High Potency Active Pharmaceutical Ingredient (HPAPI) Market Forecasts to 2028 – Global Analysis By Product (Synthetic, Biologic), Application (Central Nervous System Disorders, Hormonal Disorders) and By Geography

According to Stratistics MRC, the Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market is accounted for $24.76 billion in 2021 and is expected to reach $50.45 billion by 2028 growing at a CAGR of 10.7% during the forecast period. High potency active pharmaceutical ingredients are biologically active compounds that exhibit biological activity at extremely low dose levels. After the human genome was depicted, cancer drugs were produced not only for distinct cancer but also for different patients. The global high potency active ingredient is classified as Generic HPAPI and Innovative HPAPI. The generic HPAPI involve the same chemical agent as a drug that was once secured by chemical patent claims Whereas, Innovative HPAPI involves different chemical molecule.



Market Dynamics:

Driver:

Increasing incidence of cancer

HPAPIs are extremely effective pharmacologically active ingredients. They are highly specific in their action and offer significant efficiency even at low daily therapeutic doses. HPAPIs have the ability to target precise disease cells and are, hence, used in formulations for highly potent drugs. Owing to their target release characteristics, HPAPIs find major applications in target therapies for cancer. Globally, there is a significant growth in the incidence of cancer. This growth in the number of cancer cases has a tremendous impact on the sales of cancer drugs across the globe.

Restraint:

Large initial investments

The cytotoxic nature of HPAPIs presents significant handling challenges and thus requires heavy investments for implementing specialized containment facilities that facilitate the safety of employees from exposure. Although the HPAPIs market is an emerging and growing market, pharmaceutical manufacturers face significant challenges in upgrading their existing facilities that are capable of handling only low- or medium-potency APIs. Specialized containment to ensure protection of the employees and their environment from exposure account for a major cost. Contract manufacturers are required to heavily invest in building new facilities that are designed specifically for HPAPI manufacturing apart from the usual GMP production facilities.

Opportunity:

Developments in emerging regions

Developing economies such as India, China, and the Middle East present high growth opportunities for players in the HPAPIs market. In most of these geographies, the market is expected to show a high growth rate in the coming years owing to their huge population, increasing prosperity, and improving longevity. Diseases like musculoskeletal diseases, glaucoma, and specifically cancer have a significant impact on the health status of people worldwide, with comparatively higher growth rates in developing countries.

Threat:

Continual evolution of industry standards

One of the major challenges faced by the players in this market, especially CMOs that offer HPAPI manufacturing services, is the continual evolution of industry standards, technologies, and regulations. Companies that are willing to enter this marker are required to adopt these newer technologies, which generally translates to huge investments. For instance, SAFC (US) had to upgrade its HPAPI manufacturing facility in the US to include more robust analytical technologies with improved sensitivity and detection levels that allow for the determination of potential API carryover at part-per-billion levels. Such a rapidly evolving environment poses a challenge to the players in this market.

The oncology segment is expected to be the largest during the forecast period

The oncology segment has the largest share of the market because of the greater amount of HPAPIs found in oncology drugs. The rising prevalence of cancer is a major factor driving up demand for HPAPI. And also, some of the factors like rising demand for cancer and initiate of recent target therapy are the main cause of the increase in the development of oncology as compared to other therapeutic applications such as hormonal disorder and glaucoma.

The synthetic segment is expected to have the highest CAGR during the forecast period

The synthetic HPAPI market is growing at a faster rate because, at very low doses, these molecules are very effective in the treatment of a variety of diseases. Many synthetic molecules are also predicted to lose their patents in the years ahead, boosting market growth. The Japanese government has been advocating for the utilize of generic medicines in lowering the overall healthcare costs and the economic burden placed on patients.

Region with largest share:

North America is projected to hold the largest market share owing to the existence of prominent manufacturers and modern technical infrastructure, as well as the region’s growing demand for HPAPIs. The rising incidence of chronic diseases, as well as a well-established R&D infrastructure for innovative drug development, is driving the North American market.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR due to the growth in geriatric population, high prevalence of chronic and lifestyle diseases, increase in disposable income, prevalence of lifestyle- and age-related diseases, government efforts to reform healthcare and encourage the adoption of generics. The growing market for merchant manufacturers in this region is attributed to the low labor and manufacturing costs are driving the growth of the market in Asia.



Key players in the market

Some of the key players profiled in the High Potency Active Pharmaceutical Ingredient (HPAPI) Market include F. Hoffmann-La Roche, Bristol-Myers Squibb, Dr. Reddy's Laboratories, Novartis AG, Pfizer, Eli Lilly and Company, Sanofi, Lonza Group, Sigma-Aldrich Co LLC, Teva Pharmaceutical Industries, Cambrex Corporation, Alkermes plc, Abbvie, Novasep, and WuXi AppTec.

Key developments:

In June 2019: Lonza, a CDMO partner to the biopharma industry, announced an investment in a major expansion of Highly Potent API (HPAPI) capacity at its Visp, CH site to meet increased market demand. Lonza has entered into a long-term manufacturing agreement with AstraZeneca, and the new facility will support the delivery of a number of products from across their portfolio. The remaining capacity will allow Lonza to expand the offer to other clients.

In April 2019: Cambrex Corporation established its new facility high-potency API production in the United States. The production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m3 and contain 4 reactors ranging from 200 to 1,000 gallon capacity enabling manufacturing campaigns of batch sizes up to 300 kg. With the completion of this new facility, the Charles City site now has the flexibility to support all phases of development and offer all scales of HPAPI manufacture across the full OEL band spectrum.

Manufacturers Covered:
• In-House (Captive)
• Outsourced/ Contract

Drug Types Covered:
• Generic
• Innovative/Novel

Products Covered:
• Synthetic
• Biologic
• Biosimilar
• Biotech

Applications Covered:
• Central Nervous System Disorders
• Hormonal Disorders
• Metabolic Disorders
• Infectious Diseases
• Glaucoma
• Musculoskeletal Drugs
• Inflammation
• Oncology
• Other Applications

Regions Covered:
• North America
o US
o Canada
o Mexico
• Europe
o Germany
o UK
o Italy
o France
o Spain
o Rest of Europe
• Asia Pacific
o Japan       
o China       
o India       
o Australia 
o New Zealand
o South Korea
o Rest of Asia Pacific   
• South America
o Argentina
o Brazil
o Chile
o Rest of South America
• Middle East & Africa
o Saudi Arabia
o UAE
o Qatar
o South Africa
o Rest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2020, 2021, 2022, 2025, and 2028
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements

Free Customization Offerings:
All the customers of this report will be entitled to receive one of the following free customization options:
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o Comprehensive profiling of additional market players (up to 3)
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• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
o Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances