생식세포종양 시장 - 시장 인사이트, 역학, 시장 예측(2034년)

Key Highlights:

• Germ Cell Tumors (GCTs) are a unique and diverse group of neoplasms that arise from primordial germ cells, which are the precursors to gametes.
• While they are predominantly found in the gonads-the testes in males and ovaries in females-these tumors can also occur in extragonadal sites such as the mediastinum, retroperitoneum, and central nervous system, areas along the midline of the body where germ cells may aberrantly migrate during embryonic development.
• In 2020, the total market size of GCT in the 7MM was approximatley USD 290 million, which is expected to increase and reach approximately USD 630 million by 2034.
• In 2020, the total market size of GCT in the US was approximately USD 170 million, which is expected to increase and reach approximately USD 440 million by 2034.
• In EU4 and the UK, the total market size of GCT was approximately USD 100 million in 2020. This market is anticipated to increase and reach approximately USD 160 million by 2034.

DelveInsight's "Germ Cell Tumors - Market Insight, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the Germ Cell Tumors historical and forecasted epidemiology as well as the Germ Cell Tumors market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Germ Cell Tumors market report provides current treatment practices, emerging drugs/devices, Germ Cell Tumors market share of individual therapies, and current and forecasted Germ Cell Tumors market size from 2020 to 2034, segmented by seven major markets. The report also covers current Germ Cell Tumors treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Germ Cell Tumors: Understanding and Treatment Algorithm

Germ Cell Tumors Overview

GCTs are a unique and diverse group of neoplasms that arise from primordial germ cells, which are the precursors to gametes. While they are predominantly found in the gonads-the testes in males and ovaries in females-these tumors can also occur in extragonadal sites such as the mediastinum, retroperitoneum, and central nervous system, areas along the midline of the body where germ cells may aberrantly migrate during embryonic development. GCTs account for a significant proportion of neoplasms in specific age groups, such as testicular cancer in males aged 15-35 years, making them a critical focus in oncology.

Germ Cell Tumors Diagnosis

The diagnosis of germ cell tumors (GCTs) involves clinical history, physical examination, imaging (CT, MRI), and serum tumor markers such as AFP, B-hCG, and LDH. For ovarian GCTs, markers like AFP and B-hCG are crucial, with imaging and histological evaluation confirming the diagnosis. Testicular GCTs require immunohistochemistry for subtype identification using markers like OCT3/4, CD117, CD30, and SALL4. Extragonadal GCTs are diagnosed via cytology, biopsy, immunohistochemistry, and elevated serum markers (AFP, B-hCG, LDH). Emerging biomarkers like miR-371a-3p enhance sensitivity and specificity for GCT detection.

Germ Cell Tumors Treatment

Treatment for germ cell tumors (GCTs) varies by type, stage, and location. Ovarian GCTs often involve fertility-sparing surgery with adjuvant chemotherapy for advanced stages. Testicular GCTs are managed with orchiectomy, followed by active surveillance, radiotherapy, or chemotherapy based on risk factors and staging. For nonseminomas, p-RPLND or chemotherapy is preferred for advanced cases. Extragonadal GCTs benefit from cisplatin-based chemotherapy, with residual mass resection as needed. Modern chemotherapy has dramatically improved survival across GCT subtypes, with tailored strategies optimizing outcomes and fertility preservation.

Germ Cell Tumors Epidemiology

The Germ Cell Tumors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the Total Incidence Cases of GCT, Type-specific Incidence Cases of GCT, Age-specific Cases of GCT, Sub-type specific Cases of Gonadal GCT, Gender-specific Incidence Cases of GCTs, Total Incident Cases of GCTs by Stage, Total treatable Patient pool of GCT, Total Treatable Cases of GCT by Line of Therapy in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In the 7MM, individuals 30-44 years of age were the most affected by GCT, with approximately 11,390 cases reported in 2023. This number is projected to increase to 11,770 by 2034.
• The total incident cases of GCT in the 7MM is expected to reach approximately 26,860 by 2034 from 25,770 in 2020.
• In Japan, In 2020, the type-specific incidence cases of GCTs in Japan was approximately 2,150 cases for gonadal type and 90 cases for extragonadal type, which is estimated to increase up to approximately 2,180 cases, and 90 cases, respectively by 2034.

Germ Cell Tumors Drug Chapters

The drug chapter segment of the Germ Cell Tumors report encloses a detailed analysis of the early-stage (Phase I/II and Phase I) and mid-stage (Phase II) pipeline drug. The current key players for emerging drugs and their respective drug candidates include Cabozantinib (Exelixis), Pfizer (Talazoparib). The drug chapter also helps understand the Usher Syndrome clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, and the latest news and press releases.

Emerging Products

Cabozantinib: Exelixis

Cabozantinib is a multi-kinase inhibitor targeting pathways critical to tumor growth and metastasis, including MET, VEGFR, and AXL. While primarily approved for conditions like advanced renal cell carcinoma and hepatocellular carcinoma, it has shown promise in investigational studies for GCTs. For refractory or relapsed GCTs, cabozantinib is being evaluated for its ability to inhibit tumor progression by disrupting the tumor microenvironment and angiogenesis. Clinical trials suggest potential benefits, especially for patients who have exhausted standard therapies. The purpose of the CTO-IUSCCC-0752 study is to investigate the use of Cabozantinib for patients with incurable, refractory germ cell tumors. Patients will be treated until evidence of disease progression, non-compliance with study protocol, unacceptable major toxicity, at subject's request for withdrawal, or if the study closes for any reason.

In the U.S., CABOMETYX tablets are approved as monotherapy for the treatment of patients with advanced Renal Cell Carcinoma (RCC) and in combination with nivolumab as a first-line treatment for patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma (HCC) (Exelixis, 2024). Currently, Cabozantinib is in the Phase II stage of its clinical development for for treating refractory GCT.

Germ Cell Tumors Market Outlook

Germ cell tumors (GCTs) are neoplasms originating from primordial germ cells, the precursors to gametes. While primarily found in the gonads-testes in males and ovaries in females-they can also develop in extragonadal sites such as the mediastinum, retroperitoneum, and central nervous system due to aberrant germ cell migration during embryonic development. GCTs are especially significant in young males aged 15-35, as they are a leading cause of testicular cancer. Surgical management can help reduce the symptomatic burden and improve the functional outcomes of patients with germ cell tumors. Surgery plays a pivotal role in the management of germ cell tumors (GCTs), particularly in specific scenarios like residual disease after chemotherapy, removal of primary tumors, and treatment of teratomas or relapsed cases. some key players such as AstraZeneca (Durvalumab (MEDI4736) + Tremelimumab), Exelixis (Cabozantinib), and several others are investigating their candidates to treat GCT in the 7MM.

Germ Cell Tumors Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Germ Cell Tumors Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase I, Phase I/II, Phase II. It also analyzes key players involved in developing targeted therapeutics. Companies like Astrazeneca, Exelixis, Pfizer, and others are actively engaging their product in research and development efforts for Germ Cell Tumors. The pipeline of Germ Cell Tumors possesses many potential drugs and there is a positive outlook for the therapeutics market, with expectations of growth during the forecast period (2024-2034).

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Germ Cell Tumors 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 the Germ Cell Tumors evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical Directors, Clinical Professors, and Oncologists, and others.

DelveInsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the University of California,University of Michigan, Washington Hospital Healthcare System, University Hospital Munster, Germany etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Germ Cell Tumors 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 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.

Market Access and Reimbursement

The treatment and management of GERM CELL TUMORS are expensive. Botulinum toxin injections, commonly used to treat spasmodic torticollis, are costly and require frequent administration, leading to significant ongoing expenses for patients and healthcare systems. Effective reimbursement policies are crucial, as they can enhance treatment adherence, improve symptom control, and potentially reduce long-term healthcare costs by decreasing the need for additional medical services. To support patients, various organizations in the Seven Major Markets (7MM) offer programs like CMS coverage for botulinum toxin types A and B, the IPSEN CARES Patient Access Program, the BOTOX Savings Program, and the XEOMIN Savings Program. These initiatives help mitigate the financial burden and improve access to essential treatments.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of Germ Cell Tumors, 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 products will impact the current treatment landscape.
• A detailed review of the Germ Cell Tumors 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 KOL views, patient journey, and treatment preferences that help shape and drive Germ Cell Tumors.

Germ Cell Tumors Report Insights

• Patient Population
• Therapeutic Approaches
• Germ Cell Tumors Pipeline Analysis
• Germ Cell Tumors Market Size and Trends
• Existing and Future Market Opportunity

Germ Cell Tumors Report Key Strengths

• Eleven Years Forecast
• The 7MM Coverage
• Germ Cell Tumors Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Germ Cell Tumors Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

• What was the Germ Cell Tumors market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• What can be the future treatment paradigm for Germ Cell Tumors?
• What are the disease risks, burdens, and unmet needs of Germ Cell Tumors? What will be the growth opportunities across the 7MM concerning the patient population with Germ Cell Tumors?
• What are the current options for the treatment of Germ Cell Tumors? What are the current guidelines for treating Germ Cell Tumors in the 7MM?
• 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 Germ Cell Tumors?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Germ Cell Tumors 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.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of current 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. Germ Cell Tumors (GCTs) Market Overview at a Glance

• 3.1. Market Share (%) Distribution of GCT by Therapies in 2023
• 3.2. Market Share (%) Distribution of GCT by Therapies in 2034

4. Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Types of GCT
  • 7.2.1. Gonadal GCT
  • 7.2.2. Extragonadal GCT
• 7.3. Germ Cell Tumors: From a Developmental Perspective
• 7.4. Molecular Features of GCT Precursors
  • 7.4.1. Genomics of TGCTs
  • 7.4.2. Genomic Landscape of PMGCTs
• 7.5. Sign and Symptoms
• 7.6. Diagnosis
• 7.7. Treatment Management

8. Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale
• 8.3. Total Incident Cases of GCT in the 7MM
• 8.4. The United States
  • 8.4.1. Total Incidence Cases of GCT in the United States
  • 8.4.2. Type specific Incidence Cases of GCT in the United States
  • 8.4.3. Age-specific Cases of GCT in the United States
  • 8.4.4. Sub-type specific Cases of Gonadal GCT in the United States
  • 8.4.5. Gender-specific Incidence Cases of GCTs in the United States
  • 8.4.6. Total Incident Cases of GCTs by Stage in the United States
  • 8.4.7. Total Treatable Patient Pool of GCT in the United States
  • 8.4.8. Total Treatable Cases of GCT by Line of Therapy in the United States
• 8.5. EU4 and the UK
  • 8.5.1. Total Incidence Cases of GCT in EU4 and the UK
  • 8.5.2. Type specific Incidence Cases of GCT in EU4 and the UK
  • 8.5.3. Age-specific Cases of GCT in EU4 and the UK
  • 8.5.4. Sub-type specific Cases of Gonadal GCT in the United States
  • 8.5.5. Gender-specific Incidence Cases of GCTs in EU4 and the UK
  • 8.5.6. Total Incident Cases of GCTs by Stage in EU4 and the UK
  • 8.5.7. Total Treatable Patient Pool of GCT in EU4 and the UK
  • 8.5.6. Total Treatable Cases of GCT by Line of Therapy in EU4 and the UK
• 8.6. Japan
  • 8.6.1. Total Incidence Cases of GCT in Japan
  • 8.6.2. Type specific Incidence Cases of GCT in Japan
  • 8.6.3. Age-specific Cases of GCT in Japan
  • 8.6.4. Sub-type specific Cases of Gonadal GCT in Japan
  • 8.6.5. Gender-specific Incidence Cases of GCTs in Japan
  • 8.6.6. Total Incident Cases of GCTs by Stage in Japan
  • 8.6.7. Total Treatable Patient Pool of GCT in Japan
  • 8.6.8. Total Treatable Cases of GCT by Line of Therapy in Japan

9. Pateint Journey

10. Emerging Therapies

• 10.1. Key Cross Competition
• 10.2. Durvalumab + Tremelimumab: AstraZeneca
  • 10.2.1. Product Description
  • 10.2.2. Clinical Development
  • 10.2.3. Safety and efficacy
• 10.3. Cabozantinib: Exelixis
  • 10.3.1. Product Description
  • 10.3.2. Clinical Development
  • 10.3.3. Safety and efficacy
• 10.4. Talazoparib: Pfizer
  • 10.4.1. Product Description
  • 10.4.2. Clinical Development
• 10.5. XmAb541: Xencor, Inc.
  • 10.5.1. Product Description
  • 10.5.2. Other Developmental Activities
  • 10.5.3. Clinical Development
• 10.6. DS-9606a: Daiichi Sankyo
  • 10.6.1. Product Description
  • 10.6.2. Clinical Development
  • 10.6.3. Safety and Efficacy
• 10.7. HFB200301: HiFiBiO Therapeutics
  • 10.7.1. Product Description
  • 10.7.2. Clinical Development
  • 10.7.3. Safety and efficacy

11. Market Analysis

• 11.1. Key Findings
• 11.2. Market Outlook
• 11.3. Conjoint Analysis
• 11.4. Cost Assumptions
• 11.5. Key Market Forecast Assumptions
• 11.6. The 7MM Market Size
  • 11.6.1. Total Market Size of GCT in the 7MM
  • 11.6.2. Total Market Size of GCT by therapies in the 7MM
• 11.7. The United States
  • 11.7.1. Total Market Size of GCT in the United States
  • 11.7.2. Total Market size of GCT by Therapies in the United States
• 11.8. EU4 and the UK
  • 11.8.1. Total Market Size of GCT in EU4 and the UK
  • 11.8.2. Total Market Size of GCT by Therapies in EU4 and the UK
• 11.9. Japan
  • 11.9.1. Total Market Size of GCT in Japan
  • 11.9.2. Total Market Size of GCT by Therapies in Japan

12. KOL Views

13. SWOT Analysis

14. Unmet Needs

15. Market Access and Reimbursement

• 15.1. United States
  • 15.1.1. Centre for Medicare and Medicaid Services (CMS)
• 15.2. EU4 and the UK
  • 15.2.1. Germany
  • 15.2.2. France
  • 15.2.3. Italy
  • 15.2.4. Spain
  • 15.2.5. United Kingdom
• 15.3. Japan
  • 15.3.1. MHLW

16. Appendix

• 16.1. Bibliography
• 16.2. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer