Global Active Pharmaceutical Ingredients CDMO Market by Product (Highly Potent API, Antibody Drug Conjugate) and Region (North America, Latin America, Europe, Asia Pacific and Middle East & Africa), Forecast To 2028

Summary of the Report

Global active pharmaceutical ingredients CDMO market was valued at USD 81.6 million in 2020. It is projected to grow at a compound annual rate (CAGR of 6.7%) between 2021 and 2028. This growth can be attributed mainly to increased drug R&D and rising incidences of chronic diseases. It is also due to the growing importance of generics and the increasing use of biopharmaceuticals.

Over the past two decades, pharma companies have increased the amount of development, discovery, and manufacturing work that they outsource. The biopharma industry is not the only one that feels the need to outsource. Many small HTML3_ biotechnology HTML3_ companies rely on a Contract Development and Manufacturing Organization to produce their products through the pipeline.

COVID-19 had a significant effect on the supply chain for the Active Pharmaceutical Ingredient (API), leading to some disruption in terms raw material supply, availability, shipping delays and costs. According to the Institute for Supply Management's February 2020 survey, approximately 75.0% of respondents experienced disruptions in their supply chains as a result COVID-19. More than 44.0% didn't have a plan for dealing with supply chain disruption from China.

CDMOs have proven to be an extremely valuable tool for the pharmaceutical and biotech industry. They offer potential capabilities and cost savings that are superior to in-house manufacturing. There is a strong link between corporate size, outsourcing and general. SME's (small and medium-sized) businesses have fewer stakeholders and organizational hurdles, which allows for more fluid decision making.

Additionally, active pharmaceutical ingredient manufacturing activities are being undertaken by more than 3200 companies. Even though they are complementary businesses, only one-third (33%) of these companies are connected to a corporate group with finished dose production capabilities. This results in a lack integration.

Product Insights

Traditional active pharmaceutical ingredients dominated the market, accounting for 40.5% of the total revenue in 2020. In 2020, the 29.5% revenue share for highly potent APIs was the largest. This growth is driven primarily by the rising demand for targeted treatments and other treatments. The growth is also due to technological advancements and manufacturer investments. Most HPAPIs are used for the development of anticancer medicines. Most HPAPIs are small molecules at the moment. But, there are more powerful compounds emerging at an increasing rate.

Over the forecast period, the antibody-drug combinationate market is expected to grow at 12.3%. ADC R&D is expected to experience a 12.3% growth rate over the forecast period due to the effectiveness of Antibody Drug Conjugates and checkpoint inhibitors against cancer. R&D in the ADC biopharmaceuticals industry has seen a significant rise in research into new uses for ADCs. This includes the use of ADCs in combination therapies for cancer therapy as well as the application of ADCs to treat other types of diseases.

Synthesis Insights

In 2020, the largest revenue share was 73.2% for the synthetic segment of the active pharmaceutical ingredient market CDMO. This is due to increased availability of raw materials as well as the ease at which these molecules can be synthesized. In the next few years, many synthetic molecules will also be off-patent. This is expected to increase growth.

Biotech is expected to experience the fastest growth rate at 6.9% during the forecast period. Segment growth is being driven by factors such as a rising demand for biopharmaceuticals, and higher molecular efficacy. The segment's growth could also be explained by large investments in biotechnology and biopharmaceutical. The market for active pharmaceutical ingredients is small in biotech active pharmaceutical ingredients. Biotech active pharmaceutical ingredients have a positive outlook due to the rapid growth of the biopharmaceutical sector and increasing use of biotech drug.

Drug Insights

In 2020, the largest revenue share was 74.6% for the innovative drugs segment in the active pharmaceutical ingredients CDMO market. Segment growth is due to increased FDA approvals of new molecular entities, high costs of innovative active pharmaceutical components relative to generic pharmaceuticals and a greater focus on R&D. As a result extensive research on this topic, many unique molecules are in the pipeline and will be launched in the forecast period.

The segment of generic drugs is expected to experience the fastest CAGR at 8.5% over the forecast period. This is due to the expiration of patents and cost-effectiveness. Due to the increasing number of patents due to expire, the generic sector is expanding. The U.S. FDA estimates that approximately 158 patents on drugs will expire in 2021. This presents a huge market opportunity for generic pharmaceuticals. 44 of the 156 patents would be available to generic pharmaceutical manufacturers. Many firms are now focusing on Hanmil Pharmaceuticals' Amosartan hypertension drugs and Amlopidine, which expire in March 2021. Around 30 companies currently distribute Amosartan generics.

Application Insights

Oncology dominated active pharmaceutical ingredients CDMO market and held the largest revenue share at 35.1% in 2020. Oncology is the dominant market in terms of sales and accounted for just one-eighth percent of pharmaceutical revenue in 2017. It is predicted that it will grow by more than six percent in the next five years and gain a market share of over a third of all industry revenues by 2024. A significant portion of the growth in biologics industry is driven by cancer therapies, and also the Highly Potent API sub-sector.

In 2020, the market for active pharmaceutical ingredient CDMO was 7.0% and the glaucoma segment had the highest revenue share. This segment is expected to see the fastest CAGR at 7.0% over the forecast period. This can be attributed to rising diabetes prevalence, growing elderly population and increased healthcare spending. Brinzolamide Ophthalmic Suspension (Phentolamine Mesylate), Nyxol (Phentolamine Mesylate), Ripasudil Hydrochloride Hydrate hydrate are some of the potential drugs in the Glaucoma pipeline. While some of these drugs are in their final clinical development stages, others are still being developed.

Workflow insights

Based on workflow, commercial was the most active segment in the market for active pharmaceutical ingredient CDMO. It accounted for the largest share of revenue at 88.0% for 2020. This is due to the large revenue generated from commercial active pharmaceutical ingredient production, which accounts for 63.0% commercial CDMO revenues. APIs have a larger market share than the drug's production process.

In the market for active pharmaceutical ingredient CDMO, the clinical segment will see the fastest CAGR at 7.1% during the forecast period. This can be largely attributed to the record number of molecules in all stages of preclinical and clinical research, as well increased R&D spending. The CDMO-pharmacy industry relationship has the greatest impact on the value of the late phase clinical research.

Regional Insights

Asia Pacific was the dominant market for active pharmaceutical ingredients CDMOs and held the largest revenue share at 46.4% in 2020. This segment is expected to grow at 8.9% annually over the forecast period. Factors that dominate the CDMO market for active pharmaceutical ingredients in the region include the significantly lower manufacturing costs compared to North America, Europe, and favorable laws in China and India. China and India are now important suppliers of active pharmaceutical ingredients manufacturing services. However, the U.S. remains the main outsourcing hub for pharmaceutical research. This is due to a combination of enormous amounts of financing and a unique concentration of university-affiliated pharmaceutical research hubs.

Indian API market growth is influenced by the increasing importance of traditional medications and the rapid increase in persistent infections. Generic APIs are shipped from India to the developed world, representing 41.6% of India's total sales and 24.7% in China. The Chemical Pharmaceutical Generic Association Research shows that India is the second largest supplier of generic active pharmaceutical ingredients to America, accounting for 24.4%. It is also increasing its supply to Western Europe which makes up 19.2% of the total region's supply. Recent research shows that China is responsible for 30% of the nonexclusive global API vendor market. The top producers of nonexclusive APIs are India and the United States. India is now a major outsourcing hub for active pharmaceutical ingredients.

Market Share Insights & Key Companies

The key market players are taking various strategic initiatives, such as the signing a new partnership agreement, collaborations and mergers and acquisitions. They also aim to expand their geographic reach, strengthen their services and increase their manufacturing capabilities, giving them a competitive edge.

Corden Pharma, for instance, announced in October 2020 that it had developed a powerful API laboratory at its Boulder, Colorado facility. Customers will now be able to use the laboratory which can handle extremely strong chemicals and has an OEL of 1ng/m3.

Companies are trying to make vaccines and medications to combat the COVID-19 pandemic. After the rush to enroll candidates in clinical trials, the industry shifted its focus to manufacturing capacity acquisition, with multiple agreements being signed with CDMO's. Moderna, for example, contracted Lonza, a Swiss CDMO, to develop the active pharmaceutical component of its mRNA-1273 vaccination vaccine. AstraZeneca and Oxford University hired Novasep in June to produce the active ingredient for AZD1222, a COVID-19 vaccine. The following are some of the major players in the active pharmaceutical ingredient CDMO market:

• Cambrex

• Recipharm

• Thermo Fisher Pantheon

• Corden Pharma

• Samsung Biologics

• Lonza

• Catalent

• Siegfried

• Piramal Pharma Solutions

• Boehringer Ingelheim

Up Market Research published a new report titled “Active Pharmaceutical Ingredients CDMO Market research report which is segmented by Product (Highly Potent API, Antibody Drug Conjugate), By Players/Companies Recipharm, Corden Pharma, Catalent, Lonza, Piramal Pharma Solutions, Boehringer Ingelheim, Samsung Biologics, Thermo Fisher Pantheon, Cambrex, Siegfried”. As per the study the market is expected to grow at a CAGR of XX% in the forecast period.

Report Scope

The report covers comprehensive data on emerging trends, market drivers, growth opportunities, and restraints that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include products, applications, and competitor analysis.

Global Active Pharmaceutical Ingredients CDMO Market Report Segments:

The market is segmented by Product (Highly Potent API, Antibody Drug Conjugate).

Active Pharmaceutical Ingredients CDMO Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report.

Key Benefits for Industry Participants & Stakeholders:

• Industry drivers, restraints, and opportunities covered in the study
• Neutral perspective on the market performance
• Recent industry trends and developments
• Competitive landscape & strategies of key players
• Potential & niche segments and regions exhibiting promising growth covered
• Historical, current, and projected market size, in terms of value
• In-depth analysis of the Active Pharmaceutical Ingredients CDMO Market

Overview of the regional outlook of the Active Pharmaceutical Ingredients CDMO Market:

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa (MEA). North America region is further bifurcated into countries such as U.S., and Canada. The Europe region is further categorized into U.K., France, Germany, Italy, Spain, Russia, and Rest of Europe. Asia Pacific is further segmented into China, Japan, South Korea, India, Australia, South East Asia, and Rest of Asia Pacific. Latin America region is further segmented into Brazil, Mexico, and Rest of Latin America, and the MEA region is further divided into GCC, Turkey, South Africa, and Rest of MEA.

Highlights of The Active Pharmaceutical Ingredients CDMO Market Report:

1. The market structure and projections for the coming years.
2. Drivers, restraints, opportunities, and current trends of Active Pharmaceutical Ingredients CDMO Market.
3. Historical data and forecast.
4. Estimations for the forecast period 2028.
5. Developments and trends in the market.

                1. Highly Potent API

                2. Antibody Drug Conjugate

7. Market scenario by region, sub-region, and country.
8. Market share of the market players, company profiles, product specifications, SWOT analysis, and competitive landscape.
9. Analysis regarding upstream raw materials, downstream demand, and current market dynamics.
10. Government Policies, Macro & Micro economic factors are also included in the report.

We have studied the Active Pharmaceutical Ingredients CDMO Market in 360 degrees via. both primary & secondary research methodologies. This helped us in building an understanding of the current market dynamics, supply-demand gap, pricing trends, product preferences, consumer patterns & so on. The findings were further validated through primary research with industry experts & opinion leaders across countries. The data is further compiled & validated through various market estimation & data validation methodologies. Further, we also have our in-house data forecasting model to predict market growth up to 2028.

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Reasons to Purchase the Active Pharmaceutical Ingredients CDMO Market Report:

• The report includes a plethora of information such as market dynamics scenario and opportunities during the forecast period
• Segments and sub-segments include quantitative, qualitative, value (USD Million,) and volume (Units Million) data.
• Regional, sub-regional, and country level data includes the demand and supply forces along with their influence on the market.
• The competitive landscape comprises share of key players, new developments, and strategies in the last three years.
• Comprehensive companies offering products, relevant financial information, recent developments, SWOT analysis, and strategies by these players.