Report Description

Forecast Period

2025-2029

Market Size (2023)

 USD 17145.25 million

CAGR (2024-2029)

8.87 %

Fastest Growing Segment

In-house Manufacturing Segment

Largest Market

North India

 

Market Overview

India Active Pharmaceutical Ingredients Market has valued at USD 17145.25 million in 2023 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 8.87 % through 2029.  Active Pharmaceutical Ingredients (APIs) are the biologically active components in pharmaceutical drugs that produce the intended therapeutic effect. They are the essential chemical compounds or substances responsible for treating, alleviating, or preventing a particular medical condition or disease. APIs are the core ingredients that give a drug its medicinal properties. APIs are compounds or substances within a pharmaceutical formulation that have a pharmacological or therapeutic effect on the human body. They are the ingredients that directly interact with the body to produce the desired medical outcome. APIs can exist in various forms, including small molecules, proteins, peptides, nucleic acids, and more. The form of the API depends on the specific drug and its mechanism of action. APIs are not typically administered to patients on their own. Instead, they are formulated into various dosage forms, such as tablets, capsules, injections, or creams, to make the drug convenient and effective for use.

Indian pharmaceutical companies actively invest in research and development to develop new and innovative APIs. This commitment to innovation and improving existing drugs drives growth in the market. India has a substantial domestic pharmaceutical market with a large and growing population. The demand for APIs for both generic and innovative drugs within the country is a driver of market growth. The ability to offer custom synthesis and contract manufacturing services to pharmaceutical companies is a driver for the API market. It allows companies to work closely with clients to develop specific APIs and intermediates. The globalization of pharmaceutical supply chains has expanded the reach of Indian API manufacturers. Companies in India export APIs to a wide range of international markets, contributing to market growth.

Key Market Drivers

Rise in Domestic Pharmaceutical Market

 India has one of the world's largest populations, and the healthcare needs of this vast population are substantial. This includes the treatment of various diseases, chronic conditions, and healthcare maintenance. In India, generic medications are widely prescribed and used, often due to their affordability. These generics rely on APIs, and the demand for these medications is a primary driver for API production. APIs used in generic drugs are more affordable than their brand-name counterparts. This affordability ensures that a broader section of the population can access essential medications, further fueling demand. As India's economy grows and individuals have more disposable income, healthcare spending has been on the rise. This increased healthcare spending drives the demand for a variety of pharmaceutical products, including those requiring APIs.

The Indian government has introduced numerous healthcare initiatives and programs, such as the National Health Mission, which aim to improve healthcare access and services. These programs create a higher demand for pharmaceuticals and APIs. The rising incidence of chronic diseases in India, such as diabetes, cardiovascular conditions, and respiratory diseases, requires a consistent supply of APIs to produce medications used in disease management. The expansion of healthcare infrastructure, including hospitals, clinics, and pharmacies, supports the distribution of pharmaceutical products and APIs to meet the healthcare needs of the population. India's changing demographics, including an aging population, contribute to increased healthcare needs and the demand for medications that rely on APIs.

The growing middle class in India has higher healthcare expectations and a greater ability to access medical treatments. This demographic's demand for pharmaceuticals and APIs is significant. An increasing awareness of healthcare and the importance of early diagnosis and treatment has led to more individuals seeking medical care and driving the demand for pharmaceuticals. Expanding health insurance coverage in India has made healthcare more accessible and affordable for many individuals, resulting in higher demand for pharmaceutical products. The well-established pharmaceutical distribution networks in India ensure that medications, including those based on APIs, are readily available across the country. This factor will help in the development of the India Active Pharmaceutical Ingredients Market.

Increasing Demand of Custom Synthesis and Contract Manufacturing

Custom synthesis and contract manufacturing services allow pharmaceutical companies to obtain APIs that are specifically tailored to their unique requirements. This customization is essential for the development of proprietary drug formulations and novel medications. Pharmaceutical companies can benefit from the efficiency and cost savings offered by specialized custom synthesis and contract manufacturing providers. These services often have streamlined processes and expertise, resulting in cost-effective API production. Custom synthesis and contract manufacturing providers typically have a deep understanding of chemical processes and complex API synthesis. This expertise is valuable for pharmaceutical companies seeking to develop new drugs or optimize existing formulations. Outsourcing API production through custom synthesis and contract manufacturing can expedite drug development timelines. Companies can focus on research, development, and commercialization while relying on specialized partners for API manufacturing. Pharmaceutical companies can mitigate risks associated with API manufacturing, such as supply chain disruptions, regulatory changes, and quality control challenges, by partnering with experienced custom synthesis and contract manufacturing providers.

Reputable custom synthesis and contract manufacturing services often maintain the highest standards of quality and regulatory compliance. This is crucial for pharmaceutical companies seeking regulatory approvals for their products. Custom synthesis and contract manufacturing services offer flexibility in scaling up or down based on the specific production requirements of pharmaceutical companies. This adaptability aligns with the changing demands of drug development. Outsourcing API production allows pharmaceutical companies to optimize their internal resources, focusing on core competencies, research, and commercialization efforts. Custom synthesis and contract manufacturing providers can facilitate technology transfer agreements, ensuring a smooth transition from laboratory-scale development to large-scale manufacturing.

API manufacturers offering custom synthesis and contract manufacturing services often have a global reach, exporting their products to various international markets. This is advantageous for pharmaceutical companies with a global presence. Collaboration with custom synthesis and contract manufacturing partners can help protect intellectual property rights for pharmaceutical companies, particularly when developing proprietary drug formulations. Custom synthesis and contract manufacturing providers typically offer a wide range of APIs and can accommodate the diverse needs of pharmaceutical companies across therapeutic areas. Some of these providers engage in collaborative research and development, contributing to the development of new and innovative APIs. This factor will pace up the demand of the India Active Pharmaceutical Ingredients Market.

Growing Research and Development

The primary purpose of pharmaceutical R&D is to discover and develop new drugs. These new drugs require specific APIs that must be sourced or synthesized, leading to increased demand for these ingredients. R&D efforts are focused on developing innovative drug formulations and delivery systems. These formulations often require novel APIs, thus driving the need for the development and production of these ingredients. Ongoing R&D is aimed at optimizing and improving the efficacy, safety, and patient experience of existing drugs. This may involve developing modified APIs or new processes for their production. The trend toward personalized medicine, where treatments are tailored to an individual's genetic makeup, requires the development of APIs specific to these personalized treatments, increasing API demand. R&D efforts to address rare and orphan diseases involve the development of specialized medications, often requiring unique APIs.

The growth of biopharmaceuticals, including biologics and biosimilars, relies on R&D to develop and produce the corresponding APIs, such as monoclonal antibodies and recombinant proteins. Advanced therapies, such as gene therapies and cell therapies, are a result of extensive R&D. These therapies necessitate specialized APIs, which contribute to the demand for these ingredients. Clinical trials are a critical part of drug development. The supply of APIs for clinical trials and the subsequent production of the approved drug drive the demand for these ingredients. Early-stage R&D involves identifying potential drug targets and compounds. This research ultimately leads to the development of APIs for further drug development. As pharmaceutical companies expand their portfolios and enter new therapeutic areas, they often need to source or develop APIs for the drugs in these new markets.

R&D activities are closely linked to regulatory approvals. Meeting regulatory standards and obtaining approvals often involves a detailed understanding of the APIs and their quality attributes. Research-driven companies may invest in R&D for generic drug development once patents for brand-name drugs expire, leading to the production of generic APIs. R&D is essential for ensuring the quality, safety, and efficacy of APIs used in pharmaceutical products. This focus on quality standards drives the demand for high-quality ingredients. To remain competitive in the pharmaceutical market, companies invest in R&D to differentiate their products, necessitating the development of unique APIs. This factor will accelerate the demand of the India Active Pharmaceutical Ingredients Market


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Key Market Challenges

Quality Control and Assurance

Meeting the stringent quality standards and regulatory requirements of various international markets, such as the US FDA and the European Medicines Agency (EMA), is a continuous challenge. API manufacturers in India must invest in robust quality control and assurance processes to gain and maintain regulatory approvals. Maintaining consistent quality across different batches of APIs is a challenge. Variability in the quality of APIs can lead to manufacturing issues and may affect the safety and efficacy of the final drug product. The quality of raw materials, including starting materials and intermediates, is crucial for API production. Ensuring the quality and traceability of these materials can be challenging, especially when sourced from diverse suppliers. Ensuring compliance with Good Manufacturing Practices (GMP) standards is essential for API manufacturers. It requires a significant investment in infrastructure, equipment, training, and quality management systems. Recruiting and retaining skilled professionals with expertise in analytical chemistry, quality control, and quality assurance is a challenge. Highly qualified personnel are needed to implement quality control processes effectively.

Market Access Barriers

Meeting the stringent regulatory standards of various international markets, such as the US FDA and the European Medicines Agency (EMA), can be a significant barrier. API manufacturers must ensure that their facilities and processes adhere to these standards to gain market access. Maintaining consistent quality and adherence to Good Manufacturing Practices (GMP) is essential for market access. Variability in API quality can lead to rejection by regulatory authorities and customers. The protection of intellectual property rights can be a barrier when exporting APIs to certain markets. API manufacturers must navigate complex patent landscapes and intellectual property regulations to gain market access. Accurate and comprehensive documentation is crucial for regulatory approvals and market access. Ensuring that all required documents are in order can be a challenge. API manufacturers often face intense price competition in global markets. Ensuring cost competitiveness while maintaining quality can be a barrier. Trade barriers, such as tariffs and non-tariff barriers, can affect the export of APIs to specific countries. Negotiating these barriers can be a challenge. Complying with customs and import regulations in target markets can be complex and time-consuming, leading to delays and potential barriers.

Key Market Trends

Environmental Sustainability

 Increasingly stringent environmental regulations require pharmaceutical manufacturers, including API producers, to adopt more sustainable and environmentally friendly production processes. Compliance with these regulations is essential for market access and reputation. The adoption of green chemistry principles is gaining traction. Green chemistry focuses on minimizing the environmental impact of chemical processes, reducing waste, and conserving resources. API manufacturers are seeking ways to optimize resource use, such as water and energy, to reduce their environmental footprint and operational costs. Minimizing waste generation and improving waste management practices is a priority. Sustainable waste handling, including the disposal of hazardous materials, is crucial. Some API manufacturers are transitioning to the use of renewable energy sources to power their production facilities, reducing greenhouse gas emissions. The pharmaceutical industry is showing an interest in sourcing raw materials and starting materials from suppliers who follow sustainable practices, including responsible sourcing of natural ingredients. Efforts to reduce the carbon footprint of API manufacturing are becoming more common, with initiatives to measure, report, and reduce greenhouse gas emissions. The concept of a circular economy, where resources and materials are recycled and reused, is being applied in the pharmaceutical industry, including the recycling of solvents and reusing waste products.

Segmental Insights

Method of Synthesis Insights

In 2023, the India Active Pharmaceutical Ingredients Market largest share was held by Synthetic segment and is predicted to continue expanding over the coming years. Synthetic APIs are highly versatile and can be used in a wide range of pharmaceutical products, including both generic and innovative drugs. Their broad applicability makes them a popular choice for pharmaceutical manufacturers. Synthetic APIs are often more cost-effective to produce compared to their natural or biologically derived counterparts. This cost advantage is particularly appealing to pharmaceutical companies, as it helps reduce overall production expenses. Synthetic APIs can be manufactured with a high degree of consistency and quality control, ensuring that each batch meets strict regulatory and quality standards. This is crucial for drug safety and efficacy. Many Indian pharmaceutical companies specializing in synthetic APIs have invested in maintaining rigorous quality standards and obtaining approvals from stringent regulatory authorities like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Synthetic APIs can be tailored to meet specific requirements, allowing pharmaceutical manufacturers to create proprietary formulations and optimize drug performance. Synthetic APIs are often associated with a reliable and consistent supply, reducing the risk of shortages or disruptions in the pharmaceutical supply chain.

Source Insights

In 2023, the India Active Pharmaceutical Ingredients Market largest share was held by Contact Manufacturing Organizations (CMO) segment and is predicted to continue expanding over the coming years. The global pharmaceutical industry has witnessed a growing trend of outsourcing various aspects of drug development and manufacturing to CMOs. This trend extends to the production of APIs, with many pharmaceutical companies preferring to focus on research, marketing, and sales, while outsourcing API manufacturing. CMOs often offer cost-effective solutions for API manufacturing. They have specialized facilities, expertise, and efficient processes that can lead to cost savings for pharmaceutical companies. India is known for its cost-effective pharmaceutical manufacturing. Reputed Indian CMOs have invested in meeting stringent regulatory standards, such as those set by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This compliance is critical for API manufacturing, especially for companies seeking to export to global markets. CMOs in India often have significant production capacities and can efficiently scale up or down based on the needs of their clients. This flexibility is appealing to pharmaceutical companies looking for reliable API suppliers. Many Indian CMOs have a skilled and experienced workforce with expertise in various chemical and pharmaceutical processes. This expertise is crucial for the development and production of APIs. CMOs offer customized solutions that allow pharmaceutical companies to tailor their API production to specific requirements. This flexibility can be especially important for companies developing novel drugs or unique formulations.

Therapeutic Application Insights

In 2023, the India Active Pharmaceutical Ingredients Market largest share was held by Oncology Drugs segment and is predicted to continue expanding over the coming years.  Cancer is a leading cause of morbidity and mortality in India. The increasing prevalence of cancer in the country has driven the demand for oncology drugs, including APIs used in cancer treatments. Increasing awareness of cancer, early detection, and improved diagnostic capabilities have led to higher cancer detection rates. As a result, more patients require cancer treatments, including pharmaceutical interventions. The pharmaceutical industry has been actively investing in research and development related to oncology drugs and APIs. This has resulted in the development of new and more effective treatments for various types of cancer. India is a significant global supplier of generic oncology drugs and APIs. The country's pharmaceutical manufacturers export these products to various international markets, making it a major player in the global oncology pharmaceutical sector. The Indian government has introduced initiatives to promote the pharmaceutical industry, including the oncology segment. These initiatives include support for research, development, and manufacturing in this critical therapeutic area. Many Indian pharmaceutical companies have obtained approvals from stringent regulatory authorities, such as the US FDA and the European Medicines Agency (EMA), for their oncology products. This compliance is essential for ensuring the safety and efficacy of oncology drugs.

Drug Type Insights

In 2023, the India Active Pharmaceutical Ingredients Market largest share was held by Generic Drug type segment in the forecast period and is predicted to continue expanding over the coming years.  The global demand for generic pharmaceuticals, including APIs, is substantial. India is one of the world's leading suppliers of generic drugs and APIs, with a significant share of the global market. This is due to the affordability of generic medications, which are essential for addressing healthcare needs in India and other countries. When patents for brand-name drugs expire, it creates an opportunity to produce generic versions. India has been at the forefront of developing and manufacturing APIs for these off-patent or expiring-patent drugs, contributing to the dominance of generic drugs in the API market. Indian pharmaceutical manufacturers are known for their cost-effective production methods. This cost advantage allows them to produce generic APIs at competitive prices, making them an attractive choice for pharmaceutical companies worldwide. Many Indian API manufacturers have invested in meeting stringent regulatory standards, such as those set by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Regulatory approvals are crucial for ensuring the quality and safety of APIs used in generic drugs. Generic APIs can be used in a wide variety of pharmaceutical formulations, providing flexibility to pharmaceutical companies to create and adapt products to different markets and patient needs. Indian pharmaceutical companies have been actively investing in research and development to innovate and develop new generic drugs and their corresponding APIs. This has contributed to the continued growth of the generic drug segment.


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Regional Insights

The North India region dominates the India Active Pharmaceutical Ingredients Market in 2023. North India, particularly the states of Himachal Pradesh and Punjab, has a long history of pharmaceutical manufacturing. Many well-established pharmaceutical companies, including some of the country's largest, are based in this region. North India offers a conducive business environment with access to skilled labor, infrastructure, and connectivity. It has well-developed industrial clusters that support pharmaceutical manufacturing. The proximity of North India to the national capital, New Delhi, is advantageous for regulatory and administrative purposes. It facilitates interactions with government bodies and regulatory agencies. North India is home to several prominent educational and research institutions specializing in pharmaceutical sciences. These institutions provide a pool of trained talent and contribute to research and development in the pharmaceutical sector. The state governments in North India have often been proactive in promoting pharmaceutical manufacturing through incentives, subsidies, and the establishment of pharmaceutical parks and special economic zones.

Recent Developments

  • In April 2023, Two Indian pharmaceutical companies, Natco Pharma and MacLeods Pharmaceuticals, were preparing to release their versions of Johnson & Johnson's groundbreaking tuberculosis (TB) drug, Bedaquiline. This J&J drug represents the first global approval for TB treatment in approximately four decades, offering a less toxic and more effective alternative to traditional treatments. A key patent for this drug is set to expire in July. Notably, securing an Emergency Use Authorization (EUA) is contingent on the company's application for World Health Organization pre-qualification (PQ) and the submission of technical details. Attaining WHO PQ status will facilitate the adoption of the product by more countries for their TB programs. Natco is also involved in the production of both the Active Pharmaceutical Ingredient (API) and the finished dosage form of Bedaquiline and is in the process of obtaining additional regulatory clearances due to the unique nature of this drug.

Key Market Players

  • Teva AP| India Limited
  • Pfizer Ltd.
  • Dr. Reddy's Laboratories Ltd.
  • Sun Pharmaceutical Industries Limited
  • Cipla Limited
  • Lupin Limited
  • Aurobindo Pharma Limited
  • Aarti Drugs Ltd.
  • IOL Chemicals and Pharmaceuticals Limited
  • GlaxoSmithKline Pharmaceuticals Ltd

 

By Method of Synthesis

By Source

By Therapeutic Application

By Region

·         Synthetic

·         Biological

·         Contact Manufacturing Organizations

·         In-house Manufacturing

·         Cardiovascular Diseases

·         Anti-diabetic Drugs

·         Oncology Drugs

·         Neurological Disorders

·         Musculoskeletal Disorders

·         Others

·         North India

·         South India

·         East India

·         West India


Report Scope:

In this report, the India Active Pharmaceutical Ingredients Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

  •      India Active Pharmaceutical Ingredients Market, By Method of Synthesis:

o   Synthetic

o   Biological

  •     India Active Pharmaceutical Ingredients Market, By Source:

o   Contact Manufacturing Organizations

o   In-house Manufacturing

  •    India Active Pharmaceutical Ingredients Market, By Therapeutic Application:

o   Cardiovascular Diseases

o   Anti-diabetic Drugs

o   Oncology Drugs

o   Neurological Disorders

o   Musculoskeletal Disorders

o   Others

  •  India Active Pharmaceutical Ingredients Market, By Drug Type:

o   Generics

o   Innovator

  • India Active Pharmaceutical Ingredients 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 presents in the India Active Pharmaceutical Ingredients Market.

Available Customizations:

India Active Pharmaceutical Ingredients 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 Active Pharmaceutical Ingredients 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]


Table of content

1.    Product Overview

1.1.  Market Definition

1.2.  Scope of the Market

1.2.1.    Markets Covered

1.2.2.    Years Considered for Study

1.2.3.    Key Market Segmentations

2.    Research Methodology

2.1.  Objective of the Study

2.2.  Baseline Methodology

2.3.  Key Industry Partners

2.4.  Major Association and Secondary Types

2.5.  Forecasting Methodology

2.6.  Data Triangulation & Validation

2.7.  Assumptions and Limitations

3.    Executive Summary

3.1.  Overview of the Market

3.2.  Overview of Key Market Segmentations

3.3.  Overview of Key Market Players

3.4.  Overview of Key Regions/Countries

3.5.  Overview of Market Drivers, Challenges, and Trends

4.    Voice of Customer

5.    India Active Pharmaceutical Ingredients Market Outlook

5.1.  Market Size & Forecast

5.1.1.    By Value & Volume

5.2.  Market Share & Forecast

5.2.1.        By Method of Synthesis (Synthetic, Biological)

5.2.2.        By Source (Contact Manufacturing Organizations, In-house Manufacturing)

5.2.3.        By Therapeutic Application (Cardiovascular Diseases, Anti-diabetic Drugs, Oncology Drugs, Neurological Disorders, Musculoskeletal Disorders, Others)

5.2.4.        By Drug Type (Generics, Innovator)

5.2.5.    By Region (North India, South India, East India, West India)

5.2.6.    By Company

5.3.  Product Market Map

 

6.    India Synthetic Active Pharmaceutical Ingredients Market Outlook

6.1.  Market Size & Forecast       

6.1.1.    By Value

6.2.  Market Share & Forecast

6.2.1.    By Product Type (Organic Synthesis, Inorganic Synthesis))

6.2.2.    By Source

6.2.3.    By Therapeutic Application

6.2.4.    By Drug Type

 

7.    India Biological Active Pharmaceutical Ingredients Market Outlook

7.1.  Market Size & Forecast       

7.1.1.    By Value

7.2.  Market Share & Forecast

7.2.1.        By Product Type (Vaccines, Monoclonal Antibodies, Recombinant Proteins, Hormones, Others))

7.2.2.        By Source

7.2.3.        By Therapeutic Application

7.2.4.        By Drug Type

8.    Market Dynamics

8.1.  Drivers

8.2.  Challenges

9.    Market Trends & Developments

9.1.  Merger & Acquisition

9.2.  Product Development

9.3.  Recent Developments

10. Policy & Regulatory Landscape

11. Porters Five Forces Analysis

11.1.             Competition in the Industry

11.2.             Potential of New Entrants

11.3.             Power of Suppliers

11.4.             Power of Customers

11.5.             Threat of Substitute Products

12. India Economic Profile

13. Pricing Analysis

14. Competitive Landscape

14.1.   Teva AP| India Limited

14.2.   Pfizer Ltd.

14.3.   Dr. Reddy's Laboratories Ltd.

14.4.   Sun Pharmaceutical Industries Limited

14.5.   Cipla Limited

14.6.   Lupin Limited

14.7.   Aurobindo Pharma Limited

14.8.   Aarti Drugs Ltd.

14.9.   IOL Chemicals and Pharmaceuticals Limited

14.10. GlaxoSmithKline Pharmaceuticals Ltd

15. Strategic Recommendations

16.  About Us & Disclaimer

Figures and Tables

Frequently asked questions

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The market size of the India Active Pharmaceutical Ingredients Market is estimated to be USD17145.25 million in 2023.

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Cipla Limited and Lupin Limited are some of the key players operating in the India Active Pharmaceutical Ingredients Market.

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Stricter regulatory requirements from agencies like the US FDA and the EMA continue to be a challenge.

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Environmental concerns and sustainability have been gaining importance. API manufacturers are adopting greener and more sustainable manufacturing processes.

profile

Sakshi Bajaal

Business Consultant
Press Release

India Active Pharmaceutical Ingredients Market to grow with a CAGR of 8.87 %

Dec, 2023

Increasing healthcare infrastructure and a supportive regulatory environment are the major drivers for the India Active Pharmaceutical Ingredients Market.