Global Active Pharmaceutical Ingredient (API) Market Struggling to Overcome Patent Expiry of Leading Drugs

An active pharmaceutical ingredient(API) is a substance or substance combination in a drug that is biologically active. It is the central ingredient that has a direct effect on the prevention or cure of a disease. While APIs form the active component present in a drug, excipients are the inactive ones.

According to a report by Transparency Market Research, the global market for active pharmaceutical ingredients is anticipated to grow from a value of US$119.7 bn in 2013 to US$185.9 bn in 2020, registering a modest 6.50% CAGR from 2014 to 2020. Even though the overall pharmaceutical industry has been severely hit by the patent expiry of blockbuster drugs over the past few years, the market for active pharmaceutical ingredients is fueled by the need for low-cost substitutes and growing presence of generic medicine manufacturers in emerging economies.

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While the increase in abbreviated new drug applications (ANDA) and in drug master file (DMF) filing from Indian companies has boosted the demand for active pharmaceutical ingredients in the recent past, strict European Union and USFDA regulatory policies have been restraining the growth of the market.

Several API Manufacturers in India under FDA Scanner

Over the past couple of months, a number of Indian active pharmaceutical ingredient manufacturers have come under fire. While some have been issued warning letters by the U.S. Food and Drug Administration (FDA), others have been banned from sending products to the U.S.

This month, leading Indian pharmaceutical company Dr Reddy’s Laboratories received a warning letter from the FDA over quality issues at three of its facilities manufacturing oncology medicines and pharmaceutical raw material. Concerns over inadequate quality control measures were raised regarding two active pharmaceutical ingredient factories, one in Telangana and another in Andhra Pradesh.

Last month, the Nashik, Maharashtra site of Indian API manufacturer Megafine Pharma was banned from sending products to the U.S., citing manipulation of lab tests and unrecorded and unjustified deviations from written lab mechanisms. The site produces 24 active pharmaceutical ingredients for the U.S. market, including drugs for the treatment of depression, Alzheimer’s disease, multiple sclerosis, schizophrenia, and overactive bladders.

Using Marijuana as Active Pharmaceutical Ingredient to Treat Head Injuries

Biopharmaceutical company Kannalife Sciences Inc. based in Huntington, New York made news last year after announcing an R&D plan to study the use of cannabinoid therapeutics to treat chronic traumatic encephalopathy (CTE), a regenerative disease that affects people who have suffered repeated head injuries. The company has been working on a feasibility study for a product that it hopes would treat concussions with the help of marijuana as an active pharmaceutical ingredient.

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It was only recently announced that Bennet Omalu would be joining the scientific advisory board of Kannalife Sciences and will be involved in overlooking the clinical tracking protocols for the study. It was Omalu who conducted the autopsy on a former NFL player, which led to the discovery of CTE.

Minimum Growth Opportunities for SMEs in Active Pharmaceutical Ingredients Market due to High Initial Investment

An active pharmaceutical ingredient (API) is the basic ingredient used in the manufacturing of drugs or any formulation that has positive therapeutic and pharmacological effects. They are substances synthesized either biotechnologically or through chemical methods. Active pharmaceutical ingredients provide several health benefits and are not limited to curing or treating the disease, but are also used for prevention and diagnosis at times. 

As per a recent market study led by Transparency Market Research, the global active pharmaceutical ingredients market is anticipated to grow rapidly in the coming years. The market, which stood at US$119.7 billion in 2013, is expected to reach US$185.9 billion by the end of 2020. From 2014 to 2020, the market will register a CAGR of 6.5% due to the development in biogeneric drugs and increase in Abbreviated New Drug Applications (ANDA) in the recent past. 

However, quality control is the prime factor when it comes to manufacturing essential drugs. The global market has therefore only a limited number of manufacturers that have their own API manufacturing capabilities for producing pharmaceutical products. 

Browse Market Research Report of Active Pharmaceutical Ingredients (API) Market: 

http://www.transparencymarketresearch.com/active-pharmaceutical-ingredients.html

Small and Medium-sized Firms in Major Countries Encounter Challenges

The two major restraints for manufacturers in the global API market are price volatility and limited resources to produce high-quality active pharmaceutical ingredients. A majority of the small to medium-sized manufacturers and suppliers in major regions such as North America, Europe, and Sub-Saharan Africa have to purchase all APIs in the open market. 

The API markets in Europe and North America are highly competitive and fragmented in nature when it comes to the presence of small and medium-sized firms. However, all API suppliers are facing major challenges in these regions due to the low number of new chemical entity launches, pharmaceutical mergers and acquisitions, as well as the lack of capability differentiation in the global market. 

API costs are extremely high, since the raw materials for the same are rare and are obtained at high prices. The price of APIs is considered to be the primary restraint because its production requires substantial investment in chemical manufacturing technologies. Thus, small manufacturers in emerging countries need to navigate across the global active pharmaceutical ingredients market and look out for major manufacturers just to make sure that they get a good product at a fair price.   

Browse Press Release of Active Pharmaceutical Ingredients Market: 

http://www.transparencymarketresearch.com/pressrelease/active-pharmaceutical-ingredients.htm

While generic API production is practiced in only a limited number of countries, Chinese and Indian companies are increasingly becoming the major suppliers of active pharmaceutical ingredients. While generic API production is practiced in only a limited number of countries, Chinese and Indian companies are increasingly becoming the major suppliers for production of active pharmaceutical ingredients. Some of the successful major producers in the active pharmaceutical ingredients market such as Teva Pharmaceutical Industries Ltd., Mylan, Inc., Novartis AG, and Pfizer, Inc. are now gradually shifting from the West and establishing new production bases in India and China.