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- 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.
- 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.
The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:
- Type of product
- Ophthalmic API
- Ophthalmic drug FDF
- Type of FDF manufactured
- Liquid / suspension
- Type of primary packaging
- Ampoule / vial
- Glass / plastic bottle
- Ointment tube
- Blister packing
- Other forms
- Scale of manufacturing
- Company size
- Very large
- Target disease indication
- Age-related macular degeneration
- Dry eye
- Other disease segments
- Key geographical regions
- North America (US, Canada and Mexico)
- Europe (UK, Germany, France, Spain, Italy and rest of Europe)
- Asia-Pacific (India, China, Japan, Australia and rest of Asia-Pacific)
- Rest of the world
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Key Questions Answered
- What is the clinical research landscape of investigational ophthalmic drugs?
- What percentage of ophthalmic drug manufacturing operations are outsourced to service providers?
- What are the preferred primary packaging formats / fill finish containers of ophthalmic drugs?
- Who are the leading contract manufacturers of ophthalmic APIs and drug FDFs, across the globe?
- What are the key challenges faced by ophthalmic drug contract manufacturers?
- What is the annual, clinical and commercial demand for ophthalmic drugs?
- What is the current, installed manufacturing capacity for ophthalmic drugs?
- What are the anticipated future trends related to ophthalmic drug manufacturing?
- How is the current and future market opportunity likely to be distributed across key market segments?
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+44 (122) 391 1091Gaurav.Chaudhary@rootsanalysis.com