Inhibitors of PD-1 and PDL-1 are immunotherapeutic drugs used to treat a variety of cancer indications, primarily in advanced stages. PD-1/PDL-1 inhibitors are primarily IgG1 and IgG4 monoclonal antibodies injected into patients. The current market for PD-1 and PDL-1 inhibitors has seven commercially accessible, FDA-approved medicines. Four of the commercially available medications inhibit PD-1, whereas three inhibit PDL-1.
The immune system is essential for the development and progression of cancer. The immune system of the host aids in identifying and destroying cancer cells. These immune checkpoint inhibitors prevent cancer cells from evading resistant identification. Immune checkpoint inhibitors are being studied for their therapeutic potential in various cancer indications due to their advantages over conventional cytotoxic therapies. The rising use of immune checkpoint inhibitors across multiple cancer indications has broadened its product offering. Since its debut in 2014, Merck Sharp & Dohme Corporation gained over thirty indications for its PD-1 Inhibitor Keytruda (Pembrolizumab). Opdivo (Nivolumab), another PD-1 inhibitor from Bristol-Myers Squibb, has been approved for more than 25 indications.
All patients with locally advanced mismatch repair–deficient (dMMR) rectal cancer exhibited complete clinical responses following six months of neoadjuvant therapy with Dostarilumab. This extraordinary therapeutic outcome, combined with better overall survival in other cancer patients receiving PD-1/PDL-1 inhibitors, is anticipated to increase prescribers' and patients' confidence. The reported excellent therapeutic outcomes and the evaluation of the role of PD-1/PDL-1 inhibitors in a rising variety of cancer indications and particular subsets offer substantial prospects for PD-1/PDL-1 inhibitor therapy.
North America is the most significant shareholder in the global PD-1 and PDL-1 inhibitor market and is expected to grow significantly over the forecast period. The increased incidence of cancer in the United States, especially lung cancer, urothelial carcinomas, and skin cancer, has led to this dominance. Factors driving the growth of the US PD-1 and PD-L1 inhibitors are key product launches, high concentrations of market participants or manufacturers' presence, acquisitions and partnerships among significant players, and critical product launches by PD-1 and PD-L1 inhibitors companies in the country. According to Novartis, the FDA approved the Biologics License Application (BLA) for the anti-PD-1 immune checkpoint inhibitor tislelizumab in September 2021 to treat patients with recurrent, unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior systemic therapy.
Germany is expected to enjoy highly rapid growth compared to other European nations due to the numerous clinical trials being undertaken in the industry. Organizations such as the European Medicines Agency have emphasized PD-1/PD-L1 inhibitors for combination therapy and monotherapy trials for young patients to treat diseases in adults. The market's growth in Germany can also be attributed to increased knowledge of PD-1/PD-L1 inhibitors' low toxicity levels and compliance with local healthcare safety regulations.
The key players in the global PD-1 and PDL-1 inhibitor market are Arcus Biosciences, Inc., Amgen Inc., AstraZeneca Plc, Biocad, BeiGene Ltd., Bristol Myers Squibb Co., Hoffmann La Roche Ltd., GlaxoSmithKline Plc, Jiangsu Hengrui Pharmaceuticals Co. Ltd., Incyte Corporation, Lee's Pharmaceutical Limited, and CStone Pharmaceuticals and Shanghai Jhunsi Biosciences Ltd.