Photodynamic Therapies in Oncology Market

• Currently, only two PDTs have received approval in 1998 and 2001: PHOTOFRIN (ADVANZ PHARMA) for esophageal and endobronchial cancer and FOSCAN (Biolitec Pharma) for Head and Neck Squamous Cell Carcinoma (HNSCC).
• PDTs hold significant potential in oncology and may serve as effective treatment options for various cancers, including ovarian cancer, fallopian tube cancer, primary peritoneal cancer, Cutaneous T-cell Lymphoma (CTCL), Cutaneous Metastatic Breast Cancer (CMBC), Basal Cell Carcinoma Nevus Syndrome (BCCNS), prostate cancer, glioblastoma, and Non-Muscle Invasive Bladder Cancer (NMIBC), among others.
• Several companies, including NX Development (GLEOLAN), Soligenix (HyBryte), SpectraCure (SpectraCure P18 System), Theralase Technologies (RUVIDAR, Twinpig Biolab (TB511), and others are engaged in the development of PDTs in oncology, with many emerging therapies.
• In July 2024, Soligenix announced the interim update on the Phase III open-label, investigator initiated study evaluating extended HyBryte treatment in patients with early-stage cutaneous T-celllymphoma (CTCL). 
• In June 2024, the first patient for the Phase III trial of GLEOLAN(OVA-302) for Cutaneous Metastatic Breast Cancer (CMBC), wasenrolled.
• In April 2024, Kintara Therapeutics and TuHURA Biosciences entered into a definitive agreement for an all-stock transaction forming a company with expertise and resources to advance a risk diversified late-stage oncology pipeline.
• Theralase Technologies anticipates the presentation of the interim analysis of Phase II of TLD-1433, for the treatment of NMIBC, at the American Urological Association (AUA) annual meeting in April 2025.
• Combining PDT with other treatments can enhance effectiveness by leveraging the strengths of each approach, particularly in addressing challenges like Multi-drug Resistance (MDR) and hypoxia in prostate cancer. Multimodal therapies with PDT show promise in overcoming these issues.
• Overall, this is an exciting new class of technological agents with great potential for development and the oncology market. The maturation of current studies over the next few years will lead to a better understanding of PDTs and define their role in the therapy of cancer.
• The combination of PDT with chemotherapy, surgery, immunotherapy, and radiation therapy enhances treatment efficacy through an additive effect. However, limited clinical trials have been conducted to assess the true impact of these combined approaches. In the coming decade, more studies are expected worldwide to validate the effectiveness of PDT, particularly in combination with immunotherapy.
• Advancements in molecular biology and biochemical research have provided extensive insights into cellular and subcellular targets associated with oxidative stress-induced cytotoxicity following PDT. As a result, developers of novel targeted photosensitizers have access to a range of biologically active compounds, enabling precise, targeted delivery of therapeutic constructs to tumor sites.

DelveInsight’s “Photodynamic Therapies in Oncology Target Population, Competitive Landscape, and Market Forecast – 2034” report delivers an in-depth understanding of the PDTs in oncology, historical and competitive landscape as well as Photodynamic Therapies in Oncology therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The PDTs in the oncology market report provide current treatment practices, emerging therapies, market share of individual therapies, and current and forecasted 7MM PDTs in the oncology market size from 2020 to 2034. The report also covers current PDTs in oncology treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Photodynamic Therapies in Oncology Treatment Market

PDTs in Oncology Overview

Photodynamic Therapy (PDT) is a treatment that kills cancer cells by combining light and certain medications, sometimes known as photosensitizing agents. Only after being "turned on" or activated by specific types of light do the medications start to work. PDT is sometimes referred to as phototherapy, photoradiation therapy, or photochemotherapy.

PDT can be used in people with certain types of cancer to help them live longer and improve their quality of life. It’s becoming more widely recognized as a valuable treatment option for certain types of localized cancers (cancers that have not spread far from where they started). The oncology segment has emerged as the major therapeutic area targeted for the current clinical development of PDTs, with indications including NMSCs, ovarian cancer, lower anogenital cancer, glioblastoma, prostate cancer, lung cancer, breast cancer, and others.

Further details related to country-based variations are provided in the report...

PDTs in Oncology Market Overview

Oncological phototherapy, including current PDT, developmental Photoactivated Chemotherapy (PACT), and Photothermal Therapy (PTT), shows promising photo-efficacy for superficial and internal tumors. The dual application of light and photochemotherapeutic agents allows accurate cancer targeting, low invasiveness, and novel mechanisms of action. Current advances in new light sources and photoactive agents are encouraging for future development. PDT holds the most value in the market in phototherapies. Photosensitizers used in PDTs are classified according to historical development and conceptual approaches of first, second, and third-generation photosensitizers.

First and second-generation photosensitizers

Hematoporphyrin derivative (HpD), a complex natural mixture of oligomeric HpD, is considered to belong to the first-generation photosensitizers. A more purified preparation of HpD is known as PHOTOFRIN, which is still widely used today. The second-generation photosensitizers are synthetic compounds that include or originate from porphyrins, bactereochlorins, phthalocyanines, chlorins, benzoporphyrins, curcumin, and methylene. They are synthetic compounds that have been designed to improve upon the limitations of first-generation ones. For example, Chlorin e6, VISUDYNE, etc.

Third-generation photosensitizers

The third-generation photosensitizers are characterized by the conjugation of second-generation photosensitizers with targeting entities or moieties e.g. antibodies, carbohydrates, amino acids, and peptides, or by encapsulation into carriers. For example, G-chlorin and M-chlorin.

Further details related to country-based variations are provided in the report...

Photodynamic Therapies (PDTs) in Oncology Epidemiology

The epidemiology chapter of PDTs in oncology in the report provides historical as well as forecasted epidemiology segmented as total cases of selected indications for PDTs in oncology, total eligible patient pool of selected indications for PDTs in oncology, and total treated cases of selected indications for PDTs in oncology in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

PDTs in Oncology Therapies Chapters

The therapies chapter segment of the PDTs in the oncology report encloses a detailed analysis of approved PDTs in oncology, late-stage (Phase III and Phase II) PDTs in oncology. It also helps understand the clinical trial details of PDTs in oncology, expressive pharmacological action, agreements and collaborations, approval, and patent details, advantages and disadvantages of each included therapies, and the latest news and press releases.

PDTs in Oncology Marketed Therapies

PHOTOFRIN (porfimer sodium): ADVANZ PHARMA

PHOTOFRIN (porfimer sodium), a photosensitizer that is used in PDT for esophageal cancer, endobronchial cancer, and high-grade dysplasia in Barrett’s Esophagus. It is labeled as a first, second, and third-generation photosensitizer. Its trademark is owned by ADVANZ PHARMA (former name - Concordia Laboratories) by which it was initially approved in Canada in 1993 for the prophylactic treatment of bladder cancer. Subsequently, approvals for PHOTOFRIN were obtained in the Netherlands and France for the treatment of advanced esophageal and lung cancers; Germany for the treatment of early-stage lung cancer; Japan for early-stage lung cancer, esophageal, gastric, and cervical cancers as well as cervical dysplasia; and in the US for advanced esophageal cancer. In 1998, QLT PhotoTherapeutics (Vancouver, Canada) received US FDA approval for the use of PHOTOFRIN for early-stage lung cancer.

FOSCAN (temoporfin): Biolitec Pharma

FOSCAN (temoporfin), developed by Biolitec Pharma, is a photosensitizing agent (a light-sensitive drug), used in PDT. It received an Orphan Drug Designation (ODD) by the FDA in October 1999. Unfortunately, the US FDA declined the approval of FOSCAN in 2000. But in October 2001, FOSCAN was approved in the European Union as a local therapy for the palliative treatment of patients with advanced head and neck squamous cell cancer who have failed prior therapies and are unsuitable for radiotherapy, surgery, or systemic chemotherapy.

Note: Detailed current therapies assessment will be provided in the full report of PDTs in oncology..

PDTs in Oncology Emerging Therapies

GLEOLAN (OVA-302): NX Development

GLEOLAN is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX). The oral provision of GLEOLAN leads to a highly selective accumulation of PpIX in tumor cells. It is being investigated in Phase III for the visualization of newly diagnosed or recurrent ovarian cancer. In March 2024, GLEOLAN was granted ODD by the US FDA.

HyBryte: Soligenix

HyBryte appears to be a SAFE and effective PDT using visible fluorescent light. It is designed to be a front-line treatment for early-stage CTCL. HyBryte may enable patients to undergo more treatments to manage their disease while accumulating significantly fewer risks/toxicities. In December 2022, the FDA rejected the New Drug Application (NDA) for HyBryte to treat early-stage CTCL because it was not complete enough for a substantive review.

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

PDTs in Oncology Market Outlook

The market for PDTs in oncology is expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with oncology indications like NMSCs, ovarian cancer, CTCL, BCCNS, glioblastoma, prostate cancer, and other indications; the growing awareness of PDTs, and the increasing number of emerging therapies that are under clinical trials and filed for approval by various companies.

In recent years, PDT has made great progress as a non-invasive therapeutic approach. PDT in particular exhibits great promise for the treatment of cancer, starting with early skin infections and epidermal malignancies and progressing to solid tumor treatment. PDT relies heavily on photosensitizers, and a variety of novel multipurpose photosensitizers have surfaced, significantly expanding the potential applications of PDT. Furthermore, PDT's noninvasive nature and special therapeutic mechanism make it an ideal adjunct to immune therapy, chemotherapy, radiation, and gene therapy.

Several key players, including NX Development, Soligenix, SpectraCure AB, Theralase Technologies, and others, are involved in developing therapies for PDTs for various oncology indications such as ovarian cancer, CTCL, prostate cancer, and others, respectively. Overall, this is an exciting new class of technology with great potential for development. The maturation of current studies over the next few years will lead to a better understanding of PDTs and define their role in oncology.

PDTs in Oncology Therapies Uptake

This section focuses on the uptake rate of potential approved and emerging PDTs in oncology expected to be launched in the market during 2024–2034.

PDTs in Oncology Pipeline Development Activities

The report provides insights into PDTs in Oncology clinical trials within Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

The presence of numerous therapies under different stages is expected to generate immense opportunity for PDTs’ market growth over the forecasted period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for PDTs in oncology therapies.

KOL Views

To keep up with current and future market trends, we take Industry Experts’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on PDTs in oncology' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, therapies uptake, along challenges related to accessibility.

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Johns Hopkins Sidney Kimmel Cancer Center and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or PDTs’ market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

KOL Views

“The long-term cure rates of PDT range from 70 to 90% in NMSC patients, with excellent cosmetic results and good tolerance. However, the mechanism of action of PDT on tumors is complex. PDT not only kills tumor cells directly but also rapidly recruits immune cells to release inflammatory mediators to activate antitumor immunity.”

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient 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

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential therapies affordable. Health Technology Assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a therapies. These recommendations vary widely throughout the seven major markets, even for the same therapies.

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Continuing Medical Education (CME) program, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Key Updates on Photodynamic Therapies (PDTs)

• In October 2024, Soligenix announced the partnership with Sterling Pharma Solutions to optimize and implement a commercially viable, scalable production technology for synthetic hypericin (the active ingredient in HyBryte).
• In July 2024, Soligenix announced the interim update on the Phase III open-label, investigator-initiated study evaluating extended HyBryte treatment in patients with early-stage cutaneous T-cell lymphoma (CTCL). The FDA discussions of the drug are ongoing.
• In March 2024, GLEOLAN was granted ODD by the US FDA for the treatment of ovarian, fallopian tube, and primary peritoneal cancer.

The abstract list is not exhaustive, will be provided in the final report

Scope of the Photodynamic Therapies In Oncology Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of the Photodynamic Therapies in Oncology, explaining its mechanism, and therapies (current and emerging).
• Comprehensive insight into the competitive landscape, and forecasts, the future growth potential of treatment rate, therapies uptake, and therapies information 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 landscape.
• A detailed review of the Photodynamic Therapies in the oncology market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM therapies outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, conjoint analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM Photodynamic Therapies in the oncology market.

Photodynamic Therapies in Oncology Report Insights

• PDTs in Oncology Targeted Patient Pool
• PDTs in Oncology Therapeutic Approaches
• Photodynamic Therapies in Oncology Pipeline Analysis
• Photodynamic Therapies in Oncology Market Size and Trends
• Existing and future Market Opportunities
• PDTs in Oncology Market Drugs

Photodynamic Therapies in Oncology Report Key Strengths

• 10 years Forecast
• The 7MM Coverage
• Key Cross Competition
• Therapies Uptake and Key Market Forecast Assumptions

Photodynamic Therapies in Oncology Report Assessment

• Current PDTs in Oncology Treatment Practices
• PDTs in Oncology Unmet Needs
• PDTs in Oncology Pipeline Product Profiles
• PDTs in Oncology Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint analysis)
• PDTs in Oncology Market Drivers
• PDTs in Oncology Market Barrier

Key Questions Answered In The PDTs in Oncology Market Report

• What was the total market size of Photodynamic Therapies in Oncology, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which therapy is going to be the largest contributor in 2034?
• Which is the most lucrative market for Photodynamic Therapies in Oncology?
• What are the pricing variations among different geographies for approved therapies?
• How the reimbursement landscape has for Photodynamic Therapies in oncology evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
• What are the risks, burdens, and unmet needs of treatment with Photodynamic Therapies in oncology?
• What are the key factors hampering the growth of the Photodynamic Therapies in oncology market?
• What key designations have been granted to the therapies for Photodynamic Therapies in oncology?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy PDTs in Oncology Market Forecast Report:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the Photodynamic Therapies in the oncology market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• 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 needs of the existing market so that the upcoming players can strengthen their development and launch strategy.