PREIMPLANTATION GENETIC DIAGNOSIS MARKET ANALYSIS

Market Size and Trends

Global preimplantation genetic diagnosis market is estimated to be valued at USD 57.1 Mn in 2024 and is expected to reach USD 95.1 Mn by 2031, exhibiting a compound annual growth rate (CAGR) of 7.6% from 2024 to 2031.

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Rising infertile population, increasing public awareness about PGD, growing acceptance of assisted reproductive technologies and rising prevalence of genetic disorders can drive the market growth. However, strict regulations associated with PGD and ethical & legal issues related to embryonic research and clinical diagnosis can hamper the market growth. Growing pharmaceutical and biotech industry and ongoing research and development activities to introduce advanced preimplantation diagnosis techniques can offer new growth opportunities for the market growth in the near future.

Rising Prevalence of Genetic Disorders

With advancements in genetic science, people’s understanding of genetic disorders and diseases has increased tremendously over the past few decades.  Researchers have identified genetic mutations and errors that can lead to a host of medical conditions affecting individuals from birth throughout their lives. Some common genetic disorders include cystic fibrosis, Down syndrome, fragile X syndrome, Huntington's disease, muscular dystrophy, and others. The prevalence of these single-gene and chromosomal disorders has been rising globally. As per some estimates, over 7,000 rare disorders have been characterized so far and around 350 new disorders are identified each year. This rising disease burden due to genetic factors can boost utilization of preimplantation genetic diagnosis. With PGD, genetic disorders can be detected in embryos even before pregnancy, allowing parents to transfer only healthy embryos. This helps couples who are carriers of genetic mutations to have a healthy baby and avoid passing on diseases to their offspring. It is bringing hope to families with a history of genetic conditions in alleviating anxiety and improving outcomes. The technique is highly valued as it prevents suffering for the potential child and provides answers to parents who would otherwise take the risk of conceiving naturally. For instance, in April 2023, The Prelude Network and The HelpCureHD Foundation initiated the More Than Infertility campaign. This campaign aims to educate and raise awareness about IVF with preimplantation genetic testing (PGT) as a means to reduce genetic disorders like Huntington's disease in newborns.

Market Concentration and Competitive Landscape

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Rising Emphasis on Family Planning

In modern times, there is a lot more emphasis on carefully planning one's family and having children through a conscious decision rather than leaving everything to chance. People are delaying parenthood, having fewer children on average and are highly invested in each child's wellbeing and success. Moreover, societal pressures of earning higher degrees, establishing careers and achieving financial stability before starting a family have also increased significantly. This shifts the outlook towards family intensely. Preimplantation genetic diagnosis fits neatly as it allows testing of embryos for genetic defects before pregnancy. It empowers couples to have more control over their fecundity and family size. With the technique, people can feel confident about anticipating or avoiding hereditary health problems in offspring. The option to select healthy embryos alleviates uncertainties involved in natural conception. It streamlines the family planning approach and aligns it with modern preferences around informed choice and optimization.

Key Takeaways from Analyst-

Global preimplantation genetic diagnosis market growth is driven by rising demand from patients seeking risk-free IVF treatment. Increasing incidence of genetic diseases and growing female age worldwide can drive the market growth as more couples opt for PGD to screen embryos for genetic abnormalities before implantation. Advanced genomic technologies now enable genetic profiling of single-cell embryos with high accuracy, boosting adoption rates. However, ethical concerns from certain religious groups opposing selective implantation based on genetic traits can hamper the market growth. Regulations also vary greatly by country and additional guidelines may limit procedures.

North America currently dominates the market due to supportive regulatory environment and advanced healthcare infrastructure.  Asia Pacific will witness fastest growth due to strengthening medical tourism industries and growing medical expenditures in China, India and others. European expansion will be fueled by favorable coverage amid public health systems as effectiveness of PGD becomes more firmly established. Private players are investing in educational campaigns to expand awareness and drive uptake in underpenetrated Latin American and African markets.

Continuous progress in reproductive genetics and expanded reimbursement coverage can make PGD a standard addition to IVF programs globally. Wider panel screening for inherited conditions beyond Down syndrome, cystic fibrosis and hemoglobinopathies may further increase desirability.

Market Challenges: High cost of the procedure

The high costs associated with preimplantation genetic diagnosis (PGD) procedures can hamper the market growth. PGD involves complex laboratory procedures that are resource and labor intensive. It starts with in- vitro fertilization where multiple embryos are conceived and developed in laboratory conditions. Further, each embryo undergoes genetic testing to detect any abnormalities or inherited disorders. The process requires specialized equipment, trained personnel and advanced genetic testing techniques. All of these factors contribute to the overall high costs of procedure. On an average, a single PGD cycle costs between US$ 10,000 to US$ 15,000 in most countries, which is significantly higher as compared to a normal IVF cycle. Multiple cycles may be required to obtain healthy embryos, thus, increasing procedure costs. The out-of-pocket expenses have to be borne by patients as most health insurance policies do not cover PGD. This pricing puts the procedure out of reach for many aspiring parents from low- and middle-income groups globally. In 2020, according to the data from the United Kingdom National Health Services, nearly 60% of IVF cycles were self-funded due to lack of insurance coverage.

Market Opportunities: Emerging markets in Asia Pacific and Latin America

The emerging markets in Asia Pacific and Latin America offer tremendous growth opportunities for the global preimplantation genetic diagnosis market. These regions are witnessing rapid economic expansion coupled with rising healthcare investments that increases access to advanced infertility treatments. Countries like China, India, Brazil and Mexico have a very young population structure with growing middle class who can afford expensive procedures like IVF and PGD. As per data from United Nations Population Fund, over 60% of Latin America's population and almost 65% of Asia Pacific's population is now under the age of 30. This young demography boosts demand for advanced fertility services to build families. Social trends like women pursuing careers before childbearing boosts the need for PGD to select healthy embryos. Furthermore, governments in emerging nations recognize the social and economic burden of genetic diseases and birth defects. These are working to strengthen newborn screening programs and promoting preventive healthcare. For instance, India's 'New-born screening initiative' aims to test over 5 million babies annually for treatable genetic conditions by 2025, according to the Nation's Health Ministry. Government of Brazil launched the 'Mother Baby' program in 2021 to provide subsidized NIPT (Non-invasive prenatal tests) and ART procedures for at-risk pregnancies as per its health ministry report.

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By Type: Chromosomal Abnormalities segment contributes the highest share of the market owing to increasing prevalence

By type, chromosomal abnormalities segment is estimated to contribute the highest market share of 30.21% in 2024. Chromosomal abnormalities, also known as chromosomal aneuploidies, refer to any abnormalities or anomalies in the number or structure of chromosomes. The most common types are trisomy 21, trisomy 13, and trisomy 18. The incidence of chromosomal abnormalities increases with maternal age, occurring in about 1 in 100 pregnancies at age 30 and 1 in 30 at age 40. As women are delaying childbirth to later ages for career and lifestyle reasons, chromosomal abnormalities are rising globally. This can boost demand for preimplantation genetic diagnosis for screening embryos prior to pregnancy. Advancements in genetic screening and testing technologies have made it possible to detect chromosomal abnormalities with high accuracy at the embryonic stage itself before pregnancy. This allows doctors to select only healthy embryos for implantation, avoiding unnecessary risks, complications and sometimes even termination of pregnancies affected by genetic disorders. Early detection through PGD improve reproductive outcomes, health of newborns and reduces healthcare costs associated with long term treatment of genetic conditions. Increasing awareness about these benefits boosts uptake of PGD amongst at-risk patient groups and infertile couples. Rising prevalence of chromosomal abnormalities due to lifestyle shifts, along with enabling diagnostic technologies can boost demand for PGD testing for chromosomal abnormalities.

By End User: Diagnostic Laboratories contributes the highest share of the market due to advanced infrastructure and expertise

By end user, diagnostic laboratories segment is estimated to contribute the highest market share of 40.21% in 2024. Compared to other healthcare settings, diagnostic labs are best equipped with advanced infrastructure, high throughput testing platforms, genetic counselling capabilities and skilled professionals specifically trained to conduct embryology and genetic testing procedures involved in PGD screening. Moreover, diagnostic labs can leverage economies of scale benefits to offer these highly specialized tests at competitive prices. These are also continuously investing in technology upgrades to introduce newer diagnostic techniques and enhance testing efficiencies. This helps diagnostic laboratories maintain their superiority in delivery of high quality, faster PGD services as compared to other end users. Many fertility clinics outsource their PGD testing requirements to partner diagnostic labs in order to avoid substantial capital expenditure on infrastructure and talent development. This outsourcing model works efficiently and allows fertility clinics to stay focused on their core competency of assisted reproduction, while leveraging the expertise of diagnostic labs for auxiliary genetic testing services.

Regional Insights

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North America dominates the preimplantation genetic diagnosis market with an estimated market share of 41.2% in 2024. The U.S. accounts for the largest share and is home to several leading players in this field. Advanced medical technologies, high healthcare expenditure by both public and private players, and favorable medical reimbursement policies is expected to drive the market growth in the U.S. Growing preference for IVF treatments together with awareness regarding genetic disorders has significantly boosted demand.

Asia Pacific region, especially China and India, is witnessing the fastest growth. Rapid economic development and rising affluence over the past decade has improved access to advanced healthcare facilities in the major Asian economies. Growing medical tourism sector catering to global patients has also provided a fillip. While regulations regarding genetic screening are still evolving, private clinics in major cities successfully promote selective sex services to attract customers. This has promoted the use of PGD as a value-added service.

Market Report Scope

Key Developments

• In May 2024, Takara Bio USA, Inc., a subsidiary of Takara Bio Inc., has launched the Lenti-X Transduction Sponge, a novel microfluidic transduction enhancer for lentivirus-mediated gene delivery. This innovative product simplifies the process with a walkaway workflow, achieving high transduction efficiency across cell types. President & CEO Carol Lou highlighted its potential to revolutionize viral transduction methods, offering a reliable and non-toxic alternative to chemical enhancers, thereby streamlining research and reducing costs.
• In April 2024, GenEmbryomics Limited, a trailblazer in advanced genetic testing services for embryos, and Progenesis Inc, a top provider of preimplantation genetic testing for in vitro fertilization (IVF), have announced a transformative partnership aimed at expanding access to state-of-the-art reproductive technologies.
• In June 2023, Kindbody, a prominent fertility clinic network and provider of family-building benefits for employers, has launched Kindlabs, its new genetic testing division. This addition integrates genomics into Kindbody's comprehensive care model, enhancing patient services. Kindlabs operates a state-of-the-art reference laboratory spanning 8,000 square feet in Secaucus, NJ.

*Definition: Global Preimplantation Genetic Diagnosis,  It’s a procedure used during in vitro fertilization (IVF) to screen embryos for genetic disorders or chromosomal abnormalities before they are implanted in the uterus. The primary goal of PGD is to select embryos that are free from specific genetic conditions or to identify those that carry certain genetic traits for various purposes, such as selecting embryos with a tissue match for a sibling with a genetic disorder. This process helps reduce the likelihood of passing on genetic diseases to offspring and can also be used for gender selection in some cases, although this application is often controversial and subject to legal restrictions in many countries.

Market Segmentation

•  Type Insights (Revenue, USD Mn, 2019 - 2031)
  • Chromosomal Abnormalities
  • Aneuploidy
  • X-linked diseases
  • Single gene disorders
  • HLA Typing
  • Gender Selection
  • Others
•  End User Insights (Revenue, USD Mn, 2019 - 2031)
  • Diagnostic Laboratories
  • Hospitals
  • Clinics
  • Others
• Regional Insights (Revenue, USD Mn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • PerkinElmer, Inc.
  • Genea Limited
  • Thermo Fisher Scientific Inc.
  • Agilent Technologies, Inc.
  • Quest Diagnostics Incorporated
  • Illumina, Inc.
  • CooperSurgical, Inc.
  • Beijing Genomics Institute (BGI)
  • LabCorp of America Holdings (Laboratory Corporation of America)
  • Natera, Inc.
  • Oxford Gene Technology
  • California Pacific Medical Center
  • Good Start Genetics, Inc.
  • Invitae Corporation
  • F. Hoffmann-La Roche AG
  • Progenesis