Global PD-L1 Biomarker Testing Market Growth (Status and Outlook) 2025-2031

According to this study, the global PD-L1 Biomarker Testing market size will reach US$ 28130 million by 2031.

PD-L1 Biomarker Testing measures the amount of PDL1 on cancer cells. PDL1 is a protein that helps keep immune cells from attacking nonharmful cells in the body. Normally, the immune system fights foreign substances like viruses and bacteria, and not your own healthy cells. Some cancer cells have high amounts of PDL1. This allows the cancer cells to "trick" the immune system, and avoid being attacked as foreign, harmful substances. Current PD-L1 testing is based on immunohistochemistry (IHC) methods. Immunohistochemistry (IHC) is the process whereby antibodies are used to detect proteins (antigens) in cells within a tissue section (for instance liver, pancreas or the heart). PD-L1 is a ligand that binds to PD-1 (programmed cell death-1), expressed on activated T cells, to evade anti-tumor responses. PD-L1 plays a role in inhibiting T cell activation and proliferation and has emerged as an important target in cancer treatment. PD-L1 protein detection by immunohistochemistry (IHC) testing is widely used as a predictive biomarker assay for anti–PD-1/PD-L1 therapies. PDL1 testing is used to find out if you have a cancer that may benefit from immunotherapy.

The PD‑L1 biomarker testing market is being propelled by the rapid expansion of immune checkpoint inhibitor therapies, particularly those targeting the PD‑1/PD‑L1 axis, which have shown remarkable clinical success in treating various advanced cancers—spurring widespread demand for stratifying patients based on PD‑L1 expression to optimize treatment outcomes. Additionally, the shift toward precision medicine has heightened the importance of molecular diagnostics. Clinicians and pharmaceutical developers are increasingly emphasizing personalized approaches, using PD‑L1 testing to guide therapeutic decisions and enable companion diagnostics—especially as diagnostic technologies advance to include automated IHC systems, NGS platforms, and AI-enhanced analysis .

Despite these positive trends, the PD‑L1 testing landscape faces significant obstacles due to a lack of standardization across protocols, assay clones, scoring systems, and cut-off thresholds. This inconsistency manifests in discordant results (with variability rates reported between 19–32% across different assays), undermining diagnostic reliability and complicating clinical decision-making. Moreover, high costs associated with advanced testing techniques (IHC, NGS) and uneven reimbursement frameworks create economic barriers, particularly in developing regions, impeding broad accessibility and exacerbating healthcare disparities.

The classification of PD-L1 Biomarker Testing includes PD-L1 (22C3), PD-L1 (28-8), PD-L1 (SP142), PD-L1 (SP263) and Other, and the revenue proportion of PD-L1 (22C3) in 2024 is about 21.68%. PD-L1 Biomarker Testing is widely used in Hospital and Diagnostic Laboratories. The most proportion of PD-L1 Biomarker Testing is Hospital, and the proportion in 2024 is about 52.7%.

LPI (LP Information)' newest research report, the “PD-L1 Biomarker Testing Industry Forecast” looks at past sales and reviews total world PD-L1 Biomarker Testing sales in 2024, providing a comprehensive analysis by region and market sector of projected PD-L1 Biomarker Testing sales for 2025 through 2031. With PD-L1 Biomarker Testing sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world PD-L1 Biomarker Testing industry.

This Insight Report provides a comprehensive analysis of the global PD-L1 Biomarker Testing landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on PD-L1 Biomarker Testing portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global PD-L1 Biomarker Testing market.

This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for PD-L1 Biomarker Testing and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global PD-L1 Biomarker Testing.

This report presents a comprehensive overview, market shares, and growth opportunities of PD-L1 Biomarker Testing market by product type, application, key players and key regions and countries.

Segmentation by Type:
PD-L1 (22C3)
PD-L1(28-8)
PD-L1 (SP142)
PD-L1 (SP263)
Other

Segmentation by Application:
Hospital
Diagnostic Center
Others

This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries

The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
Agilent Technologies
Roche
Merck
Bristol-Myers Squibb
AstraZeneca
Ono Pharmaceutical
Regeneron
Innovent
Hengrui Medicine
Junshi Biosciences

Please note: The report will take approximately 2 business days to prepare and deliver.