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Report ID: HC0017
Pages: 175
Base Year: 2023
Format: PDF
Historical Date: 2019-2022
MARKET SCOPE:
The global Pre-Implantation Genetic Diagnosis (PGD) market is projected to grow significantly, registering a CAGR of 10.4% during the forecast period (2024 – 2032).
Preimplantation Genetic Diagnosis (PGD) is a specialized genetic testing method utilized alongside in vitro fertilization (IVF) to examine the genetic composition of embryos before their implantation in the uterus. The primary objective of PGD is to pinpoint genetic abnormalities or specific genetic conditions in embryos, enabling the selection and transfer of embryos devoid of the targeted genetic defects. The process is typically integrated into the IVF procedure, where eggs are retrieved from the ovaries and fertilized with sperm in a laboratory, resulting in the formation of embryos. Following fertilization, the embryos undergo cultivation and development over several days, with monitoring occurring until they reach a specific developmental stage, often the blastocyst stage. At this point, a small number of cells are extracted from each embryo for genetic testing, commonly performed on either the third day (cleavage stage) or the fifth day (blastocyst stage) of embryo development. The genetic material extracted from each embryo is then subjected to testing through various techniques, including polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), comparative genomic hybridization (CGH), and more recently, next-generation sequencing (NGS). These methodologies enable the identification of specific genetic mutations, chromosomal abnormalities, or single-gene disorders.
MARKET OVERVIEW:
Driver: The advancement in the diagnostic procedures in gene testing is predicted to foster the market growth.
Recent advancements in genomics research signal a shift from traditional monogenic genetics toward a comprehensive examination of the entire human genome. This transition involves the integration of massively parallel sequencing approaches and advanced bioinformatics. Presently, the capabilities extend beyond the original medical indication for which a patient and their family were referred for genetic testing, allowing the elucidation of single nucleotide variation (SNV), copy number variation (CNV), and structural variation (SV) in the entire human genome. Technological progress is evident in various applications such as expanded carrier screening (ECS), the end of gamete donor anonymity, preimplantation genetic testing (PGT), non-invasive prenatal testing (NIPT), and a deeper understanding of the root causes of male and female infertility.
Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening (PGD/PGS) have witnessed increased prevalence in in vitro fertilization (IVF) clinics, aiding numerous patients in achieving healthy pregnancies. The rapid evolution of biotechnologies has led to the development of new methods aimed at minimizing the negative impact on embryo development while enhancing the accuracy and efficiency of PGD/PGS. Simultaneously, non-invasive sampling methods, including time-lapse imaging technology, BF sampling, and cell-free nucleic acid collection, have been introduced into the field.
Opportunities: Use of fertility treatment options by single parents and same-sex couples is expected to pave the way for market growth in the upcoming years.
Laws endorsing the legalization of same-sex marriages have been implemented across various countries globally, signifying a substantial shift in societal perspectives and legal frameworks. This transformative trend, observed in nations like Greenland, Ireland, Canada, South Africa, and the United States, is expected to significantly influence the adoption of fertility procedures. These legal advancements underscore a more inclusive approach to family-building and reproductive rights, particularly for individuals in same-sex relationships and those who are single. For instance, in the Australian state of New South Wales, the Assisted Reproductive Technology Act 2007 has been enacted to permit all women, regardless of their marital status, to avail themselves of assisted conception procedures. This inclusive legislation ensures that single women and those in same-sex relationships have legal access to assisted reproductive technologies, including In Vitro Fertilization (IVF).
Similarly, in Western Australia, the Human Reproductive Technology Act 1991 allows all women, regardless of their sexual orientation or marital status (including lesbian or single women), to access donor insemination. This legal framework supports the reproductive rights of individuals, placing a strong emphasis on inclusivity in fertility treatments. These legal provisions signify a broader acknowledgment of diverse family structures and underscore the rights of same-sex couples and single individuals to pursue parenthood through assisted reproductive technologies. By eliminating discriminatory restrictions based on marital status or sexual orientation and granting access to fertility procedures, these laws contribute to fostering a more equitable and inclusive landscape within reproductive healthcare.
COVID IMPACT:
The global preimplantation genetic diagnosis market experienced a moderate impact during the COVID-19 pandemic. The extent to which the pandemic influenced the decision of pregnant women to undergo prenatal genetic tests remains unclear. The healthcare systems responded swiftly and extensively to the virus, implementing telehealth as a crucial component of these changes to minimize the risk of viral exposure among patients, healthcare providers, and communities. Due to the potential impact of COVID-19 on maternal and neonatal outcomes, along with the significance of prenatal genetic testing for ensuring high-quality prenatal care, various diagnosis and testing procedures were either postponed or delayed. Simultaneously, a prevailing fear of infection among individuals contributed to the reluctance to pursue these procedures. Consequently, the preimplantation genetic diagnosis market was only partially affected by the consequences of the COVID-19 pandemic.
SEGMENTATION ANALYSIS:
The Aneuploidy segment is anticipated to grow significantly during the forecast period.
Aneuploidy is a genetic disorder characterized by an abnormal number of chromosomes, wherein a human cell may possess 45 or 47 chromosomes instead of the usual 46. The rising prevalence of aneuploidy and the advancements in its diagnosis are anticipated to propel the preimplantation genetic diagnosis market. Trisomies, which involve an additional chromosome, are the most common form of aneuploidies in humans, constituting approximately 0.3% of live births. Trisomies typically result in a total of 47 chromosomes and, with few exceptions, are often incompatible with life, contributing to about 35% of spontaneous abortions.
To address the challenges associated with aneuploidy, particularly in improving live birth rates and reducing early pregnancy failure rates, preimplantation genetic testing-aneuploidy (PGT-A) has been introduced. Originally employing fluorescence in situ hybridization, which had limitations in assessing only a few chromosomes, PGT-A has evolved to encompass the evaluation of all chromosomes. Techniques such as array comparative genomic hybridization and next-generation sequencing are now utilized for comprehensive chromosomal analysis.
PGT-A serves as a valuable method to screen embryos for whole-chromosome abnormalities, aiding in the selection of embryos for transfer. In the past, embryo selection for transfer was primarily based on morphologic criteria, yet many women experienced unsuccessful pregnancies despite the transfer of morphologically optimal embryos. The expanded capabilities of PGT-A, now able to assess all chromosomes, provide a more thorough and precise screening process before embryo transfer, contributing to advancements in reproductive technologies.
The reagents and consumables segment is anticipated to grow significantly during the forecast period.
The growth of the reagents and consumables segment is propelled by the expanding applications of specific technologies, including Next-Generation Sequencing (NGS) and array Comparative Genomic Hybridization (aCGH) for whole-genome sequencing, as well as Fluorescence In Situ Hybridization (FISH) in the diagnosis of specific genetic disorders. Additionally, the increasing number of preimplantation genetic diagnosis and preimplantation genetic screening procedures conducted across major global markets contributes to the positive trajectory of this segment.
REGIONAL ANALYSIS:
The North America region is set to witness significant growth during the forecast period.
The presence of advanced healthcare facilities in this region is anticipated to propel market growth during the forecast period. Pre-implantation genetic diagnosis (PGD) is a service provided by more than 75% of fertility clinics in the United States, with its utilization in 4–6% of in vitro fertilization (IVF) procedures annually. While Preimplantation Genetic Screening (PGS) is effective in screening for aneuploidy in IVF patients, PGD is frequently employed for screening specific genetic disorders.
In 2018, a total of 306,197 Assisted Reproductive Technology (ART) cycles were conducted in the United States, resulting in approximately 73,831 live births. The advent of ART procedures has led to the birth of over one million babies in the country. Notably, 33% of IVF mothers achieve pregnancy during their initial cycle. The increasing prevalence of IVF procedures is anticipated to contribute to the market growth of the preimplantation genetic diagnosis market.
COMPETITIVE ANALYSIS
The global Pre-Implantation Genetic Diagnosis (PGD) market is reasonably competitive with mergers, acquisitions, and product launches. See some of the major key players in the market.
Scope of the Report
** In – depth qualitative analysis will be provided in the final report subject to market
Primary and Secondary Research
In order to understand the market in detail we conduct primary and secondary research. We collect as much information as we can from the market experts through primary research. We contact the experts from both demand and supply side and conduct interviews to understand the actual market scenario. In secondary research, we study and gather the data from various secondary sources such as company annual reports, press releases, whitepapers, paid databases, journals, and many other online sources. With the help of the primary interviews, we validate the data collected from secondary sources and get a deep understanding on the subject matter. Post this our team uses statistical tools to analyses the data to arrive at a conclusion and draft it in presentable manner.
Market Size Estimations
Understanding and presenting the data collected is a crucial task. Market sizing is a critical part of the data analysis and this task is performed by using Top-down and bottom-up approaches. In this process, we place different data points, market information and industry trends at a suitable space. This placement helps us presume the estimated & forecast values for coming few years. We use several mathematical and statistical models to estimate the market sizes of different countries and segments. Each of this is further added up to outline the total market. These approaches are individually done on regional/country and segment level.
Data Triangulation
As we arrive at the total market sizes, the market is again broken down into segments and subsegments. This process is called as data triangulation and is implementable wherever applicable. This step not only helps us conclude the overall market engineering process, but also gives an assurance on accuracy of the data generated. The data is triangulated based on studying the market trends, various growth factors, and aspects of both demand and supply side.