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The Wilson's disease drugs market size is estimated to grow by USD 173.3 million at a CAGR of 5.84% between 2023 and 2028. One of the driving factors for the growth of the market is growing awareness among individuals about the treatment of Wilson's disease. Many people come to the clinic complaining of abdominal pain, light-colored stools, dark-colored urine, jaundice, anxiety and depression, disturbed thoughts and emotions, mood swings, corneal limbal rings, muscle stiffness, and tremors, which are the symptoms of Wilson's disease. Various organizations, such as the Wilson Disease Association and the National Organization for Rare Disorders, are raising awareness about Wilson's disease, which will drive market growth. Wilson's Disease Association is a volunteer organization based in New York that aims to promote the well-being of patients affected by Wilson's disease by providing up-to-date information on diseases, symptoms, and treatment. In addition, the Wilson Disease Association provides funding for research and trials for Wilson's disease. Thus, increasing awareness of the treatment of Wilson's disease among individuals will drive the growth of the global market during the forecast period.
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The market share growth by the retail pharmacies segment will be significant during the forecast period. The retail pharmacies segment of the global Wilson's disease drugs market includes chain pharmacies, independent pharmacies, and drugstores that dispense prescription and over-the-counter medications to patients outside of a hospital setting. Retail pharmacies typically purchase Wilson's disease drugs in smaller quantities from wholesalers or manufacturers. They stock a range of medications used to manage Wilson's disease drugs. Retail pharmacies are often conveniently located in communities, which makes it easier for patients to obtain their medications. This helps to improve patient adherence to medication regimens, which leads to better outcomes for patients with cardiovascular conditions such as coronary artery disease, heart failure, and hypertension.
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The retail pharmacies segment was valued at USD 245.80 million in 2018. The pharmaceutical industry and research organizations are concentrating on the discovery of a treatment for Wilson's disease. The ongoing research initiatives undertaken by market leaders like Bausch Recordati and Teva Pharmaceuticals as well as other participants in that market, the deployment of new technologies, in addition to significant government and private sector funding in Wilson's disease research, will drive the growth of the chelators segment. Hence, such factors are fuelling the growth of this segment during the forecast period.
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North America is estimated to contribute 38% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that will shape the market during the forecast period. The availability of improved healthcare infrastructure and the presence of reimbursement policies and co-pay assistance programs such as Medicaid and Medicare enable individuals to opt for medical treatment. However, the increasing availability of generics in the market is expected to offset the growth partially. Drug developers are encouraged to explore new treatment options by favorable regulatory initiatives for the approval of these drugs. The US is the major revenue contributor to market in the region. Few factors are expected to drive the growth of the regional market during the forecast period.
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Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 17 market companies, including:
ANI Pharmaceuticals Inc. - The company offers Wilson's disease drugs such as ANI Pharmaceuticals Cuprimine.
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
Wilson's Disease (WD) is a rare, inherited disorder caused by mutations in the ATP7B gene, leading to copper accumulation in the liver, brain, and other organs. Neurologic symptoms, including tremors, rigidity, and psychiatric disorders, are common in advanced stages. Key diagnostic methods include eye exams for the presence of Keyser-Fleisher rings, biopsy, genetic testing, and diagnostic tests such as blood, urine, and imaging tests. WD treatment primarily focuses on chelators like Penicillamine, Trientine, and Zinc to remove excess copper from the body. Oral and parenteral forms of these medications are available in hospital pharmacies. In severe cases, medication alone may not be sufficient, and surgery or a combination of medication and surgery may be required. The market is driven by the increasing prevalence of the disease and the need for effective treatments. Chelators dominate the market due to their ability to bind copper and facilitate its excretion. The market is expected to grow, driven by the rising number of hospitalizations for WD diagnosis and treatment, and the increasing demand for advanced diagnostic tests and personalized medicine. Liver function tests and imaging tests like MRI are essential for monitoring disease progression and treatment response. Regular follow-ups and ongoing medication are crucial for managing the disease and preventing complications. There are multiple factors influencing market growth. Our researchers analyzed the data with 2023 as the base year, along with the key trends and challenges.
The growing prevalence of chronic pain is a primary trend in Wilson's disease drug market. The demand for Wilson's disease medicines is increasing due to the increase in chronic pain conditions, such as Wilson's disease. Furthermore, according to data from the National Health Interview Survey (NHIS), the prevalence of chronic pain was 20.4% globally in February 2022, and the prevalence of high-impact chronic pain was 7.4% (or 36.4% of adults with chronic pain).
Globally, women (21.7%), non-Hispanic white adults (23.6%), and those aged 65 and up (30.8%) had the highest rates of chronic pain. Therefore, the global market for Wilson's disease medicinal products will grow over the forecast period due to a growing prevalence of chronic pain. Hence, such factors are driving the market during the forecast period.
The stringent regulatory environment on Wilson's drug development and approval is a major challenge faced by the market. In order to guarantee a high level of sterileness and consistency, the majority of pharmaceutical development and approval processes are strictly regulated by different regulatory authorities. The key factors examined by these regulatory bodies include safety, efficacy, medicinal product information, pharmacodynamic effects, and interactions. Therefore, if a drug fails to comply with any of these criteria, it is likely to receive a complete response letter (CRL) or may face complete rejection from regulatory agencies. On receiving a CRL, a drug applicant (pharma company) needs to furnish additional data pertaining to the drug. This may require further studies for the drug applicant, leading to increased spending on research and development. In some cases, drug applicants withdraw their applications and discontinue their drug candidates.
Clinical trials for a drug are typically done in three phases. The US Food and Drug Administration may require further information or suspend the current study if any serious safety, efficacy, or tolerability problems are observed in all phases of animal studies or trials. Upon successful completion of all three phases of clinical trials, the applicant is required to submit a new drug application (NDA) to the US FDA. Such stringent regulatory guidelines on Wilson's drug development and approval can hamper the growth of the market during the forecast period.
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The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.
Market Customer Landscape
The market research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD Million" for the period 2024 to 2028, as well as historical data from 2018 to 2022 for the following segments
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Wilson's Disease (WD), a rare inherited disorder, affects the liver and central nervous system. Characterized by the presence of Keyser-Fleisher rings, neurologic symptoms, and high copper levels in the liver and other organs, WD requires careful management. The market landscape depends on Cell-based and gene therapies, hospital pharmacy, National Library of Medicines, Blood and Urine Test, Eye Exam. The primary treatment for WD involves the use of chelators such as Penicillamine, Trientine, and Zinc to remove excess copper from the body. These medications are available in various forms, including oral and parenteral, and can be obtained from hospital pharmacies, retail pharmacies, and online pharmacies.
Moreover, diagnosis of WD involves a series of tests, including eye exams, biopsy, and genetic testing. Diagnostic tests include blood, urine, imaging tests like MRI and CT scans, liver function tests, and neurological and psychiatric evaluations. Early diagnosis and prompt treatment are crucial for managing the symptoms and preventing complications. The market landscape depends on the online pharmacy, market, Neurological evaluation, Psychiatric evaluation, Autosomal recessive disease, D penicillamine, Syprine, Zinc salts, Tetrathiomolybdate, Liver transplantation, Chelating agents, Copper balance, Liver failure, Encephalopathy, Decompensated cirrhosis, Therapeutic candidates, Phase III, Phase II. The market is expected to grow due to the increasing number of diagnosed cases and the availability of new treatments. The market includes key players such as Merck & Co., Inc., Valeant Pharmaceuticals International, Inc., and Maquet Holding B.V. The market is segmented based on the form of medication, end-users, and regions. The end-users include hospitals, homecare, specialty clinics, and online pharmacies. The market is expected to grow due to the increasing awareness of rare diseases, the development of new treatments, and the availability of various distribution channels.
Market Scope |
|
Report Coverage |
Details |
Page number |
159 |
Base year |
2023 |
Historic period |
2018 - 2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 5.84% |
Market growth 2024-2028 |
USD 173.3 million |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
5.41 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 38% |
Key countries |
US, Germany, UK, Canada, and China |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
ANI Pharmaceuticals Inc., Apotex Inc., AstraZeneca Plc, Bausch Health Companies Inc., Breckenridge Pharmaceutical Inc., Dr Reddys Laboratories Ltd., Endo International Plc, Lupin Ltd., Merck and Co. Inc., Navinta LLC, Noblepharma Co. Ltd., Panacea Biotec Ltd., Recordati S.p.A, Sanofi SA, Taj Pharmaceutical Ltd., Teva Pharmaceutical Industries Ltd., and Tsumura and Co. |
Market dynamics |
Parent market analysis, market growth analysis, market research and growth, Market forecasting, market forecast, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, Market growth and Forecasting, COVID 19 impact and recovery analysis and future consumer dynamics, Market condition analysis for forecast period |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Distribution Channel
7 Market Segmentation by Product
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Opportunity/Restraints
11 Competitive Landscape
12 Competitive Analysis
13 Appendix
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