The oncology molecular diagnostics market is expected to register a CAGR of more than 12 % during the forecast period.
The COVID-19 pandemic has significantly impacted the oncology molecular diagnostics market. As per the Association for Molecular Pathology (AMP), 2021 survey of 163 laboratories worldwide, 85% of the respondents reported that molecular testing for cancer decreased during April-June 2020. In addition, more than half of the respondents revealed that oncology testing for clinical trials decreased due to lower enrollment, reluctance to travel, and the ability to perform testing. The survey results also indicate that the pandemic will continue to have long-term effects on molecular diagnostic testing for cancer. In addition, laboratories and universities engaged in the research and development of cancer have also witnessed a halt in activities across the globe. Moreover, the government funding from various organizations for the research is also on hold in several regions of the world.
The studied market growth can be largely attributed to the factors such as the rising prevalence of cancer worldwide, technological advancements in diagnostic testing, and increasing demand for point-of-care testing. These factors are leading to increasing demand for oncology molecular diagnostics.
The rising prevalence of cancer cases across the globe is contributing to the increasing demand for diagnosis which is boosting the oncology molecular diagnostics market. According to the World Health Organization (WHO), cancer accounted for approximately 10 million deaths in 2020. In addition, as per the 2021 statistics by the American Cancer Society, by 2040, the global burden of cancer is expected to grow to 27.5 million new cases and 16.3 million cancer deaths. Such high numbers indicate that the estimated rising prevalence of cancer is contributing to the increasing need for early diagnosis and preventive medicine. Thus, in view of the aforementioned factors, the demand for oncology molecular diagnostic tests is consistently increasing.
Also, due to the increasing technological advancements in diagnostic testing, there is a growing usage of molecular diagnostics tests for oncology. Several advancements are being made in cancer genome sequencing, computational analysis, tumor models, and innovative cancer research methods. For instance, Roche Molecular Systems, Inc. developed Cobas EGFR Mutation Test for non-small cell lung cancer patients and received approval from the United States Food and Drug Administration (USFDA) in 2020 and is a real-time PCR test to detect 42 mutations of the epidermal growth factor receptor (EGFR) gene. In addition, in March 2021, Cancer Research UK and Capital Enterprises, and Roche UK have together launched the Cancer Tech Accelerator program. The new initiative will aid researchers to translate their ideas and lifesaving innovations. Thus, in view of the aforementioned factors, the market is anticipated to witness a significant growth over the forecast period.
However, high cost of molecular diagnostic tests, lack of skilled workforce and stringent regulatory framework are some of the factors impeding the market growth.
Key Market Trends
Polymerase Chain Reaction (PCR) is Anticipated to Observe a Significant Growth
Based on technology, polymerase chain reaction (PCR) is anticipated to witness significant growth. Presently, the polymerase chain reaction (PCR) is the most preferred technology for studying cancer. The major factors contributing to the increasing demand for PCR in oncology molecular diagnostics are greater sensitivity, quantification, ease, precision, and reproducibility, better process quality, fast analysis, and lower risk of contamination. It is a sensitive and rapid technique and is ideal for the detection of lymphoid malignancies. Several manufacturers are engaged in developing PCR-based diagnostic instruments and reagents for the detection of cancer. For instance, in June 2021, the AmoyDx Pan Lung Cancer PCR Panel was launched by Amoy Diagnostics Co., Ltd., Riken Genesis Co., Ltd., and Precision Medicine Asia Co., Ltd. It is approved by the Ministry of Health, Labour and Welfare (MHLW) for marketing and production in Japan. Thus, in view of the aforementioned factors, the market is anticipated to grow significantly over the forecast period.
North America is Anticipated to Observe a Significant Growth in Oncology Molecular Diagnostics Market
Within North America, the United States has held major share of the market. The major factors contributing to the market growth are the presence of many market players engaged in manufacturing and expanding the portfolio of instruments and reagents for molecular diagnostic testing. The region also witnesses the presence of well-established healthcare diagnostic facilities. As per a 2020 report by the American Cancer Society, several professional associations, including the National Comprehensive Cancer Network (NCCN), the American Association of Clinical Oncology (ASCO), and the College of American Pathologists (CAP) have developed biomarker testing and treatment guidelines. Additionally, the increasing prevalence of cancer in the country is contributing to the oncology molecular diagnostics market in the region. As per the 2020 Statistics by the National Cancer Institute (NCI), about 1,806,590 cases of cancer were diagnosed in the United States in 2020 and the number of cancer survivors is projected to reach 2.2 million by 2030. Moreover, as per the NCI, in 2021, the most prevalent cancer type is breast cancer with 284,200 cases. These factors are leading to an increased demand for oncology molecular testing in the region. Thus, in view of the aforementioned factors, the market will witness a significant growth in the region over the forecast period.
The oncology molecular diagnostics market is highly fragmented with presence of several global and international market players. The key players are adopting different growth strategies to enhance their market presence such as partnerships, agreements, collaborations, new product launches, geographical expansions, mergers, and acquisitions. Some of the key players in the market are Danaher Corporation (Cepheid), Veracyte, Inc, Abbott Laboratories, F-Hoffmann La-Roche Ltd and Thermo Fisher Scientific Inc.
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Table of Contents
1.2 Scope of the Study
4.2 Market Drivers
4.2.1 Rising Prevalence of Cancer Worldwide
4.2.2 Technological Advancements in Diagnostic Testing
4.2.3 Increasing Demand for Point-Of-Care Treatment
4.3 Market Restraints
4.3.1 High Cost of Molecular Diagnostic Tests
4.3.2 Lack of Skilled Workforce and Stringent Regulatory Framework
4.4 Porter’s Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5.1.3 Other Product types
5.2 Technology Type
5.2.1 Polymerase Chain Reaction (PCR)
5.2.2 Isothermal Nucleic Acid Amplification Technology (INAAT)
5.2.3 DNA Sequencing and Next-Generation Sequencing
5.2.4 In-situ Hybridization
5.2.5 Mass Spectrometry
5.2.6 Transcription Mediated Amplification (TMA)
5.2.7 Chips and Microarrays
5.2.8 Other Technology Types
5.3 Application Type
5.3.1 Breast Cancer
5.3.2 Prostate Cancer
5.3.3 Colorectal Cancer
5.3.4 Lung Cancer
5.3.5 Blood Cancer
5.3.6 Liver Cancer
5.3.7 Cervical Cancer
5.3.8 Other Application Types
5.4.2 Diagnostic Centers
5.4.3 Other End-users
5.5.1 North America
220.127.116.11 United States
18.104.22.168 United Kingdom
22.214.171.124 Rest of Europe
126.96.36.199 South Korea
188.8.131.52 Rest of Asia-Pacific
5.5.4 Middle East and Africa
184.108.40.206 South Africa
220.127.116.11 Rest of Middle East and Africa
5.5.5 South America
18.104.22.168 Rest of South America
6.1.1 Abbott Laboratories
6.1.2 F-Hoffmann La-Roche Ltd
6.1.3 Bayer AG
6.1.4 Becton, Dickinson and Company
6.1.5 Danaher Corporation (Cepheid)
6.1.7 Siemens Healthineers
6.1.8 Sysmex Corporation (Sysmex Europe GmbH)
6.1.9 Illumina, Inc.
6.1.10 Thermo Fisher Scientific Inc.
6.1.11 bioMérieux SA
6.1.12 Veracyte, Inc
6.1.13 Agilient Technologies, Inc. (Dako)
6.1.14 TBG Diagnostics Limited
6.1.15 HTG Molecular Diagnostics, Inc.
A selection of companies mentioned in this report includes:
- Abbott Laboratories
- F-Hoffmann La-Roche Ltd
- Bayer AG
- Becton, Dickinson and Company
- Danaher Corporation (Cepheid)
- Siemens Healthineers
- Sysmex Corporation (Sysmex Europe GmbH)
- Illumina, Inc.
- Thermo Fisher Scientific Inc.
- bioMérieux SA
- Veracyte, Inc
- Agilient Technologies, Inc. (Dako)
- TBG Diagnostics Limited
- HTG Molecular Diagnostics, Inc.