Optical Genome Mapping Market

Market Overview

The global optical genome mapping market size was valued at USD 131.50 million in 2023. It is estimated to reach USD 883.50 million by 2032, growing at a CAGR of 24.10% during the forecast period (2024–2032).

Optical Genome Mapping (OGM) is a genomic technology that uses optical imaging to create high-resolution maps of entire genomes. It assists researchers in understanding genetic variations, gene functions and the evolution of genes by providing details on DNA structure and organisation. In various applications, such as the assembly of the genome, the detection of structural changes and the study of complex diseases, optical genome mapping is used.

The optical genome mapping market is growing due to the advancements in genomic research, aiding in the study of complex genetic variations and diseases. Additionally, the growing prevalence of genetic disorders is driving the need for advanced genomic technologies like OGM for accurate diagnosis and treatment.

Market Dynamics

Global Optical Genome Mapping Market Drivers

Increasing Prevalence of Genetic Disorders

The rising incidence of genetic disorders and cancers necessitates advanced diagnostic tools. According to the World Health Organization (WHO), genetic disorders affect millions of people globally. Optical genome mapping is particularly useful in identifying structural variations in genomes that are linked to various diseases, driving its adoption.

For instance, The Saphyr optical genome mapping system by Bionano Genomics detects all classes of structural variants down to 500 base pair resolution and 5% variant allele frequency, offering unparalleled accuracy missed by NGS technologies. It achieves 100X human genome coverage in six hours and integrates seamlessly with adaptive loading and automated health monitoring for maximum performance. This system is widely utilized in studies to identify large structural variations in the genomes of cancer patients, which traditional sequencing methods often miss.

Rising Investment in Genomics Research

Governments and private organizations are increasingly investing in genomics research to revolutionize medicine through personalized healthcare, advance disease understanding, and drive biotechnological innovation, leading to economic growth and global competitiveness.

For example, the National Institutes of Health (NIH) in the United States allocated nearly USD 3.0 billion in 2021 for genomics research, significantly increasing funding for projects that involve OGM technologies.

In the United States, the National Institutes of Health (NIH) has significantly increased funding for genomics projects, promoting the demand for advanced technologies like OGM.

Similar trends are seen in Europe, where the European Commission announced two major advancements, the USD 21.6 Million Genome of Europe project, which will sequence 100,000 genomes to create a European reference genome, and the expansion of the European Genomic Data Infrastructure to include Cyprus, Hungary, Malta, and Romania, enhancing cross-border genomic data access and collaboration.

Such investments are aimed at understanding the genetic basis of diseases and developing new diagnostic and therapeutic tools, thereby boosting the demand for OGM technologies.

Global Optical Genome Mapping Market Restraint

Navigating Regulatory Hurdles

Stringent regulatory requirements for diagnostic tools can delay the approval and commercialization of new optical genome mapping technologies. For instance, in the United States, the FDA's regulatory framework for genomic diagnostic tools requires extensive validation and clinical trial data, which can be time-consuming and costly. Similarly, the European Medicines Agency (EMA) has rigorous standards for the approval of diagnostic devices and navigating these regulatory landscapes requires substantial time and financial resources. Such stringent regulatory requirements pose challenges for companies trying to enter the market.

Global Optical Genome Mapping Market Opportunities

Expansion into Emerging Markets

Emerging markets, particularly in Asia-Pacific and Latin America, present significant growth opportunities due to increasing healthcare expenditure and improving healthcare infrastructure. Companies expanding into these regions can tap into new customer bases. Bionano Genomics, Inc. has entered into partnerships with several Chinese research institutions to introduce optical genome mapping (OGM) technology to the region. One of the outcomes of these partnerships is the approval obtained by Bionano's Chinese OEM partner, A-smart MedTech, for reagent class I registration and approval for DNA isolation and labeling kits for OGM from China's National Medical Products Administration (NMPA). These reagents are specifically designed for in vitro diagnostics (IVD) in reproductive health in China, allowing A-smart to distribute them to independent clinical laboratories and Chinese hospitals.

Moreover, governments in emerging markets are increasingly recognizing the importance of advanced healthcare technologies. Initiatives to boost healthcare infrastructure and investment, such as India's Ayushman Bharat scheme and Brazil's Unified Health System (SUS), are aimed at improving access to advanced diagnostic tools, including OGM. These initiatives are creating a favorable environment for the growth of the optical genome mapping market in these regions.

Integration with Other Technologies

Combining optical genome mapping with other genomic technologies, such as next-generation sequencing (NGS), can provide more comprehensive genomic insights. For example, researchers at the University of California, San Diego, have combined optical genome mapping with NGS to identify complex genomic rearrangements in cancer genomes that were not detectable by NGS alone. This integration can create new applications and expand the utility of optical genome mapping in research and clinical diagnostics.

Regional Analysis

Based on region, the global optical genome mapping market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global optical genome mapping market shareholder and is expected to expand substantially during the forecast period. Increased development in genetic research has made North America a leading region, exemplified by initiatives such as the United States Food and Drug Administration's (FDA) use of whole-genome sequencing (WGS) for food safety. WGS, a technology that reveals an organism's entire DNA makeup, allows the FDA to better understand genetic variations within and between species. This demonstrates North America's leadership in genetic research and its impact on the optical genome mapping market.

The United States optical genome mapping market is leading in terms of market share due to the presence of manufacturers and key product releases that significantly contributed to the growth of the optical genome mapping market. Bionano Genomics, based in California, sponsored a 2022 clinical trial on 'Validation of Optical Genome Mapping for Identification of Constitutional Genomic Variants in a Postnatal Cohort.' Using OGM with the Saphyr system, the trial aims to detect genomic SVs, showcasing the U.S.'s role in advancing optical genome mapping for genetic research and diagnostics.

Canada is expected to become a key player in the global optical genome mapping market due to its strong commitment to genomics research and innovation. Genome Canada, a leading organization in genomics research, has announced more than USD 41 million in government and private funding for eight new genomics research projects. These projects aim to translate genomics innovations into tangible applications, solutions, and products that address real-world challenges in public health, agriculture, and food security, thereby, increasing the optical genome mapping market.

Asia Pacific region is expected to emerge in optical genome mapping market due to the increasing focus on genomics research, coupled with supportive government policies and a growing biotechnology industry in the region.

China optical genome mapping market has a major role in shaping the dynamics of the Asia Pacific optical genome mapping market. Bionano Genomics' progress in China, as demonstrated by WeHealth Shanghai's adoption of the Saphyr System and various institutions' use of Optical Genome Mapping (OGM) in reproductive health and genetics, is driving the optical genome mapping market in the Asia Pacific region. These developments highlight the growing acceptance and utility of OGM technology in critical areas of genomic research and healthcare, fueling its adoption and expansion in the region.

India is poised to emerge as a key player in the optical genome mapping market due to the advancements in genomics, exemplified by Nucleome's initiatives in the country. Nucleome Informatics, India's leading genomics company, procured South Asia's first PacBio Sequel II system, enhancing its genome assembly capabilities using advanced technologies. Further, MedGenome Labs launched an Optical Genome Mapping Test (OGM) for diagnosing Facioscapulohumeral Muscular Dystrophy Type 1 (FSHD1) in India. This test can detect large-scale insertions and duplications, as well as more subtle changes in DNA that can cause FSHD1. Such innovations are driving the market growth in the country.

Segmental Analysis

The global optical genome mapping market is segmented by product & services, application, and end-user.

Based on product & services, the global optical genome mapping market is divided into instruments, consumables and reagents, software, and services.

The consumables and reagents segment for optical genome mapping market is dominant as these are essential components required for performing optical genome mapping procedures, and are needed in large quantities, contributing significantly to the market's overall revenue. Consumables and reagents include items like DNA extraction kits, labeling kits, and other reagents necessary for sample preparation and analysis. As the demand for diagnosis and research increases, the requirements for these consumables and reagents used in optical genome mapping technologies also increases, driving growth in this segment.

Based on the application, the global optical genome mapping market is bifurcated into structural variant detection, genome assembly, microbial strain typing, and others.

The structural variant detection segment dominates the global optical genome mapping market. Structural variant detection involves the identification of variations in the structure of an organism's genome, which can be crucial for understanding disease mechanisms, genetic disorders, and evolutionary processes. Optical genome mapping provides a high-resolution view of the genome, making it particularly valuable for detecting structural variants. For instance, the 2021 article in Gene's journal highlights Optical Genome Mapping (OGM) as a cost-effective, high-resolution tool for detecting structural and copy number variations in prenatal genomic analyses.

Structural variant detection is essential in various fields such as cancer research, genetic diseases, and population genetics. The increasing focus on personalized medicine and the growing importance of genomic analysis in healthcare further drive the demand for structural variant detection using optical genome mapping.

Several key players are offering innovative solutions to stay competitive in the market such as the launch of the Arima-HiC+ FFPE kit in February 2022. This demonstrates a focus on enabling scientists to detect structural variants in 3D genomic data, which is crucial for understanding disease mechanisms and identifying therapeutic targets. This emphasis on structural variant detection highlights the importance and dominance of this segment in the market.

Based on the end-user, the global optical genome mapping market is bifurcated into biotechnology and pharmaceutical companies, clinical laboratories, academic research institutes, and other.

Clinical laboratories segment dominates the global optical genome mapping market as these laboratories play a crucial role in conducting diagnostic tests and research related to genetic disorders and diseases. Optical genome mapping is increasingly being used in clinical settings for applications such as prenatal screening, cancer diagnostics, and genetic disease testing. The demand for optical genome mapping technologies in clinical laboratories is driven by the growing need for accurate and efficient genetic analysis in patient care.

For instance, in October 2022, Hamilton and Bionano Genomics, Inc. collaborated on developing the Long String VANTAGE for isolating Ultra High Molecular Weight (UHMW) DNA for optical genome mapping (OGM). This collaboration aimed to enhance Bionano's sample preparation workflow by automating the extraction of high-quality UHMW DNA, which is typically done manually. The companies planned to work with clinical research labs to test and further develop applications for the Long String VANTAGE and Bionano Prep SP kits, with some workflows expected to be commercialized by the end of 2022.

Such availability of advanced optical genome mapping systems and the integration of these technologies into clinical workflows have contributed to the dominance of clinical laboratories as a key end-user segment in the global optical genome mapping market.

Recent Developments

• January 2024, Bionano Genomics has launched the full commercial release of the Stratys system for high throughput optical genome mapping (OGM), following a successful early access program. The Stratys system offers up to a four-fold increase in data generation compared to the Saphyr instrument and can process up to 12 single-access chips independently.
• January 2024, Source Genomics, part of the Source BioScience Group, announced the expansion of its genomic laboratory capabilities by incorporating the Element Biosciences AVITI System. This addition enhances their sequencing portfolio to meet growing demand in the UK.