The global PD-1 and PDL-1 inhibitor market size was valued at USD 30.52 billion in 2022. It is estimated to reach USD 106.49 billion by 2031, growing at a CAGR of 14.87% during the forecast period (2023–2031).
Checkpoint proteins on immune cells, such as programmed cell death 1 (PD-1) and programmed death ligand 1 (PD-L1), are in charge of triggering and maintaining immunological tolerance in the tumor microenvironment. PD-1 PDL-1 inhibitors are immune-therapeutic agents used to treat various cancer indications, mainly in the advanced stages. PD-1/PDL-1 inhibitors are monoclonal antibodies, mostly IgG1 and IgG4 types, to be administered to patients via injection.
The current PD-1 PDL-1 inhibitor industry has seven approved products available commercially. Among the commercially available products, four are PD-1 inhibitors, and three are PDL-1 inhibitors. Several clinical trials are evaluating PD-1 PDL-1 inhibitors drugs in combination. The first PD-1 inhibitor Keytruda developed by Merck (MSD), entered the market in 2014. Jemperli from GlaxoSmithKline plc is the latest market entrant in the segment. Additionally, Jemperli has demonstrated an excellent result of a complete cure in colorectal cancer patients as a neoadjuvant treatment.
The immune system is crucial to the emergence and spread of cancer. The host's immune system helps identify and destroy cancer cells. These immune checkpoint inhibitors play a pivotal role in preventing the evasion of immune recognition by cancer cells. Immune checkpoint inhibitors are being researched for their therapeutic effects in various cancer indications because they have advantages over traditional cytotoxic treatments. The increased application of immune checkpoint inhibitors in multiple cancer indications has expanded their portfolio. Merck Sharp & Dohme Corp. has added more than 30 indications under its PD-1 Inhibitor Keytruda (Pembrolizumab) since its launch in 2014.
Following the same, another PD-1 Inhibitor Opdivo (Nivolumab) from Bristol Myers Squibb company, has added more than 25 indications. Other products are also in the same league of adding more and more signs to their portfolio. Keytruda, which was first approved in 2014 for the treatment of advanced melanoma, got approved for an expanded indication of advanced melanoma in 2015. In 2019, it was approved as an adjuvant treatment for melanoma involving lymph node(s) following complete resection. PD-1 and PD-L1 inhibitors in cervical cancer are also on the rise.
Similarly, Opdivo, approved for the treatment of advanced melanoma in 2014, was approved in combination with Yevoy (Iplimumab) for treating BRAF V600 Wild-Type Melanoma and Unresectable or Metastatic Melanoma Across BRAF Status in 2015 and 2016, respectively. Opdivo was approved in 2017 as an adjuvant treatment in patients with completely resected melanoma with lymph node involvement or metastatic disease, propelling the market forward.
More and more companies are evaluating these immune checkpoint inhibitors in combination with therapies to improve the response to treatment. Merck Sharp & Dohme LLC is investigating the role of Keytruda in combination with several other drug classes, such as anti-TIGIT, anti-EGFR, anti-CTLA-4, and dipeptidyl peptidase inhibitors. Most of these trials evaluate the combination therapy in the early stage of development.
Another company named Jiangsu HengRui Medicine Co., Ltd. from China is also evaluating its PD-1 Inhibitor, Camrelizumab, in various combinations such as radiation therapy, VEGFR-2 inhibitors, and chemotherapy. The indications include Head and Neck Squamous Cell Carcinoma, C-staged Hepatocellular Carcinoma in BCLC Classification, Extensive Stage Small Cell Lung Cancer, and Non-Small Cell Lung Cancer. Beigene Ltd. is also pursuing a combination regimen for its PD-1 inhibitor Tislelizumab (BGB-A317). The drug classes with Tislelizumab (BGB-A317) include chemotherapy regimens and tyrosine kinase inhibitors. Beigene Ltd. is focusing strategically on one indication, Non-Small Cell Lung Cancer, and has moved to the phase 3 stage of clinical development.
Immune-related adverse events occur following activation of the immune system leading to the development of autoantibodies which can affect almost any organ system. Several research studies have highlighted immune-related adverse events, a significant concern for field experts treating cancer cases. In a small study involving 78 patients where a PD-1 inhibitor was administered to 68%, approximately half of them reported the development of immune-related adverse events, and some said more than one adverse event. Both patients receiving checkpoint inhibitors alone or in combination have reported adverse events. The most common adverse events reported are related to gastrointestinal (GI), followed by dermatological and rheumatological diseases. Among patients taking individual PD-1 PDL-1 inhibitor therapy, less than 20% reported GI-related adverse events, approximately 30%-40% reported dermatological-related adverse events, and about 15% reported neurological-related adverse events, hampering the market growth.
Recent results of Dostarilumab demonstrated complete clinical responses in all patients with locally advanced mismatch repair–deficient (dMMR) rectal cancer with six months of neoadjuvant treatment. This remarkable therapeutic outcome and improved overall survival in other cancer patients taking PD-1/PDL-1 inhibitors are expected to boost the confidence among prescribers and patients. The reported positive therapeutic outcomes and the evaluation of the role of PD-1/PDL-1 inhibitors in a growing number of cancer indications and specific subsets provide significant opportunities for PD-1/PDL-1 inhibitor treatments.
The global PD-1 and PDL-1 inhibitor market is segmented by inhibitors type, indication, and development phase.
By inhibitors type, the global PD-1 and PDL-1 inhibitor market is segmented into the PD-1 inhibitor and PDL-1 inhibitor.
The PD-1 inhibitor is the highest contributor to the market and is expected to grow significantly during the forecast period. Due to the rising volume of research efforts, approvals, and prescriptions for these medications, such as nivolumab and pembrolizumab, the PD-1 inhibitors sector is predicted to dominate the market. Pembrolizumab (KEYTRUDA) has also seen growing use as a result of its demonstrated efficacy in treating several FDA-approved indications, including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell cancer (HNSCC). Furthermore, the governments of several nations are taking steps to raise knowledge of cancer and how to diagnose it at an early stage. For instance, the Tamil Nadu government is engaged in formulating the policy to identify 66.0% of cancer patients in the first and second stages by 2030 so that appropriate treatment can be made available, according to the state's health minister in February 2022.
By indications, the global PD-1 and PDL-1 inhibitor market is divided into non-small cell lung cancer (NSCLC), melanoma, hepatocellular carcinoma (HCC), colorectal cancer (CRC), breast cancer, and urothelial carcinoma.
The non-small cell lung cancer (NSCLC) segment owns the highest market share and is expected to grow significantly during the forecast period. Most significant businesses are focusing on the continual innovation of advanced treatments and increasing the efficacy of the current medicines because NSCLC (non-small cell lung cancer) accounts for 80%–85% of all lung cancer cases worldwide. The expansion of the non-small cell lung cancer market is being supported by an increase in NSCLC (non-small cell lung cancer) diagnosis and a rise in awareness in both developing and developed regions.
Melanoma is a cancer of skin cells that develops in skin cells called melanocytes. Melanocytes are the cell that produces skin pigment called melanin, which is responsible for skin color as well as the color of eyes and hair. Melanin protects the skin from harmful ultraviolet (UV) rays. Melanoma is one of the most severe types of skin cancer owing to its highest rate of metastasis. Although the mechanism of melanoma development following cell damage is not clearly understood, exposure to UV radiation from the sun or tanning beds has been identified as a possible cause of melanoma.
By the development phase, the global PD-1 and PDL-1 inhibitor market is divided into phase I, phase II, phase III, and phase IV.
The phase I segment is the highest contributor to the market and is expected to grow significantly during the forecast period. According to the clinical trial registry, 528 clinical studies evaluated the potential of PD-1/PDL-1 inhibitors for various indications. Tecentriq (Atezolizumab) and Keytruda (Pembrolizumab) have the maximum number of trials. They are also in the most advanced stages of clinical development. In addition, Products BMS-936558 (Nivolumab), Durvalumab (MEDI4736), Avelumab, and Atezolizumab and Pembrolizumab, are being evaluated under the maximum number of the clinical trial compared to other PD-1/PDL-1 inhibitors. Out of the total clinical trials identified, there are more than 220 clinical trials in phase I and more than 210 in Phase II.
By region, the global PD-1 and PDL-1 inhibitor market is divided into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
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 dominance results from the rising incidence of cancer cases in the United States, including lung cancer, urothelial carcinomas, and skin cancer. For instance, lung cancer was predicted by the American Disease Society Inc. to be the second most frequent cancer in 2020, causing 135,720 deaths in both men and women. As a result, such events point to significant segment expansion in the North American region.
A few causes propelling the growth of the US PD-1 and PD-L1 inhibitors market are essential product launches, high concentrations of market participants or manufacturer's presence, acquisitions and partnerships among significant players, and product launches by crucial PD-1 and PD-L1 inhibitors companies in the country. The FDA, according to Novartis, approved the Biologics License Application (BLA) for the anti-PD-1 immune checkpoint inhibitor tislelizumab in September 2021 to treat people with recurrent, unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic therapy. Therefore, it is anticipated that such a development will fuel market expansion in the United States over the forecast period.
Germany is expected to grow much more quickly than other countries in Europe as a result of the numerous clinical trials being undertaken in the industry. Organizations like the European Medicines Agency have expanded their focus on PD-1/PD-L1 inhibitors for usage in combination therapy and monotherapy trials for young patients and treating adult disorders. The market's expansion in Germany can also be linked to rising awareness of the low toxicity levels and compliance with PD-1/PD-L1 inhibitors with local healthcare safety laws.
In Asia-Pacific, China is expected to display a relatively rapid growth rate during the forecast period owing to the large population base and significant investment from private and public sectors in healthcare infrastructure development. Additionally, the rise in cancer incidence and rising demand for immune checkpoint inhibitors are anticipated to promote market growth during the forecast period. Moreover, an increasing number of product launches and innovations in oncology immunotherapy are expected to lead the market growth in China.
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