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Global MGUS Management Market to surpass US$ 53 million by 2033; expanding at a 7% CAGR: FMI Report

The global monoclonal gammopathy of undetermined significance (MGUS) management market is expected to garner a market value of US$ 27 million in 2023 and is expected to accumulate a market value of US$ 53.11 million by registering a CAGR of 7% in the forecast period 2023 to 2033. The market for Monoclonal Gammopathy of Undetermined Significance (MGUS) Management registered a CAGR of 4% in the historical period 2018 to 2022.

According to American Cancer Society estimates in January 2022, about 60,650 new cases of leukemia and 24,000 deaths from leukemia and there were around 11,450 deaths due to acute myeloid leukemia in the United States in the year 2022. The increasing demand for these treatments is expected to lead to the development of new and innovative treatments, which will drive the growth of the market in the coming years. The market is likely to witness significant growth due to the increasing incidence of blood cancers and the increasing focus on improving treatment options for patient.

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As a result of positive growth, various start-ups are entering the market. For instance , Orca Bio is a developer of allogeneic cell therapy for the treatment of blood, genetic and immune diseases. The company uses its proprietary OrcaSort technology to isolate and purify stem cells and immune cells used in hematopoietic cell grafts. The technology is optimized for performance and is designed to fit seamlessly into the clinical processing of apheresis products, providing a scalable and high-precision manufacturing platform.

North America is anticipated to acquire a market share of about 40% in the forecast period. This growth is attributable to the rising prevalence of the condition in the region. Furthermore, government initiatives and an increase in the number of research partnerships are boosting market growth across North America. Asia Pacific is a growing market due to a shift towards point-of-care healthcare. The increasing number of hospitals in India and China presents a promising market opportunity globally.

Key Takeaways from the Market Study

  • From 2018 to 2022, the monoclonal gammopathy of undetermined significance management market grew at a CAGR of 4%.
  • The global monoclonal gammopathy of undetermined significance management market is expected to grow with a 7% CAGR from 2023 to 2033.
  • As of 2033, the monoclonal gammopathy of undetermined significance management market is expected to reach US$ 53.11 Million
  • According to the FMI analysis, hospitals account for the largest market share.
  • North America is expected to possess a 40% market share in the Monoclonal gammopathy of undetermined significance management market.
  • The Asia Pacific market is predicted to increase significantly throughout the forecast period, with a share of 20% during the forecast period.

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A series of international level collaborations involving healthcare stakeholders across various institutional settings are fuelling further clinical trials and research studies dedicated to discovering monoclonal gammopathy of undetermined significance management.” says an FMI analyst

Market Competition

Key players in the market include pharmaceutical companies such as Janssen Biotech, Inc., Pfizer, Inc., Amgen, Inc., Roche Holding AG, Celgene Corporation (Acquired by Bristol-Myers Squibb), Novartis AG, Merck & Co., Inc., Sanofi S.A, Takeda Pharmaceutical Company Limited and Gilead Sciences, Inc. along with healthcare providers and technology companies among other global players.

  • In January 2022, Kura Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on their KOMET-001 Phase 1b study of the drug KO-539 for the treatment of relapsed or refractory acute myeloid leukemia (AML). This allows the company to proceed with the study to evaluate the safety and efficacy of KO-539 in patients with AML.

More Insights Available

FMI, in its new offering, presents an unbiased analysis of the global Monoclonal gammopathy of undetermined significance management market, presenting historical analysis from 2018 to 2022 and forecast statistics for the period of 2023 to 2033.

The study reveals essential insights on the basis of drug class (alendronate, risedronate, ibandronate, and zoledronic acid), diagnosis (blood tests, urine tests, imaging tests, and bone marrow tests), distribution channel (hospital pharmacies, and retail pharmacies), and end users (hospitals and specialty centers) across seven major regions (North America, Latin America, Europe, East Asia, South Asia, Oceania, and Middle East & Africa).

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Key Segments Profiled in the Monoclonal Gammopathy of Undetermined Significance (MGUS) Management Industry Survey

Drug Class:

  • Alendronate
  • Risedronate
  • Ibandronate
  • Zoledronic Acid

Distribution Channel:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies


  • Blood Tests
  • Urine Tests
  • Imaging Tests
  • Bone Marrow Tests

End Users:

  • Hospitals
  • Speciality Centers

About FMI:

Future Market Insights (ESOMAR certified market research organization and a member of Greater New York Chamber of Commerce) provides in-depth insights into governing factors elevating the demand in the market. It discloses opportunities that will favor the market growth in various segments on the basis of Source, Application, Sales Channel and End Use over the next 10-years.

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Last Updated: 08-Mar-2023