DUBLIN–(BUSINESS WIRE)–The “Ophthalmic Drugs Contract Manufacturing Market: Focus on Active Pharmaceutical Ingredients and Finished Dosage Forms (Ophthalmic Drops, Emulsions, Gels, Injections, Lotions, Ointments, Suspensions, and Tablets / Capsules), 2020-2030” report has been added to ResearchAndMarkets.com’s offering.
Current estimates indicate that the total economic burden related to vision loss is expected to reach approximately USD 384 billion by 2030, in the US alone
Ophthalmic Drugs Contract Manufacturing Market, 2020-2030 features an extensive study of the contract services market for ophthalmic products and solutions. It is worth mentioning that the study primarily focuses on small molecule active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs), including ophthalmic drops, emulsions, gels, injections, lotions, ointments, suspensions, and tablets / capsules. It features in-depth analyses, highlighting the capabilities of a diverse set of CMOs and CDMOs.
One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on various parameters, such as growth of the overall ophthalmic drugs market, cost of goods sold, and direct manufacturing costs, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2020-2030.
In order to provide a detailed future outlook, projections have been segmented on the basis of:
- [A] type of product (APIs and FDFs),
- [B] type of FDF manufactured (solids, semi-solids, and liquids / suspensions),
- [C] type of primary packaging (ampoules / vials, glass / plastic bottles, ointment tubes, blister packing, and other forms),
- [D] scale of manufacturing (preclinical, clinical, and commercial),
- [E] company size (small sized, mid-sized, and large-sized companies),
- [F] key disease indications (age-related macular degeneration, glaucoma, uveitis, dry eye, and other disease segments), and
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[G] key geographical regions, covering North America (the US, Canada and Mexico), Europe (the UK, Germany, France, Spain, Italy and rest of Europe), and Asia-Pacific (India, China, Japan, Australia and rest of Asia-Pacific).
The rise in incidence and prevalence of chronic eye disorders has prompted the medical research community to actively develop a variety of ophthalmic drugs / therapies. The current ophthalmic diseases treatment landscape is characterized by a number of blockbuster therapies, namely ALPHAGAN, COSOPT, LUMIGAN, PAZEO, RESTASIS, TRAVATAN Z, and XALATAN, and a robust pipeline of over 400 candidate drugs in various stages of clinical development, designed for the treatment of approximately 1,000 chronic eye disorders.
Owing to various reasons, such as growing manufacturing demand, need for specialized facilities, equipment and operational expertise, and high costs of development associated with certain drugs / therapies, a number of innovator companies have demonstrated a preference to outsource certain aspects of ophthalmic drug development and production operations to contract service providers.
Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are known to offer significant benefits, which include reduction in capital investment, access to larger production capacities, reductions in time-to-market and also guarantee a significant degree of commercial risk mitigation. Since 2000, more than 75 new ophthalmology focused CMOs have been established.
Amidst the tough competition, the availability of cutting-edge tools and technologies has emerged as a differentiating factor and is likely to grant a competitive advantage to certain CMOs over other players in the industry. This has caused many service providers to actively expand their respective service portfolios, either through strategic acquisitions or facility / capability expansions. Over time, many CMOs / CDMOs claim to have developed end-to-end service capabilities, ranging from drug development (including preliminary R&D, preclinical studies and clinical trials), to regulatory filings, and commercial scale production.
To account for the uncertainties associated with the growth of the ophthalmic drugs contract manufacturing market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.
Amongst other elements, the report includes:
- A detailed review of the ophthalmic drugs contract manufacturing market landscape, featuring a list of over 240 CMOs and analysis based on a number of relevant parameters, such as year of establishment, company size, geographical location, scale of operation (preclinical, pilot, clinical, and commercial), type of product (APIs and FDFs), type of FDF manufactured (solids, semi-solids, liquids, suspensions, and injectables), type of primary packaging (ampoules/vials, glass / plastic bottles, ointment tubes, sachets/pouches, blister packing, and other forms), type of service(s) offered (pre-formulation, drug formulation, method validation, process development, analytical testing, stability studies, technology transfer, scale-up, fill/finish, and regulatory support), number of manufacturing facilities, their specific locations (country-wise), as well as their regulatory accreditations and certifications.
- A company competitiveness analysis, highlighting prominent ophthalmic drug contract manufacturers based on supplier strength (which was calculated considering the size of employee base of a company and its experience in this field) and service strength (quantified based on type of FDF manufactured, type of primary packaging, type of service(s) offered, scale of operation, number and location of manufacturing facilities, and number of regulatory accreditations/certifications).
- Elaborate profiles of key players based in North America, Europe and Asia-Pacific that offer a diverse range of capabilities for the development, manufacturing and packaging of ophthalmic drug products. Each profile includes an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, and details on partnerships, recent developments (expansions), and awards and accolades received, as well as an informed future outlook.
- A detailed clinical trial analysis of completed, ongoing and planned studies of various ophthalmic drug products, highlighting prevalent trends across parameters, such as current trial status, trial registration year, enrolled patient population and trial location, phase of development, study design, leading industry and non-industry players (in terms of number of trials undertaken / conducted), study focus, and key disease indications (in terms of number of trials undertaken / conducted).
- An informed estimate of the annual commercial demand for ophthalmic APIs and drug FDFs (in million litres), taking into account the top 30 small molecule-based ophthalmic drugs; the analysis takes into consideration the target patient population, dosing frequency and dose strength of the aforementioned products. The annual clinical demand for ophthalmic drug products was also estimated, taking into account ongoing and planned clinical trials.
- A detailed capacity analysis, taking into consideration the manufacturing capacities of various stakeholders (small-sized, mid-sized, and large-sized CMOs) in the market, based on data gathered via secondary and primary research. It also provides the likely distribution of the global ophthalmic product-related manufacturing capacity available across different types of companies (small-sized, mid-sized, and large-sized), scales of operation (preclinical, clinical and commercial), types of FDFs manufactured (ampoules / vials, glass / plastic bottles, and ointment tubes), and key geographical regions (North America, Europe, and Asia-Pacific).
- A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.
- A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing CMO services to ophthalmic drug developers.
- A discussion on the emerging trends and potential market drivers, such as the growing ophthalmic drugs / therapies pipeline, rise in outsourcing activity for sterile manufacturing operations, adoption of innovative technologies and increasing opportunities in the Asia-Pacific region, which are likely to impact the evolution of the market in the coming years.
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A detailed list of over 55 ophthalmic medical device contract manufacturers, along with information on year of establishment, company size, geographical location, key application area(s) (diagnostics, drug delivery, therapeutics, and others), type of manufacturing service(s) offered (design, component manufacturing, assembly, prototype development, sterilization, quality assurance, and packaging), type of additional service(s) offered (consultancy, documentation, inspection/testing, labelling, logistics, project management, regulatory support, repair, warehouse/storage, and others), scale of operation (pilot and commercial), device class-related expertise (class I, class II and class III), number of manufacturing facilities, their specific locations (country-wise), as well as their regulatory accreditations and certifications.
Key Topics Covered
1. Preface
2. Executive Summary
3. Introduction
4. Current Market Landscape
5. Company Competitiveness Analysis
6. Ophthalmic Drugs Counteract Manufacturing in North America: Company Profiles
7. Ophthalmic Drugs Counteract Manufacturing in Europe: Company Profiles
8. Ophthalmic Drugs Counteract Manufacturing in Asia-Pacific: Company Profiles
9. Clinical Trial Analysis
10. Capacity Analysis
11. Demand Analysis
12. Market Forecast
13. Case Study: Comparison of Small Molecule and Large Molecule Ophthalmic Drugs / Therapies
14. SWOT Analysis
15. Survey Analysis
16. Executive Insights
17. Future Growth Opportunities
Companies Mentioned
- A. S. Joshi & Company
- Aarti Industries
- Abbott Medical Optics
- AccuMED
- Actiza Pharmaceutical
- Admac Formulations
- Aerie Pharmaceuticals
- AGC Biologics
- Aishwarya Lifescience
- Akorn
- Akums
- Alcon
- Alembic Pharmaceuticals
- Allergan
- Amanta Healthcare
- Ambica Pharma Sales
- AMETEK Engineered Medical Components
- Amman Pharmaceutical Industries
- AMRI
- ANI Pharmaceuticals
- Apex Pharmaceuticals
- Apicore US
- Arvincare
- Ashford Pharmaceutical Laboratories
- Aspen Pharmacare
- Assiut University
- Astellas Pharma
- Aster Pharma
- AstraZeneca
- Atrion Medical
- Aurobindo Pharma
- Avalign Technologies
- Axa Parenterals
- Bachem
- BAL Pharma
- Bausch & Lomb
- Bayer
- Baylor College of Medicine
- Beijing Second Pharmaceutical
- Bennet Pharmaceuticals
- BePharBel
- Beximco Pharmaceuticals
- Binex
- Biocon
- Bioglan
- Biomol
- Biotech Vision Care
- Boehringer Ingelheim
- Bolivac Pharmaceutical
- Bonarum Pharma
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and many, many more!
For more information about this report visit https://www.researchandmarkets.com/r/i2x3fa
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