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SYNTHETIC HORMONES MARKET ANALYSIS
Synthetic hormones are foreign substances, synthesized in the laboratory and are used for the treatment of hormonal imbalance in the human body. Hormones such as progesterone, estrogen, thyroid hormone, testosterone, and insulin are some of the synthetic hormones used widely for different health conditions. Some examples of the synthetic hormones available in the market are Ferring B.V. product Zomacton injection (Somatropin) which is used to treat growth hormone deficiency in children. Moreover, IBSA Institute Biochimique SA’s product, Tirosint, is also available as a liquid levothyroxine formulation for the treatment of hypothyroidism in individuals suffering from deficiency of thyroid hormone. Some of the manufacturers operating in the global synthetic hormones market are Pfizer Inc., McGuff Pharmaceuticals, Inc. and others.
Global Synthetic Hormones Market Drivers
Leading manufacturers are indulged in the development of new products in the global synthetic hormone market. For instance, Lyndra Therapeutics Inc. completed pre-clinical trials for an oral contraceptive pill in December 2019. The contraceptive pill is made of a gelatin capsule, which when ingested, produces a star-shaped polymer and releases the synthetic hormones for three weeks in order to prevent pregnancy.
In October 2019, Mayne Pharma signed a 20?year exclusive supply and license agreement with Mithra Pharmaceuticals, SA (Mithra) to commercialize a novel oral contraceptive comprising Estetrol (E4), and Drospirenone, (E4/DRSP) in the United States. The product is expected to be launched in 2021 post U.S. Food and Drug Administration’s (U.S. FDA) approval. Lupin Pharmaceuticals, Inc. received approval from the U.S. FDA in April 2019 for the Testosterone Gel (Strength 1.62%) which is a generic version of AbbVie, Inc.’s (AbbVie) AndroGel 1.62%. It is used for hormone replacement therapy in males who are incapable of producing endogenous testosterone.
According to the Global Reproductive Health, International Federation of Fertility Societies, 2018, prevalence of menopausal hot flashes have been increasing in the United States. Around 23 million women in the age group of 45 to 55 years are expected to experience menopausal symptoms like heavy or irregular bleeding, breast tenderness, and hot flashes, which will increase more physician visits. According to National Center for Biotechnology information (NCBI), 2018, increasing incidence of irregular menstrual cycles has led to an increase in use of oral contraceptives, birth control pills, birth control shots, vaginal rings, hormonal intrauterine devices (IUD) etc. According to American Thyroid Association, 2019, 12% of the U.S population will develop some kind of thyroid condition in their lifetime, and around 20 million Americans have been diagnosed with some kind of thyroid disorders. These factors are expected to boost the global synthetic hormone market growth over the forecast period.
Global Synthetic Hormones Market Restraints
According to National Center for Biotechnology Information (NCBI), 2017, some anti-depressants (non-hormonal) such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) (paroxetine (Paxil), citalopram (Celexa) and escitolapram (Lexapro)) were reported to show a decrease in severity of hot flashes in menopausal as well as post-menopausal women compared to synthetic hormones.
The cost effectiveness of the hormonal replacement therapy is one of the important restraining factor. According to NCBI, at least 18 tablets of Vagifem has to be used by the patient per month, therefore, the cost of the medicine per month comes down to $400 – 500 while Paroxetine is to be taken once daily per month, and hence the cost of 30 tablets comes down to $50 – 100. Moreover, Paroxetine is available as an oral dose while Vagifem is a vaginal insert. Hence, patients prefer the oral route of administration over the inserts.
Global Synthetic Hormones Market Regional Analysis
North America is expected to witness significant growth in the global synthetic hormones market over the forecast period owing to widespread presence of several key manufacturers across North America and a large customer base. Moreover, key players are engaged in development and introduction of generic products in the region. For instance, Teva Pharmaceutical Industries Ltd., launched generic version of Vagifem (estradiol vaginal inserts) in the U.S. in July 2019 which is indicated for the treatment of atrophic vaginitis in menopausal women.
Moreover, Clarus Therapeutics, a manufacturer in the U.S., recently received an U.S. FDA approval in March 2019, for the production of a soft gel capsule containing prodrug for the hormone testosterone which will be useful for the hormone replacement therapy in hypogonadal males. Other manufacturers like Pfizer Inc., McGuff Pharmaceuticals, Inc., Lyndra Therapeutics, Inc., American Regent, Inc., Acerus Pharmaceuticals Corporation and Lupin Pharmaceuticals have presence in North America.
The increasing incidence of hormonal imbalance in the population is expected to support growth of the North America synthetic hormones market. Highest incidence of hormonal imbalance have been recorded in the North America region. According to the Global Reproductive Health, International Federation of Fertility Societies, 2018, in the U.S., around 70 million women are over the age of 45 years, out of which, around 58.8% of women are expected to experience hot flashes during the menopausal and post-menopausal stage. Therefore, increasing incidences of hormonal imbalance across North America are expected to boost the global synthetic hormones market over the forecast period.
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Global Synthetic Hormones Market Key Players
Some of the key players operating in the global synthetic hormones market are Pfizer Inc., McGuff Pharmaceuticals, Inc., Lyndra Therapeutics, Inc., Ferring B.V., Slayback Pharma LLC, American Regent, Inc., Endo Pharmaceuticals Inc., IBSA Institute Biochimique SA, Acerus Pharmaceuticals Corporation, and Lupin Pharmaceuticals, Inc.
Market Taxonomy
By Product Type
· Steroid Hormones
· Peptide Hormone
· Amino Acid Derivatives
· Others
By Route of Administration
· Oral
· Nasal
· Topical
· Intravenous
By Application
· Growth Hormone Deficiency
· Thyroid Hormone Deficiency
· Menopause
· Male Hypogonadism
· Others
By End User
· Hospital Pharmacies
· Retail Pharmacies
· Online Pharmacies
By Region
· North America
· Latin America
· Europe
· Asia-Pacific
· Middle East
· Africa
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ION-SELECTIVE CLINICAL LAB ANALYZERS MARKET ANALYSIS
An ion selective analyzer comprises of ion selective electrode (ISE) and is an analytical technique used to determine the activity of ions in aqueous solution by measuring the electrical potential. It has application in the field of pharmaceuticals and biotechnology. There are four types of ISE glass electrode, crystalline electrodes, ion-exchange electrodes, and enzyme electrodes. A common example of ISE is the pH Electrode. The pH electrode is the commonly used and it consists of a thin glass membrane which calculates the H+ concentration in a solution. Orion Versa Star Pro pH/ISE is an example of ISE and is manufactured by Thermo Fisher Scientific Inc. It is used for the measurement of routine pH and ion concentration.
Moreover, Beckman Coulter, Inc. manufactures and markets reagents such as buffer, high/low serum standard, high/low urine standard, internal reference solution and Na+ /K+ selectivity check solution for the quantitative determination of sodium, potassium and chloride concentrations in human serum and urine on the Beckman Coulter ISE modules. Some of the other manufacturers are Van London Company, Abbott Point of Care Inc., and others.
Global Ion-Selective Clinical Lab Analyzers Market Drivers
Leading manufacturers in the global ion-selective clinical lab analyzers market are focused on the development of products. For instance, Erba Mannheim launched EC90, a new electrolyte analyzer in February 2020 at the MEDLAB Middle East trade fair. The EC90 analyzer contains maintenance free electrode, cleaning of the pack is not required, and waste is self-contained. Moreover, it can analyze samples in 35 seconds.
In 2017, Beckman Coulter Diagnostics, announced the U.S. Food & Drug Administration (FDA) approval and commercial launch of its new DxC 700 AU chemistry analyzer in the U.S. The analyzer has combined features of two Beckman Coulter products; DxC analyzer and AU analyzer. Moreover, the system also uses concentrated reagents, ISEs which are long lasting, and non-disposable cuvettes. Horiba, Ltd received premarket notification for marketing Yumizen C1200, in 2019. Yumizen C1200 is an automatic chemical analyzer that measures analytes in samples, in combination with reagents, calibrators, quality control (QC) material and other accessories. It consists of glucose HK, sodium electrode, potassium electrode, and chloride electrode. The device is useful in the diagnosis of levels of sodium, potassium and chloride in blood and urine samples.
Other advantages of using ion selective electrodes over other methods are that they can be used for a sample size of 0.1 to 10,000 ppm. Moreover, they are shock-proof and chemical-resistant, upon calibration, and one can monitor concentration continuously and analyze the sample within 1 to 2 minutes. The above factors are expected to drive the global ion selective clinical lab analyzers market growth over the forecast period.
Global Ion-Selective Clinical Lab Analyzers Market Restraints
Manufacturers are focused on modifying conventional ISE in order to reduce the drawbacks of the technique which include the selective membrane used in the ISE, which can allow the entry of more than one type of ion at a time, and the electrodes have to be replaced periodically. Moreover, ISE calculates ions when they move across the membrane. In case of dilute solution the number of ions near the membrane would be less than the ions present in the bulk solution. Therefore, the membrane potential recorded may get altered in both the cases.
Global Ion-Selective Clinical Lab Analyzers Market Regional Analysis
North America is expected to dominate the global ion-selective clinical lab analyzers market over the forecast period as manufacturers are focused on the development and introduction of ion selective clinical lab analyzers in the North American region. For instance, Thermo Fisher Scientific Inc. launched a premium Thermo Scientific Orion Ammonia Ion Selective Electrode in 2018. The new electrode can detect ions in low concentration as it is sensitive to ions and requires less electrode maintenance. It is an ideal product to use in drinking water and wastewater laboratories.
Moreover, Beckman Coulter Diagnostics received U.S. FDA approval for its DxC 700 AU Chemistry Analyzer in 2017. The DxC 700 AU system was initially available in the U.S. before 2017. Abbott Point of Care Inc.'s product i-STAT which is a handheld device, can perform blood analysis in four steps. The advantage of i-STAT over benchtop analyzers is that it provides faster results. The above factors are expected to boost the global ion – selective clinical lab analyzers market growth over the forecast period.
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Global Ion- Selective Clinical Lab Analyzers Market Key Players
Some of the key players operating in the global ion–selective clinical lab analyzers market are Thermo Fisher Scientific Inc., Van London Company, Abbott Point of Care Inc., Beckman Coulter, Inc., Diagnostika Pilipinas Inc. F. Hoffmann-La Roche Ltd, ECD, Alfa Wassermann Inc., Pointe Scientific, Inc., Metrohm AG, and Medica Corporation.
Market Taxonomy
Based on Product Type, the global ion–selective clinical lab analyzers market is segmented into:
· Ion –Selective Membranes
· Ion – Selective Electrodes
· Reagents
· Disposables
Based on Application, the global ion–selective clinical lab analyzers market is segmented into:
· Clinical Chemistry
· Hematology
· Urine Analysis
· Others
Based on End User, the global ion–selective clinical lab analyzers market is segmented into:
· Hospitals
· Diagnostics Centers
· Pharmaceutical and Biotechnology Companies
· Academics and Research Centres
Based on Region, the global ion–selective clinical lab analyzers market is segmented into:
· North America
· Latin America
· Europe
· Asia Pacific
· Middle East
· Africa
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IMMOBILIZED TRYPSIN MARKET ANALYSIS
Trypsin is a serine protease enzyme (EC number of 3.4.21.4), which hydrolyses esters of basic amino acids such as lysine and arginine in the peptides. Optimal temperature for trypsin activation is around 37 degrees Celsius and its optimal pH is around 7.5 to 9.0. Trypsin is available in the form of immobilized enzyme where it is attached to an inert support such as dextran, sephadex, cellulose, starch etc. Immobilized Trypsin is supplied in preservatives such as glycerol and sodium azide as a slurry. It finds applications in research for the purpose of protein identification, protein characterization, study of post translational modifications, and protein-protein interactions.
There are many manufacturers producing immobilized trypsin like Thermo Fischer Scientific who manufactures immobilized trypsin, treated with L-1-tosylamido-2-phenylethyl chloromethyl ketone (TPCK) to inhibit chymotrypsin activity without altering the activity of trypsin, in order to prevent contamination. Some of the other manufacturers are Promega Corporation, Merck KGaA, etc.
Global Immobilized Trypsin Market Drivers
Leading manufacturers are involved in manufacture of immobilized trypsin enzyme with the reduced time of incubation in the global immobilized trypsin market. For example, the immobilized trypsin manufactured by Geno Technology Inc. and Promega Corporation requires a sample to be incubated in the spin columns for 2-18 hrs. And for 30 mins at 37 degrees celsius, respectively. In case of, Merck KGaA manufactured product, trypsin spin columns with immobilized trypsin, the sample has to be incubated in the columns for 15 mins at room temperature. Therefore, the incubation time of the sample with the immobilized trypsin has been decreased in case of Merck KGaA manufactured product. This can benefit the researchers by rapid protein digestion for protein analysis.
Immobilized trypsin finds many applications in fundamental research. For instance, it is used in affinity chromatography for the purification of trypsin inhibitors from the solution. Immobilized trypsin finds many applications in research for studying protein – protein interactions as well as protein identification in systems biology to identify drug targets in the cells. Therefore, use of immobilized trypsin offers an advantage in scientific research as the technique is cost-effective. Apart from these applications, immobilized trypsin is used in other fields such as to identify the post translational modifications. Other advantages of using immobilized trypsin are, easy to use, wide spread availability, and high specificity. The above factors are expected to boost the global immobilized trypsin market growth over the forecast period.
Global Immobilized Trypsin Market Restraints
According to the National Center for Biotechnology Information (NCBI), 2017, disadvantages of using trypsin are autolysis, intolerance to high temperatures or organic solvents and missing out on particular sites of post-translational modifications, protein segments or even subsets of proteins. To overcome this drawback, other enzymes are being tested for the catalytic function, which would act as an alternatives for immobilized trypsin. For instance, according to National Centre for Biotechnology Information, (NCBI), 2016, the catalytic function of the six proteases (Chemotrypsin, LysC, LysN, AspN, GluC and ArgC,) was researched and the proteases have been shown to offer promising results. The above factors are expected to restrain the global immobilized trypsin market growth over the forecast period.
Global Immobilized Trypsin Market Regional Analysis
North America is expected to witness significant growth in the global immobilized trypsin market over the forecast period, owing to the manufacture of modified immobilized trypsin enzyme with increased throughput and confidence in results. For instance, in 2015, Thermo Fisher Scientific launched, Thermo Scientific Digest Kit, a protein analysis kit useful for applications related to biopharmaceuticals. The kit includes a thermostable immobilized trypsin for reducing digestion time and for reproducing high-quality data.
Moreover, headquarters of key manufacturers have wide-spread presence in the North America region. For instance, Promega Corporation, Merck KGaA, and Thermo Fisher Scientific are located in the U.S. Therefore, the above factors are expected to boost the global immobilized enzymes market growth over the forecast period.
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Global Immobilized Trypsin Market Key Players
Some of the key players operating in the global immobilized trypsin market are Promega Corporation, Merck KGaA, Geno Technology Inc., and Thermo Fisher Scientific
Market Taxonomy
By Types (Digestion Time)
· Immobilized Trypsin (2 – 18 hrs.)
· Immobilized Trypsin (30 minutes)
· Immobilized Trypsin (15 minutes)
By Application
· Protein Identification
· Protein Characterization
· Protein: Protein Interactions
· Others
By Region
· North America
· Latin America
· Europe
· Asia Pacific
· Middle East
· Africa
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Source https://www.coherentmarketinsights.com/ongoing-insight/immobilized-trypsin-market-3460
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Fertility and Pregnancy Rapid Test Kits Market – Insights
Pregnancy and fertility rapid tests are the point of care tests used in male and female to qualitatively detect the presence of reproductive hormones such as FSH, LH and hCG either in urine or blood sample.
To perform rapid pregnancy or fertility tests, small amount of blood or urine sample is required, depending upon the type of device being used. These devices work on color changing immunoassay techniques.
The global fertility and pregnancy rapid test kits market is estimated to account for US$ 1,217.5 Mn in terms of value in 2019 and is expected to reach US$ 1,653.5 Mn by the end of 2027.
Global Fertility and Pregnancy Rapid Test Kits Market: Drivers
High incidence of infertility is a major factor boosting growth of the global fertility and pregnancy rapid test kits market over the forecast period. For instance, according to the National Survey of Family Growth data published in September 2018, 15.5% of all women who intend to become pregnant are infertile and 6.7% of married women aged 15 to 44 years are infertile, in the U.S.
Moreover, increasing incidence of gynecological disorders is also expected to aid in growth of the market. For instance, according to the Centers of Disease Control and Prevention’s U.S. Cancer Statistics September 2019, around 94,000 women were diagnosed with gynecologic cancer each year, in the U.S., between 2012 and 2016.
North America region held dominant position in the global fertility and pregnancy rapid test kits market in 2018, accounting for 50.7% share in terms of value, followed by Asia Pacific.
Global Fertility and Pregnancy Rapid Test Kits Market: Restraints
Lack of buyers in emerging economies is expected to hinder growth of the global fertility and pregnancy rapid test kits market. In spite of high infertility rates in countries such as South Africa, Nigeria, Bangladesh, and Morocco, lack of awareness towards fertility and pregnancy rapid test products as well as inability to buy products due to economic insufficiency can hamper growth of the global market to a certain extent.
Moreover, the market for fertility and pregnancy test products is highly competitive, with number of established and local players striving to maintain their market shares. Over 300 brands are available in market for fertility or pregnancy testing, which can lead to a problem of plenty, wherein consumers cannot choose one brand and instead opt for alternative laboratory tests. This can significantly reduce consumer base and thus, lead to decline or stagnation in market.
Global Fertility and Pregnancy Rapid Test Kits Market: Opportunities
Devices for pregnancy and fertility rapid tests are not covered in most pregnancy coverage policies or health insurance. Cost of pregnancy and fertility rapid test devices are comparatively high in the U.S. and Europe. Therefore, effective reimbursement policies and reduction in costs is expected to offer lucrative growth opportunities for players in the market.
Direct-to-consumer (DTC) medical tests can be an affordable option help low income countries. Therefore, players in the market can focus on introducing DTC medical tests.
Pregnancy rapid tests segment in the global fertility and pregnancy rapid test market was valued at US$ 678.1 in 2018 and is expected to reach US$ 951.4 Mn by 2027 at a CAGR of 4.3% during the forecast period.
Market Trends/Key Takeaways
Manufacturers are offering pregnancy test kits with dual capability as well as combined packs of fertility and pregnancy tests, which can be used to qualitatively detect the presence of hCG hormone in both urine and serum/blood. For instance, various products such as QuickVue hCG Combo, Test & Confirm, and ICON 25 hCG are available that offer dual capability.
Major players in the market such as Alere and Swiss Precision Diagnostics GmbH are employing co-promotions and co-marketing strategies to expand their commercial presence in the global market. For instance, SPD GmbH co-market their products with Alere Inc. in India and with Boots Pharmaceuticals in the U.K.
Regulations
U.S.
Pregnancy test devices are classified by FDA as hCG tests system under 21 CFR, section 1155(a)
Pregnancy and fertility rapid test devices fall under subpart B- Clinical Chemistry Tests Systems in Class II and class III medical devices
Pregnancy and fertility test devices are thus subject to FDA review for premarket approval (PMA) under section 510 (k) of Federal Food drug and Cosmetics Act and the submitter may market the device immediately after 510(k) clearance is obtained
The submitter of 510 (k) for the sale of medical devices in U.S. market can be a domestic manufacturer, specification developer, re-packer or re-labeler and foreign manufacturer/exporter
As per medical devices amendment of 1976, manufacturer of class II and class III devices need to submit PMA for all changes in device that affect safety and effectiveness under new section 515 (d)(6) of FDA Modernization act
Fertility rapid test devices are classified under 21 CFR, section 862.1300 as Follicle Stimulating hormone test systems and section 862.1485 as Luteinizing hormone test system
As per amendment of May 2000, these devices are exempted from premarket notification in subpart E of part 807, chapter I of FD& C Act
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Global Fertility and Pregnancy Rapid Test Kits Market: Competitive Landscape
Major players operating in the global fertility and pregnancy rapid test kits market include, SPD Swiss Precision Diagnostic GmbH, DCC Plc., Procter & Gamble, Abbott Laboratories, Alere Inc., Quidel Corporation, bioMérieux SA, Church & Dwight Co., Inc., Prestige Brands Holdings, Inc., and Geratherm Medical AG.
Global Fertility and Pregnancy Rapid Test Kits Market: Key Developments
Players in the global fertility and pregnancy rapid test kits market are focused on raising funds to expand their product portfolio. For instance, in August 2019, Dadi, a health company that offers male fertility testing and sperm storage, announced the close of a US$ 5 million investment.
Players in the market are also focused on lunching new products to expand their product portfolio. For instance, in January 2019, Medical Electronic Systems announced availability of its YO Home Sperm test for PC platforms
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Email: [email protected]
Source: https://www.coherentmarketinsights.com/market-insight/fertility-and-pregnancy-rapid-test-kits-market-3456
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