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Market Overview

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The lung cancer genomic testing market is expected to experience significant growth in the coming years. Valued at $1,262 million in 2020, it is projected to reach $3,280 million by 2031, with a compound annual growth rate (CAGR) of 8.97% during the forecast period from 2021 to 2031. This growth will be driven by factors such as increased awareness and adoption of lung cancer genomic testing, the introduction of novel testing methods, and expanded research in the field of lung cancer, particularly in pharmacogenomics and companion diagnostics.

Lung cancer genomic testing plays a crucial role in lung cancer research, clinical studies, and the molecular analysis of genetic mutations in patients. It enables clinical oncologists to make informed decisions about treatment. With advancements in precision medicine, the lung cancer genomic testing market is poised for substantial growth, revolutionizing the diagnosis and treatment of lung cancer.

While the global lung cancer genomic testing market is still in its early stages, numerous companies are investing heavily in research and development to advance this field. This investment is expected to drive the adoption of lung cancer genomic tests further.

The shift towards precision diagnostic and precision medicine in healthcare systems will also contribute to the uptake of lung cancer genomic testing. By facilitating informed treatment decisions, these tests can improve healthcare outcomes. Global recommendations by international oncology societies endorsing genomic testing for lung cancer diagnosis create significant opportunities in the market.

Major in-vitro diagnostics (IVD) product providers have a considerable influence on the market, particularly in regions like North America and Europe. For example, Qiagen offers the therascreen Solid Tumor assays, a real-time polymerase chain reaction (PCR) test for detecting EGFR mutations in non-small cell lung cancer (NSCLC) patients. Roche provides the Cobas EGFR Mutation Test, another PCR-based test, and Foundation Medicine Inc. offers the FoundationOne CDx, an NGS-based assay for NSCLC.

Furthermore, laboratory-developed tests (LDTs) offered by companies like Quest Diagnostics and Laboratory Corporation of America (Labcorp) have a significant impact on the market. These LDTs target various lung cancer genes, such as EGFR, MET, ALK, and ROS, using techniques like Fluorescence in situ Hybridization (FISH) and NGS.

In terms of end users, diagnostic laboratories, hospitals, and clinics are the dominant contributors to the global lung cancer genomic testing market. However, the COVID-19 pandemic had a negative impact on the market due to lockdown measures and the suspension of elective procedures, which included lung cancer genomic testing. The latest Research analysis indicates a 3.24% drop in the annual growth rate of the global lung cancer genomic testing market as a result.

There are several factors driving the demand for lung cancer genomics, including the high mortality rate associated with lung cancer, advancements in next-generation technologies for genomic testing, the increasing number of targeted therapies, and the decreasing cost of genetic testing worldwide. However, challenges exist, such as the uncertain regulatory landscape for genomic testing, the lack of viable tissue biopsy samples, and the uneven reimbursement scenario for genomic testing.

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Market Segmentation

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The market is segmented based on various factors, including product type, technology, sample type, panel type, end user, and region.

Segmentation by Product Type
Products
Services

Segmentation by Technology
Polymerase Chain Reaction (PCR)
Next-Generation Sequencing (NGS)
Fluorescence In Situ Hybridization
Others

Segmentation by Sample Type
Tissue Biopsy
Liquid Biopsy

Segmentation by Panel Type
Multi-Gene Panel
Single-Gene Panel

Segmentation by End User
Research Organization
Hospitals/Clinics
Diagnostic Laboratories
Other End Users

Segmentation by Region
North America – U.S. and Canada
Latin America – Brazil, Mexico, and Rest-of-Latin America
Europe – U.K., Germany, Italy, Spain, France, and Rest-of-Europe
Asia-Pacific – Japan, China, South Korea, Singapore, Australia, India, and Rest-of-Asia-Pacific
Rest-of-the-World

The dominance of the global lung cancer genomic testing market services segment is expected due to the easy availability, accessibility, and adaptation of LDTs, which are more cost-effective compared to IVD products. In terms of overall market share, the service type accounted for the largest share (60.01%) in the global lung cancer genomic testing market in 2020. This trend is projected to continue during the forecast period from 2021 to 2031, with the segment expected to hold a share of 64.45% in 2031. The use of laboratory-developed tests (LDTs) accredited with Clinical Laboratory Improvement Amendments (CLIA) or equivalent national certifications in hospitals, clinics, and lung cancer genomic testing service provider companies plays a significant role in this trend. The favorable reimbursement policies also drive the adoption of cost-effective LDTs.

In terms of polymerase chain reaction (PCR), the global lung cancer genomic testing market is expected to be dominated by this technology due to its overall cost efficiency and high sensitivity in detecting disease-causing mutations in lung cancer. PCR contributed the largest market share (48.27%) in the global lung cancer genomic testing market in 2020. This trend is expected to continue during the forecast period, with the PCR segment holding a share of 46.44% in 2031. The low cost and high sensitivity of PCR technology in detecting genetic mutations in lung cancer, as well as its ability to process both solid and liquid biopsy samples, contribute to its dominance. The next-generation sequencing (NGS) segment is expected to experience the highest growth rate (10.19%) due to decreasing sequencing costs, advancements in genetic sequencing, and increasing recommendations for targeted lung cancer diagnosis using NGS technology by international oncology societies.

The tissue biopsy sample type is expected to dominate the global lung cancer genomic testing market due to the standard healthcare practice of extracting a lung tissue biopsy for diagnosis and subsequent genomic testing. Tissue biopsy contributed the largest market share (73.58%) in 2020, and this trend is expected to continue, with the segment holding a higher share of 69.22% in 2031. Liquid biopsy, on the other hand, will witness the highest growth rate (10.48%) due to increased awareness and adoption of non-invasive tests and reduced need for re-biopsy.

Multi-gene panel type is expected to dominate the global lung cancer genomic testing market due to its preference among healthcare professionals for analyzing multiple genes responsible for lung cancer-causing mutations. It accounted for the largest market share (65.16%) in 2020 and is projected to hold a high market share of 67% by 2031, growing at a rate of 9.24%. The preference for multi-gene panels in clinical research and academic research, as well as the identification of multiple genes by oncology healthcare providers, contribute to the dominance of this panel type.

In terms of end users, research organizations are expected to dominate the global lung cancer genomic testing market due to their involvement in drug development, companion diagnostics, and clinical trials. Research organizations accounted for the highest market share (41.09%), followed by hospitals and clinics (29.09%) in 2020. Commercial laboratories such as hospitals, clinics, and diagnostic laboratories also contribute to the market.

North America is expected to dominate the global lung cancer genomic testing market, generating the highest revenue of $714 million. This is attributed to the presence of numerous research organizations, products, and services companies in the United States.

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Competitive Landscape

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The selection of profiled companies has been based on inputs collected from primary experts, as well as an analysis of their company coverage, product portfolio, key developments, and market penetration.

Key companies profiled in this report include QIAGEN N.V., Agilent Technologies, Inc., Thermo Fisher Scientific, Inc., Quest Diagnostics Incorporated, Laboratory Corporation of America Holdings, CENTOGENE N.V., BGI, CeGaT GmbH, Illumina, Inc., F. Hoffmann-La Roche Ltd., Abbott Laboratories, CD Genomics, NeoGenomics Laboratories, Admera Health, OncoDNA, OPKO Health, Inc., Invitae Corporation, Veracyte, Inc.

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Recent Industry Developments

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In December 2021, the U.S. Food and Drug Administration (FDA) granted approval to Thermo Fisher Scientific’s Next-Generation Sequencing (NGS)-based companion diagnostic, Oncomine Dx Target Test, for EGFR Exon20 insertion mutant non-small cell lung cancer tumor tissue. This test has now received global approval for use with 12 targeted therapies for non-small cell lung cancer.

In September 2021, the FDA also approved Thermo Fisher Scientific’s tissue-based NGS companion diagnostic, Oncomine Dx Target Test, as a companion diagnostic (CDx) for Takeda’s targeted therapy for non-small cell lung cancer patients with EGFR Exon20 insertion mutations. This CDx has been approved for use with five targeted therapies in the United States.

Another significant development occurred in September 2020 when Laboratory Corporation of America Holdings formed a commercial partnership with Resolution Bioscience. As part of this partnership, Resolution ctDx lung liquid biopsy test was introduced.

Additionally, in May 2021, Qiagen launched the first FDA-approved tissue companion diagnostic designed to detect the KRAS G12C mutation in non-small cell lung cancer tumors. This diagnostic expanded the range of precision medicine options available for treating lung cancer.

Furthermore, in January 2020, Qiagen initiated a global collaboration with Amgen to develop companion diagnostics specifically for non-small cell lung cancer.

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Key Questions Answered

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How does lung cancer genomic testing impact the management of lung cancer disease?

What are the main drivers, challenges, and opportunities in the global market for lung cancer genomic testing?

What underlying factors contribute to the emerging trends in the global market for lung cancer genomic testing?

How has the COVID-19 pandemic affected the global market for lung cancer genomic testing?

What key strategies are major players implementing to maintain their competitiveness in the market?

What regulatory and reimbursement considerations are important in developed and developing regions regarding the use of lung cancer genomic testing?

What potential barriers may be faced by companies seeking to enter specific regions in the lung cancer genomic testing industry?

How is each market segment expected to grow during the forecast period of 2021-2031?

What revenue is anticipated to be generated by each segment?

What growth opportunities exist for companies offering lung cancer genomic testing within their respective regions of operation?

Who are the leading players with significant offerings in the global market for lung cancer genomic testing?

Which companies are expected to have a high level of disruption in the future, and what are the reasons for this anticipation?