Ophthalmic Drugs Contract Manufacturing Market, 2020-2030

New York, Feb. 18, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Ophthalmic Drugs Contract Manufacturing Market, 2020-2030" - https://www.reportlinker.com/p05863925/?utm_source=GNW
According to the World Health Organization’s report published in 2019, at least 2.2 billion individuals in the world are reported to be visually impaired. In fact, blindness caused due to multiple reasons, is projected to increase to 75 million affected individuals by 2020. Moreover, 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. , 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.

SCOPE OF THE REPORT
The ‘Ophthalmic Drugs Contract Manufacturing Market, 2020-2030’ report 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. 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.
• 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.

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, our 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 [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). 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.

The opinions presented in this study were influenced by inputs (through an industry-wide survey) of several key players in this domain. In addition, the report features detailed transcripts of interviews held with the following individuals:
• Rahul Gupta (Chief Executive Officer, Selvok Pharmaceutical)
• Vivek Partheeban (Chief Operating Officer, Caplin Point Laboratories) and Ashok Partheeban (Director, Latin American Operations, Caplin Point Laboratories)
• Stuart Smith (Managing Director, Phytex Australia)
• Iranna Bavalatti (General Manager, Gland Pharma)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts’ views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the likely evolution of the ophthalmic drugs contract manufacturing market in the mid to long term.

Chapter 3 presents a general overview of the field of ophthalmology, including information on various chronic eye disorder and the economic burden associated with such conditions. Further, it features a detailed discussion on a variety of ophthalmic drug formulations and affiliated primary packaging. It also provides inputs on the various benefits and challenges associated with the aforementioned products across different types of ophthalmic diseases. Further, the chapter features a brief overview of contract manufacturing and a discussion on the need for outsourcing within the ophthalmic drugs market. In addition, it includes a list of commonly outsourced aseptic manufacturing services and highlights the key factors that need to be considered during the selection of potential CMOs, along with information on key challenges that are currently associated within this market. The chapter concludes with a discussion on the key growth drivers and roadblocks related to ophthalmic drugs contract manufacturing, as well as upcoming trends that the field is expected to witness in the coming years.

Chapter 4 provides a comprehensive overview on the global ophthalmic drugs contract manufacturing landscape. It includes information related to over 240 CMOs that are currently active in this domain. In addition, it features an in-depth analysis of the market based on a number of 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.

Chapter 5 features an insightful company competitiveness analysis of both ophthalmic API and drug FDF contract manufacturers based in North America, Europe and Asia-Pacific, that we came across during our research. The analysis compares companies within each business operation and geography on the basis of 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).

Chapter 6 includes detailed profiles of some of the key players that are active in the ophthalmic drugs contract manufacturing market in North America. 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.

Chapter 7 includes detailed profiles of some of the key players that are active in the ophthalmic drugs contract manufacturing market in Europe. 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.

Chapter 8 includes detailed profiles of some of the key players that are active in the ophthalmic drugs contract manufacturing market in Asia-Pacific. 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.

Chapter 9 provides a comprehensive clinical trial analysis of completed, ongoing and planned studies of various ophthalmic drug products, highlighting prevalent trends across various relevant 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).

Chapter 10 features a comprehensive analysis of the global / regional capacity of contract manufacturers that are engaged in the manufacturing of ophthalmic drug products. The analysis takes into consideration the individual manufacturing capacities of various stakeholders (small-sized, mid-sized, and large-sized CMOs) in the market, using data from both secondary and primary research. It also examines 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).

Chapter 11 features a detailed estimate of the annual demand for ophthalmic APIs and drug FDFs (in million liters), offering an informed opinion on the required scale of supply (in terms of ophthalmic drug contract manufacturing services). In order to estimate the annual commercial demand, we considered 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 the ongoing and planned clinical trials.

Chapter 12 presents an insightful market forecast analysis, highlighting the likely growth of the ophthalmic drugs contract manufacturing market till the year 2030. In order to provide details on the future opportunity, our 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 [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).

Chapter 13 is a case study comparing the key characteristics of large and small molecule ophthalmic drugs, along with information on the steps involved in their respective manufacturing processes.

Chapter 14 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of ophthalmic drugs contract manufacturing market, under a comprehensive SWOT framework.

Chapter 15 presents the insights generated from a detailed survey, wherein we invited multiple stakeholders involved in the ophthalmic drugs contract manufacturing market.

Chapter 16 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with Rahul Gupta (Chief Executive Officer, Selvok Pharmaceutical), Vivek Partheeban (Chief Operating Officer, Caplin Point Laboratories) and Ashok Partheeban (Director, Latin American Operations, Caplin Point Laboratories), Stuart Smith (Managing Director, Phytex Australia), and Iranna Bavalatti (General Manager, Gland Pharma).

Chapter 17 highlights the emerging trends and potential market drivers for ophthalmic drug contract manufacturers. It highlights the various opportunities associated with the growing ophthalmic drugs / therapies pipeline, increase in outsourcing of aseptic 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.

Chapter 18 is an appendix, which provides a comprehensive 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.

Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 20 is an appendix, which provides the list of companies and organizations mentioned
in the report.
Read the full report: https://www.reportlinker.com/p05863925/?utm_source=GNW

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