Factors that are Reshaping Pharma Contract Manufacturing

Vishal Pratap Singh | Monday, 30 May 2022

 Vishal Pratap Singh

Post the outburst of COVID-19 pandemic, the pharmaceutical sector across the globe sought contract manufacturing in a big way.

The growth witnessed by pharma contract manufacturing from US$934.8 billion in 2017 to US$1.17 trillion in 2021 gives an insight into the exponential boom experienced by this industry. In the last three years, there has been a burden of high financial performance, especially in cases of buying and running expensive equipment for the mass production of pharmaceuticals. To combat this situation, many companies started outsourcing their manufacturing to contract manufacturers who have the equipment, facilities and labour force to carry out a more cost effective production. Industry experts consider this form of outsourcing as a game changer for pharmaceutical industry. That being said, in this article, lets have a look at some of the most prominent factors that have redefined the Pharma Contract Manufacturing.

Improved Processes and Technologies The first and foremost significant factor that is driving the growth of contract manufacturing in the pharmaceutical industry is the constantly growing need for state of the art processes and production technologies. These processes have proven significantly effective in meeting regulatory requirements. “Contract manufacturing organisations need to invest in new technologies and automation from time to time to improve its productivity and enable its customers to get to the lead molecule faster”, says Tetsuichi Okada, CEO, Bushu Pharma.

Major Outbreak of COVID-19 After the spread of COVID-19 pandemic, there is an on-going growth in the pharmaceutical sector. Companies involved in pharmaceutical innovation need to stock their pipelines with new drugs. However, majority of companies do not have the proper resources to discover, develop and manufacture products. Therefore, the requirement of contract manufacturing is significantly high in the pharmaceutical industry.

Companies such as Pfizer and AstraZeneca transferred non-COVID-19 biologics out of their proprietary manufacturing networks to make room for the new vaccines. In addition to that, due to compressed timelines and manufacturing scaling challenges for the COVID-19 vaccines and medicines, most of the contract manufacturing organisations signed service agreements at an unprecedented rate with the onset of the pandemic.

Increased Profitability Contract manufacturing organisations are consolidating as a means to enhance profitability in today’s competitive market of pharmaceutical industry. It is believed that through consolidation, the large contract manufacturers could get a chance to expand their geographical presence and penetrate multiple markets across the globe.

For example, in the year 2020, South Korea’s Celltrion, a biosimilar manufacturer, announced that it will invest USD 514 million over five years for its new plant in Wuhan which is regarded as China’s most extensive biologics facility with a capacity of 120,000 litres. This new facility is designed for the purpose of developing and manufacturing its biologics for the local market and to perform contract manufacturing work for the Chinese biotech companies’ emerging wave. “Its high time for all of us to work on finding backup series while optimizing for various parameters iteratively to get to a clinical candidate faster”, says Todd Daviau, CEO, Pharma Nobis.

Increased Focus on R&D Earlier, the pharmaceutical companies have been directing their priorities towards the core areas of competency. Hence, they prefer not to dispense available resources, expertise as well as technology in formulating the final dose of medicines. The increased competition and shrinking profit margins compelled the pharmaceutical companies to revisit their production processes and research & development activities instead of manufacturing the formulated drug to stay competitive in the market. “As a contract manufacturing organisation, our main focus is to cater to the growing demand of the large molecule outsourcing space. Also, the players with end to end scientific and manufacturing capabilities and focus on R&D have easier transition from discovery to the clinic”, says Akhil Ravi, CEO, Aurigene Pharmaceutical Services Limited (APSL).

Robust Processes According to industry experts, the most significant factor boosting the growth of contract manufacturing in the pharmaceutical industry in the Asia Pacific region is the rising demand of robust processes and production technologies. These processes have proven highly effective in meeting regulatory requirements. These factors are proved to be helpful in the proliferation of the contract manufacturing market.

In the year 2021, Fujifilm Diosynth Biotechnologies selected Holly Springs, North Carolina, for its new JPY 200 billion large scale cell culture bio-manufacturing site. This new facility will provide large scale cell culture manufacturing for bulk drug substance production. There are expectations that this facility will be operational by the year 2025.

How’s the Future of Contract Manufacturing Contract manufacturing will be readily accommodated by CMOs in the pharmaceutical industry that will further develop precision or personalized medicines for small batch productions. Infact, facilitating this will act as the advancements of new and modern equipment that can manufacture small batches of goods quickly. Medical requirements demand pharma manufacturing process to adapt to small batches of products. It is expected that this will allow pharmaceutical products to be manufactured and distributed with urgency in the coming future, especially in cases where a sudden order is needed for an out of stock medicine in a particular location.

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