Active Pharmaceutical Ingredient Market Dynamics:

DRIVER: Adoption of organ on chip models in drug development

Despite massive investments in pharma R&D, there has been a direct decrease in the annual number of new FDA-approved drugs—almost directly proportional to the increase in R&D spending. To curb the high cost of drug development, there is a growing need to develop predictive tissue models using human cells to determine drug efficacy and safety in advance of clinical testing

In this regard, the organ-on-a-chip technology is expected to fill the gaps in drug screening by offering predictive human tissue models. This technology has the potential to revolutionize the pharmaceutical industry by making drug development faster, cheaper, and successful. Thus, the adoption of organ-on-chip models in drug development is considered as a positive indicator of the growth of the APIs market.

RESTRAINT:  Unfavourable drug price control policy

Over the last few years, there has been a gradual increase in the regulation of pharmaceutical drug prices globally. The US is a major unregulated market; however, several prominent countries have regulated drug prices. Governments induce price controls to limit spending on pharmaceuticals. However, regulated drug prices mostly result in revenue losses to pharmaceutical companies. These revenue losses lead to a reduction in global R&D spending, which results in fewer new molecular entities (NMEs) being developed per annum

Such price control policies that reduce pharmaceutical revenues may provide modest relief to individual purchasers; however, they pose risks to long-term innovation in the pharmaceutical industry. For instance, the National Pharmaceutical Pricing Authority (NPPA) of India enforced the Drugs Price Control Order (DPCO) Act in 2013, which empowered it to fix a ceiling on the retail price of drugs. Since then, the list of drugs under price control has steadily expanded from 74 in 1995 to nearly 860 by 2019.

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Key Players:

The global active pharmaceutical ingredients market is highly consolidated. Prominent players in the active pharmaceutical ingredients market include Pfizer Inc. (US), Novartis International AG (Switzerland), Merck & Co. (US), Teva Pharmaceutical Industries Ltd. (Israel), Mylan N.V. (US), Boehringer Ingelheim (Germany), F. Hoffmann-La Roche AG (Switzerland), Sanofi (France), AbbVie (US), Eli Lilly and Company (US), AstraZeneca (UK), Bristol-Myers Squibb (US), and GlaxoSmithKline plc (UK).

Growth Strategies Adopted by Them:

Geographic expansions and collaborations are the key growth strategies undertaken by these companies to maintain their positions in the market.

CSL (Australia) is one of the prominent players in the active pharmaceutical ingredients market in 2019. With distribution channels in over 35 countries and 230 plasma collection centers, CSL has established itself as a significant player in the active pharmaceutical ingredients market. The company provides plasma-derived products for acute and chronic conditions such as hemophilia, Von Willebrand disease, and primary immune deficiencies.

Apart from North America, the company has a strong presence in Europe, Australia, and Asia. Its distribution network is spread across 30 countries with major facilities in Australia, Germany, Switzerland, and the US. This helps the company to ensure its products are available across the globe.

Grifols (Spain) is a leading manufacturer in active pharmaceutical ingredients market. Grifols is a global healthcare company specializing in the development, manufacture, and distribution of plasma-derived products. The company focusses on research and product innovation by investing heavily in R&D, as well as partnering with research institutes for the development of advanced plasma-derived products to fight rare diseases. For instance, in 2018, the company received FDA approval for HyperRAB rabies immune globulin (human) for rabies post-exposure prophylaxis, GamaSTAN immune globulin (human) for hepatitis A virus (HAV), and measles post-exposure prophylaxis, among others. The company also constantly focuses on the expansion of its plasma collection centers and increasing its capacity. It has more than 190 centers in the US and 35 in Europe.

Pfizer is one of the leading players in the APIs market. The leading position of the company is majorly attributed to its exhaustive product portfolio. The company has a strong brand image, which gives it a competitive edge over other players. In order to remain competitive and strengthen its market position, the company primarily focuses on adopting both organic and inorganic growth strategies such as agreements, partnerships, collaborations, product approvals, and acquisitions. In accordance with this, in July 2019, Pfizer acquired Array BioPharma Inc. (US), a clinical-stage pharmaceutical company that focuses on oncology medication.

Novartis is among the leading players in the APIs market. Its leading position can be attributed to its strong brand recognition and robust product portfolio. In order to maintain its leading position, the company invests a significant amount of its revenue in R&D activities. In 2019, the company invested 19.8% of its total revenue (USD 47.45 billion) in R&D. This significant investment in R&D enables the company to launch innovative and technologically advanced products in the market.

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Bristol-Myers Squibb is a prominent player in the APIs market and holds expertise in the area of pharmaceutical ingredients. The company has a broad product portfolio in biologics, which serves as an important factor for its future growth, especially in the biopharmaceuticals market. The company invested USD 6.15 billion, USD 6.33 billion, and USD 6.47 billion in R&D activities in 2019, 2018, and 2017, respectively. In order to maintain its leadership position in the market, the company focuses on growth strategies such as partnerships and expansions.. The company also focuses on collaborations, agreements, acquisitions, and approvals in order to meet the rising market demand for APIs. For instance, in July 2019, Bristol-Myers Squibb acquired Celgene Corporation, a company that offers therapies for the treatment of cancer and inflammatory diseases.

Boehringer Ingelheim is one of the leading player in the global APIs market. Boehringer Ingelheim’s leading position in the APIs market can be attributed to its exhaustive product portfolio. The company is focused on developing innovative therapies to prolong patient’s lives. Its Prescription Medicines segment is engaged in the development and launch of APIs. In order to remain competitive and further strengthen its market position, the company adopts and implements organic and inorganic growth strategies, such as agreements, partnerships, approvals, alliances, and collaborations. In accordance with this, in January 2020, Boehringer Ingelheim collaborated with Enleofen Bio (Singapore) to develop therapies for a broad range of fibro-inflammatory diseases.

Sanofi is one of the top players in the global APIs market. The leading position of the company is majorly attributed to its exhaustive product portfolio. The company manufactures API’s through its Sanofi Active Ingredient Solutions portfolio, which provides custom synthesis and API contract manufacturing services. The company pursues various growth strategies to strengthen its position in the APIs market. For instance, In January 2018, Sanofi collaborated with Alnylam Pharmaceuticals, Inc. (US) to develop potential new products for the treatment of rare genetic diseases.