According to Future Market Insights (FMI) analysis in a recent market survey, the global protein diagnostics market was valued at USD 4.7 Billion in 2022 and is expected to reach USD 8.3 Billion by 2033.
Market Outlook:
| Data Points | Market Insights |
|---|---|
| Market Value 2022 | USD 4.7 Billion |
| Market Value 2023 | USD 4.9 Billion |
| Market Value 2033 | USD 8.3 Billion |
| CAGR 2023 to 2033 | 5.4% |
| Share of Top 5 Countries | 54.8% |
| Key Players | Beckman Coulter, Inc.; Siemens Healthineers; F. Hoffmann-La Roche Ltd.; Agilent Technologies, Inc.; Shenzhen Mindray Bio-Medical Electronics Co.Ltd.; Elabscience Biotechnology, Inc.; Goldsite Diagnostics, Inc.; Getein Biotech, Inc.; Randox Laboratories Ltd.; Hipro Biotechnology Co. Ltd.; and Beijing Strong Biotechnologies, Inc. |
Many branches of basic and applied science, from biomolecular analysis and biophysics to clinical diagnostics, depend on the sensitive detection and quantification of target biomolecules. The study and diagnosis of biomolecular structures depend heavily on the detection of proteins.
In clinical diagnostics, plasma proteins and enzymes are crucial. Due to their high specificity, enzymes have a wide range of applications, ranging from diagnostic markers to diagnostic reagents. Despite the fact that many enzymes and proteins are already employed in diagnostic procedures, more work needs to be done to determine how other enzymes might help in the early detection of many human diseases.
Protein tests are part of regular health check-ups which help healthcare professionals to understand a patient’s health status such as high levels could indicate infection or inflammation. Low levels can be a sign of various illnesses, including kidney disease, malnutrition, and more. The total protein test measures albumin and globulin levels.
Overall, the increasing use of protein as a diagnostic tool will boost the market in the coming years.
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Sales of the protein diagnostics market grew at a CAGR of 3.3% from 2017 to 2022. The protein diagnostics market contributes a 5.8% revenue share to the global in-vitro diagnostics market value at USD 80.2 Billion in 2022.
Protein turbidimetry and nephelometry are commonly used in clinical settings to diagnose and monitor diseases that affect protein levels in the body, such as liver disease, kidney disease, and certain types of cancer.
Advances in technology have made these techniques more precise, sensitive, and automated, which has improved their accuracy and reproducibility. Turbidimetry takes into account fully automated handling without the need for laborious sample separation, resulting in increased example throughput and research center competence. It contains an adjustment mechanism for common bends and an integrated optical finding device, resulting in more subtle error changes. This enables an irregular access work procedure to be perfectly linked with the current foundation and schedule of the research centers. The linkages between the analyzers that performed the immunoturbidimetric test were also very significant.
Immunoturbidimetric, immunonephelometric, enzyme-linked immunoassay sorbent assay (ELISA), chemiluminescence immunoassay (CLIA), and lateral flow immunofluorescence assay (LFIA) are some of the most precise and sensitive immunoassay frameworks. Because macrophages and lymphocytes produce more interleukins when irritated or contaminated, the intense-stage protein known as C-Receptive Protein (CRP) rises in the blood. Recently, established gel precipitation methods for protein estimation have been replaced by rapidly evolving immunonephelometric and immunoturbidimetric techniques.
The main aim of this immunoassay is to emphasize the significance of accurate protein quantification, which has been facilitated by advancements in the creation of novel sensors and artificial reagents.
Considering this, FMI expects the global protein diagnostics market to grow at a CAGR of 5.4% through the forecasted years.
Clinical diagnostics play a crucial role in healthcare, particularly in the detection and chronic disease such as the management of cancer, which is a leading cause of mortality worldwide.
Early detection through effective prevention, screening, and diagnostic measures can significantly reduce treatment costs and save lives. Diagnostic tests can provide important information about a patient's health status, including their risk for cancer, disease stage, and prognosis. Promoting awareness of the disease and its symptoms can encourage patients to take advantage of preventive measures and seek medical care early.
Protein tests can detect these changes in protein levels, providing early indications of disease before symptoms manifest. For example, elevated levels of prostate-specific antigen (PSA) in the blood can be an early indicator of prostate cancer, and abnormal levels of protein in cerebrospinal fluid (CSF) can be a sign of neurological disorders such as Alzheimer's disease or multiple sclerosis.
C-reactive protein (CRP) is also a useful biomarker for monitoring other inflammatory conditions, such as rheumatoid arthritis and inflammatory bowel disease.
The CRP test has found an important role in COVID monitoring. Along with that detection of IgM and IgG provide a simple, quick, and accurate detection method for suspected COVID-19 cases. This increased demand for protein diagnostics kits, driving growth in the global protein diagnostics market.
Increased regular health check-ups in patients will pave the way for protein diagnostics, ultimately leading to the introduction of technologically advanced products into the market.
Principal Consultant
In-vitro diagnostic (IVD) tests are subject to risk-based regulation, which divides tests into three categories based on their potential risk to patients and public health if they are inaccurate. The lowest-risk tests are classified as Class I, such as cholesterol tests, while moderate-risk tests, like pregnancy tests, fall into Class II. The highest-risk tests, such as genetic tests used to select cancer therapies, are classified as Class III.
The level of regulatory scrutiny rises along with the risk category, with some Class II tests and the majority of Class I tests being exempted from premarket procedures. Before being utilized with patients, Class II, as well as Class III tests, have to go through some sort of premarket evaluation.
These regulatory categories are designed to ensure that IVD tests are safe and effective for their intended use and that the potential risks to patients and the public are minimized. By appropriately classifying IVD tests and subjecting them to appropriate regulatory requirements, patients and healthcare providers can have confidence in the accuracy and reliability of the tests, leading to better patient outcomes and improved public health.
These factors are expected to hamper the revenue growth of the protein diagnostics market over the forecast period.
The USA dominated the global market in 2022 and is expected to register a CAGR of 6.8% during the forecast period.
According to the Division of Laboratory Systems (DLS) of the Centers for Disease Control and Prevention, the importance of clinical laboratories in today's healthcare system is demonstrated by the fact that 70% of medical choices made today are based on the results of laboratory tests. There is an increase in the number of laboratories in the USA
According to the presentation of Quest Diagnostics at the 37th Annual JP Morgan Healthcare Investor Conference, the market for clinical diagnostics is made up of point-of-lab services, hospital lab services, independent laboratories, and hospital outreach. The largest of these markets, comprising a combined market share of 70% and around 35% of the overall US lab market, are hospital labs and independent lab services.
The demand for protein diagnostics will increase with the assistance of awareness created by the established player and create an area for diagnostics testing labs to provide low-cost health checkups, which will drive the expansion of the market.
Germany dominated the Western European market for protein diagnostics and accounted for 38.5% of the market share in 2022.
Germany is a significant player in the worldwide market for protein diagnostics since it is home to numerous top producers of diagnostic tools and technology. These producers are well known for their creativity, premium goods, and cutting-edge technology.
For instance, one of the largest manufacturers of medical technology products in the world, Siemens Healthineers is based in Erlangen, Germany. The company offers a broad range of diagnostic products, including imaging systems, laboratory diagnostics, and point-of-care testing devices. Also, Roche Diagnostics is a leading supplier of in-vitro diagnostics and point-of-care testing solutions. The company's product portfolio includes diagnostic instruments, reagents, and software for various medical applications.
The presence of prominent players in Germany will influence the overall market.
China is projected to be the most attractive market in protein diagnostics and is expected to grow over a significant CAGR of 7.6%.
The protein diagnostics market in China is expected to grow significantly in the coming years due to several factors.
Conceptually, health exams can be thought of as disease-screening procedures. Screening is essential for the quick and early detection of disease as well as the prevention and treatment of numerous illnesses.
Regular general health examinations are a well-established and crucial strategy in China and are a component of the government's health literacy agenda. In 2020, 431 million health checks were performed, which is the same as two-thirds of urban people over the age of 15 receiving a health checkup that year. Many firms in China offer health checkups as employee perks in addition to self-funded exams. These examinations may be conducted at both public and private hospitals, many of which are branches of large national chains. At state-run community health centers, people over 65 can also get yearly health checkups.
To address the healthcare needs of a large population, China came up with the Healthy China 2030 mission in October 2016. The HC 2030 blueprint has been established as a national strategy and sets the goal of making comprehensive, holistic, up-to-date medical services available to everyone throughout China.
Such futuristic steps and missions are going to escalate China’s protein diagnostics market in the projected period.
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The reagent segment held the major chunk of 62.3% of the global market by the end of 2022.
Reagents used in protein diagnostics are designed to be highly specific and sensitive to the analyte being measured, with minimal interference from other substances in the sample. They are also standardized to ensure consistency and accuracy across different laboratories and testing platforms. Any reagent kit comes with a specific amount of tests that can be performed with it.
Overall, reagents are a widely adopted product that helps diagnose and monitor a wide range of diseases and conditions, including diabetes, heart disease, kidney disease, and liver disease, among others.
Serum was the predominant segment with a market share of 35.4% in the global market by the end of 2022.
Serum, which is the clear liquid part of blood after clotting, contains a wide range of proteins, including albumin, globulins, fibrinogen, and various enzymes. These proteins can be measured to diagnose and monitor a variety of diseases and conditions. The serum is a commonly used sample type that is easy to obtain through a simple blood draw. This makes it a convenient and widely available sample type for protein tests.
As, the serum is compatible with a wide range of diagnostic assays and platforms, including immunoassays, turbidimetric assays, and nephelometric assays, making it a versatile sample type for protein testing.
The disease diagnosis segment accounted for a revenue share of 85.0% in the global market at the end of 2022.
Protein testing can help with the early detection of diseases, which can lead to better treatment outcomes. For example, certain proteins can be used to detect cancer in its early stages, when it is more treatable. Protein testing can be used in the differential diagnosis of diseases, it can help doctors distinguish between similar diseases with different underlying causes. For example, different types of hepatitis can be differentiated based on the levels of specific proteins.
By measuring the levels of specific proteins in the body, doctors can gain valuable insights into a patient's health and make informed decisions about their care. Hence disease diagnosis holds a significant share of the global market.
Turbidimetry as technology accounted for a revenue share of 76.3% in the global market at the end of 2022.
Hospital laboratories and laboratories offering healthcare services frequently use turbidimetric assays. This assay format is similar to the ELISA approach, except the capturing antibodies are coupled to small particles (latex, gold, etc.) rather than coating the wells with them as in the ELISA method. This shortens the assay time by enabling faster binding of the antibodies and antigen. Turbidimetry is better for samples with larger particles.
The persistent use of turbidimetry in areas of drug development and disease diagnosis has enabled it to become one of the most adopted technology.
The hospital segment accounted for a revenue share of 36.9% in the global market at the end of 2022.
Hospitals are designed to provide coordinated care across different departments and specialties, which can be important when multiple diagnostic tests are needed to arrive at a diagnosis. Hospitals typically have access to a wide range of specialized equipment and facilities that are needed to perform various diagnostic tests. This can include imaging equipment, laboratory facilities, and other diagnostic tools that may not be available in other healthcare settings.
Overall, hospitals offer convenient and accessible diagnostic testing for patients, making it the lucrative segment of end users.
The industry's major players are concentrating on diversifying their product offerings to boost their market share in the protein diagnostics sector and broaden their presence in developing nations. Pricing strategies, market strategies, technology improvements, regulatory compliance, and acquisition and distribution agreements with other companies to extend their business are among the primary approaches used by manufacturers to acquire a competitive edge in the market.
For instance:
Similarly, recent developments have been tracked by the team at Future Market Insights related to companies in the protein diagnostics market space, which are available in the full report
| Attribute | Details |
|---|---|
| Forecast Period | 2023 to 2033 |
| Historical Data Available for | 2017 to 2022 |
| Market Analysis | USD Million for Value |
| Key Regions Covered | North America; Latin America; China; East Asia; South Asia and Pacific; Western Europe; Eastern Europe; Central Asia; Russia and Belarus; Balkan and Baltic Countries; and Middle East and Africa |
| Key Countries Covered | Canada, Brazil, Mexico, Argentina, China, Japan, South Korea, India, Indonesia, Thailand, Philippines, Malaysia, Vietnam, the Rest of the USA, Australia and New Zealand, Germany, France, Italy, UK, Spain, BENELUX, Nordics, Poland, Hungary, Romania, Czech Republic, GCC Countries, Kingdom of Saudi Arabia, Türkiye, Northern Africa, South Africa, Israel |
| Key Segments Covered | Product, Sample, Application, Technology, End User, and Region |
| Key Companies Profiled | Beckman Coulter, Inc.; Siemens Healthineers; F. Hoffmann-La Roche Ltd.; Agilent Technologies, Inc.; Shenzhen Mindray Bio-Medical Electronics Co., Ltd.; Elabscience Biotechnology Inc.; Goldsite Diagnostics Inc.; Getein Biotech, Inc.; Randox Laboratories Ltd.; Hipro Biotechnology Co., Ltd.; Beijing Strong Biotechnologies, Inc. |
| Report Coverage | Market Forecast, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, Strategic Growth Initiatives |
| Customization & Pricing | Available upon Request |
The market is valued at USD 4.9 billion in 2023.
Beckman Coulter, Inc., and Siemens Healthineers are key market players.
The market is forecast to register a CAGR of 5.4% through 2033.
The market registered a CAGR of 3.3% from 2017 to 2022.
Increased regular health check-ups in patients are encouraging the market prospects.
1. Executive Summary 2. Market Overview 3. Key Market Trends 4. Value-Added Insights 5. Market Background 6. Global Market Demand (in Volume or Size in Units) Analysis 2017 to 2022 and Forecast, 2023 to 2033 7. Pricing Analysis 8. Global Market Demand (in Value or Size in USD Million) Analysis 2017 to 2022 and Forecast, 2023 to 2033 9. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Product 9.1. Analyzers 9.2. Reagent Kits 9.2.1. Immunoglobulin Test Kits 9.2.1.1. Immunoglobulin A 9.2.1.2. Immunoglobulin E 9.2.1.3. Immunoglobulin G 9.2.1.3.1. IgG 1 9.2.1.3.2. IgG 2 9.2.1.3.3. IgG 3 9.2.1.3.4. IgG 4 9.2.1.4. Immunoglobulin M 9.2.2. Albumin Test Kits 9.2.3. Alpha-1-Microglobulin Albumin Test Kits 9.2.4. Alpha-2-Macroglobulin Albumin Test Kits 9.2.5. C-Reactive Protein Test Kits 9.2.6. Fibrinogen Test Kits 9.2.7. Fibronectin Test Kits 9.2.8. Haptoglobin Test Kits 9.2.9. Kappa Light Chains Kits 9.2.10. Lambda Light Chains Kits 9.2.11. Transferrin Test Kits 9.2.12. Alpha-1-Acid Glycoprotein Test Kits 9.2.13. Alpha-1-Antitrypsin Test Kits 9.2.14. Apolipoprotein B Test Kits 9.2.15. Cystatin Test Kits 9.2.16. Ferritin Test Kits 9.2.17. Lipoprotein Test Kits 9.2.18. Others 9.3. Calibrators & Controls Kits/Reagents 10. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Sample Type 10.1. Serum 10.2. Plasma 10.3. Urine 10.4. Cerebrospinal Fluid 10.5. Others 11. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Application 11.1. Drug Discovery and Development 11.1.1. Antigen-Antibody Reaction 11.1.2. Immuncomplex Reaction 11.1.3. Protein Measurement 11.1.4. Others 11.2. Disease Diagnosis 11.2.1. Cancer 11.2.2. Infectious Diseases 11.2.3. Blood Coagulation 11.2.4. Renal Function 11.2.5. Liver Disease 11.2.6. Autoimmune Disorders 11.2.7. Others 11.3. Other Application 12. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Technology 12.1. Turbidimetry 12.2. Nephelometry 13. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By End User 13.1. Hospital 13.2. Diagnostic Laboratories 13.3. Reference Laboratories 13.4. Specialty Clinics 14. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Region 14.1. North America 14.2. Latin America 14.3. China 14.4. East Asia 14.5. South Asia & Pacific 14.6. Western Europe 14.7. Eastern Europe 14.8. Central Asia 14.9. Russia & Belarus 14.10. Balkan & Baltic Countries 14.11. Middle East and Africa (MEA) 15. North America Market Analysis 2017 to 2022 and Forecast 2023 to 2033 16. Latin America Market Analysis 2017 to 2022 and Forecast 2023 to 2033 17. China Market Analysis 2012 to 2022 and Forecast 2023 to 2033 18. East Asia Market Analysis 2012 to 2022 and Forecast 2023 to 2033 19. South Asia & Pacific Market Analysis 2012 to 2022 and Forecast 2023 to 2033 20. Western Europe Market Analysis 2012 to 2022 and Forecast 2023 to 2033 21. Eastern Europe Market Analysis 2017 to 2022 and Forecast 2023 to 2033 22. Central Asia Market Analysis 2012 to 2022 and Forecast 2023 to 2033 23. Russia & Belarus Market Analysis 2012 to 2022 and Forecast 2023 to 2033 24. Balkan & Baltic Countries Market Analysis 2012 to 2022 and Forecast 2023 to 2033 25. Middle East and Africa (MEA) Market Analysis 2012 to 2022 and Forecast 2023 to 2033 26. Market Structure Analysis 27. Competition Analysis 27.1. Beckman Coulter, Inc. 27.2. Siemens Healthineers 27.3. F. Hoffmann-La Roche Ltd. 27.4. Agilent Technologies, Inc. 27.5. Shenzhen Mindray Bio-Medical Electronics Co., Ltd 27.6. Elabscience Biotechnology Inc. 27.7. Goldsite Diagnostics Inc. 27.8. Getein Biotech, Inc. 27.9. Randox Laboratories Ltd. 27.10. Hipro Biotechnology Co., Ltd. 27.11. Beijing Strong Biotechnologies, Inc. 28. Assumptions and Acronyms Used 29. Research Methodology
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Protein Diagnostics Market
