Ophthalmic Drugs Contract Manufacturing Market

Ophthalmic Drugs Contract Manufacturing Market Overview

The ophthalmic drugs contract manufacturing market is estimated to be worth $0.79 billion in 2020 and is expected to grow at CAGR of 8% during the forecast period. Factors such as cost efficiency provided by CDMOs and increasing prevalence of ophthalmic diseases are driving the ophthalmic drugs contract manufacturing market growth. Ophthalmic diseases, such as age-related macular degeneration, cataract, diabetic retinopathy, dry eye and glaucoma, are considered among the leading causes of vision loss across the globe. 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.

In light of the aforementioned facts, several CMOs based in the Asia-Pacific region (such as India, China and Japan) play a critical role in the global ophthalmic API and FDF manufacturing. We believe that, the changing supply chain scenario due to the recent COVID-19 pandemic is likely to have a prominent impact on the global contract manufacturing industry, including China, in the short term. As pharma companies resume full-scale operation after the coronavirus outbreak, the demand for large-scale contract manufacturing is expected to increase significantly. Owing to this, the ophthalmic drugs contract manufacturing market is likely to witness substantial market growth during the forecast period.

Recent Developments in Ophthalmic Drugs Contract Manufacturing Market:

Several recent developments have taken place in the field of ophthalmic drugs contract manufacturing market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In September 2023, Otsuka collaborated with ShapeTX with an aim to develop novel AAV gene therapies for ocular diseases. 
• In August 2023, Lupin announced the US Food and Drug Administration approval for Bromfenac ophthalmic solution. 
• In February 2023, AbbVie entered into a strategic collaboration with Capsida Biotherapeutics in order to develop targeted genetic medicines for eye diseases with high unmet need.

Key Companies in Ophthalmic Drugs Contract Manufacturing Market 

Examples of key companies engaged in ophthalmic drugs contract manufacturing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Akorn, Catalent, Cayman Chemical, Pillar5 Pharma, Sterling Pharmaceutical Services, FARMIGEA, Lomapharm, Medichem, Recipharm, Salvat, Akums, Bal Pharma, Entod Pharmaceuticals, Glenmark Pharmaceuticals, Indiana Ophthalmics and Sunways India. This market report includes an easily searchable excel database of all the companies providing ophthalmic drugs contract manufacturing services, worldwide.

Scope of the Report

The ‘Ophthalmic Drugs Contract Manufacturing Market, 2020-2030’ market report features an extensive study of the current market landscape, market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunities of the ophthalmic drugs contract manufacturing market. It is worth mentioning that the market research report 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 market research 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.

The key objective of ophthalmic drugs contract manufacturing market report is to provide a detailed market analysis in order to estimate the existing market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunity for ophthalmic drugs contract manufacturing market during the forecast period. 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 forecast 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 market forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions presented in this market research report were influenced by inputs (through an industry-wide survey) of several key players in this domain. In addition, the market 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 market research report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What is ophthalmic drugs contract manufacturing?

Answer: Ophthalmic drugs contract manufacturing refers to manufacturing services provided by specific organizations to pharmaceutical product manufacturers for the production of novel, bulk ophthalmic drugs.

Question 2: How big is the ophthalmic drugs contract manufacturing market?

Answer: The ophthalmic drugs contract manufacturing market size is estimated to be worth $0.79 billion in 2020.

Question 3: What is the projected market growth of the ophthalmic drugs contract manufacturing market?

Answer: The ophthalmic drugs contract manufacturing market is expected to grow at compounded annual growth rate (CAGR) of 8% during the forecast period 2020 – 2030.

Question 4: Who are the leading CMO in the ophthalmic drugs contract manufacturing market?

Answer: Examples of key companies engaged in ophthalmic drugs contract manufacturing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Akorn, Catalent, Cayman Chemical, Pillar5 Pharma, Sterling Pharmaceutical Services, FARMIGEA, Lomapharm, Medichem, Recipharm, Salvat, Akums, Bal Pharma, Entod Pharmaceuticals, Glenmark Pharmaceuticals, Indiana Ophthalmics and Sunways India.

Question 5: How many companies are currently engaged in the ophthalmic drugs contract manufacturing market?

Answer: Presently, over 240 CMO are engaged in the ophthalmic drugs contract manufacturing market, having the capabilities to manufacture novel ophthalmic drugs.

Question 6: How many clinical trials are evaluating novel ophthalmic drugs?

Answer: Over 10,000 clinical trials for evaluating novel ophthalmic drugs have been registered.

Question 7: How many novel ophthalmic drug candidates are currently under clinical evaluation?

Answer: More than 400 ophthalmic drug candidates are currently under clinical evaluation.