Global and Regional Molecular Oncology Diagnostics Market Report 2022: Analysis and Forecasts, 2021-2032 - Launch of Innovative Products in Molecular Oncology Diagnostics Ecosystem - ResearchAndMarkets.com

The "Molecular Oncology Diagnostics Market - A Global and Regional Analysis: Focus on Product, Technology, Application, Cancer Type, End User, and Region - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering.

The global molecular oncology diagnostics market was valued at $3,620.6 million in 2021 and is anticipated to reach $12,130.5 million by 2032, witnessing a CAGR of 11.43% during the forecast period 2022-2032.

The industry is witnessing constant development and product launches with new and innovative upgrades. Additionally, emerging technologies like microarray are also expected to be integrated more into molecular oncology diagnostics soon, which is expected to further boost market growth.

The growth in the global molecular oncology diagnostics market is expected to be driven by the rising prevalence of cancers and increased transformations in biomarker identification.

The market for appropriate testing assay kits is expanding rapidly, owing to the increased importance of early diagnosis to minimize further hazards, especially with rates on the rise.

The rising global cancer incidence and the growing demand for early detection are expected to drive the growth of the global molecular oncology diagnostics market during the forecast period. This expanded usage of kit and assay, instrument, and software has enabled end customers to describe particular system requirements, prompting suppliers to design more appealing and practical products and molecular diagnostics choices.

Impact

The presence of major kit and assay providers of molecular oncology diagnostics has a major impact on the market. For instance, in March 2021, Biocartis NV launched Idylla GeneFusion Assay as a Rapid Lab Workflow Solution for gene fusion testing. This product provides a much faster testing solution for laboratories in comparison to other testing methods, including NGS.

Companies such as Bio-Rad Laboratories, Inc., in August 2022, acquired Curiosity Diagnostics. The company acquired all the outstanding shares of the latter from Scope Fluidics, S.A. for its growth in the medical diagnostic and healthcare markets, for a total consideration of up to $170 million.

Similarly, in February 2022, Becton and Dickinson Company (BD) acquired Cytogons to gain exclusive access to advanced assays licensed from the EuroFlow Consortium and strengthen BD's leadership position in the molecular oncology diagnostics segment.

Market Segmentation

Based on products, the global molecular oncology diagnostics market is expected to be dominated by kit and assay. This is due to the high number of applications performed by kits and their ease of integration with other systems.

Based on technology, the global molecular oncology diagnostics market is dominated by polymerase chain reaction (PCR). However, next-generation sequencing (NGS) is expected to be the fastest-growing segment in the market. This is because PCR techniques play an important role in targeted NGS sequencing because they allow for the simultaneous production of several NGS libraries and the sequencing of numerous targeted regions.

Based on applications, the global molecular oncology diagnostics market is expected to be dominated by the clinical diagnostic segment. This is due to the high usage of technologies such as companion diagnostics and liquid biopsy emerge.

Based on cancer type, the global molecular oncology diagnostics market is dominated by solid tumor cancer type, where breast cancer is expected to be the leading segment. The growth of advanced solid tumor testing has mostly focused on the treatment of distinct cancer kinds, indications, and indication subtypes. The hematological malignancy segment is expected to show a fast growth rate during the forecast period.

Based on end users, global molecular oncology diagnostics was dominated by the hospitals and diagnostic centers segment. The growth of this segment is primarily attributed to the high use of molecular diagnostic tests by hospitals in these fields.

North America dominated the global market with a revenue of $1,588.6 in 2021. However, the Asia-Pacific region, constituting several emerging economies, is expected to register the highest CAGR of 12.60% during the forecast period 2022-2032.

Recent Developments in the Global Molecular Oncology Diagnostics Market

• In August 2022, Guardant Health expanded its Guardant Reveal usage, a liquid biopsy test for residual disease detection and recurrence monitoring, to include early-stage breast and lung cancers. It is the only tissue-free test used for colorectal cancer (CRC) and is now available for patients with breast and lung cancer.
• In December 2021, QIAGEN partnered with Denovo Biopharma to develop a companion diagnostic test for the treatment of diffuse large B-cell lymphoma. This test identified patients expressing Denovo genomic marker 1 (DGM1), which responded to Denovo's investigational cancer drug DB102.
• In September 2021, Illumina partnered with Merck to develop and commercialize research tests for use in identifying specific cancer genetic mutations used in the assessment of homologous recombination deficiency (HRD).
• In August 2021, Agilent Technologies, Inc. expanded its CE-IVD marked PD-L1 IHC 22C3 pharmDx assay usage in Europe. This assay was used as an aid in identifying esophageal cancer patients for treatments with KEYTRUDA using a combined positive score.

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts, analyzing company coverage, product portfolio, and market penetration.

Some of the prominent names in this market are:

• Agilent Technologies, Inc.
• Abbott.
• Biocartis NV
• Bio-Rad Laboratories, Inc.
• F. Hoffmann-La Roche Ltd.
• QIAGEN N.V.
• Thermo Fisher Scientific, Inc.
• Danaher.
• Guardant Health
• HTG Molecular Diagnostics, Inc.
• Illumina, Inc.
• Invivoscribe, Inc.
• Myriad Genetics, Inc.
• Sysmex Corporation

Key Topics Covered:

1 Market

2 Research Methodology

3 Global Molecular Oncology Diagnostics Market: Overview

3.1 Market Overview

3.1.1 Evolution of Molecular Cancer Diagnostics and Current Status

3.2 Global Molecular Oncology Diagnostics Market Size and Forecast (2021-2032)

3.3 Global Incidence and Prevalence of Cancer (by Type)

3.3.1 Solid Tumor

3.3.2 Hematological Malignancy

3.4 Impact of COVID-19 on the Molecular Oncology Diagnostics Market

3.4.1 Impact on Market Size

3.5 Liquid Biopsy-Based Cancer Molecular Diagnostics

3.6 Laboratory Developed Test (LDT) Vs. In Vitro Diagnostic (IVD)

3.7 Role of Companion Diagnostics in the Molecular Oncology Diagnostics Market

4 Global Molecular Oncology Diagnostics Market: Industry Analysis

4.1 Legal Requirements and Framework in the U.S.

4.1.1 FDA Regulation

4.1.2 CMS Regulation (Reimbursement Scenario)

4.2 Legal Requirements and Framework in Europe

4.3 Legal Requirements and Framework in Asia-Pacific

4.3.1 China

4.3.2 Japan

5 Market Dynamics

5.1 Overview

5.1 Impact Analysis

5.2 Growth Drivers

5.2.1 Rising Incidence of Cancer Cases

5.2.2 Launch of Innovative Products in Molecular Oncology Diagnostics Ecosystem

5.2.3 Growth in Biomarker identification and Transformations in Molecular Techniques

5.3 Growth Restraints

5.3.1 Lack of Qualified Professionals

5.3.2 Opaque Regulatory Framework Delaying the Approval of New Molecular Diagnostic Tests

5.3.3 High Cost of Equipment Hindering the Adoption Rate

5.4 Growth Opportunities

5.4.1 Partnerships and Collaborations between Various Healthcare Stakeholders

5.4.2 Upsurge of Next-Generation Ultrasensitive Molecular Diagnostics

6 Competitive Landscape

6.1 Mergers and Acquisitions

6.2 Synergistic Activities

6.3 Product Launch and Approval Activities

6.4 Expansion, Insurance, and Other Key Developments

6.5 Market-Share Analysis

6.6 Growth-Share Analysis

7 Global Molecular Oncology Diagnostics Market (by Product), $Million, 2021-2032

7.1 Overview

7.2 Kits and Assays

7.3 Instruments

7.4 Software

8 Global Molecular Oncology Diagnostics Market (by Technology), $Million, 2021-2032

8.1 Overview

8.2 Polymerase Chain Reaction (PCR)

8.3 Next-Generation Sequencing (NGS)

8.4 Immunohistochemistry (IHC)

8.5 Fluorescence In-Situ Hybridization (FISH)

8.6 Flow Cytometry

8.7 Other Technologies

9 Global Molecular Oncology Diagnostics Market (by Application), $Million, 2021-2032

9.1 Overview

9.2 Clinical Diagnostic

9.3 Research Use

10 Global Molecular Oncology Diagnostics Market (by Cancer Type), $Million, 2021-2032

10.1 Overview

10.1.1 Solid Tumor

10.1.1.1 Breast Cancer

10.1.1.2 Lung Cancer

10.1.1.3 Colorectal Cancer

10.1.1.4 Prostate Cancer

10.1.1.5 Ovarian Cancer

10.1.1.6 Other Solid Tumors

10.1.2 Hematological Malignancy

10.1.2.1 Lymphoma

10.1.2.2 Leukemia

10.1.2.3 Multiple Myeloma

10.1.2.4 Other Hematological Malignancies

11 Global Molecular Oncology Diagnostics Market (by End User), $Million, 2021-2032

11.1 Overview

11.2 Hospitals and Diagnostic Centers

11.3 Reference Laboratories

11.4 Pharmaceutical and Biotechnology Companies

11.5 Academic and Research Institutes

12 Region

12.1 Overview

12.2 North America

12.3 Europe

12.4 Asia-Pacific

12.5 Rest-of-the-World (RoW)

13 Company Profiles

13.1 Company Overview

13.2 Role in the Global Molecular Oncology Diagnostics Market

13.3 Key Competitors of the Company

13.4 Business Strategies

13.4.1 Merger and Acquisition

13.4.2 Product Launch/Approval

13.4.3 Expansion

13.5 Financials

13.6 Analyst Perspective

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