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North America Hereditary Cancer Testing Market – Industry Trends and Forecast to 2029

  • Medical Devices
  • Published Report
  • Nov 2022
  • North America
  • 350 Pages
  • No of Tables: 76
  • No of Figures: 43
  • Medical Devices
  • Published Report
  • Nov 2022
  • North America
  • 350 Pages
  • No of Tables: 76
  • No of Figures: 43

North America Hereditary Cancer Testing  Market, By Test Type (Multi Panel Set, and Single Site Genetic Test), Diagnosis Type (Biopsy, Imaging, Lab Tests), Technology (Sequencing, Polymerase Chain Reaction (PCR), Microarray), Disease Type (Hereditary Breast & Ovarian Cancer Syndrome, Cowden Syndrome, Lynch Syndrome, Hereditary Leukemia And Hematologic Malignancies Syndromes, Familial Adenomatous Polyposis (FAP), Li-Fraumeni Syndrome, Von Hippel-Lindau Disease, Multiple Endocrine Neoplasias (MEN) Syndromes), End User (Hospitals, Clinics, Laboratories, Radiology Centers, Diagnostic Centers, Others), Distribution Channel (Direct Tender, Retail Sales), Trends and Forecast to 2029.

North America Hereditary Cancer Testing Market Analysis and Insights

Cancer is a genetic disease caused by certain mutations in the genes that control the function of cells, particularly affecting their growth and reproduction. Inherited genetic mutations are responsible for approximately 5-10% of all cancers. Researchers have linked mutations in specific genes to more than 50 hereditary cancer syndromes that affect people through the development of certain cancers. In addition, about 5-10% of breast cancer cases are associated with genetic mutations inherited from parents. Thus, the increasing prevalence of cancer is driving the steady growth of hereditary cancers and thus, driving the growth of the hereditary cancer testing market. In addition, increased demand for non-invasive testing methods and growing demand for better quality healthcare and early diagnosis are the major opportunities for the market growth. Moreover, Ethical challenges faced during hereditary cancer testing and rising competition among market players are the key challenges for the market growth.

However, stringent cancer diagnostic regulations and the high cost associated with tests may hamper the growth of the market.

Data Bridge Market Research analyzes that the North America hereditary cancer testing market is expected to reach the value of USD 5,596.19 million by 2029, at a CAGR of 13.3% during the forecast period. This market report also covers pricing analysis, patent analysis, and technological advancements in depth.

Report Metric

Details

Forecast Period

2022 to 2029

Base Year

2021

Historic Years

2020 (Customizable to 2019 - 2015)

Quantitative Units

Revenue in USD Million, Volumes in Units, Pricing in USD

Segments Covered

By Test Type (Multi Panel Set, and Single Site Genetic Test), Diagnosis Type (Biopsy, Imaging, Lab Tests), Technology (Sequencing, Polymerase Chain Reaction (PCR), Microarray), Disease Type (Hereditary Breast & Ovarian Cancer Syndrome, Cowden Syndrome, Lynch Syndrome, Hereditary Leukemia And Hematologic Malignancies Syndromes, Familial Adenomatous Polyposis (FAP), Li-Fraumeni Syndrome, Von Hippel-Lindau Disease, Multiple Endocrine Neoplasias (MEN) Syndromes), End User (Hospitals, Clinics, Laboratories, Radiology Centers, Diagnostic Centers, Others), Distribution Channel (Direct Tender, Retail Sales).

Countries Covered

U.S., Canada, Mexico

Market Players Covered

Invitae Corporation, Illumina, Inc., Natera, Inc., CENTOGENE N.V., 4baseCare, Biocartis, Fulgent Genetics, Ambry Genetics, BioReference, PerkinElmer Inc., LifeLabs, Abbott, BIO-HELIX, Cepheid, Eurofins Scientific, among others.

North America Hereditary Cancer Testing Market Definition

Hereditary cancer is any cancer caused by an inherited genetic mutation. Harmful variants in certain genes are associated with an increased risk of cancer. Genetic testing can estimate a person's lifetime risk of developing cancer. This can be done by looking for mutations in their genes, chromosomes, or proteins. Genetic testing is available for several types of cancer. These include breast, ovarian, colon, thyroid, prostate, pancreatic, skin cancer, sarcoma, and kidney and stomach cancer. Numerous medical studies show that 5% to 10% of common cancers are considered hereditary. Genetic tests are performed to determine whether a person carries a harmful genetic variant. These tests also help determine if a family member who has not yet had cancer has inherited the same variant as a family member known to have a cancer susceptibility alternative.

North America Hereditary Cancer Testing Market Dynamics

This section deals with understanding the market drivers, advantages, opportunities, restraints, and challenges. All of this is discussed in detail below:    

Drivers

  • Rising Incidence of Hereditary Cancer

Cancer arises from the uncontrolled growth of cells. Cancer is caused by harmful changes (mutations) in genetic messages (genes) that control the growth and division of cells, preventing them from doing their job effectively.

In hereditary cancer cases, the individual inherits a copy of the mutated growth regulatory gene from one parent and a working copy of the same gene from the other parent. The mutated gene is also called a "cancer susceptibility gene." As this cancer-susceptibility gene is inherited, it is found in every cell in the body, but a working copy of the gene keeps each cell functioning properly. However, if a mutation damages a functional copy of a gene in a cell, the cell can lose control of its growth and become cancerous. Thus, individuals who inherit a cancer gene are much more likely to develop certain cancers during their lifetime.

Thus, rising incidences of hereditary cancer increase the demand for hereditary cancer testing and may act as a driver for the growth of the North America hereditary cancer testing market.

  •  Increase In The Geriatric Population

Cancer can be a disease of aging patients. Across the globe, the geriatric population is increasing. The risk of hereditary cancer among geriatrics is much more. The rising geriatric population can result in better provision of the North America hereditary cancer testing market. It anticipated an upsurge in demand in the North America hereditary cancer testing market. An aging population is causing a redistribution of the demographic structure that will affect the future of health care. Undoubtedly, the risk of cancer increases exponentially with age.

Hereditary cancer, including its incidence and associated risk, using the world's largest complete family structure and medically confirmed cancer database, was approximately twice as high in the population aged 8-20 years born to affected parents or siblings of people who have no relatives. The risk of small bowel, testicular, thyroid, and bone cancers was five to eight times greater.

Thus, the increase in cancer incidences among the geriatric population is expected to be a driving factor for the growth of the North America hereditary cancer testing market.

Restraint

  • High Cost of Hereditary Cancer Testing

Hereditary cancer testing employs highly technologically advanced products. The development of these products involves rigorous research and development by the developing player. Thus, the procedures and product cost remains high, which proportionally increases the cost of testing. Testing kits are expensive because they are incredibly resource-intensive and involve high-paid doctors, transportation, and expensive medications.

In addition, testing procedures have also been used in cancer testing. However, such procedures are very expensive and may be associated with complications and worse long-term outcomes.

Thus, the high cost of cancer testing using advanced modalities and technology products may be a major restraining factor for the growth of the North America hereditary cancer testing market.

Opportunity

  • Strategic Initiatives By Market Players

The rise in the North America hereditary cancer testing market increases the need for strategic business ideas. It includes a partnership, business expansion, and other development. The surge in demand for hereditary cancer treatment is significantly increasing the demand for diagnostic testing methods. The planned strategies allow the market players to align with the organization's functional activities to achieve set goals. It guides the company's discussions and decision-making in determining resource and budget requirements to accomplish objectives, thus increasing operational efficiency.

These strategic initiatives, such as product launches, agreements, and business expansion by the major market players, will boost the market growth and are expected to act as an opportunity for the North America hereditary cancer testing market. The strategic initiatives are expected to aid in growth and improve the company's product portfolio, ultimately leading to more revenue generation. Hence, these strategic initiatives by the market players are expected to act as an opportunity for growth in the North America hereditary cancer testing market.

Challenge

  • Ethical Challenges Faced During Hereditary Cancer Testing

During hereditary cancer genetic testing, one of the significant ethical hindrances is health professionals' lack of basic knowledge about genetic testing and their lack of confidence in interpreting familial disease patterns. The challenge for healthcare providers is to provide sufficient information to support patient decision making-and evidence to support the reasoning behind any suggestions they might make.

The lack of reimbursement creates economic barriers to care. The process of hereditary cancer risk assessment and counseling is time-consuming, and it is unclear how best to document and bill for this service. Oncologists are often forced to navigate a potentially uncertain reimbursement environment for genetic testing, with various reimbursement policies among third-party payers.

Genetic testing for hereditary cancer elevates ethical matters, which can't be resolved with patients or their family members. The various aspects of ethical, cultural, and religious nature should not be a barrier to the act of hereditary cancer testing. All of these are issues to be solved. Therefore, ethical challenges during hereditary cancer testing are expected to challenge the market growth.

Post-COVID-19 Impact on North America Hereditary Cancer Testing Market

Many industries around the world have been disadvantaged over the past 18 months. This could be due to the major disruptions that their industrial and supply chain processes are experiencing due to various precautionary measures such as shutdowns and other restrictions that the facilities around the world have been following. The same places the North America hereditary cancer testing market. Also, consumption demand has subsequently decreased as people now have more opportunities to exclude non-essential expenses from their budgets as most people's overall finances have been severely affected by the boom. These aforementioned factors can be expected to burden the revenue margin of the North America hereditary cancer testing market during the forecast period.

Manufacturers are making various strategic decisions to bounce back post-COVID-19. The players are conducting multiple R&D activities and product launch and strategic partnerships to improve the technology and test results involved in the transplant diagnostics market.

Recent Development

  • In July 2022, Helio Genomics and its business partner, Fulgent Genetics (FLGT) has announced that the American Medical Association (AMA)  issued a new Category I Current Procedural Terminology (CPT) Proprietary Laboratory Analyses code for HelioLiver and broader adoption of advanced innovative surveillance tests for liver cancer in the U.S. This has helped the company to expand their product portfolio.

North America Hereditary Cancer Testing Market Scope

North America hereditary cancer testing market is segmented into test type, diagnosis type, technology, disease type, end user, and distribution channel. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

BY TEST TYPE

  • MULTI PANEL TEST
  • SINGLE SITE GENETIC TEST

On the basis of test type, the North America hereditary cancer testing market is segmented into multi panel test and single site genetic test.

BY DIAGNOSIS TYPE

  • BIOPSY
  • IMAGING
  • LAB TESTS

On the basis of diagnosis type, the North America hereditary cancer testing market is segmented into biopsy, imaging, and lab tests.

BY TECHNOLOGY

  • SEQUENCING
  • POLYMERASE CHAIN REACTION (PCR)
  • MICROARRAY

On the basis of technology, the North America hereditary cancer testing market is segmented into sequencing, polymerase chain reaction (PCR), and microarray.

BY DISEASE TYPE

  • HEREDITARY BREAST & OVARIAN CANCER SYNDROME
  • COWDEN SYNDROME
  • LYNCH SYNDROME
  • HEREDITARY LEUKEMIA AND HEMATOLOGIC MALIGNANCIES SYNDROMES
  • FAMILIAL ADENOMATOUS POLYPOSIS (FAP)
  • LI-FRAUMENI SYNDROME
  • VON HIPPEL-LINDAU DISEASE
  • MULTIPLE ENDOCRINE NEOPLASIAS (MEN) SYNDROMES

On the basis of disease type, the North America hereditary cancer testing market is segmented into hereditary breast & ovarian cancer syndrome, cowden syndrome, lynch syndrome, hereditary leukemia and hematologic malignancies syndromes, familial adenomatous polyposis (FAP), li-fraumeni syndrome, vol-hippel lindau disease, multiple endocrine neoplasias (MEN) syndrome.

BY END USER

On the basis of end user, the North America hereditary cancer testing market is segmented into hospitals, clinics, laboratories, radiology centers, diagnostic centers, and others.

BY DISTRIBUTION CHANNEL

  • DIRECT TENDER
  • RETAIL SALES

On the basis of distribution channel, the North America hereditary cancer testing market is segmented into direct tender, retail sales.

North America Hereditary Cancer Testing Market Regional Analysis/Insights

The North America hereditary cancer testing market is analyzed and market size information is provided test type, diagnosis type, technology, disease type, end user, and distribution channel.

The countries covered in this market report U.S., Canada and Mexico.

  • In 2022, U.S. is dominating due to the presence of key market players in the largest consumer market with high GDP and due to its latest advanced technology and inventions for the diagnosis of cancer.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impact the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts, and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of North America brands and their challenges faced due to large or scarce competition from local and domestic brands, and impact of sales channels are considered while providing forecast analysis of the country data.

Competitive Landscape and North America Hereditary Cancer Testing Market Share Analysis

North America hereditary cancer testing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in R&D, new market initiatives, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, product approvals, patents, product width and breath, application dominance, technology lifeline curve. The above data points provided are only related to the company’s focus on the North America hereditary cancer testing market.

Some of the major players operating in the North America hereditary cancer testing market are Invitae Corporation, Illumina, Inc., Natera, Inc., CENTOGENE N.V., 4baseCare, Biocartis, Fulgent Genetics, Ambry Genetics, BioReference, PerkinElmer Inc., LifeLabs, Abbott, BIO-HELIX, Cepheid, Eurofins Scientific, among others.

Research Methodology: North America Hereditary Cancer Testing Market

Data collection and base year analysis are done using data collection modules with large sample sizes. The market data is analyzed and estimated using market statistical and coherent models. In addition, market share analysis and key trend analysis are the major success factors in the market report. The key research methodology used by DBMR research team is data triangulation which involves data mining, analysis of the impact of data variables on the market, and primary (industry expert) validation. Apart from this, data models include Vendor Positioning Grid, Market Time Line Analysis, Market Overview and Guide, Company Positioning Grid, Company Market Share Analysis, Standards of Measurement, North America vs Regional, and Vendor Share Analysis. Please request analyst call in case of further inquiry.


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Frequently Asked Questions

The North America Hereditary Cancer Testing Market is projected to grow at a CAGR of 13.3% during the forecast period by 2029.
The future market value of the North America Hereditary Cancer Testing Market is expected to reach USD 5,596.19 million by 2029.
The major players in the North America Hereditary Cancer Testing Market are Invitae Corporation, Illumina, Inc., Natera, Inc., CENTOGENE N.V., 4baseCare, Biocartis, Fulgent Genetics, Ambry Genetics, BioReference, PerkinElmer Inc., LifeLabs, Abbott, BIO-HELIX, Cepheid, Eurofins Scientific, among others.
The countries covered in the North America Hereditary Cancer Testing Market are the U.S., Canada, and Mexico.