Global Multiple Myeloma Market Size To Reach USD 30.3 Billion by 2033 Says Astute Analytica
Rising prevalence, aging populations, and therapeutic innovation are reshaping the landscape of multiple myeloma care and driving sustained market growth
Chicago, May 15, 2025 (GLOBE NEWSWIRE) -- The global multiple myeloma market is witnessing steady growth, fuelled by an aging population, rising disease prevalence, and continuous advancements in treatment. Multiple myeloma, a rare but aggressive cancer of plasma cells, often evolves from precursor conditions such as MGUS and SMM. According to the World Health Organization, nearly 188,000 new cases were diagnosed globally in 2022, accounting for approximately 1% of all cancers and 10% of blood cancers. With an average diagnosis age of 69 and a rapidly aging global population, the demand for effective therapies is set to rise substantially.
Market revenue is projected to grow from USD 22.6 billion in 2024 to USD 30.3 billion by 2033, reflecting a CAGR of 3.3%. This expansion is being driven by increased adoption of systemic treatments, pharmaceutical innovation, and biomarker-based diagnostics like serum M protein levels and del(17p) detection. By 2024, around 880,000 people worldwide were receiving treatment, many already undergoing second- or third-line therapies. Given the high prevalence in older adults, age-appropriate treatment strategies are becoming increasingly vital.
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Initial treatment typically involves induction therapy using combinations such as bortezomib, thalidomide, cyclophosphamide, dexamethasone, and monoclonal antibodies like daratumumab. Regimens like VCD and Dara-VTD are common, particularly among transplant-eligible patients. While early response rates are often strong, relapse remains a persistent challenge. Drugs like Isa-Pd are used in early relapse, and targeted therapies such as Venetoclax show promise, especially in patients with the t(11;14) translocation. For triple-class refractory cases, next-generation therapies like Abecma, Carvykti, Tecvayli, Talvey, and Elrexfio are providing new options and hope.
CAR T-cell therapies, particularly Abecma and Carvykti represent one of the most groundbreaking developments, employing genetically engineered immune cells to combat cancer. Roughly 80,000 patients between second and fourth lines of therapy may qualify for CAR T-cell treatment, with another 22,000 eligible in later stages. In some cases, these therapies have extended survival for five years or longer, depending on the disease stage and healthcare access.
Cost remains a significant barrier. CAR T-cell therapies like Carvykti can exceed USD 465,000 per treatment, while bispecific antibodies such as Tecvayli cost over USD 29,000 per cycle. Access is further limited by the small number of certified CAR T treatment centers only 311 in the United States, forcing many patients to travel, increasing both financial and logistical burdens. While private insurance may cover much of the cost, public programs like Medicare often fall short. More than half of insured patients still experience financial hardship, which can lead to delays or discontinuation of therapy. As treatment options continue to advance, ensuring equitable access and affordability will be crucial for long-term sustainability and patient outcomes.Key Findings in Multiple Myeloma Market
Market Forecast (2033)
US$ 30.3 Billions
CAGR
3.3%
Top Drivers
Rising Multiple Myeloma Incidence Amid Global Aging Trends
Top Trends
Emerging Potential in Targeted and Immune-Based Therapies
Top Challenges
High Cost of Advanced Therapies Continues to Limit Patient Access
Next-Gen Advances: Immunotherapy and Precision Medicine Driving Multiple Myeloma Innovation
The treatment landscape for multiple myeloma (MM) is rapidly evolving, with CAR T-cell therapies and bispecific antibodies emerging as groundbreaking options. CAR T-cell therapies like idecabtagene vicleucel and ciltacabtagene autoleucel have shown impressive response rates, ranging from 73-98%, in relapsed or refractory patients. However, relapse remains a significant concern, as almost all patients eventually relapse, with about 50% doing so within 26.9 months. The key opportunity lies in enhancing the durability of CAR T-cell responses and combining them with other therapies to prolong remissions. Despite their potential, CAR T-cells are still not widely available as off-the-shelf treatments, limiting accessibility.
On the other hand, bispecific antibodies targeting BCMA and GPRC5D are emerging as effective off-the-shelf alternatives, with drugs like teclistamab showing response rates above 60% in patients with refractory MM. While these therapies offer great promise, issues such as toxicity and antigen escape remain challenges that need to be addressed. Combining bispecific antibodies with other therapies could enhance their effectiveness, particularly for advanced-stage multiple myeloma, opening new avenues for more durable and impactful treatments.
Regional Dynamics: Navigating the Global Evolution of Multiple Myeloma Treatment.The global multiple myeloma market is expanding rapidly, driven by regional factors such as healthcare advancements, increasing treatment availability, and varying market dynamics across different geographies. North America, Europe, and Asia-Pacific are the primary drivers of this growth, each contributing uniquely to the market's development.
North America remains at the forefront of the global multiple myeloma market, driven by a high disease prevalence, advanced healthcare infrastructure, and the early adoption of innovative therapies. In the United States alone, an estimated 35,780 new cases of multiple myeloma are expected in 2024, including 19,520 males and 16,260 females. In Canada, approximately 4,100 individuals are projected to be diagnosed with the disease, and 1,750 are expected to succumb to it. The region is also home to major pharmaceutical companies like Johnson & Johnson, Amgen, and Bristol Myers Squibb, which are heavily investing in research, development, and clinical trials. Additionally, advocacy groups and pharmaceutical education programs are crucial in increasing awareness and promoting early diagnosis of the disease.
Europe remains a strong player in the global multiple myeloma market, supported by well-established healthcare systems and significant EU-funded research initiatives focused on oncology. Countries like Germany, the UK, and France are seeing increased incidence rates, which fuel demand for treatments. However, the region faces challenges such as high drug prices and longer approval times compared to North America, which can limit faster market expansion.
Asia-Pacific is the fastest-growing region in the multiple myeloma market, driven by increased awareness, better access to treatments, and expanding research and development efforts. Japan and India are witnessing a surge in clinical trials and the introduction of new therapies for multiple myeloma. In Japan, the disease has an annual incidence of approximately 5 new cases per 100,000 people and leads to around 4,000 deaths each year. Notably, Japan approved Sarclisa (isatuximab) in February 2025, highlighting the country's commitment to expanding treatment options. This regional growth reflects the increasing focus on tackling the rising burden of multiple myeloma in Asia.
The Middle East & Africa account for a smaller share of the global multiple myeloma market, mainly due to healthcare disparities and limited treatment infrastructure in many African nations. However, countries like Saudi Arabia, the UAE, and South Africa are making strides by investing in healthcare development and increasing access to cancer treatments, showing potential for future growth in the region.
Several key players in the pharmaceutical industry, including Takeda Pharmaceutical Company Limited, Mylan N.V., Novartis AG, Teva Pharmaceutical Industries Ltd., Bristol Myers Squibb Company, Arcellx, Regeneron Pharmaceuticals, Inc., Cartesian Therapeutics, BeiGene, AbbVie Inc., Roche (F. Hoffmann-La Roche Ltd), Amgen Inc., ONO PHARMACEUTICAL CO., LTD., Janssen Pharmaceuticals, Inc., Genentech, Inc. (a subsidiary of Roche), Celgene Corporation (part of Bristol Myers Squibb), Sanofi, and Karyopharm Therapeutics Inc., are advancing treatments in the field of multiple myeloma. These companies are making significant strides in developing therapies that aim to improve patient outcomes and expand treatment options.For instance, The European Commission granted Regeneron's Lynozyfic (linvoseltamab) conditional approval for relapsed/refractory multiple myeloma after three or more therapies. In the LINKER-MM1 trial, Lynozyfic showed a 71% response rate and 50% complete response, with a 29-month median duration of response. It is the first BCMAxCD3 bispecific with response-adapted monthly dosing, offering convenience for heavily pretreated patients. Severe CRS and ICANS were rare.
AstraZeneca expanded its cell therapy portfolio by acquiring Belgian biotech EsoBiotec for up to $1 billion. EsoBiotec's in-vivo CAR-T platform provides off-the-shelf therapies for multiple myeloma, adding a faster and more cost-effective approach to AstraZeneca's portfolio, which includes its $1.2 billion 2023 acquisition of Gracell Biotechnologies.
Opna Bio's oral EP300/CBP bromodomain inhibitor, OPN-6602, received FDA Orphan Drug Designation for relapsed/refractory multiple myeloma. In Phase 1 trials, OPN-6602 demonstrated promising results in combination with dexamethasone, pomalidomide, and mezigdomide, with potential benefits in lower toxicity and improved efficacy. The designation includes tax credits, fee waivers, and seven years of market exclusivity.
In December 2024, GSK reported a 42% reduction in death risk with its Blenrep combination therapy in relapsed/refractory multiple myeloma, with patients projected to live nearly three years longer than those receiving standard care. GSK has refiled for FDA approval, with a decision expected by July 2025, and received priority review in China. The drug, once withdrawn from the U.S. market, is poised for a comeback, with peak sales projected over $3.99 billion.
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Future Outlook: Evolving the Multiple Myeloma Treatment Landscape
The multiple myeloma treatment market is poised for significant evolution in the coming years, driven by continuous advancements in dosage forms, diagnostic tools, and personalized therapies. Oral medications continue to lead the market due to their convenience and patient adherence benefits. At the same time, injectable treatments, such as CAR T-cell therapies and monoclonal antibodies are expanding rapidly, supported by their high efficacy in targeted treatment. However, these biologics are often associated with high costs, and ongoing research aims to develop more accessible and patient-friendly alternatives.
Research and development are particularly focused on addressing relapsed and refractory cases, which remain a major challenge in clinical management. The rise of online pharmacies is also contributing to increased accessibility and convenience for patients, supporting broader treatment adoption.
Genetic testing is expected to play an increasingly central role in treatment decisions, with high-throughput sequencing and AI-driven diagnostic tools becoming essential components of personalized care. The growth of multiplex biomarker platforms will further enable precise patient stratification, allowing clinicians to tailor therapies to individual genetic profiles and disease characteristics.
A shift toward preventive care will increase demand for early-stage detection tools, especially for precursor conditions like MGUS (monoclonal gammopathy of undetermined significance) and SMM (smoldering multiple myeloma), which have historically been difficult to manage. These innovations will also drive growth in the diagnostics segment, improving risk assessment and patient outcomes.
Government policies and changing reimbursement frameworks will play a crucial role in defining the future of multiple myeloma treatment. Increased funding for research and clinical development is driving progress in next-generation therapies, such as bispecific antibodies, antibody-drug conjugates, and innovative proteasome inhibitors. By 2030, the multiple myeloma treatment landscape will be shaped by a comprehensive approach that combines targeted therapies, advanced biologics, and precision diagnostics. Personalized, early-stage intervention is expected to become the standard of care, supported by improved healthcare access, affordability, and infrastructure.
Key Competitors
Takeda Pharmaceutical Company Limited
Mylan N.V.
Novartis AG
Teva Pharmaceutical Industries Ltd.
Bristol Myers Squibb Company
Arcellx
Regeneron Pharmaceuticals, Inc.
Cartesian Therapeutics
BeiGene
AbbVie Inc.
Roche (F. Hoffmann-La Roche Ltd)
Amgen Inc.
ONO PHARMACEUTICAL CO., LTD.
Janssen Pharmaceuticals, Inc.
Genentech, Inc. (a subsidiary of Roche)
Celgene Corporation (part of Bristol Myers Squibb)
Sanofi
Karyopharm Therapeutics Inc.
Others
Global Multiple Myeloma Treatment Market Segmentation (2024–2032):
By Drug Class:
Alkylating Agent
Melphalan (generic)
Cyclophosphamide (generic)
Bendamustine (Treanda)
Melphalan flufenamide (meflufen; Pepaxto)
Proteasome Inhibitors (specify names)
Bortezomib (Velcade)
Carfilzomib (Kyprolis)
Ixazomib (Ninlaro)
Immunomodulatory Drugs (IMiDs)
Thalidomide (Thalidomid/generic)
Lenalidomide (Revlimid)
Pomalidomide (Pomalyst/Imnovid)
Monoclonal Antibodies
Daratumumab (Darzalex)
Isatuximab (Sarclisa)
Elotuzumab (Empliciti)
Nuclear Export Inhibitors
Selinexor (Xpovio)
Antibody Drug Conjugate
Belantamab mafodotin-blmf (Blenrep)
CAR T Cell
Idecabtagene vicleucel (ide-cel; Abecma)
Ciltacabtagene autoleucel (cilta-cel; Carvykti)
Steroids
Prednisone (generic)
Dexamethasone (generic)
Chemotherapy
Histone Deacetylase (HDAC) Inhibitors
Panobinostat (Farydak)
Bispecific Antibodies
Teclistamab-cqyv (Tecvayl)
Elranatamab-bcmm (Elrexfio)
Linvoseltamab (Lynozyfic)
Talquetamab-tgvs (Talvey)
By Disease Stage:
Newly Diagnosed
Relapsed/Refractory
By Dosage Form:
Oral
Injectables
Others
By Distribution Channel:
Offline Channel
Hospital Pharmacies
Speciality Retail Pharmacies
Online pharmacies
By Region
North America
Europe
Asia Pacific
Middle East & Africa
South America
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About Astute Analytica
Astute Analytica is a global market research and advisory firm providing data-driven insights across industries such as technology, healthcare, chemicals, semiconductors, FMCG, and more. We publish multiple reports daily, equipping businesses with the intelligence they need to navigate market trends, emerging opportunities, competitive landscapes, and technological advancements.
With a team of experienced business analysts, economists, and industry experts, we deliver accurate, in-depth, and actionable research tailored to meet the strategic needs of our clients. At Astute Analytica, our clients come first, and we are committed to delivering cost-effective, high-value research solutions that drive success in an evolving marketplace.
Contact Us:Astute AnalyticaPhone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World)For Sales Enquiries: sales@astuteanalytica.comWebsite: https://www.astuteanalytica.com/ Follow us on: LinkedIn | Twitter | YouTube
CONTACT: Contact Us: Astute Analytica Phone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World) For Sales Enquiries: sales@astuteanalytica.com Website: https://www.astuteanalytica.com/
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T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI ®.CARVYKTI ® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI® REMS Program. WARNINGS AND PRECAUTIONS INCREASED EARLY MORTALITY - In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI® treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI® arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI® arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI® infusion, and 19 deaths occurred after CARVYKTI® infusion. Of the 10 deaths that occurred prior to CARVYKTI® infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI® infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12). CYTOKINE RELEASE SYNDROME (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® for RRMM in the CARTITUDE-1 & 4 studies (N=285), CRS occurred in 84% (238/285), including ≥ Grade 3 CRS (ASCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (≥ 10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4). Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. Please see Section 5.4; Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS). Ensure that a minimum of two doses of tocilizumab are available prior to infusion of CARVYKTI®. Of the 285 patients who received CARVYKTI® in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least one dose of corticosteroids for treatment of CRS. Monitor patients at least daily for 10 days following CARVYKTI® infusion at a REMS-certified healthcare facility for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 4 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. NEUROLOGIC TOXICITIES, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including ≥ Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI® may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, ICANS occurred in 13% (36/285), including Grade ≥3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients including those with ongoing neurologic events at the time of death or data cut-off. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients respectively. Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent ≥2% manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%) [see Adverse Reactions (6.1)]. Monitor patients at least daily for 10 days following CARVYKTI® infusion at the REMS-certified healthcare facility for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 4 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed [see Dosage and Administration (2.3)]. Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, parkinsonism occurred in 3% (8/285), including Grade ≥ 3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cut-off. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients. Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4). Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson's disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI® treatment. Guillain-Barré Syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI® despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis. Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS. Immune Mediated Myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI® in CARTITUDE-4 in a patient who received CARVYKTI® as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause. Peripheral Neuropathy occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients including those with ongoing neurologic events at the time of death or data cut-off. Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS. Cranial Nerve Palsies occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients including those with ongoing neurologic events at the time of death or data cut-off. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4). The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected. Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms. HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI®, with a median onset of 10 days (range: 8 to 99 days) and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure. Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI®. HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards. CARVYKTI® REMS: Because of the risk of CRS and neurologic toxicities, CARVYKTI® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI® REMS. Further information is available at or 1-844-672-0067. PROLONGED AND RECURRENT CYTOPENIAS: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, Grade 3 or higher cytopenias not resolved by day 30 following CARVYKTI® infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285) and anemia 2% (6/285). After Day 60 following CARVYKTI® infusion 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death. Monitor blood counts prior to and after CARVYKTI® infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines. INFECTIONS: CARVYKTI® should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections, occurred in patients after CARVYKTI® infusion. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, infections occurred in 57% (163/285), including ≥Grade 3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm. Monitor patients for signs and symptoms of infection before and after CARVYKTI® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI® infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19. Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), human immunodeficiency virus (HIV), or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice. HYPOGAMMAGLOBULINEMIA: can occur in patients receiving treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500mg/dl after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500mg/dl, after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis. Monitor immunoglobulin levels after treatment with CARVYKTI® and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI® treatment, and until immune recovery following treatment with CARVYKTI®. HYPERSENSITIVITY REACTIONS occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ≤ Grade 2. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia. Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI®. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction. SECONDARY MALIGNANCIES: Patients treated with CARVYKTI® may develop secondary malignancies. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI®. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post-marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusions and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc. at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status, seizures, neurocognitive decline, or neuropathy, patients receiving CARVYKTI® are at risk for altered or decreased consciousness or coordination in the 8 weeks following CARVYKTI® infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery during this initial period, and in the event of new onset of any neurologic REACTIONS The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia. Please read full Prescribing Information, including Boxed Warning, for CARVYKTI®. ABOUT CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL) Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient's own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.1 In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide. In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma. In September 2022, Japan's Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency's Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment. ABOUT CARTITUDE-1 CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a PI and IMiD, received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy. The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.2 ABOUT CARTITUDE-4 CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.3 ABOUT LB1908 NCT05539430 is a Phase 1, open label, dose escalation, multicenter study to evaluate Claudin 18.2-targeting CAR-T cells (LB1908) in adult patients with unresectable, locally advanced or metastatic gastric, gastroesophageal junction, esophageal, or pancreatic adenocarcinoma.4 ABOUT LB2102 NCT05680922 is a Phase 1, first-in-human, open-label, multicenter, dose escalation and expansion study of DLL3-targeted chimeric antigen receptor T-cells (LB2102) in patients with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer.5 ABOUT MULTIPLE MYELOMA Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.6 In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.7 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.8 ABOUT GASTRIC, ESOPHAGEAL AND PANCREATIC CANCERS Stomach, esophageal and pancreatic cancers affect the tissue or glands lining these organs. They are often diagnosed when the diseases have progressed to advanced stages. In the U.S., there are an estimated 123,920 people living with stomach cancer and 49,084 living with esophageal cancers.9,10 An estimated 89,248 people in the U.S. live with pancreatic cancer. While all three cancers are treatable, the five-year survival rate is just 32% for gastric cancer; 20% for esophageal cancer; and 11.5% for pancreatic cancer, with definitive treatment at all stages of progression.11,12,13 ABOUT SMALL CELL LUNG CANCER Lung cancer is a leading cause of cancer deaths, contributing to 25 percent of all cancer-related fatalities annually in the United States.14 Small cell lung cancer (SCLC) is the most aggressive, and accounts for roughly 10-15 percent of lung cancer cases in the United States.15,16 An estimated 30,000 to 35,000 people are newly diagnosed with the disease each year.16 This cancer becomes more difficult to treat once it has spread and becomes extensive stage SCLC. Approximately 60 to 70 percent of SCLC patients are diagnosed with metastatic SCLC.15,17 ABOUT LEGEND BIOTECH With over 2,600 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the US, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI's patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities. Learn more at and follow us on X (formerly Twitter) and LinkedIn. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute 'forward-looking statements' within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech's strategies and objectives; statements relating to CARVYKTI®, including Legend Biotech's expectations for CARVYKTI® and its therapeutic potential; statements related to the potential results from ongoing studies in the CARTITUDE clinical development program; and the potential benefits of Legend Biotech's product candidates. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech's expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech's patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the 'Risk Factors' section of Legend Biotech's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 11, 2025. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. ‡ Sundar Jagannath, M.D., Network Director, Multiple Myeloma Center of Excellence for Multiple Myeloma at The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, has provided consulting, advisory, and speaking services to Legend Biotech; has not been paid for any media work. INVESTOR CONTACT: Jessie YeungTel: (732) 956-8271 PRESS CONTACT: MaryAnn OndishTel: (914) 552-4625media@ REFERENCES _____________________ 1 CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.2 A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1). Available at: Accessed October 2022.3 A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). Accessed March 2024.4 Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma. Available at: Accessed May 20255 DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer. Available at: Accessed May 20256 American Cancer Society. 'What is Multiple Myeloma?'. Available at: Accessed March 2024.7 American Cancer Society. 'Key Statistics About Multiple Myeloma.' Available at: Accessed March 20248 American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: Accessed March 2023.9 Surveillance, Epidemiology, and End Results (SEER) Program. Accessed May 2022.10 Surveillance, Epidemiology, and End Results (SEER) Program. Accessed May 2022.11 American Cancer Society. Accessed May 2022.12 American Cancer Society. May 2022.13 Surveillance, Epidemiology, and End Results (SEER) Program. Accessed May 2022.14 American Cancer Society. 'Key Statistics for Lung Cancer.' Accessed November 2022.15 Byers LA, Rudin CM. Small cell lung cancer: where do we go from here? Cancer. 2015;121(5):664-72.16 Rare Diseases. 'Rare Disease Database.' Accessed November 2022.17 Gong J, Salgia R. Managing patients with relapsed small-cell lung cancer. J Oncol Pract. 2018;14(6): in to access your portfolio
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Nontuberculous Mycobacterial (NTM) Diagnostic Market to Reach USD 3,261.1 million By 2032, Growing At An 6.64% CAGR
PUNE, India, June 9, 2025 /PRNewswire/ -- According to the latest research by Credence Research, the global Nontuberculous Mycobacterial (NTM) Diagnostic Market was valued at USD 1,814.8 million in 2023 and is projected to reach USD 3,261.1 million by 2032, growing at a compound annual growth rate (CAGR) of 6.64% during the forecast period. The rising incidence of NTM infections, especially among immunocompromised patients and individuals with chronic pulmonary conditions, is a primary factor driving market demand. Technological advancements in molecular diagnostics and imaging techniques are significantly enhancing detection accuracy and speed, leading to faster diagnosis and improved clinical outcomes. Healthcare providers are increasingly adopting advanced diagnostic platforms to address the complexities of identifying NTM species, which often mimic other pulmonary disorders. This shift is further supported by growing awareness of NTM-related diseases and stronger clinical guidelines for early screening and diagnosis. Expanding healthcare infrastructure across emerging markets, coupled with increased investments in R&D by diagnostics companies, is expected to accelerate market expansion over the coming years. Browse the report and understand how it can benefit your business strategy- Key Growth Determinants: Nontuberculous Mycobacterial (NTM) Diagnostic Market The growth of the NTM Diagnostic Market is primarily driven by the rising global prevalence of NTM infections, particularly among the aging population and individuals with underlying lung conditions such as COPD, bronchiectasis, and cystic fibrosis. As awareness of these infections increases among healthcare professionals, the demand for timely and accurate diagnostic solutions is expanding. This trend is supported by an uptick in hospital admissions and outpatient consultations related to unexplained pulmonary symptoms, where NTM is an emerging differential diagnosis. Another key growth determinant is the rapid advancement in diagnostic technologies. Innovations in molecular diagnostics, PCR-based assays, and next-generation sequencing (NGS) are enabling faster, more precise identification of various NTM species, overcoming the limitations of traditional culture methods. Furthermore, increased funding for infectious disease research and growing collaborations between public health organizations and diagnostic manufacturers are creating favorable conditions for product development and market penetration. The rising implementation of clinical guidelines recommending early testing for at-risk populations is also bolstering the adoption of advanced NTM diagnostics globally. Key Growth Barriers: Nontuberculous Mycobacterial (NTM) Diagnostic Market Limited Awareness and MisdiagnosisMany clinicians and patients remain unaware of NTM infections, which often mimic tuberculosis or other chronic pulmonary conditions. This lack of awareness leads to frequent misdiagnosis or delayed testing, particularly in settings with limited diagnostic infrastructure. Diagnostic Complexity and InaccessibilityAccurate identification of NTM species is essential for effective treatment, but traditional culture methods are time-consuming and may lack sensitivity. Advanced molecular diagnostic tools, though more effective, are not widely accessible in many regions, especially in developing markets. Resource Constraints in Healthcare FacilitiesComprehensive NTM diagnostics require specialized laboratory equipment, trained personnel, and standardized testing protocols. Many healthcare systems, especially in low- and middle-income countries, face limitations in implementing such advanced diagnostics. Regulatory and Reimbursement ChallengesNavigating regulatory approval for new diagnostic tools can be time-consuming and costly. In addition, limited reimbursement policies for advanced NTM diagnostic tests discourage healthcare providers from adopting innovative solutions. Segmentation Based on Diagnostic Method: Nucleic Acid Amplification Tests (NAAT) Microscopy Culture-based Methods Biochemical Tests Immunological Tests PCR Others Based on Infection Type: Pulmonary Cutaneous Disseminated Gastrointestinal Others Based on End-User: Hospitals & Clinics Diagnostic Laboratories Others Based on region North America Europe Asia Pacific Latin America Middle East & Africa Preview the report with a detailed sample and understand how it can benefit your business strategy. Request a free sample today - Regional Analysis: Nontuberculous Mycobacterial (NTM) Diagnostic Market North America holds the largest share of the global NTM Diagnostic Market, accounting for approximately 39% of total revenue in 2023. This dominance is driven by advanced healthcare infrastructure, widespread use of molecular diagnostic technologies, and high awareness of NTM-related diseases. The presence of major diagnostic companies and strong R&D funding further support market growth in the United States and Canada. Europe follows with around 27% of the market share. Countries like Germany, the UK, and France are key contributors, supported by growing recognition of NTM infections, aging populations, and well-established public health systems. Increased focus on early diagnosis and the adoption of advanced testing tools continue to fuel regional demand. Asia-Pacific accounts for roughly 23% of the global market. Rapid improvements in healthcare infrastructure, growing patient awareness, and increased investments in diagnostic technologies are propelling growth in China, Japan, South Korea, and India. Partnerships between international diagnostic firms and regional players are expanding access to accurate NTM testing. Latin America represents about 6% of the market, led by Brazil, Mexico, and Argentina. Market growth is supported by public health campaigns and improved diagnostic capabilities, though infrastructure disparities in remote areas remain a challenge. Middle East & Africa comprise the smallest share, approximately 5% in 2023. While diagnostic capacity remains limited in many parts of the region, targeted investments in laboratory services and healthcare modernization—especially in the GCC and South Africa—are gradually improving market potential. Credence Research's Competitive Landscape Analysis Credence Research's Competitive Landscape Analysis presents a clear and focused view of key industry players in the NTM diagnostic segment with a spotlight on strategic strengths and market positioning: Credence Research identifies a handful of dominant multinational diagnostics firms—Thermo Fisher Scientific Inc., F. Hoffmann‑La Roche Ltd, Becton, Dickinson & Company (BD), and bioMérieux SA—as frontrunners in the global NTM diagnostic market. These companies differentiate themselves via wide-ranging product portfolios that encompass both molecular and immunological diagnostic tools. They cater to centralized laboratory settings and decentralized testing environments, ensuring flexibility across different healthcare infrastructures. Their strong investment in R&D, global distribution networks, and robust service support contribute to their sustained competitive edge and rapid product adoption. Through its analysis, Credence Research highlights how these industry leaders are not only maintaining market dominance but also expanding access to advanced NTM diagnostic solutions via collaborations, innovative product development, and targeted regional strategies—positioning themselves to capitalise on the projected market growth. Tailor the report to align with your specific business needs and gain targeted insights. Request Full Report Here- Key Player Analysis Thermo Fisher Scientific Inc Hoffmann-La Roche Ltd Becton, Dickinson and Company (BD) bioMérieux SA Bruker Corporation SD Biosensor Bioneer Seegene Inc. Recent Industry Developments June 2025 – Thermo Fisher Scientific introduced two advanced mass spectrometry instruments—the Orbitrap Astral Zoom and Orbitrap Excedion Pro—during the ASMS conference. Designed primarily for proteomics and biopharma applications, these systems deliver enhanced speed and sensitivity, significantly advancing the analysis of complex biological samples. Their improved resolution and throughput have potential applications in infectious disease diagnostics, including NTM-related testing. December 2024 – Shanghai MicuRx Pharmaceutical ( announced that the U.S. FDA granted Orphan Drug Designation (ODD) to its investigational anti-infective drug MRX-5 for the treatment of NTM infections, representing a significant step in developing targeted therapies for this condition. September 2023 – QIAGEN entered a strategic partnership with a major South Asian healthcare provider to integrate its proprietary diagnostics into regional laboratories, enhancing capabilities for detecting and managing NTM infections. August 2023 – bioMérieux expanded its infectious disease portfolio through the acquisition of a biotech company specializing in NTM diagnostics. July 2023 – Hologic, Inc. secured regulatory approval for a new diagnostic test specifically developed to identify NTM infections, reinforcing its commitment to infectious disease diagnostics. January 2022 – Gaelan Medical Trade LLC partnered with RedHill Biopharma Ltd. to distribute Talicia (omeprazole magnesium, amoxicillin, and rifabutin) in the United Arab Emirates. Though primarily approved for H. pylori, its components hold relevance in mycobacterial infection strategies. February 2021 – Koninklijke Philips N.V. completed the acquisition of BioTelemetry, Inc., a leader in remote monitoring and diagnostics, potentially expanding future integration of infectious disease tracking technologies. Reasons to Purchase this Report: Gain a comprehensive understanding of the market through qualitative and quantitative analyses, considering both economic and non-economic factors, with segmentation and sub-segmentation details provided in terms of market value (USD Billion). Identify regions and segments expected to experience the fastest growth or dominate the market, with a detailed analysis of geographic consumption patterns and the factors driving or hindering market performance in each region. Stay informed about the competitive environment, with rankings of major players, recent product and service launches, partnerships, business expansions, and acquisitions from the past five years. Access detailed profiles of major market players, including company overviews, insights, product benchmarking, and SWOT analysis, to understand competitive advantages and market positioning. Explore the present and forecasted market landscape, with insights into growth opportunities, market drivers, challenges, and constraints for both developed and emerging regions. Benefit from Porter's Five Forces analysis and Value Chain insights to evaluate various market perspectives and competitive dynamics. Understand the evolving market scenario, including potential growth opportunities and trends expected in the coming years. Browse the report and understand how it can benefit your business strategy - Discover additional reports tailored to your industry needs Ocular Drug Delivery System Market - Pharma Grade Synthetic Camphor Market - Topical Drug Delivery Market - Lidocaine Market - Dermatology and Eye Care Services Market - Metabolism Assays Market - Dental Implantology Drill Bit Market - Dental Implantology Drill Bit Market - Tetrabenazine Market - Follow Us: About Us: Credence Research is a viable intelligence and market research platform that provides quantitative B2B research to more than 2000 clients worldwide and is built on the Give principle. The company is a market research and consulting firm serving governments, non-legislative associations, non-profit organizations, and various organizations worldwide. 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