Concerns regarding the emergence of bioterrorism and Severe Acute Respiratory Syndrome (SARS), in addition to the search for cancer vaccines, represent drivers that will see India's vaccine production sector expand dramatically in the coming years. India's vaccines market is forecast to climb from a 2011 value of $350m to $871m by just 2016, exhibiting an extremely healthy compound annual growth rate (CAGR) of 20%.
The second most populous country in the world has emerged as a major vaccine producer in recent years, focusing efforts on geographical regions where vaccines are not funded by the UN or charitable organizations. As a result, exports constituted 65% of the Indian vaccines market last year.
The global vaccines market expanded significantly during 2005-2011, with major pharmaceutical players such as GlaxoSmithKline, Sanofi, Merck and Pfizer posting notable profits and the US recording the largest share in the world.
However, we anticipate a sizeable shift in the industry landscape, as the most promising future growth opportunities for the production and sale of vaccines come from emerging economies such as India and China.
In January 2008 the Indian government cancelled the licenses of three vaccine-producing units – the Central Research Institute, the Bacillus Calmette-Guérin Vaccine Laboratory and the Pasteur Institute of India – on account of non-compliance with Good Manufacturing Practices (GMP).
But in April 2011, India's Ministry of Health and Family Welfare (MOHFW) launched a National Vaccine Policy (NVP), stressing the future significance of the vaccine industry. Following suggestions from the NVP, the government approved plans in June of this year to revive these cancelled units.
This research report provides an analysis of biopharmaceuticals approved in 2010 and 2011, operating dynamics in the biopharmaceutical industry, the current scenario in biopharmaceutical manufacturing, key stakeholders, the current market size (2011) of biopharmaceuticals, and forecasts to 2016 for India, China, South Korea and the global market. The report also presents trends witnessed in biopharmaceutical manufacturing, preferred partnership pricing models, contract manufacturing partnerships, comparative analysis of biopharmaceutical manufacturing in India, China and South Korea, and the competitive landscape for the countries covered in the report.
This report is built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis from GBI Research's team of industry experts.
Leading Contract Manufacturing Organizations (CMOs) offer manufacturing functions both upstream and downstream equally. In addition to manufacturing in biopharmaceutical production, they also offer clinical trials, logistics, packaging, and even marketing. According to industry experts, almost 60% of the CMO market is dominated by manufacturing functions, out of which more than 50% is dominated by the downstream process. Many pharmaceutical companies are expected to outsource most parts of their R&D and biopharmaceutical manufacturing to emerging economies such as India and China. Cost rationalization and skilled labor are the main factors facilitating the outsourcing of processes to these countries.
Contract manufacturing is experiencing an upsurge in these countries; outsourcing activities for biopharmaceutical manufacturing include secondary manufacturing such as fill and finish operations, mammalian cell culture, Active Pharmaceutical Ingredient (API) biologics, microbial fermentation and plant cells. Outsourcing analyses by pharmaceutical companies reveal that product characterization testing such as biomanufacturing, toxicity, bioassays and analytical testing form the bulk of outsourcing to CMOs.
With the increase in outsourcing, biomanufacturing capacities in emerging economies have been expanding. Although the US continues to be a leader in biopharmaceutical production, with approximately 45% of the total production share, China's and India's shares have been continuously increasing, with 8% and 7% respectively. Sponsors are building strategic relationships with the contract players and progressively working towards homogenizing and simplifying manufacturing processes in order to ensure normalized products.
- Detailed overview of biopharmaceutical manufacturing, the CMO industry, and recent approvals of biopharmaceuticals.
- Annualized market data and forecasts to 2016 for the biopharmaceutical market in India, China and South Korea.
- Detailed overview of key reasons behind outsourcing, outsourcing service models and key drivers and restraints of the market.
- Detailed discussion of trends witnessed in biopharmaceutical manufacturing.
- Company profiles of key biopharmaceutical players in India, China and South Korea, including the key services they offer and the production capacity of the global top 10 biopharmaceutical companies.
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- Develop market entry and market expansion strategies by identifying areas for high growth and opportunities.
- Understand the factors shaping the biopharmaceutical industry and trends witnessed in the biopharmaceutical industry.
- Identify the top players in the biopharmaceutical industry, including their financial revenues, geographical presence and key services offered.
- Analyze the key geographies that are lucrative markets for biopharmaceutical production and CMOs.
- Understand upcoming trends that are poised to drive the future growth of biopharmaceutical production.
Click for Report details:Biopharmaceutical Manufacturing in India, China and South Korea