The global genetic analysis market was evaluated at USD 10.55 billion in 2023 and is expected to attain around USD 23.60 billion by 2033
The global genetic analysis market was evaluated at USD 10.55 billion in 2023 and is expected to attain around USD 23.60 billion by 2033, growing at a CAGR of 8.39% from 2024 to 2033. The increasing demand for genetic testing services is driving growth within the genetic analysis market.
Market Overview
The genetic analysis market is experiencing significant transformation due to advances in genetic technology, which are fundamentally changing perceptions and practices within the healthcare industry. At the heart of this transformation lies the process of genetic analysis, which involves the examination of DNA samples to identify mutations that may influence disease susceptibility or treatment response. This analysis is pivotal for understanding the structure and function of genes, with techniques such as gene cloning playing a crucial role in isolating and replicating specific genes for detailed examination.
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One notable aspect of genetic analysis is its diverse clinical applications. It serves as a diagnostic tool, aiding in the confirmation of diagnoses in symptomatic individuals, while also facilitating the monitoring of disease prognosis and treatment response. Additionally, genetic analysis enables predictive or predisposition testing, allowing for the identification of individuals at risk of developing certain diseases before symptoms manifest.
The emergence of predictive genetic testing is creating new market opportunities, as it enables proactive disease prevention strategies and early interventions. As perceptions regarding genetic testing continue to evolve, the market for genetic analysis is expected to witness sustained growth, driven by its potential to revolutionize patient care and improve health outcomes.
Key Insights
- North America dominated the market in 2023.
- By product, the reagents & kits segment dominated the market in 2023.
- By test, the disease diagnostic testing segment dominated the largest share in 2023.
- By technology, the real-time PCR system segment dominated the genetic analysis market in 2023.
- By application, the infectious diseases segment dominated the market in 2023.
- By end-use, the research & development laboratories segment dominated the market in 2023.
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North America to sustain its position in the upcoming years with the U.S. being largest contributor
In 2023, North America emerged as the dominant force in the genetic analysis market, particularly in the United States. The US showcased a robust infrastructure with 200 laboratories actively conducting 37,124 clinical tests, underscoring the region’s significant investment and adoption of genetic analysis technologies. Notably, 29 laboratories specialized in whole exome sequencing (WES), while 17 laboratories focused on whole genome sequencing (WGS), indicating a wide array of genetic testing capabilities available within the country.
The United States exhibits a proactive approach towards healthcare, as evidenced by mandatory newborn screening programs targeting a specific set of genetic diseases. Although the exact set of diseases screened may vary from state to state, the emphasis remains on conditions where early diagnosis is crucial for effective treatment or prevention strategies. This regulatory framework underscores the importance placed on leveraging genetic analysis for proactive healthcare management and disease prevention initiatives.
Beyond clinical applications, genetic analysis in North America extends to ecological and environmental contexts. The presence of invasive species such as Phragmites australis subsp. australis poses ecological challenges across multiple regions. The co-occurrence of this invasive subspecies with native counterparts and instances of hybridization necessitates precise differentiation methods for effective management strategies. Genetic analysis plays a pivotal role in distinguishing between phragmites subspecies or haplotypes, facilitating targeted management efforts to mitigate ecological harm and preserve native ecosystems.
- In September 2023, amidst global efforts to advance genome-based testing readiness, it was emphasized that Canada’s health systems couldn’t afford to fall behind.
- March 2024 saw the introduction of a novel genetic analysis tool designed to track risks associated with CRISPR edits. This classification system utilized genetic fingerprints to identify unintended ‘bystander’ edits that may be linked to emerging disease therapies.
- March 2024 witnessed the launch of Nucleus Genomics, aimed at democratizing access to whole-genome sequencing for the public. This initiative marked a significant milestone in genetic analysis accessibility.
Asia Pacific to witness lucrative opportunities in the upcoming years
Asia Pacific emerges as a pivotal region poised for substantial growth in the genetic analysis sector, driven by dynamic developments in genetic counselling and genome mapping initiatives. Forecasts indicate that Asia Pacific will experience the fastest growth rate in the genetic analysis market during the forecast period, underscoring the region’s significance in shaping the future of genetic healthcare services.
A recent milestone in the region’s genetic counselling landscape is the establishment of the Professional Society of Genetic Counsellors in Asia (PSGCA). Formed as a special interest group of the Asia Pacific Society of Human Genetics, PSGCA aims to spearhead the advancement and integration of the genetic counselling profession across Asia. With a vision to become the premier organization driving genetic counselling mainstream adoption in the region, PSGCA endeavors to ensure equitable access to genetic counselling services for individuals. Its mission centers on elevating standards of practice, curriculum, research, and continuing education to promote quality genetic counselling services throughout Asia.
The rapid evolution of genetic and genomic technologies has significantly transformed healthcare services in low- and middle-income countries (LMICs) across the Asia-Pacific region. Initially focused on population-based disease prevention strategies, genetic services have transitioned towards clinic-based and therapeutics-oriented approaches. Notably, the region’s genetic diversity, exemplified by populous and genetically varied countries such as China, India, Japan, and Indonesia, positions them as prime candidates for genome mapping research endeavors.
- In April 2023, Genome Mapping took center stage in the Asia Pacific Region, with extensive research initiatives leading the way. Large-scale projects and individual researchers explored the genetic diversity of populations to advance medicine and other fields.
How the genetic analysis market in Asia Pacific
- In February 2024, the Indian Council of Medical Research (ICMR) offered free genetic testing services for rare diseases in India. This initiative aimed to enhance accessibility to genetic testing and counselling services, particularly in Maharashtra.
- January 2023 marked Genetic Analysis AS’s collaboration with Microbiome Research Pvt. Ltd., introducing GA-map technology in India. This partnership aimed to leverage advanced genetic analysis techniques to address healthcare needs within the Indian market.
- In January 2024, SOPHiA GENETICS and Karkinos Healthcare formed a strategic partnership to advance cancer research in India. This collaboration aimed to harness innovative genetic analysis solutions to enhance cancer diagnostics and treatment outcomes.
Report Highlights
By Product
The reagents & kits segment asserted dominance in the genetic analysis market in 2023. DNA reagents play a pivotal role in various DNA-related processes and techniques, including sequencing, synthesis, cloning, and mutagenesis. These products encompass a diverse range, such as plasmids, buffers, labeling technology, columns, and comprehensive test kits utilized in DNA testing, including direct-to-consumer (DTC) genetic tests. While offering accessible information about the scientific basis of tests, the usage of DTC genetic tests carries inherent risks due to the absence of personalized guidance concerning the results.
The instruments segment emerged as the fastest-growing sector within the genetic analysis market. Core laboratory instruments constitute essential tools in genetic engineering research, facilitating precise and reliable experimentation. Polymerase Chain Reaction (PCR) machines, also known as thermal cyclers, stand as indispensable equipment in genetic engineering labs, enabling the amplification of specific DNA segments crucial for detailed analysis.
- In April 2023, CENTOGENE launched the NEW CentoGenome, the world’s most comprehensive whole-genome sequencing solution for diagnosing rare and neurodegenerative diseases.
By Test
In 2023, the disease diagnostic testing segment emerged as the dominant force in the genetic analysis market. This segment specializes in identifying whether individuals harbor specific genetic diseases by detecting alterations in particular genes. While these tests excel at pinpointing gene mutations, they often fall short in determining disease severity or age of onset. Thousands of diseases stem from mutations in a single gene, making diagnostic testing pivotal in confirming or ruling out genetic diseases and chromosomal abnormalities. Frequently utilized during pregnancy or when symptomatic, diagnostic genetic testing offers crucial insights for accurate diagnosis and timely intervention.
- In October 2023, Basepaws introduced the most extensive DNA test for dogs, focusing on health and early detection of disease risk.
The prenatal and newborn testing segment emerged as the fastest-growing sector in the genetic analysis market during the forecast period. Prenatal genetic testing provides prospective parents with vital information regarding potential genetic disorders in the fetus. Prenatal screening tests assess the likelihood of fetal aneuploidy and select disorders, while prenatal diagnostic tests definitively ascertain the presence of specific disorders. These tests, conducted on fetal or placental cells obtained through procedures like amniocentesis or chorionic villus sampling (CVS), play a pivotal role in informed decision-making during pregnancy.
Newborn screening, a subset of prenatal and newborn testing, comprises a set of laboratory tests performed on newborns to detect known genetic diseases. Typically conducted via a heel prick within the first few days of life, newborn screening enables early identification and intervention for treatable genetic conditions, thereby improving health outcomes. As the demand for early detection and preventive measures rises, the prenatal and newborn testing segment is poised for continued growth, bolstering the comprehensive landscape of genetic analysis.
- In December 2023, a reproductive startup introduced a test to identify genetic defects in IVF embryos before the initiation of pregnancy.
By Technology
In 2023, the real-time PCR system segment emerged as the dominant force in the genetic analysis market. Real-time PCR (RT-PCR) systems offer unparalleled capabilities for quantitative genotyping and detection of single nucleotide polymorphisms (SNPs), allelic discrimination, and genetic variations even in samples with minimal mutation carriers. Multiplex PCR systems, a subset of RT-PCR, are gaining prominence, particularly in plant/microbe associations, where standard PCR methods prove inadequate. Multiplex RT-PCR facilitates the identification of multiple genes through the utilization of fluorochromes and analysis of melting curves, providing enhanced accuracy and efficiency in genetic analysis.
The next-generation sequencing (NGS) segment emerged as the fastest-growing sector in the genetic analysis market. NGS technology revolutionizes DNA sequencing and RNA sequencing and variant/mutation detection by enabling high-throughput sequencing of hundreds to thousands of genes or whole genomes within a short timeframe. The sequence variants/mutations detected by NGS hold profound implications for disease diagnosis, prognosis, therapeutic decision-making, and patient follow-up, paving the way for personalized precision medicine initiatives.
- In January 2023, Agilent announced the acquisition of Avida Biomed, a developer of high-performance NGS target enrichment workflows for cancer research.
- In January 2023, QIAGEN completed the acquisition of Verogen, strengthening its leadership in Human ID / Forensics with NGS technologies.
By Application
In 2023, the infectious diseases segment asserted dominance in the genetic analysis market, offering molecular genetic tests capable of identifying common viruses or bacteria responsible for respiratory infections and infectious diarrhea. These tests, conducted on samples collected from the nose and throat or a single stool sample, facilitate rapid and accurate diagnosis, enabling timely treatment and containment of infectious outbreaks.
The genetic diseases segment emerged as the fastest-growing sector in the genetic analysis market during the forecast period. The extent to which genes contribute to diseases varies, presenting opportunities for advancements in understanding genetic mechanisms underlying various conditions. This progress facilitates the development of early diagnostic tests, novel treatments, and preventive interventions to mitigate disease onset or severity.
- In January 2022, Exact Sciences acquired PreventionGenetics to accelerate hereditary cancer testing availability for more patients. · In December 2023, Axiom and Choice Genetics announced the acquisition of Choice Genetics France, Poland, and Brazil by the Axiom Group.
By End Use
In 2023, the research & development laboratories segment emerged as the dominant force in the genetic analysis market, actively driving advancements in genetic disease study and testing technology. These laboratories are pivotal in enhancing clinical patient care by conducting rigorous research and development activities aimed at improving test strategies and introducing novel genetic tests. Board-certified directors and genetic counsellors collaborate closely with laboratory supervisors and technologists to ensure the delivery of accurate and reliable results within stipulated timelines. With a focus on meeting stringent validation standards, approved tests undergo thorough evaluations of methodology and clinical utility. Research programs within these laboratories leverage collective expertise to propel the field of genetics and genetic testing forward.
The diagnostic centers segment is poised for significant growth in the genetic analysis market during the forecast period. Diagnostic centers offer a comprehensive range of testing services crucial for diagnosing diverse medical conditions. By providing accurate and informed diagnoses, diagnostic centers enable physicians to develop effective treatment plans, ultimately enhancing patient outcomes. Leveraging advanced diagnostic technologies and techniques, these centers play a vital role in identifying underlying causes of diseases, monitoring disease progression, and devising personalized treatment approaches. Collaborating with healthcare providers like primary care physicians, specialists, and hospitals, diagnostic centers ensure accurate and timely diagnoses across a spectrum of medical conditions, reinforcing their indispensable role in modern healthcare delivery.
- In June 2022, Zoetis announced an agreement to acquire Basepaws, a leader in petcare genetics, to enhance its precision animal health solutions portfolio.
Market Dynamics
Driver: Advances in Genetic Sequencing and Gene Therapy
Significant strides in genetic sequencing, human genome analysis, and medical genetics have revolutionized disease understanding, diagnostic accuracy, and drug development targets. A pivotal breakthrough in medical genetics is the emergence of gene therapy, which involves modifying or replacing genes to treat or prevent diseases. Already applied successfully in treating conditions like inherited blindness and severe combined immunodeficiency (SCID), gene therapy is poised to expand its impact further.
Future projections indicate that gene therapy will play an increasingly vital role in medical genetics, offering treatments for previously untreatable diseases. This trajectory is expected to fuel the growth of the genetic analysis market, as the demand for advanced genetic testing and analysis escalates to support the development and implementation of gene therapy treatments.
- In February 2024, Cord Blood Registry (CBR) by CooperSurgical and Fulgent Genetics launched innovative genetic testing.
Restraint: Privacy Concerns in Genetic Analysis
Privacy concerns poses a major challenge in the genetic analysis domain due to the inherent uniqueness of genomic data, hindering true anonymization efforts. Additionally, security measures are crucial to restrict access to data based on authorized clearance levels, safeguarding against unauthorized breaches. Confidentiality emerges as a key ethical consideration, dictating the responsible sharing of genetic data. These privacy concerns, among others, including consent and data ownership, serve as significant restraints in the genetic analysis market. Addressing these challenges effectively is essential to ensure ethical practices and foster trust among stakeholders, thereby mitigating the barriers to market growth.
Opportunity: Integration of Artificial Intelligence in Genetic Analysis
The integration of artificial intelligence (AI) is revolutionizing clinical genetics, offering unprecedented opportunities for advancement. AI algorithms possess the capability to analyse vast volumes of genetic data rapidly and accurately, facilitating more precise diagnoses and tailored treatment plans. Furthermore, AI empowers predictive analysis of disease risk, enabling the development of proactive disease prevention strategies. In genetic engineering and gene therapy research, AI serves as a powerful tool, aiding in hypothesis generation and experimental techniques. Leveraging AI, researchers can detect hereditary and gene-related disorders with greater efficiency.
Moreover, AI-driven developments hold immense promise for rational drug discovery and design, ultimately impacting humanity’s well-being. As AI and machine learning (ML) technologies continue to drive innovation in drug development, genetics emerges as a prime beneficiary, with AI expected to influence every facet of the human experience. This presents a compelling opportunity for the genetic analysis market to capitalize on AI-driven advancements and propel transformative growth.
- In June 2023, Illumina introduced AI software designed to forecast genetic mutations that could lead to diseases in patients.
Recent Developments
- In March 2024, Invitae introduced an update to its Invitae Generation Clinical Variant Modeling, which enhanced variant classification accuracy.
- In July 2023, Quest launched a consumer-initiated genetic test on questhealth.com, providing personalized health risk insights.
- In June 2022, Avesthagen launched a breakthrough genetic testing portfolio for cancer and other diseases and formed a strategic alliance with Wipro.
- In November 2023, QIAGEN launched a complete Sample to Insight workflow for microbiome research.
Key Players in the Clinical Trials Market
- Thermo Fisher Scientific
- Abbott Laboratories
- PerkinElmer, Inc.
- BioRad Laboratories
- AutoGenomics Inc.
- ELITech Group
- IntegraGen
- Quest Diagnostics Inc.
- Hoffmann-La Roche AG
- Celera Group
- Qiagen
- Danaher (Cepheid)
Segments Covered in the Report
By Product
- Reagents & Kits
- Instruments
- Software
By Test
- Predictive Genetic Testing
- Carrier Testing
- Prenatal and Newborn Testing
- Disease Diagnostic Testing
- Pharmacogenomic Testing
- Others
By Technology
- Next-Generation Sequencing (NGS)
- Real-Time PCR System
- Others
By Application
- Cancer
- Genetic Diseases
- Cardiovascular Diseases
- Rare Diseases
- Infectious Diseases
- Others
By End-use
- Hospitals
- Research & Development Laboratories
- Diagnostic Centers
- Others
By Geography
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East and Africa
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