The global reproductive genetics market size was worth USD 4,520.12 million in 2022. It is anticipated to reach an expected value of USD 14,500.82 million by 2031 growing at a CAGR of 12.2% during the forecast period (2023-2031).
The need for prenatal genetic screening and testing, a component of reproductive genetics that aids in predicting the risk of fetal chromosomal disorders based on age, has increased with the rise in the number of advanced-stage pregnancies in women. Further, prenatal testing became necessary due to the increasing number of genetic disorders, such as Down syndrome, spina bifida, cleft palate, sickle cell anemia, thalassemia, fragile X syndrome, and Tay–Sachs disease. These conditions are the consequences of the mutant genes and an abnormal chromosomal structure. Therefore, prenatal testing requires the patient to be mentally prepared and helps them decide whether to continue or abort the pregnancy.
Technological advancements in the healthcare industry have always played a crucial role in the industry's overall development. Among the numerous improvements witnessed by the sector, reproductive genetics has emerged as one of the unique technologies in curbing concerns related to genetic diseases. The recent advances in the life science industry, such as sequencing technologies, regenerative medicine, and genomic technologies, supported by breakthroughs in genome sequencing and molecular research, have opened up new and promising pathways to combat genetic diseases and reduce the overall global economic burden.
The increasing literacy has promoted the understanding regarding personal genomic risk. The improved genetic literacy has also impacted the global public attitude, understanding, and interest of the population. The rising participation of the public in personal genomics activities, including research and genomic services, has also promoted public awareness and understanding of genetics. Moreover, several educational programs run by the government and the emergence of direct-to-consumer (DTC) testing in the last few years have led to a tremendous boom of genomic healthcare knowledge among the population.
Furthermore, as more companies are offering genetic tests for reproductive medicine and with the advancements in the field, more people are witnessing the availability of such tests. Hence, overall acceptance is also increasing. However, some traditional beliefs by a few communities hamper the favor in some regions. Nevertheless, molecular analysis in this field still needs to be more cohesive and manageable and may restrict the rapid adoption rate of genetic testing.
The number of screening tests is growing very fast with increasing technological advancements. In developed countries, parents are more aware of genetic anomalies and emphasize the early detection of genetic disorders. The availability of many tests and their ability to detect congenital abnormalities in fetuses or parents as a carrier is escalating the market growth. Pregnant women and their families are more concerned and are undergoing pre-delivery check-ups. In addition, the early detection of abnormalities in prenatal and carrier testing helps the family prepare for the situation and allows them to make decisions accordingly. Increasing demand for early and non-invasive procedures is also considered one of the major factors driving the growth of reproductive genetic tests such as NIPT.
Additionally, pregnant women with a high risk of developing fetal chromosomal abnormalities (women aged 35 years and older, personal or family history of aneuploidy, and positive result with conventional screening method) can plan at an early stage as delay may lead to unnecessary pain and discomfort along with various health issues with the fetus. Most of the NIPTs available in the market can be recommended as early as nine weeks to 10 weeks of gestation, contributing to the rising demand for early screening. Also, traditional invasive prenatal testing such as CVS and amniocentesis are associated with the risk of miscarriage. Women prefer NIPTs over invasive prenatal testing because they completely eliminate the danger of miscarriage. Further, tests such as carrier and infertility screening allow the identification of the root cause of genetic diseases.
Various regulatory bodies worldwide claim that the implementation of genetics tests such as NIPT and the subsequent rise in the uptake of prenatal testing is likely to increase the incidence of abortions. Therefore, professional organizations such as the American College of Obstetricians and Gynecologists, the International Society for Prenatal Diagnosis, the U.S. National Society of Genetic Counselors (NSGC), and the Japan Society of Obstetrics and Gynecology have set up guidelines that limit the use of non-invasive prenatal testing only to pregnant women at high risk of chromosomal aneuploidies. In addition, the women at high risk of fetal chromosomal aneuploidies include women aged 35 years and older, women with a personal or family history of aneuploidies, and those with positive results from conventional screening methods as ultrasonography and maternal serum tests indicating a high risk of aneuploidies. According to the ACOG, tests like NIPT should not be considered routine laboratory testing but should instead be considered an informed patient choice post-pre-test counseling.
Furthermore, in many countries such as India and China, where the termination of female fetuses is considered illegal, the implementation of prenatal testing for reproductive genetics has raised a serious ethical concern since these tests facilitate the unlawful sex determination of the fetus. In many Middle Eastern and African countries, the reproductive genetic testing market players are facing enormous challenges due to their ethical and cultural norms and also due to their skepticism toward these tests. Additionally, countries like Saudi Arabia, the U.A.E., Turkey, Iraq, Oman, and Iran have economic and infrastructural support but still need to show green signals to these tests due to the shortage of educational and government development programs supporting the need for such tests.
Payors play a significant role in introducing and using new testing technologies through their coverage and reimbursement decisions. Reimbursement policies have been a hindrance to the adoption of genetic services. Still, at many present, payors are shifting their emphasis away from the cost of genetic services toward the total cost of care. Insurance providers continuously provide reimbursement policies related to a patient's expenditure on diagnostic tests and treatments for genetic disorders. They also reimburse drug and test developers to free them from the high-cost burden. Further, to reduce the global burden of a genetic disorders, governments in various economies focus on improved reimbursement policies with comprehensive coverage of genetic diseases.
The global market is bifurcated by technology, procedure type, product types, application, technology, and region.
By procedure type, the global market has been segmented into prenatal screening, preimplantation genetic testing, infertility, and carrier screening.
The carrier screening segment accounted for the largest market share and is projected to grow at a CAGR of 11.6% during the forecast period. According to National Human Genome Research Institute, carrier screening is a genetic test on patients who risk passing the genetic disorder to their children. However, such individuals do not display any symptoms of the disease. The increased risk of genetic mutations among various ethnicities and the expanded utility of genetic testing at an early stage has acted as a driver for the increased adoption of carrier screening procedures within the market.
By product type, the global market has been segmented into kits, panels, reagents and consumables, and systems and instruments.
The kits segment is the highest contributor to the market and is estimated to grow at a CAGR of 12.3% during the forecast period. The kits within the reproductive genetic testing involve the in vitro diagnostic kits developed by the companies for commercial purposes and are also used for genetic testing. The kits are utilized for clinical diagnostics, research, and testing purposes.
By technology, the global market has been segmented into polymerase chain reaction (PCR), next-generation sequencing (NGS), fluorescent in-situ hybridization (FISH), microarray, and others.
The next-generation sequencing (NGS) segment owns the largest market share and is projected to grow at a CAGR of 13.6% during the forecast period. Owing to the rapid development of various sequencing technologies in the era post the human genomic project, large-scale sequencings such as gene groups, the human exome, and the entire human genome has become a reality. The emergence of NGS technology has enabled high-throughput molecular analysis while playing an essential role in exploring biologicals in human genomic studies. Additionally, with applications being rapidly implemented in emerging fields such as prenatal screening, carrier screening, and other early-stage diagnoses, sequencing has significantly increased the number of approaches to target genetic abnormalities.
By application type, the global market has been segmented into aneuploidy, single-gene disorders, structural chromosomal abnormalities, and others.
The next-generation sequencing (NGS) segment is the largest contributor to the market and is predicted to grow at a CAGR of 11.8% during the forecast period. According to NCBI, aneuploidy is the second most significant cause of chromosome mutation, leading to an abnormal number of chromosomes. Further, X and Y chromosomal aneuploidies are among the standard human whole-chromosomal copy number variations, with a probable incidence in the general population between 1 in 400 to 1 in 1,000. In addition, maximum aneuploidies are considered to be lethal. The most common form of aneuploidies is trisomy which is present in 0.3% of all live births.
Based on region, the global market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant shareholder in the global market and is anticipated to grow at a CAGR of 10.8% during the forecast period. The countries of North America contributing significantly to its market share are the U.S. and Canada. The U.S. is the most dominating country in revenue generated and contributed more than 93.35% of the North America market revenue. The presence of full-fledged operational units of conglomerate companies contributing to this market provided help in the establishment of many startup companies. These startup companies are contributing significantly to the technological innovations in the global market. In addition, a substantial amount of money is being invested in these startups by the conglomerate companies to support the startup companies' ongoing research projects aimed at developing disruptive sequencing technologies. Apart from this, many universities and government organizations are also making significant investments to fund several research projects to enhance and improve the efficiency, feasibility, and affordability of the carrier screening test.
Europe is predicted to grow at a CAGR of 11.7% during the forecast period. The European market has been growing since its inception. Several European countries, including France, Germany, the U.K., France, Spain, and Italy, are working persistently to enhance the adoption of such genetic testing for expecting parents and pregnant women across Europe. For instance, in most European countries, such as the U.K., Germany, France, and Spain, the government provides free prenatal testing to women above the age of 35 years and free testing for women below 35 years based on their medical condition. If the medical condition of any woman is poor, the government will bear the cost of testing; in other cases, people have to bear it on their own. Some people have medical insurance and pay their medical expenses. However, a wide variation in the pre-implantation genetic diagnosis policies across Europe often hampers the region's implantation and advancements of reproductive genetics.
The Asia-Pacific market is expected to proliferate in the next few years. Several Asia-Pacific countries, including Australia, China, India, Japan, and Singapore, are working continuously to enhance the adoption of genetic testing in the upcoming years. The Asia-Pacific region has witnessed tremendous growth in molecular diagnostic technology, and several initiatives have been undertaken to promote research and development. Even though economically developing regions in Asia-Pacific are likely to expand their testing capabilities in the future, they need to catch up to the developed countries. Furthermore, differing regulatory processes between countries for targeted therapies and molecular diagnostics create hurdles for pharmaceutical and diagnostic companies to deploy new technologies across this region.
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