Diffuse Large B-cell Lymphoma Therapeutics Market

Market Overview

The Diffuse Large B-cell Lymphoma (DLBCL) Therapeutics Market refers to the market for drugs and therapies used in the treatment of diffuse large B-cell lymphoma, which is a type of aggressive non-Hodgkin lymphoma. The market size of DLBCL therapeutics was valued at USD 4,107.50 million in 2021.

According to estimates, the DLBCL therapeutics market is projected to grow at a compound annual growth rate (CAGR) of7.50% during the forecast period from 2023 to 2030. This indicates that the market is expected to witness steady growth over the next few years.

DLBCL is a fast-growing type of cancer that affects the lymphatic system, specifically the B-cells, which are a type of white blood cells responsible for producing antibodies. The market for DLBCL therapeutics includes various treatment options such as chemotherapy, immunotherapy, targeted therapy, and stem cell transplantation.

The projected CAGR of 7.50% suggests that the DLBCL therapeutics market is likely to expand significantly during the forecast period. This growth can be attributed to several factors, including an increasing prevalence of DLBCL, advancements in treatment options, rising healthcare expenditure, and growing awareness about early diagnosis and treatment of cancer.

The market growth is also influenced by ongoing research and development activities to discover novel therapies and drugs for DLBCL treatment. Pharmaceutical companies and researchers are continuously working on developing more effective and targeted therapies that can improve patient outcomes and reduce side effects.

Factors such as favorable reimbursement policies, technological advancements in diagnostic procedures, and the availability of healthcare infrastructure also contribute to the growth of the DLBCL therapeutics market.

Market Scope And Summary

Diffuse large B-cell lymphoma (DLBCL) is a prevalent form of non-Hodgkin lymphoma (NHL), which refers to a group of cancers that originate in the lymphatic system. DLBCL specifically accounts for the largest proportion of NHL cases. It is characterized by its aggressive nature, meaning it tends to grow rapidly and requires prompt treatment.

DLBCL primarily affects a specific type of white blood cells called B-lymphocytes or B-cells. These B-cells play a crucial role in the immune system by producing antibodies, which are proteins that help fight off infections and protect the body against harmful substances.

The lymphatic system is a network of vessels, organs, and tissues that work together to carry lymph, a fluid containing white blood cells, throughout the body. This system plays a vital role in immune function and helps remove toxins and waste products from the body.

In DLBCL, the abnormal growth of B-cells occurs within the lymphatic system, leading to the formation of tumors or lymphomas. The term "diffuse" implies that the cancer cells are spread throughout the lymph nodes or other lymphatic tissues, rather than being localized to a single site.

Due to its aggressive nature, DLBCL requires prompt diagnosis and treatment. The exact cause of DLBCL is not fully understood, although certain risk factors have been identified, including genetic factors, certain infections (such as the Epstein-Barr virus), and immunodeficiency conditions.

The treatment approach for DLBCL typically involves a combination of therapies, such as chemotherapy, immunotherapy, targeted therapy, and in some cases, stem cell transplantation. The choice of treatment depends on various factors, including the patient's overall health, disease stage, and specific characteristics of the tumor.

Advancements in DLBCL research and treatment have led to improved outcomes for many patients. However, DLBCL remains a significant medical challenge, and ongoing research efforts aim to develop more effective therapies with fewer side effects.

Market Dynamics

The global market for diffuse large B-cell lymphoma (DLBCL) therapeutics is experiencing significant growth due to several key factors. Firstly, there has been a noticeable rise in the incidence of DLBCL, which is the most common form of non-Hodgkin lymphoma. This increasing prevalence has created a higher demand for effective treatment options and has consequently contributed to the growth of the therapeutics market.

Secondly, there is a growing preference among healthcare professionals and patients for targeted therapies. Targeted therapies offer the advantage of specifically targeting cancer cells while minimizing damage to healthy cells, thereby reducing side effects. This preference for targeted therapies has propelled the development and adoption of novel drugs in the DLBCL therapeutics market.

Furthermore, technological advancements have played a crucial role in the growth of this market. These advancements encompass various aspects, including diagnostic tools, imaging techniques, and drug delivery systems. The integration of advanced technologies into DLBCL therapeutics has improved treatment efficacy, patient outcomes, and overall disease management.

The combination of increasing DLBCL incidence, the preference for targeted therapies, and technological advancements in drug therapeutics has created a favorable environment for the expansion of the global DLBCL therapeutics market. This growth trend is expected to continue as further advancements are made, offering new opportunities for pharmaceutical companies and healthcare providers to develop and deliver more effective treatments for DLBCL patients.

Increasing preference for targeted therapies is expected to drive the growth in the forecast period

Targeted therapy is one of the most widely preferred methods for the treatment of diffuse large B-cell lymphoma, as targeted therapy is less toxic to healthy cells than chemotherapy. Targeted therapies act on specific molecular targets that are associated with cancer. Monoclonal antibodies, kinase inhibitors, immunomodulatory drugs, and nuclear export inhibitors are among the targeted therapies used for NHL. Rituximab is a targeted therapy that is used to treat a variety of B-cell NHL types. It works by focusing on a molecule known as CD20, which is found on the surface of both normal B cells and B-cell NHL cells. Ibrutinib is a targeted therapy that inhibits the Bruton's tyrosine kinase pathway. Mantle cell lymphoma, marginal zone lymphoma, and small lymphocytic lymphoma, as well as chronic lymphocytic leukaemia and Waldenstrom macroglobulinemia, are among the B-cell lymphomas for which it has been approved.

Recent progress in molecular biology has led to a better understanding of the oncogenic drivers of DLBCL, resulting in the development of a large number of targeted therapies undergoing evaluation in phase I and II trials. Ibrutinib (Imbruvica), a targeted therapy approved by the FDA for use in multiple forms of lymphoma, has been tested in DLBCL to investigate if it affects the subtypes differently.

High cost of treatment is likely to hamper the market growth

The high cost associated with the treatment of diffuse large B-cell lymphoma is expected to restrain the market growth to a certain extent, as this limits the number of individuals undergoing the treatment. The cost to treat diffuse large B-cell lymphoma (RR DLBCL) can be high—and that’s only taking into account first- and second-line treatments that can cost as much as $200,000. A study presented at the International Society of Pharmacoeconomics and Outcomes Research Annual International Meeting estimated the lifetime direct medical costs of third-line and subsequent treatment costs for this disease. The authors calculated the cost of third-line therapies by adding the Average Sales Price of therapies, plus the direct costs to providers in 2017. Some of the other costs considered were adverse events, treatment administration and monitoring, disease management, and future healthcare costs

They discovered that lifetime costs can vary from $600,000 to $750,000, with the costs of adverse events related to third-line treatment representing 30% of the total cost. Treatment acquisition (28%) and subsequent therapy (21%) are the other costs considered included. The lifetime cost of treating RR DLBCL can approach and surpass $1 million after including the costs of first- and second-line therapies.

COVID-19 Impact

The COVID-19 pandemic continues to endanger global health and hinder the world economy; It has been widely observed that patients with existing diffuse large b-cell lymphoma experience higher complications due to COVID-19.

The degree to which ongoing chemotherapy impacts the outcome of patients with COVID-19 remains controversial, but at least one large study shows that individuals with diffuse large b-cell lymphoma undergoing treatment when diagnosed with COVID-19 are at high risk of severe complications.  There are also data suggesting that patients with lymphoma have an increased susceptibility to infection with SARS-CoV-2. According to one report, the more intense the therapy, the greater the impact on clinical outcomes in patients who contract COVID-19. The high morbidity and mortality rates reported in patients with hematologic malignancies underscore the vulnerability of this patient population.

Most centers are screening patients beginning therapy in the out-patient clinic or even monthly on an on-going basis, or on admission to the hospital for treatment. Practices differ depending on the prevalence of COVID-19 and the availability of screening. The decision on when and how to treat in the face of a positive result must be individualized. Patients with diffuse large b-cell lymphoma who are actively undergoing treatment with an anti-CD20 antibody have an impaired response to the BNT162b2 mRNA (by Pfizer-BioNTech) COVID-19 vaccine, according to research published in Blood Advances. Patients who had any exposure to anti-CD20 therapy were less likely to have a response to the COVID-19 vaccine. Patients with an absolute lymphocyte count were also less likely to respond to the vaccine. This will create problem for patients who are presently taking therapies.

Market Segmentation

The immuno and targeted drugs segment is expected to hold the largest share in this market segment

Targeted therapeutics is a type of cancer treatment that uses drugs to precisely 'target' cancer cells without affecting normal cells. Although targeted therapy is an effective treatment, many individuals prefer to use it in combination with other therapies such as traditional or standard chemotherapy, surgery, or radiation therapy. Developments in research for DNA changes and proteins that drive cancer are proving effective to design promising treatments that target such proteins. For different types of cancers come different types of drugs that individually target distinct cancer. However, tumors are tested to check the target, and provide therapy if the drugs are available. As traditional chemotherapy can damage normal cells while killing cancer cells, the targeted therapeutics segment is expected to witness growth during the forecast period. Targeted cancer therapies market is growing due to the increasing incidences of diffuse large b-cell lymphoma (DLBCL). For instance, as per the lymphoma organization, diffuse large b-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in the United States, accounting for about 22 percent of newly diagnosed cases of B-cell NHL in the United States. More than 18,000 people are diagnosed with DLBCL each year.

Robust R&D studies are underway for the development of new drugs and therapies for DLBCLs. Several products of different companies are in different phases of clinical trials and will be available in the market during the forecast period. For instance, Roche, Glofitamab (Anti-CD20 CD3 TCB, RG6026) is a T cell-engaging bispecific antibody, designed to engage both CD20 on B cells and CD3 on T cells. By engaging both targets simultaneously, the antibody activates the T cells to attack and eliminate the B cells, allowing treatment of B cell cancers such as non-Hodgkin’s lymphoma is under Phase 1 clinical trials is expected to complete by 2022.

Market Challenges

While the diffuse large b-cell lymphoma (DLBCL) therapeutics market is witnessing growth, it also faces several challenges that need to be addressed:

High cost of therapies: DLBCL treatments, including targeted therapies and immunotherapies, can be expensive. The high cost of these therapies may limit access for patients, particularly in regions with limited healthcare resources or inadequate insurance coverage.

Drug resistance: DLBCL can develop resistance to certain treatments over time, leading to treatment failures and disease progression. Developing strategies to overcome drug resistance and improve long-term treatment outcomes is a critical challenge in DLBCL therapeutics.

Limited treatment options: while advancements have been made, some DLBCL patients still face limited treatment options, especially those with relapsed or refractory disease. Expanding the range of effective therapies available for different subtypes and stages of DLBCL remains a challenge.

Side effects and toxicity: DLBCL treatments can have significant side effects and toxicity, impacting patients' quality of life. Reducing the adverse effects associated with therapies while maintaining efficacy is an ongoing challenge.

Diagnostic challenges: accurate and timely diagnosis of DLBCL is essential for optimal treatment. However, DLBCL can present with heterogeneity, making diagnosis challenging. Improving diagnostic techniques, including advanced imaging and biomarker identification, is necessary for early detection and appropriate treatment selection.

Market Barriers

The diffuse large b-cell lymphoma (DLBCL) therapeutics market faces several barriers that hinder its growth and development:

Regulatory challenges: the regulatory approval process for new DLBCL therapies can be lengthy and complex. Strict regulations and requirements for safety and efficacy assessments can delay the introduction of innovative treatments into the market.

Limited research funding: research and development in the field of DLBCL therapeutics require substantial financial investments. Limited funding for DLBCL research may hinder the discovery and development of new therapies and technologies.

Lack of biomarkers: DLBCL is a heterogeneous disease, meaning it encompasses various subtypes with different biological characteristics. Identifying reliable biomarkers that can aid in patient stratification and treatment selection is challenging but crucial for personalized medicine approaches.

Resistance to change: adoption of new therapies and treatment approaches in clinical practice can be slow. Resistance to change, both from healthcare professionals and patients, can impede the integration of innovative DLBCL therapeutics into routine care.

Geographical Share

North America region holds the largest market share of global diffuse large b-cell lymphoma therapeutics market

North America dominates the market owing to the factor such as increasing prevalence of diffuse large b-cell lymphoma (DLBCL) cases and rising healthcare awareness among the peoples of the region. As per the lymphoma organization, diffuse large b-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in the United States, accounting for about 22 percent of newly diagnosed cases of B-cell NHL in the United States. More than 18,000 people are diagnosed with DLBCL each year. The estimates are expected to increase due to the rising trend in the Non-Hodgkin Lymphoma (NHL) incidence as well as DLBCL incidence in the region, combined with underlying demographic changes. It is a mature B-cell neoplasm emanating from the germinal center& post germinal center B-cells.

Furthermore, increasing focus of manufacturers on adoption of inorganic growth strategies such as partnerships and acquisitions, in order to strengthen their product portfolio of relapsed or refractory diffuse large B-cell lymphoma which is anticipated to drive the market growth in the region. For instance, the FDA recently authorized Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL).

Competitive Landscape

The global diffuse large b-cell lymphoma therapeutics market is highly competitive with presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include F. Hoffmann-La Roche Ltd, Novartis AG, Celltrion, Karyopharm Therapeutics, Kite Pharma, MorphoSys AG, AbbVie, CTI BioPharma, Seagen Inc., TG Therapeutics. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the wound care management devices globally. For instance, On February 19, 2019, The FDA granted Priority Review for polatuzumabvedotin in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Global Diffuse Large B-cell Lymphoma Therapeutics Market – Key Companies to Watch

F. Hoffmann-La Roche Ltd

Company Overview: Roche was founded in 1896 in Basel, Switzerland. It creates innovative medicines and diagnostic tests that help millions of patients globally. Roche was one of the first companies to bring targeted treatments to patients. With combined strength in pharmaceuticals and diagnostics, they are better equipped than any other company to drive personalized healthcare further. Two-thirds of their research and development projects are being developed with companion diagnostics. Genentech become a member of the Roche Group in March of 2009. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

Product Portfolio: The company portfolio includes Rituxan (rituximab)/MabThera was the first therapeutic monoclonal antibody to target cells that have the CD20 marker on their surface. These cells are central to many blood cancers, including common forms of lymphoma and leukaemia.

Key Developments: In June 2019, the U.S FDA approved Roche’s Polivy in combination with bendamustine plus Rituxan (rituximab) (BR) for people with previously treated aggressive lymphoma i.e., diffuse large B-cell lymphoma (DLBCL).

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