|
Forecast
Period
|
2025-2029
|
|
Market
Size (2023)
|
USD
37.63 million
|
|
CAGR
(2024-2029)
|
5.42%
|
|
Fastest
Growing Segment
|
Retinopathy
Segment
|
|
Largest
Market
|
West
India
|
Market Overview
India
Ophthalmic Clinical Trials Market has valued at USD 37.63 billion in 2023 and
is anticipated to project an impressive growth in the forecast period with a
CAGR of 5.42% through 2029. Ophthalmic clinical trials are research studies
conducted to evaluate the safety, efficacy, and effectiveness of medical
interventions, treatments, drugs, devices, or surgical procedures related to
eye health and vision. These trials are designed to gather scientific evidence
and data that inform medical decisions, regulatory approvals, and advancements
in the field of ophthalmology. Ophthalmic clinical trials aim to improve the
understanding and management of various eye diseases and conditions, as well as
to develop new treatments and technologies. Ophthalmic clinical trials involve
participation from individuals who have the specific eye condition or disease
under investigation. Participants may include those with conditions such as
glaucoma, age-related macular degeneration (AMD), diabetic retinopathy,
cataracts, myopia, and more. Clinical trials use defined endpoints or outcomes
to measure the effects of interventions. These can include improvements in
visual acuity, reduction in eye pressure, changes in retinal thickness, or
quality of life measures. Ophthalmology has seen significant technological
advancements, including innovative diagnostic tools, surgical techniques, and
drug delivery systems. These advancements drive the need for clinical trials to
assess the safety and efficacy of new technologies and treatments. The India
Ophthalmic Clinical Trials Market represents an untapped potential due to its
large and diverse patient population. This presents opportunities for
pharmaceutical companies, biotech firms, and research institutions to conduct
trials and develop treatments catering to the Indian population's specific
needs.
Key Market Drivers
Advancements
in Medical Technology
Advancements
in medical technology have significantly impacted the landscape of clinical
trials across various medical fields, including ophthalmology. These
advancements have streamlined processes, improved data collection, enhanced
patient experiences, and contributed to the overall efficiency and
effectiveness of clinical trials. Telemedicine platforms and remote monitoring
solutions enable researchers to remotely track patients' health and collect
data, reducing the need for frequent in-person visits. This is particularly
relevant in ophthalmology, where remote imaging and visual assessments can be
conducted, contributing to patient convenience and trial efficiency. EHR
systems facilitate the efficient collection and management of patient data.
Integrating EHRs with clinical trial databases streamlines data capture,
reduces errors, and enhances data quality. Advanced digital imaging
technologies, such as optical coherence tomography (OCT) and fundus
photography, enable precise and non-invasive assessments of ocular structures.
These technologies are crucial for tracking disease progression and treatment
efficacy in ophthalmic clinical trials. The integration of big data analytics
and artificial intelligence (AI) allows for the efficient analysis of large
datasets, identifying patterns, correlations, and potential biomarkers.
AI-driven algorithms can assist in patient recruitment, predict outcomes, and
optimize trial designs. Mobile apps and wearable devices enable patients to
report their symptoms and experiences in real time. This direct patient input
provides valuable insights into treatment effects and enhances patient
engagement. Blockchain technology offers enhanced data security and
transparency in clinical trials. It can be used to securely store, share, and
track trial-related data while ensuring data integrity. Technology enables the
implementation of adaptive trial designs, where trial parameters can be
adjusted based on interim results. This flexibility improves trial efficiency
and the likelihood of successful outcomes. Electronic informed consent
(eConsent) platforms provide detailed trial information to participants and
allow them to provide consent electronically. These platforms enhance patient
understanding and involvement in the trial process. Virtual reality and
simulation technologies are used to replicate surgical procedures or treatment
interventions. These tools assist in training investigators, enhancing
procedural consistency, and reducing variability in trial outcomes. Biosensors
and wearable devices can continuously monitor patient parameters, such as
intraocular pressure or blood glucose levels, in real time. This data assists
in understanding treatment effects and patient responses. Advancements in
genomics and molecular diagnostics allow for personalized treatment approaches
based on patients' genetic profiles. This precision medicine approach is
increasingly relevant in clinical trials targeting specific patient subgroups.
This factor will pace up the demand of India Ophthalmic Clinical Trials Market.
Rise
in Rare and Orphan Diseases
Rare
diseases, also known as orphan diseases, refer to medical conditions that
affect a small number of individuals within a population. The exact definition
of "rare" varies by region, but generally, a disease is considered
rare when it affects a limited number of people. Rare diseases collectively
affect a significant portion of the population. While each individual disease
may be rare, there are thousands of different rare diseases, and together they
impact millions of people across the country. Rare diseases are often
characterized by their diversity. They can manifest in various ways, making
diagnosis and treatment challenging. Due to their rarity, many rare diseases
lack approved treatments. Patients with these conditions often face limited or
no therapeutic options, leading to unmet medical needs. Conducting research on
rare diseases can be challenging due to the limited number of affected individuals.
This makes it difficult to recruit participants for clinical trials and gather
sufficient data for analysis. Rare disease patient advocacy groups play a
crucial role in raising awareness, advocating for research, and providing
support to patients and their families. Many countries offer incentives, such
as extended market exclusivity, tax benefits, and reduced regulatory fees, to
encourage pharmaceutical companies to develop treatments for rare diseases.
These incentives are often provided through orphan drug designation. The lack
of treatments for rare diseases results in a high unmet medical need.
Developing therapies for these conditions can significantly improve patients'
quality of life and life expectancy. A substantial portion of rare diseases
have a genetic basis, caused by mutations in specific genes. Advances in
genomics have contributed to identifying the genetic underpinnings of many rare
diseases. Patients with rare diseases often require specialized medical care
from experts who are familiar with the unique challenges associated with these
conditions. Rare diseases can have a significant emotional, financial, and
social impact on patients and their families. Support networks and resources
are essential for coping with challenges. This factor will help in the
development of India Ophthalmic Clinical Trials Market.
Increasing
Eye Disorders
Eye
disorders, also known as eye diseases or ocular conditions, encompass a wide
range of medical conditions that affect the eyes and visual system. These
disorders can impact various parts of the eye, including the cornea, lens,
retina, optic nerve, and surrounding structures. Eye disorders can cause
changes in vision, discomfort, pain, and in some cases, can lead to permanent
vision loss if not properly managed. Refractive Errors are conditions that
affect the eye's ability to focus light correctly, leading to blurred vision. Cataracts
involve the clouding of the eye's natural lens, leading to blurred vision,
sensitivity to light, and reduced color perception. Cataracts are often
age-related but can also be caused by other factors. Glaucoma is a group of eye
disorders characterized by damage to the optic nerve, often due to increased
intraocular pressure. It can lead to gradual vision loss and, if untreated,
blindness. India is home to a population affected by glaucoma, which is the
third leading cause of blindness in the country. Approximately 12 million
individuals, representing 12.8 percent of the total blindness population,
suffer from glaucoma. The prevalence of glaucoma in India ranges between 2.6
percent and 4.1 percent, with the latter being the most common cause of
permanent blindness. Approximately 50 percent of individuals with glaucoma are
unaware of their condition. Age-Related Macular Degeneration (AMD) affects the
central part of the retina (macula), leading to central vision loss and
difficulties with tasks that require fine detail, like reading or recognizing
faces. Diabetic Retinopathy occurs in individuals with diabetes and can lead to
damage of the blood vessels in the retina, causing vision loss if not managed
properly. Dry eye occurs when the eyes do not produce enough tears, or the
tears evaporate too quickly. This can result in discomfort, irritation, and
blurry vision. This is a serious condition where the retina pulls away from its
normal position, causing vision loss that can be sudden and severe. Conjunctivitis
is the inflammation of the conjunctiva, the thin tissue covering the front of
the eye. It can cause redness, itching, discharge, and discomfort. Strabismus
refers to misalignment of the eyes, where one eye may look straight ahead while
the other turns inward, outward, upward, or downward. This factor will
accelerate the demand of India Ophthalmic Clinical Trials Market.
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Key Market
Challenges
Post-Trial
Regulations and Market Access
Post-trial
regulations and market access can indeed be challenging aspects for the India
Ophthalmic Clinical Trials Market, as well as for clinical trials markets
globally. After a successful clinical trial, the process of obtaining
regulatory approvals for market access can be complex and time-consuming. This
challenge is not unique to ophthalmic trials but extends to trials in various
therapeutic areas. Following the completion of a clinical trial, researchers
and sponsors must submit comprehensive data to regulatory authorities for
review. This process involves scrutinizing trial results, safety data, efficacy
outcomes, and overall risk-benefit profiles of the investigational product.
Regulatory bodies, such as the Central Drugs Standard Control Organization
(CDSCO) in India, conduct thorough evaluations before granting approval for the
product to be marketed. Patient safety is of paramount importance in clinical
trials. Regulatory agencies rigorously assess the safety profile of the
investigational product to ensure that it meets acceptable safety standards.
Any safety concerns or adverse events observed during the trial must be
addressed and explained in detail during the regulatory review. The product's
labeling and packaging must comply with regulatory requirements, including
accurate representation of its indications, dosages, potential risks, and
instructions for use. Even after obtaining regulatory approvals, companies may
face challenges in bringing their products to market. Formulating effective market
access strategies involves considerations such as pricing, reimbursement,
distribution channels, and understanding the competitive landscape.
Patient
Recruitment and Retention
Patient
recruitment and retention are common challenges in clinical trials worldwide,
and this challenge extends to the India Ophthalmic Clinical Trials Market as
well. Ensuring enough eligible patients are recruited for a trial and retaining
them throughout the trial's duration are crucial for obtaining accurate and
meaningful results. Patients might not be aware of ongoing clinical trials or
the potential benefits of participating in them due to a lack of awareness
campaigns or information dissemination. There could be stigma associated with
participating in clinical trials or misconceptions about the risks and
benefits, leading to reluctance among potential participants. Patients in
remote or underserved areas might have limited access to information about
clinical trials, making it challenging to recruit participants from diverse
populations. The involvement and support of treating physicians are crucial for
patient recruitment. If healthcare professionals are not adequately informed
about ongoing trials, they might not refer eligible patients. India is linguistically
and culturally diverse. Information about trials might not be available in all
languages, and cultural considerations might impact patient willingness to
participate. Explaining the trial's purpose, procedures, and potential risks in
a way that patients can understand is essential for obtaining informed consent.
This can be challenging if the trial involves complex procedures or medical
jargon. Patients may have work, family, or logistical constraints that prevent
them from participating, especially if the trial involves frequent visits to
trial sites. Participants might move, change contact details, or lose interest,
making it difficult to track their progress and maintain communication. Lengthy
trial durations, frequent visits, and multiple assessments can lead to
participant fatigue and dropouts.
Key Market Trends
Real-World
Evidence
RWE (Real-World Evidence) refers to data collected
from real-world patient experiences in routine clinical practice, rather than
from controlled clinical trial environments. This data can provide insights
into the effectiveness, safety, and outcomes of medical interventions in
real-world settings. RWE complements data from traditional clinical trials by
providing information about how treatments perform outside of controlled
environments. In ophthalmology, it can offer insights into how interventions
work in diverse patient populations with varying coexisting conditions. Clinical
trials often have strict inclusion and exclusion criteria, leading to limited
diversity in participant populations. RWE can capture data from a wider range
of patients, including those who might not meet traditional trial criteria.
Some ophthalmic conditions require
long-term treatment and management. It can provide insights into the long-term
outcomes, safety, and effectiveness of treatments beyond the scope of clinical
trials. RWE can capture data
from rare eye diseases or complex cases that might not be feasible to study in
traditional trials due to limited patient populations. After a treatment is approved, ongoing
surveillance is necessary to monitor its real-world safety and effectiveness.
RWE can play a role in post-marketing surveillance activities. RWE can inform health economic analyses and
market access strategies by demonstrating a treatment's real-world value and
impact on healthcare resources. Advancements
in digital health technologies enable the collection of real-time patient data,
enhancing the potential for RWE generation.
Segmental Insights
Phase Insights
In 2022, the India
Ophthalmic Clinical Trials Market was dominated by the clinical
phase segment with a share of around 82.19% and is predicted to continue
expanding over the coming years. The market is experiencing a surge due to
the involvement of Pharmaceutical Companies, Research Organizations, and
Healthcare Institutions in various stages of clinical trials. The presence of a
wide variety of patients in India enables a thorough assessment of
investigational products, guaranteeing their efficacy across various genetic
and environmental factors.
Indication Insights
In 2022, the India
Ophthalmic Clinical Trials Market was dominated by the retinopathy segment with
a share of around 24.81% and will probably expand in the forecasted years. The
growth of the retinopathy segment is attributed to several factors, including
an increase in R&D activities related to the condition, as well as an
increase in the prevalence of the condition in India. A survey conducted by the
Union Ministry of Health in 2022 revealed that more than 17% of Indian citizens
have diabetic retinal disease, with a significant proportion (3.6%) of these
cases posing a risk to vision. Furthermore, a study has revealed that a
significant proportion (10.4%) of rural inhabitants had diabetes, with a
prevalence (10.3%) of diabetic retinal disease. Furthermore, a World Health
Organization (WHO) study has predicted that by 2030, the number of diabetics
suffering from retinal damage will have increased by more than 50%.
Service Type Insights
In 2022, the India
Ophthalmic Clinical Trials market was dominated by clinical trial data
management services with a share of around 33.39% and is predicted to continue
expanding over the coming years. Clinical Trial Data Management
Services play a critical role in the validation, collection, cleaning, and
analysis of clinical trial data. Quality control measures and standardised
procedures are implemented to ensure the accuracy and reliability of data.
Sponsor Type Insights
In 2022, the India
Ophthalmic Clinical Trials market was dominated by pharmaceutical/biopharmaceutical
companies with a share of around 41.85% and is predicted to continue expanding
over the coming years. The growth of the ophthalmic drug research and
development market is largely attributed to the increasing number of players
involved in this field. Furthermore, these players provide a wide variety of
products, such as ophthalmic treatments and drugs. Clinical trials are an
integral part of the development and regulatory approval process for new drugs,
pharmaceuticals, and treatment options.
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Regional Insights
The
West India region has established itself as the leader in the India Ophthalmic
Clinical Trials market. Cities
like Mumbai, Pune, and Ahmedabad in the West India region boast advanced
medical infrastructure, including renowned hospitals, research centers, and
academic institutions. These facilities provide a conducive environment for
conducting ophthalmic clinical trials. Leading research institutions and
universities in the West India region have established strong departments focused
on ophthalmology and vision science. These institutions collaborate with
pharmaceutical companies and research organizations to conduct clinical trials.
Recent Developments
- In 2022, The
company Entod Pharmaceuticals declared that it has been granted authorisation
by the Directorate General of Genomics (DG) of India to conduct Phase 3
clinical trials in the country for its 0.05 percent atropine-based eye drops
for the treatment of eye disorders. This pharmaceutical company based in Maharashtra holds
most of the market share in low-dose atropine eye drops. MYATRO (0.01 per cent)
eye drops are primarily used to treat ocular disorders such as myopia, which is
a condition in which a child can perceive nearby objects clearly but has
difficulty in perceiving distant objects.
- In 2021, Bioneeds
India was acquired by Veeda Clinical Research to expand its research and
development services. The acquisition was expected to boost the company's
service offerings in the market.
- In 2019, PMI, a
subsidiary of Promedica International, established a strategic alliance with
Dr. Ajit Agarwal's Eye Hospitals in India to carry out clinical trials. The
collaboration was announced at the OCTANe Ophthalmology Technologies Summit
(OTS), which was held at the Orange County Ophthalmology Centre in the United
States. The collaboration will enable the two companies to expand their
clinical research services in the ophthalmology field by jointly enrolling and
managing clinical studies in a broad patient population, while also ensuring
that the studies adhere to global and United States Food and Drug
Administration (FDA) qualification standards and requirements.
Key Market Players
- ProRelix
Services LLP
- Abiogenesis
Clinpharm Pvt Ltd.
- Veeda
Clinical Research
- Catawba
Research, LLC
- Novotech
- Catalyst
Clinical Services Pvt. Ltd.
- Navitas
Life Sciences
- Vedic
Lifesciences Pvt Ltd.
- Vimta
Labs Ltd
|
By Product
|
By Indication
|
By Phase
|
By Service Type
|
By Sponsor Type
|
By Region
|
- Devices
- Surgical Devices
- Intraocular Lenses
- Aspheric IOLs
- Toric IOLs
- Multifocal IOLs,
- Monofocal IOLs
- Others
|
- Macular Degeneration
- Glaucoma
- Dry Eye Disease
- Retinopathy
- Uveitis
- Macular Edema
- Blepharitis
- Cataract
- Optic Neuropathy
- Others
|
- Preclinical
- Discovery
- Clinical
- Phase I
- Phase II
- Phase III
- Phase IV
|
- Protocol Designing
- Site Identification
- Patient Recruitment
- Laboratory Services
- Bioanalytical Testing Services
- Clinical Trial Data Management
Services
- Others
|
- Pharmaceutical/biopharmaceutical
Companies
- Medical device companies
- others
|
- North India
- South India
- East India
- West India
|
Report
Scope:
In
this report, the India Ophthalmic Clinical Trials Market has been segmented
into the following categories, in addition to the industry trends which have
also been detailed below:
- India
Ophthalmic Clinical Trials Market, By Product:
o Devices
o Surgical Devices
o Intraocular Lenses
o Aspheric IOLs
o Toric IOLs
o Multifocal IOLs,
o Monofocal IOLs
o Others
- India
Ophthalmic Clinical Trials Market, By Indication:
o Macular Degeneration
o Glaucoma
o Dry Eye Disease
o Retinopathy
o Uveitis
o Macular Edema
o Blepharitis
o Cataract
o Optic Neuropathy
o Others
- India
Ophthalmic Clinical Trials
Market, By Phase:
o Preclinical
o Discovery
o Clinical
o Phase I
o Phase II
o Phase III
o Phase IV
- India
Ophthalmic Clinical Trials
Market, By Service Type:
o Protocol
Designing
o Site Identification
o Patient
Recruitment
o Laboratory
Services
o Bioanalytical
Testing Services
o Clinical
Trial Data Management Services
o Others
- India
Ophthalmic Clinical Trials
Market, By Sponsor Type:
o Pharmaceutical/biopharmaceutical
Companies
o Medical device companies
o others
- India
Ophthalmic Clinical Trials
Market, By region:
o
North
India
o
South
India
o
East
India
o
West
India
Competitive
Landscape
Company
Profiles: Detailed
analysis of the major companies present in the India Ophthalmic Clinical Trials
Market.
Available
Customizations:
Global
Dyes Market report with the given market data, Tech Sci Research offers
customizations according to a company's specific needs. The following
customization options are available for the report:
Company
Information
- Detailed analysis and profiling of
additional market players (up to five).
India Ophthalmic
Clinical Trials Market is an upcoming report to be released soon. If you wish
an early delivery of this report or want to confirm the date of release, please
contact us at [email protected]