Verified Insights
Precision-driven research you can trust. We uphold rigorous data validation processes to ensure every report is reliable and based on credible sources.
+91 9425150513 (Asia) support@24lifesciences.com
+91 9425150513 (Asia) support@24lifesciences.com
Download Sample Pdf
MARKET INSIGHTS
The global Preimplantation Genetic Testing for Monogenic & Single Gene Defects Kits market was valued at USD 532.7 million in 2024. The market is projected to grow from USD 588.1 million in 2025 to USD 975.4 million by 2032, exhibiting a compound annual growth rate (CAGR) of 7.9% during the forecast period. The U.S. market was a significant contributor, with an estimated size of USD 198.5 million in 2024, while the Chinese market is projected to reach USD 135.2 million by 2032.
Preimplantation Genetic Testing for Monogenic disorders (PGT-M) kits are specialized diagnostic tools used during In Vitro Fertilization (IVF) to screen embryos for specific, known single-gene disorders before implantation. These kits enable the analysis of one or a few specific genes to identify mutations that cause conditions such as cystic fibrosis, sickle cell anemia, or Huntington's disease. This allows for the selection of embryos without the specific genetic defect, significantly reducing the risk of passing on hereditary conditions.
The market growth is primarily driven by rising awareness and demand for genetic screening, advancements in assisted reproductive technologies (ART), and an increasing prevalence of hereditary monogenic diseases. The High-Throughput Sequencing technology segment, a key part of the market, is expected to see substantial growth due to its accuracy and scalability. Furthermore, the competitive landscape is characterized by key players such as Thermo Fisher Scientific and PerkinElmer, who hold a significant market share and continuously innovate their product portfolios to capture growth in both public and private hospital settings.
Rising Incidence of Hereditary Genetic Disorders
The global burden of monogenic disorders such as cystic fibrosis, sickle cell anemia, and Huntington's disease is a primary driver for the Preimplantation Genetic Testing for Monogenic (PGT-M) kits market. Growing awareness of these conditions and the availability of carrier screening programs are prompting more couples at risk to pursue in-vitro fertilization (IVF) with PGT-M to prevent the transmission of genetic diseases to their offspring. The success rates of IVF procedures have significantly improved, further integrating PGT-M as a standard of care for many patients.
Technological Advancements in Genetic Analysis
The shift from traditional polymerase chain reaction (PCR) based methods to more comprehensive and accurate technologies like Next-Generation Sequencing (NGS) has been a significant driver. NGS-based PGT-M kits offer higher throughput, improved accuracy in detecting single gene defects, and the ability to screen for multiple conditions simultaneously. The development of comprehensive panels that test for hundreds of genetic conditions is making PGT-M more accessible and efficient for clinics and patients alike.
➤ The integration of AI and machine learning for data analysis is enhancing the interpretation of complex genetic data, reducing human error, and improving report turnaround times.
Furthermore, supportive regulatory frameworks and government initiatives in several countries that fund or subsidize genetic testing for high-risk families are creating a favorable environment for market growth, expected to continue driving adoption over the forecast period.
MARKET CHALLENGES
High Cost and Limited Reimbursement
The significant cost associated with IVF cycles combined with PGT-M remains a major challenge for widespread adoption. The procedure is often considered elective and is not fully covered by insurance or public healthcare systems in many regions, placing a substantial financial burden on patients. This high out-of-pocket expense limits access, particularly in middle- and low-income countries, creating a barrier to market penetration.
Other Challenges
Ethical and Regulatory Hurdles
The use of PGT-M raises complex ethical questions regarding embryo selection and the potential for non-medical uses, such as sex selection. These concerns lead to stringent and often varying regulations across different countries, creating a complex landscape for manufacturers and service providers to navigate. Gaining regulatory approvals for new kits can be a time-consuming and costly process.
Technical Complexity and Need for Skilled Personnel
The procedure requires highly specialized equipment and trained embryologists and genetic counselors. The shortage of skilled professionals in many parts of the world can limit the scalability of PGT-M services and act as a bottleneck for market growth, ensuring quality control and accurate result interpretation remains a persistent challenge.
Diagnostic Accuracy and Misdiagnosis Risks
Despite technological improvements, no genetic test is infallible. The risk of misdiagnosis due to technical errors like allele dropout or contamination during biopsy, though low, remains a significant restraint. A false result can have profound emotional and medical consequences for aspiring parents, leading to cautious adoption among some clinicians and patients and necessitating confirmatory prenatal diagnosis, which adds to the overall cost and complexity.
Limited Awareness in Emerging Markets
While awareness is growing in developed nations, there is still a significant knowledge gap among the general population and even healthcare providers in many emerging economies regarding the availability and benefits of PGT-M. This lack of awareness, combined with cultural stigmas surrounding IVF and genetic testing, severely restricts market growth in regions with large populations that could otherwise benefit from these services.
Expansion into Emerging Economies
There is a substantial untapped potential in Asia-Pacific, Latin America, and the Middle East & Africa regions. Rising disposable incomes, improving healthcare infrastructure, and growing medical tourism for advanced treatments present significant growth opportunities. Strategic partnerships between global kit manufacturers and local fertility clinics can help bridge the awareness and accessibility gap, driving future market expansion.
Development of Point-of-Care and Rapid Kits
The development of streamlined, automated, and potentially point-of-care PGT-M kits that reduce processing time and technical complexity represents a major opportunity. Such innovations could democratize access by lowering the skill barrier for operation and reducing turnaround times, making the procedure more efficient and accessible to a broader range of fertility centers worldwide.
Growing Application in Oncology
Beyond inherited genetic diseases, there is a growing application of PGT-M for detecting hereditary cancer predisposition genes (e.g., BRCA1/BRCA2). Individuals carrying these mutations are increasingly using PGT-M to prevent passing the high cancer risk to their children. This expansion of clinical indications opens up a new and growing patient population for the market.
Segment Analysis:| Segment Category | Sub-Segments | Key Insights |
| By Type |
|
High-Throughput Sequencing is the dominant segment, driven by its superior ability to screen for a vast number of monogenic disorders simultaneously with high accuracy and decreasing costs. This technology offers comprehensive analysis capabilities that are increasingly favored by major diagnostic laboratories, allowing for broader panels and more detailed genetic information compared to older, targeted methods. The continuous advancements in sequencing technologies and data analysis software further solidify its leading position, enabling more accessible and comprehensive preimplantation genetic testing. Its scalability and decreasing cost-per-test make it the preferred choice for high-volume testing facilities and future-oriented clinics. |
| By Application |
|
Specialized Fertility Clinics represent the leading application segment due to their central role in providing in-vitro fertilization (IVF) services, which is the primary context for PGT-M. These clinics possess the specialized infrastructure, expertise in embryology, and direct patient pathways required for integrating genetic testing into the IVF process. They often act as early adopters of new technologies and offer comprehensive, patient-centered care packages that include genetic screening. Their focused business model on reproductive medicine allows for deeper integration of PGT-M services compared to general hospitals, creating a highly concentrated and technically advanced user base. |
| By End User |
|
Healthcare Providers are the predominant end users, as they are the direct point of care for patients undergoing IVF and genetic counseling. This segment's leadership is underpinned by the clinical necessity to utilize these kits for patient diagnosis and treatment planning within a regulated medical environment. Hospitals and clinics drive consistent demand through routine clinical use and have established procurement channels with manufacturers. Their purchasing decisions are heavily influenced by test reliability, regulatory approvals, and integration with existing clinical workflows, making them a stable and high-volume consumer base for PGT-M kits. |
| By Technology Platform |
|
Next-Generation Sequencing (NGS) platforms are the leading force in this segment, revolutionizing the field with their high-throughput, multiplexing capabilities. The ascendancy of NGS is driven by its unparalleled scalability and ability to detect a wide array of mutations from a single biopsy sample, providing a comprehensive genetic profile. This platform's flexibility allows for the development of customized panels tailored to specific patient histories or ethnic backgrounds, offering a significant advantage over more rigid, older technologies. Continuous innovation in sequencing chemistry and bioinformatics ensures NGS remains at the forefront, delivering depth and accuracy that is critical for confident clinical decision-making in preimplantation genetics. |
| By Test Specificity |
|
Multi-Gene Panel Kits are emerging as the leading category due to their ability to screen for a curated set of monogenic disorders commonly associated with hereditary risks. This approach offers a balanced solution, providing broader coverage than single-disorder tests while being more targeted and cost-effective than exhaustive whole-genome screens. They are particularly valuable for patients with a family history of genetic conditions but without a single identified mutation, allowing for efficient risk assessment. The clinical utility and operational efficiency of these panels are driving their adoption, as they streamline the testing process and provide actionable results for a range of potential genetic concerns within a single workflow. |
A dynamic market concentrated around leading diagnostic and life science giants
The global Preimplantation Genetic Testing for Monogenic & Single Gene Defects Kits market is characterized by a high level of consolidation, with the top five players accounting for a significant revenue share as of 2024. Thermo Fisher Scientific and PerkinElmer are recognized as dominant forces, leveraging their extensive portfolios, global distribution networks, and substantial R&D investments to maintain leadership. These companies benefit from established brand recognition and a wide array of supporting instrumentation and consumables, making them preferred partners for many clinical laboratories and in-vitro fertilization (IVF) centers worldwide. The competitive intensity is high, with innovation in High-Throughput Sequencing technologies being a primary battleground for market share.
Beyond the market leaders, a number of specialized and regional players contribute to the competitive dynamics. Companies like BASECARE and Peking Jabrehoo Med Tech hold notable positions, often competing by offering cost-effective solutions or focusing on specific geographic markets, such as Asia. Other significant participants include genetic analysis specialists and companies that provide comprehensive reproductive health solutions. These players often compete on the basis of test accuracy, turnaround time, customer service, and strategic partnerships with fertility clinics, carving out sustainable niches in this growing market.
List of Key Preimplantation Genetic Testing for Monogenic & Single Gene Defects Kits Companies ProfiledThermo Fisher Scientific
BASECARE
Peking Jabrehoo Med Tech
Agilent Technologies
QIAGEN N.V.
CooperSurgical, Inc.
Natera, Inc.
Oxford Gene Technology
Vitrolife AB
Good Start Genetics
CombiMatrix Corporation
The global Preimplantation Genetic Testing for Monogenic & Single Gene Defects Kits market is exhibiting a strong growth trajectory, driven by increasing demand for assisted reproductive technologies and rising awareness of genetic disorders. The market was valued at a significant figure in 2024 and is projected to reach a substantially higher value by 2032, demonstrating a notable Compound Annual Growth Rate (CAGR) throughout the forecast period. This expansion is underpinned by technological advancements and broader accessibility to genetic screening services.
Other TrendsTechnological Dominance of High-Throughput Sequencing
The market is largely segmented by technology type, with the High-Throughput Sequencing segment capturing a dominant share. This segment is projected to continue its robust growth, reaching a multi-million dollar valuation by 2032 with a high CAGR. The precision, scalability, and decreasing costs associated with next-generation sequencing technologies are making them the preferred choice for comprehensive single-gene defect analysis, positioning this segment as the primary engine of market growth.
Regional Market Dynamics
Geographically, North America, particularly the United States, held a leading position in the market in 2024. Meanwhile, the Asia-Pacific region, with China at the forefront, is anticipated to be the fastest-growing market. Government initiatives, increasing healthcare expenditure, and a growing patient population are key factors contributing to the rapid market expansion in these regions, indicating a significant shift in global market dynamics.
Consolidated Competitive LandscapeThe competitive environment is characterized by the presence of a few key global manufacturers. In 2024, the top five players, including Thermo Fisher Scientific, PerkinElmer, BASECARE, and Peking Jabrehoo Med Tech, collectively held a commanding share of the global revenue. The market's maturity is leading to strategic developments such as mergers, acquisitions, and partnerships, as companies strive to enhance their product portfolios and expand their geographic footprint to capitalize on the growing demand.
Regional Analysis: Preimplantation Genetic Testing for Monogenic & Single Gene Defects Kits MarketEurope
Europe represents a highly significant and mature market for PGT-M kits, characterized by established healthcare systems and a growing acceptance of assisted reproductive technologies. The market is supported by robust national health services in countries like the UK, Germany, and France, which often provide funding for PGT-M in cases of serious hereditary conditions. The regulatory landscape, guided by the EU's stringent In Vitro Diagnostic Medical Devices Regulation, ensures high standards of quality and safety for available kits. Cultural attitudes and ethical frameworks vary across the continent, influencing the pace of adoption in different countries. Nonetheless, a strong academic and clinical research base, particularly in Western Europe, continues to drive advancements and refine testing protocols for a wide array of single-gene disorders.
Asia-Pacific
The Asia-Pacific region is witnessing the most rapid growth in the PGT-M kits market, fueled by improving economic conditions, expanding healthcare infrastructure, and a gradually diminishing social stigma associated with IVF and genetic testing. Countries such as Japan, Australia, and increasingly China and India are emerging as key markets. Growth is driven by rising disposable incomes, allowing more couples to afford these procedures, and growing awareness of genetic disorders. However, the market landscape is fragmented, with varying regulatory approvals and reimbursement policies creating a patchwork of opportunities. Local companies are developing cost-effective testing solutions, challenging the dominance of international players and making PGT-M more accessible within the region.
South America
The South American market for PGT-M kits is in a developing phase, with growth primarily concentrated in economically advanced countries like Brazil and Argentina. Market expansion is constrained by economic volatility and limited public healthcare coverage for assisted reproductive technologies. Nonetheless, a growing number of private fertility clinics in major urban centers are offering PGT-M services to an affluent patient demographic. Awareness is increasing slowly, and the market potential is significant due to large population bases. The regulatory environment is still evolving, which presents both challenges and opportunities for market entrants looking to establish an early foothold in the region.
Middle East & Africa
The Middle East & Africa region presents a highly diverse and nascent market for PGT-M kits. The Gulf Cooperation Council countries, with their high per capita income and advanced medical tourism sectors, show the most promise, offering these services to both local and international patients. Cultural and religious factors play a significant role in shaping the adoption of PGT-M, influencing regulations and societal acceptance. In contrast, across much of Africa, access to advanced genetic testing is extremely limited due to infrastructural challenges and cost barriers. The market is characterized by a stark contrast between high-tech hubs in the Middle East and very low penetration in most African nations, with overall growth potential tied to economic development and healthcare investment.
This market research report offers a holistic overview of global and regional markets for the forecast period 2025–2032. It presents accurate and actionable insights based on a blend of primary and secondary research.
✅ Market Overview
Global and regional market size (historical & forecast)
Growth trends and value/volume projections
極By product type or category
By application or usage area
By end-user industry
By distribution channel (if applicable)
✅ Regional Insights
North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country-level data for key markets
✅ Competitive Landscape
Company profiles and market share analysis
極Key strategies: M&A, partnerships, expansions
Product portfolio and pricing strategies
✅ Technology & Innovation
Emerging technologies and R&D trends
Automation, digitalization, sustainability initiatives
Impact of AI, IoT, or other disruptors (where applicable)
✅ Market Dynamics
Key drivers supporting market growth
Restraints and potential risk factors
Supply chain trends and challenges
✅ Opportunities & Recommendations
High-growth segments
Investment hotspots
Strategic suggestions for stakeholders
✅ Stakeholder Insights
This report is designed to support strategic decision-making for a wide range of stakeholders, including:
Pharmaceutical and biotech companies
Medical device and diagnostics manufacturers
Healthcare providers and hospital systems
Contract research and manufacturing organizations
極Investors, consultants, and policy makers
-> Global Preimplantation Genetic Testing for Monogenic & Single Gene Defects Kits market was valued at USD 532.7 million in 2024 and is expected to reach USD 975.4 million by 2032.
Which key companies operate in Global Preimplantation Genetic Testing for Monogenic & Single Gene Defects Kits Market?
-> Key players include Thermo Fisher Scientific, PerkinElmer, BASECARE, and Peking Jabrehoo Med Tech, among others.
-> Key growth drivers include rising awareness and demand for genetic screening, advancements in assisted reproductive technologies, and increasing prevalence of hereditary monogenic diseases.
-> North America is the largest market, with the U.S. valued at USD 198.5 million in 2024, while Asia-Pacific shows significant growth potential.
-> Emerging trends include high-throughput sequencing technology advancements and expanded applications in both public and private hospital settings.
Our Clients
“The data provided by 24LifeScience was clear, well-organized, and useful for internal strategy planning. It helped us understand the competitive landscape more effectively.”
“We used one of their market overview reports for early-stage feasibility work. It gave us a helpful snapshot of current trends and key players in our therapeutic area.”
“I appreciated the team’s responsiveness and willingness to adjust the scope based on our feedback. The final report was aligned with our expectations and timelines.”
“Their custom report on clinical trial trends was a helpful reference as we explored new indications."
“As someone working on early product planning, I found their therapeutic area briefs quite useful. The information was presented in a way that made it easy to extract key takeaways.”
“We didn’t need anything overly complex—just solid, dependable data. 24LifeScience delivered exactly that, without unnecessary fluff.”
“Their reports gave us a good foundation to start our own market assessment. While we supplemented it with other data, this was a great starting point.”
“I’ve used a few of their reports for academic and grant writing purposes. They’re generally well-cited and reliable for understanding market scope.”
At 24LifeScience, we combine domain expertise with dependable research delivery. What truly differentiates us isn't just what we do — it's how we do it. Our clients trust us because we offer consistency, security, value, and most importantly, insight that drives action.
Precision-driven research you can trust. We uphold rigorous data validation processes to ensure every report is reliable and based on credible sources.
We uphold rigorous data validation processes to ensure every report is reliable, up-to-date, and based on credible sources.
24LifeScience powers research for top firms in 20+ nations.Chosen by leading life sciences companies worldwide.
We offer competitive pricing models that align with your project scope — no hidden charges, no lock-in. Tailored pricing for every scale and need.
8–10+ years of life sciences expertise turned into strategic insights.We don’t just summarize data we contextualize it.
Whether it's a ready-made report or a custom project, we deliver within the promised timeline With real-time updates