Serum Free Light Chain (sFLC) Assays Market Size, Share & Industry Analysis, By Technique (Latex Nephelometric, Latex Turbidometric, ELISA, and Lateral Flow Immunoassay), By Indication (Multiple Myeloma, Light Chain Amyloidosis, and Others), By End-user (Hospital Laboratories, Clinical & Pathology Laboratories, and Others), and Regional Forecast, 2025-2032

The global serum free light chain (sFLC) assays market size was valued at USD 245.8 million in 2024 and is projected to grow from USD 266.1 million in 2025 to USD 477.3 million by 2032, exhibiting a CAGR of 8.7% during the forecast period. North america dominated the serum free light chain (sflc) assays market with a market share of 49.76% in 2024.

Serum free light chain (sFLC) assays are used to detect, diagnose, and monitor plasma cell disorders, such as primary amyloidosis, multiple myeloma, and related diseases, or to monitor the effectiveness of treatment among the patients. 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 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 major key players, such as Thermo Fisher Scientific, Inc., Siemens Healthineers AG, among others, are focusing on inorganic growth strategies, including acquisitions and collaborations, to expand their geographical presence globally. Additionally, an increasing number of product approvals by regulatory agencies for quantitative analyzers is expected to support the global market growth in the forthcoming years.

• 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.

Global Serum Free Light Chain (sFLC) Assays Market Key Takeaways

Market Size & Forecast:

• 2024 Market Size: USD 245.8 million
• 2025 Market Size: USD 266.1 million
• 2032 Forecast Market Size: USD 477.3 million
• CAGR: 8.7% from 2025–2032

Market Share:

• North America dominated the global serum free light chain (sFLC) assays market with a 49.76% share in 2024, attributed to high disease prevalence, increased diagnostic awareness, new product approvals, and expanding cancer care infrastructure.
• By Technique, Latex Turbidometric Assays held the largest market share in 2024 due to widespread use of Freelite assays and high adoption across diagnostic laboratories. ELISA-based assays are expected to grow significantly during 2025–2032 owing to their high specificity and performance without antigen excess errors.

Key Country Highlights:

• Japan: Growing adoption of advanced diagnostic technologies and rising awareness of plasma cell disorders such as multiple myeloma and amyloidosis support market expansion. The Binding Site’s strategic entry and product launch plans for 2024 are expected to enhance accessibility in the region.
• United States: The U.S. remains a major revenue generator due to a large myeloma patient population (estimated 35,780 new cases in 2024), robust diagnostic infrastructure, and product innovation. Companies such as Thermo Fisher Scientific and Sebia continue to launch and expand their diagnostic portfolios.
• China: China presents a high-growth opportunity due to its large target population and rising diagnostic penetration. The Binding Site and other players are focusing on expanding product registrations to capture unmet demand in regional hospitals and pathology labs.
• Europe: Europe holds a substantial market share with 6,000+ annual myeloma cases in the U.K. alone, a strong network of clinical research centers, and increasing investments in automated diagnostics. Initiatives like ASPIRE and investments in clinical trials further fuel regional adoption.

MARKET DYNAMICS

Market Drivers

Rising Prevalence of Multiple Myeloma Among Patient Population to Drive Product Demand

There is a rising prevalence of multiple myeloma due to a surge in causative risk factors, including family history, old age, radiation exposure, or the presence of other plasma cell disorders, including smoldering myeloma, among the patient population.

• According to 2024 statistics published by the American Cancer Society, it was estimated that about 35,780 new cases of multiple myeloma will be diagnosed in the U.S.

The increase in prevalence is leading to a growing awareness of chronic disorders among the population, further supporting the increase in the number of patients undergoing diagnostic tests across hospitals and clinics. Thus, the increasing demand for diagnostic laboratory tests, including immunofixation electrophoresis (IFE), serum protein electrophoresis (SPEP), and serum free light chain (sFLC) assays across various diagnostic laboratories, is likely to drive the screening of multiple myeloma among the patient population, further augmenting the growth of the market.

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

Additionally, the rising potential benefits of serum free light chain tests, including improved monitoring of disease progression and high sensitivity, are supporting the adoption rate for these tests among the population.

Therefore, an increase in the prevalence of multiple myeloma among the patient population and the rise in multiple myeloma screening tests across healthcare settings is anticipated to drive market growth during the forecast period.

Other Prominent Drivers

• Rising Incidence of Kidney-Related Diseases to Boost the Demand
• Technological Innovations in Diagnostic Assays to Support the Market Growth

Market Restraints

Limitations Associated Serum Free Light Chain Assays Quantification to Limit Market Growth 

There is increasing adoption of serum free light chain (sFLC) assays for detecting monoclonal antibodies to diagnose plasma cell cancers. However, certain limitations associated with using this quantification technique of free light chain assays, such as detection error of antigen excess overestimation or underestimation of test results, are evident across healthcare settings.

Additionally, 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. This, along with the high cost of advanced serum free light chain assays compared to conventional products, is expected to limit its adoption across clinical settings.

• 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 (FLC) concentration was greatly affected by kidney function among the patients, where 60% of participants had kappa and 21% of participants had lambda FLC values more than the normal range of light chains. Thus, the reference intervals for FLC and FLC ratio were inaccurately measured in chronic kidney disease patients.

Therefore, the factors above, coupled with the limited geographical presence of the assays across emerging countries and the lack of new product launches among the key players, are likely to hamper the growth of the market.

Other Prominent Restraints

• Regulatory hurdles in developing countries are likely to hamper the market growth
• Limited healthcare access in remote areas is expected to limit market growth

Market Opportunities

Increasing Focus on R&D and Overseas Expansion to Offer Lucrative Growth Opportunities

The use of serum-free light chain tests for detecting cancers such as multiple myeloma, light chain amyloidosis, and Waldenström’s macroglobulinemia is high across hospitals and clinical laboratories globally. However, the presence of technologically advanced assay products and devices is limited to developed countries.

Thus, the industry players are now emphasizing the execution of overseas expansion in developed and developing countries of their diagnostic products to address the growing market opportunity in diagnostic tests of multiple myeloma. Such initiatives are expected to increase awareness and expand the presence of assays across opportunistic markets and countries with high disease prevalence.

• As per data published by Gov.UK in 2022, the binding site focuses on developing its product presence in the Nordic countries and Japan in early 2024.
• As per similar estimates, the company is further focusing on expanding the range of products registered in China to boost its presence in untapped markets.

Moreover, the leading players are now increasing R&D investments to focus on integrating artificial intelligence and machine learning in advanced diagnostic products, further improving the quantification tests, such as serum free light chains tests.

• According to the Binding Site annual report in 2022, the capitalization of research and development in in-vitro diagnostics was USD 5.67 million in 2021, compared to USD 4.58 million in 2020.

Thus, increasing emphasis on R&D and overseas expansion of product portfolio by key players will offer lucrative growth opportunities during the forecast timeframe.

Other Prominent Opportunities

• Increasing applications of sFLC assays in personalized medicine

Market Challenges

Availability of Alternative Methods to Hamper Market Growth 

The rising benefits of alternative methods such as bone marrow biopsy, quantitative immunoglobulin test, such as the detection of the stage of disease progression, is shifting the preference toward these alternative procedures among patients.

• For instance, in November 2024, The NIHR Oxford Clinical Research Facility (EMCRF) expanded its medical research trials by offering bone marrow biopsies to the volunteers participating in the BIO-004 study in the U.K.

This, along with the growing focus of key players on research and development activities toward integrating artificial intelligence and machine learning to develop and introduce innovative instruments and assays, is further likely to support the demand for these alternative methods.

Therefore, rising benefits coupled with R&D initiatives for bone marrow biopsy, among other techniques, are likely to pose a threat among the key players operating in the serum free light chain assays market.

Other Prominent Challenges

• High cost of research and development for advanced assays
• Difficulty in standardization across laboratories

Market Trends

Shifting Preference Toward Free Light Chain Tests from Conventional Test Techniques

Laboratory methods for diagnosis, prognosis, and monitoring of monoclonal gammopathies in plasma cell cancers have evolved to include serum and urine protein electrophoresis, immunosubtraction, immunofixation electrophoresis, 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 to diagnose light chain amyloidosis and light chain deposition disease.

Additionally, these serum free light chain assays can be used for real-time monitoring of disease progression or response to treatment in patients with monoclonal antibodies. Also, potential benefits associated with these tests, including early detection of diseases such as multiple myeloma, high sensitivity, and improved test results compared to conventional techniques, have led to their increased adoption in healthcare 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.

Therefore, factors including the growing potential benefits of serum free light chains compared to traditional techniques and the rising adoption of these assays in healthcare settings are boosting the market's growth.

Other Prominent Trends

• Increasing Technological Advancements – There is an increasing focus toward the advancements in immunoassay technology, such as the introduction of automated diagnostic systems, further improving the sensitivity and accuracy of sFLC assays among the key players.
• Increasing Healthcare Expenditures – Increasing per capita healthcare expenditure in developed and emerging countries, along with a rising focus toward investments in healthcare infrastructure among governmental organizations, is supporting the demand for diagnostic tests among patients. This, along with increasing awareness about the benefits of these tests, is further contributing to the growing demand for novel point-of-care testing solutions among the patient population.

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Impact of COVID-19

The COVID-19 pandemic led to slower growth of the global serum-free light chain assays (sFLC) market in 2020 globally. The impact was owing to international lockdowns imposed by several governments that deterred clinically vulnerable populations such as cancer patients and blood cancer screening patients from hospitals, clinics, and other health settings.

Thus, such global restrictions led to a substantial reduction in cancer testing volume across major regions during the pandemic. Similarly, major players recognized a decline in sales of their products in 2020 due to reduced demand across healthcare settings.

• For instance, according to the annual report published by the Binding Site in 2020, the revenue generated by their products, including serum-free light chain assays, declined by 35.0% in April and May 2020 as compared to the same months in the previous year due to COVID-19 pandemic.

However, the resurgence of patient visits to clinical settings for diagnostic screening of chronic disorders, such as multiple myeloma, led to market growth in 2021. Similarly, the rise in strategic initiatives by key players toward collaborations and acquisitions to introduce new assays across healthcare settings further augmented market growth in 2021. Also, a high emphasis on expanding product portfolio across developing countries catered to revenue growth globally.

Segmentation Analysis

By Technique

Increasing Adoption of Latex Turbidometric across Diagnostic Laboratories Boosts Segmental Growth

Amongst technique, the market is segmented into latex nephelometric, latex turbiometric ELISA, and lateral flow immunoassay.

Amongst technique, the latex turbiometric segment accounted for the largest market share in 2024. The dominance was attributed to the availability of major serum free light chain assays, such as Freelite, based on turbidometric technology, further supporting the rise in the adoption rate of these assays for diagnosing multiple myeloma, and other diseases 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 2025-2032.

• 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 compared with nephelometry/turbidimetry methods.

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By Indication

Increasing Product Approval among Regulatory Bodies to Drive Multiple Myeloma Segmental Growth

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

The multiple myeloma segment dominated the market in 2024. The increasing prevalence of the condition among the global population and the increase in approvals for serum free light chain assay products for multiple myeloma detection are a few factors contributing to the segment's growth.

• For instance, according to the 2023 statistics published by Cancer Medicine & Biology, it was reported that about 2,663 people were diagnosed with multiple myeloma in Australia.

On the other hand, the light chain amyloidosis segment is anticipated to grow significantly during the forecast period. The risk of amyloidosis increases with rising age, thus, growing age is one of the key factors responsible for the increasing demand for serum free light chain assays. Moreover, initiatives by companies and organizations to improve the diagnosis and treatment of amyloidosis also contribute to market growth.

• In October 2023, the Amyloidosis Research Consortium (ARC) launched ASPIRE, a collaboration of biotech and pharmaceutical companies, to advance solutions, improving diagnosis and systems of care for amyloidosis patients.

By End-User

Increasing Patient Admissions to Support the Hospital Laboratories Segmental Growth

Based on 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 growing patient population, increasing hospital admission for multiple myeloma and related disorders, growing awareness among the population, and increasing number of cancer hospitals, are a few factors contributing to the increasing adoption of diagnostic methods, such as serum free light chain assays, in the region.

• For instance, in September 2023, BC Cancer (Provincial Health Services Authority), in collaboration with Fraser Health Authority, is building an integrated and comprehensive cancer center as part of the new Surrey hospital. The new cancer center will aid in cancer detection, molecular imaging, supportive care, and research, for various cancers.

On the other hand, the clinical & pathology labs segment is anticipated to grow considerably during 2025-2032. 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.

Serum Free Light Chain (sFLC) Assays Market Regional Outlook

Amongst region, the market is studied across North America, Europe, Asia Pacific, and the Rest of the World.

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

North America was valued at USD 122.3 million in 2024. The growth is due to the increasing adoption of serum free light chain tests among patients in the region. Additionally, the increasing number of product launches and approvals of these assays for new disease indications is expected to boost the market 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.

U.S.

The increasing prevalence of multiple myeloma and other disorders and the rising focus of market players on product launches and approvals are a few factors supporting the growing demand for these products in the U.S., thereby contributing to the growth of the market in the region.

Europe

On the other hand, Europe is the second most dominant region in the global 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.

Asia Pacfic

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 2025-2032.

• For instance, in April 2021, Sebia, manufacturer of ELISA serum free light chain assay, started its direct operations in India. The company had an indirect presence in the Indian market through an exclusive distribution agreement with Trivitron Healthcare Pvt. Ltd. Furthermore, the company aimed to launch its ELISA based serum free light chain assay in India in the year 2024. Such factors are likely to contribute to the region’s growth.

Rest of the World

Additionally, rest of the world is also expected to grow during the forecast period. The rising target population and increasing burden of old age people in the region are a few factors contributing to the market growth. Additionally, establishments of new facilities coupled with increasing awareness regarding the proper management of multiple myeloma is increasing the adoption of screening techniques, such as serum free light chain tests, thereby raising the demand.

• For instance, in 2021, the Brazilian Association of Lymphoma and Leukemia launched online and educational actions to raise awareness regarding the condition.
• For instance, in March 2023, Cleveland Clinic opened a new cancer facility named Fatima bint Mubarak Center in Abu Dhabi. The facility is a 205,000-square-foot facility offering full-fledged personalized care for every cancer patient.

Competitive Landscape

Key Industry Players

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 2024 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 bolstered the global serum free light chain (sFLC) assays market growth in 2024.

• 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 2024. The growing focus on expanding its geographical presence in emerging countries is one of the key factors supporting its rising market share globally.

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

• July 2024: Thermo Fisher Scientific Inc. received the extension of 510k clearance from the Food and Drug Administration (FDA) to detect monoclonal gammopathy of undetermined significance (MGUS). This helped the company to increase its brand presence in the market.
• August 2023: Thermo Fisher Scientific Inc. announced the launch of its fully integrated automated mass spectrometry system, EXENT Solution, designed for transforming the detection and assessment of patients suffering from monoclonal gammopathies comprising multiple myeloma. The product is available in Belgium, France, Germany, Italy, the Netherlands, Spain, and the U.K.
• August 2022: Diazyme Laboratories 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 a latex particle enhanced immunoturbidimetric assay for the quantitative determination of free light chains of immunoglobulins in patients suffering from multiple myeloma.
• June 2021: Sebia acquired ORGENTEC Diagnostika, a specialty diagnostic company, to expand its capabilities in autoimmunity, infectious diseases, and clinical trials.
• 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.

Investment Analysis

There is an increasing focus among the prominent players towards the establishment of new manufacturing facilities and rising investment, especially in emerging countries such as Hungary, Slovakia, and others, presenting a lucrative investment opportunity for investors in the market globally.

• For instance, in 2022, Sebi, one of the prominent players in the market, established its facility in South Korea, Hungary, the Czech Republic, and Slovakia.

REPORT COVERAGE

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, it includes the factors that have contributed to the market growth in recent years with a regional analysis of different segments.

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Report Scope & Segmentation