HPAPI Market: Opportunities & Challenges

HPAPI Market: Opportunities & Challenges

The HPAPI market is fragmented market with the presence of several small and big players. Prominent players in this market include Pfizer (US), Novartis International AG (Switzerland), Sanofi (France), Boehringer Ingelheim (Germany), Bristol-Myers Squibb (US), Teva (Israel), Eli Lilly and Company (US), Merck (US), AbbVie (US), Mylan (US), and F. Hoffmann-La Roche (Switzerland).
The growth in this market is driven by factors such as increasing demand for oncology drugs, growing demand for antibody-drug conjugates, increasing focus of leading pharmaceutical companies on HPAPIs, advancements in HPAPI manufacturing technologies and growing focus on precision medicine.

The global HPAPI market is projected to register a CAGR of 8.7% during the forecast period (2018-23). The growth in this market is driven by factors such as increasing demand for oncology drugs, growing demand for antibody-drug conjugates, increasing focus of leading pharmaceutical companies on HPAPIs, advancements in HPAPI manufacturing technologies and growing focus on precision medicine. However, factors such as the requirement of large investments, discrepancies in HPAPI banding systems, uncertainties associated with products and high risk of cross-contamination are the major factors that are expected to restrain the growth of this market to a certain extent during the forecast period.

Growing opportunities for CMOs and CDMOs

A comprehensive HPAPI manufacturing facility requires extensive planning, the use of risk management and assessment tools, and a mechanism to determine which compounds are suitable for manufacturing in a given facility. The production of such compounds poses hazards and risks to workers and the environment. Pharmaceutical manufacturers also need to have the capacity for the safe production, storage, and transport of a growing range of potent compounds. This makes it evident that implementing a successful HPAPI manufacturing strategy requires significant time and investment.

Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=36582475

Hence, various sponsor companies prefer going to CMOs and CDMOs for assistance with the development, manufacturing, and distribution of HPAPIs and their formulated drug products as many of these companies have the necessary equipment. In the last few years, a large number of contract CMOs have expanded their HPAPI capacities to leverage this opportunity.

How is need for appropriate process designs a challenge?

Process designs are one of the most vital requirements for HPAPI production operations. Most HPAPI and ADC drug payloads need to be produced in small clinical and commercial quantities. However, the production of gram-scale GMP APIs and payloads is challenging. Maintaining containment control when using flexible and small equipment, including glass equipment, is a definite challenge and requires an approach that is tailored for each process and unit operation. It is also important to maintain appropriate process designs at the developmental scale to ensure that the process fits the equipment and capabilities of the facility upon scale-up.

Request Sample Pages: https://www.marketsandmarkets.com/requestsampleNew.asp?id=36582475

Furthermore, industry wide, there is an ambiguity regarding the classification of HPAPIs. Different pharmaceutical companies often have proprietary systems and the classification of new APIs is unknown due to lack of data. These issues can be overcome with appropriate process designs and containment controls, which a majority of companies lack. All these factors collectively are likely to present a significant challenge for players in the HPAPIs market.

Browse Related Reports:

Active Pharmaceutical Ingredient/ API Market by Type (Innovative, Generic), Manufacturer (Captive, Merchant), Synthesis (Synthetic, Biotech), Product (mAb, Hormone, Biosimilar) Drug (OTC, Rx), Therapy, and Region – Global Forecast to 2024

Pharmaceutical Excipients Market by Product (Organic Chemicals (Carbohyrates, Petrochemicals) inorganic chemicals), Functionality (Fillers, Diluents, Coatings, Disintegrants), Formulation (Tablet, Capsule, Topical, Parenteral) – Global Forecast to 2025

Superdisintegrants Market by Product (Modified Starch, Modified Cellulose, Crospovidone, Ion Exchange Resin), Formulation (Tablet, Capsules), Therapeutic Area (Gastrointestinal, Cardiovascular, Neurology, Oncology, Hematology) – Global Forecast to 2023

About MarketsandMarkets™

MarketsandMarkets™ provides quantified B2B research on 30,000 high growth niche opportunities/threats which will impact 70% to 80% of worldwide companies’ revenues. Currently servicing 7500 customers worldwide including 80% of global Fortune 1000 companies as clients. Almost 75,000 top officers across eight industries worldwide approach MarketsandMarkets™ for their painpoints around revenues decisions.

Our 850 fulltime analyst and SMEs at MarketsandMarkets™ are tracking global high growth markets following the “Growth Engagement Model – GEM”. The GEM aims at proactive collaboration with the clients to identify new opportunities, identify most important customers, write “Attack, avoid and defend” strategies, identify sources of incremental revenues for both the company and its competitors. MarketsandMarkets™ now coming up with 1,500 MicroQuadrants (Positioning top players across leaders, emerging companies, innovators, strategic players) annually in high growth emerging segments. MarketsandMarkets™ is determined to benefit more than 10,000 companies this year for their revenue planning and help them take their innovations/disruptions early to the market by providing them research ahead of the curve.

MarketsandMarkets’s flagship competitive intelligence and market research platform, “Knowledge Store” connects over 200,000 markets and entire value chains for deeper understanding of the unmet insights along with market sizing and forecasts of niche markets.

Media Contact
Company Name: MarketsandMarkets
Contact Person: Mr. Shelly Singh
Email: Send Email
Phone: 1-888-600-6441
Address:630 Dundee Road Suite 430
City: Northbrook
State: IL
Country: United States
Website: https://www.marketsandmarkets.com/Market-Reports/high-potency-api-market-36582475.html