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Global In-Vitro Diagnostis Market Report (2020-2026)

Healthcare industry has witnessed a significant growth over the past decade with the development of the IVD market. IVD continues to remain the dominant market in the global medical devices market accounting for 13% of the total medical devices market in 2020. Although there are various opportunities for the growth of the market, regulatory challenges, reimbursement pressure, challenges in health care budgets, and advancement of low cost providers are some of the limitations for the market growth.

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Market Snapshot

Global In-Vtiro Diagnostics Market Value, USD Million

Market Overview

In 2019, IVD segment has witnessed the highest number of M&A deals in the medical devices market. More than half of the deals in the IVD segment are in the Molecular Diagnostics market. Companies are focusing on increasing their existing product portfolio and in strengthening their product pipelines. IVD manufactures are highly focused on acquiring early stage Molecular Diagnostics companies focusing on novel technologies. With limited differentiation in the product offerings, companies with greater economies of scale will have higher competitive advantage over pricing.

Companies in the IVD industry are focusing on developing Companion Diagnostics and Molecular Diagnostics products, as these markets are having the high potential for growth. Companies are highly investing in the oncology diagnostics segment with a primary aim to provide easy diagnosis and monitoring in follow ups. Infectious disease diagnostics, endocrinology, and neurodegenerative disorders are some of the other key areas of focus. Strategic alliance of pharmaceutical and diagnostic companies is further improving the treatment options at the molecular level.

The IVD market remains attractive for low cost providers especially in the emerging market such as Asia-Pacific and South American countries. Growing regulatory challenges in United States and European regions will be restricting the entry of the low-cost manufactures into these markets. Companies with high cash are entering the market through strategic partnerships and acquisitions. Entry of new companies and acquisitions of companies focusing on novel technologies are leading to innovations across geographies. Investments in R&D as a percentage of sales has remained constant across small and large companies, yet large companies focus more on M&A for acquiring advanced technology.

Market Dynamics

Improved healthcare conditions in the India and adoption of new innovative technologies benefited the growth of the market. However, challenging price environment and limited pricing reimbursement are limiting the growth of the market. Introduction of new regulation on medical devices to reduce the registration fees will ease the availability of high-end medical devices in the country. Shift from four phase clinical trial method to two phase clinical trial method will further encourage the growth of the market in India.

Rising incidents of infectious and chronic diseases, growing adoption of automated platforms by smaller hospitals and clinics, and declining healthcare costs are some of the major factors driving the growth of the market. Lack for affordability of high end devices such as molecular diagnostics products, reimbursement cuts, changes in regulatory policies in developed nations such as US and Europe, stringent regulatory framework, and lack of standardization of products are some factors limiting the market growth. Expansion of universal healthcare scheme in Asian and South American countries, on-going investments in healthcare infrastructure, and development of novel drugs with potential for new medical diagnostics will significantly contribute to the global expansion.  

COVID-19 Impact

The COVID-19 pandemic has turned a spotlight on the In-Vitro Diagnostics industry with rapid developments of diagnostics, fast-tracked regulatory clearness, and improved distribution facilities across various regions. IVD companies are leveraging partnerships with government and non-governmental organisations to expedite time to market for new tests. Though COVID-19 tests are in high demand, the demand for other tests is down in 2020 impacting the revenues of IVD companies. The impact of the IVD market will likely to span beyond 2020 with potential consolidation at end-user and commercial level. In addition to the high demand for COVID-19 tests, there is an exponential increase in respiratory tests such as flu tests used to rule in/rule out COVID-19 and manage patients. Other types of tests such as blood gas testing and pneumonia testing will increase in 2020 as these tests are used to monitor COVID-19 patients. Tests such as fertility tests, allergy tests, per-operating tests, non-essential oncology tests, general wellness testing, organ transplants testing, and other testing related to blood donation will see a huge decline in revenue in 2020 and till mid-2021.  Capital installations, large tenders for IVD equipment and new product launches will be affected throughout 2020 and potentially beyond mid-2021.

Segmentation by Test Type

Global IVD Market by Test Type, 2019

Immunoassays, Blood Glucose Monitoring, Clinical Chemistry, and Molecular Diagnostics together accounted for more than 70% of the market share in 2019. Molecular diagnostics is one of the fastest growing segments in the global IVD market and accounts for more than 11% of the market share in 2019. Rising disease incidence and growth of the infectious diseases market is supporting the growth of the molecular diagnostics market. Further, growth of the POC diagnostics in the molecular diagnostics market will support the market growth. Availability of new technological platforms, presence of large unmet needs in healthcare market, increasing collaborations and partnerships for the development of new technological and growing investments in technologies will further support the market growth. Increased adoption of molecular diagnostics platforms among the small and mid-size hospitals is further strengthening the IVD market.

Diabetics market plays a critical role in the growth of the IVD market. Blood Glucose Monitoring represents 12% of the global IVD market. Growth of the Blood Glucose monitoring devices is supported by the growth of the self-blood glucose monitoring devices. United States remains the major market for this segment with such devices increasing at a higher rate in the emerging markets. Companies in self-glucose monitoring devices focus on the repeat sales of strips. The companies in the segment are highly competing with price acting as critical factor in gaining market share. Companies are offering huge discounts on the glucose monitoring test strips to gain competitive advantage. Lack of reimbursement and growing adoption of sensor based technologies are challenging the growth the market.

Segmentation by Geography

Global IVD Market Share by Geography, 2020

United States dominate the global IVD market with a revenue base of USD 21,487.21 million in 2019. Rise of integrated delivery network (IDN) has the challenged the pricing environment and is limiting the growth of the IVD market. Reimbursement cuts raised from Protecting Access to Medicare Act (PAMA) from January 2018 is also challenging the market growth. Revoking of Medical Device Excise Tax (MDET) will benefit the diagnostics manufactures and will improve the market conditions in US.

Europe is the second largest market in the world with as global share of 28.37% in 2018. Growth of the Europe is supported by the growth of the molecular diagnostics while is challenge by the slow growth of the blood glucose monitoring. Five nations in Europe (Germany, France, UK, Italy, and Spain) accounted for 62% of the Europe market with Germany dominating the Europe market with 19.59% share in 2019. Implementation of new European IVD Regulation (IVDR) by replacing IVD Directive (98/79/EC) has a transaction period of five years with new regulations fully applicable from May 26th, 2022. New IVD Regulations are emphasising on enhanced safety and performances of IVD devices by implementing severe inspection and by having increased accountability. Challenges in resignation process will pose a threat to the implementation of the new regulations.

Asia-Pacific market was largely driven by the continuing expanding growth of the Chinese and Japanese markets. Asia region continues to outpace the global market growth supported by the higher growth of the Immunoassays and Molecular diagnostics market. Top companies continue to dominate the market in the Multispecialty hospitals while small companies are focusing on mid-level hospitals especially for reagents. The Chinese market is largely driven by the government initiatives and strong growth of the local companies. Emergence of the new models in the healthcare systems and growing investments in the healthcare infrastructure is supporting the growth of the point for care market. Chinese IVD market is a fragmented market with more than 600 manufacturing and distribution companies. However, the market is consolidating with rise in the M&A deals in the country. Local manufacturing companies are not only competing in the matured markets such as blood glucose monitoring, haematology, and other, but are also competing in the high growth markets such as immunoassays, molecular diagnostics, and critical care market. Further, local manufactures are investing in R&D for the development of the advanced technologies in the market. China has a relatively smaller market size in the global market with huge potential for market growth. China market is estimated to increase by 60% to 5bn by 2025 from 2017 level.

Competitive Landscape

Global IVD Market Company Share Analysis, 2025

IVD market is a consolidate market with top 10 companies accounting for around 75% of the market share in 2018. By the end of the forecast, the share of the top companies is estimated to reduce by over 2%. Roche, Abbott Laboratories, Danaher, and Siemens are top 4 companies in the industry with more than half of the market share in 2018. It is estimated that Roche and Siemens will lose their market share by 1.7% and 1.3% over 2018-2025. Abbott Laboratories will significantly gain their market share in the IVD market by the end of the forecast period and it is estimated that Abbott market share will rise by over 2% over 2018-2025. The major companies in the industry are focusing on R&D investments to strengthen their product offerings and also are focusing on entering into new markets. Companies are focusing on providing customized solutions with IT Data Management offerings playing a critical role. Over 50% of the deals in the IVD sector were in the molecular diagnostics sector. The market will continue to attract the low cost providers especially in the developing nations which have restricted budgets. Companies focusing on achieving organic expansion and strengthening their product portfolio in high growth markets, while consolidating their revenue in mature markets will help in gaining competitive advantage.  

Major Players

Abbott Laboratories
Abbott Laboratories

Table of Contents

1. Research Methodology and Scope

2. Executive Summary

3. Impact of COVID-19 on In-Vitro Diagnostics Market

4. Market Dynamics

        4.1 Drivers

        4.2 Restraints

5. Competitive Landscape

        5.1 Key Strategies Adopted by Major Companies

        5.2 Company Share Analysis

6. In-Vitro Diagnostics Market Segmentation by Product

        6.1 Instruments

        6.2 Consumables

        6.3 Software

7. In-Vitro Diagnostics Market Segmentation by Test Type

        7.1 Immunoassay

        7.2 Clinical Chemistry

        7.3 Blood Glucose Monitoring

        7.4 Molecular Diagnostics

        7.5 Microbiology

        7.6 Anatomic Pathology

        7.7 Hematology

        7.8 Coagulation

        7.9 Critical Care

        7.10 Urinalysis

        7.11 Others

8. In-Vitro Diagnostics Market Segmentation by Application

        8.1 Diabetes

        8.2 Infectious Disease

        8.3 Oncology

        8.4 Cardiology

        8.5 Nephrology

        8.6 Autoimmune Disease

        8.7 Pharmacogenomics

        8.8 HIV/AIDS

        8.9 Women’s Health

        8.10 Other Applications

9. 8. In-Vitro Diagnostics Market Segmentation by End-User

        9.1 Hospitals

        9.2 Central Laboratories

        9.3 Point-of-Care

        9.4 Clinics

        9.5 Academic Institutions

        9.6 Others

10. In-Vitro Diagnostics Market by Region

        10.1 North America

                 10.1.1 United States

                 10.1.2 Canada

                 1-.1.3 Mexico

        10.2 Europe

                 10.2.1 United Kingdom

                 10.2.2 Spain

                 10.2.3 Italy

                 10.2.4 Germany

                 10.2.5 Russia

                 10.2.6 France

                 10.2.7 Netherlands

                 10.2.6 Rest of Europe

        10.3 Asia-Pacific

                 10.3.1 China

                 10.3.2 India

                 10.3.3 Japan

                 10.3.4 Australia

                 10.3.5 South Korea

                 10.3.6 Rest of Asia-Pacific

        10.4 South America

                 10.4.1 Brazil

                 10.4.2 Rest of South America

        10.5 Middle East and Africa

                 10.5.1 Saudi Arabia

                 10.5.2 Isreal

                 10.5.3 UAE

                 10.5.4 Africa

                 10.5.5 Rest of Middle East and Africa

11. Company Profiles

        11.1 Abbott Laboratories

        11.2 Roche

        11.3 Danaher Corporation

        11.4 Siemens

        11.5 Thermo Fisher Scientific

        11.6 Sysmex

        11.7 bioMérieux

        11.8 Becton Dickinson and Company

        11.9 Ortho Clinical Diagnostics

        11.10 Exact Sciences

12. Appendix

Research Methodology

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Global In-Vitro Diagnostis Market Report (2020-2026)
Global In-Vitro Diagnostis Market Report (2020-2026)
Included in this report
Industry Financial Ratios
Revenue Forecasts
Historical & Forecast Growth
Industry Market Size
Industry Major Players
Profitability analysis
SWOT Analysis
Industry Trends
Industry Operating Conditions
Porter's 5 Forces Analysis
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