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体外诊断癌症癌症诊断

市场调查报告书

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1345429

全球前列腺癌诊断市场 - 2023-2030

Global Prostate Cancer Diagnostics Market - 2023-2030

出版日期: 2023年09月06日 | 出版商:

DataM Intelligence | 英文 195 Pages | 商品交期: 最快1-2个工作天内

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简介目录

概述

全球前列腺癌诊断市场将于 2022 年达到 51 亿美元，预计到 2030 年将达到 116 亿美元，2023-2030 年预测期间复合年增长率为 11.1%。

前列腺癌通常可以通过检测男性血液中的前列腺特异性抗原 (PSA) 水平或直肠指检 (DRE) 来早期发现。根据美国的一项研究，每年进行 PSA 和 DRE 筛查确实比未筛查的男性检出更多前列腺癌，但这种筛查并没有降低前列腺癌死亡率。

前列腺癌的有效早期诊断至关重要。一旦分期开始，使用任何可用的程序进行治疗就变得具有挑战性。它还可以通过前列腺活检来诊断，该活检从前列腺中取出组织以检查其是否有癌细胞。一些泌尿科医生使用 MRI 和超声技术来实现更明显的活检目标。 PSA 血液检测主要用于筛查无症状男性的前列腺癌。这也是对怀疑患有前列腺癌的男性进行的首批测试之一。

此外，人工智能在磁共振成像（MRI）中的集成、改善诊断的新技术的不断增加以及男性对早期诊断的认识不断提高，这些都是未来几年推动市场的因素。

动力学

瑞星管道产品

近年来，由于男性前列腺癌发病率不断上升，对前列腺癌诊断的需求不断增加，一些在研产品正在不断增加。例如，2023年，Lantheus正在开发1404，这是一种Tc-99m标记分子，可与PSMA结合，用作SPECT/CT成像剂，用于诊断和检测局限性前列腺癌以及软组织和骨转移。 ROTOP 拥有在欧洲开发、製造和商业化 1404 的独家权利。

例如，圣文森特医院与 Clarity Pharmaceuticals Ltd 合作进行了 2 期临床试验，以评估 Copper-64 SAR Bombesin 在 PSMA 阴性前列腺癌中的作用。放射性标记的铃蟾肽拮抗剂类似物，探索 64Cu-SAR-BBN PET 在 PSA 升高和 PSMA PET 阴性的男性中的诊断潜力。预计完工日期为2024年6月。

人工智能集成改进诊断

人工智能辅助前列腺癌诊断的研究也在迅速发展，并有可能促进当前标准诊断途径的各个方面。此外，人工智能模型可以通过减少癌症检测中劳动密集型和经验密集型的支持任务来帮助癌症诊断，例如前列腺分割、MRI超声配准、MRI超声融合活检和用于开发癌症检测模型的MRI组织病理学配准。

例如，2023 年 3 月，Qritive 推出了 QAi Prostate，这是一种先进的人工智能 (AI) 支持的前列腺癌诊断工具。通过利用先进的机器学习 (ML) 算法，QAi Prostate 可以准确识别前列腺腺癌区域，并对活检组织样本中的恶性和良性肿瘤区域进行分类。

与活检程序相关的并发症

TRUS 活检与一些风险相关，包括疼痛、急性尿潴留、血尿、血精、直肠出血、勃起功能障碍、感染和败血症。国际上疾病和败血症发病率的上升令人担忧。从历史上看，大约 1% 接受 TRUS 活检的患者出现感染并发症，但近年来这一数字已上升至 2-4%。具有脓毒症重大危险因素的男性，如免疫功能低下、2 型糖尿病、近期住院和 COPD（慢性阻塞性肺病），可以考虑进行 TRUS 活检以外的手术。

Overview

Global Prostate Cancer Diagnostics Market reached US$ 5.1 billion in 2022 and is expected to reach US$ 11.6 billion by 2030 growing with a CAGR of 11.1% during the forecast period 2023-2030.

Prostate cancer can often be found early by testing prostate-specific antigen (PSA) levels in a man's blood or digital rectal exam (DRE). According to a study in the United States, the annual screening with PSA and DRE did detect more prostate cancers than in men not screened, but this screening did not lower the prostate cancer death rate.

Early diagnosis of prostate cancer effectively is crucial. Once the staging begins, treating with any available procedure becomes challenging. It is also diagnosed with a prostate biopsy, which removes tissue from the prostate to examine it for cancer cells. Some urologists use MRI and ultrasound technology to achieve a more apparent biopsy target. The PSA blood test is used mainly to screen for prostate cancer in men without symptoms. It's also one of the first tests done in men suspecting prostate cancer.

Furthermore, the integration of AI in magnetic resonance imaging (MRI), increasing new technologies for improving diagnosis, and rising awareness about early diagnosis among males are the factors that will drive the market in the forthcoming years.

Dynamics

Rising Pipeline products

Several Pipeline products are on the rise as the demand for prostate cancer diagnosis increased in recent years due to the rising incidence of prostate cancer among males. For instance, in 2023, Lantheus is working on the development of 1404, which is a Tc-99m-labeled molecule that binds to PSMA and is used as a SPECT/CT imaging agent to diagnose and detect localized prostate cancer as well as soft tissue and bone metastases. ROTOP has exclusive rights to develop, manufacture, and commercialize 1404 in Europe.

For instance, St Vincent's Hospital collaborated with Clarity Pharmaceuticals Ltd to conduct phase 2 clinical trials to evaluate Copper-64 SAR Bombesin in PSMA Negative Prostate Cancer. Radiolabeled antagonist analog of bombesin to explore the diagnostic potential of 64Cu-SAR-BBN PET In men with rising PSA and negative PSMA PET. The estimated completion date is June 2024.

Improvements in Diagnosis with the Integration of Artificial Intelligence

Research on AI-assisted prostate cancer diagnosis is also evolving rapidly and has the potential to facilitate all aspects of the current standard diagnostic pathway. Moreover, AI models can help cancer diagnosis by reducing supporting tasks in cancer detection that are labor and experience-intensive, such as prostate gland segmentation, MRI-ultrasound registration, MRI-ultrasound fusion biopsies, and MRI-histopathology registration for developing cancer detection models.

For instance, in March 2023, Qritive introduced QAi Prostate, an advanced artificial intelligence (AI)-powered prostate cancer diagnosis tool. By leveraging advanced machine learning (ML) algorithms, QAi Prostate can accurately identify prostatic adenocarcinoma regions and classify malignant and benign tumor areas in biopsy tissue samples.

Complications related to Biopsy procedures

TRUS biopsy is associated with some risks, including pain, acute urinary retention, haematuria, haematospermia, rectal bleeding, erectile dysfunction, infection, and sepsis. The rising rates of disease and sepsis internationally are of concern. Historically, infection complicated approximately 1% of patients who underwent TRUS biopsy, but this figure has risen to 2-4% in recent years. Men with significant risk factors for sepsis, such as immunocompromise, type 2 diabetes mellitus, recent hospitalization, and COPD (Chronic obstructive pulmonary disease), could be considered for procedures other than TRUS biopsy.

Segment Analysis

The global prostate cancer diagnostics is segmented based on test type, cancer type, stage, end-user, and region.

The Segment Accounted for Approximately 45.3% of the Market Share

Prostate-specific Antigen (PSA) is a protein produced by prostate cells, and the PSA test is performed to diagnose prostate cancer (PCa) in men and for follow-up post-treatment to check if the cancer relapses. PSA testing is essential for detecting prostate cancer, which measures PSA levels in a man's blood.

Medicare and several private insurers provide coverage for an annual PSA test for all Medicare-eligible men aged 50 and older. PSA testing is gaining popularity among clinicians and hospitals owing to the increasing number of people affected by prostate cancer. For instance, on February 2023, LynxDx, Inc., a developer of innovative diagnostic solutions, is introducing MyProstateScore 2.0 (MPS2), a non-invasive, data-driven, urine prostate cancer screening test that provides highly accurate, stratified risk assessment insights to guide clinical decisions for patients with elevated prostate-specific antigen (PSA) or abnormal digital rectal exam (DRE) findings. Due to increased innovations and advancements in PSA testing is expected to hold the largest market share in the forthcoming period.

Geographical Analysis

North America accounted for Approximately 39.2% of the Market Share in 2022

North America dominates the global prostate cancer diagnostics market, with the United States accounting as the primary contributor. Prostate cancer is one of the most common cancers in American men, which is made apparent by the statistics surrounding it. It affects 1 out of eight men in the U.S. after skin cancer; it is the most common cancer in U.S. men.

American Cancer Society estimated that in 2022, around 268,490 novel cases of prostate cancer were detected. Some of prostate cancers are aggressive, but most of them grow slowly. The number of deaths increases yearly, making prostate cancer the second leading cause of cancer death in men in the United States. Hence, it is considered to have an early diagnosis of the condition.

COVID-19 Impact Analysis

The effects of the pandemic on clinical trials were felt throughout administrative and clinical practices. Clinical trial initiation and recruitment were typically halted at the beginning of the pandemic as infection control measures were implemented. In a March 2021 report, a 60% decrease in new oncology clinical trials during the pandemic was noted, fueling concerns regarding slowing the development of new cancer therapies.

The focus of research and development efforts shifted during the pandemic, with a significant emphasis on developing vaccines and treatments for COVID-19. A major UK-based cancer research charity, Cancer Research UK, halted recruitment in 95% of their clinical trials, both to protect cancer patients and to cope with the redeployment of clinical research staff to support frontline COVID-19-facing healthcare services.

By Test Type

Digital Rectal Exam
PSA Blood Test
Biopsy

Prostate Biopsy
Transrectal Biopsy
Transperineal Biopsy
Lymph node Biopsy

Genetic Testing
Imaging Tests

Transrectal Ultrasound (TRUS)
Magnetic Resonance Imaging (MRI)
Nuclear Imaging

Others

By Cancer Type

Benign Prostate Hyperplasia
Prostatic Adenocarcinoma
Small Cell Carcinoma
Ductal prostate cancer
Others

By Stage

By End Users

Cancer Centers
Specialty Clinics
Others

By Region

North America
- U.S.
- Canada
- Mexico

Europe
- Germany
- U.K.
- France
- Spain
- Italy
- Rest of Europe

South America
- Brazil
- Argentina
- Rest of South America

Asia-Pacific
- China
- India
- Japan
- Australia
- Rest of Asia-Pacific

Middle East and Africa

Key Developments

In July 2023, BPGb partnered with Grupo Terralpe to Offer AI-Discovered Prostate Cancer Diagnostic Test in Mexico. Through their strategic partnership, Grupo Terralpe will bring the pstateDx test, BPGbio's novel prostate cancer test to Mexico in an effort to improve clinical decision support for patients with elevated PSA levels who may have prostate cancer.
On February 2023, LynxDx, Inc., a developer of innovative diagnostic solutions is introducing MyProstateScore 2.0 (MPS2), a non-invasive, data-driven, urine prostate cancer screening test that provides highly accurate, stratified risk assessment insights to guide clinical decisions for patients with elevated prostate-specific antigen (PSA) or abnormal digital rectal exam (DRE) findings.
On March 2023, Novartis Pluvicto was approved by FDA as the first targeted radioligand therapy for the treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer

Competitive Landscape

The major global players in the prostate cancer diagnostics market include: Myriad Genetics, Inc., Quanterix Corporation, MDx Health, Siemens Healthineers, F. Hoffman-La Roche AG, OPKO Health, Inc., Thermo Fisher Scientific Inc., Cellanyx Diagnostics Inc., MiR Scientific, and Proteomedix among others.

Why Purchase the Report?

To visualize the global prostate cancer diagnostics segmentation based on test type, cancer type, stage, 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 prostate cancer diagnostics 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 prostate cancer diagnostics market report would provide approximately 53 tables, 54 figures, and 195 Pages.

Target Audience 2023

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

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 Test Type
3.2. Snippet by Cancer Type
3.3. Snippet by Stage
3.4. Snippet by End User
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Rising Pipeline products
  - 4.1.1.2. Improvements in Diagnosis with the Integration of Artificial Intelligence
- 4.1.2. Restraints
  - 4.1.2.1. Complications related to Biopsy procedures
- 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. Russia-Ukraine War Impact Analysis
5.6. 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 Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. By Test Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 7.1.2. Market Attractiveness Index, By Test Type
7.2. Digital Rectal Exam
7.3. PSA Blood Test
7.4. Biopsy
7.5. Genetic Testing
7.6. Imaging Tests
7.7. Others

8. By Cancer Type

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Cancer Type
- 8.1.2. Market Attractiveness Index, By Cancer Type
8.2. Benign Prostate Hyperplasia
8.3. Prostatic Adenocarcinoma
8.4. Small Cell Carcinoma
8.5. Ductal prostate cancer
8.6. Others

9. By Stage

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage
- 9.1.2. Market Attractiveness Index, By Stage
9.2. I
9.3. II
9.4. III
9.5. IV

10. By End User

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.1.2. Market Attractiveness Index, By End User
10.2. Cancer Centers
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Specialty Clinics
10.4. Others

11. By Region

11.1. Introduction
- 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 11.1.2. Market Attractiveness Index, By Region
11.2. North America
- 11.2.1. Introduction
- 11.2.2. Key Region-Specific Dynamics
- 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Cancer Type
- 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage
- 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.2.7.1. U.S.
  - 11.2.7.2. Canada
  - 11.2.7.3. Mexico
11.3. Europe
- 11.3.1. Introduction
- 11.3.2. Key Region-Specific Dynamics
- 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Cancer Type
- 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage
- 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.3.7.1. Germany
  - 11.3.7.2. UK
  - 11.3.7.3. France
  - 11.3.7.4. Italy
  - 11.3.7.5. Spain
  - 11.3.7.6. Rest of Europe
11.4. South America
- 11.4.1. Introduction
- 11.4.2. Key Region-Specific Dynamics
- 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Cancer Type
- 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage
- 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.4.7.1. Brazil
  - 11.4.7.2. Argentina
  - 11.4.7.3. Rest of South America
11.5. Asia-Pacific
- 11.5.1. Introduction
- 11.5.2. Key Region-Specific Dynamics
- 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Cancer Type Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage
- 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.5.6.1. China
  - 11.5.6.2. India
  - 11.5.6.3. Japan
  - 11.5.6.4. Australia
  - 11.5.6.5. Rest of Asia-Pacific
11.6. Middle East and Africa
- 11.6.1. Introduction
- 11.6.2. Key Region-Specific Dynamics
- 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Cancer Type Market Size Analysis and Y-o-Y Growth Analysis (%), By Stage
- 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

12. Competitive Landscape

12.1. Competitive Scenario
12.2. Market Positioning/Share Analysis
12.3. Mergers and Acquisitions Analysis

13. Company Profiles

13.1. Myriad Genetics, Inc.
- 13.1.1. Company Overview
- 13.1.2. Product Type Portfolio and Description
- 13.1.3. Financial Overview
- 13.1.4. Key Developments
13.2. Quanterix Corporation
13.3. MDx Health
13.4. Siemens Healthineers
13.5. F. Hoffman-La Roche AG
13.6. OPKO Health, Inc
13.7. Thermo Fisher Scientific Inc.
13.8. Cellanyx Diagnostics Inc.
13.9. MiR Scientific LLC
13.10. Proteomedix

LIST NOT EXHAUSTIVE