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Determining the Strength, Weakness, Opportunities and Threats related to China Biopharmaceutical
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There has been an evident increase in the overall popularity of biopharmaceuticals. In fact, the pipeline of niche biopharmaceutical classes is growing at a relatively fast pace, which is closely matched by the entry of several biosimilar versions of products that have lost marketing exclusivity. Overall, the need for manufacturing biologics has grown significantly, creating several opportunities for contract manufacturing service providers. It is worth mentioning that traditionally, biopharmaceutical companies preferred to keep manufacturing operations of such products in-house, due to a number of concerns related to intellectual property and quality. However, owing to the increasing complexity of novel biologics and their associated development and manufacturing processes, outsourcing has become a norm in the biopharmaceutical industry.

 

Strengths

In order to meet the growing requirements of their client and to improve their capabilities, several Chinese contract manufacturers have entered into partnerships with each other. This allows CMOs to offer a wide range of services to their clients and helps in maintaining a long-term relationship with them. Various factors, including low manufacturing cost, access to one of the largest marketplaces, relatively relaxed regulatory environment, and favorable policy-making landscape, make China an attractive destination for outsourcing activities. Further, the impact of globalization has led to the establishment of world class educational institutes in China, which, in turn, has resulted in the production of a qualified workforce that is available at a low cost.

 

Weakness

Over the past several years, the bioprocessing capacity in China has witnessed dramatic growth as many established biopharmaceutical companies have expanded their biomanufacturing operations in the region.  Experts believe that as outsourcing activities continue to rise in the biopharmaceutical market, CMOs may soon be confronted with a capacity crunch. An important limiting factor that often leads to capacity constraints is hiring challenges. This is a characteristic problem of any fast-growing industry and is likely to persist in the future as well.[1] Further, when outsourcing to China, language is one of the major barriers to progress for both sponsors and service providers. Communication errors due to the language difference are known to be responsible for significant delays and setbacks. It has been observed that such errors might lead to the problems in the quality of production. In addition, different time zones can cause delays in timelines, as well as in transferring data. Quality concerns are also an inherent weakness within the biopharmaceutical contract manufacturing market in China.

 

 

Opportunities

With the increase in global and domestic demand for biopharmaceuticals, the China’s State Council launched the MAH program in 2016, which allowed certain relaxations to drug developers for outsourcing manufacturing operations to contract organizations. The plan was initially implemented in 10 provinces / municipalities of China, but later in 2019 it got implemented nationally, boosting the China’s contract manufacturing market. Further, low lease land rates, and healthcare reforms by the government, such as increased accessibility to healthcare insurance and enhanced reimbursement policies, are expected to contribute towards the growth of China outsourcing sector.[2]

 

Threats

Owing to the complex nature of biopharmaceuticals and the innate difficulties associated with their production, this segment of the pharmaceutical market has always been subject to stringent regulatory surveillance. Reproducibility is one of the primary concerns related to the manufacturing of biologics and therefore, regulatory bodies in China have imposed strict guidelines for the approval of such product candidates. Further, many biopharmaceutical companies rely heavily on APIs from China. But the recent outbreak of novel Coronavirus in China has resulted in immediate disruptions / slow-down in global pharma / biopharma supply chains, restricting the access and movement of biopharmaceuticals. Thus, in the short-term, it is anticipated to substantially impact the global contract manufacturing market, specifically those countries that have opted to lockdown.

 

[1] Source: https://www.outsourcing-pharma.com/Article/2014/12/02/CMO-use-to-grow-despite-Big-Biopharma-s-in-house-spend-say-experts

[2] Source: https://www.contractpharma.com/issues/2019-07-15/view_columns/outsourcing-in-china-how-far-can-it-go/

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