胚細胞腫瘍治療の世界市場2023年～2030年

概要

生殖細胞腫瘍は、生殖細胞とも呼ばれる生殖細胞でできた腫瘤です。生殖細胞（germ）とは発芽（germinate）の略で、成熟（mature）を意味します。女性および出生時に女性に割り当てられた人（AFAB）の場合、生殖細胞は最終的に卵子に成熟します。男性および出生時に男性に割り当てられた人（AMAB）の場合、生殖細胞は精子に成熟します。これに関連して、生殖細胞腫瘍は主に卵巣と精巣でみられます。あまり一般的ではないが、胚細胞腫瘍は腹部、胸部、腰部、頭頸部および脳など、卵巣および精巣以外の身体部位に形成されます。これらの腫瘍は性腺外腫瘍と呼ばれます。

さらに、胚細胞腫瘍の主な治療法は手術です。ほとんどの胚細胞腫瘍は化学療法または化学療法と放射線療法の併用で治療されます。小児の生殖細胞腫瘍はまれで、がん診断のわずか3.5％であると推定されています。思春期や若年成人ではより一般的で、15～19歳で診断されるがんの13.9％を占める。

市場力学：促進要因

新規治療薬に対する需要の増加

生殖細胞腫瘍の治療に対する新規治療薬に対する需要の増加は、予測期間を通じて市場を牽引するとみられます。生殖細胞腫瘍には、卵巣がん、精巣がん、性腺外がんなどさまざまな種類が含まれます。新規治療薬の開発は、アンメット・メディカル・ニーズへの対応に役立ち、患者の予後改善につながります。バイオシミラー医薬品は、様々なタイプの生殖細胞腫瘍の治療において重要な役割を果たしています。バイオシミラー医薬品は、患者により安価な医薬品を提供し、多くの場合、これらの治療をより身近なものにし、生活の質を向上させる。

例えば、2023年5月29日、アルケムオンコロジー社は、頭頸部がんの治療に使用されるセツキシマブの世界初のバイオシミラーであるセツキサを発売しました。セツキサは、アルケム・ラボラトリーズの生物学部門であるエンゼン・バイオサイエンシズ・リミテッドが独自に研究・製造しています。

さらに、規制当局の承認は、新規治療薬の開発に対する患者の信頼を高める。例えば、2023年5月9日、Acrivon Therapeutics, Inc.は、プラチナ製剤抵抗性卵巣がんおよび子宮内膜がんにおけるACR-368の開発について、米国食品医薬品局（FDA）から2つのファスト・トラック指定を受けたと発表しました。ファスト・トラック指定は、重大なアンメット・メディカル・ニーズを有する重篤な疾患を治療する有望な治験薬の開発を促進し、審査を迅速化することを目的としています。

さらに、胚細胞腫瘍の治療でより良い結果を示す細胞療法のような新規治療薬の開発のために、多くの臨床試験が進行中です。例えば、2023年8月28日、がんの治療と予防に特化したバイオテクノロジー企業であるアニキサ・バイオサイエンシズ社は、モフィットがんセンターと提携し、卵巣がんに対するアニキサの新規キメラ抗原受容体T細胞（CAR-T）療法の進行中の臨床試験において、3人目の患者の治療を開始しました。

さらに、新規治療薬は併用療法によっても治療成績を向上させるため、患者の治療成績向上のための併用療法に関する多くの研究活動や承認が行われています。例えば、2023年4月17日にHUTCHMED（China）Limitedが発表したフルキンチニブとパクリタキセルの併用による進行胃がんまたは胃食道接合部腺がんの二次治療に関する新薬承認申請は、中国国家医薬品監督管理局（NMPA）の審査に受理されました。

さらに、卵巣がん、精巣がん、頭頸部がん、腹部がんなどの胚細胞腫瘍の有病率の増加、FDA承認の増加、臨床試験の増加、新薬や治療法の開発に対する意識の高まりや進歩が、予測期間中に市場を牽引すると予想される要因です。

阻害要因

治療に伴う合併症、胚細胞腫瘍の治療費の高さ、代替治療オプションの利用可能性などの要因が市場を阻害すると予想されます。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 新規治療薬に対する需要の増加
  • 抑制要因
    • 治療に伴う合併症
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• パイプライン分析
• アンメットニーズ
• 特許分析
• ボリューム分析
• DMIオピニオン

第6章 COVID-19分析

第7章 腫瘍タイプ別

• 精巣胚細胞腫瘍
  • セミノーマ
  • 非セミノーマ
    • 卵黄嚢腫瘍
    • 胚細胞がん
    • 絨毛がん
    • 奇形腫
• 卵巣胚細胞腫
• 外胚葉細胞腫瘍
  • 縦隔胚細胞腫瘍
  • 松果体腫瘍
  • 後腹膜胚細胞腫瘍
  • 仙骨胚細胞腫瘍
• 皮膚筋炎
• 封入体筋炎
• 壊死性ミオパチー
• 若年性筋炎
• 感染性筋炎

第8章 治療タイプ別

• 化学療法
  • ブレオマイシン
  • シスプラチン
  • エトポシド
  • イホスファミド
  • その他
• 放射線療法
• 手術療法
  • 卵巣嚢腫摘出術
  • 卵巣摘出術
  • 鼠径部根治的睾丸摘出術
• その他

第9章 エンドユーザー別

• 病院
• 専門クリニック
• 学術研究センター
• その他

第10章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋地域
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第12章 企業プロファイル

• GlaxoSmithKline plc
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Merck KGaA
• AstraZeneca PLC
• F. Hoffmann-La Roche Ltd
• Bristol-Myers Squibb
• Novartis AG
• Amgen Inc.
• Accord Healthcare Limited
• GLS Pharma Pvt. Ltd.
• Cadila Pharmaceuticals

第13章 付録

Overview

A germ cell tumor is a mass made of reproductive cells, also called germ cells. Germ is short for germinate, which means to mature. For women and people assigned female at birth (AFAB), germ cells eventually mature into eggs. For men and people assigned male at birth (AMAB), germ cells mature into sperm. Related, germ cell tumors are mainly seen in ovaries and testicles. Less commonly, germ cell tumors form in body parts other than ovaries and testicles, including the abdomen, chest, lower back, head and neck and brain. These tumors are called extragonadal tumors.

Moreover, surgery is the primary treatment for germ cell tumors. Most germ cell tumors are treated with chemotherapy or a combination of chemotherapy and radiation therapy. It is estimated that germ cell tumors in children are rare, making up only 3.5% of cancer diagnoses. They are more common in adolescents and young adults, making up 13.9% of cancers diagnosed between ages 15 to 19.

Market Dynamics: Drivers

Increasing demand for novel therapeutics

The increasing demand for novel therapeutics for the treatment of germ cell tumors is expected to drive the market over the forecast period. The germ cell tumors includes various types of ovarian, testicular and extragonadal cancers. The development of novel therapeutics helps to address unmet medical needs and results in better patient outcomes. Even, biosimilars plays a crucial role in the treatment of various types of germ cell tumors, biosimilars offers patients lower-cost medicines, often making these treatments more accessible and improving quality of life

For instance, on May 29, 2023, Alkem Oncology launched Cetuxa, the world's first biosimilar of Cetuximab used for the treatment of head and neck cancer. Cetuxa has been researched and manufactured indigenously by Enzene Biosciences Limited, the biological arm of Alkem Laboratories.

In addition, the regulatory approvals increase the trust in patients about the development of novel therapeutics. For instance, on May 09, 2023, Acrivon Therapeutics, Inc. released that the company has been granted two Fast Track designations by the U.S. Food and Drug Administration (FDA) for the development of ACR-368 in platinum-resistant ovarian cancer and endometrial cancer. Fast Track designation is intended to facilitate the development and expedite the review of promising investigational drugs to treat serious conditions with significant unmet medical needs.

Moreover, many clinical trials are going on for the development of novel therapeutics like cell therapies, which shows better results in the treatment of germ cell tumors. For instance, on August 28, 2023, Anixa Biosciences, Inc., a biotechnology company focused on the treatment and prevention of cancer, in partnership with Moffitt Cancer Center, commenced treatment of the third patient in the ongoing clinical trial of Anixa's novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer.

Additionally, the novel therapeutics also improves the treatment outcomes by the combination drugs, many research activities and approvals are going on about the combination treatments for better patient outcomes. For instance, on April 17, 2023 HUTCHMED (China) Limited released its New Drug Application for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma in China has been accepted for review by the China National Medical Products Administration (NMPA).

Further, the increasing prevalence of germ cell tumors like ovarian cancer, testicular cancer, head and neck cancers, abdominal cancers and others, rising FDA approvals, increasing clinical trials, increasing awareness and advancements in the development of novel drugs and therapies are the factors expected to drive the market over the forecast period.

Restraints

Factors such as complications associated with the treatment, the high cost of the treatment of germ cell tumors and the availability of alternative treatment options are expected to hamper the market.

Segment Analysis

The global germ cell tumor treatment market is segmented based on tumor type, treatment type, end-user and region.

The surgery segment accounted for approximately 34.9% of the germ cell tumor treatment market share

The surgery segment is expected to hold the largest market share over the forecast period. Surgery is considered as a primary treatment for germ cell tumors. Surgery removes the tumor from the affected ovary (ovarian cystectomy) or the entire ovary and fallopian tubes (salpingo-oophorectomy). With testicular cancer, the testicle with the tumor is removed by radical inguinal orchiectomy.

For instance, according to NYU Langone Health, surgery alone can cure some malignant germ cell tumors in the gonads such as ovaries and testicles. For germ cell tumors in the testicles, a surgeon removes the tumor and one or both testicles through a small incision in the groin. For ovarian germ cell tumors, which typically appear on one ovary, the surgeon removes the tumor, the ovary, and the fallopian tube through a small incision in the abdomen. Leaving one ovary or testicle when possible can help preserve fertility.

Moreover, for many early-stage germ cell tumors, surgery can be curative. If the cancer is localized and hasn't spread, complete removal of the tumor through surgery may eliminate the cancer and provide a potential cure. Surgery is often complemented by adjuvant therapies such as chemotherapy or radiation, especially in cases where the cancer has advanced or has a higher risk of recurrence. The combination of treatments aims to maximize effectiveness.

Geographical Analysis

North America accounted for approximately 41.2% of the market share

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and advanced healthcare facilities. North America, especially in the United States is home to numerous major pharmaceutical and biotechnology companies that are actively involved in germ cell cancer research and the development of oncology treatments. The presence of these key players contributes to the region's dominance in the germ cell tumor treatment market.

For instance, on July 27, 2023, Anixa Biosciences, Inc., a biotechnology company focused on the treatment and prevention of cancer, released that the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance broadening protection of Anixa's novel ovarian cancer vaccine technology, which has been exclusively licensed from, and is being developed in partnership with, Cleveland Clinic.

Furthermore, the region is also known for its advanced healthcare facilities for better treatment by using advanced therapies. The region's advanced healthcare infrastructure plays a crucial role in performing research activities and clinical trials for the development of advanced treatment options. As the research activities increase, combination therapeutics are developed more precisely by reducing the adverse effects and complications associated with the therapeutics, which results in better patient outcomes.

In addition, on January 9, 2023, Sonnet BioTherapeutics Holdings, Inc. collaborated on the agreement with Roche. A clinical trial (SB221) will be conducted to assess the safety and preliminary efficacy of SON-1010 (IL12-FHAB) in combination with Roche's atezolizumab in patients with platinum-resistant ovarian cancer (PROC). Interleukin-12 (IL-12) is a cytokine, or an immune cell-signaling protein, that enhances the activity of natural killer (NK) cells and T cells. The combination of these two agents in an indication that persists as a large unmet medical need.

Competitive Landscape

The major global players in the germ cell tumor treatment market include: GlaxoSmithKline plc, Merck KGaA, AstraZeneca PLC, F. Hoffmann-La Roche Ltd, Bristol-Myers Squibb, Novartis AG, Amgen Inc., Accord Healthcare Limited, GLS Pharma Pvt. Ltd. And Cadila Pharmaceuticals among others.

Key Developments

• On July 6, 2023, Astellas Pharma Inc. cleared that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in the U.S. for these patients.
• On November 14, 2022, ImmunoGen Inc., a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, released that the US Food and Drug Administration (FDA) has granted accelerated approval for ELAHERE (mirvetuximab soravtansine-gynx) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global germ cell tumor treatment market. During the pandemic, due to concerns about COVID-19 virus exposure and healthcare system strain, some individuals may have delayed seeking medical attention for symptoms, leading to later-stage diagnoses and potentially impacting the effectiveness of treatment of germ cell tumors. The pandemic disrupted many clinical trials related to germ cell tumors due to the redirected focus towards COVID-19. This could have slowed down the development and approval of new therapies for germ cell tumors.

Why Purchase the Report?

• To visualize the global germ cell tumor treatment market segmentation based on tumor type, treatment type, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of germ cell tumor treatment market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global germ cell tumor treatment market report would provide approximately 61 tables, 59 figures, and 187 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Tumor Type
• 3.2. Snippet by Treatment Type
• 3.3. Snippet by End-User
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Demand for Novel Therapeutics
  • 4.1.2. Restraints
    • 4.1.2.1. Complications Associated with the Treatment
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Pipeline Analysis
• 5.6. Unmet Needs
• 5.7. Patent Analysis
• 5.8. Volume Analysis
• 5.9. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During the Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Tumor Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Tumor Type
  • 7.1.2. Market Attractiveness Index, By Tumor Type
• 7.2. Testicular Germ Cell Tumors*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.2.3. Seminomas
  • 7.2.4. Non-Seminomas
    • 7.2.4.1. Yolk Sac Tumors
    • 7.2.4.2. Embryonal Cell Carcinomas
    • 7.2.4.3. Choriocarcinomas
    • 7.2.4.4. Teratomas
• 7.3. Ovarian Germ Cell Tumors
• 7.4. Extragonadal Germ Cell Tumors
  • 7.4.1. Mediastinal Germ Cell Tumors
  • 7.4.2. Pineal Region Tumors
  • 7.4.3. Retroperitoneal Germ Cell Tumors
  • 7.4.4. Sacrococcygeal Germ Cell Tumors
• 7.5. Dermatomyositis
• 7.6. Inclusion Body Myositis
• 7.7. Necrotizing Myopathy
• 7.8. Juvenile Myositis
• 7.9. Infectious Myositis

8. By Treatment Type

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 8.1.2. Market Attractiveness Index, By Treatment Type
• 8.2. Chemotherapy*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.2.3. Bleomycin
  • 8.2.4. Cisplatin
  • 8.2.5. Etoposide
  • 8.2.6. Ifosfamide
  • 8.2.7. Others
• 8.3. Radiation Therapy
• 8.4. Surgery
  • 8.4.1. Ovarian Cystectomy
  • 8.4.2. Salpingo-Oophorectomy
  • 8.4.3. Radical Inguinal Orchiectomy
• 8.5. Others

9. By End-User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.1.2. Market Attractiveness Index, By End-User
• 9.2. Hospitals*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Specialty Clinics
• 9.4. Academic and Research Centers
• 9.5. Others

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Tumor Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.6.1. U.S.
    • 10.2.6.2. Canada
    • 10.2.6.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Tumor Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.6.1. Germany
    • 10.3.6.2. UK
    • 10.3.6.3. France
    • 10.3.6.4. Italy
    • 10.3.6.5. Spain
    • 10.3.6.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Tumor Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.6.1. Brazil
    • 10.4.6.2. Argentina
    • 10.4.6.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Tumor Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.6.1. China
    • 10.5.6.2. India
    • 10.5.6.3. Japan
    • 10.5.6.4. Australia
    • 10.5.6.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Tumor Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. GlaxoSmithKline plc*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Merck KGaA
• 12.3. AstraZeneca PLC
• 12.4. F. Hoffmann-La Roche Ltd
• 12.5. Bristol-Myers Squibb
• 12.6. Novartis AG
• 12.7. Amgen Inc.
• 12.8. Accord Healthcare Limited
• 12.9. GLS Pharma Pvt. Ltd.
• 12.10. Cadila Pharmaceuticals

LIST NOT EXHAUSTIVE

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us