High Performance Active Pharmaceutical Ingredients (HPAPI) Market

High Performance Active Pharmaceutical Ingredients (HPAPI) market size is forecast to reach US$741.2 million by 2027, after growing at a CAGR of 6.7% during 2022-2027. HPAPI is the pharmaceutical compound used to treat different diseases such as cancer, hormonal imbalances, and respiratory disorders, among others. Dexamethasone diluent is widely used to treat arthritis, intestinal, skin, thyroid, blood, and kidney disorders among others. Liquid chromatography is an analytical technique utilized in the pharmaceutical industry to separate a certain sample into individual components. The rapid growth in population along with the increasing incidence of chronic diseases are some of the major factors driving the market growth during the forecast period. Favorable government policies for API production and advancements in active pharmaceutical ingredient (API) manufacturing is also supporting the market growth during the forecast period 2022-2027. Rising drug research and development activities for drug manufacturing, along with the increasing usage of biopharmaceuticals are propelling the market growth. However, unfavorable drug price control policies across various countries and high manufacturing costs are likely to hamper the market growth during the forecast period.

COVID-19 Impact

The COVID-19 pandemic is impacting different industries; one of the few industries that were largely hit to some extent was the pharma industry. The pharma industry has some positive impacts compared to other industries. The pharma sales and production increased during the covid-19 pandemic. The disruption of logistical services and lack of workforce impacted the market negatively during the covid-19 crises. Coronavirus outbreak has disrupted business and economic activities globally in the first and second quarter of 2020 and is expected to have a short-term impact on the active pharmaceutical ingredients.

Report Coverage

The report: “High Performance Active Pharmaceutical Ingredients (HPAPI) Market - Forecast (2022-2027)” covers an in-depth analysis of the following segments of the High Performance Active Pharmaceutical Ingredients (HPAPI) industry.

By Type of Ingredient: Synthetic, and Biological [Monoclonal Antibodies, Recombinant Proteins, Fusion Proteins, Therapeutic Enzymes, Others].

By Type of Drugs: Innovative, Generic, and Biosimilar

By Type of Manufacturer: Captive HPAPIs and Merchant HPAPIs

By Application: Oncology, Anti-diabetic, Cardiovascular, Hormonal, Musculoskeletal, Glaucoma, Neurology, Orthopedic, Pulmonology, Pain management, and Others

By Geography: North America (USA, Canada, and Mexico), Europe (UK, Germany, Italy, France, Netherlands, Belgium, Spain, Denmark, and Rest of Europe), Asia-Pacific (China, Japan, South Korea, India, Australia, and New Zeeland, Indonesia, Taiwan, Malaysia, and Rest of APAC), South America (Brazil, Argentina, Colombia, Chile, and Rest of South America), and Rest of the World (Middle East and Africa)

Key Takeaways

The Asia Pacific is expected to register the highest CAGR of 8.1% during the forecast period (2022-2027) owing to the increasing healthcare expenditure in developing economies such as India, and China.

The Indian pharmaceutical industry has achieved tremendous growth over the past few decades and has been involved in supplying generic drugs globally. India’s API industry is ranked the third-largest in the world.

The manufacturers are involved in developing advanced drugs for different diseases. Investments in research and developments to enhance the capabilities of high-performance active pharmaceutical ingredients (HPAPI) are supporting the market growth.

The synthetic segment accounted for approximately 65% of the market share in 2020 and is estimated to grow at a significant CAGR during the forecast period. The higher availability of raw materials and easier protocols for the synthesis of synthetic APIs are supporting the segment growth. Synthetic chemical API is also known as small molecules. Approximately 3,000 small molecule drugs are available in the market space, which provides significant business growth for synthetic HPAPI production. The biological segment is expected to register a high growth rate during the forecast period. The higher efficiency of biological molecules and growing demand for biopharmaceuticals are driving market growth. The growing investments in biotechnology and biopharmaceutical sectors are also boosting the market growth.

The innovative drugs segment accounted for more than 50% of the market share in 2020 and is expected to hold a significant market share during the forecast period due to the increasing R&D initiatives for novel drug development. Increased FDA approvals for new molecular entities, along with increased focus by major companies to develop innovatively API drugs are the major driving factors supporting the market demand. The generic drug segment also holds a significant share and is expected to grow at a CAGR of 7.3% during the forecast period due to the growing consumption of generic drugs in developing nations. The generic drugs are available at a low cost compared to other drugs in the market.

The cardiovascular and oncology segment accounted for more than 30% of the market share in 2020 and is estimated to grow significantly during the forecast period 2022-2027. The increasing demand for highly potent APIs (HPAPIs) for the treatment of cancer is one of the major factors driving the market growth during the forecast period. The changing lifestyle along with the growing prevalence of cancer is driving the market for the oncology segment. According to the European Society of Cardiology 2019 analysis, cardiovascular diseases (CVD) is one of the leading causes of mortality and a major cause of morbidity in the European region. The hormone segment is expected to grow at a significant growth rate between 2022-2027. The increasing adoption of a sedentary lifestyle is driving the prevalence of various metabolic and hormonal disorders. Hormonal imbalance is a majorly growing concern in most countries.

North America region held a significant share in the high-performance active pharmaceutical ingredients (HPAPI) market in 2020 up to 31%, owing to the presence of leading API manufacturers such as Pfizer Inc., and Merck & Co among others in the region. The presence of developed nations such as the USA, and Canada is driving the market growth in the region. The growing prevalence of cardiovascular-related problems is driving the market growth in the region. The Asia Pacific region is expected to register a significant growth rate during the forecast period (2022-2027). The increasing government focus on generic drugs and rising demand for biologics and specialty drugs are supporting regional growth. In March 2020, the Indian Government has announced a package of INR 9,940 crore for the bulk drugs industry to boost domestic production and exports. China is specialized in the production of APIs and intermediates such as penicillins, vitamins, antipyretic, analgesics, and statins among others.

High Performance Active Pharmaceutical Ingredients (HPAPI) Market Drivers:

Increasing incidence of chronic diseases

The growing incidence of chronic diseases such as diabetes, cancer, coronary artery disease, arthritis, chronic obstructive pulmonary disease (COPD), hepatitis, and asthma among others are driving the market. According to the data published by International Diabetes Federation, approximately 463 million people worldwide were diagnosed with diabetes in 2019. Cardiovascular, urology, and neurology diseases have become the most dominant cause of mortality and morbidity in the world during the last three decades. Cancer has a major impact in the United States and across the world. According to the National Cancer Institute, approximately 1,806,590 new cases of cancer are diagnosed in the United States and more than 606,520 people died from cancer. Based on the statics published by WHO, Cancer causes 20% of deaths in the European Region and about 3 million new cases and 1.7 million deaths are registered each year in the region.

Increasing demand for biopharmaceuticals

Biopharmaceuticals are known as biologic medical products or pharmaceutical drugs extracted from biological sources. Biopharmaceutical products include monoclonal antibodies, recombinant growth factors, purified proteins, recombinant proteins, vaccines, synthetic immunomodulators, and cell and gene therapies among others. Currently, the world is depending on vaccines to fight against Covid-19. The HPAPI also finds its usage in developing biopharmaceutical products. According to the data published by World Data about 20.7% of the world, the population has received at least one dose of covid-19 vaccine. Approximately 2.4 billion doses are administrated globally and about 33 million doses are given every day. According to the data published by the centers for disease control and prevention report, more than 2.8 million antibiotic-resistant infections occur in the U.S. each year, and more than 35,000 people die each year. In March 2020, Thermo Fisher Scientific Inc. company invested USD 475 million as a biopharma investment to expand its drug product developments in biologics, cell, and gene therapy.

High Performance Active Pharmaceutical Ingredients (HPAPI) Market Challenges:

High manufacturing Cost High Performance Active Pharmaceutical Ingredients (HPAPI)

The high manufacturing and processing cost of HPAPIs is one of the major challenges faced by manufacturers. The companies should make costly investments for improvements in their manufacturing facilities to meet the standards such as the cGMP. The companies should follow qualification requirements and processes, and safety tests to meet the requirements of regulatory authorities. Furthermore, the company's need to spend huge amounts for obtaining regulatory approvals is relatively higher for pharmaceutical firms. The chemical synthesis of HPAPIs requires expensive and uncommon building blocks and raw materials, which further increase the manufacturing cost.

High Performance Active Pharmaceutical Ingredients (HPAPI) Market Landscape

Technology launches, acquisitions, and R&D activities are key strategies adopted by players in the High-Performance Active Pharmaceutical Ingredients (HPAPI) market. Major players in the High-Performance Active Pharmaceutical Ingredients (HPAPI) market are Bristol-Myers Squibb, Novartis, Sanofi Aventis, Pfizer, Lonza, Novasep, Hospira, BASF, Merck, Bayer, Teva Pharmaceuticals, Boehringer Ingelheim, and others.

Acquisitions/Technology Launches

In April 2021, Novartis company has signed an agreement with Roche for the production of the active pharmaceutical ingredient (API) for Roche’s Actemra/RoActemra® (tocilizumab), a treatment for rheumatoid arthritis which is also being tested in various clinical trials investigating the safety and efficacy in COVID-19 associated pneumonia

In 2019, Lonza expanded its HPAPI production capacity at Switzerland facility after entering into a long-term manufacturing agreement with AstraZeneca.


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