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Outlook In The US Market: Current Status And Future Of Infectious Disease Vaccine Development
Jan 28, 2019

Given the impact of vaccination on public health, policymakers and other stakeholders support the development of new vaccine and vaccine production technologies and seek ways to optimize the use of existing vaccines. A recent report from the US Congress summarizes the current prospects for vaccine development. The report concludes that researchers have made significant progress on complex scientific issues involving current and future vaccine production concepts and objectives. The report also recommended support for further development of vaccines. Clearly, an innovative, more flexible public + private capital partnership model is critical to driving the commercialization of vaccine development, especially if there is insufficient incentives in existing markets. In this context, this paper explores three issues: first, the status of the infectious disease vaccine industry; second, which types of companies are participating; and third, what is the impact on the future?


Vaccine industry chain


In October 2017, the US Pharmaceutical Research and Manufacturers (PhRMA) released a list of research and development candidates for 144 infectious disease vaccines. Candidate vaccines for these clinical stages include R&D products from companies in the US, Europe, Japan, Korea, Canada, and Australia, excluding candidate vaccines from manufacturers in developing countries, and manufacturers in developing countries invest less in vaccine development. Often focused on increasing access to vaccines through low-cost production. Investigators used the list as a basis and starting point for reviewing the company's website and clinical trial website. It was verified by various means that 115 drug trial studies were effective and 29 ineffective R&D were deleted (for example, the trial was terminated and the trial was not pressed Planned, or no company capital sponsorship). By looking up the company's website and conducting a cross-reference search with the clinical trial website, 17 trials were included in the statistics, and a data set of 132 trials was obtained (as of February 28, 2018). The 132 vaccine development programs involved 46 different infectious diseases. The top four vaccine programs were influenza (16%; 21), HIV (12%; 16), and respiratory syncytial virus (7%). 9 items) and Ebola virus (6%; 8 items).


In order to roughly estimate the success probability of the infectious disease vaccine development series, the investigators used historical success rates to make projections. According to the previous data, in the Phase I vaccine trial, an average of 22% of the projects may obtain the final marketing approval. After entering the Phase II trial phase, the probability is increased to 30%, and the probability of the project that can enter the Phase III trial is finally successful. It is 64%. Applying these average success rates to the current list of infectious disease vaccines, one can conclude that the vaccine will eventually be licensed from the candidate vaccine pool. In the vaccine trials against 24 pathogens that have not previously licensed vaccines, only three species - C. difficile, Ebola and respiratory syncytial virus - have entered Phase III development. In all the experimental projects under study, not only based on the historical loss rate, it is expected that there will be 19 items that will eventually be approved for marketing.


Vaccine research and development company


The vaccine market is highly concentrated. In terms of US dollars, four pharmaceutical companies: GlaxoSmithKline, Merck, Pfizer and Sanofi Pasteur, account for about 90% of global sales. Other companies rely on government agency support, NGOs or venture capital funds to participate in early stage vaccine development. However, the high cost of late vaccine development, especially in relation to manufacturing, large clinical efficacy studies, and commercialization, often hinders the research of small biotech companies. Conversely, larger biotech or pharmaceutical companies with more financial resources, existing technological capabilities, and convenient production facilities can screen for commercially available vaccines through Phase III R&D trials.


Analysis of the vaccine industry chain by clinical stage and company type can show the dynamics of these vaccine developments. Most Phase I studies (79%) were funded by public and private biotech companies. In Phase II, this percentage fell to 44% and the third phase was further reduced to 29%. For private-capital biotech companies, the share of candidate vaccine trials fell from 47% in Phase I to 16% in Phase II, with only 6% in Phase III. In the research and development phase after Phase II and Phase II, eight large pharmaceutical companies accounted for most of the R&D pilot projects.


For independent private biotech companies with a phase I trial share of 47%, the key source of funding is venture capital or other private investments. Looking back over the past 10 years of history, private investment in companies developing infectious disease vaccines has been mixed. In addition to the two rounds of large-scale financing that PaxVax and the 2015 Moderna Therapeutics have been fortunate in 2015, the average annual investment in private companies developing infectious disease vaccines is $57 million, considering the 21 private companies involved in the statistics. A number is not high.


Multinational pharmaceutical companies are critical to maintaining and expanding the infectious disease vaccine industry. The vaccine business units of these companies must make internal decisions about the allocation of resources between vaccines and all other therapeutic areas. Even among the above-mentioned "big four" companies, vaccines account for only 11-17% of global sales, making vaccines important in their internal operations, but they are not dominant. In the past few decades, to break the market share of the four major companies, other companies have faced enormous barriers, including the huge capital costs and highly specialized personnel required to build and operate vaccine manufacturing facilities. For the development of preventive vaccines for healthy people, clinical trials are demanding and very expensive. A variety of pathogen combination vaccines that are commonly used in pediatrics to minimize the number of injections, as well as barriers to entry, because of the need for channels to obtain multiple antigens. These are the reasons for attracting the four major companies to retain the vaccine business. New companies entering this field need a long-term stable strategic cooperation commitment, in order to have a large amount of capital investment guarantee for a long time.


Future prospects


Building a robust infectious disease vaccine industry chain requires a combination of scientific and technological innovation, private capital investment and public-private partnerships. Science and technology breakthroughs can successfully address the complex needs of vaccine design and immunology, which still seem challenging and illusory to date (eg, HIV vaccines). Although DNA vaccine research is progressing slower than expected, mRNA-based methods still require clinical validation, but molecularly defined nucleic acid vaccines have the potential to significantly reduce the cost-intensive and time-intensive chemical capital investments required to develop vaccines. Regardless of the size of the company, governments and non-profit organizations need to continue to provide support to ensure that infectious disease vaccines can fully realize their potential as public health guards.

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