In the first quarter of 2017, the FDA approved 66 antibody drugs, starting with the first antibody drug in 1986. The antibody drug market has soared to $87 billion over 30 years. Antibody drug for many autoimmune diseases and cancer patients has brought better treatment options, in recent years, tumor immunity and the rise of a new type of immunity antibody drug brought new breakthrough treatment, many indications in other therapeutic areas such as multiple sclerosis, asthma, cardiovascular disease, bone disease treatment, etc, also made important progress.
The number of approvals has increased steadily
In 1986, the first antibody drug, the clone OKT3, was approved by the FDA, which opened up a glorious era of antibody drugs. By the end of the first quarter of 2017, the FDA had approved 66 antibody drugs. In 1998, the launch of HER2 antibody Herceptin opened a milestone for tumor targeting therapy, which opened up a whole new treatment for cancer patients. In 2002, the tnf-alpha antibody Humira went public, becoming the first full-body antibody drug, and by 2016, Humira had been the drug king for five times and surpassed lipitor to become the best-selling drug in history. In 2011, the launch of the CTLA4 antibody Yervoy opened the era of immunodetection inhibitors, with the subsequent launch of pd-1 antibody Opdivo and Keytruda in 2014, which brought tumor immunotherapy to new heights. In March 2017, roche's CD20 antibody, ocrevus, became the first drug to be used for the development of the primary progression of multiple sclerosis.
The number of antibody-listed antibodies around the world: new drugs enter the golden age
Rapid market development
Biological drugs have grown rapidly in recent years.
However, after segmentation, it will be found that other categories such as recombinant protein drugs, vaccines and other markets have entered a stable period in addition to antibody and fusion protein drugs.
Nearly 7 years of sales changes in the category of biological drugs: antibodies to the dust
In 2016, the market of antibody drugs reached us $87 billion, and the five-year compound growth rate reached 12.6%.
If integrated protein drugs such as Enbrel and Eylea are included, the total market size in 2016 will exceed $100 billion.
Global antibody drug sales: hundreds of billions of dollars
In the treatment field, cancer and autoimmune diseases are the most important applications of antibody drugs, and the market share is constantly climbing. With the rise of pd-1 / pd-l1 antibody, the rapid development of tumor immunotherapy will further increase the market share of anti-cancer antibody. In the aspect of autoimmune disease, il-17 targets the classic tnf-alpha target in the indication of psoriasis, which can promote the further development of autoimmune disease therapy.
Changes in the sales of antibody drugs in various therapeutic areas: cancer, autoimmune disease is still the most "heavy"
It is important to note that although autoimmune diseases and tumor is still a key battleground of antibody drugs, but in a broader sense of immunology development greatly expand the application range of antibody drugs, such as IL - 4, IL - 5 targets in the breakthrough of asthma indications, CD20 antibody in multiple sclerosis, especially the breakthrough of primary progressive multiple sclerosis, and the rapid development of antibacterial antibody, many new mechanism of antibody medicine will promote the development of diversification of market pattern.
The proportion of antibody drug sales in each therapeutic area: the new mechanism is expected to change the pattern
Change of enterprise competition pattern
The market concentration of antibody drugs is high, and roche, alberi, Johnson & Johnson, bristol-myers squibb, novartis, and mosha east have a combined market share of 80%.
Among them, bristol-myers squibb is the new face of six strong, thanks to the rapid release of the pd-1 antibody. In 2016, Opdivo sold $4.6 billion in global sales, and $3.7 billion in sales of other markets, such as the division of Japan and South Korea, which was the responsibility of bristol-myers squibb. Keytruda global sales of $1.4 billion in 2016. The company has also been singled out for its $900m sales of Opdivo.
Comparison of market share of drug industry antibody drugs: pd-1 rewrote the list of the six companies
All round the antibody drug enterprise competition pattern, roche, abbvie, Johnson & Johnson, novartis antibody drugs giants such as layout for many years, its first antibody drugs have been more than 15 years, time to market is also the main of antibody drug market players.
The most typical of the antibody drugs is bristol-myers squibb. As a traditional small-molecule drugs research and development enterprise, bristol-myers squibb, enter into the field of antibody drug is not a long time, because of the PD - 1 antibodies bets and quickly became a antibody drug giant, on a par with novartis, amgen, etc.
2016 antibody drug market pattern ($1 billion) : traditional giant PK new GUI
Research and development of bio-similar drugs
The author has combed through 40 major blockbuster biologic drugs that are due to expire in recent years. These biological drugs are also the main targets for the development of similar biosimilars.
Main weight of biologic drug patent protection period statistics: biological similar drug development target
Conclusion the < < <
After more than 30 years of development, the antibody drug has become an important part of the global pharmaceutical market and has contributed to the major market expansion. On the one hand, the market concentration of antibody drugs is high, and the monopoly of the monopoly seems "detached". On the other hand, there are many new opportunities and changes in the antibody-drug market, and the new target and new mechanism of antibody drugs are emerging, and the research and development enterprises have a great deal in the field of antibody medicine. At the same time, the patent of the blockbuster antibody drug has expired, and the enthusiasm for the development of the antibody similar drug has been increased, and the market position of the patent antibody drug will be impacted in major markets such as Europe and the United States. |
