The global High Potency API Contract Manufacturing Market garnered a market value of USD 8 Billion in 2022 and is expected to accumulate a market value of USD 16 Billion by registering a CAGR of 7% in the forecast period 2022 to 2032.Because of the rising frequency of cancer cases globally, the usage of HPAPIs is increasing, which is driving the market.
Furthermore, the government is sponsoring therapeutic substance development and research, which is expected to fuel the growth of the high-potency API contract manufacturing market. As a result of the high investment funds required for manufacturing and production facilities, contract product manufacturing is being used. During the forecast period, this will drive the global market.
Increasing demand for pharmaceuticals, a greater emphasis on precision medicine and high-potency APIs, and technological developments in high-potency API production are some of the reasons driving market expansion.
The International Agency for Research on Cancer (IARC) has revised GLOBOCAN 2020 with new cancer burden projections, predicting that the cancer burden would increase to 19.3 million cases and 10 million cancer deaths in 2020. According to this new study, more than 50 million individuals will be diagnosed with cancer within the next five years. The utilization of high-potency API in various medicinal regimens is also contributing to market expansion.
For example, in 2020, the USA Center for Drug Evaluation and Research (CDER) authorized novel medicines for several malignancies, including lung, thyroid, and breast cancer. Small and big API molecules were used in these treatments. These medications' major ingredients are high-potency APIs. With an increasing number of cancer cases, the market for cancer treatment will expand in tandem.
| Data Points | Key Statistics |
|---|---|
| Estimated Base Year Value (2021) | USD 6.5 Billion |
| Expected Market Value (2022) | USD 8 Billion |
| Anticipated Forecast Value (2032) | USD 16 Billion |
| Projected Growth Rate (2022 to 2032) | 7% CAGR |
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The global demand for high potency API contract manufacturing is projected to increase at a CAGR of 7% during the forecast period between 2022 and 2032, reaching a total of USD 16 Billion in 2032, according to a report from Future Market Insights (FMI). From 2017 to 2021, sales witnessed significant growth, registering a CAGR of 5%.
The increased demand for outsourcing HPAPI manufacture, as well as a robust pipeline of targeted therapeutic medications, is projected to drive the growth of the market. However, the concentration of technological expertise in the hands of a few significant companies, as well as the absence of uniform regulatory regulations and standards, are expected to drive the growth of the market.
Other factors driving market expansion include rising demand for antibody-drug conjugates and cancer treatments. Furthermore, the approval of government regulations for the development and manufacture of innovative medicine is expected to boost market growth throughout the forecast period.
Patent Expiration of Blockbuster Drugs to Open New Growth Frontiers
The expiration of patents and subsequent launch of generic versions is a major boon for pharmaceutical businesses to extend their product portfolios and enter attractive market niches in this technology-driven industry.
Several biosimilars have been authorized in Europe, however, the US FDA has only approved one biosimilar yet. Increased research and development operations, as well as ongoing attempts to replicate branded biological medications, would pave the way for the introduction of cost-effective therapeutic options.
Several blockbuster pharmaceuticals are projected to lose their patent protection in the near future, opening up significant prospects in the biosimilar industry. Some of the key medications that will go off patent in the near future are Avastin (bevacizumab), Herceptin (trastuzumab), Synagis (palivizumab), Erbitux (cetuximab), Humira (adalimumab), Remicade (infliximab), and Rituxan (rituximab).
Growing need for Outsourcing HPAPI Manufacturing, as well as a robust pipeline of Targeted Therapeutic Medications
Pharmaceutical firms were hesitant to outsource the production of high-potency APIs; hence the vast bulk of production remained captive or in-house. The fear of patent violation was a major motivator. However, when pharmaceutical businesses began to grow geographically, they began to run out of HPAPIs.
Furthermore, rising medication development and commercialization costs increased the financial strain. With the evolving regulatory and legal environment, outsourcing has proven to be the best alternative for HPAPI manufacture.
The concentration of Technical Expertise across a handful of Players is causing Market Disruption
Manufacturing high-potency APIs is capital-demanding and needs specialized technical know-how; this has been a key obstacle for new players seeking to enter the lucrative HPAPI business. There are now just a few large companies that have established their own capabilities through mergers, acquisitions, collaborations, and Research and Development (R&D).
A host of Medicines in the Pipeline to bolster prospects for API Contract Manufacturing
The Asia Pacific region is predicted to develop at the quickest rate throughout the projection period. The expanding spectrum of prospects, particularly in Japan, China, and India, can be linked to the expansion.
Factors like as a better regulatory environment, a large potential for cost reductions, enhanced risk management skills, and a healthy medication pipeline are projected to boost the region's growth in the coming years. Furthermore, the availability of qualified labor at cheaper prices than in established nations such as the United States is expected to accelerate regional market growth.
Rising Incidence of Illnesses such as Cancer and Neurological Problems to Accelerate Market Growth
During the projection period, North America is likely to have a large market share, estimated at around 38% by 2022-end. With the incidence of illnesses such as cancer and neurological problems, the United States was the most impacted country in the world. As the incidence of these illnesses rises, so will the region's output of HPAPIs.
HPAPIs are frequently employed in cancer and other major diseases therapeutic, drug development, and other research activities. As a result, the demand for the same will be substantially larger in the North American area, where the patient population is growing faster than in other countries. Because of its growing elderly population and increased prevalence and incidence of infectious illnesses, North America is likely to dominate the high-potency APIs/HPAPI market.
Chronic disorders, such as cancer, are also prevalent in the United States. According to the American Cancer Society journal's 2020 report, there will be an estimated 1.8 million new cancer cases diagnosed and 606,520 cancer deaths in 2020.
According to the Parkinson's Foundation's 2020 estimates, around 1 million individuals in the United States have Parkinson's disease, which is greater than the total number of persons diagnosed with muscular dystrophy, multiple sclerosis, and Amyotrophic Lateral Sclerosis. By 2030, this figure is predicted to rise to 1.2 million.
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Oncology to be a promising Field for High Potency API Contract Manufacturing
According to Future Market Insights, major developments are expected to happen in the oncology segment with regard to high-potency API contract manufacturing. The rising number of cancer cases worldwide is the primary driver of this market. For example,
The Cancer Atlas predicts that there will be 29 million cancer diagnoses by 2040, up from over 18 million in 2018. Furthermore, unlike traditional, systemic treatments, some new cancer medicines in development are exceedingly precise.
Antibody-drug conjugates, which can have occupational exposure levels, and monoclonal antibodies coupled with small molecule cytotoxic chemicals are examples of such targeted HPAPIs. Because of the fast increase of cancer targets, the fraction of HPAPI applications in the therapeutic pipeline is rapidly growing. As per the report, oncology likely accounts for over 63% of all high-potency API contract manufacturing operations.
Demand for Injectables to witness a Steady Incline in Forthcoming Years
The global industry has been subdivided into Injectables, oral solids, lotions, and others based on dosage forms. In 2021, the injectable dosage form sector led the worldwide industry, comprising over 50% of global revenues.
The category is expected to grow at a stable CAGR, maintaining its dominance throughout the projected years. The speedy delivery of HPAPI to the intended area can be credited to the segment's rise. They can be administered subcutaneously (in the fat layer), intradermally (between the layers of skin), or intramuscularly (in the muscle).
Key players in the High Potency API Contract Manufacturing market are Piramal Pharma Solutions, Lonza, Catalent, Inc., VxP Pharma, Inc., Pfizer CentreOne, Gentec Pharmaceutical Group, AbbVie, Aurigene Pharmaceutical Services Ltd., CordenPharma International, and Curia Global, Inc.
Recent Developments:
| Report Attribute | Details |
|---|---|
| Market Value in 2022 | USD 8 Billion |
| Market Value in 2032 | USD 16 Billion |
| Growth Rate | CAGR of 7% from 2022 to 2032 |
| Base Year for Estimation | 2021 |
| Historical Data | 2017 to 2021 |
| Forecast Period | 2022 to 2032 |
| Quantitative Units | Revenue in USD Billion and CAGR from 2022 to 2032 |
| Report Coverage | Revenue Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends, and Pricing Analysis |
| Segments Covered | Product Type, Application, Dosage Form, Synthesis, Region |
| Regions Covered | North America; Latin America; Europe; Asia Pacific; South Asia; East Asia; Oceania; Middle East & Africa |
| Key Countries Profiled | The USA, Canada, Brazil, Mexico, Germany, The United Kingdom, France, Spain, Italy, China, Japan, South Korea, India, Malaysia, Singapore, Thailand, Australia, New Zealand, GCC, South Africa, Israel |
| Key Companies Profiled | Piramal Pharma Solutions; Lonza; Catalent, Inc.; VxP Pharma, Inc.; Pfizer CentreOne; Gentec Pharmaceutical Group; AbbVie; Aurigene Pharmaceutical Services Ltd.; CordenPharma International; Curia Global, Inc. |
| Customization | Available Upon Request |
FMI projects the global High Potency API Contract Manufacturing market to expand at a 7% value CAGR by 2032
The global high potency API contract manufacturing market is estimated at a market value of USD 8 Billion
The global High Potency API Contract Manufacturing market is expected to garner a market value of USD 16 Billion
Piramal Pharma Solutions, Lonza, Catalent, Inc., VxP Pharma, Inc., Pfizer CentreOne, Gentec Pharmaceutical Group, AbbVie, Aurigene Pharmaceutical Services Ltd., CordenPharma International and Curia Global, Inc., are some prominent High Potency API Contract Manufacturing manufacturers.
The oncology segment is expected to hold the largest market share for High Potency API Contract Manufacturing in the forecast period 2022 to 2032.
| Expected Market Value in 2024 | USD 2,118.60 million |
|---|---|
| Projected Forecast Value in 2034 | USD 4,052.30 million |
| Anticipated CAGR (2024 to 2034) | 6.70% |
| Market Value for 2024 | USD 760.8 million |
|---|---|
| Market Size for 2034 | USD 12,980.0 million |
| Market CAGR (2024 to 2034) | 32.8% |
| Expected Market Value (2023) | USD 8653.0 million |
|---|---|
| Anticipated Forecast Value (2033) | USD 12002.3 million |
| Projected CAGR (2023 to 2033) | 3.3% |
| Expected Market Value (2023) | USD 6.1 Billion |
|---|---|
| Anticipated Forecast Value (2033) | USD 72.6 Billion |
| Projected Growth Rate (2023 to 2033) | 28.1% |
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High Potency API Contract Manufacturing Market
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