Serum Free Light Chain (sFLC) Assays Market Size, Share & Industry Analysis, By Technique (Latex Nephelometric/Turbiometric and ELISA), By Indication (Multiple Myeloma, Light Chain Amyloidosis, and Others), By End-user (Hospital Laboratories, Clinical & Pathology Laboratories, and Others), and Regional Forecast, 2024-2032

The global serum free light chain (sFLC) assays market size was valued at USD 227.2 million in 2023 and is projected to grow from USD 245.8 million in 2024 to USD 477.3 million by 2032, exhibiting a CAGR of 8.6% during the forecast period (2024-2032). North American dominated the serum free light chain (sFLC) assays market with a market share of 49.87% in 2023. Moreover, the U.S. serum free light chain assay market size is projected to grow significantly, reaching an estimated value of USD 218.7 million by 2032, driven by the rising adoption of serum free light chain screenings among the patient population in the region.

Serum free light chain (sFLC) assays are used to diagnose and monitor plasma cell disorders, such as multiple myeloma, primary amyloidosis, and related diseases, or to monitor the effectiveness of treatment. These tests measure the amount of lambda and kappa free light chains in the patient's blood and human serum.

There is a high prevalence of multiple myeloma globally. Moreover, the demand for highly sensitive serum free light chain (sFLC) assays has increased owing to the surge in the prevalence of multiple myeloma and the need for highly sensitive quantitative tests globally.

• According to data published by the Canadian Cancer Society in November 2023, about 3,900 of the Canadian population were diagnosed with multiple myeloma in 2023.

Thus, the industry players are emphasizing strategic market initiatives, such as acquisitions and partnerships, to expand the presence of their existing product portfolio globally. Moreover, the surge in extension of product approvals by regulatory agencies in existing quantitative analyzers will further drive the market during the forecast period.

• In January 2023, Thermo Fisher Scientific Inc., completed the acquisition of The Binding Site, from a shareholder group led by European private equity firm Nordic Capital, at USD 2.8 billion. The acquisition will allow the expansion of Binding Site's existing specialty diagnostics portfolio with the addition of pioneering innovation in diagnostics and monitoring for multiple myeloma.

The COVID-19 pandemic led to slower global market growth for serum free light chain (sFLC) assays in 2020 globally. Travel restrictions led to a substantial reduction in cancer testing volume across major regions during this period. Major players registered a decline in sales of their products in 2020, owing to lower demand across hospitals and clinical laboratories. However, the resurgence of patient visits toward clinical settings for diagnostic screening of chronic disorders, such as multiple myeloma, led to market growth in 2021.

Serum Free Light Chain (sFLC) Assays Market Trends

Shifting Focus Toward Free Light Chain Tests from Traditional Test Techniques

Laboratory methods for diagnosis, prognosis, and monitoring of monoclonal gammopathies in plasma cell cancers have evolved to include methods such as serum and urine protein electrophoresis, immunofixation electrophoresis, immunosubtraction, and mass spectrometry. However, these methods are insensitive in detecting and quantifying free light chains, oligo secretory, and non-secretory multiple myeloma proteins in patient samples for disease diagnosis of light chain amyloidosis and light chain deposition disease.

The serum free light chain assay can be used for real-time monitoring of disease progression or response to treatment in patients with monoclonal antibodies. Moreover, potential advantages associated with serum free light chain tests, such as high sensitivity, rapid quantification, and improved test results compared to traditional techniques, have led to its increased adoption in clinical settings.

• As per data stated by BLOOD RESEARCH in September 2022, serum free light chain techniques are more sensitive than protein and immunofixation electrophoresis techniques. They are useful in follow-up and disease monitoring of patients with low levels of monoclonal proteins.

Similarly, increasing penetration of serum free light chain tests across hospitals, clinical laboratories, and other techniques for improved test outcomes has driven the market's growth. Moreover, the rising adoption of immunoturbidometric methods using these assays for detecting light chain disorders has catered to the market's growth.

• According to data published by Nordic Capital in October 2022, the Binding Site revenues increased fivefold in 2022 and recognized sales with more than 40.0 million tests on a global scale.

Thus, factors such as the high potential advantages of serum free light chains compared to conventional methods and the high adoption of these assays in clinical settings are augmenting the market's growth.

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Serum Free Light Chain (sFLC) Assays Market Growth Factors

Increasing Prevalence of Multiple Myeloma Among the Global Population to Boost Product Demand

The prevalence of multiple myeloma is increasing globally owing to a rise in causative risk factors, such as old age, family history, radiation exposure or the presence of other plasma cell disorders, including solitary plasmacytoma among the population.

• According to data revealed by NCBI in 2022, multiple myeloma represents about 1.8% of all new cancer cases and accounts for 10.0% of hematologic malignancies diagnosed in the U.S. each year.

The surge in prevalence has led to a rise in chronic disease awareness among the population and an increase in the number of patients undergoing blood chemistry tests and diagnostic laboratory tests across healthcare settings. Thus, the rising demand for diagnostic tests, such as serum protein electrophoresis (SPEP), immunofixation electrophoresis (IFE), and serum free light chain (sFLC) assays across clinical laboratories, is expected to boost the screening of multiple myeloma among patients, further propelling the market growth.

• As per Myeloma UK estimates, about 5,700 of the U.K. population are diagnosed with Myeloma annually in 2022.

Moreover, the high potential advantages of serum free light chain tests, such as high sensitivity and improved monitoring of disease progression, are further leading to their high adoption for detecting multiple myeloma among the population compared to blood chemistry and urine tests.

Thus, a surge in the prevalence of multiple myeloma among the geriatric population and the rise in multiple myeloma screening tests across healthcare settings is anticipated to drive market growth during the forecast period.

RESTRAINING FACTORS

Limitations Associated with Quantification of Serum Free Light Chain Assays to Restrict Market Growth 

In recent years, serum free light chain (sFLC) assays have been extensively adopted for detecting monoclonal antibodies to diagnose plasma cell cancers. However, technical limitations associated with using this quantification of free light chain assays, including detection error of antigen excess, underestimation or overestimation of test results, lot-to-lot variation and nonlinearity in output readings, are prevalent across clinical settings.

Moreover, other limitations, such as heterogeneous FLC and using different reagents and instruments for measuring FLC concentrations, may give diverging results that affect the assessment of patients with monoclonal gammopathies.

• Springer Nature Limited published research data in September 2022, where 75,422 participants were screened with serum FLC, serum protein electrophoresis and immunofixation tests. The serum free light chain (sFLC) assays concentration was greatly affected by kidney function among the patients, where 60% of participants had kappa and 21% had lambda FLC values more than the normal range of light chains. Thus, the FLC and FLC ratio reference intervals were inaccurately measured in chronic kidney disease patients.

Thus, the factors mentioned above, along with the limited global presence of the assays across developing countries and the lack of new product launches by industry players, are expected to hinder market growth.

Serum Free Light Chain (sFLC) Assays Market Segmentation Analysis

By Technique Analysis

High Adoption of Latex Nephelometric/Turbiometric across Clinical Laboratories Fosters Segment’s Growth

By technique, the market is segmented into latex nephelometric/turbiometric and ELISA.

Among these, the latex nephelometric/turbiometric segment accounted for the largest serum free light chain (sFLC) assays market share in 2023. The dominance was attributed to the high adoption of latex nephelometric/turbiometric methods across clinical laboratories and the rise in serum free light chain (sFLC) assays uptake with these quantification techniques for diagnosing multiple myeloma globally.

On the other hand, the ELISA segment is expected to grow at a considerable CAGR during the forecast period. The significant quantitative specificity provided by the ELISA-based assay is one of the prominent factors shifting preference toward the new technologically advanced products for light chain analysis, anticipating growth during 2024-2032.

• According to data published by Sebia in August 2021, the next-generation free light chain assay through the ELISA method gives high analytical performance results with a correct estimation of FLC values without antigen excess or overestimation by polymerization as compared with nephelometry/turbidimetry methods.

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By Indication Analysis

Rise in Product Approval by Regulatory Agencies to Augment Multiple Myeloma Segment Growth

Based on indication, the market is segmented into multiple myeloma, light chain amyloidosis, and others.

The multiple myeloma segment dominated the market in 2023. The increasing burden of the condition among the global population and the increase in extended approvals for serum free light chain assay products for multiple myeloma detection are a few factors contributing to the segment's growth

• In August 2022, Diazyme Laboratories Inc. received the U.S. FDA approval for its product, Diazyme Human Kappa Free Light Chain Assay and Diazyme Human Lambda Free Light Chain Assay under class II designation. Both the assays are intended as latex particle-enhanced immunoturbidimetric assays for the quantitative determination of free light chains of immunoglobulins in patients suffering from multiple myeloma.

On the other hand, the light chain amyloidosis segment is anticipated to grow significantly during the forecast period. The rise in the introduction of new healthcare centers offering comprehensive care for patients suffering from amyloidosis is encouraging the adoption of serum free light chain (sFLC) assays. Moreover, an increase in awareness of amyloidosis diagnostic tests among health professionals is anticipated to augment segment growth. 

• For instance, in June 2023, India's first Amyloid Center was inaugurated at Amrita Hospital, Kochi. The center was established to expand the reach of diagnosis and treatment of the disease.

By End-User Analysis

Hospital Laboratories Segment Thrives With Increasing Number of Patient Admissions Suffering From Chronic Blood Disorders

On the basis of end-user, the global market is segmented into hospital laboratories, clinical & pathology laboratories, and others.

The hospital laboratories segment captured the largest global serum free light chain (sFLC) assays market share. The increase in the prevalence of multiple myeloma among the geriatric population and the rise in the number of patient admissions suffering from chronic blood disorders to seek treatment are a few factors surging the demand for serum free light chain assay products.

• For instance, according to an article published in the American Society of Hematology in November 2022, a total of 477,065 patients in the U.S. suffering from multiple myeloma were admitted to hospitals during 2016-2019.

On the other hand, the clinical & pathology labs segment is anticipated to grow at a considerable rate during 2024-2032. The shifting preference of patients toward clinical & pathology laboratories with improved infrastructure is one of the factors contributing to the segment’s growth. Furthermore, increasing collaboration of companies with clinical laboratories and increasing establishment of new clinics offering serum free light chain tests for diagnosis of multiple myeloma are factors propelling the segment's growth.

REGIONAL INSIGHTS

Dynamic Industry Expansion by Major Players to Augment North America Market Share

On the basis of region, the market is studied across North America, Europe, Asia Pacific, and the rest of the world.

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North America was valued at USD 113.3 million in 2023 and is anticipated to continue to dominate the global market during the forecast period. The industry expansion is driven by the rising adoption of serum free light chain screenings among the patient population in the region. Moreover, the rise in the introduction of advanced products and the rise in the approval of assays for new disease indications further boosted the growth in the region.

• In December 2023, Sebia launched its serum free light chain assay in Canada to help diagnose, prognosis, and monitor multiple myeloma patients and related disorders.

Europe is the second most dominant region in the global serum free light chain (sFLC) assays market. The region held a significant share due to the strong presence of major players with extensive distribution channels. Also, a surge in the incidence of multiple myeloma among the European population and a rise in clinical studies to develop and commercialize novel products across health settings further catered to the region’s growth.

• According to Cancer Research U.K. data, 6,000 new myeloma cases are detected in the U.K. every year. Additionally, as per similar data, the incidence rate of myeloma in the country is anticipated to rise by less than 1% between 2023-2025 and 2038-2040, with around 8,300 new cases of myeloma every year.

The growing awareness for early diagnosis of plasma cell disorders and managing multiple myeloma among the population is contributing to the rising demand for serum free light chain (sFLC) assays in Asia Pacific. Moreover, increasing initiatives by major players toward product expansion across developing economies are anticipated to drive the market's growth during 2023-2032.

List of Key Companies in Serum Free Light Chain (sFLC) Assays Market

Robust Strategic Initiatives by Key Players to Propel Their Market Growth

The market for serum free light chain (sFLC) assays is highly consolidated with only a few players, including Thermo Fisher Scientific Inc., Sebia, Siemens Healthineers AG, and Diazyme Laboratories, Inc.

Thermo Fisher Scientific Inc. accounted for the highest share of the global market in 2023 due to its strong geographical presence and high adoption of freelite assay by different geographies across the globe. Furthermore, the company's rising initiatives to launch new products for detecting multiple myeloma and other diseases are a few factors contributing to its revenue growth. Moreover, the company’s efforts to expand its presence in different countries also bolstered the serum free light chain (sFLC) assays market growth in 2023.

• In May 2023, The Binding Site showcased its assays, such as Freelite and Hevylite, along with the Optilite system, at the EuroMedLab Congress. These products are its leading solution for multiple myeloma and immune status testing.

On the other hand, Sebia accounted for a significant market share in 2023. The company’s increasing focus toward expanding geographical footprints in developing nations is one of the key factors contributing to its extensive geographical presence globally.

• For instance, in 2022, Sebia established its facility in South Korea, Hungary, the Czech Republic, and Slovakia.

The other players, Siemens Healthineers AG and Diazyme Laboratories, Inc., are expected to account for a considerable market share during the forecast period. Increasing focus toward strategic initiatives such as collaborations and partnerships supports their growth in the global market.

LIST OF KEY COMPANIES PROFILED:

• Thermo Fisher Scientific Inc. (U.S.)


• Siemens Healthineers AG (Germany)


• Sebia (France)


• Diazyme Laboratories, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• August 2022: The Human Kappa Free Light Chain Assay by Diazyme Laboratories, Inc., received a premarket notification from the FDA for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The assay received approval to detect plasma cell disorders on the Beckman Coulter UniCel DxC 800 Synchron analyzer in 2019.


• September 2021: Sebia entered into a strategic partnership with Metafora Biosystems to leverage its AI-powered diagnostic platform in cancer and diagnosis of metabolic diseases.


• April 2021: Sebia announced the establishment of its operations in India. Using a direct operation base, the company intends to provide its products with superior scientific support and expertise in Asia.


• September 2020: Siemens Healthineers AG collaborated with Novartis Pharma to design, manufacture, and commercialize light chain immunoassay for patients suffering from multiple sclerosis.


• September 2020: Binding Site collaborated with ONCOtracker to develop a clinical laboratory test for detecting a novel blood-based biomarker, solubilized b-cell maturation antigen (sBCMA), for patients suffering from blood-based cancers such as multiple Myeloma.

REPORT COVERAGE

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The global market report provides a detailed market analysis. It focuses on crucial aspects such as leading players, drug types, and major indications of the product. Additionally, it offers insights into market trends, key industry developments such as mergers, partnerships, acquisitions, and the impact of COVID-19 on the market. In addition to the factors mentioned above, the report includes the factors that have contributed to the market growth in recent years with a regional analysis of different segments.

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