Market Overview
The global hemophilia market size was worth $ 11,487.8 million in 2019 and is estimated to reach US$ 23,118.2 million by 2027, at a CAGR of 9.4% during the forecast period (2020-2027).
Hemophilia is an inherited bleeding disorder in which a person lacks or has low levels of certain proteins called "clotting factors" and the blood doesn't clot properly as a result. This leads to excessive bleeding. There are 13 types of clotting factors, and these work with platelets to help the blood clot. Platelets are small blood cells that form in your bone marrow. According to the World Federation of Hemophilia (WFH), about one in 10,000 people are born with this disease.
People with hemophilia bleed easily, and the blood takes a longer time to clot. People with hemophilia can experience spontaneous or internal bleeding and often have painful, swollen joints due to bleeding into the joints. This rare but serious condition can have life-threatening complications.
The extent of the symptoms depends on the severity of your factor deficiency. People with a mild deficiency may bleed in the case of trauma. People with a severe deficiency may bleed for no reason. For instance, the NHF (National Hemophilia Foundation) allows to find treatments for inheritable bleeding disorders and help prevent complications of these disorders through research, education, and advocacy. Their programs and initiatives are in association with the Centers for Disease Control and Prevention.
Market Dynamics
Drivers
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Increasing number of incidences of bleeding disorders
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Rising awareness of early diagnostics
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Increase in R&D and new product development
Restraints
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High cost of hemophilia medications
Market Segmentation
The gene therapy segment is one of the emerging fields especially in identifying the defective DNA bases and restoring with the functional ones. Gene therapy for hemophilia involves using a modified virus (which does not cause disease) to introduce a copy of the gene that encodes for the clotting factor that’s missing in patients. Following treatment with the virus, patients should begin producing their own clotting factor normally.
The market for gene therapy in hemophilia is likely to reach USD 7,036.4 million in 2027, from its recorded value of USD 3,841.7 million in 2019, growing at a CAGR of 8.0% during the forecast period.
AMT-060 is a potential therapy developed by the UniQure for the treatment of type B and is under clinical trials. The therapy works by restoring production of factor IX in patients by delivering a functional copy of the factor IX gene into the liver cells of patients with type B.
AMT-061 is uniQure’s second gene therapy candidate for patients with hemophilia B. It is developed to deliver a variant of the F9 gene that encodes for clotting factor IX called FIX-Padua.
FLT180a is a gene therapy being developed by Freeline. A Phase 1 clinical trial (NCT03369444) is currently recruiting patients with hemophilia B in the U.K. to test FLT180a.
Sangamo Therapeutics is developing a genome editing therapy for hemophilia B called SB-FIX. A Phase 1/2 clinical trial (NCT02695160) is currently recruiting participants at several sites in the U.S. and the U.K.
Fidanacogene elaparvovec (SPK-9001) is a treatment for hemophilia B being developed in a partnership between Spark Therapeutics and Pfizer. This therapy is currently being investigated in a Phase 2 clinical trial (NCT02484092).
SPK-8011 is a gene therapy for hemophilia A being developed by Spark Therapeutics. Spark Therapeutics is developing another gene therapy called SPK-8016, which is designed to help hemophilia A patients who have developed inhibitors against their own clotting factors.
Geographical Analysis
Asia-Pacific is growing at the CAGR of 9.5% during the forecast period (2020-2027).
The Asia-Pacific market is estimated to grow at a CAGR of 9.5% during the forecast period (2020-2025) to reach a market value of USD 5,772.1 million by 2027.
Asia-Pacific is anticipated to witness the fastest growth over the forecast period. Early diagnosis of the diseases in countries including Japan, India, Indonesia, and Malaysia and rising per capita use of therapies for factor VIII and IX deficiency are the vital impact rendering drivers.
Furthermore, the booming medical tourism industry in countries such as India, China, and Malaysia are expected to boost demand for the treatment. These factors stimulate market growth over the forecasted period in the region.
Moreover, Hemophilia A is a common blood disorder and the prevalence rate is high in developing and underdeveloped regions. As per the recent statistics, around 20,000 people in India suffer from hemophilia and only 15% of the patients are registered. Increase in the number of people suffering from hemophilia A and rise in awareness among the people regarding the treatment and medications of hemophilia will result in rise in demand and adoption rate of hemophilia drugs, fueling the business growth.
In addition, the growing R&D activities in the field of biotechnology for clotting, factors especially on identifying therapeutic agents is the major factor driving the growth for the market. The main cause of hemophilia is mutation in of the genes which is responsible for providing the instructions for making the coagulation factor needed to form a blood clot.
Competitive Landscape
Bayer Healthcare, Biogen, Biotest AG, CSL Behring, Genentech, Kedrion, Novo Nordisk, Octapharma, Pfizer, Sanofi SA, are the leading market players with significant market share.
The companies are heavily investing in the market to develop new products and are collaborating and acquiring other companies which help in increasing their market share and will also strengthen the R & D. For instance,
In February 2020, Novo Nordisk announced the launch of ESPEROCT, a long-acting recombinant factor VIII product from the company for the prevention & treatment of bleeding in common individuals with hemophilia A. This new therapy has been specifically indicated for the routine prophylaxis in order to reduce the frequency of bleeding episodes, control of bleeding episodes, on-demand treatment, and perioperative management of bleeding.
In April 2019, Roche launched Emicizumab under the brand name Hemlibra in India for preventive treatment of Hemophilia A, an inherited disorder in which a person's blood does not clot properly. Hemlibra is the first weekly subcutaneous prophylaxis injection shown to prevent or reduce the frequency of bleeding episodes and improve the quality of life. The introduction of Emicizumab (Hemlibra) is a significant milestone in the treatment of Hemophilia A in India.
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