The human immune system is composed of various types of specialized molecules and cells, which are involved in complicated interactions and activities to assist immune response. Immunotherapies use body’s innate potential to precisely target a specific molecular antigen and produce an efficient immune response against cells that show disease symptoms. CD 19 acts on follicular dendritic cells and B-lineage cells. It plays an important role in autoimmune diseases and B cell malignancies. Hence, it is a potential target for a number of monoclonal antibodies (mAbs). For years, chemotherapy has been popularly acknowledged as one of the principle anti-tumor therapies to get rid of proliferative tumor cells. Anti-CD19 mAbs are being developed to treat CD19 autoimmune diseases and lymphomas. It is one of the most novel research areas in the field of drug discovery in the pharma industry. Several of the anti-CD19 techniques are presently being tested in clinical trials.
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The global CD19 therapeutics market is driven by several important factors. Acute leukemia is regarded one of the most common forms observed in childhood malignancies, which accounts for roughly around 20% to 30% of all the pediatric malignancies depending on the age. According to CDC report, 2500 new patients are diagnosed with B-lineage acute lymphoblastic leukemia (B-ALL) in the U.S. each year. High incidence rates of non-Hodgkin’s lymphoma (NHL) have been confirmed in countries in the West. Additionally, the findings suggest that most of NHL subtypes are more predominant among men than women. CD19 is a 95-kDa transmembrane glycoprotein which belongs to the immunoglobulin (Ig) superfamily. Researchers suggest that CD 19 can act as a major positive response in regulating the B cells. Other factors driving the global CD 19 therapeutics market are rise in investment in health care by government and private organizations, increase in demand for minimal invasive surgeries, growing awareness about health, and early diagnosis of diseases. However, rise in cost of treatment, side effects associated with treatment, and lack of reimbursement policies in developing countries such as India, Singapore, and Brazil are likely to restrain the market.
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The pipeline of the drug comprises products across four major classes. These are antibody drug conjugates, chimeric antigen receptor (CAR) T-Cell therapy (CAR-T therapies), engineered antibodies, and bispecific antibody (BsAb). Recent approval of BLINCYTO which is a CD19 targeting bsAb and advancements in the chimeric antigen receptor (CAR) T-Cell therapies has delivered a substantial boost to the global CD 19 therapeutics market. These innovative techniques focus primarily on hematological cancers, precisely B cell malignancies. Research suggests that several key players have entered into collaborations with other stakeholders to fund the commercial and clinical development of CAR-T therapies. For instance, KTE-C19, CTL019, JCAR015, and JCAR017 are examples of late stage products discovered through collaborative approach of top pharmaceutical companies.
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Other than pharma companies, the top research institutes involved in this area include the University of Pennsylvania, the MD Anderson Cancer Centre, the Memorial Sloan Kettering Cancer Center (MSKCC), the National Cancer Institute (NCI), and the Fred Hutchinson Cancer Research Center (FHCRC). Treatment of hematological malignancies is the primary focus of drug developers. However, approaches are also on track to use these therapies in the treatment of other symptoms including autoimmune diseases and solid tumors.
North America is the major market for CD19 therapeutics driven by rise in health care funding, presence of top players and availability of reimbursement policies. Asia Pacific is anticipated to grow rapidly in the next few years due to rise in geriatric population, increase in per capita income, and growing health care infrastructure.
The global CD19 therapeutics market is highly fragmented, with presence of large number start-ups and some of the top research organizations. Top players in this market are Bellicum Pharmaceuticals, Amgen, ImmunoGen, Affimed, MedImmune, Merck, and Novartis Juno Therapeutics.