Smoldering Multiple Myeloma | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

Multiple myeloma (MMS) is a disease associated with multiple myeloma. Because people with SMM are asymptomatic, the condition is usually diagnosed when M protein is found in a blood or urine lab sample. People with SMM are at high risk of developing multiple myeloma, but progression is not guaranteed. Over the past decade, epidemiological data on the incidence of plasma cell disorders, including SMM, have been difficult to obtain due to a lack of population-based disease registration and changes in diagnostic criteria. The management standards of SMM have been maintained. However, the term SMM is still widely recognized to include patients with asymptomatic early malignancies (MM), malignancies at high risk of progression, and malignancies with more consistent progression than MGUS. reported for SMM.

Description

An illness connected to multiple myeloma is smoldering multiple myeloma (SMM). SMM patients have no symptoms, so the condition is typically only identified when M protein is found in lab samples of blood or urine. SMM patients are more likely to develop complete myeloma, but progression is not always guaranteed. In the first five years following a diagnosis, about 10% of individuals experience multiple myeloma. The risk decreased to 3% and then to 1% ten years after diagnosis. Multiple myeloma (SMM) is an asymptomatic clonal plasma cell condition. The elevated risk of multiple myeloma (MM) separates SMM from monoclonal gammopathy of unknown significance. Significant advancements have been made in the diagnosis, diagnosis, and treatment of SMM over the past few years. These include updated disease descriptions, the discovery of a large number of fresh prognostic variables, categorization based on underlying cytogenetic changes, and fresh therapeutic options. Importantly, a subset of patients who were previously classified as SMM are now being reclassified as MM on the basis of biomarkers that reveal patients with an 80% risk of progression within 2 years. Because recent evidence indicates that early treatment is advantageous for patients, SMM becomes even more crucial. As a result, SMM patients need to be accurately diagnosed and put into a risk category, which calls for routinely combining laboratory and advanced imaging techniques. The main clinical distinction between MM and MGUS is the rate of progression to malignancy during the first five years following diagnosis, which varies from 10% per year in SMM to 1% per year in MGUS. SMM is a clinically defined entity that is composed of patient subgroups with biological malignancies (e.g., MGUS) and biological malignancies that have not yet manifested hypercalcemia, renal failure, anemia, or anaplastic lesions (CRAB) (i.e., MM) subgroup and/or other defining events related to myeloma (MDE). Therefore, MGUS patients with end-organ damage and clinical symptoms within the first two years of diagnosis (and an extremely low rate of progression) are included in SMM. Unfortunately, no pathologic or molecular signature exists that can be consistently used to separate SMM patients with precancerous clonal PC from patients with clonal malignant myeloma cells. The presence of 3 g/dL serum monoclonal protein (M) and/or 10-60% clonal bone marrow PC (BMPC) without end-organ involvement (e.g., conventional CRAB). or an additional MDE. Based on serum protein levels and the percentage of cloned BMPCs, 7 were distinguished from MGUS. The free light chain incorporation/unbinding (FLC) ratio of 100, two or more focal lesions (which are typically indicative of focal myeloid abnormalities), and a BMPC of 60% are now excluded from the definition of SMM disease. imaging by resonance (MRI). These patients, who now are thought to have MM, have an annual risk of progression of about 40%.

Smoldering Multiple Myeloma (Epidemiology)

Epidemiological data on the incidence of plasma cell disorders, including SMM, are hard to come by because population-based disease registries are lacking, and diagnostic criteria have changed over the past ten years. The incidence of SMM was, however, estimated by the US National Cancer Database (NCDB) study to be zero. 100,000, similar to a European study that found 0.4 people per 100,000. The average patient age at NCDB diagnosis was 67 years old. Due to technical challenges in carrying out extensive epidemiological studies and the lack of an International Classification of Diseases (ICD) code to distinguish SMM from MM, the incidence of SMM in the general population has not been conclusively established. However, only a small number of studies have looked back at data from significant databases to examine the incidence of SMM in MM patients. A US study that looked at the National Cancer Database (NCDB) discovered that 13.7% of roughly 86,000 patients with MM between 2003 and 2011 were also diagnosed with SMM. The age-adjusted incidence of MMM in the US was used as a benchmark, and the incidence of SMM was calculated to be 0.9 cases annually. 100 000 people. Another study using the NCDB discovered that 11,643 (17.1%) of the 68,234 patients with MM diagnosed between 2010 and 2014 already had SMM. Improved predictions are once again of interest due to growing awareness of SMM's complexity and the value of early intervention. In this regard, two studies stand out in particular. The first was the iStopMM study (NCT03327597), a population-based study that finished eligibility after enrolling 80,743 participants and screened adults over 40 for various plasma cell disorders, including SMM. The PROMISE study (NCT03689595), which is still being conducted, aims to screen 50,000 high-risk patients for MGUS and SMM and prospectively follow progression to MM. These studies' highly anticipated findings will demonstrate the incidence of SMM in the general population.

Smoldering Multiple Myeloma -Current Market Size & Forecast Trends

The market for smoldering multiple myeloma (SMM) is expected to grow significantly, with projections indicating a CAGR of 6.1% in the coming years. The overall multiple myeloma therapeutics market, which includes SMM, was valued at approximately USD 27.2 billion in 2024 and is estimated to reach around USD 58.5 billion by 2037, reflecting a CAGR of 6.6% during that period. The increasing incidence of plasma cell cancers and advancements in treatment options are driving this growth. As more cases of SMM are detected earlier due to improved diagnostic capabilities, the demand for effective management strategies is expected to rise, further contributing to the market expansion through 2035.

For SMM, the accepted standard of care has been proven. However, it is widely acknowledged that patients with early malignancy (MM) that is still asymptomatic, those with premalignancy who are at high risk of progression, and those with premalignancy whose progression rate is more in line with MGUS than that reported for SMM all fall under the umbrella of the term SMM. The diagnostic criteria for MM were updated by the International Myeloma Working Group (IMWG), and a subset of patients with early metastases are now recognized as having MM and are given treatment accordingly. The new IMWG criteria are not, however, met by all patients with early metastases. SMM continues to be a high-risk subgroup with a 50% chance of progression within 2 years; patients in these groups should be taken into account for clinical trials to test early treatment. Only by having these patients take part in clinical trials will it be possible to show the importance of early therapeutic intervention in such patients. vaccines, oral proteasome inhibitors like ixazomib, monoclonal antibodies like elotuzumab and daratumumab, and assessments of immunomodulators like pomalidomide on the outcomes of high-risk SMM patients are just a few of the many novel approaches that have been developed recently. A few findings from ongoing or recently finished but unreported well-designed studies, such as a phase 3 study, observational lenalidomide phase III studies (E1A06, NCT01169337), active observational subcutaneous daratumumab studies (AQUILA, NCT03301220), and observational subcutaneous daratumumab phase III studies (NCT03301220). Early therapeutic intervention was beneficial in SMM patients, according to the prospective phase II trial ASCENT (aggressive approaches to burn treatment to evaluate new therapies) with carfilzomib, lenalidomide, daratumumab, and dexamethasone (NCT03289299).

Report Highlights

Smoldering Multiple Myeloma - Current Market Trends

Smoldering Multiple Myeloma - Current & Forecasted Cases across the G8 Countries

Smoldering Multiple Myeloma - Market Opportunities and Sales Potential for Agents

Smoldering Multiple Myeloma - Patient-based Market Forecast to 2035

Smoldering Multiple Myeloma - Untapped Business Opportunities

Smoldering Multiple Myeloma - Product Positioning Vis-a-vis Competitors' Products

Smoldering Multiple Myeloma - KOLs Insight