Global IVD Raw Materials Market Grows Steadily at a CAGR of 5.66%

Introduction

In vitro diagnostic medical devices (IVDs) are reagents, packages, instruments, apparatus, or systems used to diagnose various diseases and health conditions or evaluate a patient's health. In contrast to in vivo diagnostics, which are performed inside the living body, in vitro diagnostics involve the evaluation of biological specimens under meticulously controlled laboratory conditions.

IVD products are frequently used alone or in combination with other diagnostic products to analyze human body specimens, such as tissue or blood, or to monitor therapeutic interventions. A GPR is a chemical reagent that collects, prepares, and analyzes human body specimens for diagnostic testing. Antigens, antibodies, and enzymes are crucial determinants of the quality and efficacy of IVD devices, and reagents are required to produce IVD devices and reagents.

Market Dynamics

Increasing Prevalence of Infectious and Chronic Diseases Drives the Global Market

The surging incidence of acute and chronic diseases, such as cardiovascular diseases, hepatitis, HIV, cancer, chronic renal diseases, diabetes, and sexually transmitted diseases (STDs), contributes to the demand for IVD raw materials. Globally, an estimated 58 million persons have chronic HIV infection, with approximately 1.5 million new infections occurring yearly. Therefore, the increasing prevalence of acute and chronic diseases drives demand for in vitro diagnostic devices and swift tests.

In addition, the number of individuals affected by infectious diseases is increasing globally. The World Health Organization (WHO) estimates that influenza epidemics cause approximately 3–5 million cases of severe illness and approximately 250,000–500,000 deaths annually throughout the globe. Thus, the increasing prevalence of infectious and chronic diseases increases the demand for IVD assays and IVD raw materials.

Surge in Preference for Personalized Medicine Creates Tremendous Opportunities

IVDs, and especially companion diagnostics, are essential to personalized medicine. In personalized or precision medicine, IVD can pinpoint specific treatments or therapies that may be effective for certain patients. Rapid technological advancements have improved personalized treatment and home-based care through devices for blood glucose monitoring, cholesterol testing, urine analyzers, hemoglobin sensors, hormone home tests, and pregnancy detection tools.

The success of precision medicine has driven the demand for IVD devices. The increase in government and stakeholder initiatives to enhance the delivery of healthcare services has been a significant factor in the global IVD market. For instance, the United States government has led several initiatives to provide information and education regarding personalized medication and IVD resources for effective patient management. This can ultimately lead to surged demand for various IVD devices, creating opportunities for market expansion.

Regional Analysis

Europe is the most significant global IVD raw materials market shareholder and is estimated to exhibit a CAGR of 5.38% during the forecast period. The rise in various infectious and autoimmune diseases, the growing demand for early diagnosis, the increasing availability of IVD devices, the growing awareness of personalized medicine, the expanding availability of various IVD raw materials, the growing demand for point-of-care diagnostics, and the advancements in lab automation are the major aspects driving the growth of the regional market. Germany, France, Italy, the UK, and Spain contribute to the regional market's revenue.

In addition, the European Commission recently passed a new regulation for the manufacture of IVD devices. Within the European Union, the IVD regulation aims to establish a market for in vitro diagnostic medical devices that are well-regulated and operate efficiently. Manufacturers must manage the transition for CE-marking their products by the new regulation. The regulation will encourage manufacturers' R&D teams to concentrate more on meeting new requirements. Therefore, manufacturers of raw materials must concentrate on providing high-quality raw materials for various applications.

North America is anticipated to exhibit a CAGR of 5.95% over the forecast period. The United States and Canada are significant revenue contributors to North America's IVD raw materials market. The increase in the target population and the prevalence of several infectious diseases, particularly sexually transmitted diseases, are significant growth drivers for the regional market. In 2018, more than 37,832 persons were diagnosed with HIV in the United States and elsewhere in North America. In addition, several infectious diseases, such as hepatitis, tuberculosis (TB), and HIV, have increased significantly in the United States alone. Due to their increasing prevalence, there is a high demand for rapid-diagnosing IVD devices for the early diagnosis of diseases. For instance, HIV screening tests include nucleic acid tests, antibody tests, and antigen/antibody tests. These assays require antigens, antibodies, and nucleic acid as raw materials.

Key Highlights

• The global IVD raw materials market was valued at USD 25.71 billion in 2022. It is estimated to reach USD 42.19 billion by 2031, growing at a CAGR of 5.66% during the forecast period (2023–2031).
• Based on the product, the global IVD raw materials market is bifurcated into antibodies and antigens, enzymes, proteins, biological buffers, and others. The antibodies and antigens segment dominates the global market and is expected to exhibit a CAGR of 6.12% during the forecast period.
• Based on technology, the global IVD raw materials market is divided into clinical chemistry, immunochemistry, molecular diagnostics, and others. The clinical chemistry segment is the highest contributor to the market and is projected to grow at a CAGR of 4.75% over the forecast period.
• Based on end-users, the global IVD raw materials market is bifurcated into pharma and biotech companies, diagnostic laboratories, and others. The pharma and biotech companies segment is the largest contributor to the market and is expected to increase at a CAGR of 5.81% throughout the forecast period.
• Europe is the most significant global IVD raw materials market shareholder and is estimated to exhibit a CAGR of 5.38% during the forecast period.

Competitive Players

1. Creative Diagnostics
2. Merck KGaA
3. Thermo Fisher Scientfic Inc.
4. OYC Americas, Inc.
5. Fapon Biotech Inc.
6. Biosynth
7. F. Hoffmann-La Roche Ltd
8. Sysmex Corporation
9. Shenzhen AIVD Biotechnology Co., LTD.
10. Glentham®f Life Sciences Limited
11. Neogen Corporation

Recent Developments

Recent Developments

• In May 2023, Sysmex Corporation, a manufacturer of medical equipment and devices, signed agreement for joint development and investment with biotechnology startup ThinkCyte for the production and sale of a new artificial intelligence-enabled cell analysis technology for in-vitro diagnostics.
• In August 2022, Biosynth, a supplier of critical materials to the life science industry, announced that it had signed an agreement to acquire EUCODIS Bioscience, experts in engineering and developing enzymes for pharma, biotech and applied markets. The two companies have worked together on innovation projects in enzyme development for a number of years, with Biosynth already stocking EUCODIS’ catalogue enzymes as part of its broad research product offering.

Analyst’s Perspective

As per our research analysts, the global market for in vitro diagnostics (IVD) raw materials is becoming highly opportunistic due to the rapid developments in biotechnology, the high incidence of chronic diseases, and an escalating demand for personalized medicine. Companies are coming up with improved products to support the high levels of innovation happening in the market. In this regard, companies are heavily investing in R&D to develop high-grade reagents, antibodies, and enzymes that promote the enhancement of diagnostic accuracy and efficiency. Moreover, expansion of healthcare infrastructure in developing countries and the growing aging population are further expected to contribute to market expansion, making it a highly lucrative sector for investment and strategic partnerships.

Segmentation

1. By Product Type
   1. Antibody
   2. Antigens
   3. Proteins
   4. Enzymes
   5. Biological Buffers
   6. Substrates
   7. Others
2. By Technology
   1. Molecular Diagnostics
   2. Clinical Chemistry
   3. Immunochemistry
   4. Others
3. By End User
   1. Diagnostic Laboratories
   2. Pharmaceutical & Biotechnological Companies
   3. Others