The global IVD raw materials market size 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).
The rise in demand for diagnostic and laboratory tests is attributable to the surge in the patient population and the prevalence of chronic conditions. IVD medical devices have become a major sector in the field of diagnosis, leading to major advances. Such factors are accelerating the adoption of IVDs, and there is a simultaneous demand for its raw materials.
In vitro diagnostic medical devices (IVDs) are reagents, kits, instruments, apparatus, or systems used to diagnose various diseases and health conditions or assess a patient's health. In vitro diagnostics entails the evaluation of biological specimens under carefully controlled laboratory circumstances, as opposed to in vivo diagnostics, which is carried out inside the living body.
IVD products are frequently used alone or in conjunction with other diagnostic products to analyze specimens derived from the human body, such as tissue or blood, or to monitor therapeutic interventions. For example, a general-purpose reagent (GPR) is a chemical reagent used to collect, prepare, and analyze human body specimens for diagnostic testing. Core raw materials like antigens, antibodies, and enzymes, which are crucial determinants of the quality and efficacy of IVD products, are needed to manufacture IVD products, such as devices and reagents.
|Market Size||USD 42.19 billion by 2031|
|Fastest Growing Market||North America|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
The increasing prevalence of several acute and chronic diseases, like cardiovascular diseases, hepatitis, HIV, cancer, chronic kidney diseases, diabetes, and sexually transmitted diseases (STDs), contributes to the demand for IVD raw materials. For instance, an estimated 58 million people have chronic HIV infection, with about 1.5 million new infections occurring per year globally. Thus, the rising burden of acute and chronic ailments propels the demand for in vitro diagnostic devices and rapid tests.
In addition, the number of people affected by several infectious diseases worldwide is increasing. The World Health Organization (WHO) estimated that influenza epidemics result in roughly 3–5 million cases of severe illness and approximately 250,000–500,000 fatalities annually worldwide. Thus, the rising number of patients affected by infectious and chronic diseases boosts the demand for IVD tests and IVD raw materials.
At-home cancer test kits have been helpful for the early detection and screening of cancer and more treatable stages, sometimes before a person shows any symptoms. These at-home tests detect cancer conditions by detecting specific markers in the samples, such as antibodies or gene mutations, which help indicate that the individual has a higher chance of developing a particular type of cancer.
At-home tests can be accurate and also encourage more individuals to undergo screening for various conditions. A 2018 study revealed that at-home testing has improved the participation of people in HPV screening. A 2021 study showed that women prefer self-sampling over Pap testing for cervical cancer screening. Similarly, the rise in awareness of various cancer diagnostic devices will drive the demand for IVD devices, propelling the need to manufacture the required IVD raw materials.
In low-income and middle-income countries (LMICs), the availability of quality-assured laboratory diagnosis has emerged as a major challenge, resulting in inaccurate or delayed diagnosis and ineffective treatment, which impacts patient safety. Some other challenges include the absence of laboratory supplies, essential infrastructure, skilled personnel, basic equipment, reliance on empirical treatment, supply chain management and equipment maintenance, inadequate quality management systems, and no government standards for laboratory testing. Therefore, there is low penetration of IVD devices in LMICs, which is expected to restrict market growth.
IVDs, particularly companion diagnostics, are integral to personalized medicine. IVD can be used in personalized or precision medicine to pinpoint specific treatments or therapies that may be effective for certain patients. Rapid developments have enhanced personalized treatment and home-based care through blood glucose monitoring devices, cholesterol testing, urine analyzers, hemoglobin sensors, hormone home tests, pregnancy detection kits, and others.
The success of precision medicine has been driving the demand for IVD devices. The surge in initiatives by governments and stakeholders to enhance the delivery of healthcare services has been an important factor for the global IVD industry. For instance, the United States government has led numerous initiatives providing information and education about personalized medication and IVD resources for effective patient management. Ultimately, this can lead to a rise in demand for various IVD devices, thereby creating opportunities for market growth.
Based on region, the global market is bifurcated into North America, Asia-Pacific, Europe, Latin America, and the Middle East and Africa.
Europe is the most significant global market shareholder and is estimated to exhibit a CAGR of 5.38% during the forecast period. The primary factors contributing to the development of the regional market include the rise in various infectious and autoimmune diseases, growing demand for early diagnosis, rising availability of IVD devices, increasing awareness of personalized medicine, widening availability of various IVD raw materials, growing demand for point of care diagnostics, and advances in lab automation. Germany, France, Italy, the UK, and Spain are significant revenue contributors to the regional market.
Recently, the European Commission adopted a new regulation for the production of IVD devices. The IVD regulation seeks to establish a well-regulated and efficiently operating market for in vitro diagnostic medical devices within the European Union. Manufacturers must manage the change to get their products CE-marked under the new regulation. The regulation will encourage the R&D teams of manufacturers to focus more on complying with new requirements. Hence, raw material manufacturers must focus on measures to provide high-quality raw materials for various applications.
North America is anticipated to exhibit a CAGR of 5.95% over the forecast period. The US and Canada are major revenue contributors to the North American market. The surge in the target population and the increase in the prevalence of several infectious diseases, especially sexually transmitted diseases, are major growth drivers for the regional market. For instance, in 2018, more than 37,832 people received an HIV diagnosis in the US and other parts of North America. Moreover, a considerable rise in several infectious diseases, such as hepatitis, tuberculosis (TB), and HIV, was reported in the US alone. With such growing prevalence, there has been a high demand for rapid-testing IVD devices for the early diagnosis of diseases. For instance, nucleic acid tests, antibody tests, and antigen/antibody tests are used as screening tests for HIV. These tests require raw materials such as antigens, antibodies, and nucleic acid. The rise in awareness of these devices is expected to propel their demand in the country.
The Asia-Pacific region has the quickest growth rate amongst all regions as various emerging countries expanding their healthcare infrastructure are part of it. Most Asian countries like China, Japan, and India have a wide availability of resources required for manufacturing IVD raw materials and cost-effectiveness, which led many manufacturers to set up their GMP-certified manufacturing facilities in these countries. For instance, Trivitron Group, one of India's largest medical devices companies, having eight functional state-of-the-art manufacturing facilities in line, launched the Labsystems Diagnostics IVD factory in India. With the growing demand for IVDs, there will be a high production of raw materials from these manufacturing facilities.
In Latin America, factors like the growing prevalence of various diseases propel the demand for IVD devices and fuel the demand for raw IVD materials used to manufacture these devices. With the growing demand for diagnostic testing in the region, several firms are expanding their business in Latin America. For instance, Novacyt, an international specialist in clinical diagnostics, entered a strategic alliance with Cepheid, an international molecular diagnostics company, to introduce a complete Human Papillomavirus diagnostic system into Latin America. Such developments will accelerate the demand for IVD raw materials required for developing these diagnostics tools and contribute to the regional market's growth.
In the Middle East and Africa, South Africa, Turkey, and Saudi Arabia contribute to the market expansion. These countries are witnessing a considerable surge in their elderly populations affected by chronic diseases. The market is expected to improve further in the coming years due to the rise in healthcare expenditure, favorable government initiatives, and improvements in healthcare infrastructure standards. Although healthcare spending in the Middle East and Africa region is currently lower compared to other regions, such as North America and Europe, the region's healthcare spending is expected to grow by about 10% annually in the coming years.
The global market is bifurcated into products, technology, and end-users.
Based on the product, the global 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. Antigens and antibodies are the primary materials for producing IVD devices and reagents. Vital raw materials, such as antigens, have become the key factors for establishing reproducible and robust immunodiagnostic test systems. These antigens are isolated from pathogen cultivation (Measles, Mumps, B. pertussis) (native antigens) or recombinant antigens (HSV, Parvovirus). Native antigens are known for their high sensitivity in diagnostic applications, especially in IgM detection, and recombinant antigens are known for their specificity, especially in IgG assays.
Enzymes are used for various IVD applications such as immunoassay, hematology, molecular diagnostics, diabetes care, point of care, microbiology, clinical chemistry, coagulation, and histology. Manufacturers apply various technologies such as enzyme application technology and reagent formulation development platform, deep mining platform for enzyme gene diversity, enzyme large-scale expression and quality control platform, a platform for directed evolution and high-throughput screening of enzyme functions, enzyme structure-function analysis, and molecular rational design platform to develop high-quality enzymes. Several suppliers provide an extensive selection of high-quality enzymes that are ideally suited for producing diagnostic kits and reagents.
Based on technology, the global 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. Clinical chemistry includes chemical processes that involve analyzing the levels of chemical components in bodily fluids and tissues for diagnostic and therapeutic purposes. The most common specimens utilized in clinical chemistry are blood and urine. These tests may use different body fluids such as plasma, urine, whole blood, serum, and cerebrospinal fluid. In addition, manufacturers offer many IVD raw materials that can be applied to clinical chemistry methods. For instance, Adaltis offers CHEMgen, a new and dedicated reagent line for all clinical chemistry assays. These assays can be applied to its Pchem instruments and HEMO One HbA1c systems.
Molecular diagnostics has emerged as one of the fastest-growing sectors in the IVD industry, fueled by the introduction of real-time-polymerase chain reaction (PCR) and next-generation sequencing (NGS), which allow amplification and decoding of genetic and epigenetic information. Molecular diagnostic methods and platforms are critical in all clinical and anatomic pathology areas. In the last decade, the clinical laboratory has witnessed an explosion in the availability of tests based on DNA and RNA analysis.
Based on end-users, the global 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. In vitro diagnostic (IVD) companies manufacture instruments and reagents to screen, diagnose, and monitor diseases. Pharmaceutical biotech and medtech companies that require R&D initiatives for production are also outsourcing the manufacturing of various in vitro diagnostic devices by procuring raw materials from other suppliers. These companies outsource their manufacturing operations due to advantages such as cost-effectivity, flexibility, commercial effectiveness, specialization, and innovative technologies.
The other end-users segment includes hospitals, research institutes, and clinical research organizations. Hospital laboratories are the exclusive unit within the hospitals. Around 92% of the hospitals operate with their laboratories. Hospitals are also one of the largest end-users of IVD instruments and consumables, which perform a wide range of patient diagnostics as required. For instance, hospital-based laboratories, which comprise about 5% of all laboratories in the US, perform most tests (55% of the total volume).
In addition, hospitals establish contracts with vendors to procure analyzers and related consumables regularly. The availability of competent healthcare professionals with knowledge and expertise in diagnosing and treating these conditions draws more patients to hospitals than other healthcare providers.