Major players in the drugs for benign prostatic hypertrophy market are Roche Ltd, Hologic, QIAGEN, Abbott, and Danaher Corporation. The global drugs for benign prostatic hypertrophy market is expected to grow from $4.
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15 billion in 2020 to $4.79 billion in 2021 at a compound annual growth rate (CAGR) of 15.4%. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $6.3 billion in 2025 at a CAGR of 7.1%.
The drugs for benign prostatic hypertrophy market consists of sales of benign prostatic hypertrophy drugs to treat enlarged prostate glands. Benign Prostatic Hypertrophy is commonly seen in men older than age 50.
The rising male geriatric population globally is driving the market for Benign Prostatic Hypertrophy drugs as the condition is commonly seen in men aged over 50 years. According to the United Nations’ 2019 World Population Ageing Report, the number of people aged 65 years or above was 703 million in 2019 and is expected to double to around 1.5 billion by 2050. According to the National Institute of Health(NIH), Benign Prostatic Hyperplasia affects around 50% of men aged between 51 and 60 years and up to 90% of men aged over 80 years.
Increasing adoption of minimally invasive surgeries due to advancements in technology is restraining the growth of Benign Prostatic Hyperplasia drugs market.Minimally invasive surgeries cause less pain and are generally conducted on an outpatient basis.
This eliminates the need to consume Benign Prostatic Hyperplasia drugs, acting as a restraint on the market. Some of the minimally invasive surgeries used to treat Benign Prostatic Hyperplasia include laparoscopic prostatectomy, transurethral microwave thermotherapy (TUMT) and transurethral needle ablation (TUNA).
Combination drugs are increasingly being used in the treatment of Benign Prostatic Hypertrophy as they are more effective and help prevent disease progression.A combination drug includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form.
These drugs reduce the development of drug resistance, have fewer side effects and low treatment failure rate. For instance, Duodart, a combination of dutasteride and tamsulosin hydrochloride is increasingly being prescribed for the treatment of Benign Prostatic Hypertrophy.
Benign prostatic hypertrophy drugs manufacturers globally are regulated by various regulatory bodies.For instance, in the European Union, the EU legislation authorizes medicines based on quality, safety, and efficacy.
Companies are mandated to submit compliance documentation for suitable quality before applying for authorization. Manufacturers are required to demonstrate safety and efficacy of drugs using clinical trials data which will be assessed by competent authorities before authorizing for sale.
Major players in the market are Allergan PLC, Astellas Pharma Inc., Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmithKline PLC
Molecular Diagnostics Devices And Equipment
The global molecular diagnostics devices and equipment market is expected to grow from $7 billion in 2019 to $18 billion in 2020 at a compound annual growth rate (CAGR) of 157.2%. The growth of this market is mainly due to the increased diagnostic testing in laboratories, hospitals, and other testing sites across various country to detect the pandemic COVID-19 virus. The need for rapid diagnostic testing such as molecular and RT PCR based testing to identify people infected by coronavirus is driving the in-vitro diagnostics market. The market is then expected to grow at a CAGR of 8.5% from 2021 and reach $14.4 billion in 2023.
The molecular diagnostics devices (or) equipment market consists of sales of molecular diagnostics devices and related services.Molecular diagnostics devices are used to diagnose infectious diseases and perform screening by detecting specific sequences in DNA or RNA at molecular level.
It helps doctors to prescribe more accurate therapeutic interventions in the early stages of a disease. This market is segmented into instruments, reagents and consumables.
In March 2019, Abbott received a CE mark for its Alinity m molecular diagnostic testing machine. This would allow it to sell the product across Europe.
The major players in the molecular diagnostic industry are focusing on developing automated solutions for devices and equipment’s used for molecular diagnostic processes.Automation of the process will help to enhance productivity and consistency of the whole diagnostic process.
Computerisation of the diagnostic process gives reliable and efficient test results that manual testing by various experts does not.The major players of the industry are using nanotechnology based Oral Fluid Nano Sensor Test (OFNASET).
The test uses a microfluidic-based nano sensor for the detection of oral cancer biomarkers in saliva.In order to keep up with the trend of automation and accuracy, Roche, created cobas connection modules (CCM) to improve scalability and sample-flow efficiency by allowing samples to automatically move between different systems and instruments.
Thus, creating a fully automated work flow.
The Molecular Diagnostic Devices And Equipment market has been geographically segmented into North America, Western Europe, APAC, Eastern Europe, South America and Middle East & Africa. The North American Market is the largest market for Molecular Diagnostic Devices And Equipment and is expected to continue to do so during the forecast period
The growth in molecular diagnostic devices and equipment market is attributed to factors such as rapid rise in various bacterial and viral epidemics.The increase in the spread of diseases increases the demand for early and improved diagnostic methods.
In order to improve the technology to enable early diagnosis of such diseases, Government and different organization’s extend their financial support towards the major key players of the industry. For example, according to the reports from Centres for Disease Control and Prevention (CDC) US, as on March 2019, 72 Zika virus disease cases were reported in U.S state and 148 Zika virus disease cases reported in US Territories. Thus, the rise of such chronic diseases serves as a prime driver for the players in the industry to develop more accurate and sophisticated diagnostic devices and equipment’s. Following the increase in demand of early diagnosis of Zika virus, Co-Diagnostics, Inc. in February 2019 launched its first multi-disease molecular diagnostic test for dengue, chikungunya and Zika.
The regulatory process involving approval of molecular diagnostic tests is often slow.The lack of clear definition coupled with constant changes in the regulations is a challenge for companies developing these kits.
In the developing nations such as India and China lack of well-defined regulatory framework negatively impacts the market, irrespective of the presence of a large population.
The molecular diagnostic devices in the US are approved by Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH).These diagnostics devices are generally approved with an accompanying assay, in order to evaluate their safety and effectiveness or substantial equivalence with reference to the assays they run and the assay’s defined performance parameters.
However, the same instruments do not require FDA approval or clearance when used for basic scientific research-purposes.The European regulatory landscape has become more stringent and technically challenging for medical device companies.
The introduction of four different risk classes of diagnostic device, i.e. classes A-D. Class A refers to lowest risk tests and class D refers to highest risk test such as HIV testing, blood grouping, and prenatal testing. Most of the genetic testing is classed into class C. The products bearing a CE mark, European approved tests, are safe to use and are in full compliance.
In the US market, because of the changes in the rules and regulations, the products already in the market may also be required to go through Food and Drug Administration (FDA)’s pre-marketing approval process.For example, CLIA (Clinical Laboratory Improvement Amendments Act) in the US certifies the validity of a laboratory based tests but it does not regulate the clinical validity of molecular diagnostic tests.
This means that it does not control whether these results are clinically correct. This argument puts a restraint to the industry and opens an argument that FDA should play a greater role in overseeing laboratories.
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