The global genetic disorders market size was evaluated at US$ 15.95 billion in 2023 and is expected to surpass around US$ 50.61 billion by 2033, growing at a CAGR of 12.24% from 2024 to 2033. The genetic disease market is expected to grow with the identification of 6,000-8,000 rare diseases (RDs), of which approximately 80% are genetic and 50-75% initiate from early childhood.
What are genetic disorders?
Genetic disorders arise when a mutation, also known as a pathogenic variant, affects your genes or when there’s an abnormal amount of genetic material. Genes, composed of DNA (deoxyribonucleic acid), carry the instructions for cellular function and the traits that make each individual unique.
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You inherit half of your genes from each biological parent, and a gene mutation may be passed down from one or both parents. Sometimes, gene mutations occur due to DNA changes. These mutations can increase the risk of developing a genetic disorder. Some genetic disorders manifest at birth, while others emerge later in life.
Report Coverage | Details |
Genetic Disorders Market Size | USD 50.61 Billion by 2033 |
Genetic Disorders Market Growth Rate | CAGR of 12.24% |
Dominated Region | North America |
Fastest Growing Region | Asia Pacific |
Genetic disorders can be classified into several types:
- Chromosomal: These disorders impact the structures (chromosomes) that hold your genes and DNA within each cell. Individuals with these conditions may have missing or duplicated chromosome material.
- Complex (multifactorial): These disorders result from a combination of gene mutations and other factors, such as chemical exposure, diet, certain medications, and the use of tobacco or alcohol.
- Single-gene (monogenic): This category includes conditions caused by a mutation in a single gene.
Top Trends in the Genetic Disorders Market:
- Advanced genetic testing: Technologies like Next-Generation Sequencing (NGS) are enabling faster, more accurate, and affordable DNA analysis. This is driving increased carrier screening, prenatal, and newborn testing.
- Personalized medicine: Genomic profiling and pharmacogenomics are tailoring treatments to individual patients based on their genetic makeup.
- Genetic Counseling and Support: Genetic disorders often come with complex emotional and psychological implications. The market supports genetic counseling services that provide essential support and guidance to individuals and families affected by genetic conditions, helping them make informed decisions and manage the impact of these disorders.
- Gene editing: Innovative tools like CRISPR-Cas9 hold immense promise for treating and potentially curing genetic diseases by modifying defective genes.
- Rising prevalence: The increasing occurrence of genetic disorders, particularly in the aging population, is driving demand for solutions.
- Digital health integration: Telegenetics and data analytics are enhancing accessibility and treatment development.
- Focus on rare diseases: There’s a growing emphasis on developing treatments for rare genetic disorders, driven by patient advocacy and orphan drug development.
Genetic Disorders Market: Growing with Innovations and Advancements
The genetic disease market has grown rapidly because of the emergence of situations like as birth defects, chronic diseases, developmental problems, and mental disorders acquired from one or both parents. These disorders are caused by mutations (genetic variants) that affect the amount of genetic material. Genes, which are made up of DNA, carry instructions for cell function and personality traits, and patients inherit half of their genes from each biological parent.
- Many of these conditions lead to rare diseases, affecting fewer than 200,000 people in the United States, with an estimated 7,000 living with this disorder. The essential to address the diversity and complexity of genetic diseases resulting from single-gene, multifactorial, and chromosomal alterations is driving market expansion and highlighting significant opportunities.
· In April 2024, SOPHiA GENETICS announced a strategic partnership with Strand Life Sciences, a pioneer in bioinformatics and diagnostics, to deliver innovative solutions that will fuel the use of precision medicine globally. The collaboration leverages the strengths of both companies to provide access to advanced genomics technologies, cutting-edge bioinformatics services, and innovative diagnostics solutions.
· In May 2023, Krystal Biotech, Inc. announced that the US Food and Drug Administration (FDA) approved VYJUVEK (beremagene geperpavec-svdt) for treating patients six months of age or older with dystrophic epidermolysis bullosa (DEB). VYJUVEK is designed to address the genetic root cause of DEB by delivering functional copies of the human COL7A1 gene, promoting wound healing and sustained functional COL7 protein expression with redosing.
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Genetic Disorders Market Dynamics
Increasing Awareness and Education to Boost the Market’s Expansion
The problems and mismanagement of genetic diseases often stem from limited knowledge, awareness and limitations. A recent study assessing pregnant women’s knowledge and attitudes about genetic diseases highlights the importance of understanding and accepting the impact of genetics. Genetic disorders can affect cognitive development, leading to learning or intellectual disabilities. Encouraging knowledge is not just about understanding the science, but also about the impact on individuals and families.
By promoting understanding, compassion and awareness, people can better support and include everyone, regardless of their genetics. Education, advocacy, and collaboration are critical to changing attitudes, providing resources, and improving the lives of people with genetic disorders. This increased awareness and education underscores the need for improved diagnostic and treatment solutions, thereby driving the growth of the disease industry.
· In July 2023, Alexion, AstraZeneca Rare Disease, announced a definitive purchase and license agreement for a portfolio of preclinical gene therapy programs and enabling technologies from Pfizer Inc. The agreement furthered Alexion and AstraZeneca’s commitment to advancing next-generation genomic medicines with complementary pipeline assets and innovative technologies.
High Costs and Technological Complexity to Hamper the Market’s Growth
The growth of the genetic disease market is limited due to high costs and complex methods involved in disease diagnosis. The complexity of these tests is determined by the number of genes or alterations evaluated and the level of adjustment required, affecting the overall cost. Customized tests designed for precise conditions or research resolutions will be more costly due to the specific protocol and analysis. Quality laboratories equipped with modern technology, experienced professionals, and strict management also pay extreme cost. Also, the technology used in these tests incurs additional costs, restricts access, and slows down the market.
Advancements in Genetic Therapies to Create Opportunities
Advances in gene therapy, containing gene therapy and gene therapy, present significant opportunities for the genetic disease industry. While gene therapy states to the expression of the function of defective genes in cells, gene therapy or the modification of defective genes in the genome to restore their function. Two strategies to eliminate the cause of the disease and the ability to complete the treatment. The ideal gene therapy will correct the defective gene without activating the oncogene or causing adverse effects, immunity or disease. Since proto-oncogenes play a key role in cell growth and development, accurate and safe gene editing opens up new opportunity for treating genetic diseases, encouraging market development and innovation.
· In April 2024, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved BEQVEZ (fidanacogene elaparvovec-dzkt) for treating adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, have current or historical life-threatening hemorrhage, or experience repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test.
Genetic Disorders Market Government Support
Government support is instrumental in driving advancements and accessibility in the genetic disorders market. Many countries are recognizing the significant impact of genetic diseases on public health and are investing in research, development, and patient care.
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Key areas of government support include:
- Research Funding: Governments allocate substantial funds for genetic research, supporting the development of new diagnostic tools, therapies, and preventive measures.
- Regulatory Frameworks: Clear and supportive regulatory environments encourage innovation in genetic technologies while ensuring patient safety and data privacy.
- Patient Support Programs: Governments often provide financial assistance, access to specialized care, and support services for patients with genetic disorders.
- Public Awareness Campaigns: Education and awareness initiatives help to reduce stigma, improve early diagnosis, and promote genetic counseling.
- Collaborations: Governments foster partnerships between public and private sectors to accelerate research and development.
- Orphan Drug Incentives: Tax breaks and other incentives encourage pharmaceutical companies to develop treatments for rare genetic diseases.
Examples of Government Initiatives:
- The U.S. National Institutes of Health (NIH): The NIH is a major funder of genetic research, supporting a wide range of studies from basic science to clinical trials.
- The UK’s 100,000 Genomes Project: This ambitious initiative aims to sequence the genomes of 100,000 patients to improve diagnosis and treatment of rare diseases and cancer.
- India’s Ayushman Bharat: While primarily focused on healthcare access, this program includes provisions for treatment of rare diseases, including genetic disorders.
Why is North America expanding the genetic disorders market?
The genetic disorders market in North America is expanding due to advanced medical care and significant investments in genetic research and technology. Rare diseases affect more than 30 million people in the United States, creating challenges in information, diagnosis, and funding. Cystic fibrosis (CF) is the leading cause of death in the United States. CORD collabrate with governments, researchers, medical professionals, and industry stakeholders to advance research, testing, treatments, and services to provide a holistic treatment that meets the needs of people living with rare diseases. This partnership has contributed to the growth of the region economy.
· In May 2024, Ambry Genetics announced their selection by the University of California, Irvine (UCI) and the GREGoR Consortium (Genomics Research to Elucidate the Genetics of Rare diseases) to support the Pediatric Mendelian Genomics Research Center (MGRC) program to better understand the underlying biology of rare diseases.
Why is Asia Pacific growing faster in the genetic disorders market?
The genetic disorders market in the Asia-Pacific region is growing rapidly due to increased medical expenditure and awareness of genetic diseases. However, the region faces significant challenges such as limited medical knowledge and lack of motivation to meet the needs of patients with rare diseases. To solve these issues, the APEC industry is encouraged to designate rare diseases and orphan products through policies and procedures, increase public and political consciousness of mild rare diseases, promote research and innovation, and create and promote human resources in healthcare and other capacities to provide early, accurate, and diagnostic pain. This generalization goal to improve the management and treatment of rare diseases, thereby driving the growth of the market in the region.
Report Highlights
By Indication
Cystic fibrosis (CF) segment indicates a significant portion of the global disease market. Rate of occurring in around 1 in 2,500 to 3,500 live births, CF is characterized by mucus production that can cause a variety of illnesses. Symptoms include difficulty breathing and digestive issues, and vary in severity from person to person. Once considered a fatal disease for children, treatment and management have increased life expectancy and allowed many people with cystic fibrosis to live older, healthier lives. Adults with cystic fibrosis continue to face health issues affecting their lungs, digestive system, and reproductive health, highlighting the need for new treatments and care strategies in this segment.
On the other hand, the Duchenne muscular dystrophy (DMD) is a main target of the genetic disease industry, caused by muscle degeneration due to mutations in the dystrophin gene. Worldwide, there are fewer than 10 cases of DMD per 100,000 male births; between 1 in 5,000 and 1 in 6,000 are affected by the dystrophic disease. DMD occurs most frequently in individuals with the XY chromosome combination and rarely affects individuals with the XX chromosome combination. It is estimated that fewer than 50,000 people in the United States have DMD. Dystrophin is important for muscle recovery from mechanical stress in normal exercise, and mutations in the DMD gene result in little or no dystrophin production. This inequity causes muscle cells to weaken, degenerate, and eventually die, leading to complete muscle loss. The devastating impact of DMD highlights the critical need for new treatments and effective care strategies in this segment.
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Recent Breakthroughs in Genetic Disorders Market
· In December 2022, Eli Lilly and Company completed its acquisition of Akouos, Inc. This acquisition expanded Lilly’s efforts in genetic medicines to include Akouos’s portfolio of potential first-in-class adeno-associated viral gene therapies for treating inner ear conditions, including sensorineural hearing loss.
· In August 2023, Regeneron Pharmaceuticals, Inc. and Decibel Therapeutics, Inc. announced a definitive agreement for Regeneron to acquire Decibel at a price of $4.00 per share of Decibel common stock payable in cash at closing, with an additional non-tradeable contingent value right (CVR) to receive up to $3.50 per share in cash upon achieving certain clinical development and regulatory milestones.
· In March 2023, Ipsen completed the acquisition of Albireo Pharma, Inc. This acquisition enriched Ipsen’s Rare Disease portfolio with promising therapeutics for pediatric and adult rare cholestatic-liver diseases, innovative pipeline potential, and scientific and commercial capabilities. Ipsen acquired all issued and outstanding shares at $42.00 per share in cash plus one non-transferable contingent value right (CVR) of $10.00 per share.
· In September 2023, Regeneron Pharmaceuticals, Inc. completed its acquisition of Decibel Therapeutics, Inc., strengthening the company’s gene therapy and auditory programs.
· In April 2023, Centogene N.V. extended its partnership with Takeda to diagnose patients with lysosomal storage disorders (LSDs).
Top Companies in the Genetic Disorders Market
· Amicus Therapeutics, Inc. (U.S)
· Alexion Pharmaceuticals, Inc. (U.S)
· Sanofi (France)
· Takeda Pharmaceutical Company Limited (Japan)
· Vertex Pharmaceuticals Incorporated U.S)
· F. Hoffmann-La Roche Ltd (Switzerland)
· Abbott (U.S)
· Amgen Inc. (U.S)
· ELITechGroup (France)
· GW Pharmaceuticals plc. (U.K)
· Pfizer Inc. (U.S)
· PerkinElmer Inc (U.S)
· AutoGenomics (U.S)
· Bio-Rad Laboratories, Inc. (U.S)
· BioMarin (U.S)
· Sarepta Therapeutics (U.S)
Market Segmentation
· By Indication
o CF
o DMD
o LSD
o PNH
· By Disease Type
o Alzheimer’s Disease
o Cancer
o Cystic fibrosis
o Sickle Cell Anaemia
o DMD
o Thalassemia
o Huntington’s Disease
o Rare Diseases
o Others
By Geography
· North America
o U.S.
o Canada
· Europe
o Germany
o France
o United Kingdom
o Rest of Europe
· Asia Pacific
o China
o Japan
o India
o Southeast Asia
o Rest of Asia Pacific
· Latin America
o Brazil
o Rest of Latin America
· Middle East & Africa (MEA)
o GCC
o North Africa
o South Africa
o Rest of Middle East & Africa
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