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Rare Disease Genetic Testing Market - A Global and Regional Analysis: Focus on Disease Type, Offering, Specialty Type, Sample Type, Trait Type, Technology, Age Group, End User, and Country Analysis - Analysis and Forecast, 2023-2033
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  • 23andMe Holding Co.
  • 3billion, Inc.
  • Agilent Technologies, Inc.
  • Konica Minolta(Ambry Genetics, Inc.)
  • BGI Group
  • CENTOGENE N.V.
  • Eurofins Scientific SE
  • GeneDx, Holdings Corp.
  • Azenta U.S.A.(GENEWIZ, Inc.)
  • Illumina, Inc.
  • Invitae Corporation
  • Laboratory Corporation of America Holdings
  • Medgenome
  • Myriad Genetics, Inc.
  • OPKO Health, Inc.
  • PerkinElmer, Inc.
  • Exact Sciences Corporation(Prevention Genetics)
  • QIAGEN N.V.
  • Quest Diagnostics Incorporated
  • Strand Life Science Pvt Ltd.

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“Global Rare Disease Genetic Testing Market to Reach $16.69 Billion by 2033.”

Introduction of Rare Disease Genetic Testing

The global rare disease genetic testing market was valued at $4.11 billion in 2022 and is anticipated to reach $16.69 billion by 2033, witnessing a CAGR of 13.69% during the forecast period 2023-2033. Cutting-edge technologies, such as whole-genome sequencing (WGS) and whole-exome sequencing (WES), involve the analysis of an individual's complete genetic code (genome) or specific protein-coding regions (exome), respectively. These methods help identify genetic variations, mutations, or abnormalities responsible for rare diseases.

KEY MARKET STATISTICS
Forecast Period2023 - 2033
2023 Evaluation$4.63 Billion
2033 Forecast$16.69 Billion
CAGR13.69%

Market Introduction

Before the advent of NGS (which includes WGS and WES), physicians relied on the Sanger sequencing-based tests, which could detect rare diseases but were extremely time-consuming. Additionally, till all the tests were completed, physicians had to rely on a general diagnostic odyssey or general diagnosis until definitive results were available. This delayed the treatment process. As per BIS Research, the global rare disease genetic testing market includes panels and tests that can be used for more rare disease genetic testing. These are predominantly polymerase chain reaction (PCR) and next-generation sequencing (NGS) based tests, panels, and assays. The most common rare disease genetic testing panels include gastroenterology, endocrine and metabolism, and neurology disease, among others.

Industrial Impact

The global rare disease genetic testing market has witnessed significant growth, attributed to the increasing demand for early detection of rare diseases. The increasing prevalence of rare diseases has played a critical role in market growth. Furthermore, growing recognition and emphasis on early detection and prevention of rare diseases in pediatric populations around the world are also expected to influence market growth.

Rare disease genetic testing has immense potential to deliver next-level healthcare solutions. For instance, in January 2023, BGI Genomics, in collaboration with the National Centre for Cardiovascular Diseases, Fuwai Hospital, and the State Key Laboratory of Cardiovascular Diseases, developed the "CardioGen automated interpretation system," which serves as the genotype and phenotype database of monogenic cardiovascular disease. Other factors also impact the market growth, including increased patient demand and low turnaround time of these tests.

Market Segmentation:

Segmentation 1: by Disease Type

Endocrine and Metabolism Disease Segment to Dominate the Global Rare Disease Genetic Testing Market (by Disease Type)

Based on disease type, the rare disease genetic testing market is led by endocrine and metabolism, which held a 21.88% share in 2022. The burden of endocrine and metabolism diseases often has a high prevalence in the general population, making their diagnosis and management particularly challenging. Their diagnosis addresses genetic testing such as NGS. Further, it also includes biomarker analysis, newborn screening, and molecular diagnostic techniques.

Segmentation 2: Offering

Services Segment to Dominate the Global Rare Disease Genetic Testing Market (by Offering)

Based on offerings, the rare disease genetic testing market is led by services, which held an 81.58% share in 2022. Services are specifically tailored to meet the distinct requirements of individuals affected by rare diseases, healthcare professionals, and researchers engaged in this field. The availability of these services complements the use of diagnostic products and facilitates comprehensive and personalized rare disease genetic testing.

Segmentation 3: by Specialty Type

Molecular Genetic Tests Occupying the Largest Share in the Market (by Specialty Type)

Based on specialty type, the rare disease genetic testing market is led by molecular genetic tests, which held a 58.89% share in 2022. The key reason for the increasing popularity of molecular genetic testing is that it provides crucial information for genetic counseling and family planning for individuals and families affected by rare diseases. By identifying specific genetic mutations, families can gain insights into the likelihood of disease inheritance and assess the risk of passing on the condition to future generations. This type of testing is utilized to identify genetic disorders in newborns, allowing for prompt intervention and treatment initiation.

Segmentation 4: by Sample Type

Blood Sample to Witness the Highest Growth Between 2023 and 2033

Based on sample type, the rare disease genetic testing market is led by blood samples, and it held a 33.99% share in 2022. Blood samples undergo processing to isolate different components, including white blood cells, serum, or plasma. These isolated components are then subjected to further analysis to detect genetic abnormalities, identify biochemical markers, or explore other diagnostic indicators. Genetic testing methods such as PCR, DNA sequencing, and microarrays can be employed on blood samples to identify specific genetic mutations that are associated with rare diseases.

Segmentation 5: by Trait Type

Inherited Trait to Witness the Highest Growth between 2023 and 2033

Based on trait type, the rare disease genetic testing market is led by inherited traits, which held an 82.59% share in 2022. Inherited traits are characteristics or conditions that are passed down from parents to their offspring through genetic material, i.e., DNA. These traits result from variations or mutations in the genes and can increase the risk of developing certain rare diseases.

Segmentation 6: by Technology

NGS to Dominate the Global Rare Disease Genetic Testing Market (by Technology)

Based on technology, the rare disease genetic testing market is led by next-generation sequencing (NGS), and it held a 43.80% share in 2022. NGS technology provides higher sensitivity and specificity in detecting genetic variants, including single-nucleotide variants (SNVs), insertions, deletions, and structural rearrangements. This technology also extends its applications to non-invasive prenatal testing, including the detection of fetal chromosomal abnormalities associated with certain rare genetic conditions.

Segmentation 7: by Age Group

Prenatal to Witness the Highest Growth between 2023 and 2033

Based on age group, the rare disease genetic testing market is led by the prenatal age group, which held a 39.68% share in 2022. Prenatal testing and diagnostics play a crucial role in identifying potential rare diseases and congenital abnormalities in the fetus. Prenatal testing methods such as chorionic villus sampling (CVS) and amniocentesis are employed to detect genetic disorders or developmental issues.

Segmentation 8: by End User

Hospitals to Dominate the Global Rare Disease Genetic Testing Market (by End User)

Based on end users, the rare disease genetic testing market is led by hospitals, which recorded a 53.12% share in 2022. Hospitals are at the forefront of adopting syndromic testing panels into routine healthcare procedures. Hospitals, particularly in leading regions such as North America and Europe, and also to a certain extent in Asia-Pacific, have incorporated syndromic testing panels and assays to provide superior care to patients.

Segmentation 9: by Region

Regions such as North America and Europe have technologically advanced industries and allocate considerable budgets to research and development (R&D) activities. Moreover, a maximum number of rare disease testing is done there, due to which these regions hold the maximum share in the global rare disease genetic testing market.

Recent Developments in the Rare Disease Genetic Testing Market

Demand - Drivers, Challenges, and Opportunities

Market Demand Drivers:

Market Challenges:

Market Opportunities:

How Can This Report Add Value to an Organization?

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.

Key Companies Profiled:

  • 23andMe Holding Co.
  • 3billion, Inc.
  • Agilent Technologies, Inc.
  • Konica Minolta (Ambry Genetics, Inc.)
  • BGI Group
  • CENTOGENE N.V.
  • Eurofins Scientific SE
  • GeneDx, Holdings Corp.
  • Azenta U.S., Inc. (GENEWIZ, Inc.)
  • Illumina, Inc.
  • Invitae Corporation
  • Laboratory Corporation of America Holdings
  • Medgenome
  • Myriad Genetics, Inc.
  • OPKO Health, Inc.
  • PerkinElmer, Inc.
  • Exact Sciences Corporation (Prevention Genetics)
  • QIAGEN N.V.
  • Quest Diagnostics Incorporated
  • Strand Life Science Pvt Ltd.

Table of Contents

1 Market

2 Competitive Insights

3 Global Rare Disease Genetic Testing Market (by disease type), 2022-2033

4 Global Rare Disease Genetic Testing Market (by Offering), 2022-2033

5 Global Rare Disease Genetic Testing Market (by Specialty Type), 2022-2033

6 Global Rare Disease Genetic Testing Market (by Sample Type), 2022-2033

7 Global Rare Disease Genetic Testing Market (by Trait Type), 2022-2033

8 Global Rare Disease Genetic Testing Market (by Technology), 2022-2033

9 Global Rare Disease Genetic Testing Market (by Age Group), 2022-2033

10 Global Rare Disease Genetic Testing Market (by End User), 2022-2033

11 Global Rare Disease Genetic Testing Market (by Region)

12 Company Profiles

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