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희귀질환 유전자 검사 시장 : 성장, 동향, COVID-19의 영향, 예측(2021-2026년)

Rare Disease Genetic Testing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

리서치사 Mordor Intelligence Pvt Ltd
발행일 2021년 05월 상품 코드 1008463
페이지 정보 영문
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희귀질환 유전자 검사 시장 : 성장, 동향, COVID-19의 영향, 예측(2021-2026년) Rare Disease Genetic Testing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)
발행일 : 2021년 05월 페이지 정보 : 영문

본 상품은 영문 자료로 한글과 영문목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

희귀질환 유전자 검사 시장 규모는 2021-2026년 예측기간 중 약 10%의 CAGR로 성장할 것으로 예측됩니다.

시기적절하고 정확한 진단의 필요성은 시장 성장을 촉진하는 중요한 요인의 하나입니다. Orphanet Journal of Rare Diseases에 게재된 전국 규모 횡단적 조사에서는 중국의 2,040명 희귀질환 환자가 포함되어 있으며, 질환 관련 정보로의 액세스가 어려운 환자는 오진될 가능성이 4-5배 높다른 결론을 내렸습니다. NGS 기반 유전자 검사 등의 신기술 발표와 진단이나 정부 대처에 대한 수요 증가는 희귀질환 유전자 검사 시장 성장에 기여할 가능성이 있습니다.

희귀질환은 극히 소수의 사람에게 영향을 미치기 때문에 조사나 임상 연구는 어렵습니다. 조사 활동을 위한 충분한 자금이 있어도 데이터 수집을 위한 환자수가 적고, 질병 진행에 대한 이해가 한정되어 있는 등 자원이 부족합니다. 또한 이러한 질병 대부분은 아동에 영향을 미치기 때문에 프로세스가 복잡해집니다. 임상시험과 관련된 진단과 과제에 대한 인식 결여는 시장 성장을 저해할 가능성이 있습니다.

희귀질환 유전자 검사(Rare Disease Genetic Testing) 시장을 조사했으며, 시장 개요, 기술별, 질환별, 최종사용자별 시장 규모 추정과 예측, 시장 성장 촉진요인 및 저해요인 분석, 시장 기회, 주요 기업 개요 등을 제공합니다.

목차

제1장 서론

제2장 조사 방법

제3장 주요 요약

제4장 시장 역학

  • 시장 개요
  • 시장 성장 촉진요인
    • 정확한 진단 필요성
    • 유전자 검사 기술 개발
    • 희귀질환에 대한 정부 대처 확대
  • 시장 성장 억제요인
    • 희귀질환에 대한 의식 결여
    • 조사를 위한 한정된 자원
  • Porter's Five Forces 분석

제5장 시장 세분화

  • 기술별
    • 차세대 시퀀싱
    • 어레이 기술
    • PCR 검사
    • FISH 검사
    • 기타 기술
  • 질환별
    • 신경학적 장애
    • 면역질환
    • 혈액질환
    • 내분비 및 대사 질환
    • 근골격질환
    • 기타 질환
  • 최종사용자별
    • 클리닉·병원
    • 진단 연구소
    • 기타 최종사용자
  • 지역별
    • 북미
    • 유럽
    • 아시아태평양
    • 기타 지역

제6장 경쟁 상황

  • 기업 개요
    • Quest Diagnostics Incorporated
    • CENTOGENE NV
    • Invitae Corporation
    • 3billion Inc.
    • ARUP Laboratories
    • Eurofins Scientific
    • Strand Life Sciences
    • Ambry Genetics
    • PerkinElmer Genetics Inc.
    • Macrogen Inc.
    • Baylor Genetics
    • Color Health Inc.
    • Health Network Laboratories

제7장 시장 기회와 동향

KSM 21.06.16

The rare disease genetic testing market is projected to register a CAGR of nearly 10% over the forecast period (2021 - 2026).

The COVID-19 pandemic impact on the rare disease genetic testing market is significant. The rise in COVID-19 cases has led to global healthcare services shift their resources toward COVID-19 care while impacting patients with rare diseases. According to the Eurordis international survey, rare disease patients seemed to have a worse experience than chronic disease patients due to the pandemic. 60% of patients have experienced interrupted care, and 80% canceled or postponed their appointments. Inability to access care is expected to make the diagnosis of potential rare diseases much more difficult. A research study published in the Journal of Medical Genetics shows that the blood draws for genetic testing decreased from 97.7% to 94.1% during the pre-virtual and virtual care period, along with the longer time taken for patients to give their blood sample in Canada's cancer center. The pandemic has led to the shut down of companies and other non-healthcare businesses to reduce the spread of the virus. The lack of healthcare services and canceled or postponed appointments result in the underdiagnosis of rare disease patients, which may impact the market.

According to Global Genes, 400 million people, worldwide, are affected by rare diseases, out of which 30 million are Americans. There is a total of 7,000 rare diseases identified, and only 5% of them have FDA-approved treatment. The need for timely and accurate diagnosis is one of the key factors that may drive market growth. A national cross-sectional survey published in Orphanet Journal of Rare Diseases, which included 2040 rare disease patients in China, concluded that patients who have difficulty accessing disease-related information are 4-5 times more likely to get misdiagnosed. In 2018, EURORDIS, Microsoft, and Takeda came together to launch 'Global Commission to End Diagnostic Odyssey for Children with a Rare Diseases', which includes Machine Learning and Blockchain patient registry to find patterns and symptoms of rare disease, raise awareness among the public and physicians, and give patients and their families control of their health records. In January 2021, UK Rare Disease Framework was launched, which focuses on faster diagnosis, awareness, care, and access to treatment for 3.5 million rare disease patients over 5 years. The launch of new technologies, such as NGS-based genetic testing and increased demand for diagnosis and government initiatives, may contribute to the growth of the rare disease genetic testing market.

Underdiagnosis of a rare disease may often go for extended periods due to the limited awareness of patients, families, and physicians, as they may have never encountered one. In April 2021, a survey was conducted in China involving 224 physicians, out of which only 5.3% were moderately well-aware of rare diseases. In February 2020, the National Organization for Rare Disorders (NORD) launched a registry for rare undiagnosed diseases, to collect information regarding unidentified rare medical cases through electronic surveys. Rare disease affects very few people, which makes research or clinical studies difficult. Even with sufficient funding for research activities, there exists a lack of resources, such as the low patient population for data collection and limited understanding of the progression of the disease. Furthermore, the majority of these diseases affect children, which adds to the complexity of the process. Lack of awareness of diagnosis and challenges associated with clinical studies is likely to inhibit the market growth.

Key Market Trends

Next-Generation Sequencing (NGS) is Expected to Occupy a Significant Share over the Forecast Period

With the emergence of COVID-19 in China, authorities started developing its genome sequence, which is crucial for diagnosing and identifying possible treatments. Thus, sequencing techniques have played a crucial role during the pandemic for research scientists and industries. The effective and rapid solutions from NGS have enabled sequencing multiple samples and detecting the virus. In December 2020, a report published in European Centre for Disease Prevention and Control assessed the risk of new virus variants in Europe. Genome sequencing was used to confirm the cases of this new variant.

Similarly, a different variant was confirmed in South Africa using the WGS sequencing. In June 2020, the US FDA gave the Emergency Use Authorization for Illumina Inc. to utilize NGS-based technology, COVIDSeq, to detect COVID-19. The COVID-19 pandemic has portrayed the true potential of this technique.

Next Generating Sequencing (NGS) may occupy a significant share of the rare disease genetic testing market over the forecast period (2021 - 2026). This is due to the high adoption of the Whole Exome Sequencing (WES) genetic testing tool. This technique targets only exons, which make 1-2% of the whole genome containing 80% of all disease-causing mutations. Such continuous technological developments and AI incorporation within sequencing are expected to provide accurate and rapid results. In December 2020, Invitae expanded its service by updating patient's reports regularly through the introduction of Routine Exome Reanalysis every six months for three years. Additionally, with declining costs of exome sequencing, overall costs of genetic testing may decrease, making it affordable.

Governments, worldwide, are increasingly getting involved in developing genome programs, such as the 100,000 Genomes Project, in the United Kingdom to improve care for rare disease individuals and the All of Us initiative for precision medicine in the United States. Recently, in January 2020, the Department of Biotechnology in India initiated a Whole Genome Sequencing project, Genome India Project (GIP), to collect 10,000 genetic samples to build a reference genome. Thus, increasing the application of NGS's potential within different healthcare aspects is expected to contribute to its major share.

North America is Expected to Dominate the Rare Disease Genetic Testing Market

The impact of COVID-19 on the United States is significant. An increasing number of people with COVID-19 were given priority over other non-emergent cases. Patients delayed or canceled their hospital visits due to fear of getting infected. Hospitals postponed appointments and switched to virtual consultations. A survey was conducted by the Rare Diseases Clinical Research Network receiving 3,400 responses, and the preliminary results give information on COVID-19 impact. According to the survey, the pandemic negatively affected rare disease patients and caregivers due to lack of access to healthcare, diet, and treatment. About 25% responded that their appointments were put on hold, and 45% switched to telemedicine. Nearly 40% of respondent's special treatment was interrupted, and 20% sought a professional due to the stress and anxiety of the pandemic.

North America is expected to dominate the Rare Disease Genetic Testing market over the forecast period. Rare diseases are prevalent in around 30 million Americans according to Global Genes and 3.1 million Canadians according to Canadian Organization for Rare Disorders. Due to the high prevalence in America, the government has provided support for patients with rare diseases through research grants and funds. With only 5% of rare diseases having FDA-approved treatment, NIH has provided USD 31 million in grants to study rare diseases between 2019 and 2020. Similarly, in October 2020, the US FDA carried out Orphan Drug Act, awarded over USD 16 million for six clinical trial research studies to industry and academia for the next four years. In June 2018, Genome Canada announced a national initiative of sequencing 30,000 rare disease patient samples and their relatives for precision medicine implementation.

In 2020, out of the total novel drug approved by the Center for Drug Evaluation and Research (CDER), 58% were orphan drugs used to treat rare diseases. Furthermore, in 2020, HDL Therapeutics Inc. received Humanitarian Device Exemptions for its Plasma Delipidation System to treat a rare genetic disease Homozygous Familial Hypercholesterolemia. Along with rising prevalence and increased approvals, the supportive healthcare infrastructure, government initiatives, and technological advancements in North America are expected to occupy a major market share.

Competitive Landscape

The rare disease genetic testing market remains highly competitive, with many players. Due to the nature of the disease, the demand for diagnosis is high. Moreover, recent developments in genetic testing technologies have led to strategic acquisitions and collaborations. Some of the major players include Quest Diagnostics Incorporated, CENTOGENE NV, Invitae Corporation, 3billion Inc., ARUP Laboratories, Eurofins Scientific, Strand Life Sciences, Ambry Genetics, PerkinElmer Genetics Inc., Macrogen Inc., Baylor Genetics, Color Health Inc., Health Network Laboratories, Prevention Genetics, Coopersurgical Inc., Opko Health Inc., Illumina Inc., Fulgent Genetics, and Progenity Inc.

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TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Need for Accurate Diagnosis
    • 4.2.2 Development in Genetic Testing Technologies
    • 4.2.3 More Government Initiatives for Rare Diseases
  • 4.3 Market Restraints
    • 4.3.1 Lack of Awareness Regarding Rare Diseases
    • 4.3.2 Limited Resources for Research
  • 4.4 Industry Attractiveness - Porter's Five Forces Analysis
    • 4.4.1 Bargaining Power of Buyers/Consumers
    • 4.4.2 Bargaining Power of Suppliers
    • 4.4.3 Threat of New Entrants
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION

  • 5.1 By Technology
    • 5.1.1 Next-generation Sequencing
      • 5.1.1.1 Whole Exome Sequencing (WES)
      • 5.1.1.2 Whole Genome Sequencing (WGS)
    • 5.1.2 Array Technology
    • 5.1.3 PCR-based Testing
    • 5.1.4 FISH
    • 5.1.5 Other Technologies
  • 5.2 By Disease
    • 5.2.1 Neurological Disorders
    • 5.2.2 Immunological Disorders
    • 5.2.3 Hematology Diseases
    • 5.2.4 Endocrine and Metabolism Diseases
    • 5.2.5 Cancer
    • 5.2.6 Musculoskeletal Disorders
    • 5.2.7 Other Diseases
  • 5.3 By End User
    • 5.3.1 Clinics/Hospitals
    • 5.3.2 Diagnostic Laboratories
    • 5.3.3 Other End Users
  • 5.4 By Geography
    • 5.4.1 North America
      • 5.4.1.1 United States
      • 5.4.1.2 Canada
      • 5.4.1.3 Mexico
    • 5.4.2 Europe
      • 5.4.2.1 Germany
      • 5.4.2.2 United Kingdom
      • 5.4.2.3 France
      • 5.4.2.4 Italy
      • 5.4.2.5 Spain
      • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
      • 5.4.3.1 China
      • 5.4.3.2 Japan
      • 5.4.3.3 India
      • 5.4.3.4 Australia
      • 5.4.3.5 South Korea
      • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Rest of the World

6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Quest Diagnostics Incorporated
    • 6.1.2 CENTOGENE NV
    • 6.1.3 Invitae Corporation
    • 6.1.4 3billion Inc.
    • 6.1.5 ARUP Laboratories
    • 6.1.6 Eurofins Scientific
    • 6.1.7 Strand Life Sciences
    • 6.1.8 Ambry Genetics
    • 6.1.9 PerkinElmer Genetics Inc.
    • 6.1.10 Macrogen Inc.
    • 6.1.11 Baylor Genetics
    • 6.1.12 Color Health Inc.
    • 6.1.13 Health Network Laboratories

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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