The global PD-L1 biomarker testing market is projected to expand at USD 777.2 million in 2025 to USD 1,700 million by 2035, at a robust CAGR of 8.1%. Growth is predominantly fueled by rising adoption of immuno-oncology therapies that require accurate PD-L1 expression measurement for patient stratification and optimal therapeutic outcomes.
High PD-L1 testing volumes are driven by its utility in checkpoint inhibitor treatment across multiple oncology indications, particularly non-small cell lung cancer (NSCLC), urothelial carcinoma, melanoma, and triple-negative breast cancer as per TNBC.
The U.S. remains the largest market, underpinned by strong reimbursement coverage from Medicare and major private insurers for FDA-approved companion diagnostics like Agilent Technologies' Dako PD-L1 IHC 22C3 pharmDx, Roche's VENTANA PD-L1 (SP142) Assay, and the PD-L1 IHC 28-8 pharmDx. Europe is closely following, with regulatory bodies such as the EMA increasingly recommending PD-L1 testing to support precision oncology regimens, thus bolstering regional market penetration. Innovation and automation are reshaping the competitive landscape.
Agilent, Roche, and Thermo Fisher Scientific continue to upgrade their PD-L1 assays, improving diagnostic precision, repeatability, and ease of use. Digital pathology and AI-driven algorithms are facilitating more consistent and rapid interpretation of immunohistochemical (IHC) slides, significantly reducing diagnostic turnaround time.
Strategic collaborations and clinical validation remain critical to market leadership. According to Roche Diagnostics CEO Thomas Schinecker, "Precision biomarker testing such as PD-L1 is becoming integral to cancer care. By partnering closely with biopharma companies to develop and validate companion diagnostics, we ensure patient access to the most effective therapies, ultimately improving patient outcomes."
Rapid uptake in emerging regions, particularly Asia Pacific, is anticipated as healthcare infrastructures advance and awareness of personalized oncology grows. Regulatory initiatives in China and Japan actively promote companion diagnostics in oncology. This indicated substantial future demand for PD-L1 biomarker testing.
Global PD-L1 Biomarker Testing Industry Assessment
| Attributes | Key Insights |
|---|---|
| Industry Size (2025E) | USD 777.2 million |
| Industry Value (2035F) | USD 1,700 million |
| CAGR (2025 to 2035) | 8.1% |
The global PD-L1 biomarker testing market compound annual growth rate (CAGR) for the first half of 2024 and 2025 is compared in the table below. This analysis reveals significant industry trends and revenue patterns to understand the development of the market.
The period from 2024 to 2034 is divided into two halves: H1 from January to June and H2 from July to December. Analysts have estimated that the market will grow at 9.0% CAGR in H1, followed by a minor contraction to 8.7% in H2, which is expected to continue steady but moderating growth.
| Particular | Value CAGR |
|---|---|
| H1 | 9.0% (2024 to 2034) |
| H2 | 8.7% (2024 to 2034) |
| H1 | 8.1% (2025 to 2035) |
| H2 | 7.7% (2025 to 2035) |
Looking forward to H1 2025 to H2 2035, analysts expect a slight downwards drift in CAGR. First-half is projected at 8.1% and the second half a wee bit lower at 7.7%. The fall in the first half has been 90 basis points and in the second half, a little steeper at 100 basis points.
In 2025, the PD-L1 22C3 assay kit is projected to dominate the global PD-L1 biomarker testing market, accounting for approximately 50.4% of the total market share. This assay plays a pivotal role in guiding immunotherapy decisions, particularly in oncology.
Developed as a companion diagnostic for pembrolizumab (Keytruda), the 22C3 assay has become a benchmark for PD-L1 testing. Its widespread adoption is attributed to its FDA approvals across multiple indications and its integration into automated immunohistochemistry platforms like the Dako Autostainer, ensuring consistent and accurate PD-L1 detection. The assay's reliability and efficiency have solidified its position in both clinical and research settings, making it a trusted tool among oncologists and pathologists.
Non-small cell lung cancer (NSCLC) is anticipated to lead the PD-L1 biomarker testing market by indication, holding approximately 63.5% of the market share in 2025. NSCLC accounts for about 85% of all lung cancer cases globally, making it a significant focus for PD-L1 testing. The strong association between PD-L1 expression and the efficacy of immune checkpoint inhibitors, such as pembrolizumab, nivolumab, and atezolizumab, underscores the importance of PD-L1 testing in NSCLC.
Patients with PD-L1 expression levels above 50% have shown better responses to monotherapy with these agents, while those with lower expression levels may benefit from combination therapies. This stratification enables healthcare professionals to personalize treatment plans, optimizing therapeutic outcomes and cost-effectiveness.
Growing Cancer Cases and Increased Use of Immunotherapy Fuel Demand for PD-L1 Biomarker Testing
The rising diagnosis rate of cancer has increased the application of PD-L1 biomarker testing, especially concerning melanoma and lung cancer. It has an important role in identifying the appropriate treatment that patients with advanced or metastatic cancer can undertake.
The test accounts for how patients are guided toward treatment in advanced-stage or metastatic cancer cases. By identifying the right treatment options, PD-L1 testing is helping improve patient outcomes and optimize care.
For example, the two drugs sold under the brand name Keytruda and Opdivo are medications like Pembrolizumab and Nivolumab that depend on PD-L1 testing to provide better results. At the level of PD-L1 in a patient's tumor, doctors can work out who will most likely respond to the treatment, and it will be targeted and individualized.
The world's governments and healthcare agencies are working together to enhance earlier detection of cancers and increase more extensive access to advanced diagnostics. The campaigns designed to raise more awareness about PD-L1 testing in improving outcomes of treatment in NSCLC patients continue with the new therapies under research to be tested against clinical trials as well, continuing to drive PD-L1 testing market growth.
Advancements in Diagnostic Technologies is driving Revenue Growth for PD-L1 Biomarker Testing
Technological advancement in diagnostic platforms has been a key driver of growth for PD-L1 testing. The automated IHC systems streamlined clinical workflows, reduced test variability, and improved reproducibility. In addition, multiplex testing was also made feasible by next-generation sequencing; multiple biomarkers, including PD-L1, can be tested at one time to increase the speed of cancer diagnosis.
Another transformative change includes the integration of artificial intelligence into digital pathology. AI-based image analysis is now increasingly used by pathologists in the analysis of complex test results for PD-L1 testing in a much more precise and uniform way.
Not only does this ensure better accuracy at diagnosis but also makes PD-L1 testing accessible with optimized lab practices and fewer errors due to humans. Improved outcomes for patients across healthcare systems around the world led to wide-ranging adoption.
Expanding Applications Beyond Oncology is Creating Opportunities in the Market
Although PD-L1 testing is basically associated with the field of oncology, evidence is emerging that describes some potential uses beyond this particular niche, for instance, autoimmune and infectious diseases. For example, the expression of PD-L1 may help forecast patient responses to therapies that modify immunological activities for diseases like rheumatoid arthritis and multiple sclerosis.
Advancements in technology for multiplex testing mean that PD-L1 can be simultaneously tested together with other biomarkers, opening its use to a wider market. Diagnostic companies and pharmaceutical businesses are getting more partnerships to introduce new companions diagnostics in different therapeutic areas. This increased potential for applications, alongside increasing uses of PD-L1 testing in clinical research, is a big chance for the market to improve in the upcoming years.
Stigma and Societal Barriers and Regulatory Challenges may Restrict Market Growth
Although it is crucial in the application of immunotherapy, affordability and accessibility in PD-L1 testing remain huge hurdles, especially for low- and middle-income countries. For many healthcare providers, the cost of performing a PD-L1 test remains unaffordable, mainly when these platforms are NGS or automated IHC systems. The issue becomes even more exacerbated by the unavailability of adequate diagnostic infrastructure within these regions to ensure that good-quality testing becomes accessible.
Protocol variations and diagnostic platforms further complicate clinical decision-making due to the variability in the test results. Standardization across labs is very difficult and contributes to inconsistent results, which undermines the reliability of these tests.
Overcoming these barriers requires harmonizing standards on testing, bringing down costs either through subsidies or innovation, and investing in infrastructure for In-vitro diagnostics device in underserved regions. Without that, the full global potential of PD-L1 biomarker testing can never be unleashed.
The global market for PD-L1 biomarker testing grew from 2020 to 2024 at an annual rate of 6.6%. During this period, the market gained value, thus increasing from a value of about USD 561.5 million in 2020 to that of about USD 726.2 million by 2024.
Historically, the market for PD-L1 biomarker testing has followed the development of immunotherapy in oncology. The mid-2010s approval of immune checkpoint inhibitors like pembrolizumab and nivolumab created a turning point, as establishing PD-L1 testing became a cornerstone of patient stratification. Initial adoption was relatively skewed toward developed markets, where more developed infrastructure for diagnostics and favorable regulatory approvals expanded adoption.
In the present time, PD-L1 testing is a routine affair in oncology, especially when it comes to NSCLC, melanoma, and bladder cancers. The marketplace has seen impressive technological advancements on the horizon through the development of automated IHC platforms and AI-driven image analysis tools.
Joint ventures between drug companies and firms that specialize in diagnostics led to the development of several approved companion diagnostics expanding the scope for PD-L1 testing. The COVID-19 pandemic briefly interrupted testing volumes, but the market has rebounded strongly with the resumption of routine cancer diagnostics.
The PD-L1 biomarker testing market has a very positive outlook for the future. Increasing applications beyond oncology, prevalence of cancer, and investment in precision medicine will be key drivers for sustained growth. The combination of AI and digital pathology with improvements in multiplex testing will further enhance diagnostic accuracy and efficiency, driving adoption. By 2035, the market is expected to experience significant expansion as awareness grows, costs decrease, and technology advances.
Tier 1 companies are the industry leaders with 62.4% of the global industry. These companies stand out for having a large product portfolio and a high production capacity. These industry leaders also stand out for having a wide geographic reach, a strong customer base, and substantial experience in manufacturing and having enough financial resources, which enables them to enhance their research and development efforts and expand into new industries.
The companies within tier 1 have a good reputation and high brand value. Prominent companies within tier 1 include F. Hoffmann-La Roche Ltd., Agilent Technologies, Inc., Merck & Co., Inc., Bristol-Myers Squibb and Thermo Fisher Scientific
Tier 2 companies are relatively smaller as compared with tier 1 players. The tier 2 companies hold a market share of 23.7% worldwide. These firms may not have cutting-edge technology or a broad global reach, but they do ensure regulatory compliance and have good technology. The players are more competitive when it comes to pricing and target niche markets. Key Companies under this category include Abcam plc., Abbott Laboratories, NeoGenomics Laboratories, Inc., HalioDx, Intas Pharmaceuticals among others
Compared to Tiers 1 and 2, Tier 3 companies offer outsourced testing services, but with smaller revenue spouts and less influence. These companies mostly operate in one or two countries and have limited customer base. They specialize in specific products and cater to niche markets, adding diversity to the industry.
The market analysis for PD-L1 biomarker testing in various nations is covered in the section below. An analysis of important nations in North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia & Pacific, and Middle East & Africa of the world has been mentioned below.
It is projected that the United States will maintain its leading position in North America through 2035, holding a value share of 89.8%. By 2035, China is expected to experience a CAGR of 8.8% in the Asia-Pacific region.
| Countries | Value CAGR (2025 to 2035) |
|---|---|
| United States | 7.8% |
| Germany | 8.3% |
| Japan | 9.1% |
| South Korea | 7.4% |
| UK | 9.3% |
| China | 8.8% |
Most health policies in Germany press on the early detection and personalization for cancer treatment. This strongly favors the growth of the PD-L1 biomarker testing market in Germany.
Investments in health care and research in medicine remain a cornerstone for Germany's approach. The country encourages partnerships among academic institutions, pharmaceutical companies, and diagnostic firms to innovate the diagnostics of cancer. For example, German research institutions often engage with global pharmaceutical giants to establish companion diagnostics focused on PD-L1 expression.
Regulatory frameworks in Germany also play a pivotal role. The nation maintains rigorous standards for the approval of diagnostic tools and therapies, ensuring reliability and efficacy. These standards, combined with high adoption rates of automated immunohistochemistry (IHC) systems and next-generation sequencing (NGS), position Germany as a leader in diagnostic precision.
In addition, the inclusion of AI-based pathology solutions further enhanced PD-L1 testing. Germany is actually a model to other countries with the aim of improving their infrastructure in oncology diagnostics.
The United States stands as the global market's leading contributor in PD-L1 biomarker testing, which is largely as a result of its high rates of cancer incidences and major investment in studies related to immunotherapy. Some of the cancer types that the USA has recorded the most diagnosed cases for include lung, melanoma, and bladder cancer, among others. Such has triggered the robust diagnostic framework, which thus resulted in swift adoption of PD-L1 biomarker testing for oncology care.
The growing coverage of private insurers and government programs, including Medicare and Medicaid, for PD-L1 biomarker testing is another driver of reimbursement policies. Public awareness campaigns regarding the importance of early cancer diagnosis and personalized medicine have further promoted the adoption of PD-L1 testing.
This widespread awareness, coupled with advanced laboratory infrastructure and integration of AI tools in pathology, guarantees that the USA remains one of the significant players in this global market.
India is an up-and-coming market for the PD-L1 biomarker testing that has rapidly expanded, fueled by growing burden of cancers and a rise in the use of precision medicine. Incidence of various cancers including lung, head and neck, gastric cancer have continuously been rising with a good majority demanding testing for PD-L1 during the planning process for their respective treatments. These needs have stimulated health care service providers to ensure incorporation of this kind of testing in their clinical care practice.
Improving cancer diagnostics in India is an initiative by the government. It has been implementing programs like the National Cancer Control Programme (NCCP), which expands diagnostic and treatment services, especially to rural and underprivileged areas.
Public-private partnerships have also contributed significantly to scaling up cancer diagnostic infrastructure. Private healthcare providers, which dominate the tertiary care landscape in India, have started embracing advanced diagnostic technologies, such as automated IHC platforms and multiplex NGS testing, to provide PD-L1 testing to a diverse patient population.
The section contains information about the leading segments in the industry. Based on product type, the PD-L1 22C3 Assay Kit segment is expected to account for 50.4% of the global share in 2025.
| By Product type | Value Share (2025) |
|---|---|
| PD-L1 22C3 Assay Kit | 50.4% |
The PD-L1 22C3 Assay Kit leads the market, in fact in the most common product used, in testing the PD-L1 as a biomarker due to its critical use in deciding matters on immunotherapy, especially with regard to cancer. The 22C3 assay developed and approved as a companion diagnostic for the broad successful immune checkpoint inhibitor Pembrolizumab (Keytruda) stands out as a benchmark for testing PD-L1.
Its position in classifying patients according to the expression levels of PD-L1 is thus fundamental in characterizing those with a higher likely response to therapies based on an anti-PD-1/PD-L1 axis, mostly in non-small cell lung carcinoma.
The 22C3 assay has been approved by FDA-approved as a companion diagnostics for many indications. Because the assay was used extensively in both research and clinical settings, oncologists and pathologists trust it. The work of the assay has been tailored on automated immunohistochemistry platforms such as Dako Autostainer, and therefore, operates consistently and accurately on PD-L1 detection. The 22C3 assay has remained at the top of the market because of reliability, efficiency, and regulatory approval.
| By Indication | Value Share (2025) |
|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | 63.5% |
With the rise in lung cancer cases and 85% of the cases being NSCLC, and its strong association with the PD-L1 inhibitors therapies makes it a leading indication for PD-L1 biomarker testing. Hence, the new diagnosis and treatment approaches which have recently been forced on NSCLC patients raise exponentially demand for PD-L1 testing in the arena of oncology.
This testing plays a major role in PD-L1 in stratifying patients to predict their responsiveness to pembrolizumab, nivolumab, and atezolizumab; thus, there is a subgroup of NSCLC patients showing more than 50% PD-L1 expression whose disease course has shown a better improvement by the use of immune checkpoint monotherapy.
Other levels of lower PD-L1 expression are considered suitable for combination treatments. This enables healthcare professionals to personalize treatment plans to maximize the efficacy of the treatment. This results in a cost effective treatment path.
In terms of this market, the companies involved are resorting to multiple strategies to retain a competitive position. Geographical expansion into the emerging markets, particularly United States and Asia Pacific countries, has been another strategic priority for these companies, where growth in the healthcare infrastructure and awareness is strong.
Recent Industry Developments in PD-L1 Biomarker Testing Industry Outlook
| Report Attributes | Details |
|---|---|
| Industry Size (2025E) | USD 777.2 million |
| Projected Market Size (2035F) | USD 1,700 million |
| CAGR (2025 to 2035) | 8.1% |
| Base Year for Estimation | 2024 |
| Historical Period | 2020 to 2024 |
| Forecast Period | 2025 to 2035 |
| Quantitative Units | Revenue in USD million; Volume in number of tests |
| By Product Type | PD-L1 22C3 Assay Kit, PD-L1 28-8 Assay Kit, PD-L1 SP142 Assay Kit, PD-L1 263 Assay Kit |
| By Test | Non-Small Cell Lung Cancer (NSCLC), Melanoma, Renal Cell Carcinoma, Gastrointestinal Tract Malignancy, Haematological Malignancies, Ovarian Cancer, Others |
| By End User | Hospitals, Diagnostic Laboratories, Cancer Research Institutes |
| By Region | North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe, Middle East and Africa |
| Key Players | F. Hoffmann-La Roche Ltd., Agilent Technologies, Inc., Merck & Co., Inc., Bristol-Myers Squibb, Thermo Fisher Scientific, Abcam plc., Abbott Laboratories, NeoGenomics Laboratories, Inc., HalioDx, Intas Pharmaceuticals, Shuwen Biotech Co. Ltd., Leica Biosystems, Bio-Rad Laboratories, Genentech, Others |
| Additional Attributes | Expansion of companion diagnostics in oncology, regulatory approvals of PD-L1 assays across geographies, and increasing adoption in treatment planning for checkpoint inhibitor therapies are key market drivers. |
| Customization and Pricing | Customization and Pricing Available on Request |
In terms of product type, the industry is divided into PD-L1 22C3 Assay Kit, PD-L1 28-8 Assay Kit, PD-L1 SP142 Assay Kit, PD-L1 263 Assay Kit
In terms of test, the industry is segregated into Non-Small Cell Lung Cancer (NSCLC), Melanoma, Renal Cell Carcinoma, Gastrointestinal tract Malignancy, Haematological Malignancies, Ovarian Cancer among Other.
In terms of end user, the industry is divided into hospitals, diagnostic laboratories and cancer research institutes.
Key countries of North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe and Middle East and Africa (MEA) have been covered in the report.
The global PD-L1 biomarker testing industry is projected to witness CAGR of 8.1% between 2025 and 2035.
The global PD-L1 biomarker testing industry stood at USD 726.2 million in 2024.
The global PD-L1 biomarker testing industry is anticipated to reach USD 1,700 million by 2035 end.
China is expected to show a CAGR of 8.8% in the assessment period.
The key players operating in the global PD-L1 biomarker testing industry are F. Hoffmann-La Roche Ltd., Agilent Technologies, Inc., Merck & Co., Inc., Bristol-Myers Squibb, Thermo Fisher Scientific, Abcam plc. Abbott Laboratories, NeoGenomics Laboratories, Inc., HalioDx, Intas Pharmaceuticals, Shuwen Biotech Co. Ltd., Leica Biosystems, Bio-Rad Laboratories, Genentech among others.
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PD-L1 Biomarker Testing Market
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