Factor Assays Market - Forecast(2024 - 2030)

Report Code: HCR 1083 Report Format: PDF + Excel

Factor Assays Market Overview

The Factor Assays Market is estimated to grow at a CAGR of 6.4% during the forecast period of 2023-2028 to reach a market size equivalent to $169.3 million by 2028. Factor assays have been used as part of the testing process to determine the cause of an unexpected or prolonged form of PT or Prolonged Activated Partial Thromboplastin Time Test (APTT). This test is performed after mixing studies have been performed and a deficiency of one or more forms of coagulations is suspected. A common condition known as high-molecular-weight kininogen (HMWK) that participates in the initiation of blood coagulation is hampered. The test results obtained are compared in the resultant time and are compared with a standard curve. The number of corrections obtained defines factor deficiencies. Due to growing blood clotting disorders along with increased expenditures to boost diagnostic testing, the factor assays industry outlook remains moderate for the forecast period of 2023-2028. According to the Centers for Disease Control and Prevention, 60,000-100,000 Americans die of venous thromboembolism, a blood clotting disorder.

Factor Assays Market Report Coverage

The report: “Factor Assays Market Forecast (2023-2028)" by IndustryARC, covers an in-depth analysis of the following segments in the Factor Assays Market.

By Type: Factor II, Factor V, Factor VII, factor VIII, Factor IX, Factor IXA, Factor X, Factor X A, Factor XI, Factor XII, Factor XIII and Others.
By Form: Factor Acquired & Factor Congenital.
By Factor of Interest: Partial Thromboplastin Time Test (Extrinsic and Common Pathway Factor) & Prolonged Activated Partial Thromboplastin Time Test (APTT) (Intrinsic Pathway Factor).
By Testing Technology: Traditional and Automated.
By End-user: Hospitals, Outpatient and Ambulatory Centers, Laboratories, Academic and Research Institutions, CDMOs and Others.
By Geography: North America (the U.S., Canada and Mexico), Europe (Germany, the UK, France, Italy, Spain, Russia and the Rest of Europe), Asia-Pacific (China, Japan India, South Korea, Australia and New Zealand and the Rest of Asia-Pacific), South America (Brazil, Argentina, Chile, Colombia and the Rest of South America) and the Rest of the World (the Middle East and Africa).

Key Takeaways

  • Geographically, North America held a dominant market share in 2022. It is owing to the region's medical capabilities such as robust diagnostic testing and the overall disease burden of blood clotting disorders propitiating the need for factor assays. However, Asia-Pacific is expected to offer lucrative growth opportunities over the forecast period of 2023-2028. It is due to a growing geriatric population probable to thrombosis and other conditions that would propel the market growth.
  • The growing healthcare spending models across the geographies to provide better care and the increasing disease burdens associated with geriatric age are some of the factors driving the market growth. However, a lower level of awareness related to testing rare conditions with stringent regulatory controls for point-of-care testing impedes market growth.

Factor Assays Market Segment Analysis - Market Share (%) by region, 2022.

Factor Assays Market

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Factor Assays Market Segment Analysis - by Type

The Factor Assays Market can be further segmented into Factor II, Factor V, Factor VII, factor VIII, Factor IX, Factor IXA, Factor X, Factor X A, Factor XI, Factor XII and Factor XIII. Factor VII held a dominant market share in 2022. As per Hemophilia Organization, factor VII deficiency is estimated to occur in 1 out of 300,000-500,000 people. The lack of the aforementioned factor disrupts the body’s healing capabilities and can be acquired under a medical condition or can run along hereditary. Factor VII, also known as proconvertin, is produced by the liver requiring Vitamin K for production. However, factor VIII deficiency is estimated to be the fastest-growing segment, with a CAGR of 7.1% over the forecast period of 2023-2028. Factor VIII deficiency is also known as hemophilia A. This condition is passed down but has a higher prevalence of being acquired through other means.

Factor Assays Market Segment Analysis - by End-user

The Factor Assays Market can be further segmented into Hospitals, Outpatient and Ambulatory Centers, Laboratories, Academic and Research Institutions, CDMOs and Others. The Laboratories segment held a dominant market share in 2022 and is estimated to be the fastest-growing one with a CAGR of 6.7% over the forecast period of 2023-2028. It is due to various tests' specificity and access to higher resource count. Various forms of technologies can be used to run factor assays tests, such as traditional and advanced - thereby requiring resources of higher knowledge and technical expertise. As per the U.S. Bureau of Labor Statistics, phlebotomists' job rates are estimated to grow by around 10% till 2031.

Factor Assays Market Segment Analysis - by Geography

The Factor Assays Market based on geography can be further segmented into North America, Europe, Asia-Pacific, South America and the Rest of the World. North America held a dominant market share of 37% in 2022. It is owing to increased disease awareness and the facilities to understand the disease prognosis using an effective diagnostic medium. Additionally, countries like the United States spend extensively on healthcare which rightly co-aligns with the market position. As per Hemophilia.Org, nearly 12 per 100,000 cases are registered for factor VIII deficiency in the U.S. However, Asia-Pacific is expected to offer lucrative growth opportunities over the forecast period of 2023-2028 owing to a significant rise in healthcare spending across age groups, propelled by a growing medium of point-of-care testing.

Factor Assays Market Drivers

The Rising Cases of Blood Clotting Disorders and Substantial Incidence of Chronic Diseases:

A blood clotting disorder, which is also known as a hypercoagulable state or thrombophilia, is a condition that makes the body highly susceptible to forming clots. Factor assays help in quantifying the determination of such conditions. The patient’s blood sample is added to the deficient plasma for the factor of interest and runs through a PT doe extrinsic and common pathways or APTT for intrinsic factors. Moreover, such clots turn into life-threatening conditions causing common problems like stroke, heart attacks, severe leg pain and others. As per U.S. CDC, nearly 697,000 people in the United States died from heart disease, while nearly one in six or 16.6% of cardiovascular deaths were results of stroke in the U.S.

The Growing Role of Diagnostic Testing with Substantial Budgetary Push:

The budgetary inclination to expand the degree of testing to lower the mortality due to rare diseases has continued to push the market growth. Furthermore, the U.S. FDA has asked for a budget of $8.4 billion to aid investments in critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure. Additionally, in countries such as India, various government regulations look to offer tax benefits for undergoing diagnostic tests with certain input tax deductions for the purchase of laboratory equipment. The following factors propel the Factor Assays as an emerging method for testing of rare diseases.

Factor Assays Market Challenges

Lower Level of Awareness Related to Testing of Rare Conditions and Stringent Regulatory Controls for Point-of-care Testing:

The awareness related to rare condition testing is low due to the nature of the disease. As per NCBI, venous thrombosis, comprising of deep vein thrombosis and pulmonary embolism incidence is 1 per 1000 annually in the adult population. Owing to the rarity of the disease, disease-specific testing is extremely low. Additionally, the level of basic blood testing per capita in the developing country runs low which impedes the market growth. Lastly, the lack of skilled professionals to perform tests in home care settings and comparatively higher cost of coagulation testing rates impedes the market growth.

Key Market Players

Product launches, mergers and acquisitions, joint ventures and geographical expansions are key strategies adopted by players in the Factor Assays Industry. The top 10 companies in the Factor Assays Industry include:

  1. Abbott Laboratories
  2. Becton Dickinson
  3. Beckman Coulter
  4. Grifols S.A.
  5. Roche Holding AG
  6. Thermo Fisher Scientific
  7. Accriva
  8. Helena Biosciences
  9. Merck & Co. Inc.
  10.  Technoclone

Recent Developments

  • In November 2022, CUREUS reported that Acquired Factor X Deficiency has proven to have a strong correlation with viral respiratory tract infection. Owing to the visual spread of COVID-19, this form of acquired deficiencies is bound to go up.
  • In May 2022, Precision Biologic, a developer of hemostasis diagnostic products launched the CRYOchem Chromogenic Factor IX assay in Canada, the EU, the United Kingdom, Australia and New Zealand. CRYOcheck Chromogenic Factor IX is the only Health Canada-authorized chromogenic FIX assay and one of only three such CE-marked assays.

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1. Factor Assays Market - Overview
    1.1 Definitions and Scope
2. Factor Assays Market - Executive Summary
3. Factor Assays Market - Comparative Analysis
    3.1 Company Benchmarking - Key Companies
    3.2 Global Financial Analysis - Key Companies
    3.3 Market Share Analysis - Key Companies
    3.4 Patent Analysis
    3.5 Pricing Analysis
4. Factor Assays Market - Start-up Companies Scenario (Premium)
    4.1 Key Start-up Company Analysis by
        4.1.1 Investment
        4.1.2 Revenue
        4.1.3 Venture Capital and Funding Scenario
5. Factor Assays Market – Market Entry Scenario Premium (Premium)
    5.1 Regulatory Framework Overview
    5.2 New Business and Ease of Doing Business Index
    5.3 Case Studies of Successful Ventures
6. Factor Assays Market - Forces
    6.1 Market Drivers
    6.2 Market Constraints/Challenges
    6.3 Porter’s Five Force Model
        6.3.1 Bargaining power of suppliers
        6.3.2 Bargaining powers of customers
        6.3.3 Threat of new entrants
        6.3.4 Rivalry among existing players
        6.3.5 Threat of substitutes
7. Factor Assays Market – Strategic Analysis
    7.1 Value Chain Analysis
    7.2 Opportunities Analysis
    7.3 Market Life Cycle
8. Factor Assays Market – by Type
    8.1 Factor II
    8.2 Factor VII
    8.3 Factor V
    8.4 Factor VIII
    8.5 Factor IX
    8.6 Factor IXA
    8.7 Factor X
    8.8 Factor X A
    8.9 Factor XI
    8.10 Factor XII
    8.11 Factor XIII
    8.12 Others
9. Factor Assays Market – by Factor of Interest
    9.1 Partial Thromboplastin Time Test (Extrinsic and Common Pathway Factor)
    9.2 Prolonged Activated Partial Thromboplastin Time Test APTT (Intrinsic Pathway Factor)
10. Factor Assays Market - by Testing Technology
    10.1 Traditional
    10.2 Automated
11. Factor Assays Market - by End-user
    11.1 Hospitals
    11.2 Outpatient and Ambulatory Centers
    11.3 Laboratories
    11.4 Academic and Research Institutions
    11.5 CDMOs
    11.6 Others
12. Factor Assays Market - by Geography
    12.1 North America
        12.1.1 The U.S.
        12.1.2 Canada
        12.1.3 Mexico
    12.2 Europe
        12.2.1 The UK
        12.2.2 Germany
        12.2.3 France
        12.2.4 Italy
        12.2.5 Spain
        12.2.6 Russia
        12.2.7 The Rest of Europe
    12.3 Asia-Pacific
        12.3.1 China
        12.3.2 India
        12.3.3 Japan
        12.3.4 South Korea
        12.3.5 Australia & New Zealand
        12.3.6 The Rest of Asia-Pacific
    12.4 South America
        12.4.1 Brazil
        12.4.2 Argentina
        12.4.3 Chile
        12.4.4 Colombia
        12.4.5 The Rest of South America
    12.5 The Rest of the World
        12.5.1 The Middle East
        12.5.2 Africa
13. Factor Assays Market - Entropy
14. Factor Assays Market – Industry/Segment Competition Landscape Premium 
    14.1 Market Share Analysis
        14.1.1 Market Share by Region – Key companies
        14.1.2 Market Share by Countries – Key Companies
    14.2 Competition Matrix
    14.3 Best Practices for Companies
15. Factor Assays Market – Key Company List by Country Premium Premium
16. Factor Assays Market - Company Analysis
    16.1 Company 1
    16.2 Company 2
    16.3 Company 3
    16.4 Company 4
    16.5 Company 5
    16.6 Company 6
    16.7 Company 7
    16.8 Company 8
    16.9 Company 9
    16.10 Company 10
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