Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/r DLBCL) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/r DLBCL) Market Outlook

Thelansis’s “Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/r DLBCL) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Relapsed or Refractory Diffuse Large B-cell Lymphoma treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/r DLBCL) Overview

Diffuse large B-cell lymphoma (DLBCL) is the most prevalent form of non-Hodgkin lymphoma (NHL), characterized by its diverse nature in terms of molecular changes, appearance, clinical behavior, and response to treatment. DLBCL, being highly aggressive, proliferates vigorously, affecting both lymph nodes and extranodal sites like the stomach, testis, and CNS. Relapse affects about 25–30% of DLBCL patients, with 10% experiencing resistance to treatment. Most relapses occur within two years of diagnosis, and many patients can't receive CAR T-cell therapy due to health issues or logistical challenges. For over two decades, the standard treatment for eligible patients with relapsed or refractory DLBCL has involved a second-line chemoimmunotherapy followed by autologous hematopoietic stem cell transplantation (AHCT). However, AHCT can cure only a minority, as most are ineligible due to age, health concerns, or resistance to second-line treatment. Nevertheless, some DLBCL patients still experience relapse after five years, often related to a favorable International Prognostic Index (IPI) score, limited-stage disease, and initial extranodal involvement. Survival rates have improved over time, with the latest 5-year relative survival rate being 62.0% in the United States and 55.4% in Europe. More than 50% of advanced-stage de novo DLBCL patients achieve a cure with rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). However, depending on the number of adverse prognostic factors from the International Prognostic Score (IPI), 20% to 50% of DLBCL patients are either refractory to R-CHOP or experience relapse after achieving complete response (CR). The FDA has approved Epkinly (epcoritamab-bysp) injection to treat adult patients with relapsed or refractory DLBCL, including cases originating from indolent lymphoma and high-grade B‑cell lymphoma after two or more prior systemic therapies. Epkinly is administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity.

• Approximately 50 to 60% of DLBCL patients attain and sustain complete remission following initial treatment, 30 to 40% experience relapse, and 10% face treatment-resistant disease.
• The occurrence of Double-Expressor Lymphoma (DEL) is more frequent in relapsed or refractory DLBCL (45%) compared to primary DLBCL (20–35%), and it is associated with poorer outcomes. Moreover, DHITsig-positive cases are more prevalent (60%) in diagnostic samples from relapsed DLBCL patients compared to those who do not experience relapse (30%).

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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