▎ WuXi AppTec content team editor
Today, industry media Outlets News released a list of the 15 pharmaceutical companies with the most R&D investment in the world in 2021 (The Endpoints R&D 15). The article said that the total R&D investment of the top 15 in 2021 was as high as $124 billion, an increase of 22% compared with 3 years ago. On Endpoints News' list, Roche, Pfizer and Merck (MSD) are in the top three. In today's article, WuXi AppTec's content team will share the details of the list with readers and friends, click "Read more/ Read more" at the end of the article to access the original list page.
Company: Roche
R&D investment: $15.7 billion (up 14% from 2020)
R&D investment accounts for about 23% of sales: 23%
The Endpoints article notes that Roche's R&D investment has increased by 74% over the past 10 years. In recent years, Roche-owned Genentech has recruited Dr. Aviv Regev, a scientist at the Broad Institute, to lead early research and development, bringing new thinking in AI and machine learning to drug development. Dr. Regev shared his thoughts on AI innovation drug development at the WuXi AppTec Global Forum 2021.
Roche's bispecific antibody therapy Vabysmo, which targets angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), was approved by the U.S. FDA this year for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). This is the first bispecific antibody approved by the FDA to treat both ophthalmic diseases.
In addition, the company's bispecific antibody mosunetuzumab, which targets CD20 and CD3, recently received positive advice from the EU EMA Committee on Human Products and is expected to be the first regulatoryly approved CD20/CD3 bispecific antibody.
Company: Pfizer
R&D investment: $13.8 billion (up 47% from 2020)
R&D investment accounts for about the proportion of sales: 17%
The Endpoints article notes that for Pfizer, the most important developments have come from the COVID-19 vaccine Comirnaty and the antiviral therapy Paxlovid. These two products have made an important contribution to saving lives around the world during the pandemic. The company's partnership with BioNTech allows Pfizer to leverage its manufacturing capabilities to take a strong position in the further development of this innovative therapeutic model of mRNA.
In addition to COVID-19 vaccines and antiviral therapies, the company's respiratory syncytial virus (RSV) vaccine has recently received two consecutive FDA-granted breakthrough therapy designations. Its acquisition of Etrasimod, an S1P receptor modulator acquired by Arena Pharmaceuticals, also achieved positive top-line results in Phase 3 clinical trials and plans to initiate regulatory application submissions this year.
Company: Merck (MSD)
R&D investment: $12.25 billion (8% lower than in 2020)
R&D investment accounts for about 25% of sales
In addition to continuing to expand the application range of keytruda, a blockbuster PD-1 inhibitor, Merck is also actively expanding its R&D pipeline. Last year, the company acquired Acceleron Pharma for about $11.5 billion for potential "first-in-class" pulmonary hypertension therapy sotatercept. At a recent investor conference, the company's executives said that the cardiovascular disease field will be outside of cancer, and the company's focus on research and development areas. Its existing cardiovascular disease post-development and product pipeline is three times higher than last year, including oral PCSK9 inhibitor MK-0616, a variety of guanylate cyclase agonists, etc. Eight therapies for cardiovascular disease are expected to be approved by 2030.
Company: Johnson & Johnson
R&D investment: $11.9 billion (Pharmaceutical Division, 24% increase over 2020)
R&D investment accounts for about 16% of sales: 16%
Cilta-cel, a BCMA-targeted CAR-T therapy developed by Johnson & Johnson's Janssen Company in collaboration with Legendary Biologics, was recently approved by the U.S. FDA for the treatment of adult patients with relapsed/refractory multiple myeloma (MM).
The company plans to restructure its structure this year to spin off its consumer health business and focus on R&D innovation. It is expected to submit market applications for 14 potential blockbuster new drugs in the next 3 years.
Company: Bristol Myers Squibb
R&D investment: $11.35 billion (2% increase over 2020)
R&D investment accounts for about 25% of sales
Bristol-Myers Squibb's acquisition of Celgene nearly doubled its R&D investment, which continued to scale last year. The company's LAG-3 antibody therapy, called loosemab, became the first FDA-approved LAG-3 antibody, combined with the anti-PD-1 antibody Opdivo, to treat adults and children (12 years of age and older) with unresectable or metastatic melanoma.
Its R&D pipeline has a number of dulodramine-based molecules to further optimize the production of CELMoD molecules, among which iberdomide and CC-92480 may replace lenalidomide and pomalidomide, which are currently treated for multiple myeloma in the future.
Company: AstraZeneca
R&D investment: $9.73 billion (62% increase over 2020)
R&D investment accounts for about the proportion of sales: 26%
AstraZeneca's collaboration with Daiichi Sankyo on antibody-conjugated drugs (ADCs) continues to yield positive results. Herertu, which targets HER2, not only reduces the risk of disease progression by 72% compared with approved ADCs in clinical trials for second-line breast cancer, but has also recently been granted a priority review by the FDA for the treatment of patients with non-small cell lung cancer with HER2 mutations.
Antisense oligonucleotide therapy (ASO), AZD8233, developed jointly with Ionis Pharamceuticals, reduced low-density lipoprotein cholesterol (LDL-C) levels by 73% in a Phase 2b clinical trial for the treatment of patients with hypercholesterolemia, reaching the primary endpoint of the trial.
Its monoclonal antibody tremelimumab, which targets CTLA-4, has also entered the regulatory review phase and is expected to become the second FDA-approved CTLA-4 antibody.
Company: Novartis
R&D investment: $9.54 billion (6% increase over 2020)
R&D investment accounts for about 18% of sales: 18%
Novartis' targeted radioligand therapy Pluuvicto (lutetium Lu 177 vipivotide tetraxetan) was recently approved by the U.S. FDA as the first targeted radioligand therapy for the treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
At this year's AACR conference, the company presented the results of an active Phase 1 clinical trial of its KRAS G12C inhibitor JDQ443. Among patients receiving the recommended dose of treatment, the ORR was 57% (4/7). Novartis is about to launch a Phase 3 clinical trial to evaluate its effectiveness in treating patients with non-small cell lung cancer carrying the KRASG12C mutation.
Company: AbbVie
R&D investment: $7.08 billion (8% increase over 2020)
R&D investment accounts for about the proportion of sales: 12.5%
The Endpoints article points out that ADC therapy telisotuzumab vedotin, which targets c-MET in the AbbVie R&D pipeline, is one of the R&D projects that has received widespread attention. It was recently recognized as a breakthrough therapy granted by the U.S. FDA for the treatment of specific patients with non-small cell lung cancer. This therapy has the potential to become a blockbuster therapy.
The bispecific antibody epcoritamab, developed in collaboration with Genmab, achieved an objective response rate of 63.1% when treating the cohort of patients with relapsed/refractory large B-cell lymphoma (LBCL).
Company: Eli Lilly and Company
R&D investment: $7.03 billion (16% increase over 2020)
R&D investment accounts for about the proportion of sales: 21%
Eli Lilly's anti-amyloid antibody donanemab for the treatment of Alzheimer's disease has reached a primary endpoint in a Phase 2 clinical trial, slowing clinical progression in patients with early Alzheimer's disease by 32%. Eli Lilly has also launched a rolling application for donanemab seeking accelerated approval from the U.S. FDA.
Another therapy of concern is the GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulin-stimulating polypeptide) receptor dual agonist for the treatment of type 2 diabetes. Eli Lilly has filed a listing application with the FDA in October 2021 and plans to use priority review vouchers. The therapy is expected to be approved by mid-2022. In addition, the therapy is being used in Phase 3 clinical trials to treat obese patients.
The company's IL-13 antibody, lebrikizumab, as a monotherapy or in combination with topical corticosteroids, has yielded positive results in critical Phase 3 clinical trials for the treatment of patients with moderate to severe atopic dermatitis.
Company: GlaxoSmithKline
R&D investment: $6.9 billion (2% increase over 2020)
R&D investment accounts for about 15% of sales: 15%
GlaxoSmithKline recently announced that it will spend about $1.9 billion to acquire Sierra Oncology, which has won the innovative JAK inhibitor menulotinib. It met all major and critical secondary endpoints in a critical Phase 3 clinical trial for the treatment of patients with myelofibrosis and is expected to file a regulatory application in the United States in the second quarter of this year.
In 2021, GlaxoSmithKline's R&D pipeline ushered in two new drugs: PD-1 inhibitor Jemperli and HIV therapy Cabenuva, a long-acting injectable therapy that changes from daily medication to monthly treatment, a major paradigm shift in the treatment of people living with HIV.
Company: Sanofi
R&D investment: $6.2 billion (3% increase over 2020)
R&D investment accounts for about the proportion of sales: 15.1%
The blockbuster IL-4/IL-13 inhibitor Dupixent, developed in collaboration with Regenerator, is expected to continue to expand its use population, and it has been qualified for priority review as an added maintenance therapy for the treatment of children with moderate to severe atopic dermatitis aged 6 months to 5 years. Recently, it has also been qualified for priority review for the treatment of patients with eosinophilic esophagitis over the age of 12.
In addition, the company's monoclonal antibody Enjaymo (sutimlimab-jome), which specifically targets the complement C1s protein, was approved by the U.S. FDA as the first therapy for the treatment of patients with cold lectin disease.
The company's innovative enzyme replacement therapy, Xenpozyme (olipudase alfa), was approved by Japan's Ministry of Health, Labor and Welfare (MHLW), becoming the first approved treatment for acidic sphingosphingolipase deficiency.
Company: Gilead Sciences
R&D investment: $5.35 billion (6% increase over 2020)
R&D investment accounts for about 19% of sales: 19%
Yescarta, a CAR-T therapy developed by Kite, a subsidiary of Gilead Sciences, has recently received FDA approval for the second-line treatment of adult patients with large B-cell lymphoma (LBCL). This is the first approved therapy in nearly 30 years to improve patient outcomes compared to standard therapies.
The company's "first-in-class" antibody-conjugated drug Trodelvy (sacituzumab govitecan-hziy), which targets Trop-2, met a primary endpoint in a Phase 3 clinical trial treating patients with HR-positive/HER2-negative metastatic breast cancer who had undergone multiple pre-treatments.
Company: Amgen
R&D investment: $4.8 billion (14% increase over 2020)
R&D investment accounts for about 18% of sales: 18%
Amgen's two "first-in-class" therapies, KRAS G12C inhibitor Lumakras and asthma therapy Tezspire, were approved for marketing by the FDA last year. At a recent investor conference, the company said it would invest more in human data, multi-specific molecules, and AI-assisted drug development to facilitate the capture of hard-to-target targets.
Potential "first-in-class" therapies in its pipeline include the DL3-targeted bispecific T-cell binder tarlatamab and the IL-2 mutant fusion protein efavaleukin alpha, among others.
Company: Takeda
R&D investment: $4.7 billion (15% increase from 2020)
R&D investment accounts for about 15% of sales: 15%
In 2021, Takeda's oral tyrosine kinase inhibitor Exkivity (mobocertinib) and antiviral therapy Livtencity (maribavir) were approved for marketing by the FDA, respectively, in patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations, respectively. and patients with refractory cytomegalovirus (CMV) infection after hematopoietic stem cell transplantation (HSCT) or solid organ transplantation (SOT) bring new treatment options.
The company has also entered into a series of collaborations to expand the development of new treatment models. For example, the company acquired Gamma Delta Therapeutics, a company dedicated to developing γδT cell therapy, which aims to develop ready-to-use cell therapies for the treatment of solid tumors and hematologic malignancies. The company is also working on multiple collaborations in gene therapies, exploring ways to deliver non-viral vectors, and developing new proteins for gene therapy through artificial intelligence.
Company: Boehringer Ingelheim
R&D investment: $4.5 billion (12.5% increase from 2020)
R&D investment accounts for about 20% of sales: 20%
The SGLT2 inhibitor Jardiance (empagliflozin), jointly developed by Boehringer Ingelheim and Eli Lilly, received FDA approval this year to reduce cardiovascular death and hospitalization risk in adult heart failure patients, providing a completely new treatment option for a wider range of patients with heart failure.
The company's IL-36R inhibitor, spessolimab, has also been granted priority review by the U.S. FDA and is expected to be approved this year for the treatment of episodes of generalized pustular psoriasis (GPP).
Resources:
[1] The Endpoints R&D 15: How many blockbusters does $124B buy the biggest spenders in drug research? (Not enough) Retrieved April 26, 2022, from https://endpts.com/the-endpoints-rd-15-how-many-blockbusters-does-124b-buy-the-biggest-spenders-in-drug-research-not-enough/
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