In 2021, the biopharmaceutical industry has made great progress: by 2022, a total of 128 biopharmaceutical enterprises in the world will be successfully listed; More than 5 billion people have been vaccinated against COVID-19. As a result of these advances, the biopharmaceutical industry will face changes in many areas such as commercialization, financing and portfolio planning. L.E.K. Consulting Company has sorted out five major development trends of the industry according to these changes.
Part 1 Innovation in the field of "advanced therapy"
In the past five years, pharmaceutical enterprises have significantly improved their research on new therapies. The most important developments include:
• CAR-T cell therapy. It is an immunotherapy aimed at stimulating the human immune system to attack tumor cells. It was previously approved for the treatment of DLBCL (diffuse large B-cell lymphoma). The new approvals from the European Drug Administration (EMA) and the US Food and Drug Administration (FDA) will greatly enhance the market potential of these therapies. At present, Gilead, an American pharmaceutical company, and Bristol Myers Squibb (BMS) are neck and neck in CAR-T cell therapy.
• RNA therapy. In 2022, the pharmaceutical industry will continue to strengthen the research on RNA therapy and focus on developing some innovative technologies, such as RNA editing, tRNA, cyclic RNA and mRNA.
• Protein degradation. More and more biopharmaceutical enterprises begin to study protein degradation technologies, such as proteolytic targeting chimeras (PROTACs). They hope to destroy pathogenic proteins through small molecules.
Part 2 Global Price Pressure Continuously Rising
In 2021, many countries have proposed new measures or plans to control drug prices. To this end, the German Federal Government plans to shorten the free pricing period of new drugs under patent protection as stipulated in the Pharmaceutical Market Restructuring Act (Amnog) from 12 months to 6 months. In addition, people are also discussing strengthening the power of medical insurance companies to limit drug costs, and extending the drug price supervision period beyond 2022. In this context, the current discussion on the benefit evaluation of rare disease drugs (orphan drugs) can not be ignored.
In the future, biopharmaceutical enterprises need to carefully balance drug pricing and contract drafting, and agreement signing based on actual value or performance may become the mainstream.
Part 3 New Marketing Concept
The COVID-19 pandemic, the integration of the hospital pattern, the strengthening of political influence and the emergence of advanced treatment methods will force biopharmaceutical enterprises to further improve their marketing methods.
50. E.K. Consulting Company expects that the way products enter the market will change: the traditional marketing model dominated by sales personnel is giving way to a more flexible marketing model, that is, more sales personnel will be replaced by virtual contacts. The epidemic has accelerated this change. At present, this change will continue even after the end of the epidemic, because artificial intelligence and machine learning can capture the dynamic changes of the market more quickly (much faster than sales personnel).
Part 4 Improve diagnosis through biomarkers
Biomarkers are widely used in clinical screening, diagnosis, efficacy evaluation and prognosis prediction tools, it is becoming a key component of the drug market. Especially in the treatment of cancer patients, the application of biomarkers is becoming more and more complex and diversified, such as liquid biopsy can be used for more extensive screening and early diagnosis. Liquid biopsy is not only helpful to detect early cancer, but also can be used to better monitor whether the treatment is really effective. However, the number of patients targeted by these specialized therapies will continue to decrease, so if they want to maintain their income, they must increase the price.
In addition to cancer treatment, the application of biomarkers will also expand to many other fields, especially the treatment of neural, immune and cardiovascular diseases. There is an urgent need for affordable non-invasive tests to diagnose Alzheimer's disease or non-alcoholic fatty liver disease at a very early stage, even before symptoms occur, and biomarkers may be able to meet this need. Some laboratories are already developing such tests, and biopharmaceutical enterprises have begun to include them in clinical trials.
To successfully bring biological drugs to the market, pharmaceutical enterprises must pay attention to the cooperation with laboratories, the availability and cost of testing, and the description of doctors and patients; As early as the R&D stage, the diagnosis strategy must be explicitly included in the R&D and market introduction plan.
Part 5 Development of innovative biotechnology financing
There seems to be a consensus between the United States and Europe that public funds should be reduced and private alternative financing should be increased. Therefore, L.E.K. expects that the number of global biotechnology public offerings (IPOs) will decrease in 2022 after the large increase in 2020 and 2021. In view of the uncertainty of the US stock market, L.E.K. predicts that venture capital investment will continue to maintain a high level, and the so-called "non dilution" financing options will increase, such as monetization of royalties or loan financing.
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