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The clock is ticking
.
By 2025, multiple "blockbuster" drugs will face huge sales losses due to the loss of patent exclusivity, a loss of up to $92 billion a year, and the patent cliff is approaching
.
Taking "drug king" Humira as an example, a key patent for the product in the United States will expire in 2023, when Humira biosimilars will be launched in the United States, or will directly affect the annual performance
of its "boss" AbbVie.
Cotellis estimates that Humira's sales in the U.
S.
were $17.
3 billion in 2021, falling to $13.
9 billion in 2023 and possibly to $1.
4 billion
by 2028.
While pharmaceutical companies can supplement their pipelines with innovative drugs and therapies, the pace of drug and therapy approvals in key markets has slowed
.
One set of data shows that the number of NME/BLAs approved by the FDA in 2022 decreased by 25%
compared to 2021.
In a recent survey, 53 percent of pharmaceutical and life sciences CEOs bluntly stated that "regulatory changes are a major disruption to their businesses.
"
However, even so, there are still many pharmaceutical companies that are gearing up and launching new technologies or treatment methods to "escort"
the future R&D pipeline.
The patent cliff looms, and the regulatory environment is increasingly uncertain.
.
.
The pharmaceutical industry is on the cusp of a storm, who can be the next generation successor of "blockbuster drugs"? Recently, Clarivate released the "Most Notable Drug Predictions for 2023"
.
The report predicts 15 late-stage clinical-stage drugs that are expected to be "blockbusters" and/or treatment paradigm-changing ("blockbusters" are defined as drugs that typically generate $1 billion in annual sales) within five years, including drugs that enter the market or launch critical indications in 2023 and are expected to be blockbusters by 2027, as well as drugs
that could change clinical treatment patterns and benefit millions of patients worldwide.
The Most Interesting Drug Predictions for 2023 focuses not only on blockbuster drugs and biologics, but also on those that have the potential to change the paradigm of treatment, even if forecasts show annual sales of less than $1 billion
.
01 Areas such as self-immunity and inflammation are the main plays
01 Areas such as self-immunity and inflammation are the main playsWhat are the characteristics of the Top15 global blockbuster and disruptive drugs in 2023?
According to the 2023 Most Interesting Drug Predictions list, it consists almost entirely of precision medicine and therapies targeted by specific biomarkers to ensure improved efficacy
.
These drugs cover a wide range of diseases from rare to difficult diseases, including AIDS, Parkinson's disease, Crohn's disease, alopecia, multiple myeloma and breast cancer
.
From the perspective of development companies, the drugs that entered this list include global pharmaceutical giants,
You can see the figures of AstraZeneca, GSK, Bristol-Myers Squibb, AbbVie, Eisai/Biogen, Eli Lilly, Gilead, Pfizer and other well-known MNC, of which Eli Lilly has two products listed; In addition, leading biotech companies will also contribute 1/3, such as Biomarin and Travere Therapeutics
.
From the perspective of target and therapeutic field, novel therapies include polydermal (circumcloven), biclonal antibodies, and gene therapy; In addition, oncology remains a key focus in the pharmaceutical industry, with the emergence of more weighty and disruptive drugs in autoimmunity and inflammation, metabolism-related and neurological fields, which will dominate in 2023
.
As far as psoriasis in the field of self-immunity is concerned, two treatment products are on the list, namely Bimekizumab of Uniratio and Deucravacitinib
of BMS.
It is worth mentioning that these two drugs are also the only blockbuster
drugs among the 15 products with expected sales of more than $2 billion in 2027.
Speaking of Bimekizumab, it is highly likely to be a strong latecomer to Humira, the first NICE-approved drug to be launched in 2021, becoming the first IL-17 to treat moderate to severe plaque psoriasis
A/F dual inhibitors
.
The decision is based on clinical trial evidence that Bimekizumab is more effective than NICE's previously approved three competing drugs, including Albervi Merlot, Johnson & Johnson ustekinumab, and Novartis Sekizumab
.
At present, Bimekizumab has been approved by multiple regulatory agencies such as the European Union, the United Kingdom, Canada, Australia, and Japan, and is expected to be approved by the FDA in
2023.
The report said that the Bimekizumab patent is expected to expire from 2027, and by 2027, the product's expected sales of $2.
045 billion, becoming a blockbuster
.
Another "potential blockbuster" in this field is Deucravacitinib of BMS, a first-of-its-kind oral targeted drug that selectively inhibits tyrosine kinase
2 (TYK2)
, or fill in gaps in plaque psoriasis treatment
.
Following the FDA's approval of Deucravacitinib in September 2022, approval is expected in Europe and Japan as well
.
For patients with symptomatic moderate to severe plaque psoriasis, safe and effective oral therapy remains an unmet need
.
Apremilast, a commercially available oral targeted therapy, is not as effective as biologics, but the launch of Deucravacitinib fills this gap
.
The product's expected sales in 2027 are slightly higher than Bimekizumab's at $2.
12 billion, and its patents are expected to expire
starting in 2033 。 In addition, there is Daprodustat, developed by GSK
(GSK1278863/Duvroq) for the treatment of anemia associated with chronic kidney disease (CKD); Mirikizumab developed by Eli Lilly
(LY-3074828), which is for IL-23
P19 submonoclonal antibody may become the first drug for the treatment of ulcerative colitis, and it is also the third drug approved for the treatment of Crohn's disease and other drugs on the list.
.
.
02 Two types of Alzheimer's disease are listed
02 Two types of Alzheimer's disease are listedThe field of neurology is also favored, and potential blockbuster drugs
are bursting out one after another.
The three drugs for Alzheimer's disease and Parkinson's disease are expected to be approved in major markets such as the United States and the European Union in 2023, and may affect tens of millions of target patients in the five years from 2023 to 2027
.
Among them, two Alzheimer's disease drugs are prominently listed, Eisai/Biogen's Lecanemab and Eli Lilly's Donanemab
.
For a long time, the field of Alzheimer's disease has been the hardest hit area for new drug research and development, with a clinical failure rate of 99.
6%, which can be called a research and development black hole
.
Pharmaceutical giants such as Johnson & Johnson, Pfizer, Eli Lilly, and Roche have folded here, and the difficulty of new drug research and development can be seen
.
Because of this, the research and development of new drugs in this field has been attracting attention
.
Biogen Aduhelm, which went on the market as early as 2021, has experienced several setbacks due to its clinical efficacy data and other issues, experiencing a series of problems
such as restricted use, dismal sales performance, and the dissolution of the sales team.
However, this did not dampen the enthusiasm
of latecomers.
At the beginning of 2023, following Aduhelm, the next-generation anti-Aβ monoclonal antibody Lecanemab was approved by the FDA for marketing with the support of a landmark Phase II clinical trial data, becoming the second Aβ monoclonal antibody approved for the treatment of Alzheimer's disease
in the world.
Compared to Eisai/Biogen Lecanemab, Eli Lilly Donanemab is relatively slower
.
In June 2021, it received breakthrough therapy designation from the FDA, and in August 2022, the FDA accepted its application for marketing authorization for biological products and granted it priority review status for accelerated approval for the treatment of early Alzheimer's disease
.
In November 2022, Eli Lilly announced TRAILblazer-ALZ, a phase III study of Donanemab for the treatment of early-stage Alzheimer's disease (AD).
4 All primary and secondary endpoints
were met in the 6-month analysis.
Donanemab is expected to be available in the U.
S.
in 2023 and in Japan and Europe in 2025
.
By 2027, Lecanemab expects sales of $1.
02 billion and Donanemab expects sales of $1.
34 billion
.
AbbVie's ongoing development of Foscarbidopa/Foslevodopa, a new formulation of the gold standard Parkinson's disease treatment (carbidopa/levodopa) administered by a subcutaneous pump for the treatment of fluctuating
motor symptoms in patients with advanced Parkinson's disease.
In May 2022, the drug submitted a marketing application to the FDA, and is expected to be marketed in the United States, Europe and Japan in 2023, with expected sales of $880 million in 2027 and expected patent expiration
from 2039.
If listed at the time of the forecast, Foscarbidopa/Foslevodopa
It will be the first subcutaneous carbidopa/levodopa drug on the market, which can address the obvious shortcomings of DUOPA/DUODOPA, such as surgical requirements, complications.
In addition to being available for a niche patient population with highly unmet needs, Foscarbidopa/Foslevodopa offers superior efficacy over oral carbidopa-levodopa, flexibility in administration, and the use of subcutaneous pumps that are more convenient than existing and upcoming competitors
.
However, it is worth noting that despite Foscarbidopa/Foslevodopa
It will be the first to enter the market, but its competitors include other subcutaneous pumps such as those made by NeuroDerm Ltd
The products are expected to be available in
mid-2024.
The expected high pricing may also limit patient use and purchase
of Foscarbidopa/Foslevodopa.
Equally worrisome is the fact that completed phase III trials have reported higher
discontinuation rates of Foscarbidopa/Foslevodopa.
03 "Bombshell" favors the field of rare diseases
03 "Bombshell" favors the field of rare diseasesThe field of rare diseases has also begun to make efforts, with three of the 2023 Top 15 global blockbuster and disruptive drugs targeting rare diseases, such as the type A hemophilia drug Valoctocogene
Roxaparvovec, paroxysmal nocturnal hemoglobinuria
(PNH) drug Pegcetacoplan, IgA rare kidney disease drug TARPEYOTM
.
Pegcetacoplan, developed by Apellis Pharmaceuticals, is available in the United States and Europe for the treatment of paroxysmal nocturnal hemoglobinuria (PNH),
a rare blood disorder.
As one of the few drugs to complete the Phase III trial of GA, Pegcetacoplan is expected to be the first treatment for map atrophy
(GA) or "age-related macular degeneration" medications
.
For GA or age-related macular degeneration, there are currently no approved drugs for the treatment of these diseases
.
Since its launch in the U.
S.
in May 2021 for the treatment of PNH, subcutaneous injection Pegcetacoplan achieved sales of $15.
1 million
in 2021.
Sales of Pegcetacoplan for the treatment of PNH will increase in the coming years as it is approved in other countries around the world, but it is expected that sales of Pegcetacoplan for the treatment of PNH may be lower
Pegcetacoplan is used to treat GA sales
.
If marketed at the predicted time, Pegcetacoplan would be the first drug on the market for the treatment of GA
.
Expected sales for the treatment of GA in 2027 are $1.
312 billion
.
Valoctocogene roxaparvovec, developed by BioMarin Pharmaceuticals, the drug
Approved by the European Commission in August 2022, it is also expected to be the first gene therapy
to be launched in the United States to treat severe hemophilia A.
Treatment benefits are expected to last for several years, with expected sales of $1.
09 billion
in 2027.
However, to achieve "bombshell" status, the product may need to overcome some obstacles, and many factors may affect it
Valoctocogene
whether roxaparvovec can be widely adopted in the target population, including whether safe and effective therapies exist; Limited to patients over 18 years of age, etc
.
In addition, the combination of loss of effectiveness, unpredictable and variable responses to treatments by individuals, and lack of long-term safety data may discourage patients and physicians from using novel gene therapies and make payers hesitant to cover this novel gene therapy
.
Coverage may depend on a range of preset conditions, and the patient's out-of-pocket portion may be higher
.
Sparsentan is an oral single-molecule first-in-class new drug that targets IgA nephropathy and FSGS, promising to halt the progression of the disease in many patients and fill gaps in treatment, said Biotech company Travere
Therapeutics
Inc
.
IgAN is a rare kidney disease that is a major cause
of end-stage renal disease (ESKD).
In February 2021, the European Commission granted orphan drug designation to Sparsentan for the treatment of IgA nephropathy, which is expected to be approved for marketing
in the United States and the European Union in 2023.
The expected sales of the drug in 2027 are $810 million
.
However, Sparsentan is not the first drug specifically for the treatment of IgA nephropathy, and the first commercial drug specifically for IgA nephropathy is TARPEYOTM, which received FDA approval through the accelerated approval route in early 2022
.
Due to the different mechanisms of action, it remains to be seen whether Sparsentan and TARPEYO will compete in the same IgA nephropathy market
.
Note: Some of the data is from Clarivate's "Most Interesting Drug Predictions for 2023"
