Generic injectable drugs are those which have same active ingredient as innovator drug and is equivalent to its innovator drug in dosage form, safety, strength (dose), route of administration, performance, quality, and intended use. Some of the world’s largest manufacturers of sterile generic injectable have been making these drugs for over 80 years. Unlike branded sterile injectable drugs, generic injectable is cost-effective, especially cancer therapies, thus government in the majority of the countries are influencing to adopt generic injectable, in order to control healthcare spending. For instance, the global pharmaceutical industry is experiencing serious pricing issue and cost reduction pressure. e.g. North America pharmaceutical industry is growing at a sluggish rate of below 2% CAGR. A growth rate in Japan and Europe has seen never before decrease in drug prices.
This, in turn, is impeding policy changes and encouraging use of generic injectable drugs in these key regions. Globally, a large number of generic drug makers are focusing on plant upgrades for an increase in captive manufacturing of sterile generic injectable drugs. Moreover, infamous regulatory delays in approval of sterile injectable drugs have contributed to the higher inclination towards investments in manufacturing of sterile generic injectable drugs in order to ensure higher quality. The average time period for regulatory approval for sterile drugs is over three to four years, however, that for bioequivalent sterile injectable is around 10-11 months. Faster regulatory approvals, low R&D investment, and the high margin are attracting manufacturers to invest in the generic injectable manufacturing.
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Generic Injectable Market: Drivers and Restraints
The global pharmaceutical industry is toning itself to fundamental changes in the marketplace and looking for new ways to achieve growth. Along with increasing efforts for manufacturing of sterile generic injectable, growing number of prescriptions for generic injectable is pushing the growth of the global generic injectable market. According to GPhA Conference report, 90% of injectable prescriptions in the U.S. in 2015 were for generic injectable, which is primarily driven by unprecedented series of patent expiration. Rapid expansion by key market players is another factor driving the growth of the global generic injectable market. Shortage of branded sterile injectable has further led to the adoption of generic injectable. Due to the complexity of manufacturing and stringency in the process, production of sterile injectable drugs is challenging and. This is causing frequent drug recalls due to safety issues. This can limit the growth of the global generic injectable market.
Generic Injectable Market: Segmentation
The global generic injectable market has been classified on the basis of product type, indication, distribution channel, and geography.
Based on product type, the global generic injectable market is divided into following:
- Monoclonal Antibodies
Based on an indication, the global generic injectable market is divided into following:
- Cardiovascular Diseases
Based on the disease type, the global generic injectable market is divided into following:
- Hospital Pharmacy
- Retail Pharmacy
- Drug Stores
- Online Prescription Stores
Generic Injectable Market: Overview
According to fact sheet published by Hospira Inc., approximately 1.5 Bn doses of generic injectable are sold every year across the globe. Monoclonal antibodies being the largest revenue generating segment, will continue to dominate the global generic injectable market over the forecast period. Other cluster consists of include opioid analgesics, general and local anesthetics, antidotes for opioid poisoning, skeletal muscle relaxants etc. Cancer and cardiovascular diseases indication segments are expected to represent highest growth opportunities over the forecast period due to the launch of several antibodies based generic injectable products.
Generic Injectable Market: Regional Overview
Geographically, the global generic injectable market is classified into regions viz. North America, Latin America, Western Europe, Eastern Europe, Asia-Pacific, Japan, Middle East and Africa. North America holds the largest share in the global generic injectable market. Even though the generic injectable industry has operations across the globe, majority of largest manufacturers produce a large volume of generic injectable in the U.S. However, overseas manufacturing facilities of these manufacturers are subject to same stringent FDA regulations and facilities are inspected on regular basis. Moreover, in the U.S. over 70% of hospital patients receive generic injectable drugs, which is further pushing the demand for generic injectable in North America. Asia Pacific is expected to experience the highest increase in production volumes of generic injectable over the forecast period of 2017–2027. Countries such as China and India have growing pharmaceutical industry of their own. According to the latest report published by PwC, India is the global leader in the production of generics and vaccines. However, Europe is expected to experience sluggish growth due to an economic slowdown.
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Generic Injectable Market: Key Players
Some of the key players identified in the global generic injectable market are Pfizer Inc.(Hospira Inc. Pfizer Established Products), Baxter International, Sanofi SA, Novartis AG (Sandoz), GlaxoSmithKline plc., AstraZeneca plc., Fresenius SE & Co. KGaA, Johnson & Johnson, Novo Nordisk A/S, Amgen Inc., Bristol-Myers Squibb Company etc. among others. Majority of these companies have independent subsidiaries that operate in a sterile injectable manufacturing. Consolidation through acquisition and partnerships are emerging as prominent trends in the global generic injectable market. A rapid expansion of emerging players such as Amneal Pharmaceuticals, Endo International plc. Alvogen, ANI Pharmaceuticals Inc. etc. among others would significantly contribute to the growth of the global generic injectable market.