The world of pharmaceuticals and biotechnology continued to evolve
this year with strategic alliances reshaping industry contours. With mid-size
deals taking centerstage, the growth trajectory appears to be marked by a
balance of both caution and calculated ambition.The deal-making environment was robust in 2023, with over 2,000
unique pharma and biotech deals totaling more than US$ 410 billion, according
to the PharmaCompass database. Last year, there were over 200 mergers and acquisitions (M&As) with transactions exceeding US$ 160 billion in total value. Oncology, infections and infectious diseases, and neurology had emerged as the top three therapeutic areas for deals.PharmaCompass’ analysis indicates that the momentum has been maintained in 2024. As of August 6, the industry had seen over 1,200 unique deals valued at more than US$ 230 billion, including over 120 M&A transactions surpassing US$ 60 billion in aggregate value. While oncology maintains its lead position, neurology and immunology have gained notable traction.The one big difference is that 2024 is yet to witness a mega-deal,
comparable to Pfizer’s US$ 43 billion acquisition of Seagen in 2023 or Amgen’s US$ 27.8 billion Horizon buyout announced in 2022. The largest transaction
thus far has been Novo Nordisk Foundation’s US$ 16.5 billion acquisition of Catalent, a contract development and manufacturing organization (CDMO).This
compilation does not include deals related to acquisition of facilities,
divestment, medical devices, diagnostics and animal health. We have considered
deals announced, irrespective of when these transactions were completed. For a comprehensive overview of CDMO deals and developments
in 2024, please refer to our dedicated roundup.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Vertex buys Alpine Immune for US$ 4.9 bn; Gilead’s CymaBay buyout pays off via FDA nodAmongst the biggest acquisitions of 2024 was Vertex Pharmaceuticals’ buyout of Alpine Immune Sciences for US$ 4.9 billion. It granted Vertex access to protein-based immunotherapies, including the promising povetacicept for IgA nephropathy, a serious kidney disease.Gilead Sciences’ acquisition of CymaBay Therapeutics for US$ 4.3 billion in February secured it
access to seladelpar (Livdelzi), an experimental drug that received FDA’s accelerated approval this month for primary biliary cholangitis, a liver disease that affects the bile ducts. Eli Lilly bolstered its presence in
the US$ 26.65 billion inflammatory bowel disease (IBD) market by purchasing Morphic Holding for approximately US$ 3.2 billion in July. Through this deal,
Lilly gained the oral IBD therapy candidate MORF-057, which will offer a more
convenient dosing option compared to injectable drugs currently available in
the market. Lilly sees the IBD space as a way to diversify beyond obesity.Merck expanded its ophthalmology portfolio by acquiring Eyebiotech Limited
for US$ 1.3 billion (plus US$
1.7 billion in milestone payments), obtaining Restoret for diabetic macular edema and neovascular age-related macular degeneration.Japanese drugmaker Ono Pharmaceutical acquired Deciphera Pharmaceuticals for US$ 2.4 billion, gaining Qinlock for
gastrointestinal stromal tumors and vimseltinib for tenosynovial giant cell
tumors. Sanofi targeted rare diseases by
purchasing Inhibrx for up to US$ 2.2 billion. The acquisition gave the French drugmaker access to INBRX-101 for Alpha-1 antitrypsin deficiency, a genetic condition that can cause lung and liver damage.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Novartis buys two oncology firms for their assets; J&J, Genmab join ADC bandwagonNovartis has been on a shopping
spree, and has made two significant purchases this year. First, it acquired MorphoSys for € 2.7 billion (US$ 2.9 billion), thereby
adding the promising bone-marrow cancer treatment pelabresib to its pipeline. Second, it
announced the acquisition of Mariana Oncology for US$ 1 billion upfront (plus US$ 750 million in milestone payments), thereby expanding into radioligand
therapies (RLTs) to treat cancers with high unmet need. RLTs take a
targeted approach, delivering radiation to the tumor, while limiting damage to
the surrounding cells.AstraZeneca entered the field of
radioconjugates, which is a promising modality in the treatment of cancer, by
acquiring Fusion Pharmaceuticals for US$ 2.4 billion.In January this year, Johnson & Johnson had announced the acquisition of
antibody-drug-conjugate (ADC) developer Ambrx Biopharma for about US$ 2 billion. With this buyout, J&J has joined the likes of Bristol Myers Squibb, AbbVie and GSK who had entered this
promising field through acquisitions last year.Similarly, Denmark’s Genmab bought ProfoundBio for US$ 1.8 billion in cash, boosting its
oncology portfolio with three next-generation ADC candidates. This includes Rina-S, which recently received FDA’s fast track designation for the treatment of ovarian cancer.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Novartis signs multiple
collaborations; GSK, Takeda, AbbVie sign billion-dollar dealsNovartis was not just busy signing M&A deals, it also signed a bevy of collaboration agreements. For instance, Shanghai-based Argo partnered Novartis on two
early-stage RNA interference candidates for cardiovascular diseases,
potentially earning the former up to US$ 4.2 billion plus tiered royalties.Novartis also agreed to pay up to US$ 3 billion (including US$ 150 million
upfront) to Dren Bio to use the latter’s Targeted Myeloid Engager and Phagocytosis platform to develop bispecific antibodies to treat cancer.Moreover, the Swiss drugmaker expanded its peptide discovery
collaboration with Japan-based PeptiDream in a deal worth over US$ 2.71 billion in milestone payments, plus an upfront payment of US$ 180 million. Peptide-drug conjugates (PDCs) are the next generation of targeted therapeutic drugs after ADCs and Novartis is, thus far, the only big pharma with FDA-approved radioligand PDCs. GSK entered a groundbreaking
partnership with Flagship Pioneering, potentially worth over US$ 7 billion, to identify and develop 10
novel drugs and vaccines. The deal, starting with respiratory and immunology
drugs, involves US$ 720 million in upfront and milestone payments for each candidate. This collaboration leverages Flagship’s extensive portfolio of over 40 biopharma companies with drug development capabilities.There were two significant deals in the field of neuroscience.
First, Takeda said it is paying Swiss
biotech AC Immune US$ 100 million upfront with potential further payments of US$ 2.1 billion for an exclusive option to license global rights to an Alzheimer’s vaccine and related immunotherapies.Second, AbbVie and clinical stage biotech Gilgamesh Pharmaceuticals joined forces in a deal
potentially worth over US$ 2 billion to develop a new class of psychedelic compounds for psychiatric conditions, combining AbbVie’s psychiatric expertise with Gilgamesh’s innovative neuroplastogen research platform.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Our viewDuring this year, companies like Novartis (with US$ 16.8 billion), GSK (US$ 14.5 billion), Sanofi (US$ 11.9 billion), Bristol Myers Squibb (US$ 11.6 billion), and AbbVie (US$ 9.1 billion) have made
substantial investments in acquisitions, collaborations and other forms of
dealmaking.Though the deal-making environment is robust, we notice a shift towards mid-size transactions. Alongside, we notice a growing interest in areas such as ADCs, radiopharmaceuticals, and protein-based immunotherapies, underscoring their growing importance in drug development. There has also been significant interest in silencing RNA (siRNA) therapeutics, highlighting the industry's focus on novel approaches to disease treatment. With the industry focusing on cutting-edge technologies that address unmet medical needs, we feel there is little reason to fret over the size of the deals.
Impressions: 591
This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity
Drugs without an Approved Generic (OPOE list). The list is a crucial
resource for promoting competition and affordability in the pharmaceutical
industry. Updated biannually in December and June, the OPOE list serves as a
transparent guide for drug manufacturers.
Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs).
ANDAs are a streamlined pathway for generic drug development,
offering a more cost-effective alternative to brand-name drugs. By highlighting
drugs that lack generic competition on the OPOE list, FDA aims to incentivize
manufacturers to develop generics, ultimately leading to greater affordability
and access for patients.
Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)
ALS drugs, cancer, asthma,
HIV treatments among new drugs added to OPOE list
The December 2023 OPOE list had 23 new applications of branded
drugs eligible for but without generic competition. The June list further added
21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic
lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in
patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and
bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).
Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms).
The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat.
The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms.
Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)
Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller
This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and
others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product.
The agency considers first generics to be important to public
health and prioritizes review of these submissions. First generics are eligible
for a 180-day exclusivity period.
Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat
thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal
chromosome in their blood cells called the Philadelphia chromosome), got its
first generic in January, which was introduced by Apotex. Tasigna brought
in sales of US$ 1.85 billion in 2023 and its sales are
projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients
with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in
April.
Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved
drug to treat tardive dyskinesia, a disorder that involves involuntary
movements. It raked in US$ 1.84 billion in 2023, registering a
year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules.
Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)
Our view
The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or
a democrat takes over the US administration, making medicines affordable should
remain a priority.
In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.
Impressions: 2497
The year 2023 was a rather
tough one for cell and gene therapy (CGT) companies. There was news about
smaller CGT players finding it difficult to get finance, with many drastically
downsizing their operations by laying off hundreds of employees. Many others
had to shut shop, making us wonder if innovation in the biopharma industry is
in for a setback.The new year began on a sour
note, with the FDA shooting off letters to six manufacturers of cancer
therapies that use CAR-T technology to add a boxed warning on their label after
the agency found a serious risk of developing secondary cancer. These therapies include Bristol-Myers Squibb’s Abecma and Breyanzi, Janssen Biotech’s Carvykti, Gilead’s Yescarta, Novartis’ Kymriah and Kite Pharma’s Tecartus. “Boxed warnings” or “black box warnings” are the highest safety warnings. A week later, FDA stepped in and finalized guidance
for companies and academic researchers working on CAR-T cell therapies.In this article, PharmaCompass looks at some of the
challenges being faced by CGT firms, and the growth prospects of this sunrise
sector.A field with complex manufacturing, high costs of developmentThere are several ways in
which CGTs can target a disease, giving
rise to various kinds of such therapies. These include gene addition, gene
silencing, gene editing, DNA therapy (such as DNA plasmids and viral vectors),
RNA therapy (ribosomal RNA, messenger RNA, microRNA, small interfering RNA and
transfer RNA), antisense oligonucleotides and gene-modified cell therapy (such
as CAR T-cell therapies and Treg cell therapies). CGTs are being deployed to treat several kinds of diseases, such as various types of cancers, including brain tumors, breast and colon cancers, as well as leukemia. Other major therapeutic areas CGTs are making an impact on are genetic and rare diseases like sickle cell disease (SCD), β-thalassemia, hemophilias, and paraplegia. CGTs are also being explored for treating Duchenne muscular dystrophy, Alzheimer's disease, Parkinson’s disease, multiple sclerosis, type 1 diabetes and macular edema.Going by FDA’s Purple Book, there are 35 CGT products
approved in the US. With three FDA approvals, bluebird bio tops the list (with
Lyfgenia, Zynteglo, and Skysona), followed by Bristol Myers Squibb (with Abecma and Breyanzi), Kite Pharma (with Tecartus and Yescarta), and Novartis (with Zolgensma and Kymriah). Recently, FDA approved Vertex Pharma-CRISPR Therapeutics’ Casgevy, the first gene-editing therapy that uses the Nobel-prize-winning CRISPR technology.Though CGTs are personalized
therapies, they come with potential risks, such as developing certain kinds of cancers, genotoxicity, allergic reactions, damage to the organs etc.Another challenge faced by
CGTs is costs. Apart from the high R&D costs, these biotechs face other challenges such as high costs of reagents like clinical-grade lentiviral vectors or gene editing reagents, as well as cell processing materials, GMP facilities and personnel costs.Little wonder then that the selling price of some of the CGTs run
into millions of dollars. CSL Behring and uniQure’s Hemgenix, a first-of-its-kind drug for hemophilia B, is the most expensive drug in the world. It costs a
whopping US$ 3.5 million. Similarly, bluebird bio’s Lyfgenia, a therapy that has
the potential to resolve vaso-occlusive events and is custom-designed to treat the underlying cause of SCD,
costs US$ 3.1 million.Smaller CGT firms get
strapped for funds, fail to land Big Pharma dealsTypically, innovation for CGTs happens at small
biotechs or universities. Many of the small firms get acquired by bigger
drugmakers or tie up with larger pharma companies so that volumes can be scaled
up once the therapy is approved.Last year, scores of biotechs announced
bankruptcies. Many smaller biotechs failed to land Big Pharma deals. They had
to contend with narrower funding options, forcing several startups in
the sector to shut shop. For example, Intergalactic Therapeutics shut down last year, after
being around for less than two years. The company said: “The current environment has led to challenging times for companies to raise capital,” even though Intergalactic’s programs have “shown promise”. Other CGT firms that shut shop last year were Locanabio, Vedere Bio II and CODA Biotherapeutics.Companies that laid off employees to cut costs are base editing biotech Beam Therapeutics, Editas Medicine, Sangamo Therapeutics, Graphite Bio, UniQure, Generation Bio, Candel Therapeutics, Lyell Immunopharma, BrainStorm Cell
Therapeutics and Nkarta. CRISPR Therapeutics, ElevateBio and Atsena also reportedly laid off employees. FDA lines up initiatives, to make 2024 ‘breakout’ year for gene therapiesThe “personalized nature” of CGTs makes them highly effective. But this trait also gives rise to multiple challenges. Acknowledging this, in January, FDA announced a pilot program called Collaboration on Gene Therapies Global Pilot (CoGenT Global) to streamline regulations pertaining to this sector. The agency has also addressed challenges such as the high cost of manufacturing, clinical development timelines, macroeconomic conditions (such as high interest rates), and operational issues being faced by CGTs. FDA is promising to make 2024 a “breakout” year for gene therapies, with a number of initiatives to promote clinical development, approvals and uptake. FDA’s Center for Biologics Evaluation and Research (CBER) is sponsoring research and encouraging collaboration with the National Institutes of Health’s Bespoke Gene Therapy Consortium. The agency has made gene editing therapies eligible for accelerated
approval and detailed the information that should be provided in an
investigational new drug (IND) application. It has also launched a pilot program Support for clinical Trials Advancing Rare disease Therapeutics (START), with the intention of speeding up development.Our viewIn 2022, Precedence Research estimated the CGT market at US$ 15.46
billion, expecting it to increase fivefold by 2032 to touch US$ 82.24 billion, with therapeutic areas such as oncology (US$ 10.4 billion) and genetic disorders (US$ 8.57 billion) expected to draw most revenues.FDA approved seven CGTs in 2023, including Casgevy. But this year, FDA and European regulators
may approve as many as 17 gene therapies. A McKinsey report says in 2024 alone, “up to 21 cell therapy launches and as many as 31 gene therapy launches—including more than 29 adeno-associated virus (AAV) therapies—are expected.” Given these estimates, we have little doubt that 2024 will be a “breakout year” for CGTs.
Impressions: 2430
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: 8103
Last
year, the pandemic impacted everyone’s life in one way or the other. It turned
the limelight on to the pharmaceutical industry, which stepped up efforts to
deliver treatments and vaccines for Covid-19. It was a year of challenges for
the drug
industry as it struggled to supply existing drugs and treat emergencies
amid disruptions in the way business was conducted the world over.
Unlike previous years when the top five drug companies largely remained unchanged, 2020 saw several movers and shakers. The acquisition of Allergan by AbbVie helped it enter the ‘top five’ list, while companies like Pfizer and Merck got edged out. Despite a 2 percent increase in revenues, Pfizer dropping out
of the top five was not a complete surprise as it spun-off its
Upjohn unit. The unit merged with Mylan to create Viatris, an entity
with over US $10 billion in revenues.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Roche emerges as top drug company by global sales
The
top five list of global pharmaceutical companies by sales in
2020 was quite a mix of surprises. While Swiss major Roche topped the
ranking of global drug companies by pharmaceutical sales (with global revenues
of US$ 49.6 billion or CHF 44.532 billion), it also witnessed a sales decline
of 8 percent, which was partially an outcome of the Swiss franc gaining against
most currencies during the pandemic. Overall, competition from biosimilars and the Covid-19 pandemic had a negative impact on Roche’s
pharmaceutical sales in 2020. However, it witnessed strong sales growth
of newly launched medicines like Tecentriq, Hemlibra, Ocrevus, Perjeta and Kadcyla, which
helped in offsetting the CHF 5 billion (US$ 5.53 billion) impact of competition
from biosimilars.
At
the
second position was Swiss drugmaker Novartis, whose global sales (at US$ 48.7 billion) were marginally lower than Roche’s. Unlike the numero uno, Novartis’ pharmaceutical sales grew 4 percent, driven by cardiology drug Entresto that witnessed a 44 percent increase in revenues. While its
oncology unit and Sandoz’s biosimilars business also posted an increase in sales, Covid-19 negatively impacted demand, particularly for the company’s ophthalmology and dermatology operations and the retail operations of Sandoz. The year also saw Novartis’ gene therapy
Zolgensma, the world’s costliest drug, reach nearly US$ 1
billion in sales.
As
the British pound became a lot stronger against the US dollar, GlaxoSmithKline Plc (GSK) witnessed a 3 percent increase in sales in constant currency terms and saw its group sales (£ 34.1 billion or US$ 47.27 billion) take the number three spot in US dollar terms. Strong sales performances
from key growth drivers in HIV, respiratory, oncology and consumer healthcare
offset disruptions from Covid-19. GSK’s consumer healthcare division reported over £10 billion (US$ 13.91 billion) in sales and the firm is on track to create new standalone biopharma and consumer healthcare companies in 2022.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
AbbVie’s international Humira sales
drop 13.6% due to biosimilars
AbbVie reported worldwide revenues of US$ 45.8
billion, an increase of 38 percent versus the previous year. This included US$ 10.3
billion in revenues from the Allergan acquisition,
growth in the immunology portfolio, and the continued strength of Humira in the US as
well as revenue growth from Imbruvica and Venclexta. Humira, the
best-selling drug since 2012, continued to dominate with US$ 19.83 billion in
sales, an increase of 3.5 percent as compared to 2019. While the
international sales of Humira dropped 13.6 percent due to competition from biosimilars, in the US sales increased as Humira is protected from biosimilar competition until 2023.
J&J’s
pharmaceutical division delivered a strong performance as its pharmaceutical
sales grew 8 percent to US$ 45.6 billion and contributed more than the combined sales of its other two units — consumer health and medical devices. This sales growth was largely attributed to primary operational drivers including Imbruvica and Stelara, which were
among the top 10 drugs by sales in 2020. J&J and AbbVie have an equal share
in the profits (and losses) from the sales of Imbruvica, which witnessed a
double digit increase in sales to US$ 9.4 billion. Similarly, J&J’s Stelara
reached US$ 8.0 billion in sales. J&J’s overall revenues grew by just 0.6 percent
to US$ 82.6 billion (including sales from its consumer health and medical
devices divisions). It will be interesting to see what J&J’s 2021
revenues look like as it benefits from the sales of its single-dose Covid-19
vaccine.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Merck’s Keytruda on its way to becoming world’s best-seller
With AbbVie’s Humira beginning to face generic competition, Merck’s oncology
drug Keytruda continued to go from strength to strength posting a sales growth of 30
percent. Keytruda delivered more than US$ 14.4 billion in sales, almost a third
of the firm’s US$ 43 billion revenue. It’s only a matter of time before Keytruda becomes the world’s best-selling drug.
Bristol Myers Squibb (BMS)
reported worldwide revenues of US$ 42.5
billion in 2020. BMS’ products Revlimid and Eliquis reported
significant growth last year, and followed Humira and Keytruda in terms of sales. Eliquis, which is also promoted by Pfizer in some geographies,
had total sales of US$ 14.1 billion while Revlimid posted over US$ 12 billion
in sales. Revlimid, which BMS picked up through its acquisition
of Celgene, will face
limited generic competition sometime after March 2022. Furthermore, while BMS’ oncology
treatment Opdivo’s sales (US$
7.2 billion) declined by 3 percent compared to 2019, it remained one of the top selling drugs in 2020 (US$
7.9 billion) with a small portion of sales coming from Ono Pharma in Japan.
Sanofi reported
approximately US$ 43.6 billion (€36 billion) in net sales
for 2020, which rose by 3.3 percent at constant exchange rates even as some of
its flagship products’ sales declined due to generic and
biosimilar competition. Solid performances from Dupixent, vaccines and its
specialty care global business unit across all geographies, more than offset
lower sales.
In
the case of Gilead, while
products like Biktarvy in its HIV
portfolio witnessed a growth of over 50 percent to more than US$ 6 billion,
it was Gilead’s treatment for Covid-19 — remdesivir — promoted under the brand Veklury which went from no sales in 2019 to US$ 2.81 billion in sales in 2020.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Our view
The
human health business of many companies was negatively impacted by the Covid-19
pandemic. However, operating expenses saw a reduction due to lower promotional
and selling costs, as well as lower R&D expenses.
This
year, as Covid vaccines from Pfizer, Moderna, J&J and AstraZeneca are rolled out in more
countries across the world, they are expected to ring in significant
revenue contributions for these companies. For instance, Pfizer recently announced
that it expects US$ 26 billion in revenues from the sale of its vaccine
in 2021. Similarly, Moderna said it expects US$ 19.2 billion in sales from its Covid-19 vaccine this
year.
Given this scenario, the order of the top drug companies and the sales contribution of various drugs will change significantly in 2021. It seems likely that Pfizer’s vaccine will become the best-selling product by sales in 2021 and the American drugmaker will be back among the top five in the global drug companies by sales list.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Impressions: 13450
In 2016, M&A deals
fell drastically in both numbers and value. One key reason was the falling
through of the Pfizer-Allergan mega merger due to America’s crack down on inversion deals.
The year 2015 went down in
history as a record year for mergers and acquisitions (M&As) in the
pharmaceutical and biotech space, when deals worth US $ 300 billion were
announced.
The
highlight of 2015 was the mega-merger announced between US drugmaker Pfizer and
Ireland-based Allergan – the biggest-ever pharma transaction that
was worth more than US$ 160 billion.
2016 saw Pfizer and Allergan walk away from their US$ 160 billion merger when the new US
Treasury rules cracked down on inversion deals that were encouraging US
companies to move overseas to cut taxes.
The merger would have allowed
New York-based Pfizer to cut its tax bill by an estimated US$ 1 billion
annually by domiciling in Ireland, where tax rates are lower.
M&A deals dip by 20
percent in 2016
Although the Pfizer-Allergan
mega-merger did not go through, The Pharma Letter tracked transactions through the year and noted that although “worldwide merger and acquisition activity in the pharmaceutical and biotechnology sector in 2016 was plentiful”, the numbers and values were “well down” on those seen in the previous two years.
The number of transactions announced in 2016 was 130, compared to 166 M&A deals in 2015 – which was a record year – and 137 in 2014, says The Pharma Letter.
Values of the top 10 deals
drop to a third
The other crucial fact about
M&A deals in 2016 was that transactions that exceeded the US$ 1 billion
mark were down to just 23 in 2016, as against 30 in 2015 and 26 in 2014.
The Pharma Letter quotes a
KPMG report published earlier this year which notes that the total value of the
top 10 completed deals in the first half of 2016 amounted to US $ 67.2 billion
as opposed to US $190.4 billion in first-half 2015.
Sanofi-Actelion — the deal that wasn’t
Sanofi made headlines, not for the acquisitions it made, but for the ones it wasn’t able to close.
Late last year, the French
pharma giant was widely identified as the big player that managed to push Johnson & Johnson away from negotiations with Actelion only to lose its US$ 30 billion bid to J&J even though it would have delivered “approximately equivalent value to Actelion’s shareholders”.
The Actelion loss came after Sanofi was out bid by Pfizer for Medivation.
Pfizer agreed to buy the US
cancer drug company for US$ 14 billion in cash, adding its blockbuster prostate
cancer drug Xtandi to
the company's growing oncology roster.
Additionally, Pfizer acquired Anacor for US$ 5.2 billion to add an eczema gel to its portfolio.
Bayer’s US$ 66 billion takeover
The biggest deal announced in
2016 was Bayer’s US$ 66 billion takeover of the US seeds company Monsanto after months of wrangling. It was the German drug and crop-chemical company’s third offer that clinched the deal, which is also known to be the largest all-cash deal on record.
This signature
deal has disrupted the agribusiness sector, which in recent years has been
involved in a consolidation race largely triggered by factors such as shifting
weather patterns, intense competition in grain exports and a souring global
farm economy.
Top pharma companies by sales
Bayer’s acquisition of Monsanto makes the ranking of top pharmaceutical companies consistently complicated since Bayer will generate more sales from its crop
science and high-tech polymer division than from the sale of prescription
drugs.
Should divisions like
diagnostics, animal health, vaccines, consumer health be counted while
determining the size of a pharmaceutical company?
In a volatile global world,
where wild exchange rate fluctuations play their own major role in determining
the size of organizations, this week PharmaCompass
shares the revenues, as presented in the 2016 annual reports of top 15
companies, so that you can draw your own conclusions on the top drug companies
of the world.
Company Name
Currency
Pharma
Consumer Health
Medical Devices/ Diagnostics
Vaccines
Animal Health
Other Revenues
Total Sales
1
Pfizer
USD
41,600
3,407
6,071
1,746
52,824
2
Novartis
USD
48,518
48,518
3
Roche
CHF
41,047
11,589
52,636
4
Merck & Co.
USD
29,360
5,791
3,478
1,178
39,807
5
GlaxoSmithKline
GBP
16,104
7,193
4,592
27,889
6
Johnson & Johnson
USD
33,464
13,307
25,119
71,890
7
Sanofi
EUR
22,932
3,330
4,577
2,708
274
33,821
8
Gilead
USD
29,953
437
30,390
9
Abbvie
USD
25,560
78
25,638
10
Bayer
EUR
16,420
6,037
1,523
22,789
46,769
11
Amgen
USD
21,892
1,099
22,991
12
Astrazeneca
USD
21,319
1,683
23,002
13
Teva
USD
20,664
1,239
21,903
14
Eli Lilly
USD
18,064
3,158
21,222
15
Bristol-Myers Squibb
USD
17,702
1,725
19,427
Sales figures are reported in millions.
Currency exchange rate used CHF: 0.99 USD/ EUR: 1.06 USD / GBP: 1.25 USD
Ranking methodology
When it came to ranking
companies, based on their total sales, we at PharmaCompass did
not face any challenges while including the sales of prescription drugs along
with those of vaccines.
But matters got a little
complicated when we got down to ranking consumer health divisions.
For instance, while we have
included consumer health divisions of companies like Sanofi, GSK and
Bayer, which primarily sell OTC drug products (such as brands like Allegra, Voltaren and Aleve), we have excluded those of companies like Johnson
& Johnson, given their focus on baby and beauty products.
Such a demarcation — based on the focus of the company — will always be a matter of debate.
Similarly, revenue generated
from the sale of medical devices/diagnostics as well as revenues of animal health divisions were not included in our rankings.
In the case of companies like Bayer, whose Covestro’s division has over US$ 10 billion in sales from customer industries such as automotive, construction, electrical and electronics, and furniture, such sales were accounted for in ‘other revenues’.
Our table highlights the sales
revenue of various divisions of companies in order to bring more clarity into the
figures which were included in our rankings.
Impressions: 13665