Frost & Sullivan releases the 'Research Report on the Current State and Future Trends of the Ophthalmic Drug Market' (with complete report access methods attached)

Frost & Sullivan (Frost & Sullivan, abbreviated as 'Frost & Sullivan') officially released the 'Research Report on the Current Development and Future Trends of the Ophthalmic Drug Market' (hereinafter referred to as the 'Report') on July 14, 2022, conducting an in-depth analysis of the global and Chinese ophthalmic drug industries.Explore the unmet clinical needs in the sub-sectors of ophthalmic drug therapy, track the development trajectory of pharmaceutical technologies, analyze market driving factors, and anticipate future industry trends. This provides a reference for those interested in the ophthalmic drug industry.

There are a large number of patients with eye diseases globally, and the harm caused by eye diseases is significant, resulting in a large number of vision impairment and blindness cases.

Eye diseases are prevalent globally, with the World Vision Report providing statistics on the global prevalence of several common eye diseases. The number of people suffering from myopia, presbyopia, age-related macular degeneration, and diabetic retinopathy has reached 2.6 billion, 1.8 billion, 196 million, and 146 million respectively. There are also 76 million people with glaucoma and 2.5 million with trachoma.

Data source: Analysis by Frost & Sullivan

When eye diseases affect the visual system and one or more visual functions, they can lead to far or near vision impairment. Vision impairment has various adverse effects on human health and socio-economic development. According to data provided by The Lancet Global Health, globally in 2020, there were approximately1.1 billionDue to eye diseases, people have suffered varying degrees of vision impairment. Among them, the number of blind patients with the most severe vision impairment has reached43 million.

With the combined effects of global population growth, accelerating aging, and lifestyle changes, the number of eye disease patients worldwide will further increase in the future. If no effective intervention and treatment are carried out under current circumstances, it is predicted that by 2050, there will be approximately1.7 billionThe number of visually impaired and blind patients will increase61 million.

Data source: Analysis by Frost & Sullivan

From the data on prevalence, visual impairment, and disability-adjusted life years, it is evident that the burden of ophthalmic diseases in China is severe.

The Report analyzes the prevalence of ophthalmic diseases and the disease burden in China based on data from three aspects: prevalence rate, number of patients, and disability-adjusted life years (DALYs) for various eye diseases.

Number of people suffering from eye diseases in China: In 2020, the number of people suffering from various common eye diseases in China far exceeded that in the United States. However, there is a significant gap in the per capita access to eye disease treatment resources compared to the United States. For example, in terms of the number of professional ophthalmologists per million people, the United States has an average of 165 ophthalmologists per million people, while China only has 37, which is less than one-sixth of that in the United States.quarterChina has a large number of patients with ophthalmic diseases who are not currently receiving adequate treatment, resulting in a significant gap in the demand for eye disease diagnosis and treatment.

Data source: Analysis by Frost & Sullivan

Number of visually impaired patients in China: China has a large population suffering from visual impairment due to eye diseases, with blindness and visual loss ranking second among all health disorders. Data published by The Lancet Global Health show that in 2019, the total number of people with moderate visual impairment, severe visual impairment, and blindness in China was nearly60 million.

Data source: Analysis by Frost & Sullivan

Years of Life Lost (DALY) Due to Disability: Using years of life lost due to disability as a measure, the total healthy life years lost from onset to death are considered. Ophthalmic diseases impose a relatively heavy disease burden on human health. According to the analysis results published in the Journal of Zhejiang University (Medical Sciences) titled 'Current Status and Thirty-Year Change Trends of Eye Disease Burden in China', the DALY caused by eye diseases in China in 2019 was approximately4.72 million.

Data source: Analysis by Frost & Sullivan

With the continuous innovation and breakthroughs in eye medication technology, the emergence of innovative eye drops will bring more treatment possibilities to patients with eye diseases.

The treatment methods for eye diseases are diverse, including drug therapy, surgical treatment, laser therapy, and instrument correction.The Report sorts out the main treatment methods for common ophthalmic diseases and analyzes the current treatment status of each disease category at this stage.Surgical treatment is a first-line treatment option for certain eye diseases, such as cataracts and angle-closure glaucoma. The basic treatment for most ophthalmic diseases is through medication. However, since the structural changes caused by some eye diseases are irreversible and the pathological mechanisms are not yet clear, the overall pain point of drug therapy currently lies in its inability to cure the disease completely. Long-term use of drugs only serves to delay the progression of the disease, control the deterioration of the condition, and reduce the occurrence of serious complications. The research and development of new ophthalmic drugs aim for more long-lasting therapeutic effects, replacing traditional drugs with poor efficacy, while also bringing innovative treatment methods to current ophthalmic diseases lacking drug therapy.

Data source: Analysis by Frost & Sullivan

China has approved fewer new ophthalmic drugs than the United States, with most being imported. The time span since entering the Chinese market is relatively long, and there is a high demand for the development of independently innovative drugs.

Between 2015 and 2021, the number of approved new ophthalmic drugs in the United States was much higher than that in China. A total of 29 new ophthalmic drugs were approved by the FDA for marketing in the United States; in China, only 7 new drugs were approved by the National Medical Products Administration (NMPA) for marketing, all imported drugs developed by multinational companies that had been approved overseas before 2015, including 2 new chemical drugs, 2 new biologics, and 3 new chemically modified drugs.

The drug R&D work of local ophthalmic pharmaceutical companies has continuously made new breakthroughs. However, the technical barriers for ophthalmic drugs are relatively high, and local companies started relatively late. The number of innovative ophthalmic drugs developed is still at a low level.The analysis of the indications for approved new drugs is summarized in the Report, showcasing the latest drug developments in multiple hot disease areas.

Data source: Analysis by Frost & Sullivan

From the perspective of the approval process, the import of new ophthalmic drugs often requires a long time. In the five years from 2015 to 2021, seven overseas ophthalmic drugs were approved for entry into the Chinese market. The average time from submitting clinical applications to final drug approval and launch was about six years. The characteristic of long approval times for imported new drugs can, to some extent, drive the development of local innovative eye medications. Domestic manufacturers are expected to be able to bring new ophthalmic drugs to domestic patients at a faster pace.

The inclusion of ophthalmic drugs in medical insurance is proceeding well, benefiting a wide range of patients. Drugs for eye inflammation and dry eye syndrome have been included in the centralized procurement list, reducing the burden on the public's medical expenses.

Many ophthalmic patients face certain economic burdens due to the need for long-term medication. The state has reduced drug prices through centralized procurement of drugs and negotiations with pharmaceutical companies. More ophthalmic medications with good therapeutic effects have been included in China's medical insurance catalog or entered the centralized procurement list, which will to some extent increase the penetration rate of ophthalmic medications and reduce the economic burden on ophthalmic patients.

The Report collates and summarizes the medical insurance coverage and centralized procurement status of ophthalmic drugs approved for marketing between 2016 and 2021.

From 2016 to 2021, among the approved ophthalmic drugs for marketing, most of those included in the medical insurance catalog are Class B drugs. Only one drug, levofloxacin eye drops produced by Tianlong Pharmaceutical, is a Class A drug covered by medical insurance.

Abicipar, produced by Bayer in 2019, is the third anti-VEGF drug to be included in national medical insurance. The high-priced and in-demand drug for treating fundus vascular diseases has seen a significant price cut.

From 2016 to 2021, 10 products included in the national centralized procurement list for ophthalmic marketed drugs were concentrated in four varieties: Sodium Hyaluronate Eye Drops, Moxifloxacin Hydrochloride Eye Drops, Olopatadine Hydrochloride Eye Drops, and Levofloxacin Eye Drops; the therapeutic indications of these drugs were focused on ocular inflammation (conjunctivitis) and dry eye syndrome.For more details, see the Report.

The number of clinical trials expected to increase across China and globally continues to grow. The indications for Chinese investigational drugs are mainly retinal diseases, optic nerve diseases, eye inflammation and infections, as well as dry eye syndrome.

Data source: Analysis by Frost & Sullivan

The annual clinical volume growth between 2016 and 2020 continued to expand, and its global share also showed a clear upward trend. The rapid growth in the number of R&D pipelines has continuously broadened the domestic ophthalmic drug R&D track. In terms of the degree of drug innovation, the main types of drugs in the clinical trials conducted are chemical generic drugs and biosimilar products. The number of new drug clinical trials soared from 4 in 2016 to 30 in 2020. Ophthalmic pharmaceutical companies have increased their efforts in new drug research and development, accelerating the clinical development of innovative pipelines.In addition, the Report summarizes the distribution of indications for ongoing research and development pipelines in the field of ophthalmic drugs globally and in China.

New treatment methods and targets bring hope to patients with eye diseases, addressing a large number of unmet clinical needs and driving rapid market growth.

The discovery of new targets is of great significance for the study of ophthalmic diseases, providing a new mechanism of action for treating diseases and becoming a breakthrough point in the discovery of a series of new drugs. In recent years, one of the representative research and development hotspots has been the VEGF target. Studies have found that its abnormal increase can cause hyperpermeability of blood vessels in the macular area and the formation of new blood vessels, demonstrating significant therapeutic effectiveness. It has rapidly become the main strategy for treating fundus neovascularization diseases, and the scope of indications has been continuously expanding as targeted research deepens.

In response to the diverse range of ophthalmic diseases, the development and introduction of modern treatment methods have become a major challenge in medicine. In recent years, innovative therapies such as gene therapy and stem cell therapy have received significant attention.The Report analyzes the application of several innovative treatment methods and new targets in ophthalmic treatment, and summarizes many current innovative R&D pipelines at home and abroad. The drugs under study show potential therapeutic efficacy and will bring hope for treatment to more patients.

Limited by the unique biological barrier of the eyes, ocular drug delivery technology faces high barriers. The duration of efficacy, targeting, and compliance are key points in research and development.

The physiological structure of the eye can be divided into anterior and posterior segments. For diseases of the anterior segment, local medication is commonly used, with topical preparations being the main form. The biological barrier of the eye causes most drugs administered through the ocular surface to be lost excessively, resulting in low bioavailability. This makes it difficult for drugs to achieve effective drug delivery in the eye, leading to less than ideal therapeutic outcomes. For diseases of the posterior segment, repetitive invasive treatment methods mainly involve intravitreal and periocular (subretinal, suprachoroidal) drug delivery. Frequent intraocular injections lead to a higher incidence of complications, and adverse reactions reduce patient compliance.

Data source: Analysis by Frost & Sullivan

Effective drug delivery technology is one of the key points in ophthalmic drug development. Currently, research directions on ocular surface drug delivery technology focus on improving formulation prescriptions, aiming to extend the drug's residence time and improve its ocular surface penetration. Developing new drug delivery systems that are convenient, safe, and capable of delivering drugs to posterior segment diseased tissues has become an urgent problem to be solved.

Based on the current clinical needs, domestic ophthalmic pharmaceutical companies have also accelerated their research and development of ophthalmic drug delivery technologies. In recent years, significant progress has been made in the clinical application of ocular delivery systems. In addition to the research and development of new dosage forms, ophthalmic companies are also actively developing innovative drug-device combinations to upgrade traditional delivery methods in terms of precision of administration, safety of use, and intelligence.

The 'Report' sorts out and summarizes the currently applied and developed ophthalmic drug delivery systems, as well as their technical principles, advantages, and clinical applications. Various innovative drug delivery systems have broken through traditional dosing limitations, showing good application prospects and great potential for clinical development.

The global ophthalmic market as a whole shows stable growth and a high degree of concentration.

With the iteration of ophthalmic disease treatment technologies and the expansion of indications, the global ophthalmic drug market is in a state of stable growth. From 2016 to 2020, the global ophthalmic drug market size increased from $27.7 billion to $32.7 billion, with a compound annual growth rate of 4.2%. It is expected to reach $46.4 billion by 2025 and $73.9 billion by 2030.

The ophthalmic drug market in China is in its infancy, with broad prospects for development and great potential for future growth.

The ophthalmology field is one of the few golden tracks with a rapidly growing market size for drugs. From 2016 to 2020, the market size of ophthalmic drugs in China increased from 151 billion yuan to 188 billion yuan, with a compound annual growth rate of 5.7%. It is expected that by 2025, it will reach 440 billion yuan and by 2030, it will reach 1166 billion yuan.For detailed market scale data and related analysis of sub-sectors within ophthalmology, please refer to the Report.

Chinese ophthalmic drugs are driven by multiple favorable factors.The Report provides an in-depth interpretation from four perspectives: medication demand, policy benefits, capital inflow, and technological innovation, revealing the driving forces behind the development of the ophthalmic drug industry.

Based on the current market situation and development dynamics,The 'Report' conducts a professional analysis and prediction of the future development trends of the ophthalmic drug industry, and makes prospects for four aspects: innovative product research and development and commercialization, drug accessibility, penetration of domestic drugs, and corporate globalization layout.

The Report provides a detailed introduction and analysis of the prevalence, epidemiological information, and treatment pain points for seven common ophthalmic diseases including retinal diseases, conjunctivitis, uveitis, dry eye syndrome, cataracts, myopia, and presbyopia. It summarizes the current treatment challenges and medication gaps, and through the review of approved and investigational drugs, it depicts the market competition landscape and development hotspots for various ophthalmic indications. The Report includes data on the development of drug markets for these sub-diseases in recent years, as well as predictions for future growth space and trends.

With the improvement of modern social and economic levels, diseases that affect quality of life such as eye diseases have received more attention. The willingness of capital to enter the ophthalmology field has significantly increased, and the market for ophthalmic drugs is heating up. Investment in new ophthalmic drugs has led to several major mergers and acquisitions, large-scale financing, product licensing, and strategic collaborations in the field of ophthalmic drug treatment in recent years.The Report summarizes the financing situations, key mergers and acquisitions events, and pipeline transactions of several ophthalmic drug research and development companies in recent years.

• Financing situation

The ophthalmic drug market has gradually become a key area of capital focus, with an increasing number of institutions participating. Top investment institutions such as Sequoia China, Hillhouse Capital, and Zhenxing Valley Capital, as well as the venture capital departments of large enterprises like Tencent, are all involved in the layout of the ophthalmic drug sector.

• M&A event

Large multinational pharmaceutical companies such as Novartis, AbbVie, and Eli Lilly have been making acquisitions to expand their ophthalmic drug portfolio. Among them, ophthalmic gene therapy companies have become hot targets for mergers and acquisitions, with five or more transactions expanding the pipeline of gene therapies for ophthalmic diseases occurring in the past six years.

• Pipeline transaction event

In recent years, there has been a surge in pipeline transaction projects in the ophthalmology field. Domestic emerging ophthalmic pharmaceutical companies such as Zhaoke Ophthalmics, Jixing Pharmaceutical, Jiemu Biotech, and Oucang Vision are accelerating their layout speed and expanding their market share through self-developed products and the 'License in' model.

Against the backdrop of continuous support from market demand, policy environment, and capital operation, in recent years, the ophthalmology track has seen the emergence of many innovative drug R&D companies, increasing their pipeline layout in the ophthalmic drug market. Multiple outstanding participants have stood out with their industry-specific advantages.The following is an introduction to some ophthalmic pharmaceutical companies (sorted by Chinese alphabetical first letters, with no particular order):

Baying Pharmaceutical:Divyin Pharma was established in 2015 and is a clinical-stage biotechnology company focused on the development of ophthalmic drugs, dedicated to providing better treatment options for patients with various ophthalmic diseases. The company emphasizes the research and development of innovative drugs with complete independent intellectual property rights, accelerating the global layout of new ophthalmic drug research and development. It has set up R&D centers in both China and the United States to achieve complementary advantages. The pipeline of ongoing research covers a rich variety of indications, including pterygium, dry eye syndrome, conjunctivochoroidal degeneration, myopia, acute meibomian gland disorder, glaucoma, and wet AMD.

Jiemu Biology:Jiemu Biology was established in 2019 and possesses a portfolio of breakthrough ophthalmic treatment technologies ranging from early discovery to commercialization stages. The company has built a rich global product pipeline through independent research and development as well as joint innovation with leading pharmaceutical companies worldwide. This pipeline mainly includes glaucoma, uveitis, myopia, presbyopia, dry eye syndrome, uveitis, retinopathy, hereditary retinal degeneration, and more.

Jixing Pharmaceutical:Jixing Pharmaceutical is a company that develops treatment methods for major diseases and life-threatening illnesses, founded in 2019 with investment from RTW Investments (RTW). It collaborates with many global biotechnology companies to develop and commercialize unique and innovative therapeutic drugs, continuously expanding its drug pipeline. Currently, the areas of ophthalmic indications it has laid out mainly focus on therapeutic drugs for dry eye syndrome and presbyopia.

newportNewForth was established in 2016 and is a gene therapy company focusing on ophthalmic diseases in China. Leveraging the mature AAV ophthalmic gene therapy technology platform, it has established a rich product pipeline, including more than 10 ongoing research projects targeting various ophthalmic diseases such as hereditary optic atrophy, optic nerve injury, and vascular retinopathy. The company has gradually expanded from rare ophthalmic diseases to common ones.

OcuvivaOcuviva was established in 2018, dedicated to identifying, developing, and commercializing first-in-class or best-in-class ophthalmic therapies. As a pioneering ophthalmic pharmaceutical platform, the company currently has more than 20 drugs for anterior and posterior segments of the eye, establishing a complete ophthalmic drug product line. Several potential pipelines have entered Phase III clinical trials, with the core product YUTIQ®, which is used for the treatment of non-infectious uveitis, recently being approved by the National Medical Products Administration (NMPA) for marketing.

Run'er Eye HospitalRun'er Ophthalmology was established in 2020, dedicated to developing ophthalmic innovative drugs with global patent protection. The areas of innovation and research include cataracts, dry eye syndrome, glaucoma, the ophthalmic immune system, ophthalmic infections, and other ophthalmic diseases. The core product GOCS-H101, as a first-in-class new drug for treating cataracts, has entered phase II clinical trials.

Shentian Pharmaceutical:Tiantian Pharmaceutical was founded in 1890 and has a history of 130 years to date. As a company focusing on ophthalmic pharmaceuticals, its products now cover patients in more than 60 countries/regions. It also has development, research, production, and sales branches in Europe, the United States, and various Asian countries, while conducting development and sales activities in many countries around the world.

Yiming Biology:Yiming Biotech was established in 2019 and is a platform company guided by pharmaceutical innovation. It has breakthrough First-in-Class innovative drugs in the field of ophthalmic drug research and development. The pipeline for multiple products is advancing simultaneously, and all major products have entered clinical trials. The research and development indications include dry age-related macular degeneration (AMD) and dry eye syndrome.

Zhaoked Eye Hospital:Zhaokew Eye Hospital was established in 2017, dedicated to the research, development, production, and commercialization of ophthalmic therapies to meet the huge global medical demand gap. Zhaokew Eye Hospital has developed a candidate drug portfolio consisting of innovative and generic drugs, covering dry eye syndrome, corneal epithelial defects, conjunctivitis, pterygium, myopia, presbyopia, wet age-related macular degeneration, diabetic macular edema, and glaucoma.