Specialty Generics Market Size, Share & Trends Analysis Report By Type (Injectables, Oral Drugs), By Application (Oncology, Inflammatory Conditions, Hepatitis C), By End-use (Specialty, Retail), By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global specialty generics market size was valued at USD 67.2 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 9.2% from 2022 to 2030. The increasing adoption of specialty generic medicines for the treatment of complex chronic diseases such as hepatitis C and their increasing prevalence is a key driver for the market. According to the World Health Organization (WHO) report 2022, globally around 58 million people have chronic hepatitis C virus infection, and about 1.5 million people are affected by this infection annually. Age is a major risk factor for the rising prevalence of complex chronic diseases such as arthritis, cardiovascular diseases, and cancer due to weak immunity and high comorbid conditions.

According to the World Health Organization (WHO), the geriatric population increased from 1 billion in 2020 to 1.4 billion in 2021. By 2030, one in six people in the world will be aged 60 years and above. Hence, the rapidly growing geriatric population is expected to create lucrative growth opportunities in the industry. Major pharmaceutical companies have undertaken mergers and acquisitions, to gain a higher market share. In October 2021, BioCena acquired a Pfizer-owned Australian plant for manufacturing drug therapies. In addition, in 2020, BioCena completed the acquisition of Pfizer Inc., owned by Hospira Adelaide. It is a leading supplier of 200 specialty generic injectables in the U.S. Such strategic initiatives are anticipated to drive market growth during the forecast period.

However, brand familiarity and loyalty, high complex nature of specialty generic products, and low profitability are some of the major entry barriers for new players in the industry that lead to rising in drug prices. For instance, Teva Pharmaceutical Industries Ltd. offered smart co-pay cards to Multiple Sclerosis (MS) patients for buying COPAXONE for their treatment. Eligible cardholders get drugs at zero cost. Such programs attract buyers' attention to their branded products and thereby, negatively impact the sales of specialty generic products.

Type Insights

The injectables segment dominated the market for specialty generics and accounted for the largest revenue share of 60.6% in 2021. The dominance of the injectables segment can be attributed to the benefits associated with injectables like long-term effects and immediate absorption, thus leading to higher patient compliance and acceptability. Furthermore, the injectables segment is also expected to witness the fastest growth during the forecast period owing to increasing product approval and higher market penetration. For instance, in September 2021, Dr. Reddy's Laboratories in partnership with Natco Pharma launched a generic version of Revlimid, Nat-lenalidomide, and Reddy-lenalidomide approved by Health Canada for the treatment of patients with myelodysplastic syndrome and multiple myeloma in Canada. This approval provides easy access to low-cost specialty generic drugs to cancer patients, thereby increasing the prescription rate.

Application Insights

The inflammatory conditions segment dominated the market for specialty generics and accounted for the largest revenue share of 27.3% in 2021 due to the increased prevalence of inflammatory conditions like rheumatoid arthritis. According to a Global RA Network estimate, around 350 million people live with arthritis worldwide. In addition, according to the NHS, more than 10 million people are suffering from arthritis. Hence, the rise in the prevalence of inflammatory conditions has paved the way for key players to enhance their market share in this sector.

The oncology segment is expected to witness significant growth during the assessment period owing to a rise in the disease burden of cancer and ANDA product approvals such as generic Xtandi (Enzalutamide) for treating castration-resistant prostate cancer in May 2021. According to Globocan, the number of new cancer cases is anticipated to reach 28.4 million within the next two decades, with a rise of 47% from 2020, owing to the adoption of the western lifestyle, and high consumption of alcohol, smoking, poor diet choices, and physical inactivity. The growing number of cancer cases is projected to propel the demand for specialty generics.

End-use Insights

The specialty pharmacy segment dominated the market for specialty generics and accounted for the largest revenue share of 76.5% in 2021. The market is expected to witness lucrative growth during the forecast period. Major specialty generic manufacturers and insurance providers choose specialty pharmacies for the distribution of products due to negligible distribution costs and easy access to medicines. According to Drug Channels Institute’s report 2021, CVS specialty, Accredo, Optum specialty pharmacy, Walgreens stores, and Humana specialty pharmacy counted as the world’s top five specialty pharmacies.

Furthermore, the low cost associated with specialty generic drug inventory offers a great return on investment on medicines compared to branded products. Factors like timely delivery, optimizing patient access, and effective distribution management of specialty pharmacies attract buyer attention to specialty pharmacy and contributes to segment growth.

Regional Insights

North America dominated the specialty generics market and accounted for the largest revenue share of 36.5% in 2021 owing to the presence of supportive regulatory policies regarding the approval of new products. The U.S. FDA has undertaken several initiatives to smoothen the overall approval process. Thus, the U.S. FDA introduced Generic Drug User Fee Amendments (GDUFA) under the Hatch-Waxman act to quicken the delivery of safe and effective low-cost generic drugs to the public. As a result, the key manufacturers are constantly making efforts for the commercialization of specialty generic drugs in the market. For instance, in June 2022, Amneal Pharmaceuticals Inc. launched LYVISPAH (baclofen), a specialty product approved by the U.S. FDA for the indication of multiple sclerosis and other spinal cord disorders.

In Asia Pacific, the market for specialty generics is estimated to grow fast during the projection period. The growth of the region is mainly driven by high unmet low-cost medicine needs and the launch of new generic drugs in the region. In 2021, BDR Pharma launched a generic version of Midostaurin with the brand name MSTARIN for the treatment of rare cancers like Acute Myeloid Leukemia (AML).

Key Companies & Market Share Insights

Regional expansion of product portfolio and service offerings is a key strategy adopted by players in the market. In June 2020, Sun Pharmaceutical Industries Ltd. and Hikma Pharmaceuticals PLC signed an exclusive licensing and distribution agreement for Ilumya in the MEA region for the treatment of moderate to severe plaque psoriasis. This agreement offers low-cost and equally effective specialty generic medicines to people with unmet treatment needs. Some of the prominent players in the specialty generics market include:

• Teva Pharmaceuticals Industries Ltd.

• Viatris Inc.

• Novartis AG (Sandoz International GmbH)

• Hikma Pharmaceuticals PLC

• Mallinckrodt

• Bausch Health Companies Inc. (Valeant Pharmaceuticals International, Inc.)

• Dr. Reddy’s Laboratories Ltd.

• Endo Pharmaceuticals Inc.

• Apotex Corp.

• Sun Pharmaceutical Industries Ltd.

• Fresenius Kabi Brasil Ltd.

• STADA Arzneimittel AG

Specialty Generics Market Report Scope

Global Specialty Generics Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global specialty generics market report on the basis of type, application, end-use, and region:

• Type Outlook (Revenue, USD Billion, 2018 - 2030)

  • Injectables

  • Oral drugs

  • Others

• Application Outlook (Revenue, USD Billion, 2018 - 2030)

  • Oncology

  • Inflammatory conditions

  • Multiple sclerosis

  • Hepatitis C

  • Others

• End-use Outlook (Revenue, USD Billion, 2018 - 2030)

  • Specialty Pharmacy

  • Retail Pharmacy

  • Hospital Pharmacy

• Regional Outlook (Revenue, USD Billion, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE