High Potency Drug Manufacturing

High Potency Drug Manufacturing Global Market Outlook

• The global market size is 26.9 billion in 2023 E, growing at a rate of 9 percent, due to increased demand from the pharmaceutical industry, increased innovative & technical advancements in high potent API manufacturing, and high prevalence of cancer and glaucoma across the world

• Market is moderately consolidated with a few major players holding around 40 percent of the market share

• In response to the increased demand for HPAPI in modern medicines, the suppliers are investing in capacity and technology

High Potency Drug Manufacturing Market Drivers & Constraints

Drivers

Increasing demand for drugs

• With the increasing burden of chronic diseases, such as cancer, glaucoma, hormonal imbalance, and others, the demand for HPAPI has increased over time. Therefore, the demand for drugs has also increased for their treatment, and this ramped up the production of HPAPI, thus driving the market growth

Increasing focus on high-potency APIS

• At present, more than 40 percent of the total number of drugs are highly potent in nature. Around 60 percent of the HPAPIs are being developed against oncological indications. Considering the upsurge in demand for novel anti-cancer therapeutics, including ADCs, high-potency compounds have generated significant interest among several researchers and industry stakeholders

Technological advancements in high-potency API manufacturing

• The key players of the HPAPI market are investing in technology and innovation to improvise the manufacturing capability and facility

Constraints

High investment requirements

• The development of highly potent APIs involves research at the genetic and molecular level, which needs precise and sophisticated instruments. It requires an adequate working environment (to prevent cross-contamination within multi-product assets), stringent manufacturing protocols (to comply with the established regulatory standards), and a trained workforce (to satisfactorily handle highly potent materials). Thus, increasing the set-up cost

• A technologically advanced lab setup is required for research and development. Setting up labs results in huge costs for the market players. This has resulted in the lower production of high-potency APIs, thus, restraining market growth

Stringent regulatory standards

• Drug development, manufacturing, and commercialization involve stringent regulatory approvals, which restrains market growth. Each country has its own regulatory guidelines and standards, which delay the regulatory clearance of the drug and further inhibit the growth of the market

HPAPI Cost Structure

• Facilities cost is the major contributor in the cost of production of HPAPI. Considering the technical requirement in HPAPI manufacturing, the labor cost also contributes to the major share in overall manufacturing cost.

Cost Drivers

• Facility cost is the major contributor for the overall HPAPI manufacturing cost. The development of HPAPI requires precise instruments and sophisticated infrastructure. The cost of maintenance of a facility with such instruments is also huge

• The manufacturing cost is also driven by labor and administration costs. HPAPI manufacturing requires labor with technical expertise to handle the HPAPIs for drug manufacturing. It also involves appropriate administration to maintain the facility, labor, and the overall HPAPI manufacturing process

• The manufacturing cost of HPAPIs in China is 30–35 percent lower than the manufacturing cost in Europe

• The labor cost for HPAPI manufacturing in India and China is lower compared to Europe and North America, which enhances the outsourcing to these APAC regions