High Potency API Contract Manufacturing Market Size, Share, Opportunities, And Trends By Product Type (Innovative, Generic), By Synthesis (Synthetic, Biotech), By Dosage Form (Injectable, Oral Solids, Creams, Others), By Application (Oncology, Hormonal Disorders, Glaucoma, Others), And By Geography - Forecasts From 2024 To 2029

The high-potency API contract manufacturing market is expected to witness significant growth during the forecasted period.

The market for contract manufacturing of high-potency active pharmaceutical ingredients (HPAPI) has grown significantly as a result of the growing need for powerful medications and intricate treatments in different therapeutic areas such as autoimmune diseases and oncology. Because of their great potency and low therapeutic dose, HPAPIs need specific handling techniques, facilities, and equipment to safeguard the environment and assure worker safety.

The manufacture of HPAPI greatly benefits from the knowledge of contract manufacturing organizations (CMOs), who provide containment technology, process optimization, and regulatory compliance. The outsourcing tendency among pharmaceutical companies to lower costs and eliminate risks associated with in-house manufacturing of HPAPIs is one of the major factors driving the market growth.

Market Drivers 

•  Increasing demand for oncology drugs is anticipated to boost the high-potency API (Active Pharmaceutical Ingredient) contract manufacturing market.

One of the main factors driving the high-potency API contract manufacturing market's growth is the rising need for cancer medications. Pharmaceutical businesses are looking for specialized manufacturing capabilities as cancer incidence climbs worldwide and personalized medication becomes more popular. Contract manufacturers provide flexibility and cost-effectiveness when it comes to outsourcing, especially for high-potency APIs that need strict safety regulations.

Oncology medicine production has created a strong demand for contract manufacturers with a track record of producing compliant facilities and regulatory competence. The industry's emphasis on effective, quality-driven production to satisfy the growing demand for cancer treatments that can save lives is reflected in this trend.

According to WHO, in 2024, the most recent estimates of the cancer burden worldwide were provided by the International Agency for Research on Cancer (IARC). In addition, the WHO released survey data from 115 nations, which demonstrated that most of them do not sufficiently fund universal health coverage (UHC)'s priority cancer and palliative care services.20 million new instances of cancer and 9.7 million deaths from the disease are predicted for 2022. 53.5 million people were predicted to still be alive five years after receiving a cancer diagnosis. One in five people will have cancer at some point in their lives; one in nine men and one in twelve women will pass away from the illness.

• Outsourcing trends in the pharmaceutical industry are expected to boost the high-potency API contract manufacturing market.

The pharmaceutical industry's outsourcing practices have a big impact on the high-potency API contract manufacturing sector. Pharmaceutical companies are depending more and more on contract manufacturers to produce high-potency APIs because they need these manufacturers to be flexible with their manufacturing capacity, have specialized knowledge, and lower costs. This tendency encourages contract manufacturers to compete with one another, which leads to investments in cutting-edge technology and regulatory compliance.

Gaining a competitive edge, companies with a track record of producing high-potency APIs can meet the increasing demand for specialized medicines and oncology drugs. All things considered, outsourcing promotes efficiency, creativity, and teamwork in the high-potency API contract manufacturing industry.

 In January 2024, to enhance decentralized clinical trial capabilities for pharmaceutical, biotech, and medical device sponsors looking to reduce site burden, speed up enrollment and clinical study timelines, and increase patient diversity and inclusion, LabCorp, a leading global provider of cutting-edge and comprehensive laboratory services, and Hawthorne Effect, Inc., a comprehensive clinical trials solution integrating technology announced a strategic collaboration.

• Technological advancements anticipated to boost the high-potency API contract manufacturing market.

By improving productivity, safety, and quality, technological developments are transforming the high-potency API contract manufacturing business. Technological advancements in analytical techniques, process automation, and containment systems allow for exact control over manufacturing processes, lowering the danger of contamination and guaranteeing consistency in the final product.

Modular production facilities and continuous flow chemistry are two examples of advanced manufacturing platforms that provide scalability and flexibility to meet different demand levels and handle diversified product portfolios. Additionally, integrating digital technologies allows for predictive maintenance and process efficiency optimization, which reduces costs and speeds up the time to market for high-potency medications. Examples of these technologies include data analytics and real-time monitoring.

IQVIA received recognition for its AI software in June 2023. In order to enable real-world data research, the program, which incorporates natural language processing technology, assists in the analysis of complicated and unstructured patient data, offering distinctive insights into patient care and disease states. What makes the AI software unique is its capacity to offer insights that can be put into practice. It opens up important perspectives on population health, such as the social determinants of health (SDoH), which determine most health outcomes. One of the biggest healthcare systems in Illinois, Northshore-Edward-Elmhurst Health, is using this technology to help doctors identify and screen 56% more at-risk patients based on SDoH, enabling patients in need to receive focused intervention.

Asia Pacific region is expected to grow significantly

The high-potency API contract manufacturing market in the Asia-Pacific region is expanding significantly as a result of various causes. Demand is being driven by rapidly growing pharmaceutical markets, especially in China, India, and South Korea, as well as rising investments in healthcare infrastructure. Multinational pharmaceutical businesses are drawn to the region to outsource production due to its talented workforce, cost-effective manufacturing options, and regulatory harmonization activities.

Moreover, the region's appeal for outsourcing pharmaceutical manufacture is fueled by the existence of well-established contract manufacturing companies with experience in high potency APIs, as well as developments in technology and quality standards, which support the expansion of the Asia-Pacific pharmaceutical market.

In June 2021, Lonza expanded its API development and manufacturing facility in Nansha, China, with a CHF 20 million investment. Three 1,000L GMP trains totaling 12 m3 of reactor volume will be part of the increased investments, together with new development and GMP laboratories equipped to produce small batches of highly potent APIs (HPAPIs). A seamless transition between early-phase and large-scale commercial production will be made possible by Nansha's expanded capacity, which will enable mid-scale manufacture. Lonza's integrated global production network is strengthened by capabilities, enabling it to uphold strict quality and regulatory standards globally.

Market Restraints

• Stringent containment measures can constrain the market for high-potency API contract manufacturing market.

In the high-potency API contract manufacturing business, maintaining strict containment measures to safeguard the environment and laborers is a significant problem. Highly powerful substances require specialized facilities and containment equipment due to the severe health and safety risks involved in handling them. Manufacturing activities become more complex and expensive when strong containment measures are implemented and maintained. Furthermore, strict legal requirements for occupational health and safety standards mean ongoing investments in compliance, monitoring, and training.

Market Development

• February 2023- In the US, Piramal Pharma Solutions opened a facility to manufacture pharmaceutical active ingredients. The manufacturing of high-potency active pharmaceutical ingredients (HPAPI) and active pharmaceutical ingredients (API) is the focus of this cutting-edge facility.
• January 2023- A new High-Potency API (HPAPI) manufacturing facility has opened at Sai Life Sciences' cGMP API Manufacturing site in Bidar, India. Sai Life Sciences is one of India's fastest-expanding Contract Research, Development & Manufacturing Organizations (CRO-CDMO). The company's manufacturing and HPAPI development capabilities have increased with the inclusion of this new facility, offering its clients a more efficient route for NCE development.

Market Segmentation

• By Product type:
  • Innovative
  • Generic
• By Synthesis:
  • Synthetic
  • Biotech
• By Dosage form:
  • Injectable
  • Oral Solids
  • Creams
  • Others
• By Application: 
  • Oncology
  • Hormonal Disorders
  • Glaucoma
  • Others
• By Geography:
  • North America
    • USA
    • Canada
    • Mexico
  • South America
    • Brazil
    • Argentina
    • Others
  • Europe
    • UK
    • Germany
    • France
    • Italy
    • Spain
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • UAE
    • Others
  • Asia Pacific
    • Japan
    • China
    • India
    • South Korea
    • Taiwan
    • Thailand
    • Indonesia
    • Others