The Indian CMO market was valued at USD 9.04 billion in 2022, and it is expected to reach USD 23.72 billion by 2031, registering a CAGR of 17.6%, during the period of 2022-2031. The rise in demand for injectable drugs, especially in cancer research, will provide an upward trend to the Indian pharmaceutical contract manufacturing market. Injectable drugs offer higher returns as compared to other drug formulation types. Therefore, higher ROI and therapeutic efficiency are expected to fuel the growth of the injectable formulation segment in the country.
– The availability of skilled labor at relatively lower cost drives the market. The Indian Government, through its national skill development program (NDMC), has launched various skill development programs for the healthcare and pharmaceutical industries. Additionally, labor cost efficiencies provide a significant competitive advantage to the Indian companies. Their workforce costs are about 33% lower than their western counterparts on average, according to POBOS. Also, 2,25,000 pharmacy students graduate from India’s education system, compared to just about 17,000 pharmacy students graduating in the United States, according to the data published by the All India Survey on Higher Education in 2018. The workforce includes highly-skilled medical practitioners and specialists who bring significant expertise and actively contribute to clinical research.
– Increasing outsourcing volume by big pharma companies drives the market. Europe and North America act as the base of the biggest pharmaceutical companies, like Pfizer, Roche, Novartis, and Mecks. However, the majority of their pharmaceutical demands are met by imported medicines. According to the data published by worldstopexports, in 2018, Europe and the United States imported 57.8% and 18% of the total drugs exported, globally, in 2018. Moreover, the Indian Drug Manufacturers Association (IDMA) mentioned the rising costs and regulatory pressure in developed markets as a driver, forcing many global pharmaceutical companies to reduce their internal capacities in research and development. For instance, aging manufacturing facilities in Europe have forced companies to outsource their research and manufacturing to India.
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– Recent quality and regulatory issues fueling apprehension are restraining the market. Indian manufacturers have been subject to constant scrutiny from the FDA in recent years. Most recently, in October 2019, FDA posted a warning letter issued to Aurobindo Pharma’s API manufacturing site located in Srikakulam district. Also, the concerns over the quality were further fueled by a Bloomberg investigation in 2018, which found that manufacturers of generic drugs and their key ingredients in China, India, and elsewhere, had in some cases, destroyed or hid testing data revealing quality failures from official records and showed passing results instead.
Scope of the Report
Over the past few decades, India has taken a major leap from pharmaceutical production, to include contract manufacturing. In basic manufacturing of medical drugs and products, India has a far superior edge over nations, such as Vietnam, China, and Ireland, due to resources including manpower, technically knowledgeable workforce, and WHO-GMP approved production premises. Further the demand of CMO service include API & Intermediates and Finished Dose services.
Key Market Trends
Generic Medicine Under Solid Finished Dose Segment Holds the Significant Share in The Market
– The solid dose formulation segment is mainly dominating the finished dose segment in India, owing to lower manufacturing cost, patent compliance, and ease of maintenance. Solid dosage forms, such as tablets, pills, capsules, powders, etc., are among the most adopted products in the country. The growth of generics drugs is one of the major factors driving the growth of the segment and India is the largest exporter of generic drugs and accounts for approximately 20% of global exports by volume.
– Recently, the growing collaborations between the Indian and Chinese pharma companies are expected to expand the segment’s scope. The only significant area where the Chinese pharma industry is lagging is finished drugs in solid dose forms. Through the partnership with Indian companies, Chinese pharma companies are keen on acquiring expertise and capability to manufacture generic formulations locally. This is expected to grow the demand for the studied segment too.
– For instance, in August 2019, Dr. Reddy’s Laboratories (DRL) became the first Indian company to export generic drugs to China. Moreover, Indian drug companies are looking for more partnerships in this region. Most recently, in 2019, Sun Pharmaceutical Industries Ltd, India’s largest drug-maker, signed a licensing pact with China Medical System Holdings for two specialty drugs.
– Moreover, the increase in outsourcing value by big pharma companies drives the market. Additionally, IDMA estimates that drugs worth USD 85 billion will lose their patents and would be available for generic manufacturing from 2020 onward. This will further boost the production capabilities of Indian CMOs as the manufacturing of those drugs won’t be viable in other countries.
– Also, new global opportunities are being made by generic manufacturers producing modified versions of approved off-patent small-molecule drugs. These so-called ‘super-generics’ offer a therapeutic advantage, distinguishing them from conventional generic drugs. For instance, India-based Ranbaxy Laboratories developed a once-a-day ciprofloxacin tablet and licensed it to Germany-based Bayer AG.
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Drugs and Pharma Exports in United States Account for Significant Market Growth
– United States relies on India for importing services and also for establishing its plants in the country. The United States and North America contribute to over 30% of the country’s outbound shipments.
– The FDA in 2019 estimated that about 80% of the medicine in the United States is imported every year. As of 2019, India has the highest number of FDA approved drug manufacturing facilities. India has over 600, US FDA-approved plants which is highest outside the United States.
– Furthermore, the US market faced a considerable price erosion in 2018, due to which the profit margins slimmed for the companies in the United States. The IDMA estimates that there is a 50% price reduction in the overall research, API, and manufacturing process, when it is outscored to emerging countries, like India and China. This will further boost the demand for CMO services in India and increase the export revenue in the future.
The India Contract Manufacturing Organization (CMO) market is fragmented, with the top vendors accounting for a significant share of the total market. Apart from these major players, there are several players in the market that are investing in innovation and partnership activities to gain an increased market share. Therefore, the intensity of competitive rivalry is high. Key players are AMRI India Pvt. Ltd., Dr. Reddy’s Laboratories, Cadila Healthcare Limited, etc. Recent developments in the market are –
– Sep 2019 – Eisai Pharmaceuticals India Pvt Ltd and Mylan Pharmaceuticals Pvt Ltd entered into a marketing license agreement, to commercialize TECERIS, the innovator’s second brand of the anticancer agent, Eribulin mesylate (Eribulin), in India. TECERIS is likely to be manufactured and supplied by Eisai India and marketed by Mylan. This partnership was an important strategy for expanding the access of Eribulin, for the treatment of metastatic breast cancer (MBC) patients in India.
– Apr 2019 – The Cipla Ltd., launched Niveoli, India’s first extra-fine particle beclomethasone-formoterol combination hydrofluoroalkane (HFA) inhaler for adults, targeting drug delivery to small airways. Niveoli is a proprietary Cipla inhaler, and the latest offering from Cipla in respiratory inhalation therapy that addresses an unmet need associated with obstructive airway diseases (OAD), such as asthma and chronic obstructive pulmonary disorder (COPD).
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