Following two years of battling the COVID19 pandemic, the global bio/pharmaceutical industry is now confronting a “new reality” in 2023 that will necessitate changes in commercial strategy and execution.

Several key issues are attempting to influence growth prospects: existing healthcare expenditures are not viable in real terms, lower net sales in the US market due primarily to discounting, an impending patent cliff resulting in increased generic-drug and biosimilar incursion, and a changing healthcare landscape in the patient-physician-payer environment. Graham Lewis, Vice President of Global Pharma Strategy at IQVIA, provided a market overview at the Pharma Industry Outlook program at DCAT Week 2022, the flagship event of the Drug, Chemical & Associated Technologies Association (DCAT), held March 21-24, 2022.

National healthcare budgets and financing will be a key issue shaping growth prospects in the global bio/pharma industry, as governments face extreme pressure not only in their own healthcare spending but also from competing for national priorities as global political conditions evolve.

Price Hike on Drugs due to tension – According to Lewis of IQVIA, there are signs of budgetary
tensions within healthcare budgets as well as between competing expenditure sectors. Despite high rates of COVID-19 vaccination (more than 50% globally and more than 65% in developed countries), governments continue to bear direct and indirect costs from rising COVID-19 infections, putting additional strain on national healthcare budgets. IQVIA estimates $250 billion in global COVID-19 incremental vaccine spending between 2021 and 2026.

There was a significant rise even before COVID-19, in the outsourcing of BIOPHARMACEUTICAL
development and manufacturing, particularly as an increasing number of small and virtual
biotechnology companies adopted business models that were entirely reliant on sourcing all
development and production activities.

Supply and demand
COVID-19-related supply chain instability is one of the other supply challenges: “With materials such as glass vials given precedence for vaccine production, biopharma manufacturing companies have had to deal with both supply delays and consumables scarcities.” Many materials required for biopharma manufacturing have experienced six to twelve-month delays, as well as increased costs due to increased demand,” said Bill Vincent, Founder of Genezen. He added that, as a result of such disruptions, it has become increasingly important for businesses to accurately predict supply, increase inventory levels, and qualify alternative suppliers in order to avoid shortages.

To meet the global requirement for the vaccine as well as therapeutic doses, a substantial portion of COVID-19 vaccine and treatment production was redistributed, including over 230 manufacturing contractual arrangements between COVID-19 vaccine and therapy builders and contract manufacturers publicly disclosed to date.

“The COVID-19 pandemic has been one of the biggest challenges worldwide for biologics
manufacturing to date,” said James Choi, Executive Vice President and Chief Information &
Marketing Officer and Head of Global Public Relations and Process Improvement at Samsung
Biologics. As a direct consequence of the pandemic, CDMOs have seen a rise in demand to carry drugs to market at previously unseen speeds. Since regular booster vaccinations are considered necessary, this usage for manufacturing support will also most likely continue into the future.”

According to a recent report by CPhI and Baxter, another supply challenge for pharma is the growing demand for sustainable sourcing. 2 “Companies are setting out a path via their procurement policies and practices to ensure a deep understanding of the supply risk emanating from environmental issues like climate change and antimicrobial resistance (AMR), social issues like human rights and ethics, and their potential economic impacts,” said Manjit Singh, Chair of the Pharmaceutical Supply Chain Initiative (PSCI), in the report. Sustainable sourcing, according to Singh, aims to improve suppliers’ ethical, environmental, and social performance, thereby mitigating any negative impacts within the supply chain. This has the potential to have a significant impact on bio/pharmaceutical manufacturing.

Scarcity of skilled labour
“A key factor that will keep affecting biopharma manufacturing in the coming year and beyond is the restricted availability of trained workers,” Vincent said. Although automation may solve some of the problems associated with labour shortages, the key problem will remain. Gearing up workers for the STEM (science, technology, engineering, and mathematics) sectors will necessitate additional investment in education – and any territory (city, state, or nation) ready to meet this challenge will be prepared to conquer the industry.”

Speed to Market
“As projects move between sites or companies to perform subsequent processes across the supply chain, the increasing pressure for speed to market clashes with transfer delays.” The effects of COVID-19 have exacerbated these delays. “The ability to avoid these delays will remain a critical criterion in selecting a manufacturing partner,” said Choi.

In the CPhI and Baxter report, Frank Kogelberg, Director of Business Development, Contract
Manufacturing, emphasized the importance of reducing transfer delays.

Poorly soluble HPAPIs
The primary issue facing by the manufacturers, according to Lonza CHI’s Rose Mary Casados, Senior Director of Product Management Marketing, is supplying oral solid dosage (OSD) formulations usually contain progressively poorly water-soluble extremely powerful active pharmaceutical components (HPAPIs). “Curing cancer remains a major area of focus for all of the global pharma and continues to motivate an enormous amount of production,” Casados clarified. Many oncology brands use HPAPIs, and the amount of global development projects involving HPAPIs has increased, according to innovators and their contract development partners.

By 2022, Lonza predicts that innovative formulation and manufacturing techniques for HPAP
I substances will become best defined and integrated earlier in progress, with inventions in c
apsule materials and technology having a particularly large impact.

Manufacturing Adaptability
Lynn Allen, Vice President of Business Development at MedPharm Ltd, described how the rising
trend of pharmaceutical research for orphan and chronic illnesses is affecting the industry,
emphasising the importance of manufacturing flexibility. “As the target indication of a drug becomes more specific, so does the patient population.” End markets for orphan drugs or drugs that target specific subsets of a patient population shrink a product’s market size. As a result, the size of manufactured batch requirements is reduced,” she explained. These smaller batch manufacturing requirements, according to Allen, “have led many developers to (use) mid-size and small-tier CMOs with the scale of equipment suited to meet the demands of a relatively small patient population.”

Conclusion-Manufacturing of pharmaceuticals and biopharmaceuticals may endure a variety of
difficulties in 2022, including difficulties with formulation and delivery as well as a lack of competent labour and tightened schedules. The incorporation of cutting-edge technologies is one potential answer to these problems. Casados claims that these technologies make it possible to produce pharmaceuticals more cheaply, efficiently, and in compliance: Pharmaceutical companies are speeding up their transition to Industry 4.0 in an effort to improve cGMP compliance. The organization will continue to face pressure to adopt cutting-edge information and data technologies, and the trend toward digitalization will have a big impact on operational costs and cost-of-goods accounting for years to come. The future of the industry’s digital enhancement will undoubtedly include advanced, automated, and data-controlled procedures.

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