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體外診斷

市場調查報告書

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1557267

全球體外診斷市場 - 2024 年至 2029 年預測

Global In Vitro Diagnostics Market - Forecasts from 2024 to 2029

出版日期: 2024年08月23日 | 出版商:

Knowledge Sourcing Intelligence | 英文 155 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

全球體外診斷市場預計將從 2024 年的 1,034.15 億美元增至 2029 年的 1,390.84 億美元，預測期內複合年成長率為 6.11%。

體外診斷（IVD）市場的成長歸因於多種因素，包括感染疾病和持續性疾病日益占主導地位。照護現場診斷的利用率不斷提高，以及與體外診斷產品相關的創新技術進步將推動市場成長。提高公眾對疾病預防的認知以及採用個人化藥物和治療方法預計將在未來幾年擴大該行業。

此外，隨著癌症患者的迅速增加，對癌症早期發現和預防的症狀治療和診斷課程的需求將會增加，這將在預測期內發展體外診斷產業。世界衛生組織 (WHO) 於 2024 年 2 月宣布，2022 年全球將新增 2,000 萬名癌症病例，到 2025 年將增加 77%，預計將有超過 3,500 萬新病例記錄。這種擴張是由於人口老化、人口成長以及菸草、酒精、空氣污染和肥胖等風險變數的暴露變化所造成的。

推動全球體外診斷市場的因素

慢性病和感染疾病的增加以及人口老化預計將推動市場擴張。

已開發市場和新興市場老年人口的增加預計將對體外診斷市場做出積極貢獻。隨著老齡化社會的快速發展，與老齡化相關的疾病的發生率預計將顯著增加。全球和其他已開發國家的人口老化正在加劇。例如，日本的勞動人口中老年人比例最高，其次是德國。美國醫學會預測，到 2030 年，65 歲及以上的老年人中 60% 將患有多種慢性病。隨後，隨著老年人口的增加，預計多種疾病將成為全世界的主要疾病。這被認為是體外診斷藥物（IVD）市場擴張的關鍵驅動力。

此外，心血管疾病（CVD）、糖尿病、呼吸系統疾病和癌症等慢性疾病的全球負擔正在迅速增加。體外診斷測試透過使用生物標記和檢測因生理變化引起的疾病，能夠早期診斷和檢測這些疾病。慢性病的增加主要是與生活方式相關的一些因素造成的，例如不健康的飲食、吸煙、消費量增加和不活躍的生活方式。

此外，根據國際糖尿病聯盟（IDF）2023年11月的最新報告，2021年將有5.37億成年人（即十分之一）患有糖尿病，到2030年將有6.43億成年人患有糖尿病，並且預計到 2045 年，人口將增至 7.83 億。 44% 的成年人（約每 2 人中就有 1 人）仍未被診斷，其中大多數患有第 2 型糖尿病。超過四分之三的糖尿病患者生活在低收入和中等收入國家，5.41 億成年人可能患有第 2 型糖尿病。此外，醫療機構和政府越來越重視預防措施以遏制慢性病負擔的不斷增加，也將推動預測期內的市場成長。

全球體外診斷市場的限制因素

不利的贖回可能會阻礙市場成長。

報銷不足是體外診斷市場開拓的重大障礙。幾年前，美國醫療保險改變了一些體外診斷（包括分子診斷）的報銷方式。很少有分子病理學測試沒有 HCPCS（醫療保健通用程序編碼系統）代碼，而是使用未發布的代碼申請。在這些情況下，醫療保險行政承包商 (MAC) 為鄰近司法管轄區設定分期付款金額。此類變化很可能對美國的分子和基因檢測產業產生負面影響，並限制體外診斷市場的擴張。

全球體外診斷市場的地理展望

北美地區預計將佔據主要市場佔有率。

預計在預測期內，北美將成為最大的體外診斷市場，由於醫療保健框架的發達和患者醫療保健意識的提高，預計該市場將繼續保持這一地位。促進新興市場開拓的其他因素包括設備的可用性、有關其使用的知識的擴展以及大量患有各種慢性病的人的存在。支持體外診斷市場開拓的另一個因素是北美許多大公司的存在。此外，由於醫療支出增加，預計該地區的糖尿病盛行率在預測期內將以最高速度成長。可能的因素，例如大量慢性疾病患者需要 IVD 檢測，正在推動該地區的市場擴張。

開拓全球體外診斷的主要市場：

2023 年 5 月，賽默飛世爾科技 (Thermo Fisher Scientific) 和輝瑞 (Pfizer) 同意在 30 多個國家（包括拉丁美洲、非洲、中東和亞洲）擴大對肺癌和乳癌患者進行基於次世代定序(NGS) 的檢測的區域範圍。該合作夥伴關係旨在將快速 NGS 測試帶到更接近患者照護端的分散實驗室。 Thermo Fisher 利用其 NGS 技術來檢測當地實驗室，並確保它們擁有必要的基礎設施、訓練有素的勞動力和品管措施。同時，輝瑞正在努力為患者提供負擔得起的 NGS 檢測機會，並提高醫療保健提供者對創新檢測的認知。
2023 年 5 月 - 西門子 Healthineers 推出了兩款大容量血液學檢測系統，消除了血液學檢測中的勞動力障礙：Atellica Hema 570 分析儀和 Atellica Hema 580 分析儀。這些分析儀執行全血球計數 (CBC)，這是實驗室最常執行的診斷測試之一。它具有連接性、直覺的介面、自動化和基於規則的整合測試，可有效解釋複雜的患者結果。這些解決方案可適應大容量血液學測試並確保記錄關鍵資料。
2023 年 5 月 - 女性健康領域的全球領導者 Hologic Inc. 與最近入選的 NFL 角衛 Kelly Ringo 及其母親、乳癌倖存者 Tralee Hale 合作，呼籲女性提高對重要健康檢查重要性的認知。每年一次的乳房X光檢查。

The in vitro diagnostic (IVD) market growth is ascribed to various components, like the rising predominance of infectious and persistent ailments. Rising utilization of point-of-care diagnostics and inventive technological progressions related to in-vitro diagnostics product profiles will surge market growth. Rising awareness among the general population for disease prevention and the adoption of personalized medications and treatment procedures will expand the industry in the coming years.

Additionally, with the fast increment in cancer cases, there will be a rise in the requirement for symptomatic and diagnostic courses for detecting and preventing cancer at an early stage, which can develop the in vitro diagnostics industry in the forecasted period. World Health Organization reported in February 2024 that the number of new cancer cases was 20 million in 2022 worldwide and is predicted to rise by 77% by 2025, with more than 35 million new cases to be recorded. This expansion is credited to population aging, population rise, and changes in exposure to risk variables, such as tobacco, alcohol, air pollution, and obesity.

GLOBAL IN-VITRO DIAGNOSTICS MARKET DRIVER:

The increased prevalence of chronic and infectious diseases, as well as an aging population, is expected to boost the market expansion.

The increasing geriatric population in developed and developing countries would positively contribute to the IVD market. The predominance of age-related disorders is anticipated to rise significantly as the world's aging population develops quickly. The aging population is increasing and growing in other industrialized economies globally. Japan, for instance, has the most elevated proportion of the elderly population to the productive population, followed by Germany. The American Medical Association reported that by 2030, it is anticipated that 60% of individuals aged 65 and over will have more than one chronic illness. Subsequently, the worldwide predominance of diverse diseases is expected to grow as the geriatric population increases. This is regarded as a major driver for IVD market expansion.

Additionally, the global burden of chronic diseases like cardiovascular diseases (CVDs), diabetes, respiratory illness, and cancer has been increasing rapidly. In-vitro diagnostic tests will empower the early diagnosis and discovery of these illnesses by using biomarkers and detecting disorders advancement by physiological changes. The rise in chronic illness can be due to numerous components majorly lifestyle-related, like unhealthy diet, use of tobacco, growing alcohol consumption, and inactive life.

In addition, as per the International Diabetes Federation's (IDF) latest report of November 2023, 537 million adults, i.e., 1 in each 10, were living with diabetes in 2021, with the number expected to rise to 643 million by 2030 and 783 million by 2045. 44% of adults stay undiagnosed, which is approximately 1 in 2, with the larger part having type 2 diabetes. Over 3 in 4 diabetes patients live in low and middle-income nations, and 541 million adults have a high chance of developing type 2 diabetes. Moreover, the rising focus of healthcare organizations and governments on preventative measures for controlling the increasing burden of chronic illness will additionally propel market growth in the predicted period.

GLOBAL IN-VITRO DIAGNOSTICS MARKET RESTRAINT:

Unfavorable reimbursement can hinder the market growth.

Inadequate reimbursement is a substantial barrier to the IVD market development. A couple of years ago, Medicare in the US changed how it repaid several IVD tests, including molecular diagnostics. Few molecular pathology tests do not have their claim Healthcare Common Procedure Coding System (HCPCS) codes, so they are charged utilizing unlisted codes instead. Medicare Administrative Contractors (MACs) set an installment sum for their nearby purviews on such occasions. These changes will likely harm the molecular and hereditary testing industry within the United States, constraining the IVD market's expansion.

Global In-Vitro Diagnostics Market Geographical Outlook

The North American region is expected to hold a substantial market share.

North America is anticipated to be the biggest market for in vitro diagnostics amid the projected period, and it is likely to proceed to do so due to its well-developed healthcare framework and rising healthcare mindfulness among patients. Other components that contribute to the market's development include the availability of devices, expanded knowledge about their utilization, and the presence of many populations suffering from diverse chronic conditions. Another component driving the in vitro diagnostics market development is the presence of many major companies in North America. Moreover, due to an increase in healthcare expenditure, the rate of diabetes in the region is expected to extend at the highest rate throughout the projection period. Conceivable factors, such as the huge populace of patients with other chronic illnesses that necessitate IVD testing, are fueling the regional market's expansion.

Global In-Vitro Diagnostics Key Market Developments:

May 2023- Thermo Fisher Scientific and Pfizer agreed to expand local access to next-generation sequencing (NGS)-based testing for lung and breast cancer patients in over 30 countries, including Latin America, Africa, the Middle East, and Asia. The collaboration aims to bring rapid NGS testing to decentralized labs closer to patients' treatment sites. Thermo Fisher works by detecting local labs by employing its NGS technology, ensuring they have the required infrastructure, trained workforce, and quality control measures. At the same time, Pfizer operates to provide affordable patient access to NGS tests and increase healthcare providers' awareness of innovative testing.
May 2023- Siemens Healthineers introduced two high-volume hematology test systems, the Atellica Hema 570 Analyzer and the Atellica Hema 580 Analyzer, which clear out labor barriers in hematology testing. These analyzers execute complete blood counts (CBC), among the most performed diagnostic tests in laboratories. They provide connectivity, intuitive interfaces, automation, and integrated rules-based testing to interpret complex patient results efficiently. These solutions address the requirement for high-volume hematology testing and deliver critical data reliably.
May 2023- Hologic Inc., a global leader in women's health, announced a collaboration with NFL cornerback Kelee Ringo, who was drafted recently, and his mother Tralee Hale, a breast cancer survivor, to raise awareness among women about the importance of making yearly mammograms and other critical health screenings a primacy.

Market Segmentation:

The Global In-Vitro Diagnostics market is segmented and analyzed as below:

By Technique

Immunoassay
Molecular Diagnostics
Hematology
Others

By Application

Infectious diseases
Autoimmune diseases
Drug Testing
Oncology
Others

By End-User

Diagnostic Laboratories
Hospitals and Clinics
Research Laboratories and Institutes

By Geography

North America
United States
Canada
Mexico
South America
Brazil
Argentina
Others
Europe
Germany
France
United Kingdom
Italy
Others
Middle East and Africa
Saudi Arabia
UAE
Israel
Others
Asia Pacific
China
Japan
India
Australia
Taiwan
Thailand
Indonesia
Others

1. INTRODUCTION

1.1. Market Overview
1.2. Market Definition
1.3. Scope of the Study
1.4. Market Segmentation
1.5. Currency
1.6. Assumptions
1.7. Base and Forecast Years Timeline
1.8. Key benefits for the stakeholders

2. RESEARCH METHODOLOGY

2.1. Research Design
2.2. Research Process

3. EXECUTIVE SUMMARY

3.1. Key Findings

4. MARKET DYNAMICS

4.1. Market Drivers
4.2. Market Restraints
4.3. Porter's Five Forces Analysis
- 4.3.1. Bargaining Power of Suppliers
- 4.3.2. Bargaining Power of Buyers
- 4.3.3. Threat of New Entrants
- 4.3.4. Threat of Substitutes
- 4.3.5. Competitive Rivalry in the Industry
4.4. Industry Value Chain Analysis
4.5. Analyst View

5. GLOBAL IN-VITRO DIAGNOSTICS MARKET BY TECHNIQUE

5.1. Introduction
5.2. Immunoassay
5.3. Molecular Diagnostics
5.4. Hematology
5.5. Others

6. GLOBAL IN-VITRO DIAGNOSTICS MARKET BY APPLICATION

6.1. Introduction
6.2. Infectious diseases
6.3. Autoimmune diseases
6.4. Drug Testing
6.5. Oncology
6.6. Others

7. GLOBAL IN-VITRO DIAGNOSTICS MARKET BY END-USER

7.1. Introduction
7.2. Diagnostic Laboratories
7.3. Hospitals and Clinics
7.4. Research Laboratories and Institutes

8. GLOBAL IN-VITRO DIAGNOSTICS MARKET BY GEOGRAPHY

8.1. Introduction
8.2. North America
- 8.2.1. By Technique
- 8.2.2. By Application
- 8.2.3. By End User
- 8.2.4. By Country
  - 8.2.4.1. United States
  - 8.2.4.2. Canada
  - 8.2.4.3. Mexico
8.3. South America
- 8.3.1. By Technique
- 8.3.2. By Application
- 8.3.3. By End User
- 8.3.4. By Country
  - 8.3.4.1. Brazil
  - 8.3.4.2. Argentina
  - 8.3.4.3. Others
8.4. Europe
- 8.4.1. By Technique
- 8.4.2. By Application
- 8.4.3. By End User
- 8.4.4. By Country
  - 8.4.4.1. Germany
  - 8.4.4.2. France
  - 8.4.4.3. United Kingdom
  - 8.4.4.4. Italy
  - 8.4.4.5. Others
8.5. Middle East and Africa
- 8.5.1. By Technique
- 8.5.2. By Application
- 8.5.3. By End User
- 8.5.4. By Country
  - 8.5.4.1. Saudi Arabia
  - 8.5.4.2. UAE
  - 8.5.4.3. Israel
  - 8.5.4.4. Others
8.6. Asia Pacific
- 8.6.1. By Technique
- 8.6.2. By Application
- 8.6.3. By End User
- 8.6.4. By Country
  - 8.6.4.1. China
  - 8.6.4.2. Japan
  - 8.6.4.3. South Korea
  - 8.6.4.4. India
  - 8.6.4.5. Australia
  - 8.6.4.6. Taiwan
  - 8.6.4.7. Thailand
  - 8.6.4.8. Indonesia
  - 8.6.4.9. Others