Preimplantation Genetic Testing Market 2025 – Market Size & Segments Analysis, Industry Trends, Manufacturers Analysis, Opportunities and Forecast 2035

The preimplantation genetic testing (PGT) is a medical procedure, where an early form of prenatal genetic diagnosis where abnormal embryos are identified, thereby allowing transfer of genetically normal embryos. This technology has become an integral part of Assisted Reproductive Technology (ART) procedures. It involves testing embryos for specific genetic conditions or chromosomal abnormalities, which ensure that only healthy embryos are implanted into the uterus. Thise procedures is crucial for couples at risk of passing on genetic disorders or those with a history of recurrent miscarriages or older women undergoing IVF. The process utilizes technologies like next-generation sequencing, fluorescence in-situ hybridization, polymerase chain reaction, comparative genomic hybridization and single-nucleotide polymorphism for identification.

MARKET OVERVIEW

The market valuation of preimplantation genetic testing market was valued at approximately USD 1.2 billion in 2024 and is projected to reach USD 3.2 billion in 2035 exhibiting a CAGR of 15.5% during the forecast period of 2025-2035. Preimplantation genetic testing significantly increases the chances of a successful pregnancy and the birth of a healthy child, by selecting the embryos free of genetic abnormalities. The market is aligned with healthcare sector, which makes it a sustainable and growing market.

GROWTH DRIVERS

The rise in incidence of genetic disorders and chromosomal abnormalities is one of the major drivers for the market. According to WHO, genetic disorders and congenital abnormalities can be responsible for up to 50% of childhood deaths in industrialized countries. These disorders can also account for up to 30% of pediatric hospital admissions. It is estimated 240 000 newborns die worldwide within 28 days of birth every year due to congenital disorders. Congenital disorders cause a further 170 000 deaths of children between the ages of 1 month and 5 years. The technological advancement in genetic testing like next generation sequencing and polymerase chain reaction significantly improves the accuracy, efficiency, and affordability of PGT.

Where the companies like Illumina and Thermo Fisher Scientific are continuously innovating in this space, which provides more precise and comprehensive genetic solutions. For instance, Thermo Fisher Scientific and Illumina signed agreement to provide research market broader access to Ion AmpliSeq technology. The global increase in the use of invitro verticalization procedures has driven the demand for the PGT market. The PGT is often integrated to IVF treatments to improve the success rate by selecting the healthiest embryos for implantation. According to CDC, the 413,776 ART cycles performed in 2021, 167,689 were egg or embryo banking cycles in which all resulting eggs or embryos were frozen for future use, its use has more than doubled over the past decade.

The trend of delayed parenthood especially in countries developed countries, has led to an increase in maternal age which is associated with high risk of chromosomal. According to NCBI, preimplantation genetic testing (PGT) is often recommended for women over 35 years of age because advanced maternal age is a significant factor that can contribute to chromosomal abnormalities in embryos. The infertility rates globally due to factors like lifestyle changes, environmental factors and delayed childbearing is one of the significant drivers of the market. According to a 2023 World Health Organization (WHO) report, around 17.5% of the adult population, or about 1 in 6 people worldwide, experience infertility at some point in their lives. This means that 10–15% of couples are affected by infertility in their lifetime.

The report also found that infertility rates are similar across high-, middle-, and low-income countries. The increase in healthcare spending, especially in emerging economies, has made advance reproductive technologies more accessible. The more disposable income rises, and healthcare infrastructure improves, the more the people can afford and access PGT services. According to Becker and WHO, the cost of global healthcare soared from 7.4% in 2022 to 10.7% in 2023, a record high. The 2024 insurer-reported cost trend is forecasted at 9.9% average worldwide, though some regions will see a steeper increase.

There is a sharp increase in government spending on health at all country income levels underpinned the rise in health spending to a new high of USD 9 trillion, which is approximately 11% of global GDP. The advocacy from patient groups and professional organizations played a significant role in promoting PGT. The organizations like Resolve the National Fertility Association and the Genetic Alliance actively campaigns for greater awareness and funding accessibility of genetic testing services. These types of efforts are crucial in increasing the adoption of the market.

MARKET SEGMENTATION:

·         By Product & Services- reagent and consumables, instruments, software and services

·         By Procedure Type- Preimplantation Genetic Diagnosis & Preimplantation Genetic Screening

·         By Technology- Next-Generation Sequencing, Fluorescence In-Situ Hybridization, Polymerase Chain Reaction, Comparative Genomic Hybridization and Single-Nucleotide Polymorphism

·         By Application- Structural Chromosomal Abnormalities (Translocations, Deletions, Inversions, Duplication), Aneuploidy, Gender Identification, Single Gene Disorders, X-Linked Disorders, HLA Typing

·         By Type of Cycle- Fresh Donor, Fresh Non- Donor, Frozen Donor, Frozen Non-Donor

·         By End-User- Hospitals, Diagnostic Laboratories, Fertility Clinics

·         By Region- North America, Europe, Asia Pacific, The Middle East and Africa, South America

Preimplantation Genetic Testing Market Segment By Product and Services Review:

The reagent and consumables are essential components that are used in PGT process, this includes chemicals, culture media, DNA extraction kits, amplification enzymes, and other laboratory supplies. These are necessary for conducting genetic analysis or embryos. The reagents are crucial for extracting DNA from embryonic cells and amplifying it for genetic analysis. The consumables including primers and nucleotides are used in PCR techniques to amplify specific DNA sequences.

The instruments used in PGT includes advanced genetic analyzers, PCR machines and NGS platforms and other specialized laboratory equipments. These instruments are designed to perform precise and reliable genetic testing on embryos. They are utilized for identifying genetic disorders and abnormalities. The software solutions in PGT process are designed to manage and analyze genetic data, providing critical insights into the genetic makeup of the embryos. These include data management systems, bioinformatics tools, and genetic analytics software. The services segment in the PGT market includes genetic counseling, laboratory testing services, technical Support, and maintenance of the genetic testing equipment. These services are crucial for effective implementation and utilization of PGT and list

Preimplantation Genetic Testing Market Segment By Procedure Type Review:

The preimplantation genetic diagnosis is a procedure used to identify genetic defects in embryos created through IVF before pregnancy. It is mainly recommended for the couples at high risk of passing on genetic disorders. It is used to detect specific inherited genetic mutation that causes single gene disorders like cystic fibrosis, sickle cell anemia and more, it helps to prevent the transmission of disease to offsprings. The preimplantation genetic screening (PGS), also known as aneuploidy screening aneuploidy like Down syndrome or Edwards syndrome.

Preimplantation Genetic Testing Market Segment By Technology Review:

The next-generation sequencing is a cutting-edge technology that enables comprehensive and high throughput analysis of genetic material. It is used in preimplantation genetic testing because of its high accuracy, speed, and ability to analyze multiple gene markers simultaneously. It can screen all 23 pairs of chromosomes, identifying aneuploidies and structural abnormalities with very high precision. The fluorescence in situ hybridization is a well-established technique that is used to detect and localize the presence or absence of specific DNA sequences on chromosomes. This is commonly used for an identifying aneuploidies and specific gene conditions in embryos.

The polymerase chain reaction is a molecular technique that is used to amplify small segments of DNA, which makes it possible to detect genetic mutations and variations in high sensitivity. This is widely used in preimplantation genetic testing for single gene disorders and chromosomal abnormalities. The comparative genomic hybridization is a genomic technique that compares the DNA of test samples to the reference genome, identifying copy number variations and other genetic abnormalities. It is useful for comprehensive chromosomal screening in embryos. It can be combined with NGS for enhanced accuracy and resolution in genetic testing. The single nucleotide polymorphism array is a high-resolution genetic testing that analyzes variations at single nucleotide positions in the genome. The arrays are used in preimplantation genetic testing for detailed genetic profiling and identification of genetic disorders. The technique is used for linkage analysis in family studies helping to identify inherited genetic mutations.

Preimplantation Genetic Testing Market Segment By Application Review:

The chromosomal abnormality involves the changes in the structures of chromosomes like translocations, deletions, inversions and duplications. PGT helps in identifying these abnormalities before implantation. Aneuploidy refers to the presence of an abnormal number of chromosomes in a cell. The common forms aneuploidy includes trisomies and monosomies. The PGT for aneuploidy helps in selecting embryos with the correct number of chromosomes, enhancing the chances of a successful pregnancy. PGT can be used for gender identification to prevent the transmission of sex-linked disorders and for family balancing purposes. It helps in identifying and selecting the embryos of a specific gender to prevent X linked genetic disorders like hemophilia and other muscular dystrophy.

The single gene disorders are caused by mutations in a specific gene. The PGT can identify these mutations in embryos to prevent transmission of inherited diseases. The X linked disorders are caused by mutations in genes on the X chromosome. These disorders often affect males more severely as they have only one X chromosome. PGT helps in selecting the female embryos or male embryos free from X linked mutations. The HLA typing through PGT is used to identify compatible donor for bone marrow or cord blood transplants, mainly in families with an existing child requiring a transplant. It ensures a genetic match for sibling needing stem cell transplants, which can be crucial for treating conditions like leukemia. It also helps families to plan for potential future medical needs by ensuring a genetic match from a new child.

Preimplantation Genetic Testing Market Segment By Type of Cycle Review:

In a fresh donor cycle, the eggs from a donor are fertilized with sperm and the resulting embryos are tested for genetic abnormalities before being transferred to the recipient's uterus. This cycle is often chosen by couples facing infertility issues due to poor egg quality or genetic concerns. Whereas, in a fresh non donor cycle, a woman's own eggs are retrieved fertilized, and the resulting embryos are tested before transfer. This is the common type of cycle used in ART for couples with normal ovarian function and no significant genetic risk.

In the frozen cycle, the donor eggs or embryos that have been previously cryopreserved are thawed, fertilized if necessary, and then tested before transfer. This approach offers flexibility and convenience for both donors and recipients. It enables the use of egg banks where eggs are stored and readily available, reducing the waiting times. In a frozen non donor cycle, a woman's own eggs or embryos from a previous IVF cycle are cryopreserved and later thawed for use. This method is often used by women who wish to preserve their fertility or those who have surplus embryos from a prior cycle. It allows women to preserve their eggs for future use which is, particularly beneficial for those undergoing medical treatments or delaying childbirth.

Preimplantation Genetic Testing Market Segment By End-User Review:

The hospitals are significant end users of PGT, as they offer comprehensive healthcare services, including advanced reproductive technologies. They provide a holistic approach to infertility treatments and genetic testing. The diagnostic laboratories specialized in genetic testing and analysis, making them a pivotal in the PGT process. These labs offer technical expertise and advanced diagnostics tools, that are required for accurate genetic screening. The fertility clinics are dedicated to providing reproductive health services including ART, IVF and PGT. These clinics are the first point of contact for couples experiencing infertility. The fertility clinics, specialized in productive medicine, offers tailored treatments and services to address infertility issues and genetic concerns.

Preimplantation Genetic Testing Market Regional Analysis:

North America is a significant market driven by the factors like presence of highly advanced healthcare system with widespread access to cutting edge medical technologies and treatment, including PGT. The region has a significant incidence of genetic disorders according to CDC, which leads to higher demand for the market. Europe is a valuable market by the factors like the presence of advanced healthcare systems, which provides a robust framework for the implementation of PGT services. The European societies have a high level of awareness and acceptance of genetic testing, due to active efforts of European Society of Human Reproduction and Embryology.

Asia Pacific is a rapidly growing market driven by the factors like rising healthcare expenditure due to economic growth in countries like China, India and Japan. According to NIH, Asia Pacific region's fertility services market in these areas are expected to have exceeded USD 5.3 billion in 2021, growing at a compounded rate of over 9% per year.  China, after removing of the one-child-policy, it is expected to grow at a rapid pace. The Middle East and Africa is a growing market due to significant investments in infrastructure including healthcare infrastructure. South America is a promising market driven by the growing investment in the healthcare sector.

Key Challenges:

The significant cost associated with the procedure of PGT, including associated IVF procedures, is often prohibitively high for many patients. The expense includes laboratory fees, genetic testing cost and other medical procedures. The most of the insurance plans do not cover PGT, placing the financial burden entirely on the patients. This may limit the access, particularly for lower income families, which is one of the significant challenges for the market. According to Forbes, in the United States the pricing of IVF at fertility clinics, expect to be quoted roughly USD 12,000 to USD 14,000 for one cycle. It is depending on your needs; a single IVF cycle can cost USD 30,000 or more. Most of the total bill will fall somewhere between USD 15,000 and USD 20,000.

Competitive Landscape:

In the highly competitive preimplantation genetic testing market, companies are investing heavily in research and development to innovate and improve the product and services. They are also collaborating, forming strategi partnerships, or acquiring other companies to gain access to new market segments, enhance distribution networks, and increase market share. Recent developments includes –  Thermo Fisher Scientific Inc.  launched two NGS based test kits commonly used in IVF and ICSI research, in 2023. The Cooper Companies launched Parental QC, Genetic PN check and PGT-A testing, in 2022. Vitrolife acquired Igenomix, in 2021. Cooper Genomics has licensed BioSkryb Genomics' patented ResolveDNA genomic amplification technology, in October 2022.

Global Key Players:

·         Illumina, Inc.

·         Thermo Fisher Scientific Inc.

·         CooperSurgical, Inc.

·         Agilent Technologies, Inc.

·         Revvity

·         Abbott

·         Takara Bio, Inc.

·         Qiagen

·         Vitrolife

·         Oxford Nanopore Technologies

·         Bioarray S.L.

·         Other Players