#Rare hematology disorders market trends
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Innovations and Developments Shaping the Future of the Paroxysmal Nocturnal Hemoglobinuria Market
Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare, life-threatening hematologic disorder characterized by the destruction of red blood cells, a process known as hemolysis. This condition is caused by a mutation in the PIGA gene, which leads to the absence of certain proteins on the surface of blood cells. As a result, these cells become vulnerable to attack by the body's own immune system. Paroxysmal Nocturnal Hemoglobinuria often presents with symptoms like dark-colored urine, fatigue, and an increased risk of blood clots, making early diagnosis and treatment crucial.
The market size for paroxysmal nocturnal hemoglobinuria was projected to be 0.36 billion USD in 2022 based on MRFR study.It is anticipated that the market for paroxysmal nocturnal hemoglobinuria would increase from 0.39 billion US dollars in 2023 to 0.7 billion US dollars in 2032. During the projected period (2024-2032), the Paroxysmal Nocturnal Hemoglobinuria Market is anticipated to increase at a CAGR of around 6.73%.
The size of the affected population is small due to the rarity of this disease. PNH primarily affects adults, with an estimated global prevalence of 1-10 cases per million people annually. However, the true size of the affected population might be underreported due to misdiagnosis or delayed diagnosis. Despite its rarity, the impact of Paroxysmal Nocturnal Hemoglobinuria on patients' quality of life and healthcare systems is significant, given its chronic nature and potential for severe complications, including aplastic anemia and acute kidney injury.
Paroxysmal Nocturnal Hemoglobinuria Share
The market share for Paroxysmal Nocturnal Hemoglobinuria therapies is concentrated among a few pharmaceutical companies, given the specialized nature of treatments and the limited patient population. Leading players such as Alexion Pharmaceuticals (now part of AstraZeneca) have dominated this market for years with their pioneering treatment, eculizumab (Soliris), and its successor, ravulizumab (Ultomiris). These therapies are C5 complement inhibitors that reduce hemolysis, providing symptomatic relief and improving patient outcomes.
The high cost of these treatments significantly contributes to the market size, with annual therapy costs often reaching hundreds of thousands of dollars per patient. The North American and European regions currently hold the largest market shares due to better access to advanced healthcare and the availability of high-cost therapies. However, increasing awareness and diagnostic capabilities in Asia-Pacific and Latin America suggest a potential rise in market share in these regions in the coming years.
Paroxysmal Nocturnal Hemoglobinuria Analysis
The analysis of the Paroxysmal Nocturnal Hemoglobinuria market reveals several critical factors influencing its dynamics. First, the rarity of the disease implies a relatively small but high-value market, driven by expensive therapies rather than a large patient volume. The increasing availability of advanced diagnostic tools, such as flow cytometry, has led to earlier and more accurate detection of PNH, contributing to the growth in market demand. Additionally, the introduction of next-generation therapies and biosimilars is expected to alter the competitive landscape by providing more options at potentially lower costs.
Emerging therapies targeting alternative pathways, such as Factor D inhibitors (e.g., iptacopan), offer a promising expansion of the treatment paradigm. These drugs are in various stages of clinical trials and may address unmet needs, especially in patients who do not respond adequately to current therapies. The analysis also points to the importance of ongoing research and development, as well as strategic collaborations among pharmaceutical companies, to drive market growth and innovation.
Paroxysmal Nocturnal Hemoglobinuria Trends
Several trends are shaping the future of the Paroxysmal Nocturnal Hemoglobinuria market.
Increased Focus on Gene Therapy: With advances in genetic research, there is growing interest in developing gene therapies that could potentially offer a cure for PNH by addressing the underlying genetic mutation. Although still in the experimental stage, this trend reflects a shift towards more curative approaches rather than just managing symptoms.
Rising Investment in Biosimilars: As patents for key PNH drugs like Soliris expire, there is a surge in the development of biosimilars. These alternatives promise to make treatment more affordable and accessible, especially in emerging markets.
Expansion of Clinical Trials: There is an increase in the number of clinical trials exploring novel treatment options for PNH. This trend is driven by the need for more effective, less burdensome therapies that can reduce the frequency of administration and side effects.
Personalized Medicine: Advances in genomics are paving the way for personalized treatment plans based on a patient's specific genetic profile. This trend aims to improve outcomes by tailoring therapies to the unique needs of each individual.
Patient Advocacy and Awareness Campaigns: Greater patient advocacy and awareness campaigns are helping to reduce the diagnostic delay associated with Paroxysmal Nocturnal Hemoglobinuria. This is particularly important because early detection can significantly improve treatment outcomes and quality of life for patients.
Reasons to Buy the Reports
Comprehensive Market Analysis: Gain insights into the Paroxysmal Nocturnal Hemoglobinuria market size, share, and future growth potential, including detailed analysis of emerging trends and therapeutic advancements.
Strategic Market Insights: Understand the competitive landscape, key players, and their market strategies to identify potential opportunities and threats in the PNH market.
Investment Opportunities: Evaluate potential investment opportunities in the rapidly evolving PNH therapy market, particularly in emerging regions with increasing diagnostic capabilities.
Clinical Development Insights: Access information on ongoing clinical trials, pipeline drugs, and innovative therapies that may significantly impact the future treatment landscape for PNH.
Patient Demographics and Epidemiology: Get detailed data on patient demographics, prevalence, and diagnosis rates, which are critical for planning market entry or expansion strategies.
Recent Developments
Recent developments in the Paroxysmal Nocturnal Hemoglobinuria market include several promising advancements:
Approval of New Therapies: In recent years, the FDA has approved new therapies like ravulizumab, offering extended dosing intervals and improved patient compliance compared to existing treatments.
Launch of Biosimilars: Several companies have announced the development of biosimilars for eculizumab, aiming to provide more cost-effective treatment options and expand access.
Advancements in Diagnostic Techniques: Improved diagnostic techniques, including flow cytometry and genetic testing, are helping clinicians detect PNH earlier and with greater accuracy.
Emergence of Complement Inhibitors: New complement inhibitors targeting different components of the complement cascade, such as Factor D and Factor B inhibitors, are showing promising results in clinical trials.
Partnerships and Collaborations: Pharmaceutical companies are increasingly forming strategic partnerships to accelerate drug development and expand their product offerings in the PNH market.
The outlook for Paroxysmal Nocturnal Hemoglobinuria remains promising, with ongoing innovations and an expanding market driven by improved diagnostic capabilities and novel treatment options.
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Global Perspective: Regional Markets and Emerging Trends in ATMP
The Advanced Therapy Medicinal Products (ATMP) Market is experiencing significant growth driven by advancements in biotechnology, regenerative medicine, and gene therapy, coupled with the increasing demand for innovative therapies for unmet medical needs. ATMPs represent a new generation of therapeutic products that harness the potential of cell and gene therapies, tissue engineering, and regenerative medicine to treat a wide range of diseases, including genetic disorders, cancer, and rare diseases.
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One of the primary drivers of market growth is the increasing prevalence of chronic and degenerative diseases, coupled with the limited efficacy of traditional treatment modalities. ATMPs offer the potential for durable and curative treatments by targeting the underlying causes of diseases at the genetic and cellular levels. Gene therapies, for example, introduce functional genes into target cells to correct genetic defects or modulate disease pathways, while cell therapies harness the regenerative properties of stem cells or immune cells to repair damaged tissues or modulate immune responses.
Major vendors in the global Advanced Therapy Medicinal Products Market: Spark Therapeutics, Inc., Bluebird Bio, Inc., Novartis AG, UniQure N.V., Celgene Corporation, Gilead Lifesciences, Inc., Kolon TissueGene, Inc., JCR Pharmaceuticals Co., Ltd., MEDIPOST, Vericel Corporation, PHARMICELL Co., Ltd, Organogenesis Inc. and Others.
Furthermore, advancements in manufacturing technologies, regulatory pathways, and market access strategies are facilitating the development and commercialization of ATMPs. The emergence of novel gene editing technologies, such as CRISPR-Cas9 and base editing, enables precise modifications of genetic sequences, enhancing the safety and efficacy of gene therapies. Similarly, innovations in cell culture techniques, biomaterials, and bioprocessing enable the scalable production of cell-based therapies and tissue-engineered products for clinical use. Regulatory agencies, such as the FDA and EMA, have established expedited pathways and frameworks to support the development and approval of ATMPs, accelerating their translation from bench to bedside.
The Advanced Therapy Medicinal Products Market is Valued USD 6.63 billion in 2024 and projected to reach USD 26.27 billion by 2032, growing at a CAGR of CAGR of 18 % During the Forecast period of 2024-2032.The ATMP market is characterized by the presence of a diverse range of products, including gene therapies, cell therapies, tissue-engineered products, and combination products. Major players in the market include Novartis AG, Gilead Sciences, Inc., Spark Therapeutics (a Roche company), bluebird bio, Inc., and Vericel Corporation, among others. These companies are actively developing and commercializing ATMPs for various indications, including hematologic disorders, solid tumors, genetic diseases, and autoimmune disorders, leveraging their expertise in biotechnology, clinical development, and commercialization.
Emerging trends in the ATMP market include the development of off-the-shelf and allogeneic cell therapies, the integration of gene editing technologies into cell and gene therapies, and the expansion of indications beyond rare diseases to more prevalent conditions, such as cardiovascular diseases and neurodegenerative disorders. Off-the-shelf cell therapies use donor-derived or engineered cells that can be mass-produced and administered to multiple patients without the need for patient-specific manufacturing, reducing costs and improving accessibility. Gene editing technologies enable precise modifications of cell genomes to enhance their therapeutic properties, improve engraftment, and evade immune rejection. Additionally, the expansion of ATMPs into new therapeutic areas and combination therapies with conventional treatments, such as chemotherapy and immunotherapy, offer new opportunities for synergistic effects and improved patient outcomes.
Looking ahead, the ATMP market is poised for continued growth driven by ongoing technological advancements, regulatory support, and the increasing adoption of personalized medicine approaches. As the field of regenerative medicine and gene therapy continues to evolve, ATMPs will play an increasingly important role in addressing unmet medical needs, improving patient outcomes, and reshaping the treatment landscape for a wide range of diseases. Collaborations between industry stakeholders, academic institutions, and regulatory agencies will be essential in driving innovation, ensuring safety and efficacy, and accelerating the translation of ATMPs from the lab to the clinic.
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A Decade of Discovery: Forecasting Trends and Advancements in Plasma Protein Therapeutics 2024-2032
The global Plasma Protein Therapeutics Market is poised for a remarkable journey of growth, innovation, and transformative breakthroughs. A recent market analysis has revealed key trends and segments, illuminating the path for substantial market expansion.
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Keyplayers:
Bayer AG
Biotest AG
CSL Behring LLC
Grifols S.A
Kedrion S.P.A.
Octapharma AG, Shire Plc.
Trends Driving Market Dynamics:
Biotechnological Advancements: The market is witnessing a surge in biotechnological innovations, leading to the development of cutting-edge plasma-derived and recombinant protein therapies. These advancements are not only enhancing treatment efficacy but also addressing the unmet medical needs of patients with rare and chronic conditions.
Personalized Medicine Revolution: With an increasing focus on personalized medicine, the Plasma Protein Therapeutics Market is aligning itself with the evolving landscape of individualized healthcare. Tailored therapies are becoming the cornerstone, providing patients with precision treatments that offer improved outcomes and quality of life.
Technological Integration: The integration of advanced technologies in manufacturing processes is streamlining production, ensuring a more efficient and scalable supply of plasma protein products. This technological leap is expected to significantly impact market growth and accessibility.
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Key Market Segments:
Plasma-Derived Products: Traditional plasma-derived products continue to dominate the market, providing essential treatments for conditions such as hemophilia, immunodeficiency disorders, and autoimmune diseases.
Recombinant Protein Therapies: The rise of recombinant protein therapies is evident, offering a promising alternative with reduced risk of viral contamination and increased production flexibility. This segment is anticipated to witness substantial growth, driven by ongoing research and development initiatives.
Neurology and Hematology Applications: Hematology and neurology applications represent key segments with remarkable growth potential. The market is witnessing an increased focus on developing therapies for neurological disorders and bleeding disorders, further expanding its therapeutic footprint.
Global Plasma Protein Therapeutics report segmentation:
By Product
Albumin
Immunoglobulin
Plasma-derived Factor VIII
Others
By Application
Hemophilia
Primary Immunodeficiency Disorder (PIDD)
Idiopathic Thrombocytopenic Purpura (ITP)
Others
Anticipated Market Growth:
The Plasma Protein Therapeutics Market is projected to experience robust growth in the coming years, fueled by a combination of technological advancements, increasing prevalence of rare diseases, and a growing patient pool. As pharmaceutical companies continue to invest in research and development, the market is expected to witness an influx of novel therapies, creating new avenues for healthcare professionals and offering renewed hope for patients globally.
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In conclusion, the Plasma Protein Therapeutics Market is at the forefront of a healthcare revolution, with trends and segments pointing towards a future defined by innovation, accessibility, and improved patient outcomes.
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Positive impact of covid-19 on Rare hematology disorders market
Rare hematology disorders market Outlook - 2027
Rare blood diseases include sickle cell disease, beta thalassemia, follicular lymphoma, multiple myeloma, antiphospholipid syndrome, thrombotic thrombocytopenic purpura, and others. Blood develops from hematopoietic stem cells (HSC) and formation takes place in the bone marrow through a sequence of the regulated process known as hematopoiesis. Blood contains component such as plasma, RBS, WBC, and platelets. Blood disorders include bleeding disorders such as hemophilia, blood clots; blood cancers (leukemia, lymphoma, and myeloma). When the normal process of the blood development fails, abnormal blood cell type is produced, which causes blood cancer and other blood disorders. The rare hematological disease includes anemia-type red blood cell conditions, white blood cell dysfunctions, immuno-disorders and other platelet-based abnormalities. The other hemoglobinopathies are also on the rise due to increasing immigration of carriers from underdeveloped nations to developed regions of the world. The rare blood disorders are difficult to diagnose and treat.
The coronavirus COVID-19 has affected 213 countries and territories around the world. COVID-19 has created new challenges that are requiring manufacturers to innovate at speeds they never have before. Supply chain disruptions, social distancing on high-touch assembly lines, limited ability to travel, and the need for oversight add significant complexity to today’s processes. The outbreak of coronavirus disease 2019 (COVID-19) has created a global health crisis that has had a deep impact on the manufacturing market there is a shortage in supply of raw materials from Chinese manufacturers which has resulted in a severe demand-supply gap. The manufacturers are further expected to be stranded on raw material orders owing to the logistics industry being significantly impacted due to lockdown amid COVID-19. This has all affected the market adversely causing a slowdown in the rare hematology disorders market due to shortage of supply and manufacturing drugs.
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Top impacting factors: Market Scenario Analysis, Trends, Drivers and Impact analysis:
Drivers:
Increased prevalence:
Rare diseases comprise a growing public health priority, as they affect above 300 million people globally and they are difficult to diagnose and treat. There is a pressing need for better ways to detect and diagnose rare diseases, as well as to provide companion diagnostics for therapy guidance, clinical trials enrollment and therapy monitoring applications. In the U.S., the condition is considered as rare when it affects less than 200,000 people in the United States or prevalence of 5 per 10,000. In Europe, 5 in 10,000 citizens are considered as rare diseases. According to Eurordis (European organization of rare diseases), there are approximately 6000 to 8000 rare diseases. Around 15 million people across the globe suffer from thalassemic disorders and nearly 1.5% of the world population is estimated to be a carrier of β-thalassemia. Rare hematology disorder treatment among the geriatric population base will show boast in future. An overall occurrence of anemia ranges from 10% to 24% among the senior adults. As the age of patient increases, the need for hematology disorder care also increases. Thus, the growing population of geriatric age group will increase the chances of developing rare blood disorders among adults, thereby boosting the demand for hematology disorder treatment in the forecast period.
Development of new therapies:
Global Blood Therapeutics (GBT) is developing biologics for the treatment of sickle cell disease. The company lead candidate, voxelotor (GBT440) is in Phase 3 trials and being investigated for the treatment of sickle cell disease. The candidate is a hemoglobin S polymerization inhibitor and its mechanism of action is modulation hemoglobin affinity for oxygen. FDA has granted has breakthrough therapy, fast track, orphan drug and rare pediatric disease designations to Vozelotor. Imara is developing novel therapeutics for patients suffering from sickle cell disease and other hemoglobinopathies. Sickle cell disease is a rare, genetic blood disease that causes red blood cells to sickle and become damaged, activating immune cells and blocking blood flow in capillaries, injuring many organs and causing daily pain. Its lead candidate is IMR-687, a small molecule inhibitor of phosphodiesterase-9 (PDE9i) for the treatment of sickle cell disease. Launched in April 2016 by orphan drug accelerator Cydan Development. Cyclerion is involved in developing therapies for treating sickle cell disease (SCD) and diabetic nephropathy. They are focused on the nitric oxide-cyclic guanosine monophosphate (cGMP) signaling pathway. Their lead candidate, Olinciguat, which is a vascular guanylate cyclase agonist. The candidate is in phase II clinical trial. They have granted Orphan Drug Designation for SCD by the U.S. Food and Drug Administration. The development of such therapies and treatment for the diseases will drive the Rare hematology disorders market growth.
Restrains:
High cost of treatment and late detection in developing countries will prove as the restrain for market growth.
Key benefits of the report:
This study presents the analytical depiction of the global rare hematology disorders industry along with the current trends and future estimations to determine the imminent investment pockets.
The report presents information related to key drivers, restraints, and opportunities along with detailed analysis of the global rare hematology disorders market share.
The current market is quantitatively analyzed from 2020 to 2027 to highlight the global rare hematology disorders market growth scenario.
Porter’s five forces analysis illustrates the potency of buyers & suppliers in the market.
The report provides a detailed global rare hematology disorders market analysis based on competitive intensity and how the competition will take shape in coming years.
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#Rare hematology disorders market size#Rare hematology disorders market growth#Rare hematology disorders market trends
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Rare Haematology Market Size Share and Industry Outlook to 2028
Global Rare Haematology Market is segmented By Product Class (Recombinant factor, Plasma-derived factors, Extended Half-Life), By Indication (Hemophilia A, Hemophilia A with Inhibitors, Hemophilia B, Acquired Hemophilia A, von Willebrand disease), By Patient Age-Group (Pediatrics (0-17), Adults (18+)), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2021-2028
Market Overview
The Global Rare Haematology Market is expected to grow at a high CAGR during the forecasting period (2021-2028).
Rare hematological diseases fall into many subcategories, including anemia-type red blood cell conditions, white blood cell dysfunctions associated with various malignancies, immuno-disorders, platelet-based abnormalities that affect coagulation, and plasma-based issues (such as hemophilia A and B, von Willebrand disease).
Globally, the Rare Hematology market was estimated at USD 10 billion in 2015 and is expected to reach USD 13 billion by 2020. The market is large and growing primarily led by Hemophilia.
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Market Growth and Trends
The global incidence of hemophilia is not well known, but it is estimated that more than 400,000 people are living with hemophilia A and B.
Approximately 75% of people with hemophilia around the globe still receive inadequate treatment or have no access to treatment. This presents a tremendous market opportunity, thus driving market growth in the future.
On the contrary, the inadequacy of data due to limited support from disease-specific foundations inhibits market growth.
However, there is still a substantial unmet need for new therapies that require significantly less frequent infusions and do not promote inhibitor formation.
Market Segmentation
Global Rare Hematology market report segments the market by product class, by indication, by age, and by region.
Based on product class, the market is classified into Recombinant factors, Plasma-derived factors, and Extended Half-Life clotting factors.
The recombinant factors segment is projected to witness the highest revenue growth, garnering more than USD 4 billion by 2022.
Based on the indication, the market is segmented into Hemophilia A, Hemophilia A with Inhibitors, Hemophilia B, Acquired Hemophilia A, and von Willebrand disease.
The market is led by Hemophilia A segment.
Based on the patient age group, the market is segmented into adults (18+) and pediatrics (0-17).
Adults account for 75% of the market.
Geographically, the market is segmented into five major regions, namely North America, South America, Europe, Asia Pacific, and RoW.
Globally North America is the largest market for Rare Hematology Treatment with the majority of demand arising from the US.
The US hemophilia drug market, which serves about 20,000 patients, is worth USD 4 billion a year.
Market Scope of the Report
By Product Class
· Recombinant factor
· Plasma-derived factors
· Extended Half-Life
By Indication
· Hemophilia A
· Hemophilia A with Inhibitors
· Hemophilia B
· Acquired Hemophilia A
· von Willebrand disease
By Patient Age-group
· Pediatrics (0-17)
· Adults (18+)
By Region
· Asia Pacific (China, Japan, India, Australia, Rest of Asia Pacific)
· Europe (Germany, France, The UK, Italy, Spain, Rest of Europe)
· North America (The USA, Canada, Mexico)
· South America (Brazil, Argentina, Rest of South America)
· Rest of the World
The report also profiles the following companies in the Rare Hematology Treatment market – Biogen Inc., Shire plc, Bayer Healthcare AG, Novo Nordisk A/S, Pfizer Inc., CSL Behring LLC, Celgene Corporation, Amgen Inc. and others.
Why purchase the report?
Visualize the composition of the Rare Hematology market across each indication, regarding type and treatment options, highlighting the critical commercial assets and players.
Identify commercial opportunities in the Rare Hematology market by analyzing trends and co-development deals.
Excel data sheet with thousands of data points of the market – level 4/5 segmentation.
PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study.
Product mapping in excel for critical products of all major market players
Target Audience
Who are the key vendors in the global hematology analyzers market?
· Equipment Suppliers/ Buyers
· Service Providers/ Buyers
· Industry Investors/Investment Bankers
· Education & Research Institutes
· Research Professionals
· Emerging Companies
· Manufacturers
· Trending Topics
· Sickle Cell Treatment Market
· Serum Separation Gel Market
· Allogeneic Stem Cells Market
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Rare Disease Genetic Testing Market Is Expected To Reach New Growth Revenues During 2021-2028
The global rare disease genetic testing market size is expected to reach USD 1.8 Billion by 2027 according to a new study by Polaris Market Research. The report “Rare Disease Genetic Testing Market Share, Size, Trends, Industry Analysis Report, By Disease Type (Neurological Disorders, Immunological Disorders, Hematology Ailments, Endocrine & Metabolism Disorders, Cancer, Musculoskeletal Disorders, Cardiovascular Disorders, Dermatology Disorders, Others); By Technology; By Specialty; By End-Use; By Regions; Segment Forecast, 2020 – 2027” gives a detailed insight into current market dynamics and provides analysis on future market growth.
The growing need for on-time diagnosis of uncommon disorders, rising prevalence of rare disorders, innovations in genomic testing, and the focused approach of the market player’s in cost-effective treatments are the key factors responsible for market growth. Moreover, government-sponsored schemes are also expected to positively impact the market. In February 2020, the government of India announced financial assistance of INR 15 lacs to the patients suffering from uncommon ailments under the Rashtriya Arogaya Nidhi scheme for a one-time treatment.
The global rare disease genetic testing industry is fragmented based on disease type, technology, specialty, end-use, and region. In terms of disease type, the market is segmented into neurological disorders, immunological disorders, hematology illnesses, endocrine & metabolism ailments, cancer, musculoskeletal disorders, cardiovascular disorders, dermatology illnesses, and others.
Based on technology, the rare disease genetic testing industry is further bifurcated into next-generation sequencing, array technology, PCR-based testing, FISH, sanger sequencing, and karyotyping. Based on specialty, the rare disease genetic testing industry is further bifurcated into molecular, chromosomal, and biochemical genomic tests. Based on end-use, the rare disease genomic testing industry is further bifurcated into research laboratories & CROs, hospitals & clinics, and diagnostic laboratories.
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Segment Highlights
Neurological ailments accounted for the largest revenue share in 2019 on account of the increasing prevalence of neurologic disorders across the globe and presence of numerous testing techniques
Based on technology, the next generation sequencing segment is projected to constitute almost half of the market in 2027. The usage of the technology in whole genome sequencing is the key factor responsible for its segment’s growth.
Molecular tests are expected to account for the highest revenue share by the end of 2027. The availability of advanced technologies and ability to test ultra-rare disorders is expected to drive market growth.
Research laboratories & CROs accounted for the largest revenue share in 2019 owing to the increasing number of tests and growing occurrence of rare disorders across the developed economies
List of Key Players
Strand Life Sciences
Myriad Genetics
Quest Diagnostics Inc.
Centogene N.V.
Invitae Corporation
Baylor Genetics
Ambry Genetics
Macrogen, Inc.
Opko Health, Inc.
Color Genomics, Inc.
Health Network Laboratories
Preventiongenetics, Progenity, Inc.
Fulgent Genetics Inc.
Others
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Polaris Market Research has segmented the rare disease genetic testing market report on the basis of disease type, technology, specialty, end-use, and region
Rare Disease Genetic Testing, Disease Type Outlook (Revenue – USD Million, 2016 – 2027)
Neurological Disorders
Immunological Disorders
Hematology Ailments
Endocrine & Metabolism Disorders
Cancer
Musculoskeletal Disorders
Cardiovascular Disorders
Dermatology Disorders
Others
Rare Disease Genetic Testing, Technology Outlook (Revenue – USD Million, 2016 – 2027)
Whole Exome Sequencing
Whole Genome Sequencing
Rare Disease Genetic Testing, Specialty Outlook (Revenue – USD Million, 2016 – 2027)
Molecular Genetic Tests
Chromosomal Genetic Tests
Biochemical Genetic Tests
Rare Disease Genetic Testing, Technology Outlook (Revenue – USD Million, 2016 – 2027)
Research Laboratories & CROs
Hospitals & Clinics
Diagnostic Laboratories
Rare Disease Genetic Testing, Regional Outlook (Revenue – USD Million, 2016 – 2027)
U.S.
Canada
France
Germany
UK
Italy
Spain
Netherlands
Austria
China
India
Japan
Malaysia
South Korea
Indonesia
Mexico
Brazil
Argentina
UAE
Saudi Arabia
Israel
South Africa
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Gene Therapy for Rare Disease Market Forecast Opportunity Analysis - 2027
The global Gene Therapy For Rare Disease Market By Drug (Approved Drugs (Tisagenlecleucel (Kymriah), Axicabtagene ciloleucel (Yescarta), Voretigene neparvovec (Luxturna), Strimvelis), Pipeline Drugs (GT-AADC, Fidanacogene elaparvovec (SPK-9011), OTL-200, bb2121, AMT-061, and Others), By Therapeutic Application (Oncology, Neurological Disorders, Ophthalmic Disorders, Hematological Disorders, Immunodeficiency Disorders, Metabolic Disorders, and Others), and Region (North America, Latin America, Europe, Asia Pacific, the Middle East, and Africa) was valued at US$ 16.3 million in 2017, and is projected to exhibit a CAGR of 35.0% over the forecast period (2018–2026).
Robust pipeline, recent success of newly launched gene therapies such as Kymriah, and Yescarta, and absence of robust therapies for several rare diseases is expected to boost growth of the global gene therapy for rare disease market. Key players in the market are focused on research and development of gene therapies for rare diseases in order to introduce their pipeline products in the market. For instance, in October 2018, bluebird bio, Inc. received European Medicines Agency (EMA) marketing authorization application (MAA) for its investigational LentiGlobin gene therapy for the treatment of adolescents and adults with transfusion-dependent β-thalassemia (TDT) and a non-β0/β0 genotype. In August 2018, Kite Pharma, Inc., a Gilead Company, received European Commission (EC) Marketing approval for its novel Yescarta (axicabtagene ciloleucel), as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. Moreover, in September 2018, Spark Therapeutics Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of LUXTURNA (voretigene neparvovec), a one-time gene therapy for the treatment of adult and pediatric patients with vision loss.
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Browse 26 Market Data Tables and 37 Figures spread through 240 Pages and in-depth TOC on Global Gene Therapy for Rare Disease Market By Drug (Approved Drugs (Tisagenlecleucel (Kymriah), Axicabtagene ciloleucel (Yescarta), Voretigene neparvovec (Luxturna), Strimvelis), Pipeline Drugs (GT-AADC, Fidanacogene elaparvovec (SPK-9011), OTL-200, bb2121, AMT-061, and Others), By Therapeutic Application (Oncology, Neurological Disorders, Ophthalmic Disorders, Hematological Disorders, Immunodeficiency Disorders, Metabolic Disorders, and Others), and Region (North America, Latin America, Europe, Asia Pacific, the Middle East, and Africa) - Global Forecast to 2026
Increasing research and development by leading players in gene therapy for rare disease is expected to support growth of the gene therapy for rare disease market. Several companies have novel gene therapies in the clinical stages for treatment of rare diseases ranging from rare cancers to rare genetic diseases. For instance, Spark Therapeutics, Inc. has SPK-7001 (Choroideremia/ Phase ½), SPK-8011 (Hemophilia A/Phase ½), and SPK-3006 (Pompe Disease/preclinical) in the pipeline. Moreover, Orchard Therapeutics has multiple therapies in the pipeline such as OTL-101, OTL-103, OTL-102, OTL-200, and OTL-201 for various indications. Some of these therapies are expected to receive the U.S. Food & Drug Administration approvals during the forecast period. These factors are expected to boost the global gene therapy for rare disease market growth over the forecast period.
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Key Takeaways of the Global Gene Therapy for Rare Disease Market:
The global gene therapy for rare disease market is expected to exhibit a CAGR of 35.0% over the forecast period, owing to increasing research and development by key players in gene therapy.
Price for therapies are highly dependent on prevalence of the disease and therefore, some drugs (which are in development for ultra-rare disease) may be expensive
There could be a significant delay in commercialization of approved therapies in regions such as Latin America, Asia Pacific, Middle East, and Africa, as these therapies have novel technologies (as patient cells may be needed for modification and reintroduction into the patient) and high prices of gene therapy treatment.
Asia Pacific is expected to witness highest growth in gene therapy for rare disease market over the forecast period
Major players operating in the global gene therapy for rare disease market include Kite Pharma, Inc. (Gilead Sciences, Inc.), Novartis International AG, Juno Therapeutics Inc. (Celgene Corporation), Bluebird Bio, Inc., Spark Therapeutics, Inc., uniQure N.V, Orchard Therapeutics Plc., PTC Therapeutics, Inc., and BioMarin Pharmaceutical Inc.
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Recombinant Plasma Protein Therapeutics Market Trends and Forecast up to 2026
Transparency Market Research (TMR) has published a new report titled, “Recombinant Plasma Protein Therapeutics Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2018–2026”. According to the report, the global recombinant plasma protein therapeutics market was valued at US$ 8.2 Bn in 2017. It is anticipated expand at a CAGR of 8.6% from 2018 to 2026. Replacement of plasma derived proteins by recombinant plasma products, increase in the number of products launched, and rise in the demand for novel therapies of hemophilia treatment are anticipated to drive the market.
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Rising Number of Regulatory Approvals to Drive Market
There has been an increase in the number of regulatory approvals in the last three years that have increased the availability of various options for patients with rare diseases such as hemophilia and other bleeding disorders. These approvals enabled companies to expand their product portfolios and gain competitive advantage. For instance, in September 2017, Ministry of Health, Labour and Welfare, Japan, approved CSL Behrings AFSTYLA, a recombinant factor VIII indicated for the treatment of hemophilia A. AFSTYLA has been also approved in the U.S., Canada, and Switzerland. In April 2018, Shire received Food and Drug Administration (FDA) approval for VONVENDI recombinant von Willebrand factor, indicated for perioperative management of bleeding in patients with von Willebrand disease (VWD). In July 2018, Bayer AG announced the approval for Kovaltry, recombinant factor VIII from the regulatory authorities in China, indicated for the treatment of hemophilia A.
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Asia Pacific offering Numerous Growth Opportunities to the Market
In Asia Pacific, increase in the number of cases of rare hematology disorders, rise in adoption of recombinant DNA technology for therapeutic use, and surge in R&D expenditure by pharmaceutical & biotechnology companies are anticipated to drive the market. Additionally, the demand for third-generation recombinant coagulation factors is increasing in Japan and China, which further creates growth opportunities in the market. Government and non-government organizations are presently taking efforts to increase awareness about hemophilia A and hemophilia B, helping the general population to understand the cases, diagnosis, and treatment methods for such rare diseases. Countries such as China, Japan, Australia, and New Zealand are currently switching to recombinant plasma therapies as standard for hemophilia A treatment, with regulatory authorities. According to Hemophilia Foundation Australia, 80% of patients with bleeding disorders are treated with recombinant coagulation factors. Therefore, increase in the use of recombinant therapies for hemophilia treatment is expected to drive the market during the forecast period.
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Strategic Approaches and Increasing Focus on R&D by Market Players
The report also provides profiles of leading players operating in the global recombinant plasma protein therapeutics market. These include CSL Limited, Shire (Takeda Pharmaceutical Company Limited), Octapharma, Novo Nordisk A/S, Bayer AG, Bioverativ Therapeutics, Inc. (Sanofi), Aptevo Therapeutics, Pharming Group NV, and Pfizer Inc.
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New product launch, acquisition, geographical expansion, collaborations, and distribution agreements enable these companies to expand their presence in the global market. In January 2019, Shire was acquired by Takeda Pharmaceutical Company Limited, a pharmaceutical company based in Japan. With this acquisition, Takeda Pharmaceutical Company Limited is expected to strengthen its geographical presence. In January 2018, Sanofi, a leading pharmaceutical company, acquired Bioverativ Therapeutics Inc., which operated as a part of Sanofi Genzyme. Other market players have also undertaken numerous initiatives to expand their business in emerging markets. Leading market players are also focusing on increasing their customer base in countries in Asia Pacific such as China, Japan, and Australia. Market players are also supporting several campaigns for increasing awareness about hematological disorders and availability of treatment options such as recombinant plasma proteins and the advantages offered by these products.
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Rare Disease Genetic Testing Market Global Industry Analysis By Trends, Future Demands, Growth Factors 2028
Rare Disease Genetic Testing Market Global Industry Analysis By Trends, Future Demands, Growth Factors 2028
The global rare disease genetic testing market size is expected to reach USD 1.8 Billion by 2027 according to a new study by Polaris Market Research. The report “Rare Disease Genetic Testing Market Share, Size, Trends, Industry Analysis Report, By Disease Type (Neurological Disorders, Immunological Disorders, Hematology Ailments, Endocrine & Metabolism Disorders, Cancer, Musculoskeletal…
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#Rare Disease Genetic Testing#Rare Disease Genetic Testing Market#Rare Disease Genetic Testing Market Share#Rare Disease Genetic Testing Market Size
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Global Protein Therapeutics Market
Global Protein Therapeutics Market Size, Share, Growth, Industry Trends and Forecast 2020-2030
The Global Protein Therapeutics Market size valued USD 176884.4 million in 2020, and anticipated to reach at USD 298842.4 million up to 2030 to grow with the CAGR of 6.0% in forecast period.Therapeutics protein are the protein which are engineered in laboratory for pharmaceutical use, which affect the covalent bond which are albumin and enzyme that help to heal from the dieses. Therapeutics protein are the important class of medicine, which help to treat different dieses like infectious dieses like infectious dieses, cancer, and others, and have potential to improve human health. Therapeutics proteins are highly specific and complex set of function. This get well immune response and well tolerate by human body. This is an effective treatment without gene therapy. There are total 239 therapeutic protein approved for clinical use by US – FDA out of them monoclonal antibiotics has largest share in the market followed by insulin, erithro protein, fusion protein, interferon, human growth hormone and others. These are helpful for the individuals whose body cannot produce essential protein naturally. It is useful for genetic, life threating, and rare dieses. According to National Cancer Institute 38.4% of global people diagnosed by the cancer in some point of their life, 3.1% of global folk fighting with the hypertension, and 8.8% of globe folk has diabetes that they can cure by using protein therapeutics.
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Market Dynamics and Factors:
Increasing prevalence of chronic diseases like cancer, and plasma derived market are the main driver of the global protein therapeutics market. Moreover, increasing awareness about protein therapeutics, instead of surgery protein therapeutics with minimum side effect, and increasing level of acceptable in user, are the factor that help to boost the protein therapeutics market. Stringent laws and regulations in some region, and high cost of product may hamper the protein therapeutics market growth. Rising global prevalence of different diabetes led to significant growth in development in the market.
Market Segmentation:
Global Protein Therapeutics Market – By Product
Monoclonal Antibodies
Insulin
Fusion Protein
Erythropoietin
Interferon
Human Growth Hormone
Follicle Stimulating Hormone
Global Protein Therapeutics Market – By Application
Metabolic Disorders
Immunologic Disorders
Hematological Disorders
Cancer
Hormonal Disorders
Genetic Disorders
Others
Global Protein Therapeutics Market– By Region
North America
USA
Mexico
Canada
Europe
UK.
Rest of Europe
Italy
Germany
France
Asia-Pacific
Japan
Rest of Asia-Pacific
Australia
India
China
RoW
Latin America
Africa
Middle East
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Geographic Scenario:
North America dominating the global protein therapeutics market, as the development pharmaceuticals infrastructure, and development in R&D sector. Moreover, technological advancement in this region help protein therapeutics market to grow. Asia Pacific is the highest growing market, as rise in protein therapeutics application and increasing awareness about it in this region. Developing the R&D sector and pharmaceutical sector in this region help protein therapeutics market growth.
Competitive Scenario:
The key player in, the global protein therapeutics industry are Eli Lilly and Company, Abbott Laboratories, Amgen Inc., Baxter International Inc., Novo Nordisk A/S, Pfizer Inc., F. Hoffmann-La Roche Ltd., Novo Nordisk A/S, Pfizer Inc., Johnson & Johnson, Merck & Co., Inc., Sanofi., Biogen, Inc., CSL Behring, Genentech, Inc., and others.
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How will this Market Intelligence Report Benefit You?
The report offers statistical data in terms of value (US$) as well as Volume (units) till 2030.
Exclusive insight into the key trends affecting the Global Protein Therapeutics industry, although key threats, opportunities and disruptive technologies that could shape the Global Protein Therapeutics Market supply and demand.
The report tracks the leading market players that will shape and impact the Global Protein Therapeutics Market most.
The data analysis present in the Global Protein Therapeutics Market report is based on the combination of both primary and secondary resources.
The report helps you to understand the real effects of key market drivers or retainers on Global Protein Therapeutics Market business.
The 2021 Annual Global Protein Therapeutics Market offers:
100+ charts exploring and analysing the Global Protein Therapeutics Market from critical angles including retail forecasts, consumer demand, production and more
15+ profiles of top producing states, with highlights of market conditions and retail trends
Regulatory outlook, best practices, and future considerations for manufacturers and industry players seeking to meet consumer demand
Benchmark wholesale prices, market position, plus prices for raw materials involved in Global Protein Therapeutics Market type
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Proactive Progression: Anticipating Growth and Dynamics in Plasma Protein Therapeutics 2032
The global Plasma Protein Therapeutics Market is poised for a remarkable journey of growth, innovation, and transformative breakthroughs. A recent market analysis has revealed key trends and segments, illuminating the path for substantial market expansion.
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Keyplayers:
Bayer AG
Biotest AG
CSL Behring LLC
Grifols S.A
Kedrion S.P.A.
Octapharma AG, Shire Plc.
Trends Driving Market Dynamics:
Biotechnological Advancements: The market is witnessing a surge in biotechnological innovations, leading to the development of cutting-edge plasma-derived and recombinant protein therapies. These advancements are not only enhancing treatment efficacy but also addressing the unmet medical needs of patients with rare and chronic conditions.
Personalized Medicine Revolution: With an increasing focus on personalized medicine, the Plasma Protein Therapeutics Market is aligning itself with the evolving landscape of individualized healthcare. Tailored therapies are becoming the cornerstone, providing patients with precision treatments that offer improved outcomes and quality of life.
Technological Integration: The integration of advanced technologies in manufacturing processes is streamlining production, ensuring a more efficient and scalable supply of plasma protein products. This technological leap is expected to significantly impact market growth and accessibility.
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Key Market Segments:
Plasma-Derived Products: Traditional plasma-derived products continue to dominate the market, providing essential treatments for conditions such as hemophilia, immunodeficiency disorders, and autoimmune diseases.
Recombinant Protein Therapies: The rise of recombinant protein therapies is evident, offering a promising alternative with reduced risk of viral contamination and increased production flexibility. This segment is anticipated to witness substantial growth, driven by ongoing research and development initiatives.
Neurology and Hematology Applications: Hematology and neurology applications represent key segments with remarkable growth potential. The market is witnessing an increased focus on developing therapies for neurological disorders and bleeding disorders, further expanding its therapeutic footprint.
Global Plasma Protein Therapeutics report segmentation:
By Product
Albumin
Immunoglobulin
Plasma-derived Factor VIII
Others
By Application
Hemophilia
Primary Immunodeficiency Disorder (PIDD)
Idiopathic Thrombocytopenic Purpura (ITP)
Others
Anticipated Market Growth:
The Plasma Protein Therapeutics Market is projected to experience robust growth in the coming years, fueled by a combination of technological advancements, increasing prevalence of rare diseases, and a growing patient pool. As pharmaceutical companies continue to invest in research and development, the market is expected to witness an influx of novel therapies, creating new avenues for healthcare professionals and offering renewed hope for patients globally.
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In conclusion, the Plasma Protein Therapeutics Market is at the forefront of a healthcare revolution, with trends and segments pointing towards a future defined by innovation, accessibility, and improved patient outcomes.
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Gene Therapy For Rare Disease Market 2021 Incredible Potential, Stagnant Progress 2021 - 2027
Gene therapy involves the insertion of genetic materials into cells of patients to provide new function or to restore missing or inappropriate functioning of the cells, due to mutations in gene. Developing gene therapy for rare diseases is gaining significant traction, as more than 80% of rare diseases have a known monogenic (single-gene) cause. Small molecule drugs often treat symptoms only rather than curing the underlying cause of the disease. Moreover, a clinically sound and successful gene therapy may only require a single dose to cure a disease rather than a lifetime treatment. The benefits of gene therapy over conventional therapies and an increase in governmental support fuel the growth of the gene therapy market.
Key Insights:
Latest Updates
Analyst Views
Future Outlook of the Market
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Major Players in this Market are as Follows Novartis AG, Kite Pharma, Novartis International AG, Bluebird Bio, Spark Therapeutics, uniQure, Orchard Therapeutics, PTC Therapeutics, BioMarin Pharmaceutical, and others.
Gene therapy being a complicated therapy, is witnessing collaborations between pharmaceutical companies and research institutes and laboratories, in urge of key players to create their dominance in the market. For instance, Novartis Pharmaceuticals received commercialization rights for Spark Therapeutics' Luxturna, which is a prescription gene therapy product used for the treatment of patients with inherited retinal disease, for selling the product outside the U.S.
Market Taxonomy:
By Drug:
Approved Drugs
Tisagenlecleucel (Kymriah)
Axicabtagene Ciloleucel (Yescarta)
Voretigene Neparvovec (Luxturna)
Strimvelis
Pipeline Drugs
GT-AADC
Fidanacogene Elaparvovec (SPK-9011)
OTL-200
bb2121
AMT-061
Others
By Therapeutic Indication
Oncology
Hematological Rare Diseases
Neurological Rare Disease
Ophthalmic Rare Disease
Immunodeficiency Rare Disorder
Metabolic Rare Disease
Others
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Market Dynamics:
Major factors that drive the growth of the gene therapy market include high demand for DNA vaccines to treat genetic diseases, targeted drug delivery, and high incidences of genetic disorders. Key players in the market are dedicated to the development of gene therapies for novel indications, such as Huntington’s disease, for which there are no specific approved medication. For instance, uniQure N.V. is developing AMT-130, a novel gene therapy for Huntington’s disease (HD), a rare, fatal, and neurodegenerative genetic disorder. AMT-130 is currently in pre-clinical trial and is expected to be completed by December 2023. Furthermore, companies are developing novel gene therapies for rare diseases, such as Hemophilia B and Hemophilia A, which can offer long term treatment and can replace lifelong medication for these diseases.
For instance, BioMarine is developing a gene therapy for Hemophilia A, named Valrox, which is currently in the phase-3 of clinical trials and is expected to be completed by 2025. Launches of such novel therapies in near future are expected to significantly create lucrative opportunities for growth of the market. Moreover, the increasing reimbursement support as well as innovative payment options is being adopted by manufacturers such as pay for performance.
FAQ's:
What are the trends adopted by key players in the global gene therapy for rare disease market?
What key factors are expected to increase the demand for gene therapy for rare disease market during the forecast period 2020-2025?
What are the major challenges inhibiting the growth of the global gene therapy for rare disease market?
Which drug contribute highest CAGR (%) in the gene therapy for rare disease market during the forecast period?
What was the total market value (US$ Mn) generated in global gene therapy for rare disease market by therapeutic indication in 2019, and what are the forecasts by 2025?
What was the total revenue generated by the global gene therapy for rare disease market across different regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and Africa) in 2019, along with CAGR (%) for the period (2020-2025)?
Who are the key players contributing to the growth of the global gene therapy for rare disease market, and what are the new strategies adopted by them to retain a market share in the industry?
What is the competitive strength of the key players in the gene therapy for rare disease market?
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Global In Vitro Diagnostics (IVD) Market Size, Share, Growth, Trends and Forecast 2018 - 2025
The global in vitro diagnostics (IVD) market was valued at $64,479 million in 2017, and is estimated to reach at $93,614 million by 2025, registering a CAGR of 4.8% from 2018 to 2025.
In vitro diagnostic (IVD) is a technique in which medical devices and reagents are used to examine specimens such as blood, urine, stool, tissues, and other body fluids, which are derived from the human body to detect diseases, conditions, and infections. The tests can be performed in stand-alone laboratory, hospital-based laboratory, and point of care. Some of the significant technologies incorporated in IVD include polymerase chain reaction (PCR), microarray techniques, sequencing technology, and mass spectrometry, which are used for test sample preparation. Incessant innovations in IVD product type design and technology have encouraged doctors and researchers to shift their focus from traditional diagnostic methods to personalized medicines.
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Rise in need for IVD testing arises due to increase in incidences of chronic and infectious diseases and growth in geriatric population prone to immunological disorders. Moreover, advancements in personalized medicines and widespread knowledge of rare diseases are expected to boost the growth of the global IVD market. In addition, increase in incidences of colorectal cancer, neurological disorders, and gynecological diseases are anticipated to boost the adoption of IVD devices and reagents. On the contrary, stringent government regulations and unfavorable reimbursement policies are expected to restrain the growth of the global market.
The report segments the market across different categories such as product type, technique, application, end users, and region. Based on product type, the market is segmented into reagents, instruments, and services & software.
Based on techniques, the market is segmented into immunodiagnostics, hematology, molecular diagnostics, tissue diagnostics, clinical chemistry, and other IVD techniques. The immunodiagnostics is further segmented into enzyme-linked immunosorbent assay (ELISA), rapid tests, enzyme-linked immunospot (ELISPOT), radioimmunoassay (RIA), and western blot. The ELISA segment is further classified into chemiluminescence immunoassay (CLIA), fluorescence immunoassay (FIA), and colorimetric immunoassay (CI). Molecular diagnostics segment is further divided into polymerase chain reaction (PCR), isothermal nucleic acid amplification technology (INAAT), hybridization, DNA diagnostics, microarrays, and others. Similarly, clinical chemistry segment is categorized into basic metabolic panel, liver panel, lipid profile, thyroid function panel, renal profile, electrolyte panel, and specialty chemicals.
By application, the market is classified into infectious diseases, cancer, cardiac diseases, immune system disorders, nephrological diseases, gastrointestinal diseases, and other indications. Based on end user, it is divided into hospitals, academic & medical schools, point of care testing, and others. Based on region, the market is studied across North America (U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (China, Japan, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and rest of LAMEA).
Key players profiled in the report include Abbott Laboratories; Becton, Dickinson and Company; bioMérieux SA, Bio-Rad Laboratories, Inc.; Danaher Corporation (Beckman Coulter, Inc.); F. Hoffmann-La Roche Ltd.; Johnson & Johnson; QIAGEN N.V.; Sysmex Corporation; and Thermo Fisher Scientific, Inc.
Key Benefits for IVD Market:
- The study provides an in-depth analysis of the market along with the current trends and future estimations to elucidate the imminent investment pockets.
- It offers a quantitative analysis from 2017 to 2025, which is expected to enable the stakeholders to capitalize on the prevailing market opportunities.
- A comprehensive analysis of all the geographical regions is provided to determine the existing opportunities.
- The profiles and growth strategies of the key players are thoroughly analyzed to understand the competitive outlook of the global market.
IVD Key Market Segments:
By Product Type
- Reagents
- Instruments
- Software & Services
By Techniques
- Immunodiagnostics
- - Enzyme-Linked Immunosorbent Assay (ELISA)
- - - - Chemiluminescence Immunoassays (CLIAS)
- - - - Fluorescence Immunoassays (FIAS)
- - - - Colorimetric Immunoassays (CIS)
- - Rapid Tests
- - Enzyme-Linked ImmunoSpot Assays (ELISPOT)
- - Radioimmunoassay
- - Western Blot
- - Hematology
- Molecular Diagnostics
- - Polymerase Chain Reaction (PCR)
- - Isothermal Nucleic Acid Amplification Technology (INAAT)
- - Hybridization
- - DNA Diagnostics
- - Microarrays
- - Others
- Tissue Diagnostics
- Clinical Chemistry
- - Basic Metabolic Panel
- - Liver Panel
- - Lipid Profile
- - Thyroid Function Panel
- - Renal Profile
- - Electrolyte Panel
- - Specialty Chemicals
- Other IVD Techniques
By End User
- Standalone Laboratory
- Hospitals
- Academic & Medical Schools
- Point of Care Testing
- Others
By Region
North America
- U.S.
- Canada
- Mexico
Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest of Europe
Asia-Pacific
- Japan
- China
- Australia
- India
- South Korea
- Rest of Asia-Pacific
LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest of LAMEA
List Of Key Players Profiled in the Report
- Abbott Laboratories
- Becton, Dickinson and Company
- bioMrieux SA
- Bio-Rad Laboratories, Inc.
- Danaher Corporation (Beckman Coulter, Inc.)
- F. Hoffmann-La Roche Ltd.
- Johnson & Johnson
- QIAGEN N.V.
- Sysmex Corporation
- Thermo Fisher Scientific, Inc.
List Of Other Players in the Value Chain (These players are not profiled in the report. The same will be included on request)
- Illumina, Inc.
- Luminex Corporation.
- Siemens Healthcare GmbH.
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Table of Contents@
CHAPTER 1: INTRODUCTION
1.1. Report description
1.2. Key benefits for stakeholders
1.3. Key market segments
1.3.1. List of key players profiled in the report
1.4. Research methodology
1.4.1. Secondary research
1.4.2. Primary research
1.4.3. Analyst tools and models
CHAPTER 2: EXECUTIVE SUMMARY
2.1. Key findings of the study
2.2. CXO perspective
CHAPTER 3: MARKET OVERVIEW
3.1. Market definition and scope
3.2. Key findings
3.2.1. Top investment pockets
3.3. Top winning strategies, 2017
3.4. Top player positioning, 2017
3.5. Porters five forces analysis
3.6. Market dynamics
3.6.1. Drivers
3.6.1.1. Increase in incidence of chronic and infectious diseases
3.6.1.2. Technological advancements in IVD
3.6.1.3. Emergence of minimal invasive technologies
3.6.1.4. Increasing government expenditures on healthcare
3.6.1.5. Increase in popularity of personalized medicine approach
3.6.2. Restraint
3.6.2.1. Unclear reimbursement policies
3.6.2.2. Stringent regulatory policies
3.6.3. Opportunities
3.6.3.1. Potential opportunities for outsourcing
3.6.3.2. Convergence of new technologies
3.6.4. Impact Analyses
CHAPTER 4: IN-VITRO DIAGNOSTICS MARKET, BY PRODUCT TYPE
4.1. Overview
4.1.1. Market size and forecast
4.2. Reagents
4.2.1. Key market trends, growth factors, and opportunities
4.2.2. Market size and forecast, by region
4.2.3. Market analysis, by country
4.3. Instruments
4.3.1. Key market trends, growth factors, and opportunities
4.3.2. Market size and forecast, by region
4.3.3. Market analysis, by country
4.4. Software & Services
4.4.1. Key market trends, growth factors, and opportunities
4.4.2. Market size and forecast, by region
4.4.3. Market analysis, by country
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#In Vitro Diagnostics (IVD) Market#In Vitro Diagnostics (IVD) Market Size#In Vitro Diagnostics (IVD) Market Share#In Vitro Diagnostics (IVD) Market Growth
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Rare Disease Genetic Testing Market Is Expected To Reach New Growth Revenues During 2021-2028
The global rare disease genetic testing market size is expected to reach USD 1.8 Billion by 2027 according to a new study by Polaris Market Research. The report “Rare Disease Genetic Testing Market Share, Size, Trends, Industry Analysis Report, By Disease Type (Neurological Disorders, Immunological Disorders, Hematology Ailments, Endocrine & Metabolism Disorders, Cancer, Musculoskeletal Disorders, Cardiovascular Disorders, Dermatology Disorders, Others); By Technology; By Specialty; By End-Use; By Regions; Segment Forecast, 2020 – 2027” gives a detailed insight into current market dynamics and provides analysis on future market growth.
The growing need for on-time diagnosis of uncommon disorders, rising prevalence of rare disorders, innovations in genomic testing, and the focused approach of the market player’s in cost-effective treatments are the key factors responsible for market growth. Moreover, government-sponsored schemes are also expected to positively impact the market. In February 2020, the government of India announced financial assistance of INR 15 lacs to the patients suffering from uncommon ailments under the Rashtriya Arogaya Nidhi scheme for a one-time treatment.
The global rare disease genetic testing industry is fragmented based on disease type, technology, specialty, end-use, and region. In terms of disease type, the market is segmented into neurological disorders, immunological disorders, hematology illnesses, endocrine & metabolism ailments, cancer, musculoskeletal disorders, cardiovascular disorders, dermatology illnesses, and others.
Based on technology, the rare disease genetic testing industry is further bifurcated into next-generation sequencing, array technology, PCR-based testing, FISH, sanger sequencing, and karyotyping. Based on specialty, the rare disease genetic testing industry is further bifurcated into molecular, chromosomal, and biochemical genomic tests. Based on end-use, the rare disease genomic testing industry is further bifurcated into research laboratories & CROs, hospitals & clinics, and diagnostic laboratories.
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Segment Highlights
Neurological ailments accounted for the largest revenue share in 2019 on account of the increasing prevalence of neurologic disorders across the globe and presence of numerous testing techniques
Based on technology, the next generation sequencing segment is projected to constitute almost half of the market in 2027. The usage of the technology in whole genome sequencing is the key factor responsible for its segment’s growth.
Molecular tests are expected to account for the highest revenue share by the end of 2027. The availability of advanced technologies and ability to test ultra-rare disorders is expected to drive market growth.
Research laboratories & CROs accounted for the largest revenue share in 2019 owing to the increasing number of tests and growing occurrence of rare disorders across the developed economies
List of Key Players
Strand Life Sciences
Myriad Genetics
Quest Diagnostics Inc.
Centogene N.V.
Invitae Corporation
Baylor Genetics
Ambry Genetics
Macrogen, Inc.
Opko Health, Inc.
Color Genomics, Inc.
Health Network Laboratories
Preventiongenetics, Progenity, Inc.
Fulgent Genetics Inc.
Others
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Polaris Market Research has segmented the rare disease genetic testing market report on the basis of disease type, technology, specialty, end-use, and region
Rare Disease Genetic Testing, Disease Type Outlook (Revenue – USD Million, 2016 – 2027)
Neurological Disorders
Immunological Disorders
Hematology Ailments
Endocrine & Metabolism Disorders
Cancer
Musculoskeletal Disorders
Cardiovascular Disorders
Dermatology Disorders
Others
Rare Disease Genetic Testing, Technology Outlook (Revenue – USD Million, 2016 – 2027)
Whole Exome Sequencing
Whole Genome Sequencing
Rare Disease Genetic Testing, Specialty Outlook (Revenue – USD Million, 2016 – 2027)
Molecular Genetic Tests
Chromosomal Genetic Tests
Biochemical Genetic Tests
Rare Disease Genetic Testing, Technology Outlook (Revenue – USD Million, 2016 – 2027)
Research Laboratories & CROs
Hospitals & Clinics
Diagnostic Laboratories
Rare Disease Genetic Testing, Regional Outlook (Revenue – USD Million, 2016 – 2027)
U.S.
Canada
France
Germany
UK
Italy
Spain
Netherlands
Austria
China
India
Japan
Malaysia
South Korea
Indonesia
Mexico
Brazil
Argentina
UAE
Saudi Arabia
Israel
South Africa
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Apheresis Equipment Market To Reach US$ 6,081.8 Million By 2027 - Coherent Market Insights
An apheresis machine separates the blood components from the blood directed to the machine from the patient/donor's veins through tubing. Apheresis can be used for the treatment of various diseases such as familial hypercholesterolemia, Goodpasture's syndrome, hyperviscosity syndrome, myasthenia gravis, the HELLP syndrome of pregnancy, Waldenstrom's macroglobulinemia, clogging of blood vessels (leukostasis) cause by severely elevated white blood count in leukemia, and severely elevated platelet counts in leukemia or myeloproliferative disorders.
The global Apheresis Equipment Market is estimated to account for US$ 2,866.4 Mn in terms of value in 2020 and is expected to reach US$ 6,081.8 Mn by the end of 2027.
Global Apheresis Equipment Market: Drivers
Increasing prevalence of COVID-19 is expected to propel growth of the global apheresis equipment market over the forecast period. For instance, according to a statement by World Apheresis Association in April 2020, apheresis therapy can be widely beneficial in the treatment of patients with the novel coronavirus.
Global Apheresis Equipment Market: Opportunities
Lipoprotein apheresis is effective in the treatment of homozygous familial hypercholesterolemia. However, the therapy is expensive and available in only a few countries. Therefore, reduction in the cost of lipoprotein apheresis and widespread availability of the therapy is expected to offer lucrative growth opportunities for the market players.
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Global Apheresis Equipment Market: Restraints
Lack of trained professionals, especially in emerging economies is expected to limit growth of the market. Hiring skilled staff for both therapeutic and donor apheresis is a major challenge faced in both developed and emerging markets. The staff required for apheresis comprises of a practicing doctor and a specialized nurse. Apheresis procedures are often termed to be labor intensive since they require the staff to be present and vigilant during the entire procedure. The skill requirement criteria in the practice of apheresis are also different compared to conventional therapeutic areas.
Key Takeaways:
Plasmapheresis segment was valued at US$ 1,303.7 Mn in 2019 and is forecast to reach a value of US$ 2,735.9 Mn by 2027 at a CAGR of 9.7% between 2020 and 2027. Frequent and increasing use of plasmapheresis is expected to support growth of the segment over the forecast period.
Neurological disorders segment held dominant position in the global apheresis equipment market in 2019, accounting for 52.6% share in terms of value, followed by hematological disorders and renal disorders, respectively. Increasing prevalence of neurological disorders is expected to support growth of the segment over the forecast period.
Market Trends
Increasing clinical trials for cystinosis, a rare genetic, metabolic, lysosomal storage disease caused by mutations in the CTNS gene on chromosome 17p13, is expected to boost adoption of apheresis, thereby boosting growth of the market. For instance, in March 2020, AVROBIO, Inc., a clinical-stage gene therapy company, announced that a second patient in the AVR-RD-04 Phase 1/2 clinical trial in cystinosis has been enrolled and has completed apheresis.
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However, several pharmaceutical companies have suspended screening, enrollment and apheresis in clinical studies. For instance, in March 2020, Bristol-Myers Squibb disclosed that the company has temporarily suspended screening, enrollment and apheresis in its cellular therapy clinical studies.
Global Apheresis Equipment Market: Competitive Landscape
Major players operating in the global apheresis equipment market include, Asahi Kasei Medical Co., Ltd., Terumo BCT, Inc., Fenwal, Inc., Haemonetics Corp., Therakos, Inc., B. Braun Melsungen AG, and HemaCare Corporation.
Global Apheresis Equipment Market: Key Developments
April 2019: Asahi Kasei Bioprocess America, a subsidiary of Asahi Kasei Medical Co., Ltd. started Massachusetts Training Center, for customer training and product collaborations in virus filtration, bioprocess and fluid management
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Newborn Screening Market - Global Industry Size, Share, Analysis By 2018-2026
Newborn screening tests look for developmental, metabolic, and genetic disorders in infants. It allows steps to be taken before development of symptoms. Although, majority of these illnesses are very rare, they can be treated with early diagnosis. Newborn screening includes over 30 conditions and illnesses. Increasing awareness among parents for disease screening is a major factor driving newborn screening market growth. Furthermore, various government and non-government organizations are actively focused on offering better fetal and maternal care. For instance, in June 2018, the American Society of Hematology (ASH) led a campaign to fight sickle cell disease in Africa and urged governments, particularly in sub-Saharan Africa, to invest in newborn screening of the disease.
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Novel treatments, biomarkers, and technologies are expected to enable various diseases to be considered as potential candidates to be included in New Born Screening (NBS) programs. For instance, new treatments such as Hematopoietic Stem Cell Transplant (HSCT), Enzyme Replacement Therapy (ERT), and gene therapy and new pharmacological drugs have allowed autoimmune diseases to be considered as potential candidates to be included in NBS programs.
Market Dynamics
Increasing number of newborn screenings, owing to rising awareness among parents and governments is expected to drive the newborn screening market growth. According to the Centers for Disease Control and Prevention (CDC) 2017, four million infants in the U.S. are routinely screened, using a few drops of blood from their heel, for certain endocrine, genetic, and metabolic disorders. The infants are also tested for hearing loss and Critical Congenital Heart Defects (CCHDs) prior to discharge from a hospital or birth center.
Furthermore, increasing incidence of hospital acquired diseases create an acute need for newborn screening. For instance, according to the Center for Disease Control and Prevention (CDC), in 2011, around one in every 25 infants was infected with at least one hospital acquired infections.
Government initiatives to support screening of newborns is also a major factor driving the newborn screening market. For instance, CDC is working to harness the latest advances in science and technology so that more disorders can be identified accurately and treated quickly. In 2005, CDC established the Newborn Screening Translation Research Initiative (NSTRI) with the CDC Foundation. NSTRI works with corporate, academic, and foundation partners to assure the quality of research methods during both pilot studies and routine screening.
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Key players operating in the global newborn screening market include, Agilent Technologies, AB SCIEX, Bio-Rad Laboratories, Covidien PLC, GE Life Sciences, Masimo Corporation, Natus Medical Inc., PerkinElmer Inc., and ZenTech S.A.
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