Oligometastatic Disease - Market Insights, Epidemiology, and Market Forecast - 2032

Key Highlights

• The concept of oligometastasis challenges the traditional view of cancer as a uniformly progressive and systemic disease, suggesting that some patients may benefit from aggressive local treatment to control or eradicate metastatic lesions.
• Advancements in imaging techniques and their increased adoption will increase recognition of oligometastatic disease among cancer patients.
• In 2022, there were about 115,000 cases of oligometastatic disease in the United States, which is expected to increase further by 2032.
• Surgical resection has been the method of choice; however, recent studies have helped establish stereotactic (ablative) body radiotherapy (SABR/SBRT) as a viable, non-invasive treatment option for many patients.
• Multidisciplinary collaboration is essential for tailoring individualized treatment plans for patients, considering their primary tumor type, metastatic site, overall patient health, and treatment goals.
• In 2022, the market size of oligometastatic disease in the United States was approximately USD 960 million, which is expected to grow further by 2032.
• The market is expected to grow, driven by factors like an increase in the patient pool and the projected entry of emerging therapies, i.e., IMSA101 (ImmuneSensor Therapeutics), PNT2002 (POINT Biopharma), and others, and their increasing usage in the treatment setting.

This ‘Oligometastatic Disease - Market Insights, Epidemiology, and Market Forecast - 2032' report delivers an in-depth understanding of the oligometastatic disease historical and forecasted epidemiology as well as the oligometastatic disease market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Oligometastatic Disease market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM oligometastatic disease market size from 2019 to 2032. The report also covers current oligometastatic disease treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered

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

Study Period: 2019-2032

Oligometastatic Disease Understanding and Treatment

Oligometastatic Disease Overview

Oligometastatic disease is a distinct state in cancer patients, characterized by limited metastatic spread, typically involving one to five distant sites beyond the primary tumor. There is no consensus on the definition of oligometastatic cancer, but no more than five radiologically visible metastases are considered a reasonable benchmark, which has also been used as a standard by the recently published ASTRO-ESTRO's clinical practice guideline for oligometastatic non-small cell lung cancer.

Oligometastatic disease is primarily subclassified into synchronous or metachronous, where synchronous patients are those that are initially diagnosed with oligometastasis, while metachronous patients are those patients that present with oligometastasis after treatment of the primary tumor. Metachronous patients are further subclassified into oligorecurrent, oligoprogressive, and oligopersistent, based on patient prognosis after primary tumor treatment.

Oligometastatic Disease Diagnosis

The accurate diagnosis of oligometastatic disease relies on advanced imaging techniques, such as positron emission tomography-computed tomography (PET-CT) and magnetic resonance imaging (MRI), to identify and localize metastatic lesions.

Oligometastatic Disease Treatment

New research has established that patients with few and slowly progressive distant lesions of small size may benefit from various local ablation techniques. These techniques have already been established as standard-of-care modalities in some cancers like non-small-cell lung cancer.

Although local interventions like stereotactic (ablative) body radiotherapy (SABR/SBRT) have been proven highly effective, other clinical variables, like patient-related and disease-related factors, should be considered before allocating such intervention to any patient.

Oligometastatic Disease Epidemiology

As the market is derived using a patient-based model, the oligometastatic disease epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total oligometastatic disease cases, oligometastatic disease cases by major cancer indications, type-specific cases of oligometastatic disease, total oligorecurrent cases, and oligorecurrent cases by major cancer indications in the 7MM covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.

• The total cases of oligometastatic disease in the 7MM was ~325,000 in 2022.
• Germany had the highest number of oligometastatic disease cases among the European countries, with ~36,000 cases in 2022. On the other hand, Spain had the lowest number of oligometastatic disease cases, with ~19,000 cases in 2022.
• Most oligometastatic disease cases are found in non-small cell lung cancer patients, with ~46,000 cases of oligometastatic non-small cell lung cancer.

Oligometastatic Disease Drug Chapters

The drug chapter segment of the oligometastatic disease report encloses a detailed analysis of oligometastatic disease marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the oligometastatic disease clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Emerging Drugs

IMSA101: ImmuneSensor Therapeutics

IMSA101 is a novel small molecule analog of cGAMP, designed with a unique defense-sensing mechanism that increases antitumor immunity to ultimately stimulate cytokines to turn “cold” tumors to “hot,” holding first-in-class potential for treating solid tumors. In early studies, IMSA101 stimulated the production of IFNs and cytokines, generating long-term memory immunity to tumors.

PNT2002: POINT Biopharma

PNT2002 (177Lu-PNT2002) is a PSMA-targeted therapy, combining the PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope lutetium-177. It has a unique radioactive API and formulation. In November 2022, Lantheus and POINT Biopharma announced strategic collaboration agreements in which Lantheus will license exclusive worldwide rights to POINT's PNT2002.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

No specific drug class has yet been well established in the treatment landscape of oligometastatic disease. The current therapeutic landscape of oligometastatic disease globally depends on locally-ablative treatments like radiotherapy and surgery, which have shown noticeable benefits in retrospective and small-scale studies.

Although no particular class has yet been established in large-scale trials, ImmuneseSensor Therapeutics is investigating the effects of intratumorally delivered STING agonists in oligometastasis. The stimulator of the interferon genes (STING) pathway is a cytosolic DNA-sensing pathway that drives activation of Type I interferons and other inflammatory cytokines in the host's immune response against tumors. The pathway is also hypothesized to have other antitumor functions, such as modulation of the vasculature and augmentation of adaptive immunity via the support of tertiary lymphoid structure development.

Additionally, radioligands combining cytotoxic radionuclide lutetium-177 and prostate-specific membrane antigen (PSMA)-targeting ligands are also being investigated to treat oligometastatic prostate cancer.

Oligometastatic Disease Market Outlook

There are currently no drug-based treatments for oligometastatic disease; instead, the focus is on locally ablative procedures such as surgery and radiotherapy, which are effective in small-scale and retrospective trials. Several Phase II trials have shown that definitive local therapy in the form of stereotactic body radiotherapy (SBRT) or surgery in combination with standard-of-care (SoC) systemic therapy can benefit selected oligometastatic patients by prolonging progression-free survival (PFS) or overall survival (OS).

In the absence of data from Phase III trials, the foundation of contemporary cancer care continues to be interdisciplinary discussion and decision-making in the form of multidisciplinary tumor boards, which make case-by-case recommendations based on the latest research and best practices.

Researchers are particularly excited about combining direct treatment of oligometastatic tumors with immunotherapy. The concept is based on the abscopal effect, a theory about cancer. The abscopal effect is when radiation given to a single tumor sparks an immune reaction against cancer across the body, although it is thought to occur rarely in patients.

Due to the lack of approved therapies for treating oligometastatic disease, novel therapies are being developed by various companies across the globe. The overall dynamics of the oligometastatic disease market are projected to change during 2023-2032, owing to the expected launch of emerging therapies.

The key players that can significantly change the market during the forecast period include IMSA101 and PNT2002. These drugs are being evaluated Phase II stage of clinical development.

• The market size of oligometastatic disease in the 7MM was ~USD 1,800 million in 2022.
• Among EU4 and the UK, Germany had the highest market size for oligometastatic disease, i.e., ~USD 150 million, in 2022. The smallest market size was estimated in Spain, with ~USD 80 million in 2022.
• Radiotherapy is generally preferred over surgery as it is a non-invasive procedure, more effective when multiple organ systems need to be treated, and also helps minimize breaks from systemic therapy.
• While surgery tends to be the optimal choice, like in cases where tumors are near vital organs or when large tissue sampling is needed for molecular testing to guide systemic therapy
• IMSA101 is a pipeline molecule being developed by ImmuneSensor Therapeutics, expected to launch in the forecast period (2023-2032).

Oligometastatic Disease Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. For example, for IMSA101, which is expected to be launched in the US by 2028, the drug uptake is expected to be medium, with a probability-adjusted peak patient share of ~10% in the US, expected to peak at 7 years from the year of launch.

Oligometastatic Disease Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for oligometastatic disease emerging therapies.

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 oligometastatic disease evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, oncologists, and Professors from renowned universities and hospitals in the US, Europe, the UK, and Japan.

This analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Kitasato University School of Medicine, Dana Farber Cancer Institute, etc., were contacted. Their opinion helped understand and validate current and emerging therapy treatment patterns of oligometastatic disease 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

The publisher performs Qualitative and Market Intelligence analysis using various competitive intelligence tools, including SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient and physician 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

Proactively approaching reimbursement can have a favorable effect both during the final stages of product development and after product introduction. In the report, we take reimbursement into account to pinpoint commercially viable indications. The ability to choose the markets with the fewest reimbursement hurdles can be a crucial business and price strategy when working with constrained resources.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of oligometastatic disease, explaining its definition, biological basis, related terminologies, types, and the diagnosis and treatment of oligometastatic disease.
• Comprehensive insights into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the oligometastatic disease, 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 expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM oligometastatic disease market.

Oligometastatic Disease Report Insights

• Patient Population
• Therapeutic Approaches
• Oligometastatic Disease Pipeline Analysis
• Oligometastatic Disease Market Size and Trends
• Existing and Future Market Opportunity

Oligometastatic Disease Report Key Strengths

• Ten years Forecast
• The 7MM Coverage
• Oligometastatic Disease Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Oligometastatic Disease Report Assessment

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

Key Questions Answered

Market Insights

• What was the oligometastatic disease total market size, the market size by therapies, and market share (%) distribution in 2019, and what would it look like by 2032? What are the contributing factors for this growth?
• What kind of uptake the new therapies approved will witness in oligometastatic disease patients in the coming years?
• Which therapy is going to be the largest contributor by 2032?
• What are the pricing variations among different geographies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risk, burdens, and unmet needs of oligometastatic disease? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to oligometastatic disease?
• What is the historical and forecasted oligometastatic disease patient pool in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What is the diagnostic pattern of oligometastatic disease?
• Which clinical factors will affect oligometastatic disease?
• Which factors will affect the increase in the diagnosis of oligometastatic disease?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of oligometastatic disease? What are the current guidelines for treating oligometastatic disease in the US, Europe, the UK, and Japan?
• How many companies are developing therapies for the treatment of oligometastatic disease?
• How many emerging therapies are in the mid-stage and late stage of development for treating oligometastatic disease?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What key designations have been granted for the emerging therapies for oligometastatic disease?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What is the 7MM historical and forecasted market of oligometastatic disease?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the oligometastatic disease market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data in the US, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis of emerging therapies to provide visibility around leading classes.
• 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 need of the existing market so that the upcoming players can strengthen their development and launch strategy.