We Lifescience Intellipedia is one of the largest pharmaceutical markets in the world. The COVID-19 impact, an ageing population and increasing chronic disease cases have drawn the attention of the Japanese government to the healthcare sector. Observing the difficulties faced in developing vaccines to combat the COVID-19 pandemic, Japan has given top priority to the research of novel drugs and vaccines.
The branded drug market in Japan experienced significant
developments and transformations from 2020 to 2022. Over the years, the
Pharmaceuticals and Medical Devices Agency (PMDA), has been actively involved
in accelerating the approval timelines for new drugs and medical devices.
As per reports, in the fiscal year 2020–2022, PMDA approved
approximately 148 novel drugs across various therapeutic categories. These new
drug approvals provided patients with access to advanced treatment options and
contributed to addressing unmet medical needs.
Pharmaceutical companies, including global players like Novartis, Pfizer, Sanofi and Takeda received
the majority of PMDA approvals for the innovative drugs.
1) Novartis Pharma KK: Overall,
Novartis obtained approval for seven drugs across different therapeutic areas:
·
Immunology;
Pulmonary and Respiratory Disease -2
·
Immunology;
Nervous System Disease– 2
·
Cardiology-
1
·
Hematology;
Oncology -1
·
Oncology–
1
The novel drugs Entresto, Scemblix and
Tabrecta are the
medications authorised for use in the therapeutic fields of cardiology, hematology;
oncology and oncology respectively. Atectura
and Enerzair were approved in the
therapeutic category of immunology; pulmonary and respiratory disease, while Kesimpta and Mayzent were approved in the therapeutic category of immunology;
nervous system disease.
According
to reports, Novartis blockbuster drugs Entresto and Kesimpta showed strong performance and generated sales of USD 4,644
million and USD 1,092 million
respectively in FY 2022.
The PMDA approved Kesimpta on March 23, 2021. It is the
first B-cell targeted therapy that can be self-administered subcutaneously at
home to treat multiple sclerosis. Strong launch uptake, rising demand and its approval
in almost 80 countries were the main drivers of the drug's increased sales. On June
29, 2020, Enteresto received approval for the treatment of patients with chronic
heart failure. The reasons for its growth in the past two years may include continued
strong demand and an increase in patient share across all markets.
2) Pfizer Japan Inc: Pfizer got PMDA approval
across the therapeutic categories of:
·
Infection
& Infectious Disease – 3
·
Cardiovascular
Disease -1
·
Congenital
and Hereditary Disease; Dermatology -1
·
Endocrinology;
Musculoskeletal Disease -1
·
Nervous
System Disease -1
3)
Sanofi KK: Sanofi received PMDA approval across:
·
Congenital
and Hereditary Disease -2
·
Hematology-2
·
Cardiovascular
Disease; Oncology -1
·
Endocrinology
-1
·
Infection
& Infectious Disease – 1
4)
Takeda Pharmaceutical: Along
with Novartis, Pfizer and Sanofi, Takeda also obtained PMDA authorization for
seven drugs:
·
Infection
& Infectious Disease-2
·
Oncology-2
·
Cardiovascular
Disease: Congenital and Hereditary Disease-1
·
Digestive
System Disease- 1
·
Nervous
System Disease- 1
The other giant players, like Bayer Yakuhin and MSD KK, received the
second-highest PMDA drug approval with six approvals each, while AstraZeneca and Chugai Pharma received
the third-highest PMDA drug approval with five approvals apiece.
Top Therapeutic Areas in
2020–2022
In the years between 2020 and 2022, PMDA Japan authorised
innovative medications in 47 therapeutic categories. The highest number of
approvals were given in the therapeutic areas of infection and infectious
disease (17 approvals), oncology (16 approvals) and nervous system disease (11
approvals).
The treatment fields related to immunology; pulmonary and
respiratory diseases, nutrition and metabolic disease, nervous system disease;
oncology, endocrinology; musculoskeletal disorders, etc. received the fewest
approvals.
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