India Biosimilars Market Analysis

India Biosimilars Market Analysis


$ 3999

India's biosimilars market size was valued at $349 Mn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 25.2% from 2022 to 2030 and will reach $2108 Mn in 2030. The market is segmented by product type and indication type. The Indian Biosimilars market will grow as India biosimilar market is driven by its cost-effective manufacturing capabilities. The key market players are Biocon Ltd (IND), Intas Pharmaceuticals Ltd (IND), Dr. Reddy's Laboratories Ltd (IND), Reliance Life Sciences Pvt. Ltd (IND), Zydus Cadila Healthcare Ltd (IND), Lupin Limited (IND)and others.

ID: IN10INPH026 CATEGORY: Pharmaceuticals GEOGRAPHY: India AUTHOR: Chandani Patel

Buy Now

India Biosimilars Market Executive Summary

The India Biosimilars market size was valued at $349 Mn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 25.2% from 2022 to 2030 and will reach $2108 Mn in 2030.  India now accounts for a sizable portion of the global market for biosimilars. When a biological product is referred to be "biosimilar," it means that it is very similar to another biological product that has already acquired regulatory clearance. They have the same efficacy and safety profiles as the reference product and are used to treat a number of disorders, including diabetes, autoimmune diseases, and cancer.

India has a substantial and rapidly growing biosimilar sector as a result of the availability of low-cost production facilities and a sizeable labour pool of highly trained scientific and technical professionals. Due to the country's highly established regulatory framework for the licencing of biosimilars, several Indian companies have had their products authorised by regulatory agencies in India, Europe, and the US. In addition, the Indian government has taken a few steps to encourage the study and development of biosimilars. The Biotechnology Industry Partnership Program (BIPP) was launched by the Indian government in 2016 to assist small and medium-sized biotech firms in the creation of biosimilars.

The National Biotechnology Development Plan was created by the Indian government to aid in the growth of the nation's biotechnology sector (NBDS). As there is a growing need for high-quality, reasonably cost biologics on a global scale, the biosimilars market in India is anticipated to expand throughout the course of the projected period.

india biosimilar market

Market Dynamics

Market Growth Drivers

India's market for biosimilars appears to be driven by the country's preference for effective production. The nation has access to a sizable pool of highly qualified scientific and technical employees, and its production facilities are less expensive than those in other countries.

A strong regulatory environment for biosimilar approval exists in India, which has helped in the production and distribution of biosimilars there. The regulations also guarantee the safety and effectiveness of biosimilars for patients.

In India, the incidence of chronic diseases including cancer, hypertension, and diabetes is rising, which is fueling an increase in demand for biosimilars across the country. Because they are frequently less expensive than other pharmaceuticals, biosimilars are a viable choice for individuals who require long-term care. The nation's healthcare system is also changing, with a stronger emphasis now placed on ensuring everyone has access to inexpensive treatment.

Market Restraints

Biosimilar providers in India deal with a number of patent-related issues, including patent litigation and the challenge of developing biosimilars prior to the reference product's patent expires. This might reduce biosimilar production and postpone the product's introduction to the market.

This might lower the profitability of companies that make biosimilars, discouraging them from investing in the development of new biosimilars. The challenges faced by producers are diverse. For example, the regulatory process could be drawn out and unpredictable, and some elements of the regulatory framework may not be completely clear.

Competitive Landscape

Key Players

  • Biocon Ltd (IND)
  • Intas Pharmaceuticals Ltd (IND)
  • Dr Reddy's Laboratories Ltd (IND)
  • Reliance Life Sciences Pvt. Ltd (IND)
  • Zydus Cadila Healthcare Ltd (IND)
  • Lupin Limited (IND)
  • Wockhardt Limited (IND)
  • Panacea Biotec Ltd (IND)
  • Emcure Pharmaceuticals Ltd (IND)
  • Torrent Pharmaceuticals Ltd (IND)
  • Pfizer Inc. (USA)
  • Novartis International AG (CHE)
  • Roche Holding AG (CHE)
  • Sanofi S.A. (FRA)
  • Merck & Co., Inc. (USA)
  • GlaxoSmithKline plc (GBR)
  • AstraZeneca plc (GBR)
  • Johnson & Johnson (USA)
  • Boehringer Ingelheim GmbH (DEU)
  • Fresenius SE & Co. KGaA (DEU)

Recent Developments

In 2021, Johnson & Johnson and Biological E Ltd. formed a cooperation for the development and marketing of a COVID-19 vaccine in India. While not being a biosimilar, this collaboration demonstrates India's rising interest in biologics and vaccines.

In order to introduce a biosimilar form of adalimumab in Brazil, Biocon Biologics formed a cooperation with Libbs Farmaceutica in 2021.

Healthcare Policies and Regulatory Landscape

For the approval and marketing of biosimilars, India has a well-established regulatory system. Following are several essential laws that apply to biosimilars in India:

In India, the Central Drugs Standard Control Organization (CDSCO) is the regulatory body in charge of approving biosimilars. The World Health Organization (WHO) and other international regulatory bodies' rules are followed by the CDSCO.

Biosimilars must go through a rigorous approval procedure mandated by the CDSCO, which includes preclinical and clinical tests to prove their safety and efficacy. The CDSCO mandates that the quality, safety, and effectiveness of biosimilars be evaluated against those of a reference biologic product. The product and the data that are available determine the degree of similarity needed for approval. Biosimilars must be labelled as such by the CDSCO in order to prevent misunderstanding with the reference biological product. To guarantee the consistency and quality of their goods, the CDSCO mandates that producers of biosimilars have an effective quality control system in place. To guarantee continued adherence to legal requirements, the CDSCO analyses biosimilar goods that have already hit the market on a regular basis. For the development and approval of biosimilar drugs in India, the CDSCO has set detailed regulations, including rules for preclinical and clinical research, manufacturing, and labelling.

1. Executive Summary
1.1 Disease Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Patient Journey
1.6 Health Insurance Coverage in Country
1.7 Active Pharmaceutical Ingredient (API)
1.8 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Epidemiology of Disease
2.2 Market Size (With Excel & Methodology)
2.3 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share

4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation
5.2 Reimbursement Process for Diagnosis
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

India Biosimilars Market Segmentation

By Product

The monoclonal antibodies, insulin, granulocyte colony-stimulating factor, erythropoietin, recombinant human growth hormone, etanercept, follitropin, teriparatide, interferons, enoxaparin sodium, glucagon, and calcitonin are among the product categories that make up the biosimilars market. Monoclonal antibodies held a sizable portion of the market in 2020. The market is being driven by elements including the widespread use of monoclonal antibodies in the treatment of autoimmune diseases, cancer, and osteoporosis, as well as the affordability of such treatments.

  • Monoclonal Antibodies
    • Infliximab
    • Trastuzumab
    • Rituximab
    • Adalimumab
    • Other monoclonal antibodies (bevacizumab, cetuximab, ranibizumab, denosumab, and eculizumab)
  • Insulin
  • Granulocyte Colony-Stimulating Factor
  • Erythropoietin
  • Recombinant Human Growth Hormone
  • Etanercept
  • Follitropin
  • Teriparatide
  • Interferons
  • Enoxaparin Sodium
  • Glucagon
  • Calcitonin

By Indication

The biosimilars market is divided into oncology, autoimmune and inflammatory diseases, chronic illnesses, blood disorders, growth hormone insufficiency, infectious diseases, and other indications based on the indication (infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases). The market's largest sector in 2020 will be oncology. This market is expanding as a result of elements like the reduced cost of biosimilars compared to novel biologics and the increased incidence and prevalence of cancer.

  • Oncology
  • Inflammatory & Autoimmune Disorders
  • Chronic Diseases
  • Blood Disorders
  • Growth Hormone Deficiency
  • Infectious Diseases
  • Other Indications (infertility, hypoglycemia, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases)

Insights10 will provide you with the reports within 10 key parameters which are:

  1. Market Overview
  2. Market Growth Drivers & Restraints
  3. Epidemiology of Disease Type
  4. Market Segmentation
  5. Market Share
  6. Competitive Landscape
  7. Key Company Profiles
  8. Healthcare Policies & Regulatory Framework
  9. Reimbursement Scenario
  10. Factors Driving Future Growth

Based on our many years of experience, we believe that these are the parameters that are critical to decision-making for business stakeholders. Our focused approach to developing reports focused on 10 key parameters, enabled us to arrive at the name “Insights10”.

 

Stage I: Market Data Collection

Primary Interviews: We have developed a network of experts, freelancers, and researchers across countries through which we engage with local experts to gather key data points and assumptions about each market. We also engage regularly with some of the best market research agencies such as Atheneum, GuidePoint, GLG, etc. to conduct surveys and interviews, and build intelligence. We have language translators as a part of our team, who between them can cover 30+ languages allowing us to extract better local insights.

Secondary Data Collection: We have developed strong expertise and experience in secondary data collection methods for developing unique data sets and research material. We gather data from multiple reliable sources to maintain a high level of accuracy and consistency. The market data is analyzed and forecasted using appropriate statistical and coherent models. The report offers an overall analysis of the market size, growth, and market share as well as a segment-level analysis of the specific market. Our report includes precise, to-the-point information related to the overall market, competition, growth drivers, challenges, regulatory updates, and competition.

Data Sources: We have access to multiple highly reliable free and subscription data sources. We have many years of experience to understand which sources are more dependable for what and which to prefer for the reliable and latest information. The key sources of information include the following, but are not limited to:

 

 

Stage II: Market Data Analysis and Statistical Model

Market Trends: We generally look at macro parameters and micro indicators. The macro parameters include changes in government policies, demand and supply of the market, government intervention programs, and major market share. The micro indicators are GDP growth, market size, market volume, etc. We also understand nuances specific to each country like the US, Canada, India, Germany, etc., and have worked across 60+ countries and hence not only understand global trends but how these differ by country, how payment models, market structure, cultural parameters, etc. differ in each country.

Market Sizing and Analysis: Our expert data analytics team has created various market forecast models by employing the top-down approach i.e. starting with the large overall market and segmenting different areas and the bottom-up approach i.e. starting with population and epidemiology and rolling up based on spend, etc., estimating the size of the market, and distributing among the geographic and/or product segments.

The top-down approach is mainly used for new product forecasting and the bottom-up approach is used for demand estimation of any product for different countries summed up to form the total market. We are able to round off insights and build stronger forecasts because we always do both these methods and triangulate the final numbers.

The study on the market covers the analysis of the leading geographies such as Asia-Pacific, Africa, Europe, Middle East, North America, and  Latin America for the period of 2022 to 2030. The qualitative analysis covers the industry landscape and trends, market opportunities, competitive landscape, and policy and regulatory scenario, and the quantitative analysis covers different market estimates and forecasts.

Data Triangulation & Validation:

Data triangulation of various sources and results of the research are carried out by benchmarking with reliable sources such as industry statistics, statistical databases, and company-level averages, etc.

We make sure to finalize the numbers in alignment with the market research. Firstly, our internal experts ensure thorough validation and checking to ensure accurate and precise analysis and then validation is also done using a multiple-data analysis model. Two-level validation is done and entails the finalization of the report scope and the way of representation pattern.

 

 

Stage III: Interpretation and Presentation

Analysis & Interpretation: The information gathered is then analyzed and synthesized. The second series of interviews are done if necessary to check and validate. The future opportunities are analyzed by understanding product commercialization and many other factors. It also comprises the analysis of data discrepancies observed across various data sources. Information procured from secondary and primary results is then, interpreted by considering the following parameters: (a partial list)

  • Establishing market drivers and trends
  • Analyzing the regulatory landscape to understand future growth
  • Market Segment based analysis to obtain revenue/volume
  • ​Analyzing current needs and determining penetration to estimate the market

Insights: Our reports deliver actionable insights backed with supporting facts and figures to assist you in achieving exemplary growth. Our in-depth analyses are interspersed with relevant insights and statistics to offer an executive-level view of a given market. The description helps in correlating many minor factors affecting the market and their impact on the different segments within the market.

Data curated from the analysis and interpretation are drawn to portray all in one consolidated report.

Presentation & Reporting: The market research report is presented in different forms such as charts by using a scientific approach for easy understanding. Historic, current, and future analysis is provided for each market in terms of both value and volume. The size of the market is interpreted in the US Dollar value and the respective unit, based on the product, for volume consumption.

The foreign exchange rates are calculated on the respective dates and for the respective regions covered in the study.

To request a free sample copy of this report, please complete the form below.


We value your inquiry and offer free customization with every report to fulfil your exact research needs.


This report addresses

  • Intelligent insights to take informed business decisions
  • Qualitative, acute and result oriented market analysis
  • Market size and forecasts from 2022 to 2030
  • Opportunities for expansion and in-depth market analysis
  • Segmentation and regional revenue forecasts
  • Analysis of the market share and competitive landscape
  • Strategic Recommendations to chart future course of action
  • Comprehensive Market Research Report in PDF and PPT formats

Need more?

  • Ask our analyst how this study was put together to learn more
  • Discuss additional requirements as part of the free customisation
  • Add more countries or regions to the scope 
  • Get answers to specific business questions 
  • Develop the business case to launch the product
  • Find out how this report may influence your business revenue
Last updated on: 09 June 2023
Updated by: Dhruv Joshi

Related reports (by category)


Related reports (by geography)


subscribe to our newsletter
up