMPS): SPAIN
• 17.6. ITALIAN MEDICINES AGENCY (AIFA): ITALY
• 17.7. PATIENT ACCESS PROGRAM

18. APPENDIX

• 18.1. ACRONYMS AND ABBREVIATIONS
• 18.2. BIBLIOGRAPHY
• 18.3. REPORT METHODOLOGY

19. DELVEINSIGHT CAPABILITIES

20. DISCLAIMER

21. ABOUT DELVEINSIGHT