PD-L1 and PIK3CA Testing Product Market Size, Share, Industry, Forecast and outlook (2024-2031)

PD-L1 and PIK3CA Testing Product Market is Segmented By Product Type( PD-L1, Cervical Cancer, Esophageal Cancer, NSCLC- Squamous, Squamous Cell Carcinoma of the Head and Neck, Triple-Negative Breast Cancer, Urothelial Carcinoma, PIK3CA), By End-User(Hospital, Diagnostic Center, Cancer Center, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030

PD-L1 and PIK3CA Testing Product Market Size

PD-L1 and PIK3CA testing product market size was valued US$ YY million in 2020 and is estimated to reach US$ YY million by 2030, growing at a CAGR of 18.45% during the forecast period (2023-2030).

PDL1 is a protein that helps keep immune cells from attacking nonharmful cells in the body. Some cancer cells have high amounts of PDL. It allows the cancer cells to trick the immune system and avoid being attacked as foreign, harmful substances. This test measures the amount of PDL1 on cancer cells.

PIK3CA Mutation Test (CE-IVD) is a real-time polymerase chain reaction (PCR) test used to identify patients with advanced or metastatic breast cancer whose tumors harbor phosphoinositide 3-kinase, catalytic, alpha subunit (PIK3CA) mutations.

PD-L1 and PIK3CA Testing Product Market Dynamics

Increasing product launches by the key players are expected to drive market growth.

Roche launched the cobas PIK3CA Mutation Test for patients with advanced or metastatic breast cancer on December 15, 2020. in vitro diagnostic (IVD) test, which was previously only available for research use (RUO), is now available in countries recognizing the CE mark. The cobas PIK3CA Mutation Test detects 17 mutations in the PIK3CA gene and can assist doctors in identifying patients who may benefit from PI3K targeted medication, as recommended by medical guidelines.

PD-L1 and PIK3CA Testing Product Market COVID-19 Impact Analysis

COVID-19 pandemic has affected the global economy in several terms, such as directly impacting the production and demand, supply chain disruption, and financial impact. With the COVID-19 disorders in various sectors, the manufacturers; supply chain in the healthcare sector has significantly improved globally to control the spread of novel coronavirus diseases. However, the ongoing pandemic further shut down the production facilities to minimize the risk of virus spread. This has led to the implementation of lockdown policies that significantly impact pharmaceutical outsourcing actives worldwide to meet high unmet medical needs among patients. Therefore, the manufacturers are keen to invest and expand their production capabilities to meet the global market's updated demand.

PD-L1 and PIK3CA Testing Product Market Segment Analysis

PDL-1 segment is expected to hold the largest market share in PD-L1 and PIK3CA testing product market.

The PDL-1 segment accounted for the largest market share in 2020. The increasing prevalence of cancer and technological advancements in the testing products are factors the market is expected to boost in the forecast period. For instance, According to the National Center for Biotechnology Information, Esophageal cancer is the sixth leading cause of cancer-related deaths and the eighth-most common cancer worldwide, with a 5-year survival rate of less than 25%. The identified 23,804 patients with esophageal adenocarcinoma and 13,919 patients with esophageal squamous cell carcinoma. Males were at an increased risk of developing both types of esophageal cancer compared to females. Moreover, Esophageal squamous cell carcinoma (ESCC) remains an intractable disease with few therapeutic options. Programmed death-ligand 1 (PD-L1), which is essential for immune evasion, is involved in the pathogenesis of ESCC and thus is a potential therapeutic target.

In addition, PD-L1 expression is increased by PIK3CA, KRAS, and BRAF mutations, microsatellite instability (MSI) caused by deficient mismatch repair (dMMR), and human papillomavirus (HPV), which might contribute to the clinical outcome of patients with ESCC. Thus, the market segment is expected to hold the largest market share in the forecast period from the above statements.

PD-L1 and PIK3CA Testing Product Market Scope

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PD-L1 and PIK3CA Testing Product Market Geographical Share

North America region holds the largest market share in the global PD-L1 and PIK3CA testing product market.

In 2020, North America accounted for the highest revenue share. Increased awareness, the rapid expansion of the test, rising prevalence of many chronic diseases such as diabetes, skin cancer, urothelial carcinomas, lung malignancies, and a large population of baby boomers necessitated efficient treatment are some of the factors due to which the market is expected to boost in the forecast period. Lung cancer, for instance, is the second most frequent cancer, with 135,720 men and women dying from it in 2020, according to the American Cancer Society. Moreover, in the United States, small cell lung cancer (SCLC) accounts for 13% of all lung cancers. In contrast, non-small cell lung cancer (NSCLC) accounts for 84 percent, a trend that is expected to continue in the future, resulting in increased demand for these products, fueling the market in the region.

Additionally, Pembrolizumab, an anti–PD-1 humanized monoclonal antibody, was recently licensed in the United States to treat patients' metastatic non–small cell lung cancer (NSCLC) (pts) who are PD-L1 positive and have advanced on platinum therapy. Therefore from the above statements, the North American region is expected to hold the largest market share in the forecast period.

PD-L1 and PIK3CA Testing Product Companies

Major key players in the PD-L1 and PIK3CA testing product market are F. Hoffmann-La Roche Ltd, Agilent Technologies, QIAGEN, EntroGen, Inc., Amoy Diagnostics, ACCB Biotech, Myriad Genetic Laboratories, Inc. and FOUNDATION MEDICINE, INC.       

F. Hoffmann-La Roche Ltd:

Overview:

F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Roche is the largest pharmaceutical company globally. The company controls the American biotechnology company Genentech, a wholly-owned affiliate, and the Japanese biotechnology company Chugai Pharmaceuticals and the United States-based companies Ventana and Foundation Medicine. It is vital in pharmaceuticals for cancer treatment, against virus diseases, and metabolic disorders. The company is the world's largest spender in pharmaceutical R&D.

­Product Portfolio:

cobas PIK3CA Mutation Test: The cobas PIK3CA Mutation Test (CE-IVD) is a real-time polymerase chain reaction (PCR) test used to identify patients with advanced or metastatic breast cancer whose tumors harbor phosphoinositide 3-kinase, catalytic, alpha subunit (PIK3CA) mutations.