Market Overview

The global clinical oncology next generation sequencing (ngs) market in terms of revenue was estimated to be worth USD 427.99 Million in 2023 and is poised to reach USD 1564.36 Million by 2032, growing at a CAGR of 15.5% from 2024 to 2032.

The Clinical Oncology Next Generation Sequencing (NGS) market is an area of study that concerns the application of next-generation sequencing technologies in the domain of oncology diagnosis, monitoring, and tailoring the treatment for cancer patients. NGS enables high-speed DNA and RNA sequencing, which facilitates a comprehensive assessment of genomic alterations associated with different types of cancers.

Growth in the clinical oncology NGS market is mainly contributed by rising technology breakthroughs, increased player competition, rising healthcare spending, and rising cancer prevalence. Also, growing R&D activities to develop solutions are likely to support the expansion of the market over the projection period. The COVID-19 pandemic has heavily impacted the market. The rules and regulations of governments for the treatment of cancer, which several countries had brought during the epidemic, dominated the market throughout. For example, on 23 December 2020, the National Cancer Treatment Response Group of the Scottish Government revised the treatment pathways for patients to allow continued, as needed, cancer treatment. Advantages of the diagnostic technology from NGS involve the capability of identifying genetic sequences and alterations of viruses.

The efforts of bringing in the technology of NGS to help in diagnostic processes came even during the COVID-19 pandemic between government officers and business enterprises. In January 2020, the U.S. Centres for Medicare & Medicaid Services opened coverage to FDA-approved laboratory diagnostic tests that include patients with ovarian or breast cancer diagnosed using the NGS technique. These factors fuelled market demand during the COVID-19 pandemic. The increasingly vast applications of NGS in the clinic for precision oncology have compelled large companies to find innovative platforms for genomic know-how.

For example, in August 2022, market leader Thermo Fisher Scientific widened access to precision oncology biomarker testing when it launched NGS Analysis and Test Software CE-IVD (IVDD). This software will enable health care providers to assess test data on the genomic in the shortest time possible. Relevance’s that this is compared to variant data are from clinical studies, supportive guidelines, treatments, as well as peer-reviewed articles. These innovations in the clinical applications of NGSs can increase market demand for them. The world sees an increase in cancer among its people, which can be considered the most significant influence driving the market today.

According to a journal published by WebMD last June 2022, more than 600,000 deaths happen due to cancer every year within the U.S. and over 80,000 people around Canada. In addition, the International Agency for Research on Cancer (IARC) estimated nearly 27.5 million new cancer cases by 2040. NGS is useful for identifying rare and novel cancer mutations, detecting familial cancer mutation carriers, and giving a molecular rationale for suitable targeted treatment. With this, the increase in cancer cases worldwide is likely to increase the demand for clinical oncology in the next generation sequencing market in the coming generations. With advancements in next-generation sequencing, companion diagnostics, and personalized medicine, the market is likely to grow. Furthermore, the generation of revenue will be through the increasing adoption of NGS for liquid biopsies. Technological advancement of NGS has been helpful in the analysis of liquid biopsy samples through the sequencing of circulating tumour DNA, which aids in the accurate profiling of malignancies and enables real-time, non-invasive surveillance of cancer. The increase in market rivalry and high efforts in R&D can increase the demand in the market. For example, a company specializing in early detection of tumours and genetic tests, Berry Oncology launched a new self-iterative liquid biopsy technique in May 2022 as HIFI System. Patients with this technology can get immediate treatment, and also allow early screening for cancers.

Key Findings

• Alecensa by Genentech Inc. received FDA approval in April 2024 for use as an adjuvant treatment after tumor resection in patients whose non-small cell lung cancer (NSCLC) was found to be anaplastic lymphoma kinase (ALK)-positive by an FDA-approved test.

Market Drivers

• Growing Demand for Precision Medicine

Precision medicine in oncology works by next-generation sequencing that allows giving highly tailored treatments to cancer patients. The technologies used here help determine those mutations or molecular changes, which may be supporting cancer progression through analysing individual cancer patient tumour genetics. As such genetic information, more effective targeted therapies become more likely with oncologists, since such treatments attack cancer-causing changes individually with more success. Traditional "one-size-fits-all" approaches are likely to be less effective and potentially more dangerous because their treatment strategies do not account for the fact that each cancer is genetically distinct, while NGS makes it possible to use targeted therapy: drugs that selectively block proteins or pathways that are specifically altered in a given cancer, thereby reducing toxicity and greatly enhancing results as a whole.

For example, the non-small cell lung cancer could be diagnosed with the mutation that is found in the genes like EGFR or ALK. Thus, a patient would get the targeted medicines, which would be EGFR inhibitors. These are much more effective than the standard chemo. The growing horizon of precision medicine, enabled by the capabilities of NGS, is revolutionizing oncology by making it available for patients to get tailored safe and effective treatments for their cancers.

Key Findings

• Agendia, Inc. and Illumina signed a multi-year agreement in January 2022 to work together on developing in vitro diagnostic (IVD) assays for oncology testing. Agendia, Inc. is a global leader in precision treatment for breast cancer.
• Agendia, Inc., a world leader in precision oncology for breast cancer, announced in January 2022 a multi-year collaboration to co-develop diagnostic (IVD) assays for oncology testing.
• Illumina Inc. partnered with Boehringer Ingelheim in January 2022 to accelerate the development of precision medications and therapy selection for patients with advanced cancer.

Market Opportunities

• Companion Diagnostics for Targeted Therapies

Next-generation sequencing indeed helps in the development of the companion diagnostics that detect these genetic alterations to guide such specific treatments for cancer. A companion diagnostic is a type of test that helps fit patients with the right treatment relevant to their genetic profile. For example, a clinician can use NGS to identify some of those mutations, like BRCA mutations in breast and ovarian cancer, which can result in the treatment that would specifically address those changes.

Pharmaceutical firms and NGS firms are increasingly tying up to develop these companion diagnostics, especially in the field of immune-oncology where drugs are aimed at boosting the body's inherent responses to cancer. This would lead to the development of accurate tests capable of identifying and detecting biomarkers of responsiveness to certain therapies, thus ensuring that a patient is treated only when he/she will most likely respond to the particular therapy. This focused strategy reduces unnecessary side effects for patients at the same time that it optimizes therapeutic effectiveness.

Regulatory bodies are further supporting the integration of companion diagnostics into cancer therapy pathways and encouraging the growth of precision medicine. NGS-based companion diagnostics have a crucial role in advancing the progress of efficient, tailored cancer care due to the compatibility of their concept with the regulatory trends and a growing focus on individualized treatment.

Market Restraining Factors

• High Costs and Reimbursement Challenges

Although revolutionary for cancer detection and therapy, NGS testing in clinical oncology is often costly for patients who cannot benefit from it. NGS has a high cost comprising very expensive reagents used and the sequencing equipment while necessitating the use of professional staff to interpret complex genomic information. That puts greater out-of-pocket burden on the patient, primarily because some do not benefit much from proper supportive healthcare resources in other locations or poor low- to middle-income nations that may simply not allow such diagnostic applications.

Inconsistencies in policy for reimbursement are yet another challenge many insurance companies remain conservative, especially when such tests are considered experimental or have not been proven to conclusively enhance outcomes, even though some countries or health care systems accept the benefits of NGS and cover them. This inconsistent reimbursement is going to make it challenging to adopt NGS harder, which may eventually hinder medical professionals from referring more patients for these tests thus delaying market expansion. It is one of the vital next steps for patients as well as healthcare systems regarding cost and reimbursement issues and increase accessibility of NGS and promotes its integration in routine oncology therapy.

Segmentation Analysis

The market scope is segmented because of by Product Type, by Technology, by Application, by End-User, by Region.

• By Product Type

Based on the Product Type of the market is segmented into Consumables, Platforms and Software.

The Clinical Oncology NGS Market is dominated by the Consumables category, that comprises kits, reagents, and the like which are needed for sequencing. As these consumables are continuously utilized in a vast spectrum of NGS applications, it ensures continuous cash inflow. For example, there are particular types of reagents which are absolutely necessary for target enrichment, library preparation, and sequencing reactions for the process of sequencing and thus ensure the generation of a steady need.

The Platforms and Software section entails the bioinformatics software and the sequencing equipment necessary for analysing genetics. Although these platforms are essential for effective and efficient sequencing, the cost upfront is very high. High-end sequencing platforms are designed and manufactured by Thermo Fisher Scientific and Illumine, which leads the market in terms of processing volumes of genomic data in the matter of a few seconds. For example, clinical oncology depends greatly on the Illumine Nextel series due to its great accuracy and high throughput. Another factor that should not be left unmentioned is the bioinformatics software required to interpret such complex data generated, where raw sequences are transformed into information researchers and physicians may apply. Taken together, these chapters illustrate the role of platforms and consumables in the development of NGS technology and personalized cancer therapy.

• By Technology

Based on the Technology of the market is segmented into Targeted Sequencing and Resequencing, Whole Genome Sequencing (WGS), RNA Sequencing.

Clinical oncology NGS market is led by targeted sequencing and resequencing because it is especially based on gene panels, which are associated with the development of various cancers. With a deeper sequencing capacity for genes that have proven crucial in the pathogenesis of cancer, this technology can provide a faster and less expensive alternative. Panels, for example, targeting a gene mutation in EGFR or KRAS, often are used to treat lung cancer a doctor would then ensure that your treatment can target the said alterations.

Even though WGS is costly, it allows for comprehensive analysis of the entire genome, making it an essential requirement for detailed studies on cancers. WGS can discover unanticipated mutations and structural variants that are not identified by targeted approaches to more profoundly understand complex cancer genomes and potentially inform new therapeutic strategies.

Also transcriptomic analysis has a lot of importance in this process. For identifying changes that can be present within a tumour gene expression, a patient should undergo RNA sequencing further for assessment. Study RNA can teach them concerning biology of a tumour could disclose potential biomarkers along with treatment evaluation. This will then all be pooled under as part of how the technologies of NGS are supposed to be applied even more to further improve upon results within cancer treatments to enable personalizing medicine.

• Regional Snapshots

By region, Insights into the markets in North America, Europe, Asia-Pacific, Latin America and MEA are provided by the study. North America captures the biggest market share because of developed healthcare infrastructures and its high research investment. There are some big giants, like Illumine and Thermo Fisher Scientific, for NGS technology in the region mainly with the attraction for the money component and widespread application on these NGS technologies. Reimbursement policies and programs, like the Precision Medicine Initiative, support the application of NGS in clinics. There is an immense burden of cancer in this region; increased awareness among people towards personalized medicine results in higher demand for testing by NGS. With North American hospitals and cancer centres increasingly making use of NGS to guide diagnosis, treatment decision-making, and monitoring, the stronghold will be quite solidified.

Europe is the most targeted market for Clinical Oncology NGS due to it being well funded by cancer research and its campaigns of precision medicine. It is mainly led by Germany, the United Kingdom, and France, using superior health care systems and sound regulatory frameworks to support the adoption of NGS technologies. The regulatory and framework guidelines to support the use of genomic technologies in clinical settings by the European Union have made innovative diagnostics accessible to patients. However, different reimbursement policies across countries, differences in regulatory approval processes, and market challenges concerning these will take time to realize the complete penetration of NGS.

With fast-growing cancer incidence, accelerating healthcare expenditure, and heightened interest in personalized medicine, the Asia-Pacific region accounts for the highest growth within Clinical Oncology NGS. Countries like China, Japan, and India also invest heavily in the nation's healthcare infrastructure and related research, paving the path for NGS technology in the region. A prevalence of cancer cases combined with government initiatives for enhanced delivery of cancer care will trigger demand for NGS tests. But even still, a high price, low awareness, or different regulatory climate may block market growth.

Markets in Latin America and the Middle East & Africa are relatively emerging ones compared to North America and Europe. In the clinical oncology NGS market, gradually, more adoption is observed in these regions as the awareness about the personalized medicine increases. There are various challenges associated with limited accessibility of the latest technologies in health care, costlier NGS technology, and unorganized reimbursement policies, among others. The health care systems are likely to continue to evolve and improve thereby driving increased demand for NGS testing in the diagnostics and treatment of cancers, hence offering room for expansion in the future.

These are dynamic regional activities characterizing the market for Clinical Oncology NGS, such as North America leading by the good infrastructure and research capabilities followed by the Asia-Pacific regions, which are supposed to grow rapidly with soaring rates of cancer and growth in healthcare investments.

List of Companies Profiled

• Illumina, Inc.
• Thermo Fisher Scientific
• Hoffmann-La Roche Ltd.
• Agilent Technologies
• Myriad Genetics
• Beijing Genomics Institute (BGI)
• Perkin Elmer
• Foundation Medicine
• Pacific Bioscience
• Oxford Nanopore Technologies Ltd.
• Paradigm Diagnostics
• Caris Life Sciences
• Partek, Inc.
• Eurofins Scientific S.E.
• Qiagen N.V.

Key Industry Developments

• Berry Oncology unveiled its state-of-the-art liquid biopsy technology, known as the HIFI System, in May 2022. This method might potentially help with early cancer identification and timely patient care.
• Tivdak, Seagen Inc. (now a part of Pfizer Inc.) received FDA approval in April 2024 for tisotumab vedotin-tftv for recurrent or metastatic cervical cancer whose disease progresses during or following chemotherapy. For this indication, tisotumab vedotin-tftv was previously given accelerated approval.

Report Coverage

The report will cover the qualitative and quantitative data on the Global Clinical Oncology Next Generation Sequencing (NGS) Market. The qualitative data includes latest trends, market players analysis, market drivers, market opportunity, and many others. Also, the report quantitative data includes market size for every region, country, and segments according to your requirements. We can also provide customize report in every industry vertical.

Report Scope and Segmentations

Regional Analysis

North America accounted for the highest xx% market share in terms of revenue in the Clinical Oncology Next Generation Sequencing market and is expected to expand at a CAGR of xx% during the forecast period. This growth can be attributed to the growing adoption of Clinical Oncology Next Generation Sequencing. The market in APAC is expected to witness significant growth and is expected to register a CAGR of xx% over upcoming years, because of the presence of key Clinical Oncology Next Generation Sequencing companies in economies such as Japan and China.

The objective of the report is to present comprehensive analysis of Global Clinical Oncology Next Generation Sequencing Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language.

Clinical Oncology Next Generation Sequencing Market Report is also available for below Regions and Country Please Ask for that

North America

• U.S
• Canada

Europe

• Switzerland
• Belgium
• Germany
• France
• U.K
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Rest of Europe

Asia-Pacific

• India
• Australia
• Philippines
• Singapore
• South Korea
• Japan
• China
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Argentina
• Peru
• Colombia
• Brazil
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Points Covered in the Report

• The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.
• The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 5 years data history and forecast.
• The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.
• Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.
• The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Questions

• How much the global Clinical Oncology Next Generation Sequencing Market valued?
• Which region has the largest share in 2024 for the global Clinical Oncology Next Generation Sequencing Market?
• What are the driving factors for the market?
• Which is the leading segment in the global market?
• What are the major players in the market?

Research Scope of the Market

• Historic year: 2019-2022
• Base year: 2023
• Forecast: 2024 to 2032
• Representation of Market revenue in USD Million

Clinical Oncology Next Generation Sequencing Market Trends: Market key trends which include Increased Competition and Continuous Innovations Trends: