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體外診斷癌症癌症診斷

市場調查報告書

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1345429

全球前列腺癌診斷市場 - 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個工作天內

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簡介目錄

概述

全球前列腺癌診斷市場將於 2022 年達到 51 億美元，預計到 2030 年將達到 116 億美元，2023-2030 年預測期間年複合成長率為 11.1%。

前列腺癌通常可以通過檢測男性血液中的前列腺特異性抗原 (PSA) 水平或直腸指檢 (DRE) 來早期發現。根據美國的一項研究，每年進行 PSA 和 DRE 篩查確實比未篩查的男性檢出更多前列腺癌，但這種篩查並沒有降低前列腺癌死亡率。

前列腺癌的有效早期診斷至關重要。一旦分期開始，使用任何可用的程序進行治療就變得具有挑戰性。它還可以通過前列腺活體組織切片來診斷，該活體組織切片從前列腺中取出組織以檢查其是否有癌細胞。一些泌尿科醫生使用 MRI 和超聲技術來實現更明顯的活體組織切片目標。 PSA 血液檢測主要用於篩查無症狀男性的前列腺癌。這也是對懷疑患有前列腺癌的男性進行的首批測試之一。

此外，人工智慧在磁共振成像（MRI）中的整合、改善診斷的新技術的不斷增加以及男性對早期診斷的認知不斷提高，這些都是未來幾年推動市場的因素。

動力學

瑞星管道產品

近年來，由於男性前列腺癌發病率不斷上升，對前列腺癌診斷的需求不斷增加，一些在研產品正在不斷增加。例如，2023年，Lantheus正在開發1404，這是一種Tc-99m標記分子，可與PSMA結合，用作SPECT/CT成像劑，用於診斷和檢測局限性前列腺癌以及軟組織和骨轉移。 ROTOP 擁有在歐洲開發、製造和商業化 1404 的獨家權利。

例如，聖文森特醫院與 Clarity Pharmaceuticals Ltd 合作進行了 2 期臨床試驗，以評估 Copper-64 SAR Bombesin 在 PSMA 陰性前列腺癌中的作用。放射性標記的鈴蟾肽拮抗劑類似物，探索 64Cu-SAR-BBN PET 在 PSA 升高和 PSMA PET 陰性的男性中的診斷潛力。預計完工日期為2024年6月。

人工智慧整合改進診斷

人工智慧輔助前列腺癌診斷的研究也在迅速發展，並有可能促進當前標準診斷途徑的各個方面。此外，人工智慧模型可以通過減少癌症檢測中勞動密集型和經驗密集型的支持任務來幫助癌症診斷，例如前列腺分割、MRI超聲配準、MRI超聲融合活體組織切片和用於開發癌症檢測模型的MRI組織病理學配準。

例如，2023 年 3 月，Qritive 推出了 QAi Prostate，這是一種先進的人工智慧 (AI) 支持的前列腺癌診斷工具。通過利用先進的機器學習 (ML) 算法，QAi Prostate 可以準確識別前列腺腺癌區域，並對活體組織切片組織樣本中的惡性和良性腫瘤區域進行分類。

與活體組織切片程序相關的併發症

TRUS 活體組織切片與一些風險相關，包括疼痛、急性尿瀦留、血尿、血精、直腸出血、勃起功能障礙、感染和敗血症。國際上疾病和敗血症發病率的上升令人擔憂。從歷史上看，大約 1% 接受 TRUS 活體組織切片的患者出現感染併發症，但近年來這一數位已上升至 2-4%。具有膿毒症重大危險因素的男性，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），可以考慮進行 TRUS 活體組織切片以外的手術。

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