Cystatin C Assay Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global cystatin C assay market, valued at US$352 million in 2022, is forecasted to grow at a robust CAGR of 7.5%, reaching US$377 million in 2023 and an impressive US$540 million by 2028. The growth of this market is majorly driven by the Increasing adoption of POC testing and presence of supportive government policies. However, raising awareness among healthcare providers about the benefits of cystatin C testing can be challenging.

Attractive Opportunities in the Cystatin C Assay Market

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Recession Impact on the Cystatin C Assay Market

During a recession, governments may face budget constraints and prioritize spending on essential services. This can lead to potential reductions in healthcare budgets, affecting reimbursement rates and procurement decisions for Cystatin C Assay products. Likewise, healthcare providers and institutions may face financial constraints and look for ways to reduce costs. This can lead to increased price sensitivity and potential pricing pressure on bone cement and glue products.

On the other hand, the conflict between Ukraine and Russia has the potential to create economic challenges and disrupt regional stability. It is possible that the conflict could contribute to a recession in the affected regions and have broader economic implications. The conflict can disrupt supply chains, leading to challenges in the procurement and distribution of bone cement and glue products. Transport routes may be affected, making it difficult to deliver products to healthcare facilities in conflict-affected areas. During economic downturns, healthcare budgets may be constrained, leading to reduced spending on diagnostic tests, including Cystatin C testing. Hospitals and healthcare facilities may prioritize essential services over non-urgent tests.

Cystatin C Assay Market Dynamics

Driver: Rising Prevalence of Kidney Diseases

Kidney diseases and disorders, including chronic kidney disease (CKD), are becoming more prevalent globally due to factors such as aging populations, hypertension, diabetes, and lifestyle changes. Cystatin C assays are valuable tools for accurately assessing kidney function and diagnosing kidney-related issues.

Chronic kidney disease (CKD) is becoming one of the world's most prevalent noncommunicable chronic diseases. The World Health Organization projects CKD to become the 5th most common chronic disease in 2040. (Source: PubMed 2023). Similarly, it is a progressive condition that affects >10% of the general population worldwide, amounting to >800 million individuals (Source: PubMed 2022). In addition, more than 850 million individuals have kidney diseases worldwide. (Source: AstraZeneca 2023).

As per the Pan American Health Organization 2021. In 2019, regionwide kidney diseases account for, 254,028 total deaths, 131,008 deaths in men, and 123,020 deaths in women. The age-standardized death rate due to kidney diseases was estimated at 15.6 deaths per 100,000 population. The countries with the highest age-standardized death rates due to kidney diseases are Nicaragua, El Salvador, Bolivia, Guatemala, Suriname, Honduras, and Ecuador.

More than 1 in 7 US adults–about 35.5 million people, or 14%–are estimated to have CKD (Source: CDC: 2023)

Likewise, Diabetes is a major risk factor for kidney diseases, particularly CKD. As the global incidence of diabetes continues to rise due to factors such as sedentary lifestyles and poor dietary habits, the prevalence of kidney diseases linked to diabetes also increases. For instance, as per the Institute of Health Metrics and Evaluation at the University of Washington found that in 2022, there were 529 million people in the world with diabetes. They projected that this will more than double to around 1.3 billion people by 2050. As

Similarly, rising government as well as private funding for kidney diseases drive the market. Government funding plays a crucial role in advancing research, diagnosis, and treatment of kidney diseases, and this funding can have a direct and positive impact on the market.

For instance, in 2023, the National Kidney Foundation (NKF) announced its latest investment through the NKF's Innovation Fund in Klinrisk, an artificial intelligence-based medical device company. Klinrisk is dedicated to transforming the early identification and management of high-risk chronic kidney disease (CKD) through accurate clinical risk prediction and decision support.

In 2023, Healthy.io, the global leader in transforming the smartphone camera into a clinical-grade device, announced that it completed a USD 50 million investment. This investment, together with a previously unannounced USD 45 million February 2022 investment, comprise the company's Series D. The company has seen increased commercial traction in the United States since July 2022, when it became the first and only company to offer an FDA-cleared smartphone-powered, at-home kidney test. Likewise, this Series D funding round is led by Schusterman Family Investments and is joined by Aleph and other existing shareholders. This investment, together with a previously unannounced USD 45 million February 2022 investment, comprise the company's Series D. The company has seen increased commercial traction in the United States since July 2022, when it became the first and only company to offer an FDA-cleared smartphone-powered, at-home kidney test.

In 2021, Monogram Health, a benefit management and care delivery company transforming care for individuals with chronic kidney and end-stage renal disease, announced that it closed a USD 160 million Series B funding round led by TPG Capital, the private equity platform of global alternative asset firm TPG.

In 2020, The Australian Government invested almost USD 35 million in Indigenous health projects including Indigenous blindness, deafness and chronic kidney disease.

Cystatin C assays offer the capability of detecting kidney dysfunction at an earlier stage, which is crucial for implementing interventions and treatments to slow down or manage the progression of kidney diseases. Additionally, cystatin C testing provides a means for monitoring kidney function over time. A result of the rising incidences of kidney diseases across the globe is expected to drive the demand of Cystatin assay market.

Restraint: High Development Costs of cystatin C assay

The cost of research, development, and validation of cystatin C assays can be a barrier for smaller diagnostic companies. Moreover, the costs associated with developing, producing, and implementing cystatin C assays, along with the required equipment and training, can pose a financial challenge for some healthcare facilities, especially in resource-constrained settings. For instance, the cost, accessibility, and the level of clinical awareness and understanding of test results. Cystatin C testing is approximately ten times more costly than creatinine testing, with a price of GBP 2.50 (USD 3.00) per test compared to GBP 0.25 (USD 0.30) for creatinine (Source: PubMed 2023).  Likewise, CysC assays can run on standard analyzers housed in most laboratories, CysC and sCr testing have similar labor costs. However, CysC reagents cost around USD 5–USD 10 per test compared with around USD 0.50 per test for sCr within the US; this cost differential will likely decline as CysC testing increases. In cost simulations of implementing CysC testing using the Gentian assay in Canada, the cost was estimated to be USD 2.88 per test for 1200 tests per year versus USD 2.17 per test based on 10,000 tests per year.  Similarly, a cystatin C test may currently cost more than a serum creatinine assay, the price of the former is not prohibitive. At Karger's institution, the University of Minnesota, a serum creatinine test costs about USD 2.50, while a cystatin C assay runs about USD 10.60 (Source: Medscape 2021).

Opportunity: Importance of companion diagnostics

Companion diagnostics include tests or assays intended to assist healthcare providers in making treatment decisions for patients based on the best response to therapy. The co-development of companion diagnostics with therapeutic products can significantly alter the drug development process and commercialize drug candidates by yielding safer drugs with enhanced therapeutic efficacy quickly and cost-effectively. With an increase in the demand for high-priced specialist therapies and safer drugs, the market for companion diagnostics is expected to showcase a high growth potential. The growing importance of companion diagnostics provides growth opportunities for the overall diagnostics market and the market.

Cystatin C, a protein that plays a role in inhibiting certain enzymes, has garnered interest in cancer research due to its potential implications in various aspects of cancer development, progression, and treatment response. In addition, pharmaceutical companies are increasingly collaborating with diagnostic companies to make safer and more effective drugs. On July 8, 2020, Thermo Fisher Scientific, Inc. (US) signed a Companion Diagnostic Agreement with Chugai Pharmaceutical Co., Ltd., (Japan), a Roche Group member. The company has also applied to the Ministry of Health, Labour and Welfare (MHLW) to elevate the use of the Oncomine Dx Target assay in Japan. Similarly, Cystatin C assay has gained importance in companion diagnostics, particularly in the field of nephrology and kidney-related diseases. Cystatin C is a sensitive and reliable marker of kidney function. It is particularly useful for the early detection and monitoring of kidney diseases, including chronic kidney disease (CKD). Companion diagnostics that include Cystatin C assays can help identify kidney dysfunction at an earlier stage, allowing for prompt intervention and management

Challenge: Dearth of skilled professionals

The scarcity of skilled professionals in the market is indeed a challenge that can affect the effective implementation and adoption of this diagnostic tool. The field of diagnostic testing requires trained personnel who can perform assays accurately, interpret results, troubleshoot technical issues, and ensure quality control. The dearth of a skilled workforce has been a challenge for several decades, resulting in an aging workforce and declining enrolment in training programs. It takes almost five to ten years of continuous practice in clinical laboratory work for technicians to gain expertise.

Europe and the UK have already reported low numbers of clinical technicians. The Gatsby Foundation stated in 2019 that over 1.5 million people serve in the health, engineering, science, and technology domains. Over 50,000 retire every year, and 700,000 technicians will be required to meet the soaring demands in the next decade. The Duquesne University School of Nursing has stated that by 2025, there will be a shortage of over 29,400 nurse practitioners and more than 400,000 home health aides

Ecosystem Analysis of Cystatin C Assay Market

An ecosystem analysis of the cystatin C assay would involve examining the various stakeholders, components, and interactions within the ecosystem that contribute to the development, adoption, and utilization of cystatin C assays in clinical and research settings. Moreover, an ecosystem analysis of the cystatin C assay helps stakeholders understand the dynamics, challenges, and opportunities within this healthcare sector. Collaboration among stakeholders and ongoing efforts to address challenges can contribute to the advancement of cystatin C testing and its impact on patient care and research.

Based on product, the cystatin C assay market is segmented into analyzers, kits, and reagents. The reagents segment is expected to account the second largest shares during the forecast period. The demand for separate reagents is driven by the specific needs of clinical laboratories and research institutions. Separate reagents are also used in clinical laboratories and research settings. The availability of high-quality reagents is crucial for accurate and consistent cystatin C measurements, ultimately contributing to the overall growth of the market.

Based on method, the cystatin C assay market is segmented into Enzyme-Linked Immunosorbent Assay (ELISA), Particle-Enhanced Turbidimetric Immunoassay (PETIA), Particle-enhanced Nephelometric Immunoassay (PENIA), Chemiluminescent immunoassay (CLIA), Immunofluorescence assay (IFA), and Others. The PETIA segment accounted for the second largest share the market in 2022 due its advantages such as many clinical laboratories prefer automated methods like PETIA because they can be easily integrated into clinical chemistry analyzers, offering efficiency and reducing the potential for manual errors. The demand for cystatin C assay methods, as PETIA, continues to be driven by the need for precise and reliable measurements in the diagnosis and monitoring of kidney function, particularly in the context of chronic kidney disease (CKD) and related conditions.

Market Segments of Cystatin C Assay Market

US accounted for the largest share of the North American cystatin c assay industry in 2022.

Based on the region, the North American cystatin c assay market is segmented into US and Canada. In 2022, the US accounted for the largest share of the North American market. Growth in this market can be attributed to presence of stringent regulatory standard, rising healthcare expenditure, the increasing number of chronic kidney diseases, the rising geriatric population, and the strong presence of cystatin c assay manufacturers.

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India registered the second highest growth rate in Asia Pacific cystatin C assay industry.

The APAC cystatin C assay market is segmented into Japan, China, India, and Rest of Apac. In 2022, India accounted for the second highest growth rate of the Asian market. The second high growth rate of India can be attributed to the increasing awareness of health issues, and rising healthcare expenditure, rising of a medical tourism and the increasing geriatric population. An increase in the number of elderly people gives rise to various nephros diseases. Therefore, growth in this population segment will directly drive the demand for cystatin C assay products.

The France in European cystatin C assay industry to witness the second highest shares during the forecast period.

The Europe cystatin C assay market is segmented into Germany, France, the UK, Italy, Spain and the Rest of Europe. France is registered the second highest shares during the forecast period. The major factors contributing to the growth of this market are the high prevalence of old age population, rising in kindey diseases, increasing R&D activities, strategic developments by key players. Clinical laboratories and diagnostic centers are key users of cystatin C assays in France. These facilities perform a wide range of diagnostic tests, including kidney function assessments, contributing to the demand for cystatin C assays.

Some of the major players operating in this market are Abbott (US), Roche Diagnostics Limited.(Switzerland), Siemens Healthcare GmbH (Germany),Thermo Fisher Scientific Inc. (US), Randox Laboratories Ltd. (UK), DiaSys Diagnostic Systems GmbH (Germany), Bio-Techne (US), Gentian Diagnostics ASA (Norway), Getein Biotech, Inc. (China), Agilent Technologies, Inc. (US), Abcam plc. (UK), Sino Biological, Inc. (China), Eurolyser Diagnostica GmbH (Austria).

In 2022, Roche Diagnostics Limited. (Switzerland), held the leading position in the market. The company’s large share can be attributed to broad usage of its analyzers and strong global presence. Abbott (US), held the second position in the cystatin c assay market in 2022.

Scope of the Cystatin C Assay Industry:

This research report categorizes the cystatin C assay market to forecast revenue and analyze trends in each of the following submarkets:

Recent Developments of Cystatin C Assay Industry

• September 2022, Gentian Cystatin C and GCAL assays received IVDR (In-Vitro Diagnostic Regulation) by TüV SÜD.
• March 2021, Roche acquired GenMark Diagnostics at USD 24.05 per share and a total transactional value of USD 1.8 billion. The acquisition strengthened Roche’s Diagnostics portfolio.

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