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  • Published On : Sep 2022
  • Code : CMI5234
  • Industry : Pharmaceutical
  • Pages : 170
  • Formats :

The global IVD raw materials market was valued at US$ 24,340.0 Mn in 2021 and is forecast to reach a value of US$ 35,895.2 Mn by 2028 at a CAGR of 5.8% between 2022 and 2028. The global IVD raw materials market is experiencing strong growth due to the high prevalence of infectious and chronic diseases, high demand for IVD testing and devices, growing awareness of early diagnosis and disease prevention, and rise in availability of advanced home care kits for cancer diagnostics. However, stringent regulations regarding product approvals and lower penetration of IVD devices are some major factors expected to hamper growth of the market.

Global IVD Raw Materials Market: Regional Insights

Based on geography, the global IVD raw materials market is segmented into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market over the forecast period due to the rising incidence of chronic diseases and rapidly growing geriatric population in this region. For instance, in vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases. As per the Centers for Disease Control and Prevention (CDC), chronic diseases, such as heart disease, cancer, and diabetes, are the leading causes of death and disability in the United States. Six in ten Americans live with at least one chronic disease.

Asia Pacific is also expected to witness robust growth in the global IVD raw materials market due to the increase in prevalence of chronic diseases and rapidly growing and growing geriatric population in this region. For instance, two in every three senior citizens in India suffer from some chronic disease, according to the first Longitudinal Ageing Study in India (LASI) by the Union Ministry of Family and Health Welfare (on January 6, 2020). This in turn is expected to increase demand for IVD raw materials in this region.

Figure 1. Global IVD Raw Materials Market Share (%), by Region, 2021

IVD Raw Materials  | Coherent Market Insights

Global IVD Raw Materials Market Drivers:

High prevalence of chronic diseases across the world is expected to augment the growth of the global IVD raw materials market during the forecast period. Chronic diseases are the leading causes of disability and death among the elderly population worldwide. According to the World Health Organization (WHO), noncommunicable diseases (NCDs) kill 41 million people each year, equivalent to 71% of all deaths globally. Cardiovascular diseases account for most NCD deaths (17.9 million), followed by cancers (9.3 million), and diabetes (1.5 million). Over 77% of all NCD deaths are in low- and middle-income countries.

Technological advancements in IVD raw materials is expected to boost the growth of the global IVD raw materials market during the forecast period. For instance, in October 2021, ELITech Group announces the launch of ELITe BeGenius, the new CE-IVD stand-alone ‘Sample – to – Result; Real Time PCR solution. ELITe BeGenius makes molecular biology accessible thanks to its compact footprint, exceptional ease-of-use, and total automation. It is a solution for labs keen on improving daily efficiencies and for labs looking to bring more testing in house.

Global IVD Raw Materials Market Opportunities:

Increasing awareness and acceptance of personalized medicine is expected to offer significant growth opportunities for players in the global IVD raw materials market. For instance, the term precision medicine refers to the tailoring of diagnostics or therapeutics to individual patients based on their unique genetic and physiologic characteristics. The trend toward personalized medicine is driving demand for diagnostics. IVD can be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies.

Increase in the use of point-of-care (POC) diagnostics is expected to provide significant growth opportunities for players in the global IVD raw materials market. The market is being driven by increased demand for quick diagnostic tests, which has prompted industry players to deliver POC solutions to decentralized regions. In May 2020, FDA approved Abbott’s ID NOW, the molecular POC test, which provides COVID-19 findings in just 13 minutes and is usable in a variety of decentralized healthcare settings such as doctors' offices and urgent care clinics.

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IVD Raw Materials Market Report Coverage

Report Coverage Details
Base Year: 2021 Market Size in 2022: US$ 25,618.5 Mn
Historical Data for: 2017 to 2020 Forecast Period: 2022 to 2028
Forecast Period 2022 to 2028 CAGR: 5.8% 2028 Value Projection: US$ 35,895.2 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Product: Antibodies & Antigens, Enzymes, Proteins, Biological Buffers, Others
  • By Technology: Clinical Chemistry, Immunochemistry, Molecular diagnostics, Others
  • By End-User: Pharma, Biotech & MedTech Companies, Diagnostic Laboratories, Others
Companies covered:

Aalto Bio Reagents, Fapon Biotech, Fujirebio, Merck KgaA, F. Hoffmann-La Roche, and Thermo Fisher Scientific, among others.

Growth Drivers:
  • High prevalence of chronic diseases across the world
  • Technological advancements in IVD raw materials
Restraints & Challenges:
  • Stringent regulations regarding product approvals
  • Lower penetration of IVD devices

Global IVD Raw Materials Market Trends:

Increase in demand for IVD raw materials worldwide is expected to propel growth of the global IVD raw materials market. For instance, in May 2022, Agilent Technologies Inc. announced that previously CE-IVD marked instruments, kits, and reagents were released as IVDR Class A, in compliance with the new EU IVDR regulation. This launch of IVDR-compliant Class A products ensures that labs in the EU who rely on Agilent IVDR instruments, kits, and reagents in their diagnostic workflows will continue to be able to use these products without disruption.

Growing geriatric population across the globe is expected to propel the growth of the global IVD raw materials market. For instance, chronic diseases are the leading causes of disability and death among the elderly population worldwide. According to World Health Organization (WHO), by 2030, 1 in 6 people in the world will be aged 60 years or over, and by 2050, the world’s population of people aged 60 years and older will double (2.1 billion).

Global IVD Raw Materials Market Restraints:

Stringent regulations regarding product approvals are expected to hamper growth of the global IVD raw materials market. IVD devices are the most highly regulated products manufactured and marketed in the world. In the European Union (EU), requirements for device safety and performance are laid out in sector-specific legislation that includes medical devices and in vitro diagnostic directives. In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) will replace the EU’s current directive on IVD medical devices.

Lower penetration of IVD devices in low-income and middle-income countries is expected to hinder growth of the global IVD raw materials market. For instance, IVD is essential for disease detection, control, and management. However, access to quality-assured diagnosis has emerged as a major challenge in low- and middle-income countries, resulting in delayed or inaccurate diagnosis and ineffective treatment, which impacts patient safety.

Figure 2. Global IVD Raw Materials Market Share (%), by Product, 2022

IVD Raw Materials  | Coherent Market Insights

Global IVD Raw Materials Market Segmentation:

The global IVD raw materials market report is segmented into Product, Technology, End-User, and Geography.

Based on Product, the market is segmented into Antibodies and Antigens, Enzymes, Proteins, Biological Buffers, and Others. Out of which, Antibodies and Antigens Segment is expected to dominate the IVD raw materials market over the forecast period and this is attributed to the increase in demand for IVD devices across the globe. Antigens and antibodies are the core raw materials used in the manufacture of IVD devices and reagents.

Enzymes Segment is also expected to witness significant growth in the near future and this is owing to the increasing use of IVD devices and increase in application of IVD. Enzymes are used for various IVD applications such as molecular diagnostics, hematology, histology, point of care, diabetes care, immunoassay, microbiology, coagulation, and clinical chemistry. 

Based on Technology, the IVD raw materials market is segmented into Clinical Chemistry, Immunochemistry, Molecular diagnostics, and others. Of which, Clinical Chemistry Segment is expected to dominate the market during the forecast period due to technological advances in IVD devices. Several advances in clinical chemistry are attributable to the recent developments in automation technologies.

Molecular Diagnostics Segment is also expected to witness robust growth in the near future and this is due to the increase in prevalence of infectious diseases around the world. Molecular diagnostics are used in identifying infectious diseases such as influenza virus, chlamydia, and tuberculosis, or specific strains such as H1N1 virus or COVID-19.

Based on End-User, the market is segmented into Pharma, Biotech, & MedTech Companies, Diagnostic Laboratories, and Others. Of which, Pharma, Biotech, & MedTech Companies Segment is expected to dominate the IVD raw materials market over the forecast period and this is attributed to the increase in disease burden and increase in demand for IVD devices, as IVD can detect diseases or other conditions, and can be used to monitor the person’s overall health to help cure, treat, and/or prevent diseases.

Global IVD Raw Materials Market: Key Developments

In June 2022, Medix Biochemica (Espoo, Finland) acquired 100% of the shares of Bioresource Technology to broaden its base matrix capabilities and further strengthen its local presence in the US market. Medix will provide its customers with a comprehensive offering of raw materials for their in vitro diagnostics (IVD) quality control products.

In March 2022, Medix Biochemica announced the launch of rejuvenated brand to reflect both the improvements to its offering as a result of recent acquisitions, and its ongoing commitment to the in vitro diagnostics (IVD) industry. The company hopes that its accelerated growth will establish its status as the ultimate IVD raw materials supplier.

Global IVD Raw Materials Market: Key Companies Insights

The global IVD raw materials market is highly competitive. This is attributed to the increasing prevalence of chronic disease and growing geriatric population, as a result, market players are focusing on launching novel materials in the market.

Some of the key players in the global IVD raw materials market are Aalto Bio Reagents, Fapon Biotech, Fujirebio, Merck KgaA, F. Hoffmann-La Roche, and Thermo Fisher Scientific, among others.

*Definition: In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, and/or prevent diseases. The core raw materials of in vitro diagnostic (IVD) reagents/kits include antibodies, antigens, enzymes, etc., which are important determinants of the quality and effectiveness of the reagents/kits.

In vitro diagnostics can detect diseases/conditions, and can be used to monitor overall health to help cure, treat, and/or prevent diseases. In vitro diagnostics are utilized to diagnose a wide range of medical disorders, such as cardiovascular disease, cancer, diabetes, infectious disease, nephrology, autoimmune diseases, and HIV/AIDS. IVD are tests done on the blood sample or tissue sample that have been taken from the human body. In short, IVD raw materials used to determine the status of a person's health. The core raw materials of in vitro diagnostic (IVD) reagents/kits include antibodies, antigens, enzymes, etc., which are important determinants of the quality and effectiveness of the reagents/kits.

Market Dynamics:

The outbreak of COVID-19, high prevalence of chronic diseases, advanced technologies in in vitro diagnostic products, rise in use of point-of-care diagnostics, rising geriatric population, and growing significance of companion diagnostics are some major factors expected to boost the growth of the global IVD raw materials market during the forecast period.

In August 2021, Roche received the U.S. Food and Drug Administration (FDA) approval for VENTANA MMR RxDx Panel to identify dMMR solid tumor patients eligible for anti-PD-1 immunotherapy. Moreover, in May 2020, ERBA Diagnostics Mannheim GmbH announced the launch of its immunoassay-based kit, ErbaLisa COVID-19 ELISA kits, for the detection of IgG and IgM antibodies to SARS-CoV-2. In March 2020, Abbott launched the RealTime SARS-CoV-2 assay, a PCR-based test, for the diagnosis of COVID-19, and BioMedomics launched a point-of-care COVID-19 test that can detect antibodies in blood within 15 minutes.

Key features of the study:

  • This report provides in-depth analysis of the global IVD raw materials market, and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period (2022–2028), considering 2021 as the base year.
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market.
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players.
  • It profiles key players in the global IVD raw materials market based on the following parameters such as company highlights, products portfolio, key highlights, financial performance, and strategies.
  • Key companies covered as a part of this study include Aalto Bio Reagents, Fapon Biotech, Fujirebio, Merck KgaA, F. Hoffmann-La Roche, Thermo Fisher Scientific, among others.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics.
  • The global IVD raw materials market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global IVD raw materials market.

Detailed Segmentation:

  • Global IVD Raw Materials Market By Product:
    • Antibodies & Antigens
    • Enzymes
    • Proteins
    • Biological Buffers
    • Others
  • Global IVD Raw Materials Market By Technology:
    • Clinical Chemistry
    • Immunochemistry
    • Molecular diagnostics
    • Others
  • Global IVD Raw Materials Market By End-User:
    • Pharma, Biotech & MedTech Companies
    • Diagnostic Laboratories
    • Others
  • Global IVD Raw Materials Market By Geography:
    • North America
    • Europe
    • Asia-Pacific
    • Middle East and Africa
    • South America
  • Company Profiles:
    • Aalto Bio Reagents
    • Fapon Biotech
    • Fujirebio
    • Merck KgaA
    • Hoffmann-La Roche
    • Thermo Fisher Scientific

Frequently Asked Questions

The global IVD raw materials market size is estimated to be valued at US$ 25,618.5 Million in 2022 and is expected to exhibit a CAGR of 5.8% between 2022 and 2028.
High prevalence of chronic diseases across the world and technological advancements in IVD raw materials are fueling the growth of the market.
The antibodies and antigens segment is the leading product segment in the market.
Stringent regulations regarding product approvals and lower penetration of IVD devices are major factors restraining growth of the market.
Major players operating in the market are Aalto Bio Reagents, Fapon Biotech, Fujirebio, Merck KgaA, F. Hoffmann-La Roche, and Thermo Fisher Scientific, among others.

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