If the competition of ordinary generic drugs is already a red ocean, then long-acting injections with unique clinical advantages, high technical barriers and high value-added can enable enterprises to avoid homogeneous competition to a large extent, but also because of the difficulty of its research and development and industrialization, the number of players in the domestic and global range has not shown a blowout, and the road of long-acting injections is still continuing.
01 Widely used in clinical practice
As a complex formulation, long-acting injectables are a class of long-acting sustained-release formulations in which a sufficient amount of drug is injected into the body and slowly released to allow the drug to continue to produce treatment. Compared to traditional dosage forms, long-acting injections reduce fluctuations in drug concentrations and achieve smooth drug release, while improving patient compliance by reducing the frequency of dosing, making them ideal for managing chronic conditions (such as schizophrenia, alcohol, or opioid abuse) that require frequent repeat dosing. In addition, because long-acting injections belong to the parenteral administration system, they can avoid the first-pass effect of the gastrointestinal tract, improve the bioavailability of the drug, and reduce other adverse reactions such as liver and kidney toxicity, which has broad clinical application prospects.
Among them, long-acting injections have been used in the field of psychiatric diseases for many years, and the first long-acting intramuscular antipsychotic drug Fluphenazine Enanthate was approved in 1966. First-generation antipsychotic long-acting injections are oil-based preparations in which an adequate dose of the drug is combined with an oily liquid to make an oily solution or suspension injection, and the antipsychotic is esterified to form a prodrug, which has significantly increased solubility in the injectable oil. Once the drug dissolved in an oily carrier is injected into the muscle, it forms a small reservoir in situ from which the drug is slowly released.
Second-generation antipsychotic long-acting injections work by blocking the activity of the chemicals dopamine D2 and serotonin (5-HT2A receptors) than typical antipsychotics, and are more selective for the midbrain limbic system than for the striatum system, causing less pyramidal syndrome. Second-generation antineurological drugs include benzodiazepines (clozapine, quetiapine, olanzapine) and benzisooxazoles (such as risperidone, ziprasidone), among which the long-acting formulations are risperidone microspheres, paliperidone palmitate, aripiprazole, and olanzapine, all of which have been in the market for many years, and have not even competed with generic drugs for a period of time.
In addition to decades of extensive clinical application in the field of psychiatric diseases, long-acting injections have also made great achievements in the field of anti-tumor, HIV and other diseases, especially Cabenuva, which has been approved in recent years, which is the first FDA-approved complete injection regimen for HIV-infected adult patients, and the approved regimen is administered once a month. The drug consists of rilpivirine and cabotegravir. Rilpivirine is an oral, non-nucleoside reverse transcriptase inhibitor. Cabotegravir is an integrase inhibitor that works by inhibiting the integration of viral DNA into the genome of human immune cells, and the approval of Cabenuva also represents the beginning of the era of long-acting HIV treatment, with three-month and six-month long-acting HIV injections currently in development. In addition, long-acting injections have shown great potential in the treatment of chronic diseases such as Parkinson's and Alzheimer's disease, but it will take time to confirm.
02 Market size of long-acting injections
According to data, the global long-acting injectable market is expected to grow from US$1.06 billion in 2023 to US$4.62 billion in 2035, with a compound annual growth rate of 13.1%. Although the market prospect is good and the com...
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