The global "ruxolitinib market" size was valued at US$ XX million in 2020 and is estimated to reach US$ XX million by 2028, growing at a CAGR of XX % during the forecast period (2022-2029).
Ruxolitinib is U.S FDA-approved drug for the treatment of myelofibrosis (a cancer of the bone marrow in which the bone marrow is replaced by scar tissue and causes decreased blood cell production). It is a kinase inhibitor.
Source: DataM Intelligence Analysis (2021)
The increasing incidence of myelofibrosis and the increased demand for the treatment of COVID-19 are expected to drive the global ruxolitinib market.
Increasing incidence of myelofibrosis is expected to drive the market growth in the forecast period
The prevalence of myelofibrosis is approximately 1 per 100,000 individuals worldwide. Myelofibrosis is a disease that affects the middle-aged and elderly population with a mean age of 60 years at diagnosis. Males are more commonly affected than females. The male to female ratio is approximately 1.5 to 1. In the United States, Primary myelofibrosis is an uncommon disease with an annual incidence of approximately 0.5-1.5 cases per 100,000 individuals.
Primary myeloﬁbrosis (PMF) is a clonal hematopoietic stem cell disorder classiﬁed as a myeloproliferative neoplasm. Most reports of clinical and laboratory features of persons with PMF are from whites from Europe and North America and include few Asians. Some studies suggest important differences between Asians and whites with hematologic neoplasms. For example, chronic lymphocytic leukemia is common among whites but rare in Asians. Others reported correlations between DNA haplotypes and the risk of myeloproliferative neoplasms. Based on these considerations, one might expect differences in PMF between whites and Chinese. For instance, ruxolitinib is an orally administered inhibitor of Janus kinases (JAK) 1 and 2 used in the management of patients with myelofibrosis. Clinical trials with ruxolitinib, notably the phase III COMFORT-I and -II studies and their extensions, have demonstrated marked and durable clinical benefits in terms of reductions in splenomegaly and disease-related symptoms in patients with intermediate-2 or high-risk myelofibrosis. Hence, the increasing prevalence of myeloﬁbrosis is expected to boost the use of Ruxolitinib.
The increasing demand for ruxolitinib for the treatment of COVID-19 is expected to drive the global ruxolitinib market
Since the outbreak of the novel coronavirus, SARS-CoV-2 has created massive global health and economic problems. COVID-19 is the disease caused by SARS-CoV-2. In most cases, COVID-19 is associated with mild respiratory symptoms. In 15% of the patients, however, hospitalization is required and about 5% of patients develop severe lung injury that can result in acute respiratory distress syndrome. Acute respiratory distress syndrome may be accompanied by septic shock, sepsis, and multiorgan failure including cardiac injury and acute kidney injury.
COVID-19 patients with the heavy inflammatory syndrome were treated successfully with ruxolitinib. As COVID-19 induces a significant burden to societies worldwide, appropriate treatment for COVID-19 associated acute respiratory distress syndrome would be beneficial. However, in the patients treated with ruxolitinib, only one patient was mechanically ventilated before the start of ruxolitinib. In patients, ruxolitinib not only potently reduced ARDS-associated inflammatory blood cytokine levels such as IL-6 and the acute phase protein ferritin but was also associated with cardiac improvement, rapid respiratory and clinical stabilization. Based on the close temporal association between the ruxolitinib start and clinical response, it is tempting to speculate that JAK1/2-inhibition effectively contributed to the favorable clinical course. Importantly, the virus load as determined by PCR did not increase in patients during ruxolitinib treatment. Artificial intelligence and pre-clinical studies have recently suggested that baricitinib, a numb associated kinase (NAK) and JAK1/2-inhibitor, inhibits clathrin-mediated endocytosis and thereby antagonizes SARS-CoV-2 infection of cells. Thus, besides ruxolitinib, baricitinib, which is approved in treating rheumatoid arthritis, is another promising candidate with significant potential in treating COVID-19 disease. However, since baricitinib may not penetrate lung tissue, it is hypothesized that it might be less effective in COVID-19-associated ARDS.
Drawbacks associated with the drug is expected to hamper the global ruxolitinib market
Commonly reported side effects of ruxolitinib include: anemia, balance impairment, dizziness, headache, labyrinthitis, Meniere's disease, neutropenia, thrombocytopenia, vertigo, and orthostatic dizziness. Other side effects include weight gain and flatulence. Ruxolitinib may interact with many types of medications. Though ruxolitinib treatment was shown to be safe among COVID-19 patients with severe systemic hyper inflammation, it failed to demonstrate a significant reduction in the proportion of COVID-19 patients who experienced death, respiratory failure requiring mechanical ventilation, or admission to the intensive care unit in Phase III trial. For instance, before starting ruxolitinib treatment, patients should make sure to tell the doctor about any other medications they are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).Should not receive any immunization or vaccination without doctor's approval while taking ruxolitinib. Inform health care professionals if they are pregnant or may be pregnant prior to starting this treatment. For both men and women should not conceive a child while taking ruxolitinib.
Supply Chain Analysis:
The healthcare industry has been affected by COVID-19. To stop its growth, government-imposed lockdown. People are fearful they might get affected by Covid. All the manufacturing, as well as supply chains, have been hit due to the COVID-19 restrictions. Treatment with ruxolitinib was shown to be safe among COVID-19 patients with severe systemic hyper inflammation, it failed to demonstrate a significant reduction in the proportion of COVID-19 patients who experienced death, respiratory failure requiring mechanical ventilation, or admission to the intensive care unit in Phase III trial. Hence, the global ruxolitinib market is expected to be impacted by COVID-19.
15 mg tablets segment is expected to dominate the global ruxolitinib market
Jakavi is indicated for treating disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythemia vera, or post essential thrombocythaemia myelofibrosis. Approximately 15.0 x 7.0 mm ovaloid curved white to almost white tablets with “NVR” debossed on one side and “L15” on the other side. Ruxolitinib when administered with strong CYP3A4 inhibitors or dual inhibitors of CYP3A4 and CYP2C9 enzymes, by approximately 50% the unit dose of ruxolitinib should be reduced to be administered twice daily. Daily with fluconazole doses greater than 200 mg avoid the concomitant use of ruxolitinib. More frequent monitoring of hematology parameters and clinical signs and symptoms of ruxolitinib-related adverse drug reactions is recommended while on strong CYP3A4 inhibitors or dual inhibitors of CYP2C9 and CYP3A4 enzymes.
For instance, the recommended starting dose of ruxolitinib in MF is 15 mg twice daily for patients with a platelet count between 100,000/mm3 and 200,000/mm3 and 20 mg twice daily for patients with a platelet count of >200,000/mm3. 15mg Jakavi tablet is used in the treatment of chronic idiopathic myelofibrosis and Polycythemia vera. Polycythemia vera is a type of blood cancer that causes excessive production of red blood cells. This may lead to blood clot formation and lead to other serious health issues. Jakavi 15mg tablet kills or stops cancer cells' growth and prevents the multiplication of cancer cells. It is an effective yet toxic medicine, and patients should discuss the risks and benefits with the doctor. Avoid drinking smoking or alcohol while having this treatment, and drink plenty of water to stay hydrated.
The moderate Risk Myelofibrosis segment is expected to dominate the global ruxolitinib market
Myelofibrosis (MF) is a rare disorder of the bone marrow characterized by excessive reticulin and collagen fibers. MF includes primary MF (PMF), post-essential thrombocythaemia (post-ET) MF, and post-polycythemia vera (post-PV) MF. Among the Philadelphia chromosome-negative chronic myeloproliferative neoplasms (MPNs), MF is the most symptomatic and carries the worst prognosis. According to epidemiological studies, it is estimated that the incidence of MF may be as high as 1.5 per 100,000 individuals. In clinical series, the median age at diagnosis for the majority of patients was 65 years. In total, ∼22% of the cases occur in patients younger than 56 years old and 11% in patients younger than 46 years old. Other studies indicate that 10–15% of cases may transform into secondary MF by the end of the second decade after PV or ET diagnosis. Ruxolitinib has been approved for the treatment of MF patients in 101 countries, and also it has been approved for the treatment of PV patients in more than 75 countries. At present, FDA has only approved Ruxolitinib for the treatment of moderate to high-risk MF patients.
North America is expected to hold the largest market share in the global ruxolitinib market
Myelofibrosis is a rare condition, with about 1.5 cases reported per 100,000 people each year in the United States. It occurs in both men and women. People of any age can have myelofibrosis, although it is more likely to be diagnosed in people over age 50. With the increasing incidence of the disease is expected to fuel the demand for Ruxolitinib. For instance, in patients with intermediate and high-risk myelofibrosis, ruxolitinib is an approved oral JAK1/2 inhibitor based on its proven spleen and symptom burden reduction. Its impact on hematopoietic stem cell transplantation (HSCT) outcomes is largely unknown, however. A significant number of patients proceeding to HSCT have been treated with ruxolitinib.
Incyte announced the U.S. Food and Drug Administration (FDA) had extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) for the treatment of adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD).
Source: DataM Intelligence Analysis (2021))
The global ruxolitinib market is highly competitive with drug launches, FDA approvals, and company mergers. Major key players in the global ruxolitinib market are Novartis, DCS Pharma AG, Concert Pharmaceuticals, Incyte Corporation, Innovent Biologics Inc
Overview: Novartis International AG is a Swiss-American pharmaceutical corporation with headquarters in Basel, Switzerland, and Cambridge, Massachusetts, in the United States. Novartis products reach nearly 1 billion. About 125 000 people of more than 140 nationalities work at Novartis around the world.
Product Portfolio: The company's pipeline drug Jakavi (ruxolitinib) significantly improved outcomes in patients with steroid-refractory/dependent chronic graft-versus-host disease (GvHD) in its Phase III clinical trials.
Key Development: On December 14th, 2020, Novartis announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint.
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