HbA1c Testing Market Analysis

HbA1c Testing Market Overview

HbA1c is a modified form of hemoglobin that is present in red blood cells. Most of the hemoglobin is in HbA form and during their lifespan, only a small fraction transforms into HbA1. HbA1 is further separated into HbA1a, HbA1b, and HbA1c. A high level of HbA1c is present in the body of diabetes patients as its formation occurs only during a process called glycosylation that converts glucose into glycogen for storage purposes. This HbA1c test results in the blood sugar level of the past 2 to 3 months of the diabetes patient’s body.

Worldwide, diabetes is one of the most prevalent epidemics and there are three types of diabetes. Out of them, type 2 diabetes is the common type. In September 2016, according to the National Center for Biotechnology Information (NCBI) research, diabetes is expected to be the seventh leading cause of death by the year 2030.  In 2017, according to the report of the International Diabetes Federation, there are 12,465,800 diabetes cases are reported globally and the prevalence of diabetes in Brazil was 8.7% among adults. Due to these increasing occurrences, various testing methods like HbA1c testing equipment are diagnosed to the patients. This is the major driving factor of the HbA1c testing market growth.

COVID-19 Analysis:

The COVID-19 pandemic affects millions of people and brought the world to a standstill. Diabetic people and the market of HbA1c testing are also impacted by this pandemic. This testing volume was decreased by 66% in March and April 2020. Due to the pandemic, the stay at home orders and social distancing regulations are imposed and thus results in decrement of HbA1c testing volumes convert to postponed testing’s and decline in HbA1c testing frequency. Moreover, in this way or any other reasons, the missing of HbA1c point of care testing leads to adverse impacts of glucose control, clinical outcomes, and diabetes-related medical prices. In this way, the HbA1c testing procedures are impacted by COVID-19 and decline its market growth. Further, post-COVID, the market of HbA1c testing is rapidly increased due to its increased usage.

HbA1c Testing Market Dynamics

Drivers:

Rising per capita disposable income and developing healthcare infrastructure is the major driving factor for the growth of the market. Introducing advanced innovations in treatment options is propelling the growth of the market. Due to poor dietary choices, lack of physical activities, and higher stress levels, the people affected with diabetes are increasing day by day and the physicians are prescribing the HbA1c test fasting to their patients which increases the market growth of the HbA1c testing.

Additionally, the emergence of point of care and other latest innovations that reducing diabetes testing costs is aiding the HbA1c testing market growth. The continuous rise in the geriatric population leads to rising in diabetes patients all over the world. The rising scope of medical tourism in developing countries is boosting the HbA1c testing equipment market.

Restraint:

The testing devices are expensive. In few developing countries, these technologies are less adopted and are limiting the growth of the hemoglobin A1c testing devices market. 

Opportunities:

Rising adoption of advanced diagnostic tools and devices along with strategic activities like partnerships, and agreements among the prominent key players may create the opportunity to increase the market growth. The emergence of the latest testing procedures and advanced technologies like handheld devices is predicted to provide a lucrative opportunity for the market growth of HbA1c testing. The rising awareness among the people regarding the management of diabetes efficiently is offering the growth of the market.

Challenges:

Manufacturing of these testing devices is cost high which poses a challenge for the market growth. Due to the discrepancies in interpretations, the HbA1c standard range testing result may be inaccurate which is hindering the HbA1c assay market growth.

Study Objectives -

• To provide detailed information about the market of HbA1c testing structure along with various forecast segments and sub-segments for the next 10 years.


• To provide the factors that are affecting the growth of the HbA1c testing market value.


• To analyze the HbA1c testing industry analysis based on porter’s five force analysis, factors-price analysis, supply chain analysis, etc.


• To provide history and forecast revenue segments and sub-segments of the HbA1c testing global market revenue for the main geographies.


• To provide the country-level analysis of the current HbA1c testing market size and future prospective.


• To provide country-level analysis of the HbA1c testing industry growth by region, form, and application.


• To provide a strategic profile of the prominent key players in the market, analyze their core competencies, and draw a market growth of HbA1c testing landscape.


• To track and analyze new product developments, strategic alliances, and global HbA1c testing market research.

HbA1c Testing Market Segment Insights

The market of HbA1c testing has been divided into segments based on technology, product, end-user, and region.

HbA1c Testing Technology Insights

Based on the technology, the global hemoglobin testing market is classified into few types as ion-exchange HPLC, TINIA, enzymatic assay, and others. Out of these, ion-exchange HPLC is holding the largest market share for its high demand in the market. It is the most widely used testing kit that consumes less time, recognizes variants, and is also used in point-of-care settings. TINIA is expected to grow at a significant rate during the review period which offers the benefits like accurate results, cost-effectiveness, and quick-swiftness.

HbA1c Testing Product Insights

The global HbA1c testing machine market based on the product is bifurcated into two types as reagents & kits, and instruments. Further, the instruments are divided into a bench-top device and a handheld device.

HbA1c Testing End-user Insights

By end-user, the global HbA1c testing equipment market is analyzed into hospitals &clinics, diagnostic laboratories, and others. The hospitals &clinics segment is dominating the HbA1c testing market share due to the growing geriatric population worldwide.

HbA1c Testing Region Insights

Regionally, the global Hemoglobin testing machine market is categorized into four main geographies such as Europe, Asia-Pacific, America, and the Middle East & Africa. America is dominating the largest market share for its rising activities like awareness campaigns, research, and joint ventures by public and private organizations in emerging countries like the US and Canada.

HbA1c Testing Market Regional Analysis

Geographically, the HbA1c testing global market is divided into four major regions like Asia-Pacific, Europe, America, and the Middle East & Africa. Out of these regions, America is holding the leading position in the market of HbA1c testing for its rising activities like awareness campaigns, research, and joint ventures by public and private organizations in the US and Canada. Europe is predicted to hold the second-largest market share for their increasing adoption of advanced diagnostic tools and devices coupled with strategic activities like partnerships and agreements by the major key players is accelerating the market growth in this region.

Due to the developing healthcare infrastructure and increasing per capita disposable income, Asia-Pacific is witnessing the fastest-growing region. Due to limited access to healthcare, growing awareness regarding healthcare, and availability of the latest treatments, the Middle East & Africa is witnessing steady growth.

Competitive Landscape

The prominent key players in the HbA1c testing market outlook are the following:

• Bio-Rad Laboratories, Inc. (US)


• Abbott Laboratories (US)


• ARKRAY, Inc. (Japan)


• Danaher Corporation (US)


• Hoffmann-La Roche Ltd (Switzerland)


• Transasia Bio-Medicals (India)


• Siemens Healthineers (US)


• EKF Diagnostics (UK)


• PTS Diagnostics (US)


• Agappe Diagnostics Ltd (India)


• Trinity Biotech PLC (Ireland)


• DiaSys Diagnostic Systems GmbH (Germany)


• CPC Diagnostics Pvt. Ltd. (India)


• Tosoh India Pvt. Ltd (India)


• Rapid Diagnostics Group of Companies (India)

Recent Developments

February 2023:Bio-Rad Laboratories, Inc. (US) launched the D-100 Hemoglobin A1c assay, a high-performance liquid chromatography (HPLC) method offering accurate and precise HbA1c measurement on their D-Series analyzers. 

August 2022:Transasia Bio-Medicals (India) received approval from the Indian Council of Medical Research (ICMR) for their HbA1c self-testing kit, marking a significant step towards increased accessibility in India.

October 2023:Abbott Laboratories (US) received FDA clearance for the FreeStyle Libre 3 system, a continuous glucose monitoring (CGM) device offering 14-day wear and improved accuracy. While not directly an HbA1c test, CGM data can be used to estimate HbA1c levels.

HbA1c Testing Market Segmentation

Globally, the HbA1c Testing market trends have been segmented into four types based on the technology, product, end-user, and region.

HbA1c Testing Technology Outlook

• Ion-exchange HPLC


• TINIA


• enzymatic assay 


• others

HbA1c Testing Product Outlook

• Reagents & kits


• Instruments

HbA1c Testing End-user Outlook

• Hospitals & clinics 


• Diagnostic laboratories


• others

HbA1c Testing Region Outlook

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  North America

  
  

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  US

  
  


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  Canada

  
  

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  Spain

  
  


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  Asia-Pacific

  
  
  
  
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    China

    
    
  
  
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    Japan

    
    
  
  
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    India

    
    
  
  
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    Australia

    
    
  
  
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    South Korea

    
    
  
  
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    Australia

    
    
  
  
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    Rest of Asia-Pacific

    
    
  
  
  
  


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  Rest of the World

  
  
  
  
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    Middle East

    
    
  
  
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    Africa

    
    
  
  
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    Latin America