PD-L1 Biomarker Testing Market Trends and Forecast
The future of the global PD-L1 biomarker testing market looks promising with opportunities in the hospital and diagnostic center markets. The global PD-L1 biomarker testing market is expected to grow with a CAGR of 12.5% from 2025 to 2031. The major drivers for this market are the increasing adoption of personalized cancer treatments, the rising demand for targeted therapies, and the growing awareness of cancer biomarker testing.
• Lucintel forecasts that, within the type category, PD-L1 (22C3) is expected to witness the highest growth over the forecast period.
• Within the application category, diagnostic center is expected to witness higher growth.
• In terms of region, APAC is expected to witness the highest growth over the forecast period.
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Emerging Trends in the PD-L1 Biomarker Testing Market
The PD-L1 biomarker testing market is experiencing rapid growth driven by advancements in immunotherapy, personalized medicine, and increasing cancer prevalence worldwide. As the demand for targeted treatments rises, the market is evolving with innovative testing methods, expanding applications, and strategic collaborations. These developments are transforming how clinicians diagnose and tailor treatments for cancer patients, ultimately improving outcomes. The following key trends highlight the major shifts shaping this market, reflecting technological progress, regulatory changes, and increasing adoption across healthcare settings. Understanding these trends is essential for stakeholders aiming to capitalize on emerging opportunities and navigate the competitive landscape effectively.
• Adoption of Next-Generation Sequencing: NGS technology is increasingly used for PD-L1 testing, offering comprehensive genomic insights. It enables simultaneous detection of multiple biomarkers, improving accuracy and efficiency. This trend reduces turnaround times and enhances personalized treatment plans, making it a preferred choice over traditional methods. As NGS becomes more affordable and accessible, its integration into routine diagnostics is expected to expand, driving market growth and enabling more precise patient stratification.
• Expansion of Companion Diagnostics: The development of companion diagnostics linked to PD-L1 testing is a significant trend. These tests are designed to identify patients most likely to benefit from specific immunotherapies, ensuring targeted treatment approaches. Regulatory approvals for such diagnostics are increasing, fostering collaborations between pharmaceutical companies and diagnostic providers. This trend enhances treatment efficacy, reduces unnecessary side effects, and supports the shift toward personalized medicine, ultimately boosting market demand.
• Integration of Artificial Intelligence and Digital Pathology: AI-powered algorithms and digital pathology tools are revolutionizing PD-L1 testing by improving accuracy, consistency, and speed. These technologies assist pathologists in interpreting complex data, reducing human error, and enabling high-throughput analysis. The integration of AI also facilitates real-time decision-making and remote diagnostics, expanding access to testing in underserved regions. This trend is expected to significantly enhance diagnostic precision and operational efficiency within the market.
• Increasing Adoption in Non-Oncology Applications: While primarily used in cancer diagnostics, PD-L1 testing is increasingly being explored for other medical conditions, such as infectious diseases and autoimmune disorders. This diversification broadens the market scope and opens new revenue streams. As research progresses, new indications for PD-L1 testing are likely to emerge, encouraging healthcare providers to adopt these tests beyond traditional oncology settings, thereby expanding market reach.
• Regulatory and Reimbursement Developments: Evolving regulatory frameworks and reimbursement policies are shaping the market landscape. Clearer guidelines and coverage decisions are facilitating wider adoption of PD-L1 testing. Governments and insurance providers are recognizing the clinical and economic benefits of personalized immunotherapy, leading to increased reimbursement rates. This trend reduces financial barriers for patients and providers, accelerating market penetration and encouraging innovation in testing technologies.
In summary, these trends are collectively transforming the PD-L1 biomarker testing market by enhancing technological capabilities, broadening application areas, and improving access through regulatory support. They are driving a shift toward more precise, efficient, and personalized cancer diagnostics, ultimately improving patient outcomes and fostering sustainable market growth.
Recent Development in the PD-L1 Biomarker Testing Market
The PD-L1 biomarker testing market has experienced significant growth driven by advancements in immunotherapy and personalized medicine. As cancer treatments become more targeted, the demand for precise biomarker testing has surged, prompting innovations in testing techniques and expanding applications across various cancer types. Regulatory approvals and increasing awareness about the importance of PD-L1 testing further propel market expansion. Additionally, collaborations between biotech firms and healthcare providers are fostering technological advancements and improving testing accessibility. These developments collectively enhance diagnostic accuracy, treatment efficacy, and patient outcomes, positioning the PD-L1 biomarker testing market as a critical component in modern oncology care.
• Technological Advancements: Development of next-generation testing methods such as multiplex assays and digital pathology has improved detection accuracy and reduced turnaround times, enabling more timely treatment decisions and expanding market reach.
• Regulatory Approvals: Recent approvals by agencies like the FDA for PD-L1 testing kits have increased market confidence, encouraging healthcare providers to adopt these tests widely and boosting overall market growth.
• Expansion of Indications: The application of PD-L1 testing has broadened beyond lung and melanoma cancers to include bladder, gastric, and other cancers, increasing demand and market size.
• Strategic Collaborations: Partnerships between biotech companies and diagnostic labs have accelerated innovation, facilitated the development of more comprehensive testing panels, and improved access to testing services.
• Rising Adoption of Immunotherapy: Growing use of immune checkpoint inhibitors has heightened the need for PD-L1 biomarker testing to identify suitable candidates, directly impacting market demand and growth trajectory.
In summary, these developments are significantly transforming the PD-L1 biomarker testing market by enhancing testing accuracy, expanding its applications, and increasing adoption rates. This progress is driving market growth, improving patient stratification, and supporting the broader integration of personalized cancer therapies.
Strategic Growth Opportunities in the PD-L1 Biomarker Testing Market
The PD-L1 biomarker testing market is experiencing rapid growth driven by advancements in immunotherapy and personalized medicine. As cancer treatments become more targeted, the demand for precise biomarker testing increases across various applications. This evolution is creating new opportunities for healthcare providers, diagnostic companies, and researchers to improve patient outcomes and optimize treatment strategies. Key applications such as lung cancer, melanoma, bladder cancer, gastric cancer, and head and neck cancers are witnessing significant development. These growth opportunities are shaping the future landscape of the market, fostering innovation, and expanding access to advanced diagnostic solutions.
• Lung Cancer: Enhanced diagnostic accuracy and early detection are driving growth in PD-L1 testing for lung cancer, leading to more effective immunotherapy options and improved survival rates.
• Melanoma: Increasing adoption of PD-L1 testing in melanoma enables personalized treatment plans, boosting response rates and reducing unnecessary exposure to ineffective therapies.
• Bladder Cancer: Growing awareness and technological advancements are expanding PD-L1 testing applications in bladder cancer, facilitating better patient stratification and targeted therapies.
• Gastric Cancer: Rising prevalence and research focus on gastric cancer are promoting the integration of PD-L1 testing, supporting tailored immunotherapy approaches, and improving prognosis.
• Head and Neck Cancers: The expanding use of PD-L1 biomarkers in head and neck cancers enhances treatment precision, leading to better management and increased survival outcomes.
These growth opportunities are significantly impacting the PD-L1 biomarker testing market by increasing demand, fostering innovation, and enabling more personalized cancer treatments, ultimately improving patient care and clinical outcomes.
PD-L1 Biomarker Testing Market Driver and Challenges
The PD-L1 biomarker testing market is influenced by a variety of technological, economic, and regulatory factors that shape its growth trajectory. Advances in diagnostic technologies, increasing cancer prevalence, and evolving regulatory standards are key drivers. Economic factors such as rising healthcare expenditure and the demand for personalized medicine further propel market expansion. Conversely, challenges like high testing costs, regulatory complexities, and limited awareness hinder growth. Understanding these drivers and challenges is essential for stakeholders to navigate the market effectively and capitalize on emerging opportunities while addressing potential barriers.
The factors responsible for driving the PD-L1 biomarker testing market include:-
• Technological Advancements: The development of more accurate, faster, and cost-effective testing methods such as immunohistochemistry (IHC) and next-generation sequencing (NGS) has significantly enhanced diagnostic capabilities. These innovations enable precise identification of PD-L1 expression levels, facilitating better patient stratification for immunotherapy. As technology continues to evolve, the accessibility and reliability of PD-L1 testing improve, encouraging widespread adoption among healthcare providers. This technological progress directly correlates with improved treatment outcomes and increased market demand, making it a primary driver for growth.
• Rising Cancer Incidence: The global increase in cancer cases, particularly non-small cell lung cancer (NSCLC), melanoma, and bladder cancer, has heightened the need for effective diagnostic tools like PD-L1 testing. Early and accurate detection of PD-L1 expression helps determine patient eligibility for immunotherapy, which has become a standard treatment option. The growing burden of cancer worldwide, coupled with the shift towards personalized medicine, fuels the demand for biomarker testing, thereby expanding the market significantly.
• Increasing Adoption of Immunotherapy: The approval and integration of immune checkpoint inhibitors, such as pembrolizumab and nivolumab, have revolutionized cancer treatment. PD-L1 testing is essential for identifying suitable candidates for these therapies, making it a critical component of treatment planning. As clinicians increasingly adopt immunotherapy protocols, the reliance on PD-L1 biomarker testing intensifies. This trend not only boosts market growth but also encourages further research and development in the field, reinforcing the importance of PD-L1 testing in oncology.
• Regulatory Approvals and Reimbursement Policies: Favorable regulatory decisions and reimbursement frameworks in various regions have facilitated the integration of PD-L1 testing into routine clinical practice. Clear guidelines and coverage policies reduce financial barriers for patients and healthcare providers, promoting widespread utilization. Regulatory approvals of companion diagnostics alongside immunotherapies further validate the importance of PD-L1 testing, encouraging manufacturers to innovate and expand their offerings. These factors collectively create a conducive environment for market growth and stability.
The challenges facing this PD-L1 biomarker testing market include:-
• High Testing Costs: The expense associated with PD-L1 testing, especially when utilizing advanced techniques like NGS, poses a significant barrier. High costs limit accessibility, particularly in developing regions with constrained healthcare budgets. This financial burden can delay or prevent patients from receiving timely diagnosis and treatment, ultimately impacting market growth. Additionally, reimbursement issues and lack of insurance coverage further exacerbate the affordability problem, hindering widespread adoption and putting pressure on healthcare providers to balance cost and diagnostic accuracy.
• Regulatory Complexities: Navigating the regulatory landscape for diagnostic tests remains a challenge due to varying standards across countries. Obtaining approvals for new tests or modifications can be time-consuming and costly, delaying market entry and innovation. Stringent validation requirements and evolving guidelines create uncertainty for manufacturers, potentially stifling product development. These regulatory hurdles can slow down the availability of cutting-edge testing solutions, impacting the overall growth and competitiveness of the market.
• Limited Awareness and Infrastructure: In many emerging markets, limited awareness among healthcare professionals about the benefits of PD-L1 testing hampers adoption. Additionally, inadequate laboratory infrastructure and skilled personnel restrict the implementation of advanced diagnostic techniques. This lack of awareness and infrastructure results in underutilization of available tests, preventing the market from reaching its full potential. Addressing these issues requires targeted education, investment in healthcare facilities, and capacity-building initiatives to expand access and improve diagnostic rates.
In summary, the PD-L1 biomarker testing market is driven by technological innovations, rising cancer incidences, and supportive regulatory policies, which collectively promote growth and adoption. However, high costs, regulatory complexities, and infrastructural limitations pose significant challenges that could hinder progress. Balancing these factors is crucial for stakeholders aiming to expand access, improve diagnostic accuracy, and optimize treatment outcomes. Overall, the markets future depends on strategic efforts to leverage drivers while mitigating challenges, ensuring broader patient access, and sustained growth.
List of PD-L1 Biomarker Testing Companies
Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies PD-L1 biomarker testing companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the PD-L1 biomarker testing companies profiled in this report include-
• Agilent Technologies
• Roche
• Merck
• Bristol-Myers Squibb
• AstraZeneca
• Ono Pharmaceutical
• Regeneron
• Innovent
• Hengrui Medicine
• Junshi Biosciences
PD-L1 Biomarker Testing Market by Segment
The study includes a forecast for the global PD-L1 biomarker testing market by type, application, and region.
PD-L1 Biomarker Testing Market by Type [Value from 2019 to 2031]:
• PD-L1 (22C3)
• PD-L1(28-8)
• PD-L1 (SP142)
• PD-L1 (SP263)
• Others
PD-L1 Biomarker Testing Market by Application [Value from 2019 to 2031]:
• Hospital
• Diagnostic Center
• Others
PD-L1 Biomarker Testing Market by Region [Value from 2019 to 2031]:
• North America
• Europe
• Asia Pacific
• The Rest of the World
Country Wise Outlook for the PD-L1 Biomarker Testing Market
The PD-L1 biomarker testing market has experienced significant growth driven by advancements in immunotherapy and personalized medicine. As cancer treatments become more targeted, the demand for precise diagnostic tools like PD-L1 testing has surged globally. Countries are investing in research, expanding testing capabilities, and integrating these diagnostics into clinical practice to improve patient outcomes. Regulatory approvals and technological innovations continue to shape the market landscape, with key players focusing on developing more accurate, faster, and cost-effective testing methods. The evolving regulatory environment and increasing awareness about immunotherapys benefits are further propelling market expansion across major regions.
• United States: The United States has seen rapid adoption of PD-L1 testing, driven by extensive research and high healthcare expenditure. Major biotech firms and hospitals are investing in advanced testing platforms, including companion diagnostics for immunotherapies like pembrolizumab. Regulatory agencies such as the FDA have approved several PD-L1 tests, boosting market confidence. The integration of PD-L1 testing into routine cancer diagnostics, especially lung and bladder cancers, has increased. Additionally, reimbursement policies are improving, making testing more accessible. The U.S. market continues to innovate with the development of multiplex assays and liquid biopsy-based tests.
• China: China is experiencing rapid growth in the PD-L1 biomarker testing market, supported by government initiatives to promote cancer diagnostics and immunotherapy. The country has increased investments in biotech research and manufacturing capabilities. Local companies are developing cost-effective, rapid testing solutions to meet domestic demand. The approval of several PD-L1 tests by Chinese regulatory authorities has facilitated market expansion. The rising prevalence of cancers such as lung, gastric, and liver cancer has further driven demand. Collaborations between Chinese firms and international companies are enhancing technological capabilities. The market is also benefiting from increased awareness and healthcare infrastructure improvements.
• Germany: Germanys market for PD-L1 testing is characterized by high-quality healthcare infrastructure and strong regulatory standards. The country is focusing on integrating PD-L1 testing into standard diagnostic protocols for cancers like non-small cell lung cancer and melanoma. German biotech companies are developing innovative testing methods, including digital pathology and automated assays. The market benefits from robust reimbursement policies and a well-established healthcare system. Additionally, Germany is involved in European Union initiatives to standardize and improve biomarker testing. The emphasis on personalized medicine and early diagnosis continues to drive market growth, with increasing adoption of companion diagnostics.
• India: India is witnessing a growing demand for PD-L1 testing, driven by rising cancer incidence and expanding healthcare infrastructure. The government’s focus on improving cancer diagnostics and treatment access is fostering market growth. Local laboratories are adopting advanced testing technologies, often at lower costs, to serve a large patient population. The approval of PD-L1 tests by Indian regulatory authorities has facilitated market entry. Increasing awareness about immunotherapy options among clinicians and patients is boosting demand. The market is also seeing collaborations between domestic and international firms to develop affordable, rapid testing solutions suitable for the Indian healthcare landscape.
• Japan: Japans PD-L1 biomarker testing market is expanding due to its aging population and high cancer prevalence. The country emphasizes early diagnosis and personalized treatment strategies. Japanese companies are developing innovative testing platforms, including automated and high-throughput assays. The government supports biomarker research through funding and regulatory incentives. Reimbursement policies are favorable, encouraging widespread adoption. Japan is also involved in international clinical trials, which help validate and improve testing methods. The integration of PD-L1 testing into routine oncology care is increasing, with a focus on improving treatment outcomes for lung, gastric, and other cancers prevalent in the region.
Features of the Global PD-L1 Biomarker Testing Market
Market Size Estimates: PD-L1 biomarker testing market size estimation in terms of value ($B).
Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
Segmentation Analysis: PD-L1 biomarker testing market size by type, application, and region in terms of value ($B).
Regional Analysis: PD-L1 biomarker testing market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
Growth Opportunities: Analysis of growth opportunities in different types, applications, and regions for the PD-L1 biomarker testing market.
Strategic Analysis: This includes M&A, new product development, and competitive landscape of the PD-L1 biomarker testing market.
Analysis of competitive intensity of the industry based on Porter’s Five Forces model.
FAQ
Q1. What is the growth forecast for PD-L1 biomarker testing market?
Answer: The global PD-L1 biomarker testing market is expected to grow with a CAGR of 12.5% from 2025 to 2031.
Q2. What are the major drivers influencing the growth of the PD-L1 biomarker testing market?
Answer: The major drivers for this market are the increasing adoption of personalized cancer treatments, the rising demand for targeted therapies, and the growing awareness of cancer biomarker testing.
Q3. What are the major segments for PD-L1 biomarker testing market?
Answer: The future of the PD-L1 biomarker testing market looks promising with opportunities in the hospital and diagnostic center markets.
Q4. Who are the key PD-L1 biomarker testing market companies?
Answer: Some of the key PD-L1 biomarker testing companies are as follows:
• Agilent Technologies
• Roche
• Merck
• Bristol-Myers Squibb
• AstraZeneca
• Ono Pharmaceutical
• Regeneron
• Innovent
• Hengrui Medicine
• Junshi Biosciences
Q5. Which PD-L1 biomarker testing market segment will be the largest in future?
Answer: Lucintel forecasts that, within the type category, PD-L1 (22C3) is expected to witness the highest growth over the forecast period.
Q6. In PD-L1 biomarker testing market, which region is expected to be the largest in next 5 years?
Answer: In terms of region, APAC is expected to witness the highest growth over the forecast period.
Q7. Do we receive customization in this report?
Answer: Yes, Lucintel provides 10% customization without any additional cost.
This report answers following 11 key questions:
Q.1. What are some of the most promising, high-growth opportunities for the PD-L1 biomarker testing market by type (PD-L1 (22C3), PD-L1(28-8), PD-L1 (SP142), PD-L1 (SP263), and others), application (hospital, diagnostic center, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
Q.2. Which segments will grow at a faster pace and why?
Q.3. Which region will grow at a faster pace and why?
Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
Q.5. What are the business risks and competitive threats in this market?
Q.6. What are the emerging trends in this market and the reasons behind them?
Q.7. What are some of the changing demands of customers in the market?
Q.8. What are the new developments in the market? Which companies are leading these developments?
Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?
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