Key factors shaping the future of clinical services organizations in the APAC market

The pharmaceutical sector faces intense competition, cost pressures, rapid technological advancements and increasing consolidation. These challenges, coupled with the rising demand for generic medicines and biologics that require significant investment in advanced manufacturing technologies, have led pharma companies to seek out streamlined, cost-effective solutions.

Clinical services organizations can help pharma companies address complex challenges related to global drug development and clinical trial solutions.

“When pharma companies partner with clinical services organizations, they gain access to deep resources and extensive expertise,” says Kevin Cheong, Clinical Operations Director APAC for Almac Group. “By partnering with a clinical services organization, pharma companies are empowered to take a holistic approach to overcoming the challenges they face.”

The fast-growing clinical services organization/CDMO market in the Asia–Pacific (APAC) region is expected to top $140 billion by 2031. Pharma companies that outsource supply chain logistics and production matters to CDMOs allows them to focus on their core competencies of research and development.

Factors fueling demand

The global generic drug market is projected to attain a compound annual growth rate of 5.59 percent from 2021 to 2030, reaching $574 billion. In conjunction with increased demand for generic drugs, clinical trials have become more complex and sponsors have stared conducting trials in more sites and across more countries to speed patient recruitment, manage costs and expand market access.

Cheong points to the broad spectrum of patient demographics in the APAC region for creating substantial opportunities for clinical trial sponsors who are keen to meet enrolment targets at an expedited pace. The region contributed almost 50 percent of new global clinical trial activity and has been dubbed a “clinical trial powerhouse.”

“As the clinical trials landscape continues to evolve post-pandemic, competition is intensifying and study completion timelines are becoming more aggressive,” says Cheong. “APAC is also home to an increasingly experienced investigator and CRO community and strong research infrastructure. There is an abundance of local government support for drug development in APAC, making it a desirable clinical trial destination for global players, as well as local pharma companies.”

APAC is considered a more stable and predictable alternative to Europe and the Middle East in light of ongoing global geopolitical situations that have prompted pharma companies to reconsider their activities in those markets. Cheong notes that there is a trend toward spreading the risk by moving from a singular distribution strategy toward partners that can provide a large global network and infrastructure and alternative distribution lanes to ensure the right drugs reach the right patients at the right time.

Partnering for success

Increasing globalization means companies must adhere to national and international requirements and regulatory standards. Cheong points to increased pressure on APAC sponsors to remain compliant with myriad requirements for all facets of clinical trial activity, including assuring product safety in labeling and distribution, as a significant challenge for pharma companies that are operating with limited internal resources and expertise. Quality control is another challenge linked to maintaining compliance.

“Increasing globalization can make [delivering consistency] difficult to achieve,” says Cheong. “Introducing consistent standardized operating procedures across all global production facilities involved can support sponsors to mitigate risks to quality that could otherwise lead to the need for rework, delays, and even the potential for unblinding to occur.”

The rise of biologics, cell and gene therapies has also increased demand for effective cold-chain solutions while minimizing waste and reducing the carbon footprint of drug development. Several pharma companies have joined the Health Systems Task Force, a public-private partnership aimed at achieving net zero healthcare. As part of their commitment, the companies have agreed to joint minimum climate and sustainability targets for their suppliers.

Cheong notes that these commitments require pharma companies to reconsider and redesign their clinical supply chains to optimize efficiency and demonstrate enhanced sustainability credentials, adding, “Progressive clinical services organizations that invest in the future of drug development will have significant capability to store, handle, and ship complex investigational medicinal products across multiple temperature ranges [and] partnering with clinical services organizations can significantly lower risk for companies operating in these segments.”

By partnering early, pharma companies can offer valuable insights into their protocol requirements, allowing clinical services organizations to optimize each function and provide expert supply chain planning and development and solutions designed to streamline operations and implement solutions overcome challenges relating to global regulatory compliance, quality assurance, supply chain complexity, inventory control and the environmental impact of clinical trials.

To learn more about Almac Clinical Services visit: https://www.almacgroup.com/clinical-services/

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