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GLOBAL CHIMERIC ANTIGEN RECEPTOR (CAR) T CELL THERAPY MARKET: HOTBED OF OPPORTUNITIES

GLOBAL CHIMERIC ANTIGEN RECEPTOR (CAR) T CELL THERAPY MARKET: HOTBED OF OPPORTUNITIESReportocean.com have announced the addition of a new report titled “Global Car T Cell Therapy Market Research Report Forecast to 2025”.

Chimeric Antigen Receptor (CAR) T Cell Therapy uses these cells which have been genetically engineered to treat cancer. These cells are engaged to produce an artificial T- cell receptor for the immunotherapy. In this very promising treatment T- cells from the patient body are segregated first and then injected in the CAR gene whereby the gene for the specific receptor binds to a specific protein on the patient’s cancer cells. These modified cells are expected to recognize cancer cells, target, and destroy them. T- cells are harvested, genetically altered, and then infused into cancer struck patient to destroy his tumor. They target a specific antigen present on the surface of tumor, so that healthy cells are not affected. This therapy is used when existing drugs are proving inadequate.

The CAR design has evolved over several generations. Now we have fourth generation CARs, also called armoured CARs, that are sufficiently fortified for T cell expansion, persistence, and anti-tumoral action. They have allowed doctors to precisely control the persistence or further activity of the T-cells in the patient’s body, besides reducing toxic side effects. The specialist can trigger death or limit activation of T cells and regulates them via a separate drug. All these clinical developments over many year s have led to a successful, and very promising, commercial application of the treatment. Little wonder then that the cell therapy market for CAR has been growing at a CAGR of whopping 58.52% between 2018–2025. Whereas it was valued at USD 346.75 million in 2018, the market is expected to grow to USD 8,716.06 million by 2025. The research and product development is in growth stage of product life cycle; thus the scope for market growth are immense. Ever growing number of clinical studies coupled with technical advancements in the field across the world is further fueling the expansion. Having said that there is no gainsaying the fact that whereas CAR-T cells are a major breakthrough for cancer treatment, serious side effects cannot be ruled out including neurological toxicity. Besides, it being a new treatment, long term effect of the therapy are yet to be documented, with concerns about long term patient survival.

Yet, on balance the treatment has tremendous potential and promise, as witnessed by the CAGR figure of nearly 59%, for the cancer patients worldwide. Remember, according to WHO, cancer is the second leading cause of deaths worldwide and led to 9.6 million deaths in 2018. In absence of surefire treatment of this dreaded disease, the latest CAR-T cell therapy definitely offers a ray of hope.

Increasing number of cases on one hand and growing research and developmental activities on the other are contributing towards spread of the therapy. Further fuel is provided by commercial investments in product development and expansion of production capacities.

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DIVIDE AND CONQUER

The market, like any other, is not monolithic nor can it be handled through a common strategy. Hence there is a need to segment it. Subsequently the approachable segments can be targeted wherein our product can be uniquely positioned; the so called STP approach to sales and marketing can be adopted thus.

We can divide the market on geographical, target antigen, or application basis. In geographical terms the market can be subdivided into US, Europe, China, and Rest of the world. According to the American cancer society, in 2017, nearly 1.7 million new cancer cases were reported. The US market thereby dominates the possibility of administering this cell therapy. The cases are increasing overtime due to multiple factors, including better reporting and worsening lifestyle. The European market is estimated to come after US. In UK alone the cancer incidence is projected to rise by 2% between 2014–2035, at nearly 750 cases per 100,000 by the terminal year. Hematologic cancers such as leukemia, lymphoma, and multiple myeloma are majorly contributing to further spread of the disease. Third, China is projected to be the fastest growing and most promising market since the disposable income is rising there and healthcare infrastructure is being put in place. The latter is fueling high quality research in this domain. Besides, most top companies are interested in hitherto untapped market by setting up R & D. centers in China and other developing countries. Clinicals trials are relatively easier here because of relatively lax laws. Finally, the rest of the world also offers a lot of promise, including market like India, where the governments are making healthcare affordable at increasing rate and as of now access to treatment is limited.

On the basis of application, the market can be divided into three parts: Diffuse Large B-Cell Lymphoma (DLBCL), Acute Lymphoblastic Leukemia, (ALL), and others like multiple myeloma. Out of these DLBCL is the commonest non-Hodgkin lymphoma (NHL). As we know the lymphatic system is the body‘s disease fighting network. Lymphoma is a cancer of this system. As per the Lymphoma Research Foundation the incidence of NHL doubled between 1975–2013. In US alone 72,000 new cases were reported in 2016. The disease may originate in lymph nodes but can develop in region like skin, testes, indeed in any organ of the body. US FDA has approved two therapies for large B-cell lymphoma, while others are in the pipeline. Thus, both the demand and supply side forces, increasing numbers of reported DLBCL and product approved by regulatory bodies worldwide, are providing fodder for boosting the market. The second, ALL, is one of the types of blood and bone marrow cancers that progresses rapidly by generating immature blood cells, which later produce lymphoblasts. The latter are the cause of tumors in the body. The reported cases for ALL in recent years are on the rise; according to the American cancer society in US alone there may be nearly 6000 new cases. So, it has become a promising potential treatment and development of products area for the companies in this field. The US FDA has been granting approval to anti ALL therapies too in recent past, one such being approved for Novartis AG, for example. Finally, this therapy can also be directed at multiple myeloma, pancreatic cancer, neuroblastoma, ovarian cancer, and others. Increasing number of successful clinical trials is perhaps an indicator that the market is likely to witness a spurt in demand.

The third way the market can be targeted is in term of antigens, such as CD19, CD22, and others. The sophistication of the engineered CAR receptors has grown overtime; these are known as first, second, third, and fourth generation CARs depending on there composition. After successful clinical trials and product approval these are launched for commercial exploitation. The CD19 antigen is deployed as a biomarker for the treatment of hematological afflictions like lymphomas and leukemia. This segment accounted for the largest market share in 2018. This antigen modulates both independent and dependent intracellular T-cell signaling of B cell receptor. Thus, it is crucial for mounting of an optimum immune response. As of March 2019, there were around 364 ongoing clinical trials happening globally involving CAR-T cells. The majority of these trials target blood cancers. CD19 continues to be the most popular antigen target, followed by BCMA. Nearly 50% of the trials are for CD19. But some cells do not express CD19 and so evade recognition by CD19- CAR-T cells, a phenomenon known as antigen escape. Then we have CD22 which is a transmembrane receptor: its expression is restricted to inhibition of B cells, thereby providing humoral immunity. This ability of CD22 and its exclusive presence in B cells has made it suitable in treating B-cell derived malignancies and autoimmune disease. Currently clinical trials are going on to assess the safety and efficacy of these dual specificity cells, targeting CD19 and CD22, in certain category of patients. Since the hit rate of successful clinical trials and consequent product development is likely to gain further momentum, this treatment type will also get a filip. Finally, clinical trials are also going for targeting PSCA, CEA, HER2, and many more across the globe. These should eventually lead to successful commercial exploration of available opportunities in this area of treatment.

Overall, increasing incidence of cancer cases, inadequacy of alternative treatments, growing consciousness about the menace, increasing number of trials, burgeoning health budgets, and many other such factors have together kindled a hope that future for CAR T cell therapy market is bright and shining.

 

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