U.S. Specialty Injectable Generics Market Analysis By Therapeutic Use (Oncology, Cardiovascular, Central Nervous System, Infectious Diseases, Autoimmune Disorders), And Segment Forecasts, 2018 - 2025

Industry Insights

The U.S. specialty injectable generics market size was valued at USD 8.05 billion in 2016 and is expected to witness a lucrative CAGR of 14.9% over the forecast period. Increase in the prevalence of target diseases, such as cancer, hepatitis C, multiple sclerosis, and others, has resulted in high demand for specialty generic drugs. In addition, rise in the number of patent expirations of blockbuster medication is expected to boost the market. Patents of branded drugs are anticipated to expire in the coming years, and this is expected to create opportunities for injectable generics.

Some of the major patent expirations in 2017 are Eloxatin, Alimta, Norditropin, and Remodulin. Rising incidence of conditions, such as rheumatoid arthritis, osteoporosis, and infectious diseases, is also a key factor contributing to growth. The market is consistently growing due to introduction of favorable healthcare reforms by the U.S. government and the presence of well-developed healthcare facilities in the country.

Spending on specialty medication has increased in the past decade to growing availability of generics in the market. Branded drug manufacturers collaborate with that of the generics to temporarily handle drug shortage and boost their profit margins. Mergers and acquisitions by prominent generic manufacturers are predominantly driving this market.

Midsized to smaller companies are seeking to commercialize products in new markets by collaborating with companies. For instance, in September 2014, Hikma Pharmaceuticals PLC acquired the generic injectables manufacturing business of Ben Venue Laboratories, Inc. to expand its R&D and strengthen its product pipeline.

New product launches and growing demand for advanced therapeutics are also among major factors driving growth. In the past few years, focus of pharmaceutical firms has shifted from branded drugs owing to decline in sales revenue due to patent expiration and loss of exclusivity. An increasing number of patents are expiring due to which they are expected to face competition from generic versions in the coming years. During the forecast period, approximately 72 patents are expected to expire in the U.S.

Therapeutic Use Insights

In 2016, oncology accounted for the largest share of the therapeutic use segment and is expected to maintain its dominance during the forecast period. This can be attributed to a significant rise in the prevalence of various cancers, such as melanoma, leukemia, colon, breast, lung, &prostate cancers. New product launches and growing demand for advanced therapeutics in oncology are major factors driving the growth of this segment.

An increasing number of physicians are adopting specialty injectable generics due to their associated benefits, such as relatively higher efficacy compared to conventional routes of administration. The largest share attained by this segment is also due to a significant upsurge in patent expiration of blockbuster drugs used for cancer treatment. For instance, the generic version of Clolar (clofarabine injection), which is used for treatment of acute lymphoblastic leukemia, was approved by FDA in May 2017.

Central Nervous System (CNS) is expected to grow at a lucrative rate owing to limited availability of cost-efficient alternatives for the treatment of neurological disorders. Also, consistent efforts by prominent pharmaceutical companies to expand their CNS product portfolio are creating opportunities for the growth of this segment. For example, in 2014, Pfizer acquired InnoPharma, Inc., a generic injectables manufacturer specializing in the development of injectables for the treatment of cancer and CNS disorders. Currently, a limited number of specialty injectable generics are available for the treatment of CNS disorders. However, this segment is expected to exhibit lucrative growth due to high long-term costs associated with branded versions.

The cardiovascular segment is anticipated to grow at a constant rate over the coming years due to the wide gap between demand and supply of generic injectables for the treatment of major cardiovascular diseases. There are untapped growth opportunities as patents of high selling branded injectables are set to expire, which is likely to fuel the market during the forecast period. According to the Centers for Disease Control and Prevention (CDC), approximately 610,000 deaths occur in the U.S. every year due to cardiovascular diseases.

Shortage of supply and urgency to decrease spending on cardiovascular drugs are factors encouraging generics influx in this area. Payers have implemented stringent utilization guidelines and restrictions on approximately 80% of initial prescriptions on cardiovascular disease medications, thereby creating opportunities.

Competitive Insights

Some of the key players are Pfizer, Inc.; Fresenius SE & Co. KGaA; Mylan N.V.; Teva Pharmaceutical Industries Ltd.; and Hikma Pharmaceuticals PLC. Extensive expansion strategies, new product launches, and mergers &acquisitions are anticipated to propel growth. The aforementioned has resulted in high competition as it is fragmented.

The competition is also driven by mergers and acquisitions by prominent generic drug manufacturers. To sustain growth, generic manufacturers establish partnerships and employ strategies for acquiring license to launch new products and commercialize patent expired drugs. This is anticipated to boost sales in the coming years. For instance, in September 2015, Pfizer acquired Hospira to expand its product portfolio of generic injectables.

In this dynamic scenario, even major pharma players have started creating divisions for specialty injectables. For instance, in May 2014, Hikma Pharmaceuticals acquired the U.S. generic injectables business of Bedford Laboratories to expand its product pipeline and strengthen its R&D.

Report Scope

Segments covered in the report

This report forecasts revenue growth in the U.S. and provides analysis on industry trends in each of the sub-segments from 2014 to 2025. For purpose of this study, Grand View Research has segmented U.S. specialty injectable generics market on the basis of therapeutic use:

• Therapeutic Use Outlook (Revenue, USD Million, 2014 - 2025)

  • Oncology

  • Cardiovascular

  • CNS

  • Infectious Diseases

  • Autoimmune Disorders

  • Others