The European Medicines Age ncy (EMA) said on Tuesday it had begun a "rolling review" of Pfizer and BioNTech's Novel Coronavirus booster vaccine.
A "rolling review" means that the EMA evaluates the vaccine in batches after obtaining relevant data until sufficient data are available to confirm the safety, efficacy and quality of the product before it is officially approved for market use.
The vaccines reviewed are bivalent against the two novel coronavirus subvariants BA.4 and BA.5 of Omicron, which is widely circulating in Europe and the United States. Clinical trials of the vaccine will begin this month.
The EMA said last month it had begun a "rolling review" of another vaccine from the two companies, which targets the original SARS-CoV-2 strain and the Omicron subtype BA.1, pending final approval.
German biotechnology company BioNTech reported second-quarter results on Monday that missed market expectations on both revenue and earnings per share, but it reiterated its forecast for vaccine revenue this year.
The bioTech expects to begin delivery of the two vaccines against the Omicron variant of Novel coronavirus as early as October, and said delivery of the vaccines would help stimulate demand in the fourth quarter.
Demand for COVID-19 vaccines is falling as most people in Western countries have already received three or four shots. However, a booster shot for the new Omicron variant will increase demand for the vaccine in the fall.
Although the existing novel coronavirus vaccine can provide good protection and effectively reduce the hospitalization rate and mortality caused by COVID-19, the vaccine effectiveness has been hit by the evolution of the virus. The bivalent vaccine is a new breakthrough.
Eu officials plan to roll out the bivalent vaccine in the coming autumn vaccination season. The EMA expects approval of the new vaccine under review in September.
But the EMA also said it was possible to use a vaccine against the BA.1 variant in the autumn vaccination wave, given the lag in clinical development of vaccines against the BA.4 and BA.5 strains.
Overview of market area prospect of nucleic acid extraction instrument
By region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa (MEA). North America is further divided into countries such as the United States and Canada. The European region is further divided into The United Kingdom, France, Germany, Italy, Spain, Russia and the rest of Europe. The Asia Pacific region is further subdivided into China, Japan, Korea, India, Australia, Southeast Asia and the rest of Asia Pacific. The Latin America region is further subdivided into Brazil, Mexico and the rest of Latin America, and the MEA region is further divided into GCC, Turkey, South Africa and the rest of MEA.
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Analysis and forecast of the market size of PCR diagnostic industry
Polymerase chain reaction (PCR) is a nucleic acid synthesis technology that uses the principle of DNA double-strand replication to replicate specific DNA fragments in vitro. With this technology, the detection equipment can amplify the target gene in a large number in a short time, expanding the target gene fragment to the order of millions to billions, thus achieving high sensitivity detection. At present, polymerase chain reaction (PCR) diagnosis of infectious diseases such as hepatitis, venereal disease, intestinal respiratory disease and tumor single gene detection is an important application field. In 2020, polymerase chain reaction (PCR) diagnostic technology was identified as the "gold standard" for COVID-19 diagnosis due to its high sensitivity and accuracy.
China's PCR diagnostic market is developing rapidly, with the market size growing rapidly from about RMB 2.37 billion in 2015 to about RMB 5.93 billion in 2019, with a compound annual growth rate of 25.8%. China's PCR industry experienced explosive growth due to the huge demand for testing caused by the outbreak of COVID-19 in 2020, and the market size of China's PCR diagnostic industry exceeded 10 billion yuan in 2020. With the introduction of a large number of PCR diagnostic instruments, the PCR diagnostic industry will enter a new stage of development. It is expected that the PCR diagnostic industry will maintain a double-digit growth rate, and the market size of the PCR diagnostic industry will reach about 23.42 billion yuan in 2030 based on the factory price, and the cagR will reach about 13.3% from 2019 to 2030.
Market Demand of the nucleic acid extraction instrument
The DNA/RNA Extraction Kit market and other nucleic acid extraction instrument s are projected to grow at a CAGR of 8.26% during the forecast period 2022-2027.
The COVID-19 pandemic has impacted the nucleic acid extraction instrument market for a short time due to restrictions on different business and research activities for nucleic acid extraction instrument s. In addition, diagnostic tests for other diseases and medical conditions in hospitals and other clinical diagnostic facilities have been affected as COVID-19 has led to fewer patients taking tests. However, the high rate of COVID-19 infection and research activities are undertaken by major companies in the field of sequencing to expand their understanding of the virus and its origins, as well as molecular diagnostics of the SARS-COV-2 virus, have led to the development and launch of many DNA - and RNA-BASED COVID-19 kits, The kits proved so important that they were in great demand.
Market drivers for the nucleic acid extraction instrument
The growth of the DNA/RNA extraction kit market is primarily driven by increased investment in R&D activities in different areas, including molecular diagnostics for different chronic and infectious diseases. For example, the US spent $842 billion on R&D activities in 2020, followed by China at $664 billion, according to the ORGANISATION for Economic Co-operation and Development. Technological advances worldwide, new product launches by major market players, and an increase in cancer cases are also likely to complement the growth of the markets under study.
Other factors, such as increased demand for automation of DNA/RNA extraction technologies, new user-friendly and easy extraction kits, and DNA/RNA for analysis of new diseases causing microorganisms, are expected to drive DNA/RNA growth. RNA Extraction Kit market during the forecast period. Therefore, low awareness and availability of the kit and low market penetration in less developed and developing regions around the world are the major factors limiting the growth of the DNA/RNA extraction kit market.
North America is expected to dominate the global nucleic acid extraction instrument market during the forecast period
North America, which holds a major share in the nucleic acid extraction instrument market, is expected to show a similar trend during the forecast period, mainly due to the high level of R&D activity in the region and the presence of major market players in the region constantly developing their products for the markets studied.
In the region, the US is expected to take a major share of the DNA/RNA extraction kit market due to heavy investment in R&D by government and private entities, increased demand for nucleic acid extraction instrument s, and the rising prevalence of chronic diseases.
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