The Next Generation Sequencing (NGS) Markets in Japan

Executive Summary 

Summary Table: The NGS Market Size and Forecast in Japan (USD, Million)

Impact of COVID-19 Pandemic

Market Overview 

NGS Workflow 

Library Preparation and Amplification

Sequencing

Data Analysis

NGS Market Trends

Market Drivers

Technological Advancements

Declining Costs

Precision Medicine Initiatives

Health Insurance Coverage

Increasing Demand from Clinical Applications Segments

Growing Investments in Companion Diagnostics (CDx) Development

Market Restraints

Impact of COVID-19

High Costs Compared to Alternative Genomic Platforms

Lack of Effective Software Solutions for Data Management and Downstream Analysis

NSG Data Management, Interpretation and Sharing: Ethical and Legal Issues

Lack of Geneticists

Lack of Awareness

Market Entry Barriers for New Comers

Health Insurance Landscape in Japan

Table 1: Government Agencies Responsible for Health Policy in Japan

Public Health Insurance in Japan

Residence-based National Health Insurance (NHI)

Employer-based Health Insurance

Health Insurance for the Elderly

Private Health Insurance in Japan

Reimbursement Fee Decision Process in Japan

Health Insurance Coverage for Sequencing Tests

Table 2: NGS-based Clinical Diagnostics Tests with Insurance Coverage in Japan

Regulatory Landscape Promoting NGS in Japan

Regulatory Options for NGS-based Tests

Genomic Data Sharing Policies

Regulatory Process for Companion Diagnostics

Table 3: Regulatory Process for Companion Diagnostics Approval in Japan

The NGS Market Landscape in Japan

Industry Consolidation Trends

Setbacks to Industry Consolidation

Partnerships Focusing on NGS Services and Other Segments

NGS Market in Japan and Impact of COVID-19 Pandemic

Table 4: The NGS Market Size and Forecast in Japan (2019-2024; USD, Million)

NGS Markets in Japan by Methods

Targeted Genome Sequencing and Resequencing

Table 5: NGS Panels Approved for Clinical Diagnostics Applications in Japan

Whole Genome Sequencing (WGS)

Large-Scale WGS Studies on Japanese Population

Table 6: Selected List of Large-Scale WGS Projects in Japan

Table 7: Selected List of Organisations Conducting Large-Scale WGS Projects in Japan

Whole Exome Sequencing (WES)

Table 8: Selected List of Large Scale WES Projects in Japan

RNA-Seq

Commercial Platforms, Kits and Data Analysis Products for RNA-seq

Table 9: Selected list of Companies Offering RNA-Seq Library Preparation Kits

mRNA-Seq

Non-Coding RNA-seq

Single-cell RNA-seq (scRNA-seq)

Table 10: Selected Cell Isolation and Library Preparation Platforms in the Market for scRNA-Seq. 70

Table 11: Selected List of scRNA-Seq Data Analysis Products

Transcriptomics Moving from Microarrays to RNA-seq

Other NGS Methods

The Market Size and Growth Trends of the Leading NGS Methods

Table 12: The NGS Market Size and Forecast in Japan by Method (2019-2024; USD, Million)

NGS Markets in Japan by Products and Services

Instruments

Single Cell Sequencing

Table 13: Popular NGS Platforms in the Japanese Market

NGS Workflow Automation

Table 14: Selected List of Products Facilitating Automation of NGS and their Suppliers

Consumables and Accessories

Table 15: Selected List of NGS Library Preparation Products in Japan for Research Use

Bioinformatics Tools for NGS

Primary Data Analysis

Secondary Data Analysis

Tertiary Data Analysis

Table 16: Commonly Used Bioinformatics Tools for NGS: For Primary, Secondary, and Tertiary Data Analysis

Rising Influence of Cloud Computing

Key Challenges of NGS Data Analysis Players

Role of Reference Laboratories as NGS Moves to Clinical Diagnostics in Japan

NGS Data Analysis in Japan: Key Players and Capabilities

NGS Service Providers in Japan

Table 17: Selected List of Leading NGS service Providers in Japan

NGS Market Size and Growth Trends in Japan by Products and Services

Table 18: The NGS Market Size and Forecasts in Japan by Products and Services (2019-2024; USD, Million)

NGS Markets in Japan by Application Segments

Clinical Diagnostics

The Clinical Genetics Medical Care System in Japan

Table 19: Selected List of Associations influencing Clinical Genetics in Japan

Genetic Counsellor Certification System in Japan

Concerns Regarding Genetic Information Abuse Potentials

NGS-based Cancer Diagnostics in Japan

Regulations Influencing NGS-based Cancer Diagnosis in Japan

Table 20: The Basic Plan to Promote Cancer Control Programs in Japan

Guidelines for NGS-based Gene Panel Tests for Cancer in Japan

Table 21: Evidence Levels as per the Guidance for Gene Panel Testing of Solid Cancers in Japan

NGS-based CDx Tests for Cancer in Japan: Regulations and Reimbursement Status

Concerns about Accuracy of NGS-based Cancer Diagnostics for Japanese Population

Gene Panel Tests Dominate NGS-based Cancer Diagnostics Segment

Approved NGS-based Gene Panel Tests for Cancer in Japan

Table 22: NGS-based Gene Panel Tests for Cancer Diagnostics in Japan

Reimbursement for Gene Panel Tests for Cancer in Japan

NGS-based Cancer Diagnostics: Infrastructure and Other Challenges in Japan

NGS-based Precision Oncology Initiatives and their Influence in Clinical Diagnostics in Japan

Influence of Academia in Driving Gene Panel Tests Demand

The Future of NGS-based Cancer Diagnostics in Japan

Table 23: Core Hospitals Designated for Cancer Genomic Medicine across Japan

NGS-based Reproductive Health Diagnostics in Japan

The Rising Global Demand for NIPT

Table 24: Diseases and Aneuploidies Commonly Tested by NIPT Assays

Table 25: Selected List of NGS-based NIPT Tests in the Global Market

NIPT Market – An Assessment of the IP Landscape of NGS Platforms

Rising Investments in the New-born and Prenatal Testing Markets

Prenatal Testing Insurance Coverage Status: Japan Vs Other Regulated Markets

Reproductive Health Focus of the Japanese Society and Bioethics Concerns

Regulatory Status of Preimplantation Genetic Testing (PGT) in Japan

Availability of NGS-based New-born and Prenatal Tests in Japan

Table 26: New-born Screening Program in Japan: Incidences of Diseases Targeted

The Issue of Unauthorised NIPT Service Providers in Japan

NGS Demand in Other Clinical Diagnostics Segments

Infectious Diseases

Tuberculosis

SARS-CoV-2 Testing

HLA Typing

Direct-to-Consumer (DTC) Genetic Testing

The Evolving Regulatory Landscape of DTC Genetic Testing

Regulatory Scrutiny Triggering Novel Consumer Genomics Business Models

Legal Framework for DTC Genetic Testing in Japan

Genomic Software Firms Filling the Gap of Genetic Counsellors

Online Availability of DTC Genetic Tests

Acceptance of DTC Genetic Tests in Medical Fields

Status of DTC Genetic Testing in Japan

Emerging Consumer Genomics Applications Attracting New Investments in Japan

Research Applications

Academic Research

Table 27: Selected Institutions in Japan Active in NGS Research/ Research Services

Large-Scale Genome-wide Sequencing Projects in Japan

Table 28: Selected List of Large Scale Genome-wide Sequencing (GWS) Projects in Japan

Influence of Public-Private Partnership

Industry R&D

Other Emerging NGS Application Segments

Table 29: The NGS Market Size and Forecasts in Japan by Application Segments (2019-2024; USD, Million)

Company Profiles

10x Genomics, Inc

10x Genomics Products and Response to COVID-19

Table 30: Selected List of NGS Products Offered by 10x Genomics

Impact of COVID-19 Pandemic

Acquisitions and Partnerships

Table 31: Selected List of Partnerships and Acquisitions of 10x Genomics

Activities in the Japanese Market

Agilent Technologies

NGS Products Offered by Agilent

Impact of COVID-19 in Agilent’s NGS Business

BGI Group

BGI Genomics Co Ltd and MGI Tech

Table 32: Sequencers Produced and Marketed by the BGI Group

Table 33: NGS-based Assays and Services Provided by BGI Group

Partnerships and Collaborations

Table 34: Selected List of Recent Partnerships of BGI Group*

Response to COVID-19

BGI in Japan’s NGS Market

Eurofins Scientific S.E.

Global Expansion through Innovation and Acquisitions

Role in the NGS Market

Response to COVID-19

Presence in Japan’s NGS Market

F. Hoffmann-La Roche Ltd

Response to COVID-19

NGS Products and Services

Table 35: Acquisitions and Partnerships Related to Roche’s NGS Business

Japan Updates

Foundation Medicine, Inc

Products and Services

Impact of COVID-19 Pandemic

Partnerships

Table 36: Selected List of Partnerships and Collaborations of Foundation Medicine

Foundation Medicine in Japan

Genesis Healthcare Co., Japan

Products and Services

Table 37: Genetic Testing offered under GeneLife Brand by Genesis Healthcare

GeneQuest Co. Ltd

Genewiz (Japan Genewith Co,, Ltd)

Role in the NGS Market

Activities in Japan

Illumina

Expanding Consumer Segments

NGS Business – Strategies, Products, and Services

Table 38: Selected List of Sequencing Systems offered by Illumina

Table 39: Selected List of Assays Offered by Illumina

Response to COVID-19 Pandemic

Focus on Innovation and Related Investments

Clinical Diagnostics Strategies

Table 40: Selected List of Partnerships Targeting Diagnostics Applications

Illumina in Japan’s NGS Market

Macrogen Inc

NGS Services Offered by Macrogen

Table 41: Gene Panel Tests Offered by Macrogen

Collaborations and Partnerships

Table 42: Selected List of Partnerships and Collaborations of Macrogen*

Response to COVID-19

Activities in the Japanese Market

Oxford Nanopore Technologies

Table 43: Sequencers produced by Oxford Nanopore Technologies

Response to COVID-19 Pandemic

Partnerships and Collaborations

Table 44: Selected List of Recent Partnerships of Oxford Nanopore Technologies

Activities in the Japanese Market

Pacific Biosciences of California, Inc

Table 45: Selected List of the Products Offered by PacBio

Partnerships and Collaborations

Table 46: Selected List of Partnerships of PacBio in the last 5 years

Impact of COVID-19 Pandemic

Activities in Japan’s NGS Market

Perkin Elmer Inc

Response to COVID-19

NGS Products and Services

Table 47: Selected NGS Products of Perkin Elmer

Perkin Elmer in Japan

Qiagen N. V

COVID-19 Pandemic Effect on NGS Business

NGS business of Qiagen

Qiagen in Japan’s NGS Market

RIKEN Genesis Co. Ltd

Partnerships

Table 48: Selected List of Partnerships of RIKEN Genesis

Sysmex Corporation

Response to COVID-19

Role in Japan’s NGS Market

Takara Bio Inc

NGS Products and Services

Impact of the COVID-19 pandemic

Partnerships and Agreements

Table 49: Partnerships and Collaborations of Takara Bio in the past 5 years

Thermo Fisher Scientific Inc

Response to COVID-19 pandemic

Partnerships and Acquisitions

Table 50: Selected Partnerships and Acquisitions of Thermo Fisher (2017-2020)

NGS Products and Services

Table 51: NGS Instruments Offered by Thermo Fisher Scientific

Table 52: Selected List of NGS-based Assays and Services of Thermo Fisher Scientific

Thermo Fisher Scientific in Japan’s NGS Market

Glossary

LIST OF TABLES

SUMMARY TABLE: THE NGS MARKET SIZE AND FORECAST IN JAPAN (USD, MILLION)

TABLE 1: GOVERNMENT AGENCIES RESPONSIBLE FOR HEALTH POLICY IN JAPAN

TABLE 2: NGS-BASED CLINICAL DIAGNOSTICS TESTS WITH INSURANCE COVERAGE IN JAPAN

TABLE 3: REGULATORY PROCESS FOR COMPANION DIAGNOSTICS APPROVAL IN JAPAN

TABLE 4: THE NGS MARKET SIZE AND FORECAST IN JAPAN (2019-2024; USD, MILLION

TABLE 5: NGS PANELS APPROVED FOR CLINICAL DIAGNOSTICS APPLICATIONS IN JAPAN

TABLE 6: SELECTED LIST OF LARGE-SCALE WGS PROJECTS IN JAPAN

TABLE 7: SELECTED LIST OF ORGANISATIONS CONDUCTING LARGE-SCALE WGS PROJECTS IN JAPAN

TABLE 8: SELECTED LIST OF LARGE SCALE WES PROJECTS IN JAPAN

TABLE 9: SELECTED LIST OF COMPANIES OFFERING RNA-SEQ LIBRARY PREPARATION KITS

TABLE 10: SELECTED CELL ISOLATION AND LIBRARY PREPARATION PLATFORMS IN THE MARKET FOR SCRNASEQ

TABLE 11: SELECTED LIST OF SCRNA-SEQ DATA ANALYSIS PRODUCTS

TABLE 12: THE NGS MARKET SIZE AND FORECAST IN JAPAN BY METHOD (2019-2024; USD, MILLION)

TABLE 13: POPULAR NGS PLATFORMS IN THE JAPANESE MARKET

TABLE 14: SELECTED LIST OF PRODUCTS FACILITATING AUTOMATION OF NGS AND THEIR SUPPLIERS

TABLE 15: SELECTED LIST OF NGS LIBRARY PREPARATION PRODUCTS IN JAPAN FOR RESEARCH USE

TABLE 16: COMMONLY USED BIOINFORMATIC TOOLS FOR NGS: FOR PRIMARY, SECONDARY, AND TERTIARY

DATA ANALYSIS

TABLE 17: SELECTED LIST OF LEADING NGS SERVICE PROVIDERS IN JAPAN

TABLE 18: THE NGS MARKET SIZE AND FORECASTS IN JAPAN BY PRODUCTS AND SERVICES (2019-2024; USD,Million)

TABLE 19: SELECTED LIST OF ASSOCIATIONS INFLUENCING CLINICAL GENETICS IN JAPAN

TABLE 20: THE BASIC PLAN TO PROMOTE CANCER CONTROL PROGRAMS IN JAPAN

TABLE 21: EVIDENCE LEVELS AS PER THE GUIDANCE FOR GENE PANEL TESTING OF SOLID CANCERS IN JAPAN128

TABLE 22: NGS-BASED GENE PANEL TESTS FOR CANCER DIAGNOSTICS IN JAPAN

TABLE 23: CORE HOSPITALS DESIGNATED FOR CANCER GENOMIC MEDICINE ACROSS JAPAN

TABLE 24: DISEASES AND ANEUPLOIDIES COMMONLY TESTED BY NIPT ASSAYS

TABLE 25: SELECTED LIST OF NGS-BASED NIPT TESTS IN THE GLOBAL MARKET

TABLE 26: NEW-BORN SCREENING PROGRAM IN JAPAN: INCIDENCES OF DISEASES TARGETED

TABLE 27: SELECTED INSTITUTIONS IN JAPAN ACTIVE IN NGS RESEARCH/ RESEARCH SERVICES

TABLE 28: SELECTED LIST OF LARGE SCALE GENOME-WIDE SEQUENCING (GWS) PROJECTS IN JAPAN

TABLE 30: SELECTED LIST OF NGS PRODUCTS OFFERED BY 10X GENOMICS

TABLE 31: SELECTED LIST OF PARTNERSHIPS AND ACQUISITIONS OF 10X GENOMICS

TABLE 32: SEQUENCERS PRODUCED AND MARKETED BY THE BGI GROUP

TABLE 33: NGS-BASED ASSAYS AND SERVICES PROVIDED BY BGI GROUP

TABLE 34: SELECTED LIST OF RECENT PARTNERSHIPS OF BGI GROUP*

TABLE 35: ACQUISITIONS AND PARTNERSHIPS RELATED TO ROCHE’S NGS BUSINESS

TABLE 36: SELECTED LIST OF PARTNERSHIPS AND COLLABORATIONS OF FOUNDATION MEDICINE

TABLE 37: GENETIC TESTING OFFERED UNDER GENELIFE BRAND BY GENESIS HEALTHCARE

TABLE 38: SELECTED LIST OF SEQUENCING SYSTEMS OFFERED BY ILLUMINA

TABLE 39: SELECTED LIST OF ASSAYS OFFERED BY ILLUMINA

TABLE 40: SELECTED LIST OF PARTNERSHIPS TARGETING DIAGNOSTICS APPLICATIONS

TABLE 41: GENE PANEL TESTS OFFERED BY MACROGEN

TABLE 42: SELECTED LIST OF PARTNERSHIPS AND COLLABORATIONS OF MACROGEN*

TABLE 43: SEQUENCERS PRODUCED BY OXFORD NANOPORE TECHNOLOGIES

TABLE 44: SELECTED LIST OF RECENT PARTNERSHIPS OF OXFORD NANOPORE TECHNOLOGIES

TABLE 45: SELECTED LIST OF THE PRODUCTS OFFERED BY PACBIO

TABLE 46: SELECTED LIST OF PARTNERSHIPS OF PACBIO IN THE LAST 5 YEARS

TABLE 47: SELECTED NGS PRODUCTS OF PERKIN ELMER

TABLE 48: SELECTED LIST OF PARTNERSHIPS OF RIKEN GENESIS

TABLE 49: PARTNERSHIPS AND COLLABORATIONS OF TAKARA BIO IN THE PAST 5 YEARS

TABLE 50: SELECTED PARTNERSHIPS AND ACQUISITIONS OF THERMO FISHER (2017-2020)

TABLE 51: NGS INSTRUMENTS OFFERED BY THERMO FISHER SCIENTIFIC

TABLE 52: SELECTED LIST OF NGS-BASED ASSAYS AND SERVICES OF THERMO FISHER SCIENTIFIC