Claudin18.2 Positive Gastric Cancer | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

A highly selective biomarker, claudin18.2 (CLDN18.2) is an isoform of claudin18, a member of the tight junction protein family, and is expressed only minimally in normal tissues. It is frequently expressed abnormally during the occurrence and development of various primary malignant tumors, including gastric cancer/gastroesophageal junction (GC/GEJ) cancer. According to the American Cancer Society, stomach cancer will affect roughly 26,560 people in 2021 (16,160 men and 10,400 women). The average age at diagnosis is 68 years old. Due to the various detection methods, positive cutoffs, and patient populations used in various investigations, the CLDN18.2 positive rate varies. One of the challenges with detection is that it needs to be standardized to distinguish between splice variants like CLDN18.2 and CLDN18.1 by using a highly specific reagent.

Description

Claudin18.2 (CLDN18.2) is an isoform of claudin18, a member of the tight junction protein family. It is a highly selective biomarker with limited expression in normal tissues and frequently abnormal expression during the occurrence and development of various primary malignant tumors, including gastric cancer/gastroesophageal junction (GC/GEJ) cancer. CLDN18.2 promotes the proliferation, differentiation, and motility of tumor cells. Recent studies have suggested that CLDN18.2 expression may serve as a special marker for the detection and treatment of GC malignancies as well as other tumor types. Due to its unique expression pattern, CLDN18.2 has become a distinctive molecule for the treatment of GC.

Claudin18.2 Positive Gastric Cancer (Epidemiology)

According to the American Cancer Society, there will be approximately 26,560 cases of stomach cancer in 2021 (16,160 male cases and 10,400 female cases). The average age at diagnosis is 68 years old. Gastric cancer is the fifteenth most common cancer in the US. After skin, lung, breast, prostate, colon, and rectum cancers (non-melanoma), stomach cancer, which was once the second-most common cancer worldwide, is now ranked sixth. Stomach cancer is the third most common cause of death from cancer. Globally, 783,000 people died of stomach cancer in 2018, according to the World Health Organization.

Claudin18.2 Positive Gastric Cancer -Current Market Size & Forecast Trends

The market for Claudin18.2 positive gastric cancer is part of the broader gastric cancer treatment landscape, which was valued at approximately USD 4.6 billion in 2023 and is projected to reach around USD 12.5 billion by 2032, reflecting a compound annual growth rate (CAGR) of 11.26% during this period. The increasing focus on targeted therapies, particularly those that exploit Claudin18.2 as a biomarker, is driving this growth. Notable developments include ongoing clinical trials for therapies such as bispecific antibodies and CAR T-cell treatments targeting Claudin18.2, which show promise in improving patient outcomes. The rising incidence of gastric cancer and advancements in personalized medicine further contribute to market expansion. As research progresses and new therapies are developed, the market for Claudin18.2 positive gastric cancer is expected to continue its upward trajectory through 2035, with increasing investment in R&D and collaborations among pharmaceutical companies enhancing the treatment landscape.

The various detection methods, positive cutoffs, and patient groups used in various investigations all affect the CLDN18.2 positive rate differently. One of the challenges with detection is the need for standardization to distinguish between splice variants like CLDN18.2 and CLDN18.1 by using a highly specific reagent. A unified detection approach should be used to specifically identify CLDN18.2. As the detection technique is standardized and patient selection is based on a CLDN18.2 positive threshold, precision will rise. It is necessary to standardize the best cutoff value used to determine CLDN18 positive expression in order to identify patients who should receive targeted therapy. If different patient groups (races) need different cut-off expression levels, more study is needed to answer this question. Since there is still no conclusive evidence that CLDN18.2 can be used in a way that is comparable to HER-2 as a useful prognostic indicator, the prognostic usefulness of CLDN18.2 is another subject of discussion. We need to look into the prognostic value more. A wide range of CLDN18.2 medicinal medicines have been under development for the past few years. However, the majority of CLDN18.2 initiatives are still in the early stages of clinical research and have not made much progress. Candidates for tumor immunotherapy that target CLDN18.2 include mAbs because they have a track record of clinical use by doctors, sound regulatory frameworks, extensive and advanced technological development expertise, efficient commercial production techniques, and affordable prices. Because of this, these agents will undoubtedly be important in future treatments. As a result, the majority of the CLDN18.2-targeted drugs under development are mAbs. Bispecific/trispecific mAbs against CLDN18.2 are novel and distinctive therapeutic forms, but their production, regulation, and safety face significant challenges. Osemitamab (Transcenta Holding), CT 041 (CARsgen), Zolbetuximab (Ganymed Pharmaceuticals), and other newly developed treatments have the potential to drive the market for gastric cancers that are CLDN18.2 positive.

Report Highlights

Claudin18.2 Positive Gastric Cancer - Current Market Trends

Claudin18.2 Positive Gastric Cancer - Current & Forecasted Cases across the G8 Countries

Claudin18.2 Positive Gastric Cancer - Market Opportunities and Sales Potential for Agents

Claudin18.2 Positive Gastric Cancer - Patient-based Market Forecast to 2035

Claudin18.2 Positive Gastric Cancer - Untapped Business Opportunities

Claudin18.2 Positive Gastric Cancer - Product Positioning Vis-a-vis Competitors' Products

Claudin18.2 Positive Gastric Cancer - KOLs Insight