Targeted cancer therapy is the primary objective of extensive research related to cancer drugs. Our immune cells are programmed to attack the foreign cell on activation. PD-1 and PDL-1 are among those activation points present on the immune cells. Sometimes cancer cells also use this PD-1 and PDL-1 trigger points to avoid being attacked by the immune cells. Therefore, cancer drugs targeting these cells hold tremendous potential in the cancer treatment market. Approved PD-1 and PDL-1 inhibitor drugs have become blockbuster products. The global PD-1 and PDL-1 inhibitors market is segmented based on the drug type and application as follows:
PD-1 inhibitors are effective in treating non-small-cell lung carcinoma (NSCLC), kidney cancer, melanoma of the skin, head and neck cancers, bladder cancer, and Hodgkin lymphoma. Opdivo is leading the race with US$ 3.8 Bn in sales in 2016, compared to US$ 1.4 Bn of Keytruda in 2016. Both these drugs have garnered significant development in past two years with respect to extended therapeutic application and approvals in European countries and Japan.
PDL-1 inhibitors are proven to be effective in NSCLC, bladder cancer, and Merkel cell skin cancer. Avelumab received FDA approval in March 2017 for metastatic Merkel cell carcinoma (MCC), a rare skin cancer with no approved therapies. The drug therefore, received approval under the accelerated approval process, requiring the developers, Pfizer, Inc. and Merck KGaA to conduct larger clinical trials to establish complete safety and efficacy of the drug. The drug is also being tested for bladder cancer, NSCLC, gastric cancer, ovarian cancer, and renal cancer, under the JAVELIN clinical trial program. Extended therapeutic applications widens the potential opportunity for the drugs in the global PD-1 inhibitors and PDL-1 inhibitors market.
Active research activities to spur the global PD-1 and PDL-1 inhibitors market growth
PD-1 and PDL-1 biomarkers are also called immune checkpoints. Trails from Merck & Co. and Bristol-Myers Squibb have shown PD-1 and PDL-1 inhibitors to be effective in patients expressing higher level of PD-1 and PDL-1 biomarkers, restricting the potential market to only these patients. Therefore, all of the big pharma companies in the global market of PD-1 and PDL-1 inhibitors are combining the PD-1 and PDL-1 inhibitors with other targeted cancer drugs to cater to a larger set of population. The global PD-1 and PDL-1 inhibitors market is poised to grow significantly with more product developments in the segment. There are 65 clinical studies in phase 2 and phase 3 phase globally. Commercialization of a novel drug in this segment would be a great booster for the growth for the PD-1 and PDL-1 inhibitors market.
Regional PD-1 and PDL-1 inhibitors market outlook
A major share of the revenue of the global PD-1 and PDL-1 inhibitors market is currently concentrated in North America, Europe, and Japan as these are the three major revenue generating nations with high insurance coverage, high healthcare investment, and are highly developed pharmaceutical markets. The market players would be eyeing other regions for tapping the cancer treatment market opportunities in those regions. Uncertain regulations challenging the sales of patented pharmaceutical products has been a major deterring factor for global pharmaceutical companies to enter into emerging economies. However, novel rugs for cancer type with no treatment available currently would find positive outlook in these regions, though the high pricing would inhibit their sales in emerging economies.
Key players operating in the global PD-1 and PDL-1 inhibitors market include Pfizer, Inc., Bristol-Myers Squibb, Merck KGaA, AstraZeneca plc, F. Hoffmann-La Roche AG, Merck & Co. Inc., Regeneron Pharmaceuticals, Inc., Novartis AG, and Ono Pharmaceutical Co., Ltd.
Research and development activities related to PD-1 and PDL-1 inhibitors is expected to boost the market growth. For instance, in March 2018, researchers from University Hospital Carl Gustav Carus, Germany, observed that the expression of the inhibitory immune checkpoints PD-L1 and VISTA may explain the poor responsiveness of prostate cancer patients to cytotoxic T lymphocyte antigen-4 blockade and supports the design of a combination therapy targeting both molecules.
In May 3, 2019, researchers from Shin-Kong Wu Ho-Su Memorial Hospital reported that PD-1 inhibitors show anti-tumor effects on advanced malignancies, including metastatic melanoma, advanced cutaneous squamous cell carcinoma, urothelial tumors, and duodenal adenocarcinoma in renal transplant patients.
In August 2019, researchers from Jagiellonian University, Poland, used well-known in vitro methods and revealed that there is no direct binding between CA-170 – the only small-molecule modulator in clinical trials targeting PD-L1 and VISTA proteins and PD-L1.
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