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ION-SELECTIVE CLINICAL LAB ANALYZERS MARKET ANALYSIS

priyacmi — Tue, 01 Dec 2020 08:39:22 GMT

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

priyacmi — Tue, 01 Dec 2020 08:38:36 GMT

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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Fertility and Pregnancy Rapid Test Kits Market – Insights

priyacmi — Tue, 01 Dec 2020 08:37:44 GMT

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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North America Medical Carts Market – Insights

priyacmi — Thu, 26 Nov 2020 17:28:47 GMT

Medical carts are movable equipment used to carry medical supplies and medical instruments for the management of medical emergencies. These carts are useful and built on a stable and strong platform delivering ultimate solution to healthcare settings such as operating theatres, dental clinics, hospital wards, ICU, and many other medical areas.

North America medical carts market is estimated to account for US$ 751.3 Mn in terms of value in 2019 and is expected to reach US$ 1,698.1 Mn by the end of 2027.

North America Medical Carts Market: Drivers

Increasing healthcare expenditure is expected to boost growth of North America medical carts market over the forecast period. For instance, according to the Centers for Medicare & Medicaid Services (CMS), health spending in the U.S. is projected to grow at an average rate of 5.5 percent per year for 2018-27 and to reach nearly US$ 6.0 trillion by 2027.

Focus on increasing facilities and maximizing operating room utilization is also expected to aid in growth of the market. Medical carts aid in improving the efficiency of surgeons in the treatment of diseases. Moreover, integration of information technology in medical carts helps to manage patient data.

U.S. held dominant position in North America medical carts market in 2018, accounting for 90.7% share in terms of value, followed by Canada.

North America Medical Carts Market: Restraints

Safety issues with battery-powered mobile medical carts are expected to hinder growth of the market. Battery-powered mobile medical carts may catch fire or explode.

Moreover, limited room for new entrants is also expected to limit growth of the market. North America medical carts market is highly fragmented with several market players, which limits the opportunities for new market entrants. New players are required to undergo an initial capital intensive process to enter into the market and to establish an effective distribution network.

North America Medical Carts Market: Opportunities

Increasing cases of trauma, injury, and infection lead to high number of hospitalization cases or hospital visits, thereby offering lucrative growth opportunities for players in the market. For instance, according to World Health Organization (WHO) factsheet in 2018, around 37.3 million falls are recorded, annually worldwide.

Emergence of pandemic and epidemic disease is also expected to aid in growth of the market. For instance, according to the Centers for Disease Control and Prevention, the U.S. recorded 3,487 cases of coronavirus disease as of March 16, 2020.

Computer Medical Cart segment in North America medical carts market was valued at US$ 241.2 Mn in 2019 and is expected to reach US$ 681.3 Mn by 2027 at a CAGR of 14.0% during the forecast period.

Market Trends/Key Takeaways

Manufacturers are focused on offering technologically advanced products. For instance, Stinger Medical offers a Clinical Adoption Support Technology (CAST) app that allows IT personnel to connect directly with the wireless board on each cart and access important operational information about the device (such as utilization, location, and trending information).

Growing number of hospital-based ambulatory surgical centers is boosting growth of the market. For instance, in January 2020, Grady Health System choose Skanska and its joint venture partner H.J. Russell & Co. to build a new Center for Advanced Surgical Services in Atlanta.

Value Chain Analysis

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North America Medical Carts Market: Competitive Landscape

Major players operating in North America medical carts market include, Herman Miller, Inc., Omnicell, Inc., The Harloff Company, Capsa Healthcare, Medline Industries, Inc., Armstrong Medical Industries, Inc., Waterloo Healthcare, Ergotron, Inc., TouchPoint Medical, and AFC industries Inc.

North America Medical Carts Market: Key Developments

Major players in the market are focused on launching new products to expand their product portfolio. For instance, in September 2018, Ergotron, Inc. launched new CareFit Slim Laptop Cart and Slim LCD Cart, the first products to be launched within the company’s CareFit healthcare product line.

Major players in the market are also focused on adopting M&A strategies to expand their portfolio. For instance, in October 2019, Herman Miller, Inc. acquired the remaining shares of Naughtone (Holdings) Limited, a contemporary U.K.-based furniture designer.

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Neuropathic Pain Market – Insights

priyacmi — Thu, 26 Nov 2020 17:27:38 GMT

Neuropathic pain is a complex, chronic pain state that usually is accompanied by tissue injury. It may lead to damage, dysfunction, or injury of nerve fibers, thereby leading to misfiring of signals to other pain centers. The impact of a nerve fiber injury includes a change in nerve function both at the site of injury and areas around the injury.

The global neuropathic pain market is estimated to account for US$ 6,313.4 Mn in terms of value in 2019 and is expected to reach US$ 9,862.3 Mn by the end of 2027.

Global Neuropathic Pain Market: Drivers

High prevalence of cancer is expected to boost growth of the global neuropathic pain market over the forecast period. For instance, according to the World Health Organization, around 18.1 million new cases and 9.6 million deaths were registered due to cancer worldwide in 2018.

Moreover, increasing geriatric population is also expected to aid in growth of the market. For instance, according to the World Health Organization, geriatric population is expected to reach 2 billion by 2050, up from 900 million in 2015.

North America region held dominant position in the global neuropathic pain market in 2019, accounting for 35.9% share in terms of value, followed by Europe.

Global Neuropathic Pain Market: Restraints

Incomplete pain relief is expected to hinder growth of the global neuropathic pain market. For instance, use of strong opioids such as oxycodone in the treatment of neuropathic pain often leads to low reduction in pain.

Moreover, side-effects of medications are also expected to limit growth of the market. Use of opioids and steroids may lead to complications such as heart attack, kidney failure, and damage in lungs.

Global Neuropathic Pain Market: Opportunities

High prevalence of neuropathic-like pain in psoriatic arthritis is expected to offer lucrative growth opportunities for players in the market. For instance, in July 2019, researchers from Cardiff University, U.K., reported that neuropathic-like pain as evidence of abnormal pain processing is common in patients with psoriatic arthritis.

Moreover, R&D in neuropathic pain is also expected to aid in growth of the market. For instance, in March 2020, researchers from Heidelberg University, Germany, reported assessment of the phytochemical composition and the possible prophylactic effects of an aqueous ethanol extract of Haematoxylon campechianum flowers on peripheral neuropathic pain in a chronic constriction injury rat model.

Anticonvulsants segment in the global neuropathic pain market was valued at US$ 2,548.1 Mn in 2019 and is expected to reach US$ 4,310.3 Mn by 2027 at a CAGR of 6.4% during the forecast period.

Market Trends/Key Takeaways

Use of flavonoids can be effective in the treatment of neuropathic pain due to spared nerve injury, spinal nerve ligation, partial sciatic nerve injury, diabetes-induced neuropathy, chemotherapy-induced neuropathy, and chronic constriction injury.

Several studies have demonstrated that electroacupuncture can be effective in decreasing neuropathic pain. For instance, in January 2020, researchers from Huazhong Agricultural University, China, demonstrated that Synaptotagmin 1 (Syt-1), a synaptic vesicle protein for regulating exocytosis of neurotransmitters, impairs neuropathic pain and that electroacupuncture relieves neuropathic pain through down-regulating spinal Syt-1.

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Global Neuropathic Pain Market: Competitive Landscape

Major players operating in the global neuropathic pain market include, Pfizer, Inc., Johnson & Johnson Services, Inc., Sanofi S.A., Eily Lily and Company, GlaxoSmithKline PLC, Biogen Idec., Bristol-Myers Squibb, Baxter Healthcare Corporation, and Depomed, Inc.

Global Neuropathic Pain Market: Key Developments

Major players in the market are focused on approval and launch of new products in order to expand their product portfolio. For instance, in March 2020, Senzer Pharmaceuticals secured the Investigational New Drug application and data package for its ongoing FDA registration program from its former US strategic partner in order to get approval for its cannabinoid respiratory device for the treatment of side effects induced by anti-cancer treatments, specifically nausea, vomiting, and neuropathic pain.

Major players in the market are also focused on conducting clinical trials to expand their product portfolio. For instance, in February 2020, NoNO Inc., a privately-held biotechnology company, reported that novel peptide, nerinetide, without prior administration of alteplase, demonstrated medically important improvements in patients with acute ischemic stroke, in a multicenter, randomized, study.

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Life Science Products Market – Insights

priyacmi — Thu, 26 Nov 2020 17:26:20 GMT

Life science, also referred as biology, is the study of life and living things. It includes anatomy, animal biology, bacteriology, biochemistry, cell biology, ecology, evolutionary biology, genetics, molecular biology, plant biology, physiology, and virology. Life science plays major role in drug discovery, tissue engineering, drug screening, forensic testing, and genetic analysis.

Statistics:

The global life science products market is estimated to account for US$ 4,735.8 Mn in terms of value by the end of 2027.

Global Life Science Products Market: Drivers

Increasing funding in the life science sector is expected to boost growth of the global life science products market over the forecast period. For instance, in February 2020, Purdue-affiliated Amplified Sciences LLC and Brightlamp Inc. received a grant of US$ 250,000 each from the Purdue Foundry Investment Fund for R&D in life science technologies.

Moreover, R&D in rare diseases is also expected to aid in growth of the market. For instance, Oraxion Therapeutics, Inc., a subsidiary of India-based Aten Porus, is undergoing preclinical and efficacy study of the drug, ORX-301, which can be used in the treatment of FSGS. In February 2018, Oraxion Therapeutics, Inc. entered into an Option Agreement with a U.S-based biopharmaceutical company. Under the, agreement, the U.S.-based company gets exclusive rights for further clinical studies and license of ORX-301 in the U.S.

Asia Pacific region held dominant position in the global life science products market in 2019, accounting for 42.6% share in terms of value, followed by North America.

Figure 1. Global Life Science Products Market Share (%), by Region, 2019

Global Life Science Products Market: Restraints

High cost of life science products is expected to hinder growth of the market. Development of novel products in the life science domain requires complex processes, which lead to expensive products.

Moreover, several users do not prefer to invest in such expensive products, especially for research groups with limited budgets and funding, due to the uncertainties in the results expected from complex experiments. Most of the research products procured from different vendors tend to show ambiguous results and products have also been known to have lot-to-lot variability. Therefore, researchers find it difficult to reproduce published research, thereby severely limiting progress of research. Such scenarios are expected to limit growth of the market.

Global Life Science Products Market: Opportunities

Market players may focus on expanding their presence in emerging regions. Biotech projects can be outsourced in emerging economies such as India, owing to significant availability of skilled labor and qualified manpower at affordable costs.

Increasing government initiatives to boost the life science sector is expected to offer lucrative growth opportunities for players in the market. For instance, in March 2020, the U.K. government pledged an investment of US$ 24.57 billion per year by 2024-25 in its budget for R&D investment, including in the life sciences.

Academic & Research Institutes segment in the global life science products market was valued at US$ 1,444.8 Mn in 2019 and is expected to reach US$ 1,967.6 Mn by 2027 at a CAGR of 3.9% during the forecast period.

Market Trends/Key Takeaways

The adoption of big data in the life science sector allowed market players to classify potential clients, thereby allowing them to offer appropriate content and to track the effectiveness of campaigns. However, in May 2018, the EU implemented the General Data Protection Regulation (GDPR), which strengthened the data protection laws. Therefore, market players need to reassess their policies to suit the European market.

The life science sector in Europe has witnessed an increase in the number of patents. For instance, according to the European Patent Office, in 2019, the pharmaceutical sector witnessed a 4.4% rise in number of patents over 2018, whereas and biotechnology sector recorded a rise of 1.7% over 2018.

Regulations

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Global Life Science Products Market: Competitive Landscape

Major players operating in the global life science products market include, Abcam Plc., A.M.S. Biotechnology (Europe) Limited, Bio-Rad Laboratories Inc., BPS Bioscience Inc., Crown Bioscience Inc., Genscript Biotech Corporation, Merck Millipore Limited, PerkinElmer Inc., Sigma Aldrich Corp., and Thermo Fisher Scientific Inc.

Global Life Science Products Market: Key Developments

Major players in the market are focused on launching new products to expand their product portfolio. For instance, in October 2019, Thermo Fisher Scientific Inc. launched Cytomat 2 C-LiN Series Automated Incubator, which is designed to offer cell growth and environmental control across a range of micro plate applications that include cell-based screening, immuno-capture assays, microbiology, and enzyme testing.

Major players in the market are also focused on conducting clinical trials to expand their product portfolio. For instance, in March 2020, Achieve Life Sciences, Inc., a clinical-stage pharmaceutical company, presented additional analyses from the ORCA-1 Phase 2b trial that assessed the efficacy of ‘Cytisinicline’, a plant-based alkaloid with a high binding affinity to the α4β2 nicotine receptor, at the SRNT Annual Meeting in New Orleans (U.S).

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Lysosomal Storage Diseases Therapeutics Market – Insights

priyacmi — Thu, 26 Nov 2020 17:24:15 GMT

Lysosomal storage diseases (LSDs) are a group of rare inherited metabolic disorders that result from defects in lysosomal function. The absence of lysosomal enzymes such as hydrolase responsible for breakdown of specific substrate, its activator or a transporter, result in accumulation of substrates, leading to LSDs. Examples of LSDs include the mucopolysaccharidoses, mucolipidoses, oligosaccharidoses, Pompe disease, gaucher disease, Fabry disease, the Niemann-Pick disorders, and neuronal ceroid lipofuscinoses.

The global lysosomal storage diseases therapeutics market is estimated to account for US$ 7,217.9 Mn in terms of value in 2019 and is expected to reach US$ 15,734.5 Mn by the end of 2027.

Global Lysosomal Storage Diseases Therapeutics Market: Drivers

Significant prevalence of LSDs is expected to boost growth of the global lysosomal storage diseases therapeutics market over the forecast period. For instance, according to a report updated by National Center for Biotechnology Information, in January 2020, the prevalence of Fabry disease in white, male populations was 1:17,000 to 1:117,000. Moreover, classic Fabry disease mutations were evident in around 1:22,000 to 1:40,000 males and atypical presentations were associated with about 1:1000 to 1:3000 males and 1:6000 to 1:40,000 females.

Moreover, increasing awareness regarding rare diseases is also expected to aid in growth of the market. For instance, the European Organization for Rare Diseases celebrates Rare Disease Day annually on the last day of the month of February.

North America region held dominant position in the global lysosomal storage diseases therapeutics market in 2018, accounting for 32.4% share in terms of value, followed by Europe.

Global Lysosomal Storage Diseases Therapeutics Market: Restraints

Geographic dispersal of LSDs hampers efforts to understand the disease, given that certain rare diseases are even rarer in some regions. For instance, birth prevalence of LDSs differ considerably between various countries and population groups—Ashkenazi Jewish Ancestry have high prevalence of several genetic diseases, including some LSDs. Also, there is unusually high prevalence of Mucopolysaccharidosis (MPS) VI, GM1 gangliosidosis and fucosidosis in UAE, owing to ethnic isolation.

Moreover, high cost of enzyme replacement therapy for the treatment of LDSs is also expected to hamper growth of the market.

Global Lysosomal Storage Diseases Therapeutics Market: Opportunities:

R&D in LSDs is expected to offer lucrative growth opportunities for players in the global lysosomal storage diseases therapeutics market. For instance, in February 2020, researchers from BioStrategies LC, State University (U.S.), reported that biodistribution studies in LSD models provide evidence for the theory that the RTB-lectin transports corrective doses of enzymes across the blood–brain barrier for the treatment of central nervous system pathologies.

Moreover, use of advanced technologies in the treatment of LSDs is also expected to aid in growth of the market. For instance, in November 2019, researchers from Nacional Health Institute Doctor Ricardo Jorge, Portugal, reported that CRISPR-Cas9 has great potential for successful disease modelling of sphingolipidoses, an important group of rare diseases among LSDs.

Enzyme replacement therapy segment in the global lysosomal storage diseases therapeutics market was valued at US$ 6,856.2 Mn in 2019 and is expected to reach US$ 14,938.7 Mn by 2027 at a CAGR of 10.0% during the forecast period.

Market Trends/Key Takeaways:

The cost of therapies for the treatment of LSDs is high. For instance, Elaprase was regarded as one of the most expensive drugs by Forbes Index, which costs US$ 375,000 per year whereas Naglazyme costs US$ 365,000/patient/year.

In the U.S., Medicare and Medicaid programs provide good extent of reimbursement for LSDs. Around 84% of prescription drug plans covered under Medicare part D and part B provide reimbursement for orphan drugs for FDA approved indication. For instance, cost of Fabrazyme therapy reimbursed under Medicare part B is 80% of the allowable amount for Fabrazyme, for beneficiaries who administer Fabrazyme at a physician’s office or as hospital outpatient.

Regulations

North America

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Global Lysosomal Storage Diseases Therapeutics Market: Competitive Landscape:

Major players operating in the global lysosomal storage diseases therapeutics market include, Shire plc, Pfizer, Inc., Sanofi, BioMarin Pharmaceutical Inc., Actelion Ltd., Raptor Pharmaceutical Corp., Protalix Biotherapeutics Inc., and Amicus Therapeutics, Inc.

Global Lysosomal Storage Diseases Therapeutics Market: Key Developments:

Major players in the market are focused on adopting M&A strategies to expand their product portfolio. For instance, in January 2020, Quest Diagnostics acquired Blueprint Genetics to expand its product portfolio in genetic and rare diseases.

Major players in the market are also focused on adopting collaboration strategies to expand their portfolio. For instance, in 2019, Amicus Therapeutics, Inc. collaborated with the University of Pennsylvania, under which the company received disease-specific worldwide rights to the university’s Next Generation Gene Therapy Technologies from the Wilson Lab for LSDs and other twelve rare diseases.

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Huber Needles Market – Insights

priyacmi — Thu, 26 Nov 2020 07:17:46 GMT

Huber needles are used for repetitive access to veins for blood withdrawal and infusion of medication, blood products, and nutritional solutions in conjunction with a port implanted in a chronically ill patient body. These needles are designed to pierce the port without dislodging it. Huber needles are widely used in hospitals, oncology centers, clinics and ambulatory surgical centers. These needles are specifically used for medication and nutrition infusion, blood withdrawal, and imaging solution infusion.

Statistics:

The global Huber needles market is estimated to account for US$ 66.1 Mn in terms of value and 51,270,030 Units in terms of volume by the end of 2027.

Global Huber Needles Market: Drivers

Increasing prevalence cancer is expected to boost growth of the global Huber needles market over the forecast period. For instance, according to the World Health Organization, around 18.1 million new cases and 9.6 million deaths were registered due to cancer worldwide in 2018.

Moreover, favorable reimbursement scenario for vascular access needles is also expected to aid in growth of the market. According to the Center of Medicare and Medicaid Services (CMS), reimbursement for chemotherapy administration procedures includes payment for supplies such as Huber needles, IV setup, butterfly set, gauze, syringes, and catheters. Items such as syringes and needles (including huber needles) are often reimbursed by commercial players.

North America region held dominant position in the global Huber needles market in 2019, accounting for 42.1% share in terms of value, followed by Europe.

Figure 1. Global Huber Needles Market Share (%), by Region, 2019

Global Huber Needles Market: Restraints

Risk of infection associated with Huber needles is expected to hamper growth of the market. During the use of Huber needles, the caregiver repetitively needs to access the implanted port and pierce a silicon septum with non-corning Huber needle. The Huber needles pose high risk of needle stick injuries during the removal of needle.

IV Cancer Application segment in the global Huber needles marke t was valued at US$ 16.8 Mn in 2019 and is expected to reach US$ 29.4 Mn by 2027 at a CAGR of 7.2% during the forecast period.

Market Trends/Key Takeaways

Increasing focus on reducing needle stick injuries has led companies to develop and introduce various needles with enhanced safety features in the market. Products with advanced features such as self-retracting needles and needles with safety locking are gaining traction among healthcare professionals and patients.

Moreover, high prevalence of HIV and blood-borne diseases has also led manufacturers to develop safe needles. For instance, according to Joint United Nations Program on HIV/AIDS, 37.9 million people globally were living with HIV at the end of 2018.

Increasing prevalence of end-stage renal disease is expected to boost growth of the global Huber needles market. For instance, according to November 2019 data of National Center for Biotechnology Information, the prevalence of end-stage renal disease is rising at a stable number of about 20,000 cases per year.

Major players in the market are focused on adopting various marketing strategies to expand their customer base. For instance, in February 2020, Baxter International Inc. presented at the 9th Annual SVB Leerink Global Healthcare Conference in New York, N.Y.

Regulations:

U.S.

The U.S. FDA authorizes the use of Huber needles for long term medication infusion and blood withdrawal
Huber needles are type of safety vascular access needles that fall under class II with special controls. However, companies need a premarket approval before commercializing the device.
FDA mandates performance tests for stiffness, bending breakage, corrosive resistance and elasticity of Huber needles
Huber needle manufacturers are expected to submit performance tests in investigational device exemption applications (IDEs) and premarket approval applications (PMAs) to support the safety and effectiveness of Huber needles. These devices require a premarket approval (PMA) application before marketing and commercialization.
According to FDA, the basic structure of Huber needle contains needle, needle cap and needle hub. These needles are either straight type available in gauges 19, 20, and 22, and length 1’’ to 1-1/2’’ or bent 90 degree angle available in gauges 19, 20, and 22, and length 1’’ to 1-1/2’’
FDA has set few standard guideline in order to meet the safety requirement. These devices falls under the category of class II devices (Special Controls) or Class III (PMA).

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Global Huber Needles Market: Competitive Landscape

Major players operating in the global huber needles market include, Baxter International Inc., B. Braun Medical Inc., Smiths Medical, NIPRO Medical Corporation, AngioDynamics, Inc., and C. R. Bard, Inc.

Global Huber Needles Market: Key Developments

Major players in the market are focused on adopting M&A strategies to expand their product portfolio. For instance, in February 2019, B. Braun Medical Inc. acquired Medisystems Streamline Bloodlines business that includes the Streamline Bloodline for the Dialog+ hemodialysis system, Streamline Bloodline for the Fresenius Medical Care hemodialysis system, and Streamline Bloodline Long for the Fresenius Medical Care hemodialysis system.

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Hip Replacement Market – Insights

priyacmi — Thu, 26 Nov 2020 07:14:38 GMT

Hip replacement is a surgical procedure in which the hip joint is replaced by an artificial prosthetic implant. The procedure is called hip arthroplasty. The surgery is generally conducted to relieve joint pain (arthritis) or for the treatment of physical hip joint damage and hip fractures. Hip replacement surgery can be performed as a total replacement or a hemi (half) replacement.

Statistics:

The global hip replacement market is estimated to account for US$ 10,311.3 Mn in terms of value by the end of 2027.

Global Hip Replacement Market: Drivers

Increasing prevalence of musculoskeletal disorders is expected to boost growth of the global hip replacement market over the forecast period. For instance, according to the study, ‘Osteoarthritis year in review 2019: epidemiology and therapy’, published in the journal Osteoarthritis and Cartilage in January 2020, the median proportion of years lived with disability due to musculoskeletal disorders increased from 11.8% in 2000 to 13.5% (9.6–16.6) in 2015.

Moreover, increasing number of knee arthroplasty procedures is also expected to aid in growth of the market. For instance, in 2018, the American Academy of Orthopedic Surgeons (AAOS) and the American Joint Replacement Registry (AJRR) recorded over 1 million patients and over 1.4 million hip and knee arthroplasty procedures.

North America region held dominant position in the global hip replacement market in 2014, accounting for 45.5% share in terms of value, followed by Europe.

Figure 1. Global Hip Replacement Market Share (%), by Region, 2019

Source: Coherent Market Insights Analysis (2020)

Global Hip Replacement Market: Restraints

Stringent regulator scenario regarding marketing of hip replacement is expected to hinder growth of the market. For instance, from May 2016, the U.S. FDA mandated that all manufacturers of metal-on-metal total hip implants are required to stop marketing their devices and submit premarket approvals for approval before marketing the devices.

Moreover, high cost of hip implant products and surgeries is expected to hamper growth of the market. For instance, hip replacement surgery costs around US$ 20,000 to US$ 60,000 in the U.S.

Global Hip Replacement Market: Opportunities

Increasing geriatric population is expected to offer lucrative growth opportunities for players in the global hip replacement market. For instance, according to the World Health Organization, geriatric population is expected to reach 2 billion by 2050, up from 900 million in 2015.

Moreover, increasing number of accidents is also expected to aid in growth of the market. For instance, according to 2018 Fatal Motor Vehicle Crashes: Overview by National Highway Traffic Safety Administration, a U.S. federal agency, 10,511 deaths were registered in the U.S. in 2018.

Total Hip Replacement Implant segment in the global hip replacement market was valued at US$ 4,179.1 Mn in 2019and is expected to reach US$ 6,112.4 Mn by 2027 at a CAGR of 4.9% during the forecast period.

Market Trends/Key Takeaways

The U.S. FDA has not approved any metal-on-metal total hip replacement devices for use in the US. There are two FDA-approved metal-on-metal hip resurfacing devices available, one of which was developed by Smith & Nephew.

In the U.S., government bodies are focused reducing expenditures of common inpatient surgeries for Medicare beneficiaries. For instance, in February 2020, the Centers for Medicare & Medicaid Services issued a proposed rule in the Federal Register proposing a three-year extension and changes to the episode definition and pricing in the Comprehensive Care for Joint Replacement Model.

Regulations

U.S.

According to the U.S. FDA most, but not all, prosthetic components and controls are classified as class I. Almost all class I devices are exempt from premarket notification by FDA, but as such are subject to regulation by the U.S. FDA, Center for Devices and Radiological Health (CDRH).

According to 21 CFR Part (Parts 800-1299) of the FDA’s Product Classification Listings, all prosthetic devices must comply with Federal regulations through FDA/CDRH processes. (Parts 890.3420 and 890.3025), the FDAs product classification listings, external limb prosthestic components, and accessories are defined as physical medicine devices and are generally considered class I devices.

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Global Hip Replacement Market: Competitive Landscape

Major players operating in the global hip replacement market include, Depuy Synthes (Johnson & Johnson), Microport Scientific Corporation, Zimmer Biomet, Exactech Inc., DJO Global Inc., Stryker Corporation, B. Braun Melsungen, and Smith & Nephew.

Global Hip Replacement Market: Key Developments

Major players in the market are focused on expanding their service portfolio. For instance, in February 2020, Smith & Nephew announced 'Positive Connections', a turnkey service to support healthcare providers that are focused on offering increased access for orthopedic cases to Ambulatory Surgery Centers (ASCs) and other outpatient settings.

Players in the market are also focused on launching Artificial Intelligence (AI)-based products. For instance, in December 2019, RSIP Vision, an AI, computer vision, and image processing technology company, launched a new AI-based total hip replacement solution that provides a precise, automated 3D structure of the patients' hip for effective surgery.

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