When the 2020 trend predictions were made in 2019 no one expected the massive epidemic of New Crown pneumonia that would lead to nearly 100 million infections as well as a global economic downturn. Ringing in a year with the launch of the New Crown vaccine and mass vaccination and the urgent approval of antiviral drugs to market …… is not something that can be simply predicted either. So, how will the global neo-crown epidemic head in 2021 from the current perspective? Which area is the most popular among big pharma companies? What about investment and financing trends in the pharmaceutical industry?
GEN, the world’s most influential biotech magazine, has made seven trend predictions for 2021 through interviews and observations.
1,The New Crown Epidemic: Seeing the End
On December 11, 2020, the FDA gave emergency approval to the new crown vaccine jointly developed by Pfizer and BioNtech, and by the end of December, 1,893,400 people had received Pfizer’s vaccine; on December 18, the FDA approved another similar application for the Moderna vaccine; meanwhile, on December 30, the new crown vaccine jointly developed by AstraZeneca and Oxford University was also in the UK On December 30, the new Crown vaccine, developed by AstraZeneca and Oxford University, was approved in the United Kingdom, and universal vaccination was launched on January 4.
Antiviral drugs also received urgent approval in 2020: on October 22, 2020, Gilead’s raltegravir was approved by the FDA for the treatment of adults and children over 12 years of age with neocoronavirus infection. Ridecivir, which was granted emergency use authorization by the FDA back in May, generated global sales of $873 million in the third quarter.
Another drug for the treatment of neo-coronavirus is Regeneron’s neutralizing antibody REGEN-COV2, which received emergency authorization in November and for which Regeneron reported sales of $40.2 million in the third quarter.
Some analysts have released studies that predict a nearly 150-fold increase in vaccinations from 35 million in the fourth quarter of 2020 to 5 billion in the fourth quarter of 2021, as multiple new vaccines are approved.
The question then becomes, where is the market space for anti-neo-coronavirus drugs after multiple vaccines are approved globally in 2021? Should the antiviral drugs in research continue to be researched and prepared for the next “pandemic”, who will support it?
2,Gene therapy: big drug companies, big deals & patient fatalities
If there is one area of concern for big pharma in 2020 that will definitely continue to ferment in 2021, gene therapy is the most likely area.
In October 2020, Bayer announced its proposed $4 billion acquisition of AskBio, a gene therapy technology platform with a clinical pipeline that includes treatments for Pompe disease, Parkinson’s disease and congestive heart failure, as well as unlicensed clinical indications for hemophilia and Duchenne muscular dystrophy.
In the same month, Novartis also acquired ocular gene therapy developer Vedrere Bio for $280 million, and Roche spent $1.8 billion to sign a deal with Dyno Therapeutics to use the latter’s technology platform to develop adeno-associated virus (AAV) vectors for gene therapy in central nervous system (CNS) diseases and liver-targeted therapies.
On December 15, Eli Lilly and Prevail announced an agreement to acquire Prevail, a company focused on the development of potential adeno-associated virus 9 vector-based gene therapies for patients with neurodegenerative diseases, for $1.04 billion, and Lilly will expand its research efforts with this acquisition to create a gene therapy program.
But gene therapy has also been in the spotlight for four patient deaths in 2020, with Astellas announcing two deaths of patients following high-dose AT132 gene therapy in May and June; Astellas announcing another patient death of the same cause in August; and Lysogene announcing the death of a five-year-old girl with mucopolysaccharide storage disorder type IIIA (MPS IIIA) during a clinical trial of LYS-SAF302’s AAV gene therapy in October.
Both of these clinical trials are still on hold, and no accurate predictions have emerged as to where they will go in 2021.
Even so, Alliance for Regenerative Medicine statistics show a 114% increase in funding between January 2020 and September 2020, to $12 billion.
3,Gene editing: a huge partnership
In November 2020, Eli Lilly entered into a potentially up to $2.7 billion partnership with gene editing company Precision BioSciences, opening the way for gene therapy for Duchenne muscular dystrophy (DMD).
A commercial research firm released a market report on Nov. 20 predicting that the global market for CRISPR technology will grow from $1.65 billion in 2020 to $2.57 billion in 2023, then jump to $6.7 billion by 2030.
In foreign countries, CRISPR technology is considered to be a duel between China and the United States in biomedical development, known as the “Sputnik 2.0” competition, “Science” magazine statistics, the United States holds 872 patent applications related to CRISPR, followed by China to 858.
4,Investment and financing: a large inflow of funds
Previously, E Drug Manager had statistics on domestic pharmaceutical industry investment and financing in 2020, an unprecedented 75 companies made IPOs in a year, 2.68 times more than the previous year, and despite the epidemic, the annual investment and financing amount did not decline significantly, with a total disclosed amount of 135 billion yuan in 2020 and 164.982 billion yuan in 2019.
The same is true abroad, with GEN Magazine concluding that there was a significant flow of capital into biopharmaceutical companies in 2020, with strong growth in M&A and IPO activity, a trend that will continue in 2021.
The MoneyTree Report, a quarterly publication from PwC and CB Insights, shows that a record $5.9 billion was invested in the biopharma-related sector in the third quarter of 2020, with $3.9 billion invested in 104 deals in biotechnology alone, more than double the 74 deals and $1.9 billion in the third quarter of 2019.
The IPO market is also showing strength in 2020, with Nasdaq seeing biopharma companies raise $9.32 billion in 51 IPOs in the first three quarters of 2020, more than double the 41 IPOs, or $3.6 billion, in the first three quarters of 2019, according to EvaluatePharma. Overall, biotech stocks continue to grow during 2020. As of Nov. 20, the Nasdaq Biotechnology Index stood at 4,364.15 points, up 22 percent from 3,581.05 points a year ago.
Notably, both Skylanders Bio and Legendary Bio were included in the NASDAQ Biotechnology Index in December 2020.
5,Drug development: whether new Alzheimer’s drugs are approved
The biopharmaceutical industry abroad is concerned that the new Alzheimer’s drug aducanumab, which has gone through a lot of twists and turns in 2020, has finally submitted its marketing application, but there is also speculation whether the drug will be approved in 2021, and the forecast given by Biogenic is that a decision on whether the FDA will approve it is expected on March 7, 2021.
In November 2020, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee declined to approve aducanumab because the FDA usually approves drugs with two valid studies with supporting evidence, and only one of the drug’s two phase III clinical trials showed positive results.
6,Cellular therapeutics: Financing is growing at an alarming rate
MNC is also spending big on cellular therapies in 2020. in September, Takeda announced it would cut costs by about $2 billion a year by the end of 2021 to focus on oncology and rare disease drug development, a strategy that hinges on next-generation cellular therapies. has opened a 2,000-square-meter R&D and manufacturing center in Boston that will be responsible for the clinical development of three ongoing pipeline programs, with two additional programs expected to enter clinical development by the end of 2021.
in October, Astellas announced that it will open a $120 million R&D center in Massachusetts focused on cellular therapies
In November, Sanofi acquired Dutch cell therapy company Kiadis Pharma for a total of 308 million euros ($358 million), gaining access to the latter’s NK (natural killer) cell platform and products.
Funding for cellular therapies is growing at an alarming rate. According to Alliance for Regenerative Medicine, funding for cellular therapies reached $11 billion for the year ending November 2020, a 242% increase over the same period. The number of Phase I clinical trials for cellular therapies increased from 41 to 50.
Of course, CAR-T products, and even the price of cell therapy is still controversial, the world’s first CAR-T product Novartis’ Kymriah one-time fee of $475,000 (equivalent to RMB 3.078 million), for the average patient is still a high treatment fee.
7,Synthetic biology: great potential
Synthetic biology revolves around the logic of the functioning of living organisms, using the laws and modus operandi to manually “modify” organisms in order to give them the desired function and value.
According to SynBioBeta, the total funding for synthetic biology reached $3.041 billion in the first half of 2020, compared to $1.9 billion in the same period in 2019.
Of course, the growth of synthetic biology comes from its diverse technology application directions, which are used in several fields including the aforementioned cell therapy, gene therapy, and CRISPR.
According to data analyzed by CB Insights, the global synthetic biology market reached $5.3 billion in 2019. The synthetic biology market size is expected to grow at a compound annual growth rate (CAGR) of 28.8% to reach $18.9 billion by 2024, compared to 2019.