In Vitro Diagnostics Market Outlook

The in vitro diagnostics market is set to thrive at a steady CAGR of 4.8% during the forecast period. The market holds a share of USD 81.3 billion in 2023 while it is anticipated to cross a value of USD 129.9 billion by 2033.

The research report on in vitro diagnostics market explains that growing awareness amongst people regarding their health checkups is experiencing a surge. Thus, the demand for advanced in vitro diagnostics is rising as it is one of the latest methods of detecting issues. From testing the blood, and urine samples to diagnosing them in the lab and monitoring them most skillfully is the key to any diagnostic operations.

Furthermore, the addition of advanced automation and instruments along with quality controls and quality assurance software is likely to transform the market in the future. The government increasing its spending on microfluidic technology to enhance in vitro diagnostic solutions. The integration of biotechnology, laboratories, and diagnostic technology is likely to strengthen and save the future of in vitro diagnostics market.

The in vitro diagnostics market outlook states that well-established technologies like lateral flow strips and immunosensors, as well as the continued downsizing of circuits and improved computational capacity of devices, fueled this growth of in-vitro diagnostic medical devices.

This shift from a centralized to the point care testing system is expected to drive the demand for in-vitro diagnostics forward. Furthermore, the rising cases of chronic diseases force people to keep a check on their health and change their lifestyle according to it.

Attributes Details
In Vitro Diagnostics Market CAGR (2023 to 2033) 4.8%
In Vitro Diagnostics Market Size (2023) USD 81.3 billion
In Vitro Diagnostics Market Size (2033) USD 129.9 billion

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How is the Future Outlook (2023 to 2033)  for In Vitro Diagnostics Market in Comparison to the Historical Pattern (2017 to 2022)? 

From 2017 to 2022, the global in vitro diagnostics market registered a comparatively higher CAGR of 5.9%. The rising frequency of chronic and infectious diseases is responsible for the rise in the usage of in-vitro diagnostics medical devices. The rising prevalence of chronic diseases drives the need for extensive diagnostic procedures, which drives the market.

The current in-vitro diagnostics market outlook is positively rising as a result of the IVD market's utilization of modern technology. A paradigm change has occurred, with traditional diagnostics giving way to a new wave of diagnostics that act at the gene level.

The incorporation of modern technologies in the IVD platform, such as genetic testing, molecular diagnostics, polymerase chain reaction (PCR), and next-generation sequencing (NGS), makes this possible. In addition, the sales of in-vitro diagnostics are likely to be driven by an increase in product introductions with enhanced features The In vitro diagnostics market is anticipated to thrive at a CAGR of 4.8% between 2023 to 2033.

What are the Primary In Vitro Diagnostics Market Dynamics?

The frequency of age-related ailments is predicted to rise dramatically as the world's elderly population grows rapidly.

Biomarkers also have a lot of clinical value and interest in the medical business because they can help with illness screening, treatment, and medication.

The accessibility of biomolecular tools and the incorporation of biomarkers are projected to aid in the creation of a new variety of condition-specific tests, giving rise to new in vitro diagnostics products.

The IVD industry is characterized by fierce competition. As competitors seek to maintain their presence and drive R&D and innovation, the in vitro diagnostics market adoption is fast evolving with automation, AI, and advanced data analytics.

To fulfill the changing demand for in vitro diagnostics from providers such as clinical laboratories and point-of-care diagnostic centers, companies have begun to automate diagnostic testing.

With the introduction of quick Proof of Concept technology, facilities were able to streamline workflows and reduce personnel requirements to process a larger sample load.

Diagnostic testing and laboratory industries have banded together to aid public health efforts, provide data for testing, and develop new transformational diagnostic technologies.

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What are the Factors Restraining the In Vitro Diagnostics Market?

Due to continual technological advancements in medicine, countries with unfavorable reimbursement scenarios have issues in their financial systems.

A few years ago, Medicare in the United States amended its funding method for various in-vitro diagnostic tests, including molecular diagnostic testing.

Some molecular pathology tests don't have their own Healthcare Common Procedure Coding System (HCPCS) codes; thus, they're invoiced with unlisted codes instead. Medicare Administrative Contractors (MACs) set a payment amount for their local jurisdictions in such circumstances.

Molecular diagnostic tests focused on NGS analysis panels and cancer detection tests are among the diagnostics available. These changes in the reimbursement system are projected to harm the molecular and genetic testing market in the United States, stifling the in-vitro diagnostics market growth.

What are the Key Threats Prevalent in the In Vitro Diagnostics Market?

Clinical laboratories in key markets are still evolving; technicians confront operational issues in assuring effective sample procurement, storage, and transportation, especially as new technologies like NGS and lab-on-a-chip PCR machines become more widely adopted.

To reduce cross-contamination and ensure efficient time management, laboratory space must also be modified to fulfill the requirements of conducting certain diagnostic procedures needed for pathogen detection. This drives up the expense of maintaining and operating modern in-vitro diagnostic test kits and instruments, especially those that can only handle a single sample type.

Furthermore, clinical laboratories must implement innovative technology capable of rapid sample diagnosis due to the quick mutation of microorganisms and the increased incidence of epidemics. The lack of competent laboratory professionals to operate modern diagnostic equipment, particularly in emerging areas, has hampered their broad acceptance.

Another barrier faced by in-vitro diagnostics companies is a reluctance to move away from manual procedures and toward automation. Many providers find it difficult or impossible to make a move from manual or traditional procedures to IT-based approaches.

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What are the Opportunities Available to the Market Players in the In Vitro Diagnostics Market?

The integration of biomarkers and the availability of biomolecular tools are likely to aid in the development of a new set of condition-specific tests, thereby expanding the in vitro diagnostics industry reach.

The development of new biomarkers for diagnosing various diseases, particularly cancer, has revolutionized medicine. Biomarkers have become more effective in illness identification thanks to advances in sequencing technology and a better understanding of genetics.

As a result, demand for precision medicine is likely to rise, providing considerable potential prospects for in-vitro diagnostics market size growth.

Country-wise Insights

Region Absolute Market Growth
United States USD 18.1 billion
United Kingdom USD 1.2 billion
China USD 6.2 billion
Japan USD 2.1 billion
India USD 3.2 billion

Which Region leads the Market in terms of Market Share?

Increased Healthcare Spending along with the Rising Prevalence of Chronic Diseases like Diabetes and Cancer are propelling the Regional Growth

Region Attributes
United States Market CAGR (2023 to 2033) 4.4%
United States Market Absolute Doller Growth (USD million/billion) USD 18.1 billion

United States is expected to be the leading regional market for in vitro diagnostics during the forecast period, owing to its well-connected healthcare system and increased healthcare awareness among patients, as well as Obama's Affordable Care Act (ACA), technological advancements, and a recovering American economy. The United States regional market is likely to surge at a CAGR of 4.4% between 2023 to 2033 while it is anticipated to reach a value of USD 51.9 billion by 2033.

Other factors that contribute to the market's growth include the widespread availability of devices, increased knowledge about their usage, and the existence of a significant number of senior populations suffering from a variety of chronic ailments.

What makes India a Leading In Vitro Diagnostics Market in terms of CAGR?

Region Attributes
Indian Market CAGR (2023 to 2033) 8.8%
Indian Market Absolute Doller Growth (USD million/billion) USD 3.2 billion

India with its leap in the vaccine race is expanding its roots in the diagnostics industry and is flourishing at a leading CAGR of 8.8% between 2023 to 2033. The regional market is anticipated to reach a value of USD 5.7 billion by 2033. The growth is attributed to the increase in healthcare expenditure and the incidence of diabetes in the region, India is predicted to expand at the quickest rate throughout the projection period.

Various reasons, such as the large patient population of other chronic illnesses that necessitate IVD testing, also contribute to the overall Indian market's growth.

Category-wise Insights

Segment Top Technology
Top Sub-segment Clinical Chemistry
CAGR (2017 to 2022) 5.4%
CAGR (2023 to 2033) 4.2%
Segment Top Application
Top Sub-segment Infectious Disease
CAGR (2017 to 2022) 6.0%
CAGR (2023 to 2033) 4.6%

Wider Panel Options along with the Specialty Chemical Tests are Propelling the Segment’s Growth

The technology category is divided into molecular diagnostics, immunoassays, clinical chemistry, point of care, etc. Clinical chemistry holds a substantial market share as it covers most of the diagnostic panels. The segment thrives at a higher leading CAGR of 4.2% between 2023 to 2033.

Higher Consumption along with Increased Penetration is the driving factors for the Segment’s Growth

The application segment is likely to be driven by an increase in market participants developing infectious disease detection tests for in vitro diagnostics. The infectious disease led the market in 2020, accounting for 41.8 percent of total revenue, owing to the rising prevalence of infectious diseases such as SARS-CoV-2, HIV, AIDS, TB, and pneumonia. The segment now thrives at a CAGR of 4.2% between 2023 to 2033.

For example, Siemens Healthineers' 12 novel tests for viral hepatitis and other disorders obtained premarket approval from the United States Food and Drug Administration in December 2018. These tests are utilized in the Atellica Solution, which offers hepatitis C screening, diagnosis, and monitoring.

Competition Scenario

The market for in vitro diagnostics is indeed competitive, with numerous significant competitors. The industry is currently dominated by a few big companies in terms of market share. Mid-size to smaller businesses, on the other hand, are expanding their market presence by releasing new items at reduced prices, thanks to technical improvements and product innovations. In addition, important players are active in strategic alliances with firms that complement their product lines, such as acquisitions, collaborations, and partnerships.

Market Developments

  • F. Hoffmann-La Roche Ltd. and GenMark Diagnostics, Inc. announced their formal merger agreement in March 2021. Roche may benefit from this purchase by gaining access to GenMark's innovative technology for testing a wide spectrum of infections with a single patient sample.
  • Becton Dickinson and Company completed the acquisition of NAT Diagnostics in May 2020 to broaden its infectious disease point-of-care testing portfolio.
  • Siemens Healthineers AG, BD (Becton, Dickinson, and Company), Seegene Inc., DiaSorin S.p.A., and Quest Diagnostics Incorporated are among the other industry participants having a substantial presence in the worldwide market. To grow their market share, these businesses are anticipated to focus on launching new items.

Key Contributors

  • Thermo Fischer Scientific Inc
  • Abbott Laboratories
  • Siemens Healthcare GmbH
  • F. Hoffmann-La Roche AG

Key Segments

By Product & Service:

  • Reagents
  • Instruments
  • Services & Software

By Technology:

  • Immunodiagnostics
  • Hematology
  • Molecular diagnostics
  • Tissue diagnostics
  • Clinical chemistry
  • Others

By Application:

  • Infectious diseases
  • Cancer
  • Cardiac diseases
  • Immune system disorders
  • Nephrological diseases
  • Gastrointestinal diseases
  • Others

By End User:

  • Standalone laboratories
  • Hospitals
  • Academics & Medical Schools
  • Point-of-Care
  • Others

By Region:

  • North America
  • Latin America
  • Europe
  • Asia Pacific (APAC)
  • The Middle East & Africa (MEA)

Frequently Asked Questions

How Big is the In Vitro Diagnostics Market Currently?

In 2023, the market size is estimated to be USD 81.3 billion.

Who are the Key In Vitro Diagnostics Market Players?

Thermo Fischer Scientific Inc., Abbott Laboratories, and Siemens Healthcare GmbH are the key players in the market.

What Opportunities Await for the Market Players?

Rise in demand for precision medicine is likely to be opportunistic for market players.

What are Key Challenges in the In Vitro Diagnostics Market?

Need for more competent laboratory professionals is the key challenge.

Which Region Holds High Lucrativeness?

North America is expected to be the leading region.

What is the Growth Forecast for the In Vitro Diagnostics Market?

The market is expected to register a CAGR of 4.8% through 2033.

Table of Content
	1. Executive Summary 
	2. Market Overview
	3. Market Background
	4. Global Market Analysis 2017 to 2022 and Forecast, 2023 to 2033
	5. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Technology
		5.1. Molecular Diagnostics
			5.1.1. Polymerase Chain Reaction
			5.1.2. Isothermal Nucleic Acid
			5.1.3. Microarray
			5.1.4. Hybridization
			5.1.5. DNA Sequencing & Next Generation Sequencing
			5.1.6. Other MDx Technologies
		5.2. Immunoassays
			5.2.1. ELISA
			5.2.2. RIA
			5.2.3. ELISpot Assay
			5.2.4. Rapid Test
			5.2.5. Other Immunoassay techniques
		5.3. Clinical Chemistry
			5.3.1. Basic Metabolite
			5.3.2. Electrolyte Panel
			5.3.3. Liver Panel
			5.3.4. Lipid Panel
			5.3.5. Renal Panel
		5.4. Point of Care
		5.5. Whole Blood Glucose Monitoring
		5.6. Hematology
		5.7. Clinical Microbiology
		5.8. Coagulation and Hemostasis
		5.9. Others
	6. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Application
		6.1. Drug Testing
		6.2. Infectious Disease
		6.3. Oncology
		6.4. Metabolic Disease
		6.5. Autoimmune Disease
		6.6. Others
	7. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By End-user
		7.1. Diagnostics Laboratories
		7.2. Hospitals
		7.3. Academic & Research Centers
		7.4. Home Care
		7.5. Others
	8. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Region
		8.1. North America
		8.2. Latin America
		8.3. Europe
		8.4. Asia Pacific
		8.5. Middle East and Africa
	9. North America Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country
	10. Latin America Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country
	11. Europe Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country
	12. Asia Pacific Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country
	13. Middle East and Africa Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country
	14. Key Countries Market Analysis
	15. Market Structure Analysis
	16. Competition Analysis
		16.1. Roche Diagnostics
		16.2. Siemens Healthineers
		16.3. Danaher Corporation
		16.4. Abbott
		16.5. Thermo Fisher Scientific
		16.6. Johnson & Johnson
		16.7. Becton, Dickinson and Company
		16.8. Bio-Rad Laboratories
		16.9. Sysmex Corporation
		16.10. bioMérieux
		16.11. DiaSorin
		16.12. Ortho Clinical Diagnostics
		16.13. QIAGEN N.V.
	17. Assumptions & Acronyms Used
	18. Research Methodology
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