Market Place
The pharma industry clearly recalibrated itself in 2023, turning its focus away from Covid and onto two of the biggest threats to human health – obesity and cancer. The top lines of the major pharma companies reflect this shift in focus.We
always knew that Pfizer’s record US$ 100 billion revenue for 2022 wasn’t sustainable. Even though Pfizer’s 2023 sales were lower by nearly 42 percent against its 2022 sales, the New York-headquartered drugmaker managed to retain its pole position. The two main reasons behind its ‘top of the charts’ sales of US$ 58.5 billion were Pfizer’s record nine new molecular entity approvals by the US
Food and Drug Administration (FDA) and the launch of its vaccine for
respiratory syncytial virus (RSV).Johnson & Johnson came second with sales of US$ 54.8
billion (excluding its consumer business and MedTech units). AbbVie took bronze despite Humira being subject to biosimilar competition
and Merck maintained its fourth position. Roche nabbed the fifth position from Novartis (which stood sixth). Bristol Myers Squibb maintained its position at seven, as did
AstraZeneca (eighth) and Sanofi (ninth). And Eli Lilly bumped into the tenth spot, knocking out
GSK.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available)Keytruda, Eliquis, Humira top charts; Novo’s Ozempic debuts top 10 list at number fourMerck’s Keytruda became the number one selling drug in the world, a position that was held
by AbbVie’s Humira for long, and Pfizer’s Comirnaty in the Covid years. This
oncology drug raked in a whopping US$ 25 billion, with sales increasing 19 percent last
year. In fact, Keytruda accounted for 46.7 percent of Merck’s pharmaceutical sales, which grew 3 percent in 2023 to US$ 53.6 billion.At number two was
Pfizer and BMS’ anticoagulant Eliquis — it posted global sales of US$
18.95 billion (marking a
growth of 4
percent on 2022 sales). With
competition from generics, Humira’s sales fell by 32 percent to US$ 14.5 billion. As a result, this
blockbuster anti-rheumatic drug fell to the third rank.The
fourth spot was taken up by Novo Nordisk’s Ozempic, the wonder drug that treats type 2
diabetes. Gilead’s Biktarvy, a med that treats HIV-1, saw sales jump 14 percent — from US$ 10.39 billion posted in 2022 to US$ 11.85 billion last year. This way, Biktarvy emerged as
the fifth largest selling drug of 2023.At
number six was Sanofi and Regeneron’s Dupixent. This allergic diseases med posted
11-figure sales in 2023, netting € 10.72 billion (US$ 11.59 billion) globally, a growth of 34 percent over
2022 numbers.At
number seven was J&J’s biggest blockbuster immunology drug Stelara that raked in US$ 11.3 billion in 2023. Coming a close eighth was Pfizer-BioNTech’s Covid-19 vaccine Comirnaty — its sales fell by over 70 percent to US$ 11.22 billion in 2023. At the ninth spot was Lilly and Boehringer’s diabetes drug Jardiance that saw a 27.7 percent increase in
total global sales at US$ 10.6 billion. And rounding off the list at number 10
is BMS’s Opdivo, a Keytruda rival. Opdivo hauled in US$ 10 billion
in total global sales in 2023, a year-on-year increase of 8 percent.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available)Driven by diabetes, obesity care meds,
Novo, Lilly post double-digit sales growthDemand
for diabetes and new weight-loss drugs catapulted Novo Nordisk to emerge as the most valuable public
company in Europe. Its net sales zoomed 31 percent to DKK 232.3 billion (US$ 33.75 billion) compared to DKK 177
billion (US$ 25.8 billion) in 2022. Net profit jumped 51 percent to DKK 83.68 billion (US$ 12.51 billion) in 2023 from DKK
55.5 billion (US$ 8.32
billion) in 2022 — the highest annual profit for the Danish drugmaker in over three decades.The
growth was driven by Ozempic, whose sales spiked 60 percent in 2023
to DKK 95.7 billion (US$ 13.91 billion), from DKK 59.8 billion (US$ 8.71 billion) the
year before.Rival
Eli Lilly’s revenue grew 20 percent in 2023 to US$ 34.1 billion from US$ 28.5 billion in 2022. Mounjaro turned out to be a star for the
Indianapolis drugmaker with its sales rocketing 970 percent in 2023 to US$ 5.16 billion. FDA also approved it to treat obesity
under the brand name Zepbound in November, which brought in additional
revenues of US$ 176 million.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available) GSK’s RSV jab makes strong debut; AbbVie’s immunology drugs post steep growthGSK’s Arexvy was the first RSV vaccine approved by the FDA. It made a strong debut — Arexvy contributed £ 1.2 billion (US$ 1.5 billion) to GSK’s sales in just four months.AbbVie posted another solid financial year.
Though the drop in Humira revenue was offset by two newer
immunology blockbuster drugs, Skyrizi and Rinvoq, the Illinois-headquartered drugmaker
did posted a marginal decrease in revenue of 6.4 percent to US$ 54.3 billion. However, revenue from Skyrizi soared 50 percent to US$ 7.8 billion,
while Rinvoq’s sales increased 57 percent to US$ 4
billion. AbbVie expects a combined US$ 16 billion from Skyrizi (US$ 10.5 billion) and Rinvoq (US$ 5.5 billion) sales in 2024. BMS attributed its 2 percent decrease in
revenue (of US$ 45 billion) to lower sales of Revlimid in the US due to competition from
generics. Sales of the multiple myeloma treatment dropped 39 percent to US$ 6.1
billion. Ophthalmology drug Eylea saw a drop in sales of
4 percent, at US$ 9.21 billion (from US$ 9.65 billion), as competition from Roche’s Vabysmo triggered a price cut by Regeneron. Vabysmo saw sales balloon 324 percent
from CHF 591 million (US$ 685.56 million) to CHF 2.4 billion (US$ 2.78 billion) in 2023.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available) Our viewAccording
to data analytics company GlobalData, GLP-1 agonist drugs (such as Ozempic and Mounjaro that treat type 2 diabetes) are slated to overtake PD-1 antagonists (such as oncology drugs
Keytruda and Opdivo) as the top-selling drugs on the market
in 2024. It estimates a robust compounded annual growth rate (CAGR) of 19.2
percent from 2023 to 2029 for GLP-1 drugs that seem to have more benefits
besides bringing down blood sugar levels (such as weight management, benefits
to the heart etc).The
market size for GLP-1 is likely to increase to US$ 105 billion by 2029. In
contrast, the data firm projects a CAGR of 4.7 percent in the PD-1 antagonist
market, with its market size projected to be around US$ 51 billion in 2029.
Given these projections, we are likely to see more movers and shakers in our
top 10 drug list this year.
Impressions: 3048
https://www.pharmacompass.com/radio-compass-blog/top-pharma-companies-drugs-in-2023-merck-s-keytruda-emerges-as-top-selling-drug-novo-lilly-sales-skyrocket-due-to-glp-1-drugs
#PharmaFlow by PHARMACOMPASS
25 Apr 2024
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In 2022, the pandemic continued to bring in a windfall for
pharmaceutical companies manufacturing Covid-19 products, with Pfizer’s total annual sales reaching
a record high by surpassing US$ 100 billion for the first time.AbbVie, despite not having any Covid products
in its portfolio, maintained its second position due to the sales of its blockbuster drug Humira and other medicines. Johnson & Johnson held
onto the third spot, while Merck experienced the most significant
change, climbing to the fourth position from seventh place in the previous
year. AstraZeneca also moved up a spot to the
eighth position. On the other hand, Novartis (fifth), Roche (sixth), BMS (seventh) and Sanofi (ninth) slipped in the rankings,
while GSK (tenth) retained its position.
There were no new entries in the top 10 in terms of pharmaceutical sales.View Our Interactive Dashboard on Top Drugs by Sales in 2022 (Free Excel Available)Pfizer retains top position
as Comirnaty, Paxlovid, together generate over US$ 56 billion In 2022, Pfizer’s Covid-19 products — vaccine Comirnaty and antiviral pill Paxlovid — generated combined sales of US$ 56.7 billion. With a haul of US$ 37.8 billion, Comirnaty comfortably
maintained its position as the top-selling drug for a second year in a row.
Paxlovid brought in US$ 18.9 billion in its first full year on the market, grabbing the number four spot.Moderna’s messenger RNA
Covid vaccine Spikevax generated US$ 18.4 billion in revenues, emerging as the
fifth largest drug by sales in 2022.View Our Interactive Dashboard on Top Drugs by Sales in 2022 (Free Excel Available) AbbVie’s Humira, J&J’s Stelara post impressive growth; BMS face revenue declineAbbVie’s cash cow Humira, the bestselling non-Covid
product in biopharma history, achieved sales of US$ 21.24 billion (partner Eisai reported another US$ 370 million) in 2022. While Humira brought in approximately 37 percent of the company’s total net revenues of US$ 58 billion in 2022, strong revenues from blood cancer drug Imbruvica, psoriasis treatment Skyrizi and rheumatoid arthritis med Rinvoq also contributed to AbbVie’s strong performance.J&J generated US$ 52.56 billion in 2022
revenues. Its pharmaceutical segment experienced an operational growth of 6.7 percent, driven by impressive
performance of key drugs such as Stelara for inflammatory diseases
and Darzalex for multiple myeloma.
Stelara, which generated US$ 10.2 billion in overall sales last year (a
growth of 6.9 percent), is expected to face
generic competition in the US as its
exclusivity is ending in 2023.BMS’ sales remained relatively
unchanged even though its blockbuster multiple myeloma drug, Revlimid, experienced a 22 percent
revenue decline due to generic competition. While Revlimid still generated
sales of US$ 9.98 billion (partner BeiGene reported another US$ 80 million) in 2022, two other drugs, anticoagulant Eliquis and cancer drug Opdivo performed well. Eliquis
generated US$ 11.8 billion in sales (partner Pfizer reported another US$ 6.5
billion), a 9.2 percent increase over 2021, while Opdivo achieved US$ 8.25 billion in sales (partner Ono Pharmaceuticals reported another US$ 1.05 billion). The drugmaker also introduced new products like Opdualag, Abecma and Reblozyl, which bolstered
its overall sales.View Our Interactive Dashboard on Top Drugs by Sales in 2022 (Free Excel Available)Merck expands use of blockbuster Keytruda; oncology drugs boost Astra’s revenueMerck’s blockbuster cancer drug Keytruda had a remarkable year,
achieving a significant year-on-year growth of 22 percent and generating US$ 20.9 billion in 2022 sales. This success propelled Keytruda to the third position among the top-selling drugs. Keytruda’s continuous expansion into new indications and treatment lines has solidified its position as a leading PD1 inhibitor, and is expected to maintain its momentum in 2023. Additionally, Merck’s Covid-19 pill Lagevrio recorded impressive sales of US$ 5.7 billion in 2022. Overall, at US$ 52 billion, the drugmaker posted spectacular
growth in sales of 22 percent.AstraZeneca also experienced an
impressive growth of 18 percent in 2022 to reach US$ 43 billion in revenue. The
growth was primarily driven by the success of its cancer treatments, with
blockbuster drugs like Tagrisso, Farxiga, Imfinzi, Lynparza playing a vital role. These drugs accounted for 35 percent of AstraZeneca’s overall revenue.View Our Interactive Dashboard on Top Drugs by Sales in 2022 (Free Excel Available)Newer
meds bolster Roche’s growth; Sanofi thrives with DupixentIn 2022, Roche experienced a sales growth of 2 percent at Constant Exchange Rate (CER) to reach CHF 45.55 billion (US$
49.8 billion). The company’s strong pharmaceutical sales were fueled by increasing demand for newer medicines, including Ocrevus (for multiple sclerosis), Hemlibra (for hemophilia A), Vabysmo
(for eye conditions), Evrysdi (for spinal muscular
atrophy) and cancer drug Tecentriq. In 2022, Sanofi recorded global sales of €43 billion (US$ 47.1 billion), representing a 7 percent growth at CER. The French drugmaker’s strong performance was driven by major drugs, particularly Dupixent and its vaccine franchise.
Dupixent brought in impressive sales of €8.3 billion (US$ 9.1 billion), marking a significant 57 percent increase over the previous year. Originally approved by the FDA in 2017 for atopic dermatitis,
Dupixent has expanded its applications to include moderate to severe asthma and
eosinophilic esophagitis, contributing to its continued growth. Sanofi expects
Dupixent to reach €10 billion (US$ 10.7 billion) in sales
in the current year.In July 2022, GlaxoSmithKline changed its name to GSK and demerged its consumer
healthcare business to form Haleon, thereby becoming a fully
focused biopharmaceutical company. The British drugmaker reported a modest 8 percent growth in revenue — at £29.32 billion (US$ 36.15 billion).View Our Interactive Dashboard on Top Drugs by Sales in 2022 (Free Excel Available)Our viewAs the pandemic wanes, 2023 could be a year of transition for many
drugmakers. Companies such as Pfizer, Moderna and AbbVie are implementing
significant changes to their business strategies. Pfizer foresees a substantial
decline in revenue, projecting a sharp drop of 33 percent with the reduced demand for
its Covid-19 products. AbbVie, on the other hand, anticipates a decline in
sales of its cash cow Humira due to increasing competition from biosimilars.
These drugmakers are turning to innovative therapies, new indications,
cost-cutting measures, acquisitions and partnerships to restrict the
anticipated drop in revenues and ensure sustained growth.Barring these drugmakers, several other big players shared
positive growth in the first quarter of 2023. While analysts predict Keytruda
and Dupixent to continue their strong growth, there is optimism surrounding diabetes and obesity drugs,
with Novo Nordisk’s Wegovy experiencing unprecedented
demand. Eli Lilly is also anticipating the US
approval of Mounjaro for obesity later this year.
All in all, we anticipate more changes in our list of top companies and drugs
for 2023!
Impressions: 5298
https://www.pharmacompass.com/radio-compass-blog/top-pharma-companies-and-drugs-in-2022-pfizer-breaks-us-100-billion-barrier-abbvie-s-humira-retains-second-spot
#PharmaFlow by PHARMACOMPASS
01 Jun 2023
In 2022, the world finally began to emerge out of Covid-related
restrictions. Though 2020 and 2021 saw several travel-related curbs, there was
no let up in the speed at which generic active pharmaceutical ingredient (API)
manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug
Administration (FDA). In the four years between 2018 and 2021, the number of
Type II DMF submissions (i.e. submissions for drug substance, drug substance
intermediate, and material used in their preparation, or drug product) remained
steady at over 630 per year.In 2022, the DMF submissions rose at an impressive pace of 12.1
percent. A total of 1,024 DMFs (Types II, III, IV and V) were submitted in
2022, as opposed to 913 in 2021.Last year, Type II DMF submissions increased by 7.2 percent — a total of 715 Type II DMFs were submitted in 2022 as opposed to 667 in 2021. However, of the 715 DMFs filed with the FDA, only 190 (26 percent) had their reviews completed.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) DMF submissions from India dip 10.6%, China’s filings increase 45%As always, DMFs filed from India and China were significantly higher than DMFs from other countries. However, the year saw DMF submissions from India drop by 10.6 percent. Overall DMF submission from India stood at 336, as opposed to 376 in 2021. In comparison, China’s DMF filings increased by 45 percent to 231 in 2022, as opposed to 159 in 2021. Interestingly, FDA had issued 31 Form 483s in 2022 out of which 15 were issued to Indian drugmakers. Out of 15, seven Form 483s were issued to manufacturing units belonging to four Indian API manufacturers — Lupin, Aurobindo Pharma, Torrent and Biocon Biologics.While DMFs are submissions to FDA that may be used to provide
confidential, detailed information about facilities, processes, or articles
used in the manufacturing, processing, packaging, and storing of human drug
products, a Form 483 is a notification sent by the FDA to a
drugmaker regarding objectionable conditions at a facility. A Form 483 is
issued at the conclusion of an inspection, when an investigator finds
regulatory violations and/or non-compliance of good manufacturing practices. January 2023 saw a spate of Form
483s issued to Indian drugmakers, raising concerns within the pharma
industry.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) India’s Metrochem API tops DMF submissionsIndia’s Metrochem API led the list of companies with the highest number of DMF submissions at 19. MSN Labs stood second with 16 submissions.Other top Indian companies were Aurobindo Pharma (15), Biophore India (15), Hetero Group (11) and Cipla (10), followed by two Chinese companies — BrightGene Bio-Medical Technology and Changzhou Pharmaceutical Factory — with 9 submissions each.The maximum number of DMF filings were for elagolix sodium (11), empagliflozin (eight), tofacitinib citrate (six), revefenacin (six), apixaban (five), brivaracetam (five), cannabidiol (five), followed by mirabegron (five) and tafamidis (five).A total of 79 DMFs were filed for the
first time for 64 products, of which 28 had their GDUFA (Generic Drug User Fee Amendments) review
completed. These
include revefenacin (six), migalastat hydrochloride (three), cupric sulfate (three), ivosidenib (two), upadacitinib (one) and voxelotor (one). Revefenacin is losing
its marketing exclusivity this year.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) Our viewIn our last (H1 2022) review of DMF submissions, we had mentioned that less than half of the 350 Type II DMFs filed by the FDA had been reviewed, as the user fee program had not been reauthorized.FDA published the New GDUFA III fee structure at the eleventh hour — on September 30, 2022. GDUFA III includes several enhancements to the abbreviated new drug
application (ANDA) assessment process to maximize the efficiency and utility of
each assessment cycle. These enhancements aim to reduce the number of
assessment cycles and facilitate timely access to safe, effective, high-quality
and affordable generics.With the GDUFA III, the US government has made clear its intent to
lower generic drug prices. In future, more drugs are likely to go off-patent and we are likely to see the number of
DMF submissions rise even further.In
the second quarter of 2022, FDA resumed unannounced inspections in India. The regulator has also stepped up onsite inspections. FDA wants cheaper drugs, but not at the cost of quality. There are no short-cuts for generic and bulk drug manufacturers wanting to export to the US.(This article has been updated to accurately reflect the information on Metrochem API and MSN Labs.)
Impressions: 2310
https://www.pharmacompass.com/radio-compass-blog/dmf-submissions-rise-12-1-in-2022-india-sees-10-6-drop-in-type-ii-filings
#PharmaFlow by PHARMACOMPASS
02 Feb 2023
Every year, the list of top pharmaceutical products and companies by sales sees some churn. But the year 2021 was a lot different — it saw the pharma industry landscape change dramatically. It was a
year when the industry was busy developing vaccines and therapies so that the
world could recover from the Covid-19 pandemic. And this resulted in many
drugmakers raking in billions of dollars in sales.
As a result,
the top company of 2020 in terms
of pharmaceutical sales — Roche — slipped to the number five spot, while Pfizer, which was at number eight in 2020 after
spinning off its generic business, moved up to the number one slot.
The year
proved to be a good one for pharmaceutical companies.
Interestingly, last year none of the top 20 pharmaceutical companies saw a decline in
their revenue.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
Pfizer’s Comirnaty steals the show
The
company that reaped the maximum gains from its Covid vaccine was Pfizer.
Comirnaty (tozinameran) was the top selling pharmaceutical
product of 2021, posting global revenues of US$ 36.8 billion. This
messenger-RNA Covid-19 vaccine, developed along with its German partner BioNTech, catapulted Pfizer to the slot of the top company by sales in 2021. Pfizer’s global topline grew from US$ 41.7 billion in 2020 to US$ 81.3 billion in 2021.
In
2020, Pfizer was at
number eight, behind Roche, Novartis, GSK, AbbVie, J&J, Merck and BMS. In 2021, it took a lead of billions of dollars on all these companies. The second largest drug company by sales — AbbVie — was way down at US$ 56.1 billion in global revenues. In fact, Comirnaty has
become the fastest-selling drug in the history of the pharmaceutical
industry.
Back in
December 2020, when both Comirnaty and Moderna’s Spikevax had bagged the US Food and Drug Administration’s emergency use authorization (EUA), there was a lot of uncertainty around how the promised doses would be delivered across the world. But both Comirnaty and Spikevax have proven to be a resounding success. Spikevax emerged as the third largest selling pharmaceutical product of 2021, bringing in US$ 17.7 billion for Moderna.
Analysts
expect both Pfizer-BioNTech and Moderna to sell even more vaccines in
2022. The reasons are manifold. First, SARS-CoV-2 is able to mutate often, and
is unlikely to be eradicated in the near future, creating a need for booster
shots. Second, the younger age groups are still to get vaccinated.
Along with
Comirnaty, Pfizer is battling Covid-19 with its antiviral pill, Paxlovid. Though the sales of Paxlovid have nosedived of late, Pfizer expects
Comirnaty and Paxlovid to help the New York-headquartered drug behemoth achieve US$ 100 billion
in 2022 revenues.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
AbbVie
moves up, sans Covid product; Roche slips to number five
With no
Covid-19 related products, AbbVie did fairly well in 2021 — it moved up from the number four spot in 2020 to number two position, thanks to its Allergan acquisition, cash cow Humira (adalimumab), the continued success of its
cancer drug Imbruvica (ibrutinib) and an increase in sale of its psoriasis treatment Skyrizi (risankizumab) by a whopping 85 percent in 2021. Humira brought in sales of US$ 21.2 billion for AbbVie in 2021. However, things may change soon, with biosimilars of Humira slated to enter the market in 2023. The years 2022 and 2023 are likely to be transition years for AbbVie, as it works to build the market for its Humira successors — Rinvoq and Skyrizi.
Roche
emerged as a big loser in 2021, as several copycats of its blockbuster drugs
hit the market. Copycats to Roche’s three blockbuster cancer drugs—Avastin, Herceptin and Rituxan—eroded US$ 4.9 billion (CHF 4.73 billion) from the company’s sales in 2021. A large chunk
of growth for Roche came from its multiple sclerosis med Ocrevus, hemophilia drug Hemlibra, inflammatory disease therapy Actemra and PD-L1 inhibitor Tecentriq. The pandemic resulted in
lower-than-expected sales of Ocrevus (ocrelizumab) due to fears around its
immunosuppressive effects.
Like Roche, Novartis also slipped last year. It fell from
number two in 2020 to the number four slot in 2021. Essentially, Novartis is
struggling with a relatively lackluster pipeline. It had sold its 33 percent stake in Roche last
year for US$ 20.7 billion. It plans to use that sum for acquisitions in order
to beef up its pipeline. The Swiss drugmaker has also drawn up a restructuring
plan that includes layoffs of thousands of employees.
Before the
pandemic, Merck’s Keytruda was touted as the drug that would overtake
Humira at the top in 2024. The checkpoint inhibitor has continued to grow
impressively, adding new indications and treatment lines. Keytruda is now used
in close to 40 indications. With US$ 17.2 billion in sales, Keytruda emerged as
the fourth largest selling drug of 2022.
Overall
though, Merck slipped from number six to the number eight slot. This was due to
the fact that Merck had spun out its women’s
health, biosimilars and established brands businesses into Organon. However, its Covid-19 antiviral pill — Molnupiravir — was able to compensate for the lost revenue. Though the FDA is yet to grant the drug a full approval (it bagged an EUA in December 2021), advance sales agreements helped it rack up US$ 952 million in sales in the fourth quarter.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
BMS moves
up with Eliquis, Revlimid; J&J lands at number three
Bristol Myers Squibb (BMS) moved up from number seven in 2020 to number six, thanks to two of its drugs that made it to top 10 — anticoagulant Eliquis at number five and oncology drug Revlimid at number six. However, Revlimid will soon face competition — four generic companies now have the approval to sell their versions of Revlimid (lenalidomide) after March 2022. Revlimid
sales are expected to drop from US$ 12.9 billion to just US$ 2.06 billion in
2026.
BMS posted
US$ 46.4 billion in global revenues, a nine percent increase from US$ 42.5
billion reported in 2020. In immuno-oncology, Opdivo
brought in US$ 7.52
billion in sales, while Yervoy drew in sales of US$ 2 billion
(an increase of 20 percent).
J&J’s pharma division brought in US$ 52.1 billion in revenues
last year, an increase of 14 percent over its revenues of US$ 45.6 billion
posted in 2020. Drugs like Darzalex (for multiple myeloma), Stelara and its Covid-19 vaccine brought in growth during 2021,
helping J&J move up from number five to the number three slot. J&J’s Covid-19 vaccine brought in US$ 2.4 billion in
sales.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
GSK bags
approval for shingles vaccine; Takeda suffers setbacks
GlaxoSmithKline (GSK) slipped four places — from number three in 2020 to number seven in 2021. Though GSK did not have a drug in the top 10, sales of GSK and Vir Biotechnology’s Covid-19 antibody treatment
sotrovimab helped produce a seven percent increase in its 2021 revenue. The British drugmaker also bagged a critical FDA approval — its vaccine to prevent shingles (herpes zoster), Shingrix, bagged the agency’s nod in July. GSK hopes to double the sales of Shingrix by 2026.
GSK is also undergoing a major transformation, and plans to demerge its consumer health unit this year. The unit generated revenues of £9.6 billion (US$ 13 billion) last year, and GSK sees the demerger as a necessary step to fuel growth through the development of new vaccines and specialty medicines.
Sanofi managed to retain its ninth slot, even as
its global turnover increased from US$ 39.3 billion (Euro 36.04 billion) to US$
41.6 billion (Euro 37.76 billion). It snapped up Kymab, Tidal Therapeutics, Translate Bio, Kadmon Holdings, Origimm Biotechnology and Amunix in deals that bolstered its presence in immunology, immuno-oncology and vaccines. Dealmaking is on the French drugmaker’s menu for 2022 and beyond, Sanofi’s CFO said at this year’s virtual JP Morgan Healthcare Conference.
AstraZeneca’s global revenues grew from US$ 26.6 billion in 2020 to US$ 37.4 billion in 2021. However, its rank fell from nine in 2020 to 10 in 2021.
AstraZeneca
wrapped up the US$ 39 billion acquisition of Alexion in July 2021. Alexion’s rare disease franchise—led by C5 inhibitors Soliris and Ultomiris—added an extra US$ 3.1 billion to Astra’s top line last year.
Takeda suffered several clinical and regulatory setbacks in 2021, which it labeled as an “inflection year.” For Gilead, sales of its Covid-19 antiviral Veklury brought in US$ 5.6 billion last year,
helping its revenues grow by 11 percent.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
Our view
If anything,
the pandemic has taught us that change is the only constant. It has also taught
us that products can become blockbusters in a matter of a few months.
The industry
landscape continues to change. On the one hand, we are seeing people scrambling
to get Covid vaccines and booster shots, on the other hand, the FDA has limited the use of monoclonal antibodies, such as Eli Lilly’s bamlanivimab and etesevimab and
Regeneron’s REGEN-COV (casirivimab and
imdevimab), in treating Covid caused by the Omicron variant. The FDA has also pulled the authorization
granted to GSK and Vir Biotechnology’s antibody therapy this month,
citing data that suggested it was unlikely to be effective against the dominant
Omicron sub-variant.
And last
week, there was news that demand for Pfizer’s
antiviral pill Paxlovid has remained unexpectedly low. The supply
of Paxlovid, which reduced hospitalizations or deaths in high-risk patients by
around 90 percent in a clinical trial, has far outstripped demand in many
countries like the US, the UK and South Korea.
Though Pfizer is hopeful of crossing US$ 100 billion in revenue this
year, much depends on how the pandemic pans out and what new research has to
say about the novel coronavirus. A lot will change once the pandemic becomes endemic.
The first four months of 2022 tell us that vaccines like Comirnaty and Spikevax
will continue to perform well.
But two years down the line, our charts could look very different.
Impressions: 8047
https://www.pharmacompass.com/radio-compass-blog/top-pharma-companies-drugs-in-2021-covid-vaccines-pills-cause-churn-in-list
#PharmaFlow by PHARMACOMPASS
28 Apr 2022
Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 55009
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
The US Food and Drug Administration’s (FDA) momentum of new drug approvals dropped marginally in 2019 — while 62 novel drugs were approved in 2018, 54 were approved in 2019. FDA’s Center for Drug Evaluation and Research (CDER) approved 48 drugs while another six were approved by the Center for Biologics Evaluation and
Research (CBER).
Novartis dominated new drug approvals as CDER approved five of its new drugs across five different therapeutic areas. But then, it also made headlines when the FDA raised data accuracy issues over the Swiss drugmaker’s gene therapy — Zolgensma — which sent the company into a crisis
management mode.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
The gene therapy drug
came into the fold of Novartis in April 2018 through the US$ 8.7 billion acquisition of Illinois-based AveXis Inc.
Zolgensma — the world’s most expensive drug — was approved as a one-time treatment for spinal muscular atrophy (SMA) in May 2019.
However, in March 2019, Novartis learnt of manipulation in the raw data derived
from a mice assay used at the time to test Zolgensma samples, but only alerted the FDA in June — about a month after the drug gained US approval.
Post that, Novartis came under fire from US lawmakers who said the company should have informed the regulators about the data irregularities before the drug’s approval in May, instead of waiting to conclude an internal investigation.
Novartis’ other approvals were brolucizumab (for treatment of macular
degeneration), siponimod (to treat multiple sclerosis), alpelisib (breast cancer), crizanlizumab (sickle
cell disease) and triclabendazole (fascioliasis, a tropical disease).
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Vertex’s Trikafta leads in estimated sales potential
At PharmaCompass,
we compiled the sales forecasts for the new drugs approved by the FDA in 2019. Vertex’s cystic fibrosis treatment — Trikafta — with expected sales of US$ 3.935 billion by 2024, leads our list.
Trikafta is a combination of ivacaftor, tezacaftor and elexacaftor. Vertex already has three cystic fibrosis drugs on the market — Kalydeco (a standalone ivacaftor treatment), Symdeko (a combination of ivacaftor and tezacaftor) and Orkambi (which contains ivacaftor and lumacaftor).
Trikafta’s stellar clinical data made the FDA approve the drug within three months of Vertex’s application filing and five months before FDA’s action date.
Abbvie’s Humira, the top-selling drug in the world, is beginning to face generic competition in certain parts of the world and two new drug approvals in 2019 — Skyrizi (risankizumab for
plaque psoriasis) and Rinvoq (upadacitinib for rheumatoid arthritis) — are critical to AbbVie's plans to
grow beyond Humira. The two drugs are expected to contribute over US$ 5.5 billion by 2024 to AbbVie’s top-line.
In April, AstraZeneca struck a deal worth US$ 6.9 billion with Japanese drug major
Daiichi Sankyo, to jointly develop and commercialize the antibody drug conjugate cancer therapy —trastuzumab deruxtecan. The
breast cancer treatment won FDA approval in December and analysts forecast
sales of US$ 2.5 billion by 2024 with some believing that the drug could
achieve US$ 7 billion in peak sales.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
The rise of new drugs from Asia
While Daiichi won the FDA nod for its cancer treatment — Turalio (pexidartinib) — new drugs from established Japanese drug makers like Shionogi, Kyowa Kirin and Eisai also bagged the American agency’s approval.
Shionogi’s novel antibiotic — Fetroja (cefiderocol) — got approved for complicated urinary tract infections while Kyowa won the nod for its Parkinson’s treatment — Nourianz (istradefylline). Eisai’s insomnia drug — Dayvigo (lemborexant) — was one of the last drugs approved in the year and is expected to generate sales of US$ 329 million.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
In 2019, the FDA also
approved new drugs from China and Korea. Zanubrutinib (branded
as Brukinsa) developed by Chinese biotech BeiGene won accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive and rare form of blood cancer.
This was followed, almost immediately, by news that the agency approved a new treatment for partial-onset seizures in adults. The drug — cenobamate — will be sold as Xcopri by SK Life Science,
the US subsidiary of the massive Korean conglomerate SK Group. Xcopri will
provide another therapeutic option to patients with epilepsy. This approval
marked the first time a Korean company independently took a compound from the
stage of discovery to FDA approval.
Xcopri is SK Life Science’s first commercial product and wraps a decade of quiet growth from SK Life Science, which has been developing its presence in the pharmaceutical industry.
The company plans to hire a salesforce to support the drug’s launch, which is expected to generate over US$ 1.5 billion in sales.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Sanofi’s controversial dengue vaccine, cast-off drug get approved
The FDA very narrowly approved Sanofi’s controversial dengue vaccine — Dengvaxia. The vaccine, which took 20 years to develop, got embroiled in a controversy when in 2017, Sanofi disclosed that Dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus.
In Philippines, 800,000 school-age children had been vaccinated against dengue, the world’s fastest growing infectious disease.
The year 2019
had begun with Bristol-Myers Squibb (BMS) and Celgene announcing their US$ 74 billion mega-merger. As the firms worked through the year to get the merger approved, the FDA signed off on Celgene’s myelofibrosis drug Inrebic
(fedratinib).
Inrebic — the once-daily oral drug — is the first new treatment in nearly a decade approved to treat myelofibrosis. The story of Inrebic’s rise from the dead is a major success for Celgene,
which picked up the drug as a part of a US$ 1.1 billion acquisition of Impact
Biomedicines in January 2018. Before that, Inrebic had passed through multiple
hands.
Fedratinib was a flop
for Sanofi as patients began to develop a dangerous neurological
condition tied to vitamin B deficiency called Wernicke’s encephalopathy. As a result, the FDA put a clinical hold on it in 2013 and Sanofi ultimately shelved the effort.
Executives
at BMS have said the drug is among a group of potential blockbusters at
Celgene.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Our view
With over 40 companies from across the world getting new
drugs approved in 2019 across 17 therapeutic areas, the horizon for new drug
development across the globe continues to widen.
Although 2018 was a landmark year for approvals, given all
the development activity underway, the day is not far when this record too will get beaten. And
2020 could well witness that day!
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Impressions: 14589
https://www.pharmacompass.com/radio-compass-blog/novartis-leads-in-new-drug-approvals-vertex-s-cystic-fibrosis-med-holds-highest-sales-potential
#PharmaFlow by PHARMACOMPASS
31 Dec 2019
