The neuro immunoassay market is projected to be valued at USD 5,303.1 million by 2033, up from USD 2,616.1 million in 2023, increasing at a CAGR of 7.3% during the forecast period.
Immunoassays (IAs) are crucial in several bioanalytical settings like biopharmaceutical analysis, clinical diagnostics, security, environmental monitoring, and food testing. It is a chemical test done for the detection and quantifying of a particular substance with the use of an immunological reaction. Neuro Immunoassay is a test method that is swift and precise and can be used on-site and in the laboratory to identify specific molecules.
The demand for neuro immunoassays is increasing as these procedures rely on the technique of an antibody to bind to a particular structure of a molecule. Immunoassays can be either quantitative or qualitative. The latter is used to ascertain the concentration of an analyte, measuring the strength of a signal created by indicator reactions, and quantitatively used in situations such as determining if a woman is pregnant, which can usually be diagnosed within 2 days of fertilization.
The global demand for neuro immunoassay is surging as they have been broadly used for pharmaceutical analysis, such as pharmacokinetic and bioequivalence of drug discovery, diagnosis of disease, and drug monitoring.
Immunoassays are of various formats like monoclonal, polyclonal sandwich assays, competitive inhibition assays, antigen-down immunoassays, and rapid assays. The importance of neuro immunoassay in the pharmaceutical industry is owing to its fundamental specificity, sensitivity for the analysis of biological samples, and high throughput.
The market growth is also anticipated to be driven by the increasing approval and introduction of immunoassay instruments. A notable example is the Food and Drug Administration's (FDA) approval in December 2022 of Roche's AD assay, which utilizes the Cobas immunoassay analyzer. Likewise, in July 2022, the FDA designated the Elecsys Amyloid Plasma Panel as a breakthrough device, enabling the measurement of Alzheimer's disease biomarkers from a blood sample.
| Attributes | Details |
|---|---|
| Historical Value (2022) | USD 2,456.1 million |
| Current Year Value (2023) | USD 2,616.1 million |
| Expected Forecast Value (2033) | USD 5,303.1 million |
| Historical CAGR (2018 to 2022) | 6.2% |
| Projected CAGR (2023 to 2033) | 7.3% |
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Prevalence of Neurodegenerative Diseases:
The primary market driving factor contributing to the growth of the neuro immunoassay market is the increasing prevalence of neurodegenerative diseases. Expanding biotechnology, more investments in neuroscience research and pharmaceutical industries are some of the other crucial elements promoting the market growth of neuro immunoassay.
Rising Geriatric Population:
The geriatric population is increasing, which is resulting in more cases of neurodegenerative diseases such as Alzheimer’s disease, Parkinson’s disease and Huntington’s disease. This is said to promote the growth of this market, and thereby, the market share of neuro immunoassay is said to propel during the forecast period.
Technological Advancement:
Technological advancement coupled with rising awareness pertaining to the application of immunoassay in monitoring and diagnosis purpose of neuro diseases are said to support the market of neuro immunoassay by surging its demand in the market.
Importunity for High-Quality Antibodies:
Rising demand for superior quality antibodies owing to identifying the novel potential drug target, the structural protein in the brain, signaling molecules along with developing recognition of the anti-brain specific autoantibodies’ role in human diseases are said to promote the neuro immunoassay market growth.
Extensive R&D Investments:
There is an alarmingly growing number of research and abundant investments done towards neuroscience research. This has encouraged several medical and healthcare giants along with the Governments to promote sanctions towards various research and development, thereby boosting the neuro immunoassay market growth.
Besides the various market promoting factors, some factors such as strict regulations by the government, lack of experience in using these techniques, and higher costs associated with the procedure are anticipated to restrict the neuro immunoassay market growth.
Moreover, quality and concerns pertaining to the cost of the production of antibodies will also hinder the market growth during the forecast period.
By considering the present neuro immunoassay market situation across the globe, North America is anticipated to dominate the global market and attribute to the biggest market share in terms of revenue owing to better government initiatives and better economic conditions.
North America is said to hold 33.8% of the total neuro immunoassay market share during the forecast period. In North America, a country like the United States is said to lead, and the neuro immunoassay market is driven by growing molecular diagnosis.
The European region accounts for 29.6% of the neuro immunoassay market share, owing to its high disposable income and increasing demand for affordable treatment and cost-effective therapies.
In Europe, owing to the rising trend toward racing competitors and increasing awareness amongst the population. The focus of stakeholders on research projects involving proteins, associated biomolecules, and genes are the crucial factors that are promoting the neuro immunoassay market growth in Europe.
| Countries | 2022 Value Share in Global Market |
|---|---|
| United States | 30.4% |
| Germany | 6.2% |
| Japan | 3.6% |
The United States holds a significant share in the global neuro immunoassay industry. The growth in the United States neuro immunoassay market can be attributed to several factors, including
The United States is witnessing an increased prevalence of autoimmune diseases. As per the Parkinson's Foundation, the number of individuals living with Parkinson's disease in the United States was around one million in 2022. It is projected that this figure could increase to 1.2 million by 2030. Parkinson's disease is the second-most prevalent neurodegenerative disorder, following Alzheimer's disease. There is a growing focus on understanding and diagnosing Alzheimer's and Parkinson's diseases in the United States. Therefore, the high prevalence of neurological diseases is expected to contribute to market growth significantly.
Key players are strategically taking initiatives to expand their market share through the development of advanced biomarker technology for diagnostics and treatment research. In December 2022, the United States FDA approved two immunoassays developed by F. Hoffmann-La Roche Ltd.: Elecsys Phospho-Tau (181P) CSF (pTau181) and Elecsys beta-Amyloid (1-42) CSF II (Abeta42). These assays enable the measurement of two important biomarkers, tau proteins, and beta-amyloid, in adult patients, thereby aiding in the confirmation of Alzheimer's disease diagnosis. In March 2022, Quanterix entered into a licensing agreement with Eli Lilly and Company. This agreement allows Quanterix to utilize pTau 217 for near-term clinical research purposes and for long-term in vitro diagnostic (IVD) applications.
The incidence of neurological disorders in Germany is increasing. Neurological disorders include brain aneurysms, brain tumors, epilepsy, memory disorders, multiple sclerosis, Parkinson's disease, peripheral neuropathy, and spinal cord tumors. The Germany neuro immunoassay market is expected to grow as a result. According to the German Brain Tumor Association, 25% of cancer diagnoses in young individuals involve tumors in the brain and central nervous system.
Germany has a significant burden of neurological disorders, with conditions like Alzheimer's disease and Parkinson's disease affecting a large portion of the population. The Alzheimer's Association reported that over 1.6 million people in Germany had Alzheimer's Disease in 2021. The large number of Alzheimer's patients indicates a significant market opportunity in the country. In February 2021, STADAPHARM GmbH, based in Germany, launched a new triple combination product for advanced Parkinson's disease treatment. The product incorporates modern pump technology. The introduction of such products is expected to contribute to the market's growth.
Japan has one of the world's highest proportions of elderly citizens, according to World Bank statistics published in July 2022. This leads to a significant burden of age-related neurological disorders. The aging population in Japan creates a substantial demand for accurate diagnostic tools. This demand, in turn, drives the growth of the neuro immunoassay market. The Japan government has implemented various initiatives to promote healthcare innovation and improve patient care.
A study published in the Journal of Alzheimer's Diseases in March 2021 revealed predictions for Japan's dementia cases. It is estimated that between 6.5 million to 7 million people could have dementia in 2025, and the numbers could increase from 8.5 million to 11.5 million by 2060. Additionally, in Japan, it is reported that 50-75% of dementia cases are attributed to Alzheimer's disease.
Companies are striving to innovate and expand their presence in the market. An example of this is the marketing approval obtained by Sysmex Corporation in Japan in December 2022 for their HISCL β-Amyloid Assay Kits. These kits are designed to detect and measure amyloid beta levels in blood samples, aiding in the diagnosis of Alzheimer's disease (AD).
| Countries | Value CAGR (2023 to 2033) |
|---|---|
| United Kingdom | 6.3% |
| China | 8.5% |
| India | 7.3% |
About one out of every six individuals in the United Kingdom is affected by at least one neurological condition, and it is estimated that around 600,000 people receive a diagnosis each year. The United Kingdom is experiencing a shift toward personalized medicine. Neuro immunoassays are crucial in identifying specific biomarkers and tailoring treatments accordingly. This trend is driving the adoption of advanced immunoassay techniques. The United Kingdom neuro immunoassay market growth is expected to be fueled by key players engaged in the development of neurological biomarkers.
The market in the United Kingdom benefits from collaborations between industry players and the National Health Service. For example, in November 2021, the Department of Health and Social Care announced a substantial investment of USD 456.62 million in neurodegenerative research in the United Kingdom. Additionally, the utilization of clinical data informatics platforms by productive research organizations is projected to play a role in propelling the United Kingdom neuro immunoassay market growth during the forecast period.
China has the world's largest population, exceeding 1.45 billion people. The aging population in China is especially susceptible to neurological disorders. This vulnerability emphasizes the importance of advanced diagnostic tools such as neuro immunoassays. In China, the concept of precision medicine has gained significant traction. This has resulted in the adoption of personalized approaches to diagnose and treat neurological disorders. The country has experienced a considerable rise in healthcare expenditure. This increase has facilitated patient access to advanced diagnostic procedures.
The prevalence of Parkinson's disease among individuals aged 65 years or older is around 1.7%. It is projected that about 1.7 million individuals in China aged 55 years or older are affected by Parkinson's disease. These findings indicate that the prevalence of Parkinson's disease in China is comparable to that observed in developed countries. On the other hand, the population of individuals affected by Alzheimer's disease in China is about six million. The prevalence of dementia among different age groups is estimated to be 5% among 65-year-olds, 11.5% among 75-year-olds, and 30% among 85-year-olds.
India has witnessed a significant increase in the prevalence of neurological disorders, primarily due to factors like
The country has witnessed remarkable advancements in the field of neuro immunoassay technology. The Indian government has launched several initiatives to address the rising burden of neurological disorders. With more than 1.48 billion people, India now boasts the largest population in the world. This provides a significant market opportunity for neuro immunoassay tests.
India neuro immunoassay market growth is also expected to be driven by the expansion of the pharmaceutical and biotechnology industries during the forecast period. A noteworthy example is the projected triple growth of the domestic market in India, as stated in the Indian Economic Survey 2021. Ranked among the top five global pharmaceutical intermediary manufacturers, India possesses significant prowess in the pharmaceutical industry. Furthermore, India boasts the maximum number of production companies approved by the United States FDA outside of the United States.
Multiple neuro immunoassay market opportunities for growth are being opened as various neuro immunoassay market manufacturers are focusing on additional expenditure on research and development activities to create advanced immunoassay therapies. It has been predicted that several new entrants will be focusing on the neuro immunoassay market in the future.
One of the key potential start-ups is Nomic, a Canadian start-up that collected USD 17 Mn to enhance its automated, high-throughput ELISA platform. This start-up focuses on giving a 21st-century upgrade to decades-old, hand-performed ELISA test.
Some of the key players in the neuro immunoassay market are: Intrinsic LifeSciences, Danaher Corporation (Beckman Coulter), Becton Dickinson and Company, Akers Biosciences, Inc., Abbott Laboratories, Inc, EDP Biotech Corporation, Hologic (Gen-Probe), Biomérieux, and others.
Recent Development in the Neuro Immunoassay Market:
| Segment | 2022 Value Share in Global Market |
|---|---|
| ELISA Technology | 39.90% |
| Reagents and Kits | 62.30% |
Based on the technology, in 2022, the ELISA segment led the market for neuro immunoassay and was accountable for a larger revenue share. A few of the key advantages of this method are quantitative results, decreased assay time, and the need for limited antisera for analysis.
ELISA (Enzyme-Linked Immunosorbent Assay) has traditionally dominated the market due to its sensitivity, specificity, established methodology, wide analyte range, cost-effectiveness, and ability to provide quantitative results. With its high sensitivity and specificity, ELISA can detect low concentrations of analytes relevant to neurological disorders. The methodology is well-documented, and commercially available ELISA kits exist for specific analytes. This makes it accessible to researchers and clinicians. Newer technologies may challenge ELISA's dominance in the future. However, ELISA remains a reliable choice for neuro immunoassays. It offers accurate results in quantifying biomarkers. ELISA is also cost-effective compared to some advanced immunoassay technologies.
In the product segment, in 2022, reagents and kits segment led the global neuro immunoassay market and is said to dominate during the forecast period. This is due to rising demand for immunoassay reagents and kits for diagnosis purposes as there is rising cases of autoimmune and infectious diseases.
Reagents and kits are essential components required for accurately detecting and quantifying biomarkers in neuro immunoassays. They offer various applications, providing customizable solutions for different biomarkers and assay formats. Reagents and kits also ensure standardization and quality control, allowing for reproducible results. Their convenience and time efficiency make them preferred choices, simplifying the workflow for researchers and clinicians. Additionally, the increasing demand for neuro immunoassays, driven by the rising prevalence of neurological disorders, contributes to the dominance of this segment in the market.
The market is valued at USD 2,616.1 million in 2023.
Abbott Laboratories, Inc, EDP Biotech Corporation, Hologic are the prominent market players.
The market is expected to witness a a CAGR of 7.3% through 2033.
The market is predicted to be worth USD 5,303.1 million by 2033.
From 2018 to 2022, the market held a CAGR of 6.2%.
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Neuro Immunoassay Market
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