PD-L1 Biomarker Testing Market Report – Actionable Insights and Recommendation 2017 - 2027

Author: Chhidami Ahirwar

Immunotherapy is one of the most exciting field in the area of cancer research. Immunotherapy has the power to manage immune system, recognize the cancer cell and fight against it. Our immune system has T- cell that fight against diseases, infections including cancer. The cancer cell represents the protein known as PD-L1 protein. The PD-L1 protein binds to the receptor on the T cell. The PD-L1 protein, that is expressed on the cancer cell inactivate the T cell from attacking the cancer cell. The companies are involved in the research and development in the cancer research by inactivating the protein on the cancer cell e.g. the antibody drug candidate blocks the PD-L1 protein on the cancer cell, so that it does not bind to the PD-1 receptor on the T cell. The PD-L1 protein is the important target and mostly studied in cancer research. Governments in developed countries such as the U.S. raise funds for cancer research to aid in the diagnosis and treatment. Clinical trials are also funded by governments to support companies in developing effective therapy for cancer diagnosis and treatment. The companies are advancing research in the field of immunotherapy and is targeting PD-L1/PD-1 pathway to address different immune pathway for cancer research.

The pharmaceutical companies are focusing on development of different receptor ligand interaction for chronic diseases such as cancer, in order to make sure that next-generation drugs be more efficacious. In April 2016, the U.S. Government allocated US$ 5.2 Bn for the National Cancer Institute (NCI), a Federal Government agency, for cancer research and training. The budget increased by 5.3% as compared to the previous year. NCI conducts clinical trials on cancer patients who require repetitive diagnosis to check the prognosis of cancer. The monoclonal antibodies, that blocks the interaction between checkpoint molecules PD-1 on T cells and PD-L1 on cancer cells are into pipeline, clinical trials are on the way, if approved will act as a driving factor for revenue generation. Research funding from governments and improving reimbursement scenario for cancer therapy would aid the growth of global PD-L1 biomarker testing market.

PD-L1 Biomarker Testing Market: Drivers and Restrains

Major growth drivers in this segment are rise in prevalence of cancer, constantly growing list of cancer biomarkers, increasing discretionary funding for cancer research, increased medicare coverage for cancer diagnosis and treatment, research in the field of cancer immunotherapy, insurance coverage and reimbursement issues and others are some of the factors boosting the PD-L1 biomarker testing market, drug candidates have been designated as orphan drug to gain accelerated approval and it also allows the company to benefit from a seven year marketing exclusivity, if approved for the particular indication. The FDA undertakes accelerated approval process to bring these therapies to the market faster and make them available for patients in need. According to the Organisation for Economic Co-operation and Development (OECD) statistics, the global biomarkers market for companion diagnostics is was valued at US$ 5.2 Bn in 2012 and is expected to rake US$ 8.4 Bn by 2016 Also, strict regulations, need huge investment of time and money, invest in expensive clinical utility studies, and there is no guarantee that the product will get coverage, and others are some of the factors restraining the market growth

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PD-L1 Biomarker Testing Market: Segmentation

The global PD-L1 Biomarker Testing market has been classified on the basis of product type, application, end user and geography.

Based on Assay Type, the global PD-L1 biomarker testing market is divided into following:

  • PD-L1 IHC 22C3 Assay
  • PD-L1 IHC 28-8 Assay
  • PD-L1 (SP142) Assay
  • PD-L1 (SP263) Assay

Based on the disease indication, the global PD-L1 biomarker testing market is divided into following:

  • Non-Small Cell Lung Cancer (NSCLC)
  • Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
  • Bladder Cancer
  • Others

Based on the End User, the global PD-L1 Biomarker Testing market is divided into following:

  • Hospital Associated Labs
  • Independent Diagnostic Laboratories
  • Biotechnology and Pharmaceutical Company
  • Cancer Research Institutes
  • Others

PD-L1 Biomarker Testing Market: Overview

The PD-L1 Biomarker Testing market is segment based on assay type, disease indication, end-user and geography. Based on the product type, PD-L1 biomarker testing market is segmented on the basis of PD-L1 IHC 22C3 Assay, PD-L1 IHC 28-8 Assay, PD-L1 (SP142) Assay, PD-L1 (SP263) Assay and others. Maximizing market penetration on install base, strategic partnerships to enhance consumer base are some of the factors expected to drive the growth of the market. Based on the disease indication segment, the PD-L1 Biomarker Testing market is sub-segmented on the basis of Non-Small Cell Lung Cancer (NSCLC), Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma, Bladder Cancer and others. On the basis on end user, the PD-L1 Biomarker Testing market is segmented on the basis of hospital associated laboratory, independent diagnostic laboratories, biotechnology and pharmaceutical companies, cancer research institutes and others

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PD-L1 Biomarker Testing Market: Regional Overview

Region wise, the global PD-L1 Biomarker Testing market is classified into regions namely, North America, Latin America, Western Europe, Eastern Europe, Asia-Pacific, Japan, Middle East and Africa. North America is estimated to account for major share due to increased awareness and technological advancements in the U.S., demand for new and advanced diagnostic equipment’s, Kits and others, government initiatives and funding for production of cost-effective monoclonal antibodies in the U.S. Europe is expected to account for second largest market share due to easy approval procedure for diagnostic tests, Significant increase in cancer diagnosis rates in primary care settings in U.K. Germany, France and other European countries. Significant economic development has led to an increase in healthcare availability in Asia Pacific region providing an opportunity for companies to penetrate Asia Pacific regions. Rising investment in cancer research by government is driving market growth, rise in cancer awareness are some if the factors driving growth in Asia Pacific region

PD-L1 Biomarker Testing Market: Key Players

Some of the key players in global PD-L1 Biomarker Testing market are Agilent Technologies, Inc., Eli Lilly and Company, AstraZeneca, Ventana Medical Systems, Inc. Genentech Inc., Bristol-Myers Squibb, Merck & Co., Inc., Pfizer Inc. and others

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