India Genomic Diagnostics Market Analysis

India Genomic Diagnostics Market Executive Summary

India Genomic Diagnostics Market was valued at $593.77 Mn in 2023 and is predicted to grow at a CAGR of 19.5% from 2023 to 2030, to $2,066.31 Mn by 2030. 

Genomic diagnostics is a rapidly evolving field that uses an individual's genetic information to diagnose diseases, assess predisposition to future health problems, and guide treatment plans by analyzing DNA or RNA for disease-linked variations. This includes karyotyping to examine chromosome abnormalities, targeted mutation analysis for specific disease-related genes, and next-generation sequencing (NGS) for a comprehensive genetic analysis. Applications encompass disease diagnosis, carrier testing for informed family planning, predictive testing for disease risk assessment, and pharmacogenomics for personalized medication treatments. The benefits of genomic diagnostics include early disease detection, personalized medicine, and improved disease management and prognosis.

In 2022, around 10.5% of South Africa's population, or 149 Mn people, were aged 60 and above, with projections indicating this will double to 20.8% by 2050. Hypertension affected approximately 4.74 Mn South Africans in 2019, making it the most prevalent chronic condition and a significant health concern. Diabetes poses a severe risk, with 13 Mn adults at risk of type 2 diabetes due to impaired fasting glucose levels, and is the second deadliest disease in the country.

Market is therefore driven by significant factors like increasing prevalence, technological advancements, and government initiatives. However, the high cost of testing, fragmented market structure, and regulatory challenges restrict the growth and potential of the market.

A prominent player in this field is Illumina, which has partnered with AstraZeneca to leverage genomics and AI for faster drug development by identifying new therapeutic targets and biomarkers, 23andMe acquired Lemonaid Health to enhance its personalized healthcare offerings through telehealth and prescription drug delivery services based on genetic information. Other contributors include Myriad Genetics, and Amgen among others.

Market Dynamics

Market Growth Drivers

Increasing Prevalence: The rise in chronic diseases like cancer and genetic disorders drives demand for genomic testing in India. In 2022, approximately 1.5 Mn new cancer cases were recorded, and over 70 Mn people suffer from rare diseases, underscoring the need for advanced diagnostics.

Technological Advancements: Innovations in genomic technologies, especially next-generation sequencing (NGS) and polymerase chain reaction (PCR), have improved genetic testing's accuracy, speed, and cost-effectiveness. These advancements enable comprehensive analysis of multiple genes, beneficial for diagnosing complex disorders.

Government Initiatives: The Indian government's genomic research initiatives, such as mapping over 10,000 genomes by 2023, are expected to stimulate investment and interest in genomic diagnostics, supporting market growth.

Market Restraints

High Cost of Testing: Despite technological advancements, the high cost of genetic tests remains a barrier, particularly in rural areas, limiting access to essential services for a large segment of the population.

Fragmented Market Structure: The Indian diagnostics market is highly fragmented, with many small players leading to inconsistencies in quality and service delivery, posing challenges for scalability and standardization in genomic diagnostics.

Regulatory Challenges: The evolving regulatory landscape for genetic testing in India creates uncertainty for companies, with compliance to varying regulations affecting operational efficiency and market entry.

Regulatory Landscape and Reimbursement Scenario

India's regulatory landscape for medical devices and in vitro diagnostics, including genomic tests, is evolving with key bodies such as the Central Drugs Standard Control Organization (CDSCO) and the Indian Council of Medical Research (ICMR) playing crucial roles. CDSCO is the central authority for drug regulation, actively working to regulate in-vitro diagnostics, while ICMR, primarily a research body, sets standards and guidelines for medical research, including genomics. Additionally, state-level drug control authorities contribute to the regulatory framework with their regulations.

Reimbursement for genomic diagnostics in India is complex and varies widely. The public healthcare system provides limited coverage for genomic tests, typically under specific government schemes. Private health insurance offers varying levels of coverage depending on the plan and test. A significant portion of the population relies on out-of-pocket payments for these services. Reimbursement challenges include a lack of robust clinical evidence demonstrating the cost-effectiveness of genomic tests, high costs, and limited awareness among healthcare providers and patients about the benefits of genomic testing.

Competitive Landscape

Key Players

Here are some of the major key players in the India Genomic Diagnostics

• Illumina, Inc.
• Myriad Genetics, Inc.
• Amgen, Inc.
• 23andMe
• MedGenome
• Mapmygenome
• Clevergene
• CORE Diagnostics
• Lilac Insights
• Acrannolife