首頁 > 市場調查報告書 > 醫療設備

醫學影像診斷 CT/MRI/X光

市場調查報告書

商品編碼

1345453

全球 PSMA PET 成像市場 - 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: 約2個工作天內

價格

※ 本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

簡介目錄

概述

全球 PSMA PET 成像市場將於 2022 年達到 15 億美元，預計到 2030 年將達到 20 億美元，2023-2030 年預測期間年複合成長率為 3%。

全球 PSMA PET 成像市場預計在未來幾年將出現顯著成長，影響其動態的因素有多種，例如前列腺癌檢測的採用率不斷提高、臨床試驗不斷增加等。政府對 PSMA PET 開發的投資將繼續推動和提振全球市場。全球 PSMA PET 成像市場越來越重視減少其影響。

前列腺特異性膜抗原 (PSMA) 正電子發射斷層掃描 (PET) 成像技術是一項不斷發展的技術，用於檢測男性前列腺癌。前列腺癌被認為是世界上第四大最常見的癌症。 FDA 批准的 PSMA PET 成像技術有兩種，例如鎵 68 (Ga-68) PSMA PET 成像和氟 18 (F-18) PSMA PET 成像。同樣，北美在白癜風治療市場上佔據主導地位，由於該地區有利的報銷政策、先進的醫療基礎設施和主要參與者的存在，佔據了最大的市場佔有率。

由於前列腺癌的患病率不斷增加，人們對前列腺癌的認知不斷提高，早期診斷不斷增加，臨床試驗不斷增加，對非侵入性診斷技術的需求不斷增加，PSMA PET 成像擴大用於早期診斷，以及PSMA PET 成像技術的進步是預計的主要因素在預測期內推動全球 PSMA PET 成像市場。

動力學

臨床試驗的增加預計將推動市場的成長

預計臨床試驗數量的增加將在預測期內推動市場的成長。臨床試驗建立了患者對安全性和有效性的信任。臨床試驗的積極結果可以增強投資者對成像技術的信心和患者的信任。這種信心的增強可以吸引資金進行進一步的研發並進行更多的臨床試驗，從而使公司能夠投資更多的創新技術並推動市場發展。

此外，臨床試驗可以提供一個重要的平台來證明 PSMA PET 成像在各種臨床場景中的功效。這種驗證對於獲得監管部門的批准和接受至關重要。臨床試驗探索 PSMA PET 成像的新應用和適應症。這種應用的擴展可以極大地推動市場。臨床試驗的積極結果可以將 PSMA PET 成像涵蓋臨床指南和護理標準，從而增加其在常規臨床實踐中的採用。

例如，2023 年 6 月 14 日，Clarity Pharmaceuticals 與西門子 Healthineers 公司旗下的 PETNET Solutions Inc、全球正電子發射斷層掃描 (PET) 放射性藥物網路以及美國領先的 PET 成像放射性藥物製造商簽訂了主服務協議協議和臨床供應協議涵蓋Clarity 的64Cu SAR-bisPSMA，這是一種用於前列腺癌成像的下一代診斷放射性藥物產品。 64Cu SAR-bisPSMA 是一種研究性 PET 製劑，預計將於 2023 年底前在美國進入關鍵的 III 期試驗，並可能於 2024 年進入第二次 III 期試驗。

FDA 批准的增加預計也將推動市場的成長

FDA 批准的增加預計也將在預測期內推動市場的成長。 PSMA PET 成像技術的監管批准不斷增加，為患者和醫療保健提供者提供了更多選擇。這種診斷成像擴展選擇可以促進市場成長，因為它滿足了個人對更好的前列腺癌成像的需求。 FDA 批准等監管部門的批准也增加了患者對已批准的診斷成像技術的信任。

此外，FDA 批准的 PSMA PET 產品和放射性藥物通常被認為更可信，可以提高患者的信任度，從而在醫療保健提供者和機構中得到更多採用。 FDA 的批准可以促進與保險提供商和政府衛生機構就 PSMA PET 手術報銷問題進行討論，使患者更容易獲得該手術。

例如，2023 年5 月30 日，美國食品和藥物管理局(FDA) 批准了最佳化的高親和力放射性混合前列腺特異性膜抗原(PSMA) 靶向正電子發射斷層掃描(PET) 成像劑氟洛司他氟18 (波斯盧瑪）。 Flotufolastat F-18 適用於疑似轉移的前列腺癌患者的 PSMA 陽性病變的 PET 成像，這些患者是初始確定性治療的候選者或基於血清前列腺特異性抗原 (PSA) 水平升高而疑似復發的患者。它是第一個也是唯一一個經 FDA 批准的、採用專有放射混合技術開發的 PSMA 靶向顯像劑。

PSMA PET 成像的嚴格定價預計將阻礙市場成長

PSMA PET 成像嚴格的定價預計將阻礙預測期內市場的成長。由於需要更專業的設施和嚴格的品質控制，開發和製造 PSMA PET 放射性藥物和成像設備可能會更加昂貴。這些嚴格的成本可能會轉嫁給最終用戶，從而導致價格上漲。

此外，在某些地區，報銷政策可能無法充分支付 PSMA PET 成像的費用，從而使患者更難獲得該成像，並可能限制市場成長。對於許多前列腺癌患者來說，嚴格的費用可能難以承受，這預計將阻礙市場的成長。

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