Bilirubin Blood Test Market By Product Type (Consumables {Reagents, Kits, Calibrators}, Instruments {Analyzers, Spectrophotometers}), By Test Method (Enzymatic Methods, Colorimetric Methods, Fluorometric Methods), By Application (Liver Disease Diagnosis {Hepatitis, Cirrhosis, Liver Cancer}, Neonatal Jaundice Testing, Hemolytic Anemia Diagnosis, Gallbladder & Bile Duct Disease Diagnosis, Other), By End-user (Hospitals & Clinics, Diagnostic Laboratories, Home Care Settings, Research & Academic Institutes), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Bilirubin Blood Test market accounted for USD 1.38 Billion in 2024 and is expected to reach USD 2.82 Billion by 2035, growing at a CAGR of around 6.7% between 2025 and 2035. The diagnostic tests done on the bilirubin blood test used to determine the level of bilirubin in the blood are used to diagnose liver disorders, neonatal jaundice, hemolytic anemia, bile duct disorders, and other illnesses.

The market's growth is attributed to the increasing cases of liver diseases, higher incidence of neonatal jaundice cases, and the latest developments in diagnostics. Hemoglobin-based products are also on the rise due to the ever-increasing utilization of point-of-care testing and the increasing trend of home-based bilirubin monitoring. North America and Europe are prominent due to the concentrated and proper healthcare structure, and Asia-Pacific is anticipated to grow in the forthcoming years due to enhanced healthcare consciousness and better diagnostic methods. There are improvements in spectrophotometry and automated bilirubin analyzers that strengthen the demand for the market in terms of test dexterity and precision.

Report Scope:

Market Dynamics

Rising liver diseases are increasing the prevalence of hepatitis, cirrhosis, and liver cancer cases.

Hepatitis, cirrhosis, and liver cancer are among the diseases that have made liver disease incidence rates rise globally and become a concern to humans. Hepatitis B and C result in chronic liver infections resulting in complications that are dangerous to human health. Some of the risks that are known to lead to liver cirrhosis include alcohol consumption, obesity, and metabolic disorder implications. Also, non-alcoholic fatty liver disease is increasingly prevalent owing to a modern lifestyle and improper nutrition. Liver cancer is a fatal disease, which may develop from long-term liver diseases such as HCC.

This has made individuals who are suffering from liver diseases seek early diagnosis and diagnostic tests such as total bilirubin blood tests. It is now considered that improvements in the tests facilitate better disease diagnosis and management. To mitigate this crisis, governments and healthcare organizations aimed at increasing awareness campaigns and screening programs. H1 argued that there is a positive correlation between healthcare costs, diagnosis, and treatment. Investigations into novel biomarkers and therapeutic solutions are also increasing day by day. A steady growth in the rates of liver diseases implies the necessity of efficient diagnostic and prevention measures all over the world.

Advancements in diagnostic technology Improved spectrophotometry and automated analyzers enhance accuracy.

There is marked progress in trends towards enhanced diagnosis of bilirubin through enhanced technology in this field. A precise measurement of bilirubin concentrations with the use of spectrophotometry has led to the early diagnosis of liver and neonatal jaundice illnesses. Technological advancement has brought in the favorites of automated analyzers, which have provided efficiency to the bilirubin tests, eliminating a human error factor. The use of AI in diagnostics along with machine learning algorithms also enhances the test interpretations. Today, hand-held diagnostic devices that give near-patient results are commonly known as point-of-care testing or point-of-care testing. Improvement of microfluidic processes and biosensors produced bilirubin testing that was more progressive and easier. Home and remote patient monitoring is supported by portable and compact analyzers.

Outsourcing data management in diagnostic systems improves data results storage and sharing for greater outcomes in treatment. Thus, the constant efforts to find other methods of bilirubin testing without using a needle may help to replace the standard blood tests. One of the most significant advances has been the development of high-speed laboratory analyzers that have provided ease of large-volume testing and incremental value beneficial to hospitals and diagnostic centers. These are some of the technological factors that are fueling the use of bilirubin blood tests across the world. Information handling, diagnostic precision, and the use of automated diagnosis procedures also lead to improved disease and patient treatment.

The high cost of advanced testing equipment and expensive analyzers limits adoption in low-income regions.

The costly equipment used in performing the bilirubin blood test is a key factor that limits the market, especially in low-income areas. Being nearly expensive to purchase and maintain, such as analyzers and spectrophotometers used in the determination of bilirubin levels, they remain inaccessible to small healthcare centers, clinics, etc. A major challenge, however, is the scarcity of funds to purchase such tools for diagnosis in the many healthcare facilities in the developing world. Other operational cost factors include the cost of consumables such as reagents and testing kits that are normally very expensive. Because many of the healthcare providers operating within developing nations depend on limited resources, many of them make use of old-fashioned or traditional techniques of testing; therefore, these tests may not be very accurate. To sum up the primary reasons for the current situation related to market development, one can also mention the lack of sufficient funds for government initiatives and insufficient reimbursement rates.

This reduces the accessibility to health in basic facilities in the regions, which hinders early diagnosis of diseases. This essay focuses on delayed diagnosis of liver disorders, neonatal jaundice, and hemolytic anemia and the health risks associated with these diseases. This is due to the high capital investment required to set up this equipment; hence, new diagnostic centers will not be able to afford to invest in bilirubin testing machines. Furthermore, since the maintenance and calibration of high-tech analyzers are needed, the cost of skilled labor is high. There is a need for cheap solutions in implementing this challenge together with increased funding of healthcare facilities.

Technological advancements Innovations in bilirubin analyzers improve accuracy and efficiency in diagnostics.

The advancement in the technology of the instrument in bilirubin analysis is improving accuracy and making diagnosis more effective and easier. Advanced spectrophotometry, microfluidics, and high-end automation in the form of artificial intelligence are some of the features offered in contemporary analyzers, resulting in efficiency and accurate determination of bilirubin levels. These innovations also minimize human error, increase the sensitivity of the test, and help in the early detection of liver diseases, neonatal jaundice, and hemolytic disorders. New miniature and handheld devices used in hospitals, clinics, and even at home provide real-time bilirubin measurement, helping the patients. In diagnostic laboratories, some aspects are automated to lessen the amount of time taken and expenses incurred.

To this effect, non-invasive bilirubin meters, in particular those developed for neonatal screening, do not hurt the patient and reduce the risks of acquiring infections. It also makes it easy to integrate with cloud-based healthcare systems, boosting information sharing and remote health check-ups. Advancements in technologies are encouraged to have a positive impact on the accuracy of bilirubin testing. Regular market expansion of the device means added portability, hence improved coverage to annex better parts of the world. An increased number of people continue to use digital health solutions, therefore improving the efficiency of diagnosing bilirubin. New trends arising in this field include the use of a smartphone to detect bilirubin in the body. They all collectively enhance disease control and prevention as well as the general maintenance of people’s health.

Point-of-care testing is expanding; home-based and rapid testing solutions enhance market growth.

Consequently, home-based and rapid point-of-care (POC) testing has greatly impacted the bilirubin market growth. Point-of-care bilirubin meters are very handy; they save time, and the patients need not visit the laboratory or the hospital to get the results. Hemolysis, or hemolysis, is facilitated by these devices in the early diagnosis of liver diseases, neonatal jaundice, and other conditions, hence leading to early treatment. Home-based testing procedures are useful in maximizing patient cooperation and follow-ups, particularly in cases of newborns as well as patients suffering from chronic liver disease. Hence, the availability of more enhanced microfluidics and biosensor systems makes the POC bilirubin tests more sensitive and accurate. It is also needless to mention that non-invasive bilirubin meters, especially those used for neonate screening, cause no pain or irritation and do not lead to infections.

Telemedicine integration ensures that non-present healthcare providers can scan bilirubin levels and, as a result, expand the range of diagnostic opportunities. This has created a need for portable diagnostic devices that may be obtainable from decentralized settings. Programs introduced by the government for home-based healthcare accelerate the growth of the market at a faster pace. Some of POC bilirubin's test characteristics include portability and simplicity, making them available to be used in low-income countries. There is growing concern among patients, as well as caretakers, about liver health, thus the high uptake of the solution. Each of these advances enhances patient care and the market situation.

Industry Experts Opinion

“This recognition is not only a personal achievement but a reflection of the hard work, dedication, and invaluable contribution of our entire team at LifeLabs. I’m excited about what we will accomplish together as we continue to advance healthcare.”

• Charles Brown, CEO of LifeLabs

“Innovation is at the heart of what we do at HemoSonics, and we’re thrilled to be mentioned alongside companies of all industries who are changing the world for the better. Our technology positively impacts hospitals and patient outcomes, and recognition such as this helps drive our company forward in our pursuit of excellence and further innovation.”

• Bob Roda, President and CEO of HemoSonics

Segment Analysis

Based on the Product Type, the Bilirubin Blood Test Market is classified as bilirubin meters, analyzers, and spectrophotometers, which is very high due to its applicability in hospitals and labs. Other factors, similar to automating and AI-assisted analyzers, make them more careful and faster, consequently fostering growth. Consumables include reagents and test kits; calibrators also widened the growth because of routine bilirubin tests in neonatal and liver disorders. The growth of the availability and utility of portable devices supports the increasing demand for point-of-care testing solutions to carry out tests in-home or decentralized settings, specifically for bilirubin analyzers. Also, non-invasive and transcutaneous bilirubin meters are preferred as they do not cause any pain and discomfort to the patient, particularly the neonates.

Based on the Application, the Bilirubin Blood Test Market is classified into neonatal jaundice, liver diseases, and others. The largest segment is neonatal jaundice because jaundice is common in newborns, and if not diagnosed on time, it may lead to complications. Another major segment is liver disease diagnosis, such as hepatitis, cirrhosis, and diseases of the gallbladder; the occurrence of liver-related diseases is increasing globally. Hemolytic disorders, drug-induced liver injuries, and preoperative assessment are also covered by bilirubin testing, hence the strong growth for the industry. The increasing use of point-of-care (POC) devices and noninvasive bilirubin meters contributes to the same need in these applications. It is further propelled by improved casual awareness and government campaigns on neonatal and liver disease screening in the future.

Regional Analysis

North America is the largest regional market for bilirubin blood tests due to its more developed healthcare industry, a higher rate of neonatal jaundice and liver diseases, and the growing use of POC diagnostics. The American market has the top share of the global neonatal intensive care equipment market due to increased expenditure on healthcare IT, raising consciousness of diseases, and state funding for neonatal screenings. Besides, the market has significant industry giants like Philips, Beckman Coulter, and Thermo Fisher Scientific that contribute to the growth of this market. The contribution of technological development, such as artificial intelligence-based diagnosis and bilirubin measuring devices, also continues to drive the growth of new opportunities. Web-based and home and remote monitoring is a growing trend in this region as it increases the conveniences for the patients.

The markets in the Asia-Pacific region are expected to be the fastest-growing due to increased birth rates, increasing incidences of liver diseases, and enhancement of healthcare facilities. Asian countries, such as China, India, and Japan, are some of the growing markets owing to increased birth rates, government support, and rising knowledge of early diagnosis of diseases. The growth of point-of-care testing and non-invasive bilirubin analyzers also helps the other markets to grow rapidly. The increasing number of important manufacturers, growth in the healthcare sector, and technological development boost the region’s revenue. Regions, especially the growing markets of Asia-Pacific, are adding to the demand, which makes Asia-Pacific an active player in the global bilirubin blood test market.

Competitive Landscape

The competition profile of the bilirubin blood test market is highly saturated with several large companies and several emerging companies trying to bring innovations to the market. Some of the leading global players that offer high-end analyzers and diagnostic solutions in the global market are Philips, Dräger, Natus Medical, Konica Minolta, and Beckman Coulter. Currently, competition is on the rise in the market because of improvements in technology in POC and bilirubin meters. Local firms and companies, including HemoSonics and Leonia’s Advanced Instruments, are establishing themselves by introducing new and affordable solutions.

Joint ventures, partnerships, joint business ventures, mergers, and acquisitions are evident as businesses seek broader portfolios and wider markets. Therefore, the Asia-Pacific region is considered an attractive market for growth in this industry due to rising investments and awareness of the healthcare sector. Employers are also placing their anticipations on increasing diagnostic effectiveness through the use of artificial intelligence and medical engineering. Other factors explaining the market growth include government policies to encourage disease diagnosis in its early stage and improvement of neonatal health care. Thus, specialists investing in portable and rapid bilirubin analyzers will be compared to those companies that increase the demand for home-based tests.

Bilirubin Blood Test Market, Company Shares Analysis, 2024

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Recent Developments:

• In June 2024, Roche Diagnostics India Private Limited and Manipal Academy of Higher Education (MAHE) entered into a Memorandum of Understanding (MoU) to establish a Centre of Excellence at MAHE in Manipal, Udupi district of Karnataka. The objective of this collaboration is to augment the development of skills and foster innovation in the domain of diagnostics.
• In January 2024 Roche, a prominent multinational company in the fields of biotechnology and in-vitro diagnostics, inaugurated its Digital Centre of Excellence in Pune, India. The opening ceremony represents a noteworthy achievement in Roche's history in India, reiterating the company's dedication to being a center for digital expertise and innovative leadership in the healthcare sector.

Report Coverage:

By Product Type

• Consumables
  • Reagents
  • Kits
  • Calibrators
• Instruments
  • Analyzers
  • Spectrophotometers

By Test Method

• Enzymatic Methods
• Colorimetric Methods
• Fluorometric Methods

By Application

• Liver Disease Diagnosis
  • Hepatitis
  • Cirrhosis
  • Liver Cancer
• Neonatal Jaundice Testing
• Hemolytic Anemia Diagnosis
• Gallbladder & Bile Duct Disease Diagnosis
• Other

By End User

• Hospitals & Clinics
• Diagnostic Laboratories
• Home Care Settings
• Research & Academic Institutes

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• Abbott Laboratories
• Advanced Instruments LLC
• AMETEK Inc.
• Anamol Laboratories Pvt. Ltd.
• Bigoenix Inc. Pvt. Ltd.
• DiaSys Diagnostic Systems GmbH
• Dragerwerk AG and Co. KGaA
• ELITechGroup SAS
• F. Hoffmann La Roche Ltd.
• Jaiprakash Associates Ltd.
• Koninklijke Philips N.V.
• Merck KGaA
• Siemens AG
• Randox Laboratories Ltd.
• Thermo Fisher Scientific Inc.

Frequently Asked Questions (FAQs)