オリゴ転移疾患市場 - 市場の洞察、疫学、市場予測：2034年

主なハイライト

• 主要7ヶ国のオリゴ転移疾患の市場規模は2023年に約19億米ドルとなりましたが、症例数の増加と新規治療法の発売により、予測期間（2024年～2034年）に大幅な増加が見込まれます。
• オリゴ転移疾患とは、限局性疾患と広域性疾患の間の移行状態を指します。通常、原発巣を越えて1～5カ所の遠隔部位に転移します。
• 2023年には、米国がオリゴ転移疾患の症例数で最も多く、約40％が主要7ヶ国で発見されました。
• オリゴ転移のがんの主な種類は、乳がん、前立腺がん、大腸がん、腎細胞がん、非小細胞肺がんなどです。
• 2023年の米国における乏血転移症例数は約3万例で、乏血転移症例数が最も多いのは非小細胞肺がんでした。
• オリゴ転移疾患治療薬の開発をさまざまな段階で進めている市場開拓の主な企業は、ImmuneSensor Therapeutics、POINT Biopharma、Novartis Pharmaceuticals、AstraZeneca PLC、Bristol-Myers Squibb Companyなどです。
• オリゴ転移疾患の正確な診断は、転移病変を同定し局在化させるために、陽電子放射断層撮影法（PET-CT）や磁気共鳴画像法（MRI）などの高度な画像診断技術に依存しています。
• オリゴ転移前立腺がんは、放射線療法やホルモン療法などの全身療法で治療されます。放射線療法を行うことで、ホルモン療法からの休薬期間が長くなります。
• オリゴ転移非小細胞肺がんでは、免疫療法や化学療法を行った後に放射線療法や手術を行うことで長期的な効果が得られることが多いです。
• オリゴ転移腎がんは、定位体放射線療法（SBRT）やその他の放射線療法で治療することができます。
• オリゴ転移大腸がんは、大腸がんが体内の他の部位に転移することで発生します。オリゴ転移大腸がんが肝臓に限局している場合は、SBRT、ラジオ波焼灼療法、手術別治療が最も効果的です。
• 現在、オリゴ転移疾患の治療薬として承認されているものはありません。オリゴ転移疾患の治療法はほとんど研究されていないのです。開発に携わっている主な企業には、ImmuneSensor Therapeutics（IMSA101）、POINT Biopharma（PNT2002）、Novartis Pharmaceuticals（PLUVICTO）などがあります。
• オリゴ転移疾患患者の長期転帰と生存についての理解は、現在のところ限られています。局所治療効果の持続性を評価し、疾患再発のパターンを評価し、生存とQOLに影響する予後因子を同定するためには、縦断的研究が必要です。さらに、サバイバーシップと治療の晩期効果に焦点を当てた研究は、患者の治療後のケアと支援戦略を最適化するのに役立つとみられています。

• オリゴ転移疾患市場レポートでは、疫学セグメントと予測に関する広範な知識を提供し、診断率、疾患の進行、治療ガイドラインにおける将来の潜在的成長についての深い理解を提示します。これらの側面に関する包括的な洞察を提供し、主題の徹底的な評価を可能にします。
• さらに、現在の管理技術や新たな治療法に関する包括的な説明や、現在の治療状況に影響を与え、全体的な市場シフトをもたらすであろう後期（フェーズII）および著名な治療法の詳細なプロファイルが当レポートで提供されています。
• 当レポートはまた、オリゴ転移疾患市場の包括的な分析を網羅し、その市場規模実績と予測市場規模（2020年～2034年）の詳細な検証を提供しています。また、治療薬の市場シェア、詳細な前提条件、調査手法の根拠も記載しています。また、主要7ヶ国地域の薬剤アウトリーチも掲載しています。
• 主要7ヶ国のオリゴ転移疾患市場の形成と推進に役立つSWOT分析、様々な病院や著名大学の専門家を含む専門家の洞察/KOLの見解、患者の旅、治療の嗜好を通して動向を理解し、事業戦略を開拓する際に強みとなる定性的洞察を含んでいます。

オリゴ転移疾患は転移の一種であり、原発腫瘍のがん細胞が全身に広がり、さらに1～2ヵ所に少数の転移性腫瘍を形成します。例えば、がん細胞は大腸から肝臓へ、あるいは乳房から脳へ移動し、1～2個の新しい腫瘍を発生させます。

この概念は、がんは一様に進行する全身性の疾患であるという従来の考え方に疑問を投げかけるものであり、転移病変を制御または根絶するための積極的な局所治療が有効な患者もいることを示唆しています。

オリゴ転移患者を正確に同定するためには、PETや脳MRIなどの最新の画像診断技術を用いることが、従来の画像診断技術では見えなかった潜行転移の存在を検出するために不可欠です。MRIは脳転移の検出においてCTより優れており、しばしばCTでは見えない病変を検出します。PET/CTによる画像診断は、標準的なCTでは見えない転移がPET/CTで検出されると病期が移行するため、より良好な生存転帰と関連します。このようなより高度な画像検査は、当初乏転移性と考えられていた患者の潜伏転移を検出することができ、その結果、治療効果が期待できない患者に積極的な局所療法が適用されるのを防ぐことができます。

遠隔転移病変の数が少なく、進行が緩やかで、病変の大きさが小さい患者には、様々な局所焼灼術が有効であることを示唆するエビデンスが増えつつあります。これらの手法は、非小細胞肺がん、大腸がん、腎細胞がん、肉腫などの一部のがんでは、標準治療法としてすでに確立されています。

これまでは外科的切除が選択されてきましたが、最近の研究により、定位（切除）体放射線治療（SABR/SBRT）が多くの患者にとって実行可能な非侵襲的治療法として確立されつつあります。

これらの局所介入は非常に有効であることが証明されていますが、このような介入をどの患者にも割り当てる前に、患者関連因子（一般的な健康状態、患者の嗜好、社会経済的背景）や疾患関連因子（原発腫瘍部位、増殖動態、同期転移、準同時転移）など、いくつかの臨床的変数を考慮する必要があります。

• 主要7ヶ国の中で、米国はオリゴ転移症例数が最も多く（～117,800年）、2023年にはこれに日本が続きます。
• オリゴ転移が観察される主ながん種は、乳がん、非小細胞肺がん、ホルモン療法未実施前立腺がん、去勢抵抗性前立腺がん、頭頸部がん、大腸がん、膵臓がん、腎細胞がんです。2023年には、米国の非小細胞肺がんで最も多くの乏血転移が観察されました。
• 2023年には、米国では約70％の症例でメタクロナスオリゴ転移が認められ、これにシンクロナスオリゴ転移が続きました。
• EU4ヶ国と英国のうち、2023年の症例数が最も多かったのはドイツで、次いで英国とフランスでした。

Eli Lilly and Company/POINT Biopharma、ImmuneSensor Therapeutics、Novartis Pharmaceuticalsなど、さまざまな主要企業がオリゴ転移疾患の治療状況をリードしています。国別および治療法別の市場規模の詳細を以下に示します。

• 2023年、米国は主要7ヶ国の中で最大のオリゴ転移疾患市場規模を占め、主要7ヶ国のオリゴ転移疾患市場規模全体の～50%を占めています。
• 予測期間中に上市される可能性のあるパイプライン中のオリゴ転移疾患治療薬の数は限られているため、現在利用可能な全身療法が2034年までに支配的な地位を維持すると予想されます。
• ImmuneSensor Therapeutics社のIMSA101は、予測期間中にオリゴ転移疾患の市場規模を大きく獲得すると予想されます。
• EU4ヶ国と英国の中では、ドイツが最大のオリゴ転移疾患市場規模をカバーすると予測され、最小のオリゴ転移疾患市場規模はスペインがカバーすると予測されます。

オリゴ転移疾患治療薬の新薬

IMSA101：ImmuneSensor Therapeutics

IMSA101は、環状グアノシン一リン酸-アデノシン一リン酸（cGAMP）の腫瘍内投与型新規低分子アナログであり、抗腫瘍免疫を増加させ、最終的にサイトカインを刺激して「冷たい」腫瘍を「熱い」腫瘍に変えるユニークな防御感知メカニズムで設計されています。現在、オリゴ転移疾患の治療薬として第II相臨床試験が行われています。

PNT2002（177Lu-PNT2002）：POINT Biopharma/Eli Lilly and Company

177Lu-PNT2002は前立腺特異的膜抗原（PSMA）を標的としたルテチウム177ベースの放射性リガンド治療薬です。現在、定位放射線治療（SBRT）の前に177-Lutetium-PSMAを投与することで、前治療後に再発した1～5個の前立腺がん患者（オリゴ転移症）のがん制御率を改善できるかどうかを検証する第II相試験が実施されています。

オリゴ転移疾患には薬剤ベースの治療法はなく、現在の治療パラダイムは、レトロスペクティブ研究や小規模研究で顕著な効果が示されている放射線治療や手術などの局所切除療法に依存しています。いくつかの第II相試験では、定位放射線治療（SBRT）または手術と標準治療（SoC）全身療法との併用による確定的局所療法が、無増悪生存期間（PFS）または全生存期間（OS）を延長することにより、選択されたオリゴ転移患者に有益であることが示されています。

第III相オリゴ転移疾患臨床試験のデータがない中、現代のがん治療の基本は、最新の調査とベストプラクティスに基づいて症例ごとに推奨を行う集学的腫瘍委員会（multidisciplinary tumor board）による学際的な議論と意思決定であり続けています。がん患者に対する集学的腫瘍ボードの日常的な使用は、臨床転帰を改善し、SoCの遵守を高め、より充実した治療勧告をもたらすことが実証されています。

開発の主な企業は、ImmuneSensor Therapeutics、POINT Biopharma、Novartis Pharmaceuticals、AstraZeneca PLC、Bristol-Myers Squibb Companyなどです。

オリゴ転移疾患パイプラインには、予測期間（2024-2034年）中に発売が期待される薬剤はほとんどありません。新興のオリゴ転移疾患治療薬であるIMSA101（ImmuneSensor Therapeutics）とPNT2002（POINT Biopharma）は、いずれも臨床第2相段階にあります。

当レポートでは、主要7ヶ国におけるオリゴ転移疾患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 オリゴ転移疾患市場概要

• 2020年のオリゴ転移疾患の市場シェア（％）分布
• 2034年のオリゴ転移疾患の市場シェア（％）分布

第4章 オリゴ転移疾患のエグゼクティブサマリー

第5章 疾患の背景と概要

• イントロダクション
• オリゴ転移疾患の生物学的基礎
• オリゴ転移疾患に関連する用語
• オリゴ転移がんの主な種類
• 診断
• 欧州がん調査治療機構（EORTC）：オリゴ転移疾患の特徴づけと分類に関するコンセンサス勧告
• 治療と管理
• 外科的切除
• 放射線治療
• 凍結療法
• さまざまながんにおけるオリゴ転移の治療
• ASTRO/ESTROオリゴ転移非小細胞肺がん治療に関する臨床実践ガイドライン
• オリゴ転移前立腺がんに対する放射線療法の推奨事項：ESTRO-ACROP Delphiコンセンサス
• 第5回ESO-ESMO進行乳がん国際コンセンサスガイドライン（ABC 5）
• SEOM軟部肉腫治療臨床ガイドライン（2020年）
• 治療アルゴリズム

第6章 調査手法

第7章 疫学と患者人口

• 主な調査結果
• 仮定と根拠
• 主要7ヶ国におけるオリゴ転移疾患症例の総数
• 米国
• EU4ヶ国と英国
• 日本

第8章 オリゴ転移疾患の患者動向

第9章 新たなオリゴ転移疾患治療法

• キークロス
• IMSA101：免疫センサー治療
• 製品説明
• 臨床開発活動
• PNT2002（177Lu-PNT2002）：POINT Biopharma
• 製品説明
• その他の発達活動
• 臨床開発活動
• プルビクト（177Lu-PSMA-617）：Novartis Pharmaceuticals
• 製品説明
• 臨床開発活動

第10章 オリゴ転移疾患市場：主要7ヶ国市場分析

• 主な調査結果
• オリゴ転移疾患の市場展望
• オリゴ転移疾患コンジョイント分析
• オリゴ転移疾患市場予測の前提条件
• 主要7ヶ国におけるオリゴ転移疾患の総市場規模
• 主要7ヶ国における治療別オリゴ転移疾患市場規模
• 米国：オリゴ転移疾患市場規模
• EU4ヶ国と英国：オリゴ転移疾患の市場規模
• 日本：オリゴ転移疾患市場規模

第11章 KOLの見解

第12章 SWOT分析

第13章 アンメットニーズ

第14章 オリゴ転移疾患の市場アクセスと償還

• 米国
• EU4ヶ国と英国
• 日本

第15章 付録

第16章 DelveInsightのサービス内容

第17章 免責事項

List of Tables

• Table 1: Summary of Oligometastatic Disease, Market and Epidemiology (2020-2034)
• Table 2: Oligometastatic State Definition for NSCLC
• Table 3: Recommendations for the Treatment of Oligometastatic NSCLC
• Table 4: Consensus Recommendations for the Treatment of Oligometastatic Prostate Cancer
• Table 5: Total Oligometastatic Disease Cases in the 7MM (2020-2034)
• Table 6: Total Oligometastatic Disease Cases in the United States (2020-2034)
• Table 7: Oligometastatic Disease Cases by Major Cancer Indications in the United States (2020-2034)
• Table 8: Type-specific Cases of Oligometastatic Disease in the United States (2020-2034)
• Table 9: Total Oligorecurrent Cases in the United States (2020-2034)
• Table 10: Oligorecurrent Cases by Major Cancer Indications in the United States (2020-2034)
• Table 11: Total Oligometastatic Disease Cases in EU4 and the UK (2020-2034)
• Table 12: Oligometastatic Disease Cases by Major Cancer Indications in EU4 and the UK (2020-2034)
• Table 13: Type-specific Cases of Oligometastatic Disease in EU4 and the UK (2020-2034)
• Table 14: Total Oligorecurrent Cases in EU4 and the UK (2020-2034)
• Table 15: Oligorecurrent Cases by Major Cancer Indications in EU4 and the UK (2020-2034)
• Table 16: Total Oligometastatic Disease Cases in Japan (2020-2034)
• Table 17: Oligometastatic Disease Cases by Major Cancer Indications in Japan (2020-2034)
• Table 18: Type-specific Cases of Oligometastatic Disease in Japan (2020-2034)
• Table 19: Total Oligorecurrent Cases in Japan (2020-2034)
• Table 20: Oligorecurrent Cases by Major Cancer Indications in Japan (2020-2034)
• Table 21: Key Cross-Emerging Drugs
• Table 22: IMSA101, Clinical Trial Description, 2023
• Table 23: PNT2002 (177Lu-PNT2002), Clinical Trial Description, 2023
• Table 24: PLUVICTO (177Lu-PSMA-617), Clinical Trial Description, 2023
• Table 25: Key Market Forecast Assumptions for IMSA101
• Table 26: Key Market Forecast Assumptions for PNT2002
• Table 27: Total Oligometastatic Disease Market Size in the 7MM in USD million (2020-2034)
• Table 28: Oligometastatic Disease Market Size by Therapies in the 7MM in USD million (2020-2034)
• Table 29: Total Oligometastatic Disease Market Size in the United States in USD million (2020-2034)
• Table 30: Oligometastatic Disease Market Size by Therapies in the United States in USD million (2020-2034)
• Table 31: Total Oligometastatic Disease Market Size in EU4 and the UK in USD million (2020-2034)
• Table 32: Oligometastatic Disease Market Size by Therapies in EU4 and the UK in USD million (2020-2034)
• Table 33: Total Oligometastatic Disease Market Size in Japan in USD million (2020-2034)
• Table 34: Oligometastatic Disease Market Size by Therapies in Japan in USD million (2020-2034)

The List of Tables is not exhaustive, will be provided in the final report.

List of Figures

• Figure 1: Oligometastatic Disease vs. Systemic Disease
• Figure 2: Oligometastatic Disease vs. Systemic Disease
• Figure 3: Development of Clinically Overt Malignant Disease With a Possibility of Oligometastatic Cancer, as an Intermediate State Between Locoregionally Advanced and Typical Metastatic Disease, and its Different Forms
• Figure 4: Oligometastatic Prostate Cancer
• Figure 5: Oligometastatic Breast Cancer
• Figure 6: Oligometastatic Lung Cancer
• Figure 7: Diagnosis
• Figure 8: Decision Tree for Classification of Oligometastatic Disease
• Figure 9: Illustration of the Oligometastatic Disease Classification System
• Figure 10: OMBC Patients' Selection for MDT Based on Prognostic and Predictive Factors
• Figure 11: Multimodal Treatment Strategies for Oligometastatic or Oligoprogressive RCC
• Figure 12: Clinical Drivers of Decision-making in Prostate Cancer
• Figure 13: Multistep Process of Decision-making in Oligometastatic Cancer Patients
• Figure 14: Allocation of Local Therapy or Systemic Treatment Based on the Extent of Metastasis
• Figure 15: Total Oligometastatic Disease Cases in the 7MM (2019-2032)
• Figure 16: Total Oligometastatic Disease Cases in the United States (2019-2032)
• Figure 17: Oligometastatic Disease Cases by Major Cancer Indications in the United States (2019-2032)
• Figure 18: Type-specific Cases of Oligometastatic Disease in the United States (2019-2032)
• Figure 19: Total Oligorecurrent Cases in the United States (2019-2032)
• Figure 20: Oligorecurrent Cases by Major Cancer Indications in the United States (2019-2032)
• Figure 21: Total Oligometastatic Disease Cases in EU4 and the UK (2019-2032)
• Figure 22: Oligometastatic Disease Cases by Major Cancer Indications in EU4 and the UK (2019-2032)
• Figure 23: Type-specific Cases of Oligometastatic Disease in EU4 and the UK (2019-2032)
• Figure 24: Total Oligorecurrent Cases in EU4 and the UK (2019-2032)
• Figure 25: Oligorecurrent Cases by Major Cancer Indications in EU4 and the UK (2019-2032)
• Figure 26: Total Oligometastatic Disease Cases in Japan (2019-2032)
• Figure 27: Oligometastatic Disease Cases by Major Cancer Indications in Japan (2019-2032)
• Figure 28: Type-specific Cases of Oligometastatic Disease in Japan (2019-2032)
• Figure 29: Total Oligorecurrent Cases in Japan (2019-2032)
• Figure 30: Oligorecurrent Cases by Major Cancer Indications in Japan (2019-2032)
• Figure 31: Total Oligometastatic Disease Market Size in the 7MM in USD million (2019-2032)
• Figure 32: Oligometastatic Disease Market Size by Therapies in the 7MM in USD million (2019-2032)
• Figure 33: Total Oligometastatic Disease Market Size in the United States in USD million (2019-2032)
• Figure 34: Oligometastatic Disease Market Size by Therapies in the United States in USD million (2019-2032)
• Figure 35: Total Oligometastatic Disease Market Size in EU4 and the UK in USD million (2019-2032)
• Figure 36: Oligometastatic Disease Market Size by Therapies in EU4 and the UK in USD million (2019-2032)
• Figure 37: Total Oligometastatic Disease Market Size in Japan in USD million (2019-2032)
• Figure 38: Oligometastatic Disease Market Size by Therapies in Japan in USD million (2019-2032)
• Figure 39: Health Technology Assessment
• Figure 40: Reimbursement Process in Germany
• Figure 41: Reimbursement Process in France
• Figure 42: Reimbursement Process in Italy
• Figure 43: Reimbursement Process in Spain
• Figure 44: Reimbursement Process in the United Kingdom
• Figure 45: Reimbursement Process in Japan

The List of Figures is not exhaustive, will be provided in the final report.

Key Highlights:

• According to DelveInsight's patient-based forecasting model, the oligometastatic disease market size in the 7MM was around USD 1,900 million in 2023, which is expected to significantly increase over the forecast period (2024-2034), owing to an increase in the cases and the launch of new therapies.
• The oligometastatic disease refers to a transitional state between localized and widespread disease. It typically involves one to five distant sites beyond the primary tumor.
• In 2023, the United States accounted for the highest number of oligometastatic disease cases with approximately 40% cases found in the 7MM.
• Major types of oligometastatic cancers include oligometastatic breast cancer, oligometastatic prostate cancer, oligometastatic prostate cancer, oligometastatic colorectal cancer, oligometastatic renal cell cancer, oligometastatic non-small cell lung cancer.
• There were around 30,000 cases of oligorecurrent cases in the United States in 2023 and the highest number of oligorecurrent cases were observed in non-small cell lung cancer.
• The key Oligometastatic Disease companies in the market who are in different phases of developing Oligometastatic Disease Therapies are - ImmuneSensor Therapeutics, POINT Biopharma, Novartis Pharmaceuticals, AstraZeneca PLC, Bristol-Myers Squibb Company, and others.
• The accurate diagnosis of the oligometastatic disease relies on advanced imaging techniques, such as positron emission tomography-computed tomography (PET-CT) and magnetic resonance imaging (MRI), to identify and localize metastatic lesions.
• Oligometastatic prostate cancer is treated with systemic therapies, like radiation therapy or hormone therapy. Using radiation therapy gives patients a much longer break from hormone therapy.
• Oligometastatic non-small cell lung cancer patients often see long-term benefits from using radiation therapy or surgery after some immunotherapy or chemotherapy.
• Oligometastatic kidney cancer can be treated with stereotactic body radiation (SBRT) and other forms of radiation.
• Oligometastatic colorectal cancer occurs when colorectal cancer spreads to other sites in the body. If oligometastatic colorectal cancer is limited to the liver, it is treated most effectively with SBRT, radiofrequency ablation, and surgery.
• Currently, there are no approved drugs for the treatment of oligometastatic disease. Few oligometastatic disease therapies are being investigated for the treatment of oligometastatic disease. Some of the key players involved in the development are ImmuneSensor Therapeutics (IMSA101), POINT Biopharma (PNT2002), and Novartis Pharmaceuticals (PLUVICTO).
• Understanding the long-term outcomes and survival of patients with oligometastatic disease is currently limited. Longitudinal studies are needed to assess the durability of local treatment responses, evaluate patterns of disease recurrence, and identify prognostic factors that influence survival and quality of life. Additionally, studies focusing on survivorship and the late effects of treatment will help optimize post-treatment care and support strategies for the patient.

Oligometastatic Disease Market Report Summary

• The oligometastatic disease market report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the oligometastatic disease market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The oligometastatic disease market report includes qualitative insights that provide an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM oligometastatic disease market.

The table given below further depicts the key segments provided in the report:

Oligometastatic Disease Treatment Market

Oligometastatic Disease Overview

Oligometastatic disease is a type of metastasis in which cancer cells from the primary tumor spread throughout the body and create a few metastatic tumors in one or two additional locations. For instance, cancer cells can migrate from the colon to the liver or from the breast to develop one or two new tumors in the brain.

The oligometastatic disease is characterized by limited metastatic spread, typically involving one to five distant sites beyond the primary tumor.The concept challenges the traditional view of cancer as a uniformly progressive and systemic disease, suggesting that some patients may benefit from aggressive local treatment to control or eradicate metastatic lesions.

Oligometastatic Disease Diagnosis

To identify oligometastatic patients accurately, using modern imaging techniques, such as PET and brain MRI, is essential to detect the presence of occult metastases that are not visible with conventional imaging techniques. MRI is superior to CT in detecting brain metastases, often detecting lesions not visible on CT. PET/CT imaging is associated with better survival outcomes because metastases detected with PET/CT, which are not visible on standard CT, result in stage migration. These more advanced imaging tests can detect occult metastases in patients initially considered oligometastatic, thus preventing the application of aggressive local therapy in patients unlikely to benefit from treatment.

Oligometastatic Disease Market Treatment

There has been growing evidence, suggesting that patients with few and slowly progressive distant lesions of small size may benefit from various local ablation techniques. These techniques have already been established as standard-of-care modalities in some cancers like non-small-cell lung cancer, colorectal cancer, renal cell carcinomas, and sarcomas.

Surgical resection has been the method of choice; however, recent studies have helped establish stereotactic (ablative) body radiotherapy (SABR/SBRT) as a viable, non-invasive treatment option for many patients.

Although these local interventions have been proven to be highly effective, several other clinical variables are needed to be taken into account, including patient-related factors (general health status, patient preferences, and socioeconomic background) and disease-related factors (primary tumor site, growth kinetics, synchronous, or metachronous metastases) before allocating such intervention to any patient.

Oligometastatic Disease Epidemiology

The Oligometastatic Disease epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Oligometastatic Disease Cases, Oligometastatic Disease Cases by Major Cancer Indications, Type-Specific Cases of Oligometastatic Disease, Total Oligorecurrent Cases, and Oligorecurrent Cases by Major Cancer Indications in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Among the 7MM, the US recorded the highest (~117,800) number of oligometastatic disease cases, which was followed by Japan in 2023.
• The major cancer types in which oligometastasis is observed includes breast cancer, non-small cell lung cancer, hormone naive prostate cancer, castration resistant prostate cancer, head and neck cancer, colorectal cancer, pancreatic cancer, renal cell cancer. In 2023, highest number of oligometastasis were observed in non-small cell lung cancer in United States.
• As per DelveInsight's analysis, in 2023, there were approximately 70% cases of metachronous oligometastatic disease, which was followed by synchronous oligometastatic disease in the US.
• Among EU4 and UK, Germany accounted for the highest number of cases in 2023, followed by the UK and France, respectively.

Oligometastatic Disease Market

Various key players are leading the treatment landscape of oligometastatic disease, such as Eli Lilly and Company/ POINT Biopharma, ImmuneSensor Therapeutics, and Novartis Pharmaceuticals. The details of the country-wise and therapy-wise market size have been provided below.

• In 2023, the United States accounted for the largest Oligometastatic disease market size among the 7MM, making ~50% of the total Oligometastatic disease market size of the 7MM.
• There are limited number of Oligometastatic disease therapies in pipeline which may get launched during the forecast period and hence, currently available systemic therapies are expected to maintain dominant position by 2034.
• ImmuneSensor Therapeutics' IMSA101 is expected to capture a significant Oligometastatic disease market size of oligometastatic disease during the forecast period.
• Among EU4 and the UK, Germany is anticipated to cover the largest Oligometastatic disease market size, while the smallest Oligometastatic disease market size is expected to be covered by Spain.

Oligometastatic Disease Drug Chapters

The Oligometastatic Disease drug section report provides an in-depth evaluation of mid-stage pipeline drugs (Phase II) related to oligometastatic disease drug market.

The Oligometastatic Disease drug chapters section provides valuable information on various aspects related to Oligometastatic Disease clinical trials of disease, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting oligometastatic disease.

Emerging Oligometastatic Disease Therapies

IMSA101: ImmuneSensor Therapeutics

IMSA101 is an intra-tumoral adminsitred, novel small molecule analog of cyclic guanosine monophosphate-adenosine monophosphate (cGAMP), designed with a unique defense-sensing mechanism that increases antitumor immunity to ultimately stimulate cytokines to turn "cold" tumors to "hot," IMSA101 holds first-in-class potential for treating solid tumors. It is currently being investigated in Phase II clinical trial for the treatment of oligometastatic disease.

PNT2002 (177Lu-PNT2002): POINT Biopharma/Eli Lilly and Company

177Lu-PNT2002 is a prostate-specific membrane antigen (PSMA)-targeted lutetium 177-based radioligand therapy. It is currently being investigated under a Phase II trial to test whether 177-Lutetium-PSMA given before stereotactic body radiotherapy (SBRT) works to improve cancer control rate in patients with 1-5 prostate cancer tumors that have come back after prior treatment (oligorecurrent).

Oligometastatic Disease Market Outlook

No drug-based treatments are available for oligometastatic disease, with the current treatment paradigm being reliant on locally-ablative treatments like radiotherapy and surgery, which have shown noticeable benefits in retrospective and small-scale studies. Several Phase II trials have shown that definitive local therapy in the form of stereotactic body radiotherapy (SBRT) or surgery in combination with standard-of-care (SoC) systemic therapy can benefit selected oligometastatic patients by prolonging progression-free survival (PFS) or overall survival (OS).

In the absence of data from Phase III oligometastatic disease clinical trials, the foundation of contemporary cancer care continues to be interdisciplinary discussion and decision-making in the form of multidisciplinary tumor boards, which make case-by-case recommendations based on the latest research and best practices. It has been demonstrated that routine use of multidisciplinary tumor boards for cancer patients improves clinical outcomes, increases adherence to SoC, and results in more well-rounded treatment recommendations.

The key Oligometastatic Disease companies in the market who are in different phases of developing Oligometastatic Disease Therapies are - ImmuneSensor Therapeutics, POINT Biopharma, Novartis Pharmaceuticals, AstraZeneca PLC, Bristol-Myers Squibb Company, and others.

The oligometastatic disease pipeline possesses few drugs that are expected to be launched during the forecast period (2024-2034). Both of the emerging oligometastatic disease therapies, IMSA101 (ImmuneSensor Therapeutics) and PNT2002 (POINT Biopharma) are in Phase II clinical stage.

KOL Views

To stay abreast of the latest trends in the oligometastatic disease market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of oligometastatic disease, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts at Delveinsight connected with more than 10 KOLs across the 7MM. We contacted institutions such as the Dana Farber Cancer Institute, Royal Marsden Hospital, Kitasato University School of Medicine, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the oligometastatic disease market, which will assist our clients in analyzing the overall epidemiology and market scenario.

The opinion of experts from various regions has been provided below:

Oligometastatic Disease Qualitative Analysis

We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of 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.

Conjoint Analysis analyzes multiple approved and emerging oligometastatic disease therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in trials for oligometastatic disease, one of the most important primary endpoints was progression-free rate. Based on this, the overall efficacy is evaluated.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the oligometastatic disease drug in clinical trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging oligometastatic disease therapies are decided.

Oligometastatic Disease Market Access and Reimbursement

Because newly authorized oligometastatic disease drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the oligometastatic disease market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

The Oligometastatic disease market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Oligometastatic Disease Market Report Insights

• Oligometastatic disease Patient Population
• Oligometastatic disease Therapeutic Approaches
• Oligometastatic Disease Market Size
• Oligometastatic disease Market Trends
• Existing Oligometastatic disease Market Opportunity

Oligometastatic Disease Treatment Market Report Key Strengths

• Eleven-year Forecast
• The 7MM Coverage
• Oligometastatic Disease Epidemiology Segmentation
• Key Cross Competition

Oligometastatic Disease Market Report Assessment

• Current Treatment Practices
• Oligometastatic disease Reimbursements
• Oligometastatic disease Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis)

Key Questions:

• Would there be any changes observed in the treatment approach for oligometastatic disease over the forecast period?
• Will there be any new drug included in oligometastatic disease management recommendations?
• Would research and development advancements pave the way for future tests and therapies for oligometastatic disease?
• Would the diagnostic testing space change significantly and lead to a positive shift in the treatment landscape of oligometastatic disease?
• What kind of uptake will the new therapies witness in coming years in oligometastatic disease patients?

Table of Contents

1. Key Insights

2. Report Introduction

3. Oligometastatic Disease Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Oligometastatic Disease in 2020
• 3.2. Market Share (%) Distribution of Oligometastatic Disease in 2034

4. Executive Summary of Oligometastatic Disease

5. Disease Background and Overview

• 5.1. Introduction
• 5.2. Biological Basis for Oligometastatic Disease
• 5.3. Terminologies Related to Oligometastatic Disease
• 5.4. Major Types of Oligometastatic Cancers
• 5.5. Diagnosis
• 5.6. The European Organization for Research and Treatment of Cancer (EORTC): Consensus Recommendations on Characterization and Classification of Oligometastatic Disease
• 5.7. Treatment and Management
• 5.8. Surgical Resection
• 5.9. Radiation Therapy
• 5.10. Cryotherapy
• 5.11. Treatment of Oligometastasis in Different Cancers
  • 5.11.1. Breast Cancer
  • 5.11.2. Melanoma
  • 5.11.3. Colorectal Cancer
  • 5.11.4. Soft Tissue Sarcoma
  • 5.11.5. Renal Cell Carcinoma
  • 5.11.6. Prostate Cancer
  • 5.11.7. Future Therapeutic Directions
• 5.12. ASTRO/ESTRO Clinical Practice Guideline for the Treatment of Oligometastatic Non-small Cell Lung Cancer
• 5.13. Recommendations for Radiation Therapy in Oligometastatic Prostate Cancer: An ESTRO-ACROP Delphi Consensus
• 5.14. 5th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 5)
• 5.15. SEOM Clinical Guideline of Management of Soft-tissue Sarcoma (2020)
• 5.16. Treatment Algorithm

6. Methodology

7. Epidemiology and Patient Population

• 7.1. Key Findings
• 7.2. Assumptions and Rationale
• 7.3. Total Oligometastatic Disease Cases in the 7MM
• 7.4. The United States
  • 7.4.1. Total Oligometastatic Disease Cases in the United States
  • 7.4.2. Oligometastatic Disease Cases by Major Cancer Indications in the United States
  • 7.4.3. Type-Specific Cases of Oligometastatic Disease in the United States
  • 7.4.4. Total Oligorecurrent Cases in the United States
  • 7.4.5. Oligorecurrent Cases by Major Cancer Indications in the United States
• 7.5. EU4 and the UK
  • 7.5.1. Total Oligometastatic Disease Cases in EU4 and the UK
  • 7.5.2. Oligometastatic Disease Cases by Major Cancer Indications in EU4 and the UK
  • 7.5.3. Type-Specific Cases of Oligometastatic Disease in EU4 and the UK
  • 7.5.4. Total Oligorecurrent Cases in EU4 and the UK
  • 7.5.5. Oligorecurrent Cases by Major Cancer Indications in EU4 and the UK
• 7.6. Japan
  • 7.6.1. Total Oligometastatic Disease Cases in Japan
  • 7.6.2. Oligometastatic Disease Cases by Major Cancer Indications in Japan
  • 7.6.3. Type-Specific Cases of Oligometastatic Disease in Japan
  • 7.6.4. Total Oligorecurrent Cases in Japan
  • 7.6.5. Oligorecurrent Cases by Major Cancer Indications in Japan

8. Oligometastatic disease Patient Journey

9. Emerging Oligometastatic disease Therapies

• 9.1. Key Cross
• 9.2. IMSA101: ImmuneSensor Therapeutics
• 9.3. Product Description
• 9.4. Clinical Developmental Activities
• 9.5. PNT2002 (177Lu-PNT2002): POINT Biopharma
• 9.6. Product Description
• 9.7. Other Developmental Activities
• 9.8. Clinical Developmental Activities
• 9.9. PLUVICTO (177Lu-PSMA-617): Novartis Pharmaceuticals
• 9.10. Product Description
• 9.11. Clinical Developmental Activities

10. Oligometastatic Disease Market : Seven Major Market Analysis

• 10.1. Key Findings
• 10.2. Oligometastatic disease Market Outlook
• 10.3. Oligometastatic disease Conjoint Analysis
• 10.4. Key Oligometastatic disease Market Forecast Assumptions
• 10.5. Total Market Size of Oligometastatic Disease in the 7MM
• 10.6. Oligometastatic disease Market Size by Therapies in the 7MM
• 10.7. United States: Oligometastatic disease Market Size
  • 10.7.1. Total Market Size of Oligometastatic Disease in the United States
  • 10.7.2. Market Size of Oligometastatic Disease by Therapies in the United States
• 10.8. EU4 and the UK: Oligometastatic disease Market Size
  • 10.8.1. Total Market Size of Oligometastatic Disease in EU4 and the UK
  • 10.8.2. Market Size of Oligometastatic Disease by Therapies in EU4 and the UK
• 10.9. Japan: Oligometastatic disease Market Size
  • 10.9.1. Total Market Size of Oligometastatic Disease in Japan
  • 10.9.2. Market Size of Oligometastatic Disease by Therapies in Japan

11. KOL Views

12. SWOT Analysis

13. Unmet Needs

14. Oligometastatic disease Market Access and Reimbursement

• 14.1. The United States
  • 14.1.1. Centre for Medicare & Medicaid Services (CMS)
• 14.2. EU4 and the UK
  • 14.2.1. Germany
  • 14.2.2. France
  • 14.2.3. Italy
  • 14.2.4. Spain
  • 14.2.5. United Kingdom
• 14.3. Japan
  • 14.3.1. MHLW

15. Appendix

• 15.1. Bibliography
• 15.2. Report Methodology

16. DelveInsight Capabilities

17. Disclaimer

The Table of Contents is not exhaustive, will be provided in the final report.