The global specialty generics market size was estimated at USD 30.0 billion in 2016. Rise in prevalence of chronic diseases, such as cancer, multiple sclerosis, hepatitis C, and others, has led to high demand for specialty generic drugs. According to American Cancer Society, in the U.S., around 1,688,780 new cancer cases are estimated to be diagnosed in 2017. It also estimated that 13.0% of all cases diagnosed in people aged 20 years and above are rare types of cancer. Thus, growing prevalence of chronic diseases is considered as one of the high impact rendering drivers boosting the demand for specialty generic medicines.
Many specialty medicines are facing patent expiration, giving rise to opportunities for generic medicines. Loss of patent protection of these drugs greatly impacts the pharmaceutical industry. Some of the major patent losses of specialty drugs in the year 2017 are Gleevec, Copaxone, Velcade, Sustiva, Sandostatin LAR, and Viread. Imatinib is the generic name for Gleevec/Glivec, and some major players including Teva Pharmaceutical Ltd., Sun Pharmaceutical Industries Ltd., Mylan N.V., and Apotex Corp. have received FDA approval for it.
Germany specialty generics market by type, 2014 - 2025 (USD billion)
Healthcare costs have risen due to expensive pharmaceuticals; therefore, governments all over the world are emphasizing on synthesis of cost-effective drugs. The U.S. is the highest spending country with regards to healthcare, and has recently begun emphasizing on cutting healthcare expenditure. Similarly, price regulations in Japan and downsizing of healthcare budget in India have raised demands for cost containment in health care systems. Current financial & economic crisis and the presence of a significant aging population are some of the key reasons for imposition of cost containment in healthcare systems. This emphasizes the need for developing new, improved, and cost-effective methods for synthesis of specialty generics. The abovementioned factor is expected to bring down healthcare expenditure and boost the market.
Specific guidelines for development and manufacturing of generic specialty medicines have been laid down by various regulatory authorities, such as FDA and European Medicines Agency (EMA). Specialty generic drugs are approved by the authorities under Abbreviated New Drug Applications (ANDAs). These regulations are established to maintain the safety profile and effectiveness of a proposed drugs. According to FDA and other regulatory authorities, the specialty generic drug manufacturer must prove that an active ingredient in the generic drug is the same as that in the branded drug, and this should be reviewed by FDA.
In 2016, the injectables segment accounted for the largest market share because of several advantages, such as quick absorption, long duration of action, and immediate dose distribution. The rise in prevalence of chronic diseases such as inflammatory conditions, multiple sclerosis, and cancer is also expected to drive the demand for injectables.
According to Multiple Sclerosis Foundation 2015 statistics, nearly 400,000 in the U.S. and 2.5 million people across the world suffered from multiple sclerosis. Every year, around 10,000 new cases of this disease are diagnosed, as stated by MultipleSclerosis.net. Thus, increase in number of multiple sclerosis cases has led to huge demand for specialty generic drugs. Teva Pharmaceuticals Ltd. ventured into management of multiple sclerosis by launching Copaxone (glatiramer acetate).
The injectables segment is expected to grow at the fastest rate during the forecast period because of growing adoption of self-administered injectables by patients. The leading players such as Pfizer, Inc.; Sun Pharma; and Teva are undertaking various strategic initiatives, such as acquisitions and new product launches, to gain higher share in the injectables market. For instance, in September 2015, Pfizer, Inc. completed the acquisition of Hospira, Inc for USD 17 billion. After acquisition, Pfizer has access to Hospira’s injectable drugs, infusion technologies, and biosimilars business.
The oral drug segment is expected to exhibit lucrative growth over the study period due to rising incidence of arthritis, inflammatory conditions, and cancer. The demand for these products, such as Gleevec and Tarceva, is rising because patients can self-administer the drugs instead of visiting a healthcare provider for an infusion or injection.
In 2016, oncology segment dominated the overall market in terms of revenue. Increased incidence of cancer, such as breast cancer, prostate cancer, melanoma, colon cancer, lung cancer, and leukemia, has led to rise in demand for generic specialty medicines across the globe. According to International Agency for Research on Cancer (IARC), globally, around 14.1 million new cases of cancer were diagnosed in 2012, and this number is projected to reach about 21.7 million by 2030.
As compared to developed countries, death rate due to cancer is higher in underdeveloped and developing countries. The high cost of cancer treatment and drugs as well as inaccessibility to advanced healthcare infrastructure in these countries are some of the foremost factors accountable for high mortality rate. Thus, there is huge demand for low-cost generics that are highly effective and less expensive compared to branded drugs.
The inflammatory conditions segment is expected to grow at lucrative rate during the forecast period due to rise in incidence of asthma, tuberculosis, rheumatoid arthritis, and Crohn's disease. According to CDC, around 54.4 million people in the U.S. had some form of arthritis, lupus, gout, or fibromyalgia during the year 2013 to 2015.
There are several leading vendors, including Teva Pharmaceuticals USA; Novartis; Pfizer, Inc.; Mylan N.V.; and Sun Pharmaceutical Industries Ltd., that provide advanced oral therapeutics for treatment of such chronic diseases. For instance, in September 2016, Teva Pharmaceutical Industries Ltd. launched the generic version of Epzicom1 (abacavir and lamivudine) tablets, 600 mg/300 mg in the U.S.
Japan specialty generics market share, by application, 2016 (%)
In 2016, specialty pharmacy held the largest revenue share in the overall market as these specialty medicines are highly complex, costly, and need to be handled very carefully. Thus, these drugs are specifically distributed by manufacturers through these pharmacies. Some of the major pharmacies are CVS Health, Express Scripts Holding Company, and Diplomat Pharmacy, Inc.
Furthermore, increase in focus on improvement of healthcare infrastructure in developing countries of Asia Pacific and African regions is expected to accelerate the growth of the segment. Rising healthcare awareness and availability of innovative therapeutics for treatment of various chronic diseases are projected to propel the segment growth.
Retail pharmacy held the second largest share in the end-use segment in 2016, and it is expected to grow at significant rate during the forecast period. The significant share can be attributed to high accessibility to retail stores and affordability. The affordability is a result of reimbursement on prescription prices that encourages patients to rely on retail pharmacies.
Hospital pharmacy held a significant market share due to increase in number of admissions of patients suffering from cancer, multiple sclerosis, inflammatory conditions, and hepatitis C. Specialty generics are used for various treatments such as chemotherapy. Thus, there is rise in demand for these drugs for treatment of admitted patients, which is anticipated to drive the segment growth.
North America dominated the market with the largest revenue share due to favorable healthcare reforms by the government and well-developed healthcare facilities in this region. Furthermore, healthcare organizations, such as WHO, are extensively involved in formulating policies, such as the National Cancer Control Programmes, and they are anticipated to widen the growth potential in this region.
Europe was the second largest market for specialty generic drugs due to high demand for advanced therapeutics for chronic diseases. In addition, strong distribution network of leading players, including Teva Pharmaceuticals USA, Inc.; Sandoz International GmbH; Mylan N.V.; Mallinckrodt; and Pfizer, Inc., supports growth. Moreover, highly developed healthcare infrastructure, especially in Germany, UK, Switzerland, and France, is projected to drive the regional market.
The Asia Pacific market is expected to grow at the highest rate during the forecast period. The market is driven by rise in prevalence of chronic diseases as well as high demand for cost-effective generic drugs. In addition, rise in disposable income, which increases the probability of usage of specialty generics, and continual upgradation of healthcare infrastructure are presumed to provide the market with high potential growth opportunities over the forecast period.
The specialty generic drugs market is fragmented with a large number of local and global players. Some of the leading companies in the industry are Mylan N.V.; Teva Pharmaceuticals USA, Inc.; Sandoz International GmbH; Mallinckrodt; Akorn, Inc.; Valeant Pharmaceuticals International, Inc.; Endo Pharmaceuticals, Inc.; Pfizer, Inc.; Sun Pharmaceutical Industries Ltd.; and Apotex Corp.
The major players are involved in mergers & acquisitions, strategic collaborations, and new product launches to gain higher revenue share in the industry. Mergers, acquisitions, and strategic collaborations help companies expand their businesses and geographical reach. For instance, in October 2016, Teva Pharmaceutical Industries Ltd. announced that it acquired Anda, Inc., a generic pharmaceuticals distributor in the U.S., from Allergan with an aim of providing access to generic drugs across the country.
Also, in November 2016, Mylan N.V. entered into an agreement with Medicines Patent Pool (MPP) with an aim of facilitating access to chronic hepatitis C drugs in developing regions. This agreement provides license to Mylan for producing a generic version of Bristol-Myers Squibb Company's Daklinza (daclatasvir) tablets, 30 mg and 60 mg, and distributing to 112 low- and middle-income countries.
Base year for estimation
Actual estimates/Historical data
2014 - 2016
2017 - 2025
Revenue in USD Billion & CAGR from 2017 to 2025
North America, Europe, Asia Pacific, Latin America, & MEA
U.S., Canada, UK, Germany, France, Italy, Spain, Japan, India, China, Brazil, Mexico, South Africa, Saudi Arabia
Revenue forecast, company share, competitive landscape, growth factors, and trends
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Segments covered in the report
This report forecasts revenue growth at global, regional, & country levels and provides analysis on the industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research, Inc. has segmented the global specialty generic drugs market on the basis of type, application, end use, and region:
Type Outlook (Revenue, USD Billion; 2014 - 2025)
Application Outlook (Revenue, USD Billion; 2014 - 2025)
End-use Outlook (Revenue, USD Billion; 2014 - 2025)
Regional Outlook (Revenue, USD Billion; 2014 - 2025)
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