Specialty Generics Market is segmented By Indication (Oncology, Inflammatory conditions, Autoimmune Diseases, Infectious Diseases, Others), By Route of Administration (Oral, Injectable, Others), By Distribution Channel (Hospital Pharmacy, Pharmacy Stores, Other), By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031
Specialty Generics Market Overview
Specialty Generics Market is predicted to reach at a high CAGR 9.1% during the forecast period (2024-2031). Specialty generics are generic versions of specialty drugs, once they get off-patent. Specialty generics are the generic versions of specialty pharmaceutical products. They are cost-effective when compared with specialty pharmaceuticals. Specialty generics include biopharmaceuticals, blood derived products and complex molecules. Several blockbuster specialty drug molecules are coming off patent in the coming years.
Specialty Generics Market Summary
Metrics |
Details |
Market CAGR |
9.1% |
Segments Covered |
By Indication, By Route of Administration, By istribution Channel, and By Region |
Report Insights Covered |
Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, and Other key insights. |
Fastest Growing Region |
Asia Pacific |
Largest Market Share |
North America |
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Specialty Generics Market Dynamics
Specialty generics growth is driven by the rising research and development (R&D) activities to create new and innovative formulations that offer more efficient and cost-effective options as compared to their branded counterparts are the factors responsible for the growth of this market. Moreover, the rising demand for improved healthcare infrastructure are expected to drive the market.
The cost effectness of these medicines is expected to drive the market growth
Development of cost-effective drugs to treat oncology, multiple sclerosis and other infectious diseases can create significant opportunities for the specialty generics manufacturers. For instance, a patient has to spend around US$ 72,000 annually to treat multiple sclerosis conditions by using copaxone (Glatiramer). However, Novartis developed generic version of copaxone that costs only US$ 63,000. Hence, many insurance companies are showing interest to reimburse the specialty generics owing to their low cost.
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 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. Thus the cost effectness of these medicines is also driving its market growth in the forecast period.
The increasing prevalence rate of of chronic diseases, is expected to drive the growth in the forecast period
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 the 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 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.
Cancer, for instance leads to one in every six deaths across the globe and is the second leading cause of death. Increase in risk factors such as excessive drinking and smoking and exposure to growing levels of indoor and outdoor pollution are set to help the market chart a higher growth curve.
Presence of branded as well as cheaper generic version drugs is likely to hinder the market growth
However, presence of branded as well as cheaper generic version is expected to restrain its global market in the forecast period.
COVID-19 Impact Analysis on Specialty Generics Market
The impact Covid-19 has created in China and the lockdown in India, United States, and other countries, further increases the chances of shoot up in the cost of raw materials and drugs. 13% of the brand and generic manufacturers are based out of China and according to the FDA, as of 2018, 24% of medicines and 31% of medical ingredients were imported from India. The profit for these types of drugs is very marginal and the supply chain is lean. The API plant for these are often overseas with India and China dominating the API market. The API may be manufactured in a single plant and each stage holds very little inventory. The problem at any stage can cause drug shortage with the average drug shortage lasting for 14 months and there are cases where it has lasted for 3 years even. According to a recent survey, specialty generics drugs mostly get affected due to shortage. It is believed that the shortage might not occur for now as companies have stocks at least for the next 5 months.
Specialty Generics Market Segmentation Analysis
Oncology segment is expected to grow at the fastest CAGR during the forecast period (2024-2031).
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 the 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 a 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 a lucrative rate during the forecast period due to rise in the incidence of asthma, tuberculosis, rheumatoid arthritis, and Crohn's disease. According to the CDC, around 54.4 million people in the U.S. had some form of arthritis, lupus, gout, or fibromyalgia during the year 2013. These factors are driving the market growth in the forecast period.
The hospital pharmacy are expected to dominate the Specialty Generics market during the forecast period
The hospital pharmacies held the largest share in the Specialty Generics market. This is mainly owing to increasing number of patients suffering from conditions which are treated in hospitals equipped with advanced infrastructure and adequate facilities. Moreover, growing number of hospitals along with adequate reimbursement policies is also contributing to the growth of this segment.
Specialty Generics Market Geographical Share
North America region holds the largest market share global specialty generics
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 Programs, and they are anticipated to widen the growth potential in this region. In addition, strong distribution network of leading players supports growth. Moreover, highly developed healthcare infrastructure is projected to drive the regional market.
Specialty Generics Companies and Competitive Landscape
The specialty generics market is moderately competitive with presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include 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. among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the specialty generics globally.