研究所開発のテスト市場 - 2031 年の成長予測、統計および事実

  • Report Code : TIPRE00019603
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 183
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研究所が開発した検査市場は、2021 年の 45 億 2,475 万米ドルから 2028 年までに 72 億 6,930 万米ドルに達すると予想されています。 2021 年から 2028 年にかけて 7.0% の CAGR で成長すると予想されています。



臨床開発検査 (LDT) は、単一検査施設内で設計され使用される体外診断検査の一種です。これらの検査は、タンパク質、生体分子/化合物 (グルコース、コレステロールなど)、およびヒトの被験者から収集した検体から抽出された DNA などの分析対象物を推定または区別するために使用できます。正確でエラーのない分析を行うための検査機関や薬局向けの自動体外診断 (IVD) 法の拡大により、検査機関が開発した検査市場の成長が加速しています。





研究室開発検査市場の成長は主に、がんや遺伝性疾患の増加、多数の製品発売などの要因によるものです。しかし、規制情勢の変化が市場の成長を妨げています。たとえば、ヨーロッパでは、2022 年 5 月からすべての体外診断検査に体外機器規制 (IVDR) への準拠が義務付けられます。この規制は、医療検査の臨床的有効性と安全性を確保することを目的としており、それによって診断業界を変革することは、市場関係者にとって大きな懸念事項となっています。



検査機関が開発した検査市場における収益性の高い地域

市場洞察



個別化医療に関する継続的な研究は、研究室開発の試験市場参加者に成長の機会を提供する



LDTは、有望な手段として証明される可能性が高い個別化医療の開発において重要な役割を果たします効果的な治療法や治療法がはるかに得られていない病気に取り組むこと。 Personalized Medicine Coalition によると、2005 年に FDA が新たに承認した分子エンティティのうち、個別化医療はわずか 5% を占めていました。しかし、2016 年には、この数字は 25% 以上に上昇しました。さらに、パイプラインに含まれる全化合物の 42% と腫瘍学用化合物の 73% は、個別化医薬品として機能する可能性があります。バイオ医薬品企業は過去 5 年間で個別化薬への研究開発投資をほぼ 2 倍にしており、今後 5 年間でさらに投資を 33% 増加すると予想されています。生物医薬品研究者は、今後 5 年間で個別化医薬品の開発が 69% 増加すると予測しています。臨床検査は、病気の診断、薬への反応の予測と監視、さらには複雑な予測アルゴリズムに必要な情報データの取得に使用されます。



個別化医療はがん治療のトレードマークになりつつあります。これは、個々の遺伝子構造に応じて治療をカスタマイズすることに基づいた、絶えず進化するアプローチです。 2019年、FDAは病気の根本原因を調査して対処するための12の個別化医薬品を承認し、臨床ケアに精密医療を組み合わせました。個別化医療に対する需要の高まりは、研究室開発の検査市場で事業を展開するプレーヤーの成長に大きな成長機会をもたらしています。





タイプベースの洞察



研究室が開発した検査市場はタイプ別に、臨床生化学、救命救急、血液学、微生物学、分子診断に分類されます。 、免疫学など。分子診断セグメントは、2021 年に市場で最大のシェアを保持すると予想されます。ただし、血液学セグメントは、予測期間中に市場で最も高い CAGR を記録すると予想されます。



種類別の臨床検査市場- 2021 年と 2028 年

アプリケーションベースの洞察



アプリケーションごとに、研究所は、学術機関、臨床研究組織、病院の研究室、専門診断センターなどへのテスト市場アプリケーションを開発しました。病院検査部門は、2021 年に最大の市場シェアを占めると推定されています。ただし、専門診断センター部門は、予測期間中に市場で最も高い CAGR を記録すると予想されます。



戦略的洞察

製品の発売と承認は、世界的な拠点と製品ポートフォリオを拡大するために企業が一般的に採用する戦略です。さらに、研究所開発型テスト市場のプレーヤーは、顧客層を拡大するためのパートナーシップ戦略に焦点を当てており、それにより、世界的にブランド名を維持することが可能になります。



レポートは、研究所開発型テスト市場を次のように分類しています。



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研究室開発の検査市場は、タイプに基づいて、臨床生化学、救急治療、血液学、微生物学、分子診断、免疫学などに分類されます。アプリケーションに基づいて、研究所開発の検査市場は学術機関、臨床研究機関、病院の研究所、専門診断センターなどに分類されます。地理に基づいて、研究所が開発したテスト市場は、北米(米国、カナダ、メキシコ)、ヨーロッパ(英国、ドイツ、フランス、イタリア、スペイン、その他のヨーロッパ)、アジア太平洋(中国、日本、インド、オーストラリア、韓国、その他のアジア太平洋地域)、中東とアフリカ(UAE、サウジアラビア、南アフリカ、その他の中東とアフリカのその他の地域)、中南米(ブラジル、アルゼンチン) 、およびその他の南中米)。



会社概要





  • Quest Diagnostics Incorporated

  • F. HOFFMANN-LA ROCHE LTD.、

  • QIAGEN

  • Illumina, Inc.、

  • Eurofins Scientific

  • Biodesix

  • >適応バイオテクノロジー

  • バイオセラノスティックス

  • Rosetta Genomics Ltd.、

  • Guardant Health


Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What is laboratory developed test mean?

A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed and used within a single laboratory. These tests can be utilized to estimate or distinguish an extensive assortment of analytes materials such as proteins, chemical compounds like glucose or cholesterol, or DNA, from a specimen received from human anatomy. The expansion of automated in vitro diagnostics (IVD) methods for labs and dispensaries to render precise, and error-free analysis is anticipated to fuel the increment.

What are the driving factors for the laboratory developed test market across the globe?

The growth of the laboratory developed test market is mainly attributed to factors such as the increasing incidents of cancer and genetic disorders, large number of product launches. However, changing regulatory landscape for instance, in Europe, the In-Vitro Device Regulation (IVDR) compliance will be mandatory for all in vitro diagnostic tests from May 2022; the regulation aims to secure the clinical effectiveness and safety of medical tests, thus transforming the diagnostic industry is a great concern to hinder the market growth. In August 2021, eMed, a telehealth company democratizing healthcare through digital-point-of-care solutions, and Quest Diagnostics the world's leading provider of diagnostic information services, are collaborated to bring clinician-guided rapid antigen testing for COVID-19 to employers seeking to foster safer environments by decreasing the risk of COVID-19 exposure in their workplaces which is contributing to the growth of the target market. Such strategic steps are also projected to drive the market growth.

What is the regional analysis in terms of laboratory developed test market?

The growth of the region is attributed to factors such as rising public–private partnerships, and increasing funding activities are widely enhancing the performance of medical devices. Moreover, presence of well-developed healthcare infrastructure and government support are some of the prominent factors propelling the market growth in Asia Pacific. In Asia Pacific, India is the largest market for laboratory developed test. The market growth in Asia Pacific is mainly attributed to factors such as the growing usage of laboratory developed test in combating Covid-19, increasing incidents of cancer and genetic disorders, large number of product launches. However concerns high capital investment for setting up advanced labs hinders the market growth in Asia Pacific.

What are future trends of Laboratory Developed Test Market?

The automation of LDTs can significantly boost productivity and simplify compliance procedures. Clinical laboratories are under huge pressure to manage increasing test volumes and conduct more complex diagnostic assays, which further underlines the need for flexible automation systems. Many MedTech companies are offering automation solutions to help streamline clinical laboratory processes. For instance, Roche Cobas Omni–Utility Channel is beneficial for both IVD assays and high-volume LDTs. It is designed to meet the growing needs of efficient workflows in laboratories, as it can assist in different stages ranging from sample processing to quick data interpretation. It can run up to 96 results in about 3 hours and up to 864 results in 8 hours, thereby boosting the efficiency of laboratories.

Which type is expected to dominate the market in the forecast period?

The laboratory developed test market is led by type molecular diagnostics segment is growing significantly due to the increasing attention to the development of genetic therapeutics. The growing research in human genomics is playing a vital role in developing laboratory developed tests. The technological advantages of molecular tests make them compelling diagnostic tools, and they have become valuable for detecting a wide range of genetic diseases. For instance, in November 2017, Edico Genome launched the DRAGEN Clinical Genomics Information System (CGIS).

The List of Companies - Laboratory Developed Test Market

 

  1. Quest Diagnostics Incorporated
  2. F. HOFFMANN-LA ROCHE LTD.,
  3. QIAGEN
  4. Illumina, Inc.,
  5. Eurofins Scientific
  6. Biodesix
  7. Adaptive Biotechnologies
  8. Biotheranostics
  9. Rosetta Genomics Ltd.,
  10. Guardant Health

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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