Predictive and Presymptomatic Testing Market - Growth, Trends, and Forecasts (2023-2028)

The predictive and presymptomatic testing market is poised to grow at a CAGR of 8.4% over the forecast period.

The emergence of COVID-19 had its impact on the predictive and presymptomatic testing market as during the initial pandemic days there were strict lockdown restrictions imposed by the governments to curb the spread of COVID-19 which led to a decline in the number of predictive and presymptomatic testing. However, the market is recovering since the lockdown restrictions were lifted around the world and as the cases of COVID-19 are on the decline and the demand for predictive and presymptomatic tests is increasing. Hence, the studied market is expected to grow over the forecast period.

The market for predictive and presymptomatic testing is expected to grow over the forecast period due to factors such as the increasing prevalence of genetic disorders and rising demand for genetic counseling as they can be used to determine whether the patient has a hereditary disease-causing mutation or genetic disorders. Also, the rising awareness regarding genetic diseases among the global population is leading to an increase in demand for genetic counseling, thereby contributing to the growth of the market. For instance, the NHP data published in June 2021 stated that 300 million people are living with a rare disease worldwide and 70% that genetic rare diseases start in childhood. Similarly, according to the article published by Frontiers in 2021, in Japan, the rare hereditary disease prevalence was equivalent to less than 1 in 2,500 people. Also, as per the PHO statistics in 2021, about 10,000 diseases are monogenetic worldwide. Such a high prevalence of rare hereditary diseases and genetic disorders is expected to contribute to the demand for predictive and presymptomatic testing, thereby boosting the market growth.

Furthermore, the launch of new predictive and presymptomatic testing services across the globe, increasing investments, rising research and development activities, and adoption of key strategic initiatives by key market players are expected to contribute to the significant growth of the market. For instance, in September 2021, MedGenomeLabs launched its direct-to-consumer website, Genessense for consumers in India. The company offered two tests, Kardiogen and Curegen, through the Genessense website e-commerce platforms. Kardiogenis a polygenic risk score-based predictive test for coronary artery disease with a proven specificity of 90% for the Indian population. Thus, the above-mentioned factors are expected to drive the growth of the market during the forecast period. However, the high costs of tests and ethical issues in predictive testing are expected to restrain the development of the market.

Predictive & Presymptomatic Testing Market Trends

Breast and Ovarian Cancer is Expected to Witness Highest CAGR Over the Forecast Period

The breast and ovarian cancer segment is expected to dominate the market due to the high prevalence of genetically inherited cancer among the global population and the rising demand for early diagnosis.

The growth of the studied segment is mainly due to the identification of the BRCA1 and BRCA2 genes responsible for hereditary breast/ovarian cancer (HBOC) for the prevention of genetically inherited cancer. As per the NCBI study published in February 2021, early detection has the potential to reduce cancer mortality, but an effective screening test must demonstrate asymptomatic cancer detection years before conventional diagnosis. The study stated that late-stage cancers often lack an effective treatment option. Survival rates increase significantly when cancer is identified at early stages, as the tumor can be surgically removed or treated with milder drug regimens. Thus, such research studies proving the importance of early screening for the detection of breast and ovarian cancers to obtain appropriate treatments are also expected to contribute to the growth of the studied segment.

On the other hand, frequent product launches to meet the growing demand for presymptomatic testing of breast cancer and ovarian cancer are also expected to contribute to the growth of the studied segment. For instance, in March 2022, LifeCell launched a breast screen panel, a comprehensive genetic screening test that assesses the risk of breast cancer in women. The panel not only screens for the mutations in the most common BRCA1 and BRCA2 genes but also screens for all 20 high and moderate-risk non-BRCA genes associated with hereditary breast and ovarian cancer.

The increasing prevalence of genetically inherited breast and ovarian cancer, globally, is a major driver for the use of predictive and presymptomatic tests for these cancers, as a conventional cancer treatment is non-effective in such cases and a pre-emptive mastectomy is the only available treatment for BRCA-mediated breast and ovarian cancer. For instance, as per the ACS data published in June 2022, an estimated 287,850 new cases of invasive breast cancer are expected to be diagnosed in women in the United States along with 51,400 non-invasive breast cancer in 2022. Such prevalence of breast cancer among the population is expected to contribute to the growth of the studied segment.

North America is Expected to Hold Significant Share in the Market the Predictive and Presymptomatic Testing Market Over the Forecast Period

North America is expected to hold a significant share of the market over the forecast period due to increasing awareness about genetic counseling, the rising prevalence of genetic disorders, high adaptability to advanced diagnostics, and a well-structured healthcare system. For instance, according to the United States Oncology Network data published in August 2021, more than 21,500 patients received genetic consultations at 14 Genetic Risk Evaluation and Testing (GREAT) practices in the United States Oncology Network with an 8% mutation identification rate. Such a high preference for genetic counseling to be aware of genetically inherited diseases is expected to contribute to the growth of the market.

Also, the increasing prevalence of various cancer cases in North American countries is expected to contribute to the growth of the market. For instance, as per the American Cancer Society data in 2022, it is estimated that around 65,950 new cases of uterine body cancer are diagnosed in the United States, in 2022. Also, an NCBI article published in May 2022, mentioned that an estimated 233,900 cancer are expected in Canada in 2022. Such an increase in cancer cases in this region is expected to drive the demand for predictive and presymptomatic testing, thereby contributing to the growth of the market in North America.

Additionally, with high investment related to the diagnosis and management of the United States genetic disorders by the government and private entities, the market is expected to grow in the United States over the forecast period. For instance, the Lancet Journal article published in November 2022, mentioned that in March 2022, a USD 289 million increase in research funding to the NIH for Alzheimer's disease and related dementias was signed into law, bringing total funding for these diseases by the NIH to more than USD 3 billion. Therefore, due to these above-mentioned factors, such as the high prevalence of genetically inherited diseases, increasing awareness among the population and high investment by the government, the predictive and presymptomatic testing market is expected to grow during the forecast period in the region.

Predictive & Presymptomatic Testing Market Competitor Analysis

The predictive and presymptomatic testing market is moderately competitive and is majorly comprised of local players in different countries. Some of the global players such as 23andMe, Abbott Laboratories, and Myriad Genetics hold a major share of the market. With the growing focus on genetic testing, it is expected that a few small to mid-sized companies will penetrate the market in the near future.

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