China is a giant market buoyed with international scientific and technical capabilities in biopharmaceuticals. However, various challenges associated with the development process of biologics, such as complex stages of manufacturing, limitations of analytical sciences, lack of incentives and the current statutory and regulatory framework, have contributed heavily to the demand for consistent evolution of product development and biomanufacturing processes. The aforementioned challenges faced by developers may translate into lucrative business opportunities for Chinese contract service providers.
Outsourcing Activities to Witness Significant Growth in the Coming Years
The specificity, efficacy and safety-related advantages of biologics have captured the attention of various stakeholders in the pharmaceutical and biotechnology industry. Even though the larger players have the necessary resources to conduct in-house manufacturing, complex requirements related to the manufacturing of biologics have compelled these players, along with mid-sized and smaller players, to outsource such operations, specifically in developing countries, such as China. It has been observed that China is increasingly being preferred as a potential outsourcing destination owing to the various benefits offered by this region, such as the availability of skilled labor at much lower costs. In addition, the cost for drug research, development and manufacturing is significantly low in this region. Further, the shift in regulatory policies, such as the implementation of MAH program, enable developers to get Chinese FDA approval for drugs which are manufactured with the involvement of contract organizations, thereby supporting outsourcing activities in China.
Integration and Adoption of New and Innovative Technologies
Over the years, a number of novel technologies for developing and manufacturing biopharmaceuticals have entered the market. These include various next generation production technologies, such as single use bioreactors, perfusion and continuous processes and bioprocess automation technologies. In addition, we believe that transgenic plants / animals, stem cells and advanced cloning methodologies are likely to have a notable impact on biopharmaceutical development and manufacturing in the coming years. Several Chinese biopharmaceutical CMOs are already using advanced and improved expression systems, and next generation bioprocessing technologies in order to cut down on costs and meet the growing demands of their customers in a more resourceful manner.
Focus on Niche Therapeutic Area
A number of niche and evolving therapeutic areas in the biopharmaceutical industry are anticipated to sustain the growth of the China biopharmaceutical contract manufacturing market. These include various antibody-based therapies (ADCs and bi-specific antibodies), cell-based therapies (T-cell immunotherapies, stem cell therapies and dendritic cell therapies), other personalized therapies along with the appropriate companion diagnostics, and gene therapies.
Growing Biosimilar Market to Contribute to the Growth of the Contract Services Segment
The growing success of biologics is likely to sustain their demand in the long term as well. Once these proprietary products lose patent exclusivity, their biosimilars are expected to flood the market. In February 2019, National Drug Regulators in China approved the country’s first biosimilar drug, HLX01, developed by Shanghai Henlius Biotech, intended for the treatment of non-Hodgkin’s lymphoma. The current Chinese biosimilars pipeline is vast and is expected to grow further as more biologics lose patent protection in the coming years.
Challenges Faced by both Sponsors and Service Providers
It has been observed that dealing with a contract manufacturer that doesn’t speak English thoroughly, or doesn’t have the knowledge of the same terminologies that are used by the outsourcing company can become troublesome for the companies, which can lead to problems in the quality of the final product. Other concerns include documentation and vendor qualification / selection issues, quality assurance and quality control concerns, issues related to scale up and scale down, regulatory issues, and technology-related concerns.
However, we believe that as more biopharmaceutical product candidates progress into late stage clinical trials, the dependence of various stakeholders on CMOs is likely to increase. Despite the many shortcomings, the China biopharmaceutical contract manufacturing market is anticipated to strengthen further in the foreseen future.