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表紙：分子診断の世界市場-2023年～2030年
市場調査レポート
商品コード
1297778

分子診断の世界市場-2023年～2030年

Global Molecular Diagnostics Market - 2023-2030
出版日: | 発行: DataM Intelligence | ページ情報: 英文 195 Pages | 納期: 約2営業日

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価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=156.76円
分子診断の世界市場-2023年～2030年
出版日: 2023年06月15日
発行: DataM Intelligence
ページ情報: 英文 195 Pages
納期: 約2営業日
ご注意事項 :
本レポートは最新情報反映のため適宜更新し、内容構成変更を行う場合があります。ご検討の際はお問い合わせください。
  • 全表示
  • 概要
  • 目次
概要

市場概要

分子診断の世界市場は、2022年に228億米ドルに達し、2030年には357億米ドルに達し、有利な成長が予測されています。分子診断の世界市場は、予測期間中（2023-2030年）に5.9%のCAGRを示すと予測されています。がんの有病率の増加と様々なアプリケーションの研究開発の進展が、分子診断市場の動向を牽引しています。

遺伝子変異の同定としても知られる分子診断学の目標は、検出、診断、分類、転帰の予測、治療反応の追跡を容易にすることです。分子診断学という学問分野は、特に分子ゲノム技術の大幅な進歩に照らして、臨床検査医学、ゲノミクスの専門知識、技術の相互作用の成功から生まれたものです。

これらの要素はすべて、遺伝性疾患の遺伝的背景を同定し、正確に特徴付けるのに役立ち、正確な診断を下すのに不可欠です。ゲノムワイド関連解析や次世代シーケンシングなどのハイスループット技術は、疾患の原因に関する重要な洞察を提供します。

分子診断市場は、腫瘍学、心血管疾患、感染症などのアプリケーションで構成されており、分子診断市場のシェアを拡大しています。分子診断の世界市場は、診断技術の進歩の増加や、各国における今後の医療承認などの要因により拡大しており、分子診断市場の成長にも明るい見通しが生まれています。

市場力学

これらの診断製品が提供する数多くの利点が分子診断市場の成長を後押ししています

これらの分子診断は、例えば特異性、感度、用途、納期など様々な利点を提供します。増幅技術は、手法の感度を高め、低濃度でしか存在しない重要な標的分子を特定するのに有効です。分子技術は、対象となる特定の分子に焦点を当てることで、偽陽性の可能性を低減します。

分子アプローチでは一般的に、従来の培養手順よりも、検査開始から結果報告までの所要時間が短縮されます。分子技術は、腫瘍マーカーの同定やモニタリング、薬剤耐性、法医学、遺伝子検査、感染症など、より幅広い応用が可能です。したがって、新製品の優位性が高まることが分子診断市場を牽引しています。

主要企業別技術進歩の高まりは、メーカーに有利な機会を創出します

技術的に先進的な様々な製品が大手企業によって開発・発売されています。現在、分子診断技術や製品タイプにおいて数多くの進歩がなされています。

さらに、2023年5月には、結核の原因菌の天敵であり、身体の免疫系を逃れるように進化したファージが、病気の早期発見に利用されるようになっています。英国初のファージ研究センターは、5月16日に正式に発表され、Innovate UK Actiphageでハイライトされます。ファージに基づく結核の分子診断法は、KTNのUK Phage Innovation Showcaseで紹介されます。

結核菌（Mycobacterium tuberculosis、Mtb）は、DNAの放出をブロックする厚い細胞壁を持つ細菌で、検出が難しく、培養しても増殖が遅いことが判明しています。Actiphageは、Mtbにのみ感染するウイルスであるファージを用いて、血液中の生きたMtb細胞を探索します。レスターにあるNIHR呼吸器生物医学研究センターの調査によれば、Actiphageを使って血液中に発見されたMtbは、活動性の結核疾患の兆候です。

偽の検査結果が市場成長の妨げになります

表現型ではなく病原体の核酸に依存する診断アッセイは、いくつかの問題によって妨げられます。重大な要因は、偽陽性および偽陰性の結果が多いことです。環境、研究室、さらには反応ミックスを調製するための道具のDNA汚染によって、病気が誤って同定されることがあります。DNA汚染は、表面や実験器具から除去するのは、容易に除去できる生細胞汚染よりも困難です。

偽陽性の結果は、死を引き起こし、ゲノムワイドなDNAがサンプルに残っている病原性生物を同定することから生じる可能性があります。このような状況では、RNAはDNAよりも耐久性に劣るため、NASBAやRT-PCRのようなRNAベースの手順は、分子的なバックアップを提供します。したがって、これらの上記の要因が分子診断市場の成長を制限しています。

COVID-19影響分析

COVID-19のパンデミックと世界各国での封鎖により、あらゆる業種の企業の財務状況が影響を受けています。そのため、COVID-19公衆衛生緊急事態の期間中、米国食品医薬品局（FDA）は、スポンサーと研究者を支援し、試験参加者の安全を確保し、適正臨床実施（GCP）を遵守し、試験の完全性に対するリスクを最小限に抑えるための一般的な考慮事項を含むガイドラインを発行しました。

リアルタイムRT-PCRは、COVID-19ウイルスを同定するために最も使用されている検査技術の一つです。多くの国がエボラウイルスやジカウイルスのような他の病気の診断にリアルタイムRT-PCRを採用しているが、多くの国がこの技術をCOVID-19ウイルスに適応させ、国の診断能力を拡大するための支援を求めています。

ロシア・ウクライナ紛争の影響分析

ロシア・ウクライナ紛争は、同地域の主要市場プレイヤーの数が少ないことから、世界の分子診断市場に与える影響は低いと推定されます。しかし、原材料の輸出入による影響は、予測期間中、分子診断世界市場の成長にほとんど影響を与えないと予想されます。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

  • 影響要因
    • 促進要因
      • これらの診断製品が提供する数多くの利点
      • ポイントオブケア診断薬に対する需要の増加
    • 抑制要因
      • 誤った検査結果
    • 機会
      • 主要企業別技術進歩の高まり
    • 影響分析

第5章 産業分析

  • ポーターの5フォース分析
  • サプライチェーン分析
  • 価格分析
  • 規制分析

第6章 COVID-19分析

第7章 製品タイプ別

  • 試薬とキット
  • 機器
  • ソフトウェア＆サービス

第8章 テクノロジー別

  • PCR（ポリメラーゼ連鎖反応）
  • 蛍光in situハイブリダイゼーション
  • 次世代シーケンサー
  • 等温核酸増幅技術（INAAT）
  • その他

第9章 用途別

  • 腫瘍学
  • 心血管疾患
  • 感染症
  • その他

第10章 エンドユーザー別

  • 診断研究所
  • 病院
  • その他

第11章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • イタリア
    • スペイン
    • その他欧州
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
      • その他アジア太平洋地域
  • 中東およびアフリカ

第12章 競合情勢

  • 競合シナリオ
  • 市況/シェア分析
  • M&A分析

第13章 企業プロファイル

  • F. Hoffmann-la Roche Ltd
    • 会社概要
    • 製品タイプ別ポートフォリオと説明
    • 財務概要
    • 主な発展
  • Illumina, Inc.
  • Abbott
  • BD
  • Bio-Rad Laboratories, Inc.
  • Hologic, Inc.
  • Agilent Technologies Inc.
  • Myriad Genetics, Inc.
  • Thermo Fisher Scientific Inc.
  • Danaher

第14章 付録

目次
Product Code: CD235

Market Overview

The Global Molecular Diagnostics Market reached US$ 22.8 billion in 2022 and is projected to witness lucrative growth by reaching up to US$ 35.7 billion by 2030. The Global Molecular Diagnostics Market is expected to exhibit a CAGR of 5.9% during the forecast period (2023-2030). The increasing prevalence of oncology and the growing research and development for various applications drive demand for molecular diagnostics market trends.

The goal of molecular diagnostics, also known as the identification of genetic variations, is to make it easier to detect, diagnose, classify, predict outcomes, and track therapeutic response. The discipline of molecular diagnostics results from the successful interaction of laboratory medicine, genomics expertise, and technology, particularly in light of substantial advancements in molecular genomic technologies.

All these elements help identify and precisely characterize the genetic underpinnings of hereditary disorders, which is essential for providing an accurate diagnosis. High-throughput techniques, such as genome-wide association analyses and next-generation sequencing, offer crucial insights into disease causes.

The Molecular Diagnostics Market scope comprises applications as oncology, cardiovascular disorders, infectious diseases and others, which has increased the molecular diagnostics market share. The global market for molecular diagnostics is expanding as a result of factors including the increasing advances in diagnostics technology and their upcoming medical approvals across countries are also creating a positive outlook for the molecular diagnostics market growth.

Market Dynamics

Numerous Advantages Provided by these Diagnostic Products drive the growth of the molecular diagnostics market.

These molecular diagnostics provide various benefits for instance, specificity, sensitivity, applications and turnaround time. Amplification techniques are beneficial for raising a methodology's sensitivity and locating target molecules of significance that only exist at deficient concentrations. Molecular techniques reduce the likelihood of false positive test findings by focusing on the particular molecule of interest.

Molecular approaches typically offer faster turnaround times from receiving to result reporting than traditional culture procedures. Molecular techniques have a wider range of applications, including in identifying and monitoring tumor markers, medication resistance, forensics, genetic testing, and infectious disorders. Hence, the growing novel products' advantages drives the molecular diagnostics market.

Rising Technological Advancements by Key Companies create lucrative opportunities for manufacturers.

A variety of technologically advanced products are being developed and launched by the major players. Numerous advancements are currently being made in molecular diagnostic technology and product type.

Furthermore, in May 2023, A phage, a natural enemy of the bacteria that causes tuberculosis and which has evolved to elude the body's immune system, is now being used to identify the illness at an early stage. The first Center for Phage Research in the UK will be formally unveiled on May 16 and highlighted in the Innovate UK Actiphage, a molecular diagnostic for tuberculosis based on phages will be featured in the UK Phage Innovation Showcase on KTN.

Mycobacterium tuberculosis (Mtb), a bacterium with a thick cell wall that blocks the release of its DNA, has proven challenging to detect and is slow to grow in culture. Actiphage searches the blood for live Mtb cells using a phage, a virus that only infects Mtb. Mtb discovered in the blood using Actiphage is a sign of active TB disease, according to research from the NIHR Respiratory Biomedical Research Centre in Leicester; this represents a possible advance in the fight to End TB.

False Test Outcomes will hamper the growth of the market.

Diagnostic assays that depend on the nucleic acids of the pathogen instead of on its phenotype are hampered by a few issues. A significant contributing factor is the high number of false positive and false negative outcomes. A disease may be mistakenly identified due to DNA contamination in the environment, the lab, and even the tools for preparing the reaction mix. DNA contamination is more difficult to remove from surfaces or lab equipment than living cell contamination, which can be easily done.

A false positive outcome could come from identifying pathogenic organisms that cause death and whose genome-wide DNA remains in the sample. Since RNA is less durable than DNA in these circumstances, RNA-based procedures like NASBA or RT-PCR provide a molecular backup. Hence these above-mentioned factors are limiting the molecular diagnostics market's growth.

COVID-19 Impact Analysis

The financial health of companies across all industries has been impacted by the COVID-19 pandemic and lockdown in numerous nations worldwide. Therefore, for the period of the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA) issued guidelines that include general considerations to aid sponsors and researchers, ensuring the safety of trial participants, adhering to good clinical practice (GCP), and minimizing risks to trial integrity.

Real-time RT-PCR is one of the most used laboratory techniques to identify the COVID-19 virus. Although many nations have employed real-time RT-PCR to diagnose other illnesses like the Ebola and Zika viruses, many still want assistance in adapting this technique for the COVID-19 virus and expanding their national diagnostic capacities.

Russia-Ukraine War Impact Analysis

The Russia-Ukraine conflict is estimated to have a low impact on the global molecular diagnostics market, owing to the low number of key market players in this region. However, the impact of the import and export of raw materials is expected to have little influence over the global molecular diagnostics market growth over the forecast period.

Segment Analysis

The Global Molecular Diagnostics Market is segmented based on product type, technology, application, end-user and region.

Instruments from the product type segment account for 37.3% of the market share owing to rising novel product launches.

Sample-to-answer instruments are designed to accept single-use cartridges with integrated Reagents and Kits that allow the detection of single or multiple targets in a patient's sample. The ideal option for mobile laboratories are diagnostic devices utilizing hermetically sealed cartridges that can withstand travel and extended storage in various climatic conditions without requiring a cold chain.

Various instruments are being launched with advanced technology. For instance, molecular biology, genomics, proteomics, and pharmacology techniques can all be accommodated by the Liquid Handling workstation known as EXTRAlab. It is distinguished by its great degree of adaptability. The workstation enables the creation of a fully automated lab to carry out sample preparation, dilution, and dispensing.

The modular design allows for simple reconfiguration to fit the customer's unique needs. For example, the liquid handling system can be modified to handle a variety of volumes and can have additional devices integrated on the basic platform.

Geographical Analysis

Due to major players' strong presence and increasing technological advancements, North America accounted for approximately 37.1% of the market share.

Manufacturers have chances to expand their operations in this region because of the rising demand for molecular diagnostics for advancements in North America. The area has many producers and suppliers, and its rapid economic development has raised industrial production of molecular diagnostics, increasing demand.

North America has a large number of producers and suppliers. As a result of the swift economic development of the area, industrial production has increased, fueling the demand of molecular diagnostics.

Rising new product types or applications will drive market growth. Growth is also fueled by rising technological advancements, regulatory approvals and novel product launches. Researchers are becoming more aware of various diagnostic approaches for cancer or other disorders, leading to expanding the market in this region. These factors shows the dominance of North America.

Competitive Landscape

The major global players in the molecular diagnostics market include: Illumina, Inc., F Hoffmann-la Roche Ltd, Abbott, Bio-Rad Laboratories, Inc., BD, Hologic Inc., Myriad Genetics, Inc., Agilent Technologies Inc., Thermo Fisher Scientific Inc. and Danaher among others.

Why Purchase the Report?

  • To visualize the Global Molecular Diagnostics Market segmentation based on product type, technology, application, end-user and region, and understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development.
  • Excel data sheet with numerous molecular diagnostics market-level data points with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available as Excel consisting of key products of all the major players.

The Global Molecular Diagnostics Market Report Would Provide Approximately 53 Tables, 54 Figures And 195 Pages.

Target Audience 2023

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Product Type
  • 3.2. Snippet by Technology
  • 3.3. Snippet by Application
  • 3.4. Snippet by End User
  • 3.5. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Numerous Advantages Provided by these Diagnostic Products
      • 4.1.1.2. Increasing Demand for Point-of-care Diagnostics
    • 4.1.2. Restraints
      • 4.1.2.1. False Test Outcomes
    • 4.1.3. Opportunity
      • 4.1.3.1. The Rising Technological Advancements by Key Companies
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's 5 Forces Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis

6. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario Before COVID-19
    • 6.1.2. Scenario During COVID-19
    • 6.1.3. Post COVID-19 & Future Scenario
  • 6.2. Pricing Dynamics Amid COVID-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. By Product Type

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 7.1.2. Market Attractiveness Index, By Product Type
  • 7.2. Reagents and Kits *
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Instruments
  • 7.4. Software & Services

8. By Technology

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 8.1.2. Market Attractiveness Index, By Technology
  • 8.2. PCR (Polymerase Chain Reaction) *
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Fluorescence In Situ Hybridization
  • 8.4. Next-Generation Sequencing
  • 8.5. Isothermal Nucleic Acid Amplification Technology (INAAT)
  • 8.6. Others

9. By Application

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.1.2. Market Attractiveness Index, By Application
  • 9.2. Oncology *
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Cardiovascular Diseases
  • 9.4. Infectious Diseases
  • 9.5. Others

10. By End User

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.1.2. Market Attractiveness Index, By End User
  • 10.2. Diagnostic Laboratories *
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 10.3. Hospitals
  • 10.4. Others

11. By Region

  • 11.1. Introduction
    • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 11.1.2. Market Attractiveness Index, By Region
  • 11.2. North America
    • 11.2.1. Introduction
    • 11.2.2. Key Region-Specific Dynamics
    • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.2.7.1. The U.S.
      • 11.2.7.2. Canada
      • 11.2.7.3. Mexico
  • 11.3. Europe
    • 11.3.1. Introduction
    • 11.3.2. Key Region-Specific Dynamics
    • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.3.7.1. Germany
      • 11.3.7.2. The U.K.
      • 11.3.7.3. France
      • 11.3.7.4. Italy
      • 11.3.7.5. Spain
      • 11.3.7.6. Rest of Europe
  • 11.4. South America
    • 11.4.1. Introduction
    • 11.4.2. Key Region-Specific Dynamics
    • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.4.7.1. Brazil
      • 11.4.7.2. Argentina
      • 11.4.7.3. Rest of South America
  • 11.5. Asia-Pacific
    • 11.5.1. Introduction
    • 11.5.2. Key Region-Specific Dynamics
    • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.5.7.1. China
      • 11.5.7.2. India
      • 11.5.7.3. Japan

Australia

      • 11.5.7.4. Rest of Asia-Pacific
  • 11.6. Middle East and Africa
    • 11.6.1. Introduction
    • 11.6.2. Key Region-Specific Dynamics
    • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

12. Competitive Landscape

  • 12.1. Competitive Scenario
  • 12.2. Market Positioning/Share Analysis
  • 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

  • 13.1. F. Hoffmann-la Roche Ltd *
    • 13.1.1. Company Overview
    • 13.1.2. Product Type Portfolio and Description
    • 13.1.3. Financial Overview
    • 13.1.4. Key Developments
  • 13.2. Illumina, Inc.
  • 13.3. Abbott
  • 13.4. BD
  • 13.5. Bio-Rad Laboratories, Inc.
  • 13.6. Hologic, Inc.
  • 13.7. Agilent Technologies Inc.
  • 13.8. Myriad Genetics, Inc.
  • 13.9. Thermo Fisher Scientific Inc.
  • 13.10. Danaher

LIST NOT EXHAUSTIVE

14. Appendix

  • 14.1. About Us and Services
  • 14.2. Contact Us