The global PD – L1 biomarker testing market holds a valuation of USD 597.9 Million by the end of the year 2022. Throughout the forecast period of 2023 to 2033, the market is likely to display growth at a CAGR of 9.14%, and is expected to hold a market value of around USD 1.58 Billion in 2033.
Market Outlook
| Data Points | Market Insights |
|---|---|
| Market Value 2022 | USD 597.9 Million |
| Market Value 2023 | USD 659.6 Million |
| Market Value 2033 | USD 1.58 Billion |
| CAGR 2023 to 2033 | 9.14% |
| Market Share of Top 5 Countries (2022) | 75.8% |
| Key Market Players | F. Hoffmann - La Roche Ltd., Agilent Technologies, Inc., Abcam plc, Shuwein Biotech Co. Ltd., NeoGenomics Laboratories, Inc., HalioDx, Abcam plc, Merck, Bristol-Myers Squibb, AstraZeneca |
Cancer diagnostics involves detection of specific biomarkers, proteins, and symptoms of cancers in patients that indicate the development of abnormal cancerous cells. The detection make use of specific technology and devices used in its diagnosis. PD-L1 is a protein that helps to keep the immune system in check. In cancerous conditions, this protein is found in higher concentrations.
Cancer has a significant impact on society worldwide. It is one of the world's leading causes of death, with a higher prevalence in developed and emerging markets. According to the article published in a cancer journal for clinicians in 2021 regarding global cancer statistics 2020, International Agency for Research on Cancer estimated 19.3 million new cancer cases and almost 10.0 million cancer deaths occurred in 2020 in 185 countries. The alarming rise in cancer prevalence requires healthcare providers to reconsider cancer treatment goals and shift their focus to preventive care.
Rising research activities for the treatment of several cancer indications are expected to bode well for the market. Increasing applications of biomarker testing across abundant tumour types, including an earlier-stage cancer detection is anticipated to provide opportunities for key players to invest and research in the biomarker testing market.
The innovation of biomarker testing is finding a new niche in cancer immunotherapy, which will help the market expand.
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The PD – L1 biomarker testing market expanded at a CAGR of 6.96% between 2017 and 2022 due to increased awareness of cancer disease, advanced technologies used for cancer diagnosis.
The market value for PD-L1 biomarker testing market was around 1.0% of the overall USD 67.2 Billion of the global diagnostic biomarkers market in 2022.
PD-L1 biomarker testing is a reliable diagnostic approach in cancer management since it is based on the fact that each person has distinctive levels of the PD-L1 protein. For instance, early stages of non-small cell lung cancer (NSCLC) and melanoma are found using PD-L1 biomarkers in cancer diagnoses and analysis.
The growing availability of high-quality immunotherapy products worldwide is addressing unmet cancer treatment needs. In the current scenario, lifestyle changes such as physical inactivity, tobacco consumption and smoking, as well as an unhealthy diet, are main contributors to the rising burden of cancerous indications.
Key market players are focusing on the development or extension of novel biologics using existing biologic resources for innovative product identification and the provision of patented therapies. Cancer immunotherapy has advanced the diagnostic approach to cancer detection and management, propelling the PD-L1 biomarker testing market forward.
| Market Statistics | Details |
|---|---|
| Jan to Jun (H1), 2021 (A) | 8.30% |
| Jul to Dec (H2), 2021 (A) | 12.06% |
| Jan to Jun (H1),2022 Projected (P) | 8.27% |
| Jan to Jun (H1),2022 Outlook (O) | 9.11% |
| Jul to Dec (H2), 2022 Outlook (O) | 11.69% |
| Jul to Dec (H2), 2022 Projected (P) | 11.06% |
| Jan to Jun (H1), 2023 Projected (P) | 8.30% |
| BPS Change : H1,2022 (O) - H1,2022 (P) | 85↑ |
| BPS Change : H1,2022 (O) - H1,2021 (A) | 82↑ |
| BPS Change: H2, 2022 (O) - H2, 2022 (P) | 63↑ |
| BPS Change: H2, 2022 (O) - H2, 2022 (A) | (-) 37↓ |
Principal Consultant
Increasing number of cancer cases worldwide is the key driver to boost the global market. Cancer is at the second place for prevalence in the world.
According to World Cancer Research Fund International, detected cancer cases were 18,094,716 million globally in 2020. Prevention of cancer is very challenging and needs an early detection.
The development of reliable PD-L1 biomarker testing with appropriate licensing for use is expected to drive PD-L1 biomarker testing sales in the coming years. Because of PD-L1 biomarker screening tests, the pharmacological diagnosis of cancer were possible. It is helping in production of personalised medicines, thus anticipated to increase the cancer screening biomarkers like PD-L1 biomarker.
The lifestyle choices, dietary habits, and social factors like drinking, smoking, and tobacco habits have dramatically increased in recent years all throughout the world, especially among younger generations.
These factors directly adds to the rising incidence of lung cancer around the world. People's awareness of early detection and diagnosis of lung cancer has grown in recent years, and more people are undergoing such tests. This, too, is expected to benefit the market in the forecast period.
The challenges in testing and identifying biomarkers, as well as their validation and implementation in molecular diagnostics, are factors limiting the demand for PD-L1 biomarker testing. Trials including clone evolution, tumour heterogeneity detection, and biomarker testing are also likely to have a detrimental effect on market expansion.
The growth of the PD-L1 biomarker testing market is also hampered by the lack of skilled laboratory technicians because diagnostic laboratories use cutting-edge technology and automation. Despite the availability of advanced tools that make testing simple, critical mistakes regarding the dependability of data across multiple platform, as well as comparable difficulties in analytical validation, will affect sales.
Molecular testing faces considerable obstacles in several regions due to difficulties with regulatory authorities' drug licencing and testing procedures as well as the availability of constrained reimbursement. These characteristics favour on-demand testing, which is expected to restrain the market's expansion for PD-L1 biomarker testing in the years to come.
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| Country | The USA |
|---|---|
| Market Share (2023) | 54.3% |
| Market Share (2033) | 57.4% |
| BPS Analysis | 311 |
| Country | The United kingdom |
|---|---|
| Market Share (2023) | 6.8% |
| Market Share (2033) | 7.3% |
| BPS Analysis | 46 |
| Country | Canada |
|---|---|
| Market Share (2023) | 5.6% |
| Market Share (2033) | 4.1% |
| BPS Analysis | -148 |
| Country | Germany |
|---|---|
| Market Share (2023) | 5.2% |
| Market Share (2033) | 4.7% |
| BPS Analysis | -54 |
| Country | China |
|---|---|
| Market Share (2023) | 4.5% |
| Market Share (2033) | 5.2% |
| BPS Analysis | 70 |
In 2023, with 54.3% of the market share, the United States will dominate the global market. The country's high prevalence of lung cancer and related chronic illnesses, as well as rising investments in the production of cutting-edge medications, medical technology in the oncology market, and increasing attention on early cancer diagnosis will aid the USA market grow throughout the duration of the forecast period.
According to American Cancer Society, the estimated values for lung cancer in the USA in 2023 are 238,340 new cases of lung cancer about and about 127,070 deaths from lung cancer.
TheUnited kingdom market is anticipated to expand at a 9.9% CAGR over the forecast period, accounting for a significant part of the market for increased PD-L1 testing in the Europe.
Sales in the market are expected to be boosted by the presence of governed predictive testing within the nation under national and regional regulations, awareness of early cancer diagnosis, and technological development. Increasing medical tourism in the United kingdom will further increase the demand for PD-L1 biomarker testing.
According to Cancer Research United kingdom, estimated 167,000 cancer deaths occur in the United kingdom each year due to the high frequency of the disease.
PD-L1 biomarker testing market in China will expand at a CAGR of 10.8% over the forecast period. The need for PD-L1 biomarker testing is being driven by an increase in cancer cases in the nation.
According statistical presentation by GLOBOCAN 2022, there were approximately 4,820,000 new cancer cases identified in China in 2022. Among this number, 2,625,070 men and 2,195,764 women were diagnosed. These metrics support the transitive efforts by the country to present biomarker testing into the overall healthcare structure.
PD-L1 22C3 assay kit demand will hold 49.90% of the overall market share in 2023. Sales in this market will grow during the forecast period due to the efficiency of PD-L1 22C3 tests used in non-small cell lung cancer testing and patients' positive responses to immune checkpoint inhibitors.
Global demand for PD-L1 Biomarker Testing for NSCLC is growing as lung cancer incidence rises. In 2023, the category is set to hold 62.8% of the global market share, and it is anticipated that this pattern will hold in the upcoming years. The availability of PD-L1 protein is the only biomarker, which can guide treatment with immune checkpoint inhibitors in non-small cell lung cancer (NSCLC).
In terms of end users, 44.1% of the global market share in 2023 will be held by cancer research institutes. The study and development of innovative treatments for oncological purposes across various cancer research centers is gaining traction as the prevalence of cancer-related morbidity increases globally.
The focus of key players is on the development and introduction of novel PD-L1 biomarkers for the treatment of various cancers. Market exclusivity and government incentives to promote new and innovative options for cancer treatment will create lucrative opportunities for market players.
Some recent developments include
Similarly, recent developments have been tracked by the team at Future Market Insights related to companies in the PD-L1 Biomarker Testing market, which are available in the full report.
| Attribute | Details |
|---|---|
| Forecast Period | 2023 to 2033 |
| Historical Data Available for | 2017 to 2022 |
| Market Analysis | USD Million for Value, and Units for Volume |
| Key Regions Covered | North America, Latin America, Europe, East Asia, South Asia, Oceania, Middle East and Africa (MEA) |
| Key Countries Covered | USA, Canada, Brazil, Mexico, Argentina, United kingdom, Germany, Italy, France, Spain, Russia, BENELUX, China, Japan, South Korea, India, Indonesia, Malaysia, Thailand, Australia, New Zealand, GCC countries, Türkiye, South Africa and North Africa. |
| Key Market Segments Covered | Product, Type, Application, and Region |
| Key Companies Profiled |
F. Hoffmann – La Roche Ltd.; Agilent Technologies, Inc.; Abcam plc, Shuwein Biotech Co. Ltd.; NeoGenomics Laboratories, Inc.; HalioDx, Abcam plc; Merck, Bristol-Myers Squibb; AstraZeneca |
| Report Coverage | Market Forecast, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, Strategic Growth Initiatives |
| Pricing | Available upon Request |
The market in 2023 is valued at USD 659.6 Million
By 2033, the market is expected to reach USD 1.58 Billion
The market is likely to expand at a 9.14% CAGR through 2033.
From 2018 to 2022, the market record a 6.96% CAGR.
In 2023, the United States accounts for 54.3% revenue.
1. Executive Summary | PD-L1 Biomarker Testing Market 2. Market Overview 3. Key Market Trends 4. Key Success Factors 5. Market Background 6. Global Market Volume (Units) Analysis 2017 to 2022 and Forecast, 2023 to 2033 7. Global Market - Pricing Analysis 8. Global Market Demand (in Value or Size in USD Million) Analysis 2017 to 2022 and Forecast, 2023 to 2033 9. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Product 9.1. PD-L1 22C3 Assay Kit 9.2. PD-L1 28-8 Assay Kit 9.3. PD-L1 SP142 Assay Kit 9.4. PD-L1 263 Assay Kit 10. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Indication 10.1. NSCLS 10.2. Melanoma 10.3. Renal Cell Carcinoma 10.4. Gastrointestinal Tract Malignancy 10.5. Hematological Malignancies 10.6. Ovarian Cancer 10.7. Other 11. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By End User 11.1. Hospitals 11.2. Diagnostic Laboratories 11.3. Cancer Research Institutes 12. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Region 12.1. North America 12.2. Latin America 12.3. Europe 12.4. East Asia 12.5. South Asia 12.6. Oceania 12.7. Middle East and Africa 13. North America Market Analysis 2017 to 2022 and Forecast 2023 to 2033 14. Latin America Market Analysis 2017 to 2022 and Forecast 2023 to 2033 15. Europe Market Analysis 2017 to 2022 and Forecast 2023 to 2033 16. East Asia Market Analysis 2017 to 2022 and Forecast 2023 to 2033 17. South Asia Market Analysis 2017 to 2022 and Forecast 2023 to 2033 18. Oceania Market Analysis 2017 to 2022 and Forecast 2023 to 2033 19. Middle East and Africa (MEA) Market Analysis 2017 to 2022 and Forecast 2023 to 2033 20. Market Structure Analysis 21. Competition Analysis 21.1. F. Hoffmann – La Roche Ltd. 21.2. Agilent Technologies, Inc. 21.3. Abcam plc 21.4. Shuwein Biotech Co. Ltd. 21.5. NeoGenomics Laboratories, Inc. 21.6. HalioDx 21.7. Abcam plc 21.8. Merck 21.9. Bristol-Myers Squibb 21.10. AstraZeneca 22. Assumptions and Acronyms Used 23. Research Methodology
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PD-L1 Biomarker Testing Market
