India Active Pharmaceutical Ingredient (API) Market by Manufacturing Type, Type, and Product Type - Forecast and Analysis 2024-2028

India Active Pharmaceutical Ingredient (API) Market Forecast 2024-2028

The India active pharmaceutical ingredient market size is estimated to grow by USD 7.56 billion, at a CAGR of 6.49% between 2023 and 2028. The market research and growth report also includes an in-depth analysis of drivers, trends, and challenges. Our market growth and forecasting report examines historical data from 2018-2022, besides analyzing the current market scenario.

The market in India is gaining momentum due to rising healthcare spending in urban areas and a growing elderly population. Additionally, the surge in DMF filings, particularly type II DMFs, with the US FDA is contributing to this traction. Type II DMFs, which provide detailed information on drug substances and intermediates, are commonly filed, indicating increased outsourcing by pharmaceutical manufacturers. This trend underscores the reliance on Indian API manufacturers for generic and patented drug production, driving market growth.

What will be the size of the India API Market During the Forecast Period?

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India API Market Segmentation

By Manufacturing Type Analysis

The market share by the captive APIs segment will be significant during the forecast period. The increased adoption of healthcare services has benefited the active pharmaceutical ingredient (API) market in India significantly. There is a huge focus on increasing the accessibility to affordable healthcare services, and this has led to increased demand for access to low-cost medicines, in turn inducing the demand for low-cost APIs for manufacturing finished drugs. Furthermore, the development of biopharmaceutical products incurs a huge investment of time and money, and even a small variation in the APIs can result in the spoilage of the entire batch of medicine, leading to significant financial loss to the innovator company. 

The captive APIs segment was valued at USD 9.81 billion in 2018. Furthermore, the increasing emphasis of healthcare regulatory authorities on quality control of APIs and their production facilities is a growing concern for manufacturers, resulting in increased dependency on in-house capabilities for the manufacturing of high-quality APIs. Owing to such factors, the captive manufacturing type is expected to witness significant adoption, which will drive the development of the segment and thereby expand the growth of the market during the forecast period.

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By Type Analysis

The innovative?segment will account for the largest share of this segment.?Innovative APIs refer to new or novel pharmaceutical ingredients that have never been used in a commercial product before. Innovative may include new chemical entities, new biologics, new biosimilars, or other novel formulations. These APIs are complex and require a lot of research and development (R&D) and regulatory approval before they can be applied to the development of new drugs. Additionally, regulatory agencies' focus on strict quality and safety requirements further fuels the demand for innovative APIs in the country as consumers develop a sense of additional trust due to the existence of stringent regulations. Consequently, the increasing revenue growth of the segment will accelerate the growth of the active pharmaceutical ingredient (API) market in India during the forecast period.

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Key Market Players 

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:

AbbVie Inc.: The company offers APIs such as Biperiden, Cyclosporine, Dasabuvir, organometallic and gaseous HCl.

• Aurobindo Pharma Ltd.
• Cadila Pharmaceuticals Ltd.
• Cipla Ltd.
• Divis Laboratories Ltd.
• Dr Reddys Laboratories Ltd.
• Glenmark Pharmaceuticals Ltd.
• Granules India Ltd.
• Hetero Labs Ltd.
• Ind Swift Laboratories Ltd.
• IOL Chemicals and Pharmaceuticals Ltd.
• Ipca Laboratories Ltd.
• JB Chemicals and Pharmaceuticals Ltd.
• Jubilant Pharmova Ltd.
• Laurus Labs Ltd.
• Lupin Ltd.
• Solara Active Pharma Sciences Ltd.
• Sun Pharmaceutical Industries Ltd.
• Suven Pharmaceuticals Ltd.
• Torrent Pharmaceuticals Ltd.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

India API Market Dynamics and Customer Landscape

There are multiple factors influencing market growth. Our researchers analyzed the data with 2022 as the base year, along with the key trends, and challenges. 

Significant Market Trends

A paradigm shift in the manufacturing process is one of the primary market trends. Traditionally, India has been known for producing generic drugs, but there is a significant movement toward complicated and high-value API manufacture. This transition is being driven by causes such as rising global demand for specialty pharmaceuticals, the necessity for complicated new therapeutics, and severe regulatory regulations. Further, the emphasis on R&D promotes innovation in API synthesis methods, process optimization, and green chemistry practices.

Furthermore, the synthesis of complicated chiral APIs and peptides is gaining traction, reflecting the industry's search for higher-value products. Additionally, the paradigm change demonstrates the industry's resilience and dedication to remaining ahead of global pharmaceutical manufacturing trends. Therefore, the paradigm shift from captive manufacturing to contract manufacturing is anticipated to have a positive impact on the market during the forecast period.

Major Challenges

A stringent regulatory environment is a significant challenge that affects market expansion. The low-cost structure in India has led to a more rapid and expansive boost in manufacturing in India. Regulatory scrutiny of manufacturers, particularly in Asia, remains very high; however, quality problems continue to persist, mainly due to the intensive manufacturing in the region. Globally, this county represents a significantly growing, organized, highly regulated market for pharmaceutical products, owing to the presence of a proper regulatory framework guiding the development, approval, manufacturing, and commercialization of pharmaceutical products.

Moreover, with the growth of a large and expanding generic drug industry, along with the global expansion of the chemical and pharmaceutical industries, the production of bulk actives has increased significantly in India. International sourcing of APIs started to exhibit a growing concern for the pharmaceutical industry. Non-adherence to these guidelines might restrict the entry of APIs into the regulated markets, thereby causing significant losses to API manufacturers. This discourages manufacturers from venturing into the API industry, thereby limiting the development prospects of the market during the forecast period.

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Key Market Customer Landscape

The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.

 Customer Landscape

Segment Overview

The market report forecasts market growth analysis by revenue and provides an analysis of the latest trends and growth opportunities from 2018 to 2028. 

• Deployment Outlook
  • Captive APIs
  • Contract APIs

• Type Outlook
  • Innovative APIs
  • Generic APIs

• Product Type Outlook
  • Prescription
  • Over-the-counter (OTC)

Market Analyst Overview: 

The market is a crucial component of the pharmaceutical industry, supplying raw materials for the production of prescription medications, essential drugs, and treatments for various chronic diseases. With a significant focus on combatting ailments such as HIV, cancer, epilepsy, malaria, and diabetes, the demand for APIs remains high. However, challenges such as shortage of drugs and reliance on imports from China underscore the need for domestic production of active pharmaceutical ingredients. In response, the government of India has introduced production-linked incentives (PLIs) and established bulk drug parks to encourage API manufacturing. This initiative aims to reduce dependency on foreign markets and ensure a stable supply of key starting materials (KSM) and chemical compounds.

Furthermore, collaborations, agreements, and business strategies between Indian pharmaceutical companies and regulatory bodies like USFDA and UKMHRA are enhancing generic drug production and expediting drug approvals. Particularly in the oncology segment, where cases are rising, the availability of chemotherapy drugs and biosimilar assets like Ustekinumab, Denosumab, and bevacizumab (Avastin) is crucial. Additionally, the geriatric population also drives demand for treatments for cardiovascular disorders, neurological disorders such as Parkinson's disease, and genetic disorders. Initiatives like those led by the Tamil Nadu Health Minister in collaboration with organizations like Wacoal India and Cancer Patients Aid Association (CPAA) highlight the importance of cancer awareness, diagnosis, and treatment. In navigating the competitive landscape, Indian pharmaceutical companies are employing innovative strategies to address market demands while adhering to drug price policies and ensuring quality and safety in API production.

India Active Pharmaceutical Ingredient (API) Market Scope
Report Coverage	Details
Page number	137
Base year	2023
Historic period	2018-2022
Forecast period	2024-2028
Growth momentum & CAGR	Accelerate at a CAGR of 6.49%
Market Growth 2024-2028	USD 7.56 billion
Market structure	Fragmented
YoY growth 2023-2024(%)	5.68
Competitive landscape	Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks
Key companies profiled	AbbVie Inc., Aurobindo Pharma Ltd., Cadila Pharmaceuticals Ltd., Cipla Ltd., Divis Laboratories Ltd., Dr Reddys Laboratories Ltd., Glenmark Pharmaceuticals Ltd., Granules India Ltd., Hetero Labs Ltd., Ind Swift Laboratories Ltd., IOL Chemicals and Pharmaceuticals Ltd., Ipca Laboratories Ltd., JB Chemicals and Pharmaceuticals Ltd., Jubilant Pharmova Ltd., Laurus Labs Ltd., Lupin Ltd., Solara Active Pharma Sciences Ltd., Sun Pharmaceutical Industries Ltd., Suven Pharmaceuticals Ltd., and Torrent Pharmaceuticals Ltd.
Market dynamics	Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for the forecast period.
Customization purview	If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the growth market between 2024 and 2028
• Precise estimation of the size and its contribution to the market in focus to the parent market
• Detailed analysis of customer landscape covering Diver of price sensitivity, Adoption of the lifecycle, and key purchase criteria 
• Companies landscape comparing criticality of inputs and factors of differentiation
• Exclusive Matrix on companies' position and classification
• Accurate predictions about upcoming trends and changes in consumer behavior
• Growth of the market across India
• A thorough analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of companies

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