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全球 PSMA PET 成像市场 - 2023-2030

Global PSMA PET Imaging Market - 2023-2030

出版日期: 2023年09月06日 | 出版商:

DataM Intelligence | 英文 186 Pages | 商品交期: 约2个工作天内

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简介目录

概述

全球 PSMA PET 成像市场将于 2022 年达到 15 亿美元，预计到 2030 年将达到 20 亿美元，2023-2030 年预测期间复合年增长率为 3%。

全球 PSMA PET 成像市场预计在未来几年将出现显着增长，影响其动态的因素有多种，例如前列腺癌检测的采用率不断提高、临床试验不断增加等。政府对 PSMA PET 开发的投资将继续推动和提振全球市场。全球 PSMA PET 成像市场越来越重视减少其影响。

前列腺特异性膜抗原 (PSMA) 正电子发射断层扫描 (PET) 成像技术是一项不断发展的技术，用于检测男性前列腺癌。前列腺癌被认为是世界上第四大最常见的癌症。 FDA 批准的 PSMA PET 成像技术有两种，例如镓 68 (Ga-68) PSMA PET 成像和氟 18 (F-18) PSMA PET 成像。同样，北美在白癜风治疗市场上占据主导地位，由于该地区有利的报销政策、先进的医疗基础设施和主要参与者的存在，占据了最大的市场份额。

由于前列腺癌的患病率不断增加，人们对前列腺癌的认识不断提高，早期诊断不断增加，临床试验不断增加，对非侵入性诊断技术的需求不断增加，PSMA PET 成像越来越多地用于早期诊断，以及PSMA PET 成像技术的进步是预计的主要因素在预测期内推动全球 PSMA PET 成像市场。

动力学

临床试验的增加预计将推动市场的增长

预计临床试验数量的增加将在预测期内推动市场的增长。临床试验建立了患者对安全性和有效性的信任。临床试验的积极结果可以增强投资者对成像技术的信心和患者的信任。这种信心的增强可以吸引资金进行进一步的研发并进行更多的临床试验，从而使公司能够投资更多的创新技术并推动市场发展。

此外，临床试验可以提供一个重要的平台来证明 PSMA PET 成像在各种临床场景中的功效。这种验证对于获得监管部门的批准和接受至关重要。临床试验探索 PSMA PET 成像的新应用和适应症。这种应用的扩展可以极大地推动市场。临床试验的积极结果可以将 PSMA PET 成像纳入临床指南和护理标准，从而增加其在常规临床实践中的采用。

例如，2023 年 6 月 14 日，Clarity Pharmaceuticals 与西门子 Healthineers 公司旗下的 PETNET Solutions Inc、全球正电子发射断层扫描 (PET) 放射性药物网络以及美国领先的 PET 成像放射性药物製造商签订了主服务协议协议和临床供应协议涵盖Clarity 的64Cu SAR-bisPSMA，这是一种用于前列腺癌成像的下一代诊断放射性药物产品。 64Cu SAR-bisPSMA 是一种研究性 PET 製剂，预计将于 2023 年底前在美国进入关键的 III 期试验，并可能于 2024 年进入第二次 III 期试验。

FDA 批准的增加预计也将推动市场的增长

FDA 批准的增加预计也将在预测期内推动市场的增长。 PSMA PET 成像技术的监管批准不断增加，为患者和医疗保健提供者提供了更多选择。这种诊断成像扩展选择可以促进市场增长，因为它满足了个人对更好的前列腺癌成像的需求。 FDA 批准等监管部门的批准也增加了患者对已批准的诊断成像技术的信任。

此外，FDA 批准的 PSMA PET 产品和放射性药物通常被认为更可信，可以提高患者的信任度，从而在医疗保健提供者和机构中得到更多采用。 FDA 的批准可以促进与保险提供商和政府卫生机构就 PSMA PET 手术报销问题进行讨论，使患者更容易获得该手术。

例如，2023 年5 月30 日，美国食品和药物管理局(FDA) 批准了优化的高亲和力放射性混合前列腺特异性膜抗原(PSMA) 靶向正电子发射断层扫描(PET) 成像剂氟洛司他氟18 (波斯卢玛）。 Flotufolastat F-18 适用于疑似转移的前列腺癌患者的 PSMA 阳性病变的 PET 成像，这些患者是初始确定性治疗的候选者或基于血清前列腺特异性抗原 (PSA) 水平升高而疑似復发的患者。它是第一个也是唯一一个经 FDA 批准的、采用专有放射混合技术开发的 PSMA 靶向显像剂。

PSMA PET 成像的严格定价预计将阻碍市场增长

PSMA PET 成像严格的定价预计将阻碍预测期内市场的增长。由于需要更专业的设施和严格的质量控制，开发和製造 PSMA PET 放射性药物和成像设备可能会更加昂贵。这些严格的成本可能会转嫁给最终用户，从而导致价格上涨。

此外，在某些地区，报销政策可能无法充分支付 PSMA PET 成像的费用，从而使患者更难获得该成像，并可能限制市场增长。对于许多前列腺癌患者来说，严格的费用可能难以承受，这预计将阻碍市场的增长。

Overview

Global PSMA PET Imaging Market reached US$ 1.5 billion in 2022 and is expected to reach US$ 2.0 billion by 2030, growing with a CAGR of 3% during the forecast period 2023-2030.

The global PSMA PET imaging market is expected to experience significant growth in upcoming years, with various factors influencing its dynamics such as increasing adoption for prostate cancer detection, rising clinical trials, and others. Government investments in the development of PSMA PET will continue to drive and boost the global market. The global PSMA PET imaging market is placing increasing emphasis on reducing its impact.

The prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging technique is an evolving technique, which is used to detect prostate cancer in men. Prostate cancer is considered the fourth most commonly diagnosed cancer in the world. There are two FDA-approved PSMA PET imaging technologies, such as Gallium-68 (Ga-68) PSMA PET imaging, and Fluorine-18 (F-18) PSMA PET imaging. Similarly, North America dominates the vitiligo treatment market, capturing the largest market share owing to the region's favorable reimbursement policies, advanced healthcare infrastructure, and presence of major players.

Owing to the increasing prevalence of prostate cancer, growing awareness and early diagnosis, rising clinical trials, increasing demand for non-invasive diagnostic techniques, increasing adoption of PSMA PET imaging for early diagnosis, and advancements in PSMA PET imaging techniques are the major factors expected to drive the global PSMA PET imaging market over the forecast period.

Dynamics

Increasing Clinical Trials is Expected to Drive the Growth of the Market

The increasing number of clinical trials is expected to drive the growth of the market over the forecast period. Clinical trials build trust in patients about safety and efficacy. The positive results from clinical trials can boost investor confidence and patient trust in the imaging technique. This increased confidence can attract funding for further research and development and conduct more clinical trials, allowing companies to invest in more innovative technologies and driving the market.

Further, clinical trials can provide an essential platform for demonstrating the efficacy of PSMA PET imaging in various clinical scenarios. This validation is crucial for gaining regulatory approvals and acceptance. Clinical trials explore new applications and indications for PSMA PET imaging. This expansion of applications can significantly drive the market. Positive outcomes in clinical trials can lead to the incorporation of PSMA PET imaging into clinical guidelines and standard of care, increasing its adoption in routine clinical practice.

For instance, on June 14, 2023, Clarity Pharmaceuticals, and PETNET Solutions Inc, a Siemens Healthineers Company, a global positron emission tomography (PET) radiopharmaceutical network and the leading manufacturer of radiopharmaceuticals for PET imaging in the US have entered into a Master Service Agreement and a Clinical Supply Agreement covering Clarity's 64Cu SAR-bisPSMA, a next-generation diagnostic radiopharmaceutical product for prostate cancer imaging. 64Cu SAR-bisPSMA is an investigational PET agent anticipated to be entering a pivotal Phase III trial in the US before the end of 2023 and, potentially, a second Phase III trial in 2024.

Rising FDA Approvals is Also Expected to Drive the Growth of the Market

The rising FDA approvals are also expected to drive the growth of the market over the forecast period. The increasing regulatory approvals for PSMA PET imaging techniques improve the options available to patients and healthcare providers. This diagnostic imaging expansion choice can increase the market growth as it meets the needs of individuals for better imaging of prostate cancer. The regulatory approvals such as FDA approvals also increase the patient's trust about the approved diagnostic imaging technologies.

Additionally, FDA-approved PSMA PET products and radiopharmaceuticals are often perceived as more credible and improve trust in patients, leading to increased adoption among healthcare providers and institutions. FDA approvals can facilitate discussions with insurance providers and government health agencies regarding reimbursement for PSMA PET procedures, making it more accessible to patients.

For instance, On May 30, 2023, the U.S. Food and Drug Administration (FDA) approved the optimized, high-affinity radiohybrid prostate-specific membrane antigen (PSMA)-targeted positron-emission tomography (PET) imaging agent flotufolastat fluorine-18 (Posluma). Flotufolastat F-18 is indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. It is the first and only FDA-approved, PSMA-targeted imaging agent developed with proprietary radiohybrid technology.

Stringent Pricing of the PSMA PET Imaging is Expected to Hamper the Market Growth

The stringent pricing of PSMA PET imaging is expected to hamper the growth of the market over the forecast period. Developing and manufacturing PSMA PET radiopharmaceuticals and imaging equipment can be more expensive due to the need for more specialized facilities and rigorous quality control. These stringent costs may be passed on to end-users, contributing to higher prices.

Moreover, in some regions, reimbursement policies may not adequately cover the costs of PSMA PET imaging, making it less accessible to patients and potentially limiting market growth. The stringent cost may be unaffordable for many prostate cancer patients which is expected to hamper the market growth.

Segment Analysis

The global PSMA PET imaging market is segmented based on technology, end-user, and region.

The Gallium-68 (Ga-68) PSMA PET Imaging Segment Accounted for Approximately 45.6% of the PSMA PET Imaging Market Share

The Gallium-68 (Ga-68) PSMA PET Imaging Segment is expected to hold the largest market share over the forecast period. Ga-68 PSMA PET imaging is highly sensitive in detecting small lesions and metastases, even at low prostate-specific antigen levels, making it useful for early diagnosis and staging. It also provides precise information about the extent and location of prostate cancer, aiding in accurate staging, re-staging, and treatment planning by minimizing unnecessary interventions.

For instance, on October 13, 2022, Telix Pharmaceuticals Limited announced that Health Canada has approved Illuccix [kit for the preparation of gallium (68Ga) gozetotide injection] for use in staging and re-staging intermediate and high-risk prostate cancer and localizing tumor tissue in recurrent prostate cancer. Illuccix after radiolabeling with gallium (68Ga), is indicated for use with the positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. It helps in risk stratification, guiding treatment decisions, and minimizing unnecessary interventions.

Furthermore, Ga-68 PSMA PET imaging usually offers a non-invasive technique and can be used to monitor the response to prostate cancer treatments such as surgery, radiation therapy, and chemotherapy. Ga-68 PSMA PET can be used in theranostics, where the same PSMA-targeted molecule can be labeled with different isotopes for both imaging (diagnosis) and therapy.

For instance, on March 23, 2022, Novartis announced that the FDA approved Locametz (kit for the preparation of gallium Ga 68 gozetotide injection). Locametz (gallium Ga 68 gozetotide), a diagnostic kit for radiopharmaceutical injectable preparation is indicated for positron emission tomography (PET) of PSMA-positive lesions in adult patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen level and for selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

Geographical Penetration

North America Accounted for Approximately 39.4% of the Market Share in 2022, Owing to the Strong Presence of Major Players and Well-Established Healthcare Infrastructure

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and well-established healthcare infrastructure. The region is well known for its advanced and well-established healthcare infrastructure including hospitals, diagnostic imaging centers, specialty clinics, research and academic centers, and others. The presence of well-established healthcare infrastructure helps to provide better insurance coverage for prostate cancer patients for advanced diagnosis with PSMA PET imaging.

Moreover, North America is a home for many pharmaceutical and medical device companies, which are actively involved in performing clinical trials and research activities by favorable investments. These major players in the region collaborating and expanding the diagnostic techniques for PSMA PET.

For instance, on November 14, 2022, Lantheus Holdings, Inc. and POINT Biopharma Global Inc. announced a strategic collaboration and license agreements that leverage the complementary strengths of both companies in radiopharmaceutical oncology and look to enhance the potential impact that these compelling therapeutic candidates could provide to patients. This collaboration expands Lantheus's radiopharmaceutical portfolio with two late-stage therapeutic candidates PNT2002, a PSMA-targeted 177Lu-based therapy for metastatic castration-resistant prostate cancer (mCRPC).

Competitive Landscape

The major global players in the PSMA PET imaging market include: Novartis Pharmaceuticals Corporation, Lantheus company, RadioMedix, Clarity Pharmaceuticals, Blue Earth Diagnostics, Inc., Siemens Medical Solutions USA, Inc., Eckert & Ziegler, Telix Pharmaceuticals, Canon Medical Systems, USA, and Jubilant Draximage Radiopharmacies, Inc., among others.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for pharmaceutical and medical device industries worldwide, including the global PSMA PET imaging market. During the pandemic, many clinical trials, research activities, and regulatory approvals have been temporarily postponed due to the redirected focus on the COVID-19 pandemic and its related restrictions.

The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting regular diagnostic imaging, appointments, and consultations for prostate cancer patients worldwide. Many hospitals are focused on COVID-19 cases, which reduces the diagnostic imaging for prostate cancer patients.

Moreover, the COVID-19 pandemic severely disrupted global supply chains, impacting the transportation of raw materials and medical devices. Movement restrictions and border closures delayed shipments and caused imaging delays in prostate cancer patients. Additionally, some countries faced shortages of PSMA PET related raw materials for diagniosis due to disruptions in their supply chain networks.

Russia-Ukraine Conflict Analysis

The Russia-Ukraine conflict is estimated to have a moderate impact on the global PSMA PET imaging market. Many clinical trials and research activities are temporarily disrupted. The conflict has less impact mainly due to the absence of key market players in this region.

By Technology

Gallium-68 (Ga-68) PSMA PET Imaging
Fluorine-18 (F-18) PSMA PET Imaging

By End-User

Hospitals
Specialty Clinics
Diagnostic Imaging Centers
Research and Academic Centers
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

On May 30, 2023, Blue Earth Diagnostics announced that the U.S. FDA has approved a new positron emission tomography imaging agent for prostate cancer. Brand-named Posluma is indicated for PET scans of prostate-specific membrane antigen (PSMA)-positive lesions in men with the disease. The imaging agent is targeted toward individuals with metastasized prostate cancer who are either candidates for therapy or have a suspected recurrence based on elevated PSA levels.
On February 24, 2022- Palette Life Sciences, a global medical device company dedicated to improving prostate radiation therapy outcomes, announced the signing of an Agreement with Lantheus Holdings, Inc. to support the promotion of PYLARIFY (piflufolastat F 18) in the United States. PYLARIFY injection is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone, and soft tissue metastases to determine the presence of recurrent and/or metastatic prostate cancer.
On May 27, 2021, the FDA approved Pylarify (piflufolastat F 18) a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. With the approval of Pylarify, certain men with prostate cancer will have greater access to PSMA-targeted PET imaging that can aid healthcare providers in assessing prostate cancer.

Why Purchase the Report?

To visualize the global PSMA PET imaging market segmentation based on technology, 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 PSMA PET imaging 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 PSMA PET imaging market report would provide approximately 61 tables, 58 figures, and 186 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 Technology
3.2. Snippet by End-User
3.3. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Increasing Clinical Trials
  - 4.1.1.2. Rising FDA Approvals
- 4.1.2. Restraints
  - 4.1.2.1. Stringent Pricing for the PSMA PET imaging
- 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 Conflict 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 the Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. By Technology

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 7.1.2. Market Attractiveness Index, By Technology
7.2. Gallium-68 (Ga-68) PSMA PET Imaging *
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Fluorine-18 (F-18) PSMA PET Imaging

8. By End-User

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 8.1.2. Market Attractiveness Index, By End-User
8.2. Hospitals *
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Specialty Clinics
8.4. Diagnostic Imaging Centers
8.5. Research and Academic Centers
8.6. Others

9. By Region

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 9.1.2. Market Attractiveness Index, By Region
9.2. North America
- 9.2.1. Introduction
- 9.2.2. Key Region-Specific Dynamics
- 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.2.5.1. U.S.
  - 9.2.5.2. Canada
  - 9.2.5.3. Mexico
9.3. Europe
- 9.3.1. Introduction
- 9.3.2. Key Region-Specific Dynamics
- 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.3.5.1. Germany
  - 9.3.5.2. UK
  - 9.3.5.3. France
  - 9.3.5.4. Italy
  - 9.3.5.5. Spain
  - 9.3.5.6. Rest of Europe
9.4. South America
- 9.4.1. Introduction
- 9.4.2. Key Region-Specific Dynamics
- 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.4.5.1. Brazil
  - 9.4.5.2. Argentina
  - 9.4.5.3. Rest of South America
9.5. Asia-Pacific
- 9.5.1. Introduction
- 9.5.2. Key Region-Specific Dynamics
- 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.5.5.1. China
  - 9.5.5.2. India
  - 9.5.5.3. Japan
  - 9.5.5.4. Australia
  - 9.5.5.5. Rest of Asia-Pacific
9.6. Middle East and Africa
- 9.6.1. Introduction
- 9.6.2. Key Region-Specific Dynamics
- 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

10. Competitive Landscape

10.1. Competitive Scenario
10.2. Market Positioning/Share Analysis
10.3. Mergers and Acquisitions Analysis

11. Company Profiles

11.1. Novartis Pharmaceuticals Corporation *
- 11.1.1. Company Overview
- 11.1.2. Product Portfolio and Description
- 11.1.3. Financial Overview
- 11.1.4. Key Developments
11.2. Lantheus company
11.3. RadioMedix
11.4. Clarity Pharmaceuticals
11.5. Blue Earth Diagnostics, Inc.
11.6. Siemens Medical Solutions USA, Inc.
11.7. Eckert & Ziegler
11.8. Telix Pharmaceuticals
11.9. Canon Medical Systems, USA
11.10. Jubilant Draximage Radiopharmacies, Inc.

LIST NOT EXHAUSTIVE