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體外診斷

市場調查報告書

商品編碼

1606505

全球體外診斷 (IVD) 市場 - 2024-2031

Global In-vitro diagnostics (IVDs) Market - 2024-2031

出版日期: 2024年12月04日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

概述

2023年，全球體外診斷（IVD）市場規模達862億美元，預計2031年將達到1,398.3億美元，2024-2031年預測期間複合年成長率為6.9%。

體外診斷 (IVD) 是一個廣泛的術語，涵蓋對人體樣本（例如血液、尿液和組織）進行的各種醫學測試。這些測試旨在幫助診斷疾病、監測健康狀況並指導治療決策。 IVD 包括各種設備，例如試劑、工具和軟體系統，可以更輕鬆地檢查樣本並提供有關患者健康的重要資訊。 FDA 表示，IVD 是現代醫學的重要工具，使醫療保健從業者能夠及早發現疾病、評估治療的成功並更好地管理患者護理。

慢性病盛行率的增加是預測期內推動市場的促進因素。例如，根據泛美衛生組織的數據，全球預計將有 2,000 萬人新診斷癌症，1,000 萬人因癌症死亡。未來二十年，癌症負擔將增加近 60%，給醫療保健系統、個人和社區帶來進一步的負擔。

市場動態：

驅動程式和限制

慢性病盛行率增加

慢性病盛行率的不斷上升預計將成為全球體外診斷（IVD）市場成長的重要因素。慢性病的日益普及是推動全球體外診斷 (IVD) 產業發展的重要動力。糖尿病、心血管疾病和癌症越來越普遍，需要更好的診斷技術來進行早期檢測和管理。由於這些疾病需要持續監測和治療，因此對 IVD 測試的需求增加。人口老化加劇了這種趨勢，因為老年人更容易患慢性病，導致定期健康檢查和診斷測試的需求增加。

例如，根據美國國立衛生研究院的數據，到 2023 年，美國預計將出現 1,958,310 例新癌症病例和 609,820 例癌症死亡病例。前列腺癌發生率在經歷了二十年的下降之後，從 2014 年到 2019 年每年上升 3%，新增病例增加 99,000 例。年癌症發生率為每 10 萬名男性和女性 440.5 例（基於 2017 年至 2021 年的病例）。每年癌症死亡率（癌症死亡率）為每 10 萬名男性和女性 146.0 人（基於 2018 年至 2022 年的死亡人數）。到 2024 年，預計將有 14,910 名 0 至 19 歲的兒童和青少年被診斷出患有癌症，其中 1,590 人因此死亡。

此外，根據美國國立衛生研究院的數據，約有 4.62 億人患有第 2 型糖尿病，相當於世界人口的 6.28%。例如，根據美國疾病管制與預防中心的數據，大約有 3,840 萬各個年齡層的人（占美國人口的 11.6%）被診斷出患有糖尿病。在18歲及以上的成年人中，這一數字上升至3,810萬，占美國成年人總數的14.7%。

嚴格的監管要求

嚴格的監管要求等因素預計將阻礙全球體外診斷（IVD）市場。嚴格的監管要求預計將嚴重阻礙全球體外診斷（IVD）市場，這主要是由於歐洲體外診斷醫療器材法規（IVDR）等新立法帶來的複雜性。例如，2022 年 5 月生效的 IVDR 透過建立更嚴格的績效評估和上市後監管標準，改變了 IVD 的監管格局。許多 IVD 以前可以自我聲明合規性，但是，IVDR 要求通知組織對這些設備的很大一部分進行審查。

In vitro diagnostics (IVDs) is a broad term encompassing a variety of medical tests performed on human body samples such as blood, urine, and tissue. These tests are intended to help diagnose diseases, monitor health conditions, and guide treatment decisions. IVDs include a wide range of devices, such as reagents, tools, and software systems that make it easier to examine specimens and offer crucial information about a patient's health. According to the FDA, IVDs are vital tools in modern medicine, enabling healthcare practitioners to detect diseases early, assess the success of treatments, and better manage patient care.

The increasing prevalence of chronic diseases is the driving factor that drives the market over the forecast period. For instance, according to the Pan American Health Organization, globally, there were an expected 20 million new cancer diagnoses and 10 million cancer deaths. Over the next two decades, the cancer burden will rise by almost 60%, putting a further burden on healthcare systems, individuals, and communities.

Market Dynamics: Drivers & Restraints

Increasing prevalence of chronic diseases

The increasing prevalence of chronic diseases is expected to be a significant factor in the growth of the global in-vitro diagnostics (IVDs) market. The growing prevalence of chronic diseases is a significant driver driving the global in-vitro diagnostics (IVD) industry. Diabetes, cardiovascular disease, and cancer are growing increasingly prevalent, demanding better diagnostic technologies for early detection and management. As these disorders necessitate continual monitoring and treatment, the demand for IVD tests has increased. The aging population exacerbates this tendency, since older people are more susceptible to chronic illnesses, resulting in an increased demand for regular health checkups and diagnostic testing.

For instance, according to the National Institute of Health, in 2023, the United States is expected to see 1,958,310 new cancer cases and 609,820 cancer deaths. Prostate cancer incidence climbed by 3% every year from 2014 to 2019, after two decades of reduction, resulting in an additional 99,000 new cases. The annual cancer incidence rate is 440.5 per 100,000 men and women (based on cases from 2017 to 2021). The cancer death rate (cancer mortality) is 146.0 per 100,000 men and women annually (based on deaths from 2018-2022). In 2024, a projected 14,910 children and adolescents between the ages of 0 and 19 will be diagnosed with cancer, with 1,590 deaths from the condition.

Moreover, according to the National Institute of Health, approximately 462 million individuals were affected by type 2 diabetes corresponding to 6.28% of the world's population. For instance, according to the Centers for Disease Control and Prevention, approximately 38.4 million individuals of all ages, representing 11.6% of the U.S. population, were diagnosed with diabetes. Among adults aged 18 and older, this figure rose to 38.1 million, accounting for 14.7% of all U.S. adults.

Stringent Regulatory Requirements

Factors such as stringent regulatory requirements associated are expected to hamper the global in-vitro diagnostics (IVDs) market. Stringent regulatory requirements are expected to severely impede the global in-vitro diagnostics (IVD) market, owing mostly to the complications brought by new legislation such as the In Vitro Diagnostic Medical Device Regulation (IVDR) in Europe. For instance, the IVDR, which went into effect in May 2022, changed the regulatory landscape for IVDs by establishing more stringent standards for performance evaluation and post-market surveillance. Many IVDs could previously self-declare compliance, however, the IVDR requires notified organizations to review a significant percentage of these devices.

Segment Analysis

The global in-vitro diagnostics (IVDs) market is segmented based on product and service, technology, specimen, test type, application, end-user, and region.

Oncology segment is expected to dominate the global in-vitro diagnostics (IVDs) market share

The oncology category is expected to dominate the global in-vitro diagnostics (IVDs) market due to a number of compelling factors, the most prominent of which is the global increase in cancer incidence. Cancer is still one of the top causes of illness and mortality worldwide, with millions of new cases diagnosed each year. This increased frequency has created a greater demand for reliable diagnostic techniques that can aid in early detection and treatment outcomes. One of the primary causes of this expansion is the emphasis on early cancer detection, which increases the likelihood of successful treatment. Healthcare providers and groups are becoming more vocal about frequent screening and diagnostic testing, especially among high-risk populations.

The increasing prevalence of cancer is one of the major reasons making oncology the dominant segment. For instance, according to the World Health Organization (WHO), cancer diagnoses are predicted to exceed 22 million by 2023 and in the case of breast cancer, 1 in 12 women will be diagnosed with breast cancer in their lifetime and 1 in 71 women die of it. underscoring the critical need for better therapeutic strategies.

Geographical Analysis

North America is expected to hold a significant position in the global in-vitro diagnostics (IVDs) market share

North America is expected to hold a significant portion of the global in-vitro diagnostics (IVDs) market. North America is expected to have a significant part in the worldwide in-vitro diagnostics (IVDs) market, owing to its advanced healthcare infrastructure, high prevalence of chronic diseases, and presence of major diagnostic businesses. The region's solid healthcare system, which includes vast laboratory networks and powerful diagnostic technology, makes it easier for breakthrough IVD solutions to be widely adopted. This infrastructure not only supports a large volume of diagnostic testing but also allows for the rapid introduction of new technologies into clinical practice.

The rising prevalence of chronic diseases such as diabetes, cardiovascular disease, and cancer is fueling the need for IVDs in North America. For instance, according to an article published by the National Institute of Health, in 2024, 2,001,140 new cancer cases and 611,720 cancer deaths are projected to occur in the United States. Cancer mortality continued to decline through 2021, averting over 4 million deaths since 1991 because of reductions in smoking, earlier detection for some cancers, and improved treatment options in both adjuvant and metastatic settings. However, these gains are threatened by increasing incidence for 6 of the top 10 cancers.

Asia Pacific is growing at the fastest pace in the global in-vitro diagnostics (IVDs) market

Asia Pacific is experiencing the fastest growth in global in-vitro diagnostics (IVDs) owing to the increasing incidence of chronic diseases and technological advancements in the region. For instance, according to the National Institute of Health, the expected number of cancer cases in India for 2022 is 14,61,427 (crude rate: 100.4 per 100,000). In India, one out of every nine people is likely to develop cancer over his or her lifetime. Males and females were most likely to develop lung and breast cancer, respectively.

Competitive Landscape

The major global players in the global in-vitro diagnostics (IVDs) market include F. Hoffmann-La Roche Ltd, Abbott, Hologic, Inc., Danaher Corporation, Bio-Rad Laboratories, Inc., Revvity, Siemens Healthcare Private Limited, Thermo Fisher Scientific Inc., Illumina, Inc., and Sysmex Corporation among others.

Emerging Players

Genomtec, QuantiLight, and GeneSys Bio among others

Key Developments

In August 2024, InBios International Inc., a leading developer and manufacturer of diagnostic tests for emerging infectious diseases and biothreats announced the launching of a new in vitro serological ELISA kit for presumptive clinical laboratory diagnosis of Strongyloides infection that offers results in under 75 minutes.
In December 2023, Thermo Fisher Scientific announced the launch of a nucleic acid purification instrument and kit for automated viral and bacterial respiratory testing. The KingFisher Apex Dx system automates the extraction of up to 24 or 96 DNA, RNA, protein, or cell samples and transitions from clinical research to diagnostics by offering research use only (RUO) and in vitro diagnostics (IVD) software modes.

Why Purchase the Report?

Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
Post-market Surveillance: Uses post-market data to enhance product safety and access.
Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global in-vitro diagnostics (IVDs) market report would provide approximately 53 tables, 47 figures, and 176 pages.

Target Audience 2023

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
Supply Chain: Distribution and Supply Chain Managers.
Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
Academic & Research: Academic Institutions.

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 and Service
3.2. Snippet by Technology
3.3. Snippet by Specimen
3.4. Snippet by Test Type
3.5. Snippet by Application
3.6. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Increasing Prevalence of Chronic Diseases
- 4.1.2. Restraints
  - 4.1.2.1. Stringent Regulatory Requirements
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Reimbursement Analysis
5.6. Patent Analysis
5.7. SWOT Analysis
5.8. DMI Opinion

6. By Product and Service

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product and Service
- 6.1.2. Market Attractiveness Index, By Product and Service
6.2. Instruments*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Kits
6.4. Software

7. By Technology

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 7.1.2. Market Attractiveness Index, By Technology
7.2. Immunoassay*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Hematology
7.4. Urinalysis

8. By Specimen

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 8.1.2. Market Attractiveness Index, By Specimen
8.2. Blood*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Saliva
8.4. Urine
8.5. Others

9. By Test Type

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 9.1.2. Market Attractiveness Index, By Test Type
9.2. Laboratory Tests*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Point-of-Care Tests

10. By Application

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.1.2. Market Attractiveness Index, By Application
10.2. Oncology*
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Autoimmune Diseases
10.4. Infectious Diseases
10.5. Others

11. By End-User

11.1. Introduction
- 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.1.2. Market Attractiveness Index, By End-User
11.2. Hospitals and Clinics*
- 11.2.1. Introduction
- 11.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
11.3. Diagnostic Centers
11.4. Academic and Research Institutes

12. By Region

12.1. Introduction
- 12.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 12.1.2. Market Attractiveness Index, By Region
12.2. North America
- 12.2.1. Introduction
- 12.2.2. Key Region-Specific Dynamics
- 12.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product and Service
- 12.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 12.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 12.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 12.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.2.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.2.9. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.2.9.1. The U.S.
  - 12.2.9.2. Canada
  - 12.2.9.3. Mexico
12.3. Europe
- 12.3.1. Introduction
- 12.3.2. Key Region-Specific Dynamics
- 12.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 12.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 12.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 12.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.3.8.1. Germany
  - 12.3.8.2. UK
  - 12.3.8.3. France
  - 12.3.8.4. Italy
  - 12.3.8.5. Spain
  - 12.3.8.6. Rest of Europe
12.4. South America
- 12.4.1. Introduction
- 12.4.2. Key Region-Specific Dynamics
- 12.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 12.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 12.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 12.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.4.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.4.8.1. Brazil
  - 12.4.8.2. Argentina
  - 12.4.8.3. Rest of South America
12.5. Asia-Pacific
- 12.5.1. Introduction
- 12.5.2. Key Region-Specific Dynamics
- 12.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 12.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 12.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 12.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.5.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.5.8.1. China
  - 12.5.8.2. India
  - 12.5.8.3. Japan
  - 12.5.8.4. South Korea
  - 12.5.8.5. Rest of Asia-Pacific
12.6. Middle East and Africa
- 12.6.1. Introduction
- 12.6.2. Key Region-Specific Dynamics
- 12.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 12.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 12.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
- 12.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

13. Competitive Landscape

13.1. Competitive Scenario
13.2. Market Positioning/Share Analysis
13.3. Mergers and Acquisitions Analysis

14. Company Profiles

14.1. F. Hoffmann-La Roche Ltd*
- 14.1.1. Company Overview
- 14.1.2. Product Portfolio and Description
- 14.1.3. Financial Overview
- 14.1.4. Key Developments
14.2. Abbott
14.3. Hologic, Inc
14.4. Danaher Corporation
14.5. Bio-Rad Laboratories, Inc
14.6. Revvity
14.7. Siemens Healthcare Private Limited
14.8. Thermo Fisher Scientific Inc.
14.9. Illumina, Inc.
14.10. Sysmex Corporation

LIST NOT EXHAUSTIVE