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Depression is a common mental illness, with continuous and long-term depression as the main clinical feature, severe cases will appear hallucinations, delusions, and even self-harm suicidal tendencies
.
According to a recent WHO report, there are more than 350 million people with depression worldwide
.
The new crown epidemic has greatly increased the incidence of depression in the world by 25%, of which nearly 1/3 of residents isolated at home will have varying degrees of depression, anxiety, insomnia and acute stress response, and more than 10% of people have not fully recovered to normal
after the outbreak of the epidemic.
The increasing patient demand has promoted the R&D, production, and update and iteration
of antidepressants.
At the same time, with the layout of more and more domestic enterprises, the domestic antidepressant market structure is also changing
.
1 Over 10 billion antidepressant market
1 Over 10 billion antidepressant marketAccording to the Blue Book of Depression in China 2022, there are up to 95 million people with depression in China, with an average of one in 14 people suffering from depression, and about 280,000 people commit suicide every year, of which 40% suffer from depression
.
However, due to the lack of awareness of depression, misconceptions and prejudices make patients reluctant to visit a psychiatric department
.
Surveys show that in China, only 2% of depressed patients have received treatment, and a large number of patients cannot be diagnosed and treated in time, their condition deteriorates, and even serious consequences
of suicide.
In order to solve this problem, the state has repeatedly issued relevant policies
.
In September 2020, the National Health Commission required that in 2022, the awareness rate of depression prevention and treatment knowledge in pilot areas should reach 80%, the rate of depression treatment increased by 50%, the treatment rate increased by 30%, and the recognition rate of depression by non-psychiatric hospital physicians increased by 50% in 2022
.
With the increasing attention of the country and society to psychological problems, people's understanding of depression is getting deeper and deeper, and the understanding of antidepressants is gradually increasing, and the corresponding scale of China's antidepressant market is also expanding
.
According to Huajing Industry Research data, the market size of antidepressants in China will be 10.
94 billion yuan in 2020, with a growth rate of 16.
01%.
At the same time, according to Frost & Sullivan, the market size will maintain a compound annual growth rate of 12.
7% from 2018 to 2022, reaching 18.
41 billion yuan
in 2022.
At present, there are more than 30 kinds of
antidepressants in the domestic market.
It is mainly divided into monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), serotonin reuptake inhibitors (SSRI), serotonin and norepinephrine reuptake inhibitors (SNRI), NE-specific 5-HT antidepressants (NaSSA), 5-HT receptor antagonism and reuptake inhibitors (SARIs), etc
.
Among them, SSRIs and SNRIs occupy almost all of the antidepressant market
.
The mechanism of action of SSRIs is mainly to act specifically on the 5-HT transporter, inhibit the reuptake of 5-HT, and thereby increase 5-HT in the synaptic cleft
The content improves the function of
5-HT.
SSRI has the characteristics of wide spectrum of antidepressant, strong applicability, high bioavailability, especially in the safety of medication has made great progress, patients accidentally overdose, will not cause serious consequences, especially for depressed patients with suicidal tendencies has special significance, has become a first-line antidepressant drugs
.
Representative drugs of SSRI are: paroxetine, fluoxetine, sertraline, citalopram, fluvoxamine and so on
.
A: Paroxetine B: fluvoxamine
SSRI stands for Drug Molecular Structure Source: References[1]
SNRI is characterized by a dual mechanism of action that specifically acts on 5-HT and NE, and its role in treating depressive behavior is mainly achieved
by changing the reuptake function of two neurotransmitters, 5-HT and NE.
Such drugs have a good therapeutic effect on various types of patients with depression, and have dose compliance, and the drug has the characteristics of poor affinity for the receptor site, which also greatly improves the safety and tolerability of
the drug.
Representative drugs of SNRI are: duloxetine, venlafaxine, milnacipran and so on
.
A: Venlafaxine B: Duloxetine
SNRI stands for Drug Molecular Structure Source: References[1]
SSRIs and SNRIs, as the top two antidepressant drug classes, together account for nearly 90% of the market share and are relatively stable
.
Among them, escitalopram, sertraline, venlafaxine accounted for half of the market size, and became the focus of
competition among pharmaceutical companies.
2 Domestic substitution is time
2 Domestic substitution is timeFor a long time, the domestic antidepressant market has been dominated
by international pharmaceutical giants represented by Pfizer, Lundbeck and Eli Lilly.
However, as the patents of original drugs expire one after another, generic drugs are listed in batches, domestic pharmaceutical companies continue to make efforts, and the market structure is being reshaped
.
In addition, since the 4+7 pilot of quantitative procurement in 2019, antidepressants have been included in the centralized procurement varieties
.
As of the seventh batch of centralized procurement, a total of 9 antidepressant drug varieties have been included, and 27 local enterprises have won bids, all of which are domestic generic drugs
.
Antidepressant drug collection varieties Source: References[2]
With the blessing of the normalization of collective procurement, some popular varieties have accelerated the realization of domestic substitution
.
Among the most competitive varieties are: escitalopram, agomelatine, sertraline and venlafaxine
.
Escitalopram is jointly developed and marketed by Lundbeck Pharmaceutical in Denmark and Forest Laboratory in the United States, approved by the FDA in 2002 for marketing in the United States, and entered the Chinese market in 2006, and is one of
the preferred antidepressant drugs.
At present, there are more than 31 domestic escitalopram approvals, and domestic generic drugs such as Jingwei Pharmaceutical and Kelun Pharmaceutical have gradually exceeded the market share
of the original drug.
Agomelatine is a new antidepressant drug developed by Servier, which was first approved for marketing in the European Union in 2009 and listed
in China in 2011.
In 2014, the first generic drug of agomelatine produced by Haosen Pharmaceutical was approved for marketing, and soon quickly occupied more than 90% of the domestic market share, and it was approved for supplementary application in August this year, becoming the first enterprise
to pass the evaluation of the product.
Sertraline was developed by Pfizer and approved by the FDA in 1991, and was approved to enter the Chinese market
in 1998.
At present, the market structure is mainly divided
by Pfizer, Jingxin Pharmaceutical and Huahai Pharmaceutical.
Venlafaxine was developed by Wyeth (later acquired by Pfizer), approved by the FDA in December 1993, and entered the Chinese market
in 2000.
At present, there are more than 43 domestic venlafaxine approvals, among which Kanghong Pharmaceutical Co.
, Ltd.
quickly seized the market with its first imitation identity, exclusive sustained-release tablets launched by dosage form innovation, and entered medical insurance class B with a lower price, forming a situation
of competition with Pfizer.
Driven by the volume procurement policy, while the price of antidepressants has dropped sharply, the market position of generic drugs and original drugs has been reshuffled
.
With the increasing number of antidepressant drugs over-evaluated, the first-mover advantage of original drugs is no longer obvious, and it is inevitable
that domestic generic drugs will replace the market position of original drugs.
3 Can new drugs disrupt the situation?
3 Can new drugs disrupt the situation?While the antidepressant market is undergoing internal exchange, new antidepressants from the outside are trying to bring about greater change
.
Current antidepressants still have certain physical or psychological side effects, which greatly limit their clinical research and widespread use, and a large proportion of patients are still resistant to existing therapies
.
Therefore, scientists are still constantly exploring new antidepressants
.
Among them, esketamine, Spravato nasal spray developed by Johnson & Johnson, which is different from existing depression therapies mostly acts on the serotonin signaling network, which helps repair the neural connections of brain cells in patients with depression by regulating glutamate receptor function, becoming the first FDA-approved drug
to reduce depressive symptoms within 24 hours.
The drug was approved by the FDA in March 2019 and submitted a marketing application in China in January this year and was accepted
.
AXS-05 is a novel oral N-methyl-D-aspartate (NMDA) receptor antagonist developed by Axsome in the United States, which has a different mechanism of action than most currently available depression drugs, it is composed of dextromethorphan and bupropion, and uses Axsome's metabolic inhibition technology
.
In April 2021, the FDA accepted AXS-05's NDA for the treatment of depression and granted it priority review status
.
Cariprazine is an atypical once-daily antipsychotic developed
by AbbVie.
Pharmacodynamic studies have shown that it may act as a partial agonist with high affinity for dopamine D3, dopamine D2, and serotonin 5-HT1A receptors
.
In February of this year, cariprazine submitted a supplementary new drug application to the FDA for adjuvant therapy for patients with major depressive disorder who are receiving antidepressant therapy
.
In terms of domestic antidepressant drug research and development, 14 drugs are currently in the approved clinical stage or above, involving more than ten enterprises
such as Tianlux, CSPC Pharmaceutical Group, Enhua Pharmaceutical, and Guangwei Pharmaceutical.
Among them, the fastest progress in research and development is Luye Pharmaceutical's Sulfaxine hydrochloride (LY03005).
This is a 5-HT, norepinephrine, and dopamine triple reuptake inhibitor
.
Compared with dual reuptake inhibitors, it helps to improve hedonia, cognitive performance, and sexual function
.
The marketing application of the drug was accepted
by the Drug Evaluation Center of the State Food and Drug Administration last year.
Research and development of antidepressants in China Source: References[3]
In addition, the 2018 issue of Nature
Genetics published a core paper, which found that depression is partly genetically determined by genome-wide association meta-analysis and identified 44 gene variants
that can cause depression.
This discovery could pave the way for the development of new and diversified antidepressant therapies, and more blockbuster antidepressants
may emerge in the future.
— Conclusion —
— Conclusion —Any glorious past passes with time, only change is eternal
.
With the improvement of the treatment rate of depression in China, China's antidepressant drug market will continue to expand
.
While domestic companies are seizing the market share of international pharmaceutical companies with the advantage of generic drugs, they have increased the research and development of a new generation of antidepressants, and it is expected to achieve comprehensive domestic substitution
in the future.
References:
References:1.
"Research Progress on the Pathogenesis of Depression and Antidepressant Drugs", China Medical Herald
2.
"Three years of the epidemic, 70 million new depressed patients!" Where are the incremental opportunities in the tens of billions of antidepressants market? , Xinkangjie, 2022-10-08
3.
"Sitting on 350 million patients - 10 billion antidepressant drug track inventory" E Pharmacy Academy, 2022-10-27
4.
"About 280 million patients worldwide! Janssen, AbbVie, Luye Pharmaceutical, etc.
are being developed, can these new anti-depressant drugs bring new breakthroughs? Guanlan, 2022-05-23
5.
"Antidepressant Drug Development and Domestic Market Analysis", Drug Times, 2021-4-22
