Polivy Market Summary

Key Factors Driving Polivy Growth

Market Share Gains and New Patient Starts

• POLIVY (polatuzumab vedotin), an antibody–drug conjugate (ADC) developed by Roche, is gaining market traction in the diffuse large B-cell lymphoma (DLBCL) landscape, particularly in frontline and relapsed/refractory settings.
• New patient starts are increasing as POLIVY becomes more firmly embedded in standard treatment regimens, supported by strong survival benefits demonstrated in pivotal trials.
• Roche’s targeted hematology-oncology commercial strategy, coupled with robust physician education and guideline inclusion, is accelerating adoption across academic and community oncology practices.

Expansion Across Key Indications

• Frontline DLBCL: POLIVY in combination with R-CHP has emerged as a key alternative to R-CHOP in previously untreated DLBCL patients, supported by superior progression-free survival outcomes.
• Relapsed/Refractory DLBCL: Continued use in combination with bendamustine and rituximab (Pola-BR) supports sustained utilization in later-line settings.
• Broader B-Cell Lymphomas: Ongoing studies are evaluating POLIVY in other aggressive and indolent B-cell non-Hodgkin lymphomas.
• Pipeline and Combination Strategies: Additional combinations with novel agents and immunotherapies may further expand POLIVY’s role across treatment lines.

Geographic Expansion

• Global Commercial Footprint: POLIVY is approved and commercialized across major markets including the United States, Europe, and Japan.
• Emerging Markets: Expansion into emerging markets is supported by Roche’s established oncology infrastructure and increasing access to advanced lymphoma therapies.
• Asia-Pacific Growth: Rising lymphoma incidence, improved diagnostic rates, and greater access to biologics are expected to support accelerated growth in Asia-Pacific regions.

New Indication Approvals

• Frontline DLBCL Approval: Regulatory approval of POLIVY in combination with R-CHP for untreated DLBCL significantly broadened its treatment landscape.
• Label Expansion Strength: Approvals in both frontline and relapsed/refractory settings enhance Roche’s competitive positioning and diversify revenue streams.
• Regulatory Momentum: Ongoing studies may support additional label refinements or expansions into specific DLBCL subpopulations.

Strong DLBCL Volume Momentum

• High Unmet Need in Aggressive Lymphomas: Despite curative intent, a significant proportion of DLBCL patients relapse or fail first-line therapy, sustaining demand for improved regimens.
• Compelling Clinical Outcomes: Improved progression-free survival and consistent benefit across risk subgroups are driving strong treatment volumes.
• Guideline Inclusion: Incorporation into major clinical guidelines is reinforcing sustained prescription momentum globally.

Competitive Differentiation and Market Trends

• Targeted ADC Mechanism: POLIVY delivers a cytotoxic payload directly to CD79b-expressing B cells, differentiating it from conventional chemotherapy and naked antibodies.
• Chemotherapy Backbone Optimization: Replacement of vincristine in frontline regimens addresses efficacy limitations of historical standards of care.
• Shift toward Precision Oncology: Growing emphasis on targeted and biomarker-driven therapies supports POLIVY’s positioning in aggressive lymphomas.
• Increasing Role of Real-World Evidence (RWE): Post-approval RWE is reinforcing payer and prescriber confidence in POLIVY’s long-term benefit–risk profile.

Polivy Recent Developments

POLIVY’s market position was significantly strengthened following regulatory approvals for frontline use in combination with R-CHP, based on the POLARIX Phase III trial, which demonstrated superior progression-free survival compared with standard R-CHOP in previously untreated DLBCL patients. Roche has continued to report consistent real-world and subgroup analyses supporting the durability of benefit across patient populations. Ongoing clinical programs are exploring POLIVY in additional combination regimens and earlier treatment settings, reinforcing its role as a cornerstone targeted therapy in aggressive B-cell lymphomas.

“Polivy Sales Forecast, and Market Size Analysis – 2034” report provides comprehensive insights of Polivy for approved indication like Diffuse large B cell lymphoma; as well as potential indications like Follicular lymphoma; Chronic lymphocytic leukaemia; Non-Hodgkin's lymphoma; and Richter's syndrome in the 7MM. A detailed picture of Polivy’s existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 –2034 is provided in this report along with a detailed description of the Polivy for approved and potential indications. The Polivy market report provides insights about Polivy’s sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current Polivy performance, future market assessments inclusive of the Polivy market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of Polivy sales forecasts, along with factors driving its market.

Polivy Drug Summary

Polivy (polatuzumab vedotin) is an antibody-drug conjugate (ADC) developed by Genentech (Roche) comprising a humanized monoclonal antibody targeting CD79b—a B-cell-specific antigen covalently linked via a protease-cleavable linker to the microtubule-disrupting agent monomethyl auristatin E (MMAE). Upon binding to CD79b on malignant B cells, it internalizes, releases MMAE intracellularly, inhibits cell division, and induces apoptosis, selectively delivering cytotoxicity to proliferating B cells in lymphomas while sparing healthy tissues more than traditional chemotherapy. FDA-approved in 2019 for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after ≥2 prior therapies in combination with bendamustine and rituximab, and expanded in 2023 for previously untreated DLBCL or high-grade B-cell lymphoma (IPI ≥2) with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP), it is administered intravenously every 21 days (1.8 mg/kg) under premedication. The report provides Polivy’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Polivy Market Report

The report provides insights into:

• A comprehensive product overview including the Polivy MoA, description, dosage and administration, research and development activities in approved indications like Diffuse large B cell lymphoma; as well as potential indications like Follicular lymphoma; Chronic lymphocytic leukaemia; Non-Hodgkin’s lymphoma; and Richter’s syndrome.
• Elaborated details on Polivy regulatory milestones and other development activities have been provided in Polivy market report.
• The report also highlights Polivy‘s cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan. 
• The Polivy market report also covers the patents information, generic entry and impact on cost cut.
• The Polivy market report contains current and forecasted Polivy sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The Polivy market report also features the SWOT analysis with analyst views for Polivy in approved and potential indications.

Methodology

The Polivy market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Polivy Analytical Perspective by DelveInsight

In-depth Polivy Market Assessment

This Polivy sales market forecast report provides a detailed market assessment of Polivy for approved indication like Diffuse large B cell lymphoma; as well as potential indications like Follicular lymphoma; Chronic lymphocytic leukaemia; Non-Hodgkin’s lymphoma; and Richter’s syndrome in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted Polivy sales data uptil 2034.

Polivy Clinical Assessment

The Polivy market report provides the clinical trials information of Polivy for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

Polivy Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

Polivy Market Potential & Revenue Forecast

• Projected market size for the Polivy and its key indications
• Estimated Polivy sales potential (Polivy peak sales forecasts)
• Polivy Pricing strategies and reimbursement landscape

Polivy Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• Polivy Market positioning compared to existing treatments
• Polivy Strengths & weaknesses relative to competitors

Polivy Regulatory & Commercial Milestones

• Polivy Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

Polivy Clinical Differentiation

• Polivy Efficacy & safety advantages over existing drugs
• Polivy Unique selling points  

Polivy Market Report Highlights 

• In the coming years, the Polivy market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The Polivy companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Polivy’s dominance.
• Other emerging products for Diffuse large B cell lymphoma; as well as potential indications like Follicular lymphoma; Chronic lymphocytic leukaemia; Non-Hodgkin’s lymphoma; and Richter’s syndrome are expected to give tough market competition to Polivy and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Polivy in approved and potential indications.
• Analyse Polivy cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted Polivy sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Polivy in approved and potential indications. 

Key Questions

• What is the class of therapy, route of administration and mechanism of action of Polivy? How strong is Polivy’s clinical and commercial performance?
• What is Polivy’s clinical trial status in each individual indications such as Diffuse large B cell lymphoma; as well as potential indications like Follicular lymphoma; Chronic lymphocytic leukaemia; Non-Hodgkin’s lymphoma; and Richter’s syndrome and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Polivy Manufacturers?
• What are the key designations that have been granted to Polivy for approved and potential indications? How are they going to impact Polivy’s penetration in various geographies?
• What is the current and forecasted Polivy market scenario for approved and potential indications? What are the key assumptions behind the forecast? 
• What are the current and forecasted sales of Polivy in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?  
• What are the other emerging products available and how are these giving competition to Polivy for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is Polivy? What is the duration of therapy and what are the geographical variations in cost per patient?